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HIV Overview

HIV/AIDS: The Basics

Key Points

 HIV is the virus that causes HIV infection. AIDS is the most advanced stage of HIV infection.  HIV is spread through contact with the blood, semen, pre-seminal fluid, rectal fluids, vaginal fluids, or breast milk of a person with HIV. In the United States, HIV is spread mainly by having anal or vaginal sex or sharing drug injection equipment with a person who has HIV.  Antiretroviral therapy (ART) is the use of HIV medicines to treat HIV infection. People on ART take a combination of HIV medicines (called an HIV regimen) every day.  ART can’t cure HIV infection, but it can help people with HIV live longer, healthier lives. HIV medicines can also reduce the risk of transmission of HIV.

What is HIV/AIDS?

HIV stands for human immunodeficiency virus, which is the virus that causes HIV infection. The abbreviation “HIV” can refer to the virus or to HIV infection.

AIDS stands for acquired immunodeficiency syndrome. AIDS is the most advanced stage of HIV infection.

HIV attacks and destroys the infection-fighting CD4 cells of the immune system. The loss of CD4 cells makes it difficult for the body to fight infections and certain cancers. Without treatment, HIV can gradually destroy the immune system and advance to AIDS. 2

How is HIV spread?

HIV is spread through contact with certain body fluids from a person with HIV. These body fluids include:

 Blood  Semen 3

 Pre-seminal fluid  Vaginal fluids  Rectal fluids  Breast milk

The spread of HIV from person to person is called HIV transmission. The spread of HIV from a woman with HIV to her child during pregnancy, childbirth, or breastfeeding is called mother-to-child transmission of HIV.

In the United States, HIV is spread mainly by having sex with or sharing drug injection equipment with someone who has HIV. To reduce your risk of HIV infection, use condoms correctly and consistently during sex, limit your number of sexual partners, and never share drug injection equipment.

Mother-to-child transmission is the most common way that children become infected with HIV. HIV medicines, given to women with HIV during pregnancy and childbirth and to their babies after birth, reduce the risk of mother-to-child transmission of HIV.

You can’t get HIV by shaking hands or hugging a person who has HIV. You also can’t get HIV from contact with objects such as dishes, toilet seats, or doorknobs used by a person with HIV. HIV does not spread through the air or through mosquito, tick, or other insect bites.

What is the treatment for HIV?

Antiretroviral therapy (ART) is the use of HIV medicines to treat HIV infection. People on ART take a combination of HIV medicines (called an HIV regimen) every day. (HIV medicines are often called antiretrovirals or ARVs.)

ART prevents HIV from multiplying and reduces the amount of HIV in the body. Having less HIV in the body protects the immune system and prevents HIV infection from advancing to AIDS.

ART can’t cure HIV, but it can help people with HIV live longer, healthier lives. ART also reduces the risk of HIV transmission. 4

What are the symptoms of HIV/AIDS?

Within 2 to 4 weeks after a person becomes infected with HIV, they may have flu-like symptoms, such as fever, chills, or rash. The symptoms may last for a few weeks after they become infected.

After this earliest stage of HIV infection, HIV continues to multiply but at very low levels. More severe symptoms of HIV infection, such as signs of opportunistic infections, generally don’t appear for many years. (Opportunistic infections are infections and infection-related cancers that occur more frequently or are more severe in people with weakened immune systems than in people with healthy immune systems.)

Without treatment with HIV medicines, HIV infection usually advances to AIDS in 10 years or longer, though it may take less time for some people.

HIV transmission is possible at any stage of HIV infection—even if a person with HIV has no symptoms of HIV.

How is AIDS diagnosed?

The following criteria are used to determine if a person with HIV has AIDS:

 The person’s immune system is severely damaged, as indicated by a CD4 count of less than 200 cells/mm3. A CD4 count measures the number of CD4 cells in a sample of blood. The CD4 count of a healthy person ranges from 500 to 1,600 cells/mm3. AND/OR  The person has developed certain opportunistic infections.  Where can I learn more about HIV/AIDS?  How Is HIV Transmitted? from HIV.gov  HIV 101 from the Centers for Disease Control and Prevention (CDC)  This fact sheet is based on information from the following sources:  From CDC: HIV Basics 5

 From the National Institute of Allergy and Infectious Diseases (NIAID): HIV/AIDS

The HIV Life Cycle

Key Points

 HIV gradually destroys the immune system by attacking and killing a type of white blood cell called a CD4 cell. CD4 cells play a major role in protecting the body from infection.  HIV uses the machinery of the CD4 cells to multiply (make copies of itself) and spread throughout the body. This process, which is carried out in seven steps or stages, is called the HIV life cycle. HIV medicines protect the immune system by blocking HIV at different stages of the HIV life cycle.  Antiretroviral therapy or ART is the use of HIV medicines to treat HIV infection. People on ART take a combination of HIV medicines from at least two different HIV drug classes every day. Because each class of drugs is designed to target a specific step in the HIV life cycle, ART is very effective at preventing HIV from multiplying. ART also reduces the risk of HIV drug resistance.  ART can’t cure HIV, but HIV medicines help people with HIV live longer, healthier lives. ART also reduces the risk of HIV transmission (the spread of HIV to others).

HIV attacks and destroys the CD4 cells of the immune system. CD4 cells are a type of white blood cell that play a major role in protecting the body from infection. HIV uses the machinery of the CD4 cells to multiply (make copies of itself) and spread throughout the body. This process, which is carried out in seven steps or stages, is called the HIV life cycle.

What is the connection between the HIV life cycle and HIV medicines?

Antiretroviral therapy (ART) is the use of HIV medicines to treat HIV infection. HIV medicines protect the immune system by blocking HIV at different stages of the HIV life cycle.

HIV medicines are grouped into different drug classes according to how they fight HIV. Each class of drugs is designed to target a specific step in the HIV life cycle. 6

ART combines HIV medicines from at least two different HIV drug classes, making it very effective at preventing HIV from multiplying. Having less HIV in the body protects the immune system and prevents HIV from advancing to AIDS. ART also reduces the risk of HIV drug resistance.

ART can’t cure HIV, but HIV medicines help people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission (the spread of HIV to others).

What are the seven stages of the HIV life cycle?

The seven stages of the HIV life cycle are: 1) binding, 2) fusion, 3) reverse transcription, 4) integration, 5) replication, 6) assembly, and 7) budding. To understand each stage in the HIV life cycle, it helps to first imagine what HIV looks like. 7

Now follow each stage in the HIV life cycle, as HIV attacks a CD4 cell and uses the machinery of the cell to multiply. 8

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Where can I learn more about the HIV life cycle?

Visit these webpages from the National Institute of Allergy and Infectious Diseases (NIAID) to learn more about the HIV life cycle and the development of antiretroviral drugs to treat HIV.

 HIV Replication Cycle  Antiretroviral Drug Discovery and Development

The Stages of HIV Infection

Key Points

 Without treatment with HIV medicines, HIV infection advances in stages, getting worse over time.  The three stages of HIV infection are (1) acute HIV infection, (2) chronic HIV infection, and (3) acquired immunodeficiency syndrome (AIDS).  There is no cure for HIV infection, but HIV medicines (called antiretrovirals or ARVs) can prevent HIV from advancing to AIDS. HIV medicines help people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission.

Without treatment, HIV infection advances in stages, getting worse over time. HIV gradually destroys the immune system and eventually causes acquired immunodeficiency syndrome (AIDS).

There is no cure for HIV infection, but HIV medicines (called antiretrovirals or ARVs) can prevent HIV from advancing to AIDS. HIV medicines help people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission (the spread of HIV to others). 10

There are three stages of HIV infection:

1. Acute HIV Infection Acute HIV infection is the earliest stage of HIV infection, and it generally develops within 2 to 4 weeks after a person is infected with HIV. During this time, some people have flu-like symptoms, such as fever, headache, and rash. In the acute stage of infection, HIV multiplies rapidly and spreads throughout the body. The virus attacks and destroys the infection-fighting CD4 cells of the immune system. During the acute HIV infection stage, the level of HIV in the blood is very high, which greatly increases the risk of HIV transmission.

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2. Chronic HIV Infection The second stage of HIV infection is chronic HIV infection (also called asymptomatic HIV infection or clinical latency). During this stage of the disease, HIV continues to multiply in the body but at very low levels. People with chronic HIV infection may not have any HIV-related symptoms, but they can still spread HIV to others. Without treatment with HIV medicines, chronic HIV infection usually advances to AIDS in 10 years or longer, though it may take less time for some people.

3. AIDS AIDS is the final, most severe stage of HIV infection. Because HIV has severely damaged the immune system, the body can’t fight off opportunistic infections. (Opportunistic infections are infections and infection-related cancers that occur more frequently or are more severe in people with weakened immune systems than in people with healthy immune systems.) People with HIV are diagnosed with AIDS if they have a CD4 count of less than 200 cells/mm3 or if they have certain opportunistic infections. Without treatment, people with AIDS typically survive about 3 years.

This fact sheet is based on information from the following sources:

 From HIV.gov: What Are HIV and AIDS?  From the Centers for Disease Control and Prevention (CDC): HIV/AIDS Basics

What is a Latent HIV Reservoir?

Key Points

 HIV infects immune system cells in the body and uses the cells’ machinery to make copies of itself. These infected cells can go into a resting state and stop producing HIV. A group of infected cells that are not actively producing HIV is called a latent HIV reservoir.  Latent HIV reservoirs can wake up and start making more HIV. If someone with HIV is not taking HIV medicines when this happens, the level of HIV in their body (called the viral load) will start to increase.  Latent HIV reservoirs can be found in many places throughout the body, and HIV can hide out for years inside reservoirs.

What is a latent HIV reservoir? 12

A latent HIV reservoir is a group of immune cells in the body that are infected with HIV but are not actively producing new HIV.

HIV attacks immune system cells in the body and uses the cells’ machinery to make copies of itself. After entering the body, HIV inserts its genetic blueprint into the DNA of an immune system cell, such as a CD4 cell. The infected cell starts producing HIV proteins that act as the building blocks for new HIV. To find out more about how HIV attacks cells, read the AIDSinfo HIV Life Cycle fact sheet.

Some HIV-infected cells, however, go into a resting (or latent) state. While in this resting state, the infected cells don’t produce new HIV.

When HIV infects cells in this way, it can hide out inside these cells for years, forming a latent HIV reservoir. At any time, cells in the latent reservoir can become active again and start making more HIV.

Where are latent HIV reservoirs found in the body?

Latent HIV reservoirs can be found throughout the body, including in the brain, lymph nodes, blood, and digestive tract.

Do HIV medicines work against latent HIV reservoirs?

HIV medicines reduce the amount of HIV in the body (called the viral load) by preventing the virus from multiplying. Because the HIV- infected cells in a latent reservoir aren’t producing new copies of the virus, HIV medicines have no effect on them.

People with HIV must take a daily combination of HIV medicines (called an HIV regimen) to keep their viral loads low. If someone is not taking HIV medicines when the infected cells of the latent reservoir begin making HIV again, the viral load in the body will start to increase. That’s why it’s important to continue taking HIV medicines every day as prescribed, even when viral load levels are low.

How are researchers targeting latent HIV reservoirs?

Finding ways to target and destroy latent reservoirs is one of the major challenges facing HIV researchers. New studies are exploring different strategies for clearing out reservoirs, including: 13

 Using gene therapy (which means manipulating genes to treat or prevent disease) to cut out certain HIV genes and inactivate the virus in HIV-infected immune cells.  Developing drugs or other methods that reactivate latent HIV reservoirs so that the immune system or new therapies can effectively eliminate them.  Developing approaches that enhance the immune system’s ability to recognize and clear reactivated latent HIV reservoirs.

This fact sheet is based on information from the following sources:

From the National Institute of Allergy and Infectious Diseases (NIAID):

 HIV Viral Eradication  Sustained HIV Viral Remission

HIV Testing

Key Points

 HIV testing shows whether a person is infected with HIV. HIV stands for human immunodeficiency virus. HIV is the virus that causes AIDS (acquired immunodeficiency syndrome). AIDS is the most advanced stage of HIV infection.  The Centers for Disease Control and Prevention (CDC) recommends that everyone 13 to 64 years old get tested for HIV at least once and that people at high risk of infection get tested more often.  Risk factors for HIV infection include having unprotected sex (sex without a condom) with someone who is HIV positive or whose HIV status you don’t know; having sex with many partners; and injecting drugs and sharing needles, syringes, or other drug equipment with others.  CDC recommends that all pregnant women get tested for HIV as early as possible during each pregnancy.

What is HIV testing?

HIV testing shows whether a person is infected with HIV. HIV stands for human immunodeficiency virus. HIV is the virus that causes AIDS (acquired immunodeficiency syndrome). AIDS is the most advanced stage of HIV infection. 14

HIV testing can detect HIV infection, but it can’t tell how long a person has been infected with HIV or if the person has AIDS.

Why is HIV testing important?

Knowing your HIV status can help keep you—and others—safe.

If you are HIV negative: Testing shows that you don’t have HIV. Continue taking steps to avoid getting HIV, such as using condoms during sex and, if you are at high risk of becoming infected, taking medicines to prevent HIV (called pre-exposure prophylaxis or PrEP). For more information, read the AIDSinfo fact sheet on HIV prevention.

If you are HIV positive: Testing shows that you are infected with HIV, but you can still take steps to protect your health. Begin by talking to your health care provider about antiretroviral therapy (ART). ART is the use of HIV medicines to treat HIV infection. People on ART take a combination of HIV medicines every day. ART helps people with HIV live longer, healthier lives. ART also reduces the risk of transmission of HIV. People infected with HIV should start ART as soon as possible. Your health care provider will help you decide what HIV medicines to take.

Who should get tested for HIV?

The Centers for Disease Control and Prevention (CDC) recommends that everyone 13 to 64 years old get tested for HIV at least once. As a general rule, people at high risk for HIV infection should get tested each year. Sexually active gay and bisexual men may benefit from getting tested more often, such as every 3 to 6 months.

Factors that increase the risk of HIV infection include:

 Having vaginal or anal sex with someone who is HIV positive or whose HIV status you don’t know  Injecting drugs and sharing needles, syringes, or other drug equipment with others  Exchanging sex for money or drugs 15

 Having a sexually transmitted disease (STD), such as syphilis  Having hepatitis or tuberculosis (TB)  Having sex with anyone who has any of the HIV risk factors listed above

Talk to your health care provider about your risk of HIV infection and how often you should get tested for HIV.

If a person has been sexually assaulted, they should get tested for HIV as soon as possible after the assault. Post-exposure prophylaxis (PEP) can also be considered. PEP involves taking antiretroviral (ARV) medicines very soon after a possible exposure to HIV to prevent becoming infected with HIV. To learn more, read the AIDSinfo fact sheet on PEP.

Should pregnant women get tested for HIV?

CDC recommends that all pregnant women get tested for HIV as early as possible during each pregnancy. Women who are planning to get pregnant should also get tested.

Women with HIV take HIV medicines during pregnancy and childbirth to reduce the risk of mother-to-child transmission of HIV. HIV medicines used as recommended during pregnancy can reduce the risk of mother-to-child transmission of HIV to less than 1%. For more information, read the AIDSinfo fact sheet on Preventing Mother-to-Child Transmission of HIV.

What are the types of HIV tests?

There are three main types of HIV tests: antibody tests, combination tests (antibody/antigen tests), and nucleic acid tests (NATs). How soon each test can detect HIV infection differs because each test has a different window period. The window period is the time between when a person gets HIV and when a test can accurately detect HIV infection.

 Antibody tests check for HIV antibodies in blood or fluids from the mouth. HIV antibodies are disease-fighting proteins that the body produces in response to HIV infection. It can take 3 to 12 weeks for a person’s body to make enough antibodies for an antibody test to detect HIV infection. (In other words, the window period for antibody tests in most people is somewhere between 3 to 12 weeks from the time of infection.) 16

 Combination tests (antibody/antigen tests) can detect both HIV antibodies and HIV antigens (a part of the virus) in blood. A combination test can detect HIV infection before an HIV antibody test. It can take 2 to 6 weeks for a person’s body to make enough antigens and antibodies for a combination test to detect HIV infection. Combination tests are now recommended for HIV testing that’s done in labs, and they are becoming more common in the United States.  NATs look for HIV in the blood. NATs can detect HIV infection about 7 to 28 days after a person has been infected with HIV. NATs are very expensive and not routinely used for HIV screening unless the person had a high-risk exposure or a possible exposure with early symptoms of HIV infection.

A person’s initial HIV test will usually be either an antibody test or a combination test. If the initial test result is positive for HIV infection, then follow-up testing will be done to make sure that the diagnosis is correct. If the initial test result is negative and the test was done during the window period, re-testing should be done 3 months after the possible exposure to HIV.

How long does it take to get the results of an HIV test? 17

It usually takes a few days to a few weeks to get results of an HIV test. Some rapid HIV tests can produce results within 30 minutes.

Is there an HIV test for home use?

There are two HIV tests approved by the U.S. Food and Drug Administration (FDA) for home use. Both are HIV antibody tests.

The Home Access HIV-1 Test System is a home collection kit, which involves pricking the finger for a blood sample, sending the sample to a lab for testing, and then calling the lab for results as early as the next business day. If the result is positive for HIV, the lab will do a follow-up test on the same blood sample to confirm the initial HIV-positive test result.

The OraQuick In-Home HIV Test comes with a test stick and a tube with a testing solution. The test stick is used to swab the gums to get a sample of oral fluids. To get results, the test stick is inserted into the test tube. Test results are ready in 20 minutes. A positive result on this home HIV test must always be confirmed by additional HIV testing performed in a health care setting.

Is HIV testing confidential?

HIV testing can be confidential or anonymous.

Confidential testing means that your HIV test results will include your name and other identifying information, but only people allowed to see your medical records will see your test results. HIV-positive test results will be reported to local or state health departments to be counted in statistical reports. Health departments remove all personal information (including names and addresses) from HIV test results before sharing the information with CDC. CDC uses this information for reporting purposes and does not share this information with any other organizations.

Anonymous testing means you don’t have to give your name when you take an HIV test. When you take the test, you receive a number. To get your HIV test results, you give the number instead of your name.

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Where can I get tested for HIV?

Your health care provider can give you an HIV test. HIV testing is also available at many hospitals, medical clinics, community health centers, and AIDS service organizations. Use this CDC testing locator to find an HIV testing location near you.

You can also buy a home testing kit at a pharmacy or online.

This fact sheet is based on information from the following sources:

 From CDC: HIV Basics: Testing  From CDC: HIV Testing

FDA-Approved HIV Medicines

Last Reviewed: August 17, 2017

Treatment with HIV medicines is called antiretroviral therapy (ART). ART is recommended for everyone with HIV. People on ART take a combination of HIV medicines (called an HIV regimen) every day. A person's initial HIV regimen generally includes three HIV medicines from at least two different drug classes.

ART can’t cure HIV, but HIV medicines help people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission.

The following table lists HIV medicines approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in the United States. The HIV medicines are listed according to drug class and identified by generic and brand names. Click on a drug name to 19

view information on the drug from the AIDSinfo Drug Database. Or download the AIDSinfo Drug Database app to view the information on your Apple or Android devices.

To see a timeline of all FDA approval dates for HIV medicines, view the AIDSinfo FDA Approval of HIV Medicines infographic.

FDA-Approved HIV Medicines

FDA Generic Name Brand Drug Class Approval (Other names and acronyms) Name Date Nucleoside Reverse Transcriptase Inhibitors (NRTIs) NRTIs block reverse transcriptase, abacavir Ziagen December an enzyme HIV needs to make (abacavir sulfate, ABC) 17, 1998 copies of itself. didanosine Videx October 9, (delayed-release didanosine, dideoxyinosine, enteric-coated 1991 didanosine, ddI, ddI EC) Videx EC October 31, (enteric- 2000 coated) emtricitabine Emtriva July 2, 2003 (FTC) lamivudine Epivir November (3TC) 17, 1995 stavudine Zerit June 24, (d4T) 1994 20

FDA-Approved HIV Medicines

FDA Generic Name Brand Drug Class Approval (Other names and acronyms) Name Date tenofovir disoproxil Viread October 26, fumarate 2001 (tenofovir DF, TDF) zidovudine Retrovir March 19, (azidothymidine, AZT, ZDV) 1987 Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) NNRTIs bind to and later alter efavirenz Sustiva September reverse transcriptase, an enzyme (EFV) 17, 1998 HIV needs to make copies of itself. etravirine Intelence January 18, (ETR) 2008 nevirapine Viramune June 21, (extended-release nevirapine, NVP) 1996 Viramune March 25, XR 2011 (extended release) rilpivirine Edurant May 20, (rilpivirine hydrochloride, RPV) 2011 Protease Inhibitors (PIs) PIs block HIV protease, an enzyme atazanavir Reyataz June 20, HIV needs to make copies of itself (atazanavir sulfate, ATV) 2003 21

FDA-Approved HIV Medicines

FDA Generic Name Brand Drug Class Approval (Other names and acronyms) Name Date darunavir Prezista June 23, (darunavir ethanolate, DRV) 2006 fosamprenavir Lexiva October 20, (fosamprenavir calcium, FOS-APV, FPV) 2003 indinavir Crixivan March 13, (indinavir sulfate, IDV) 1996 nelfinavir Viracept March 14, (nelfinavir mesylate, NFV) 1997 ritonavir Norvir March 1, (RTV) 1996

*Although ritonavir is a PI, it is generally used as a pharmacokinetic enhancer as recommended in the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection. saquinavir Invirase December 6, (saquinavir mesylate, SQV) 1995 tipranavir Aptivus June 22, (TPV) 2005 Fusion Inhibitors 22

FDA-Approved HIV Medicines

FDA Generic Name Brand Drug Class Approval (Other names and acronyms) Name Date Fusion inhibitors block HIV from enfuvirtide Fuzeon March 13, entering the CD4 cells of (T-20) 2003 the immune system. Entry Inhibitors Entry inhibitors block proteins on maraviroc Selzentry August 6, the CD4 cells that HIV needs to (MVC) 2007 enter the cells. Integrase Inhibitors Integrase inhibitors block HIV dolutegravir Tivicay August 13, integrase, an enzyme HIV needs to (DTG, dolutegravir sodium) 2013 make copies of itself. elvitegravir Vitekta September (EVG) 24, 2014 raltegravir Isentress October 12, (raltegravir potassium, RAL) 2007 Isentress HD May 26, 2017 Pharmacokinetic Enhancers Pharmacokinetic enhancers are cobicistat Tybost September used in HIV treatment to increase (COBI) 24, 2014 the effectiveness of an HIV 23

FDA-Approved HIV Medicines

FDA Generic Name Brand Drug Class Approval (Other names and acronyms) Name Date medicine included in an HIV regimen. Combination HIV Medicines Combination HIV medicines abacavir and lamivudine Epzicom August 2, contain two or more HIV (abacavir sulfate / lamivudine, ABC / 3TC) 2004 medicines from one or more drug classes. abacavir, dolutegravir, and lamivudine Triumeq August 22, (abacavir sulfate / dolutegravir sodium / lamivudine, ABC / DTG 2014 / 3TC) abacavir, lamivudine, and zidovudine Trizivir November (abacavir sulfate / lamivudine / zidovudine, ABC / 3TC / ZDV) 14, 2000 atazanavir and cobicistat Evotaz January 29, (atazanavir sulfate / cobicistat, ATV / COBI) 2015 darunavir and cobicistat Prezcobix January 29, (darunavir ethanolate / cobicistat, DRV / COBI) 2015 efavirenz, emtricitabine, and tenofovir disoproxil fumarate Atripla July 12, 2006 (efavirenz / emtricitabine / tenofovir DF, EFV / FTC / TDF) elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide Genvoya November 5, fumarate 2015 (elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide, EVG / COBI / FTC / TAF) 24

FDA-Approved HIV Medicines

FDA Generic Name Brand Drug Class Approval (Other names and acronyms) Name Date elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil Stribild August 27, fumarate 2012 (QUAD, EVG / COBI / FTC / TDF) emtricitabine, rilpivirine, and tenofovir alafenamide Odefsey March 1, (emtricitabine / rilpivirine / tenofovir AF, emtricitabine / 2016 rilpivirine / tenofovir alafenamide fumarate, emtricitabine / rilpivirine hydrochloride / tenofovir AF, emtricitabine / rilpivirine hydrochloride / tenofovir alafenamide, emtricitabine / rilpivirine hydrochloride / tenofovir alafenamide fumarate, FTC / RPV / TAF) emtricitabine, rilpivirine, and tenofovir disoproxil fumarate Complera August 10, (emtricitabine / rilpivirine hydrochloride / tenofovir disoproxil 2011 fumarate, emtricitabine / rilpivirine / tenofovir, FTC / RPV / TDF) emtricitabine and tenofovir alafenamide Descovy April 4, 2016 (emtricitabine / tenofovir AF, emtricitabine / tenofovir alafenamide fumarate, FTC / TAF) emtricitabine and tenofovir disoproxil fumarate Truvada August 2, (emtricitabine / tenofovir DF, FTC / TDF) 2004 lamivudine and zidovudine Combivir September (3TC / ZDV) 27, 1997 lopinavir and ritonavir Kaletra September (ritonavir-boosted lopinavir, LPV/r, LPV / RTV) 15, 2000 25

This fact sheet is based on information from the following sources:

 From FDA: Antiretroviral Drugs Used in the Treatment of HIV Infection  From the National Institute of Allergy and Infectious Diseases: Drugs That Fight HIV-1  From the National Library of Medicine: Drug information from the DailyMed website

What is an Investigational HIV Drug?

Key Points

 An investigational HIV drug is a drug that is being tested and is not approved by the U.S. Food and Drug Administration (FDA) for general use or sale in the United States.  Medical research studies—also called clinical trials—are done to evaluate the safety and effectiveness of an investigational HIV drug.  Investigational HIV drugs include drugs to treat or prevent HIV and vaccines to treat or prevent HIV.  Investigational HIV drugs can only be accessed through clinical trials and expanded access programs.

What is an investigational HIV drug?

An investigational HIV drug is a drug that is being tested to treat or prevent HIV infection and is not approved by the U.S. Food and Drug Administration (FDA) for general use or sale in the United States. Medical research studies—also called clinical trials—are done to evaluate the safety and effectiveness of an investigational HIV drug.

What types of investigational HIV drugs are being studied?

Currently, there are investigational drugs for treating HIV and preventing HIV. There are also investigational drugs for treating HIV- related opportunistic infections. (Opportunistic infections are infections and infection-related cancers that occur more frequently or are more severe in people with weakened immune systems than in people with healthy immune systems.) 26

Although no HIV vaccines exist yet, researchers are studying investigational preventive vaccines and treatment vaccines. The goal of a preventive HIV vaccine is to prevent HIV in people who don’t have HIV but who may be exposed to the virus. The goal of an HIV treatment vaccine, also called a therapeutic vaccine, is to slow the progression of HIV infection or delay the onset of AIDS in people with HIV. To learn more, read the AIDSinfo What is a Preventive HIV Vaccine? and What is a Therapeutic HIV Vaccine? fact sheets.

How are clinical trials of investigational drugs conducted?

Clinical trials, which are medical research studies, are conducted in phases. Each phase has a different purpose and helps researchers answer different questions about the investigational drug.

 Phase 1 trials: Researchers test the investigational drug in a small group of people (20–80) for the first time. The purpose is to evaluate its safety and identify side effects.  Phase 2 trials: The investigational drug is administered to a larger group of people (100–300) to determine its effectiveness and to further evaluate its safety.  Phase 3 trials: The investigational drug is administered to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it with standard or equivalent treatments, and collect information that will allow the investigational drug to be used safely.

In most cases, an investigational drug must be proven effective and must show continued safety in a Phase 3 clinical trial to be considered for approval by FDA for sale in the United States. (Some drugs go through FDA’s accelerated approval process and are approved before a Phase 3 clinical trial is complete.) After a drug is approved by FDA and made available to the public, researchers track its safety in Phase 4 trials to seek more information about the drug’s risks, benefits, and optimal use. For more information, read the AIDSinfo HIV/AIDS Clinical Trials fact sheet. 27

How can I get access to an investigational HIV drug?

One way to get access to an investigational HIV drug is by enrolling in a clinical trial that is studying the drug. Another way is through an expanded access program. Expanded access involves using an investigational drug outside of a clinical trial to treat a person who has a serious or immediately life-threatening disease and who has no FDA-approved treatment options. Drug companies must have permission from FDA to make an investigational drug available for expanded access. Talk to your health care provider to see if you may qualify to take part in an expanded access program.

How can I find a clinical trial on an investigational HIV drug?

To find an HIV/AIDS clinical trial on an investigational HIV drug, use the AIDSinfo clinical trial search. For help with your search, call an AIDSinfo health information specialist at 1-800-448-0440 or email [email protected]. 28

You can also join ResearchMatch, which is a free, secure online tool that makes it easier for the public to become involved in clinical trials.

Is it safe to use an investigational HIV drug?

One goal of HIV research is to identify new drugs that are less toxic and have fewer side effects. Researchers also try to make HIV/AIDS clinical trials as safe as possible. But investigational HIV drugs may have side effects that are not well known yet. Although this risk of poorly understood side effects is explained to you before you start taking the investigational drug, this makes it hard to know your actual risk. As testing of an investigational HIV drug continues, additional information on possible side effects is collected.

How can I find more information on investigational HIV drugs?

To find more information on investigational HIV drugs, use the AIDSinfo Drug Database, which includes up-to-date information on many investigational HIV drugs.

This fact sheet is based on information from the following sources:

 From the National Institutes of Health (NIH):  NIH Clinical Research Trials and You: The Basics  NIH Clinical Research Trials and You: Finding a Clinical Trial  From the National Institute of Allergy and Infectious Diseases (NIAID):  HIV/AIDS Overview  From the U.S. Food and Drug Administration (FDA):  Expanded Access: Information for Patients

29

What is a Therapeutic HIV Vaccine?

Key Points

 A therapeutic HIV vaccine is a vaccine that’s designed to improve the body’s immune response to HIV in a person who already has HIV.  There are currently no therapeutic HIV vaccines approved by the Food and Drug Administration (FDA), but research is under way.  Researchers are exploring therapeutic HIV vaccines (1) to slow down the progression of HIV infection, (2) to eliminate the need for antiretroviral therapy (ART) while still keeping undetectable levels of HIV, and (3) as part of a larger strategy to eliminate all HIV from the body.

What is a therapeutic HIV vaccine?

A therapeutic HIV vaccine is a vaccine that’s designed to improve the body’s immune response to HIV in a person who already has HIV.

Researchers are developing and testing therapeutic HIV vaccines to slow down the progression of HIV infection and ideally result in undetectable levels of HIV without the need for regular antiretroviral therapy (ART). (ART is the recommended treatment for HIV infection and involves using a combination of different HIV medicines to prevent HIV from replicating. Currently, a person with HIV must remain on ART to keep HIV at undetectable levels.)

A therapeutic HIV vaccine may also slow a person’s progression to AIDS and may make it less likely that a person could transmit HIV to others.

Researchers are also evaluating therapeutic HIV vaccines as part of a larger strategy to eliminate all HIV from the body and cure people of HIV. This kind of strategy may involve using other drugs and therapies in addition to a therapeutic HIV vaccine. HIV cure research is still in early exploratory stages, and it is not known what strategies may or may not work. 30

How is a therapeutic HIV vaccine different from a preventive HIV vaccine?

A preventive HIV vaccine is given to people who do not have HIV, with the goal of preventing HIV infection in the future. The vaccine would teach the person’s immune system to recognize and effectively fight HIV in case the virus ever enters the person’s body.

A therapeutic HIV vaccine is given to people who already have HIV. The goal of a therapeutic HIV vaccine is to strengthen a person’s immune response to the HIV that is already in the person’s body. 31

Are there any FDA-approved therapeutic HIV vaccines?

There are currently no Food and Drug Administration (FDA)-approved therapeutic HIV vaccines, but research is under way.

Where can I get more information about clinical trials studying therapeutic HIV vaccines?

A list of clinical trials on therapeutic HIV vaccines is available from the AIDSinfo database of ClinicalTrials.gov study summaries. Click on the title of any trial in the list to see more information about the study.

Where can I learn more about therapeutic HIV vaccine research?

Visit the websites below to learn more about therapeutic HIV vaccine research. This fact sheet is based on information from these sources:

 From the National Institute of Allergy and Infectious Diseases (NIAID):  HIV Vaccine Development  HIV Viral Eradication  Sustained HIV Viral Remission  From the HIV Vaccine Trials Network (HVTN):  How Vaccines Work

What is a Preventive HIV Vaccine?

Key Points

 A preventive HIV vaccine is given to people who do not have HIV, with the goal of preventing HIV infection in the future.  There are currently no preventive HIV vaccines approved by the Food and Drug Administration (FDA), but research is under way. You must be enrolled in a clinical trial to receive a preventive HIV vaccine. 32

What is a preventive HIV vaccine?

A preventive HIV vaccine is given to people who do not have HIV, with the goal of preventing HIV infection in the future. The vaccine would teach the person’s immune system to recognize and effectively fight HIV in case the person is ever exposed to HIV.

Are there any FDA-approved preventive HIV vaccines?

There are currently no preventive HIV vaccines approved by the Food and Drug Administration (FDA), but research is under way. You must be enrolled in a clinical trial to receive a preventive HIV vaccine.

How is a preventive HIV vaccine different from a therapeutic HIV vaccine?

While a preventive HIV vaccine is given to people who do not have HIV, a therapeutic HIV vaccine is given to people who already have HIV. The goal of a therapeutic HIV vaccine is to strengthen a person’s immune response to the HIV that is already in the person’s body. Researchers are exploring therapeutic HIV vaccines:

 To slow down the progression of HIV infection  To eliminate the need for antiretroviral therapy (ART) while still keeping undetectable levels of HIV  As part of a larger strategy to eliminate all HIV from the body

To learn more, read the AIDSinfo What is a Therapeutic HIV Vaccine? fact sheet.

Can I get HIV from a preventive HIV vaccine?

No, you cannot get HIV from a preventive HIV vaccine. The preventive HIV vaccines being studied in clinical trials do not contain HIV. Of the approximately 30,000 people who have participated in HIV vaccine studies around the world in the last 25 years, no one has gotten HIV from any of the vaccines tested. 33

Why is a preventive HIV vaccine important?

Treatment options for HIV infection have improved a lot over the last 30 years. But HIV medicines can have side effects, can be expensive, and can be hard to access in some countries. Also, some people may develop drug resistance to certain HIV medicines and then must change medicines.

Current prevention tools for HIV, such as using condoms correctly and pre-exposure prophylaxis (PrEP), work well. But researchers believe a preventive HIV vaccine will be the most effective way to completely end new HIV infections.

What research is being done on preventive HIV vaccines?

Some of the areas of interest being studied in clinical trials include:

 The safety of preventive vaccines.  Whether a preventive vaccine protects against HIV infection.  Whether a preventive vaccine controls HIV if a person gets HIV while enrolled in a study. (Some people in a clinical trial may get HIV by having sex with or sharing drug injection equipment with someone who has HIV, while they are participating in the study. But you cannot get HIV from the vaccine being tested.)  The immune responses that occur in people who receive a preventive vaccine.  Different ways of giving preventive vaccines, such as using a needle and syringe versus a needle-free device.

Where can I get more information about clinical trials studying preventive HIV vaccines?

A list of clinical trials on preventive HIV vaccines is available from the AIDSinfo database of ClinicalTrials.gov study summaries. Click on the title of any trial in the list to see more information about the study.

If you are interested in participating in a vaccine study, you can also contact the National Institutes of Health (NIH) Vaccine Research Center by calling 866-833-LIFE (5433) or by emailing [email protected]. 34

Where can I learn more about preventive HIV vaccine research?

Visit the websites below to learn more about preventive HIV vaccine research. This fact sheet is based on information from these sources:

 From the National Institute of Allergy and Infectious Diseases (NIAID): o Vaccine Research Studies Frequently Asked Questions o HIV Vaccine Development  From the HIV Vaccine Trials Network (HVTN): o How Vaccines Work o HIV Vaccine Myths and Facts o HVTN Studies

HIV/AIDS Clinical Trials

Key Points

 HIV/AIDS clinical trials are research studies that look at new ways to prevent, detect, or treat HIV/AIDS. Clinical trials are the fastest way to determine if new medical approaches to HIV/AIDS are safe and effective in people.  Examples of HIV/AIDS clinical trials under way include studies of new HIV medicines, studies of vaccines to prevent or treat HIV, and studies of medicines to treat infections related to HIV.  The benefits and possible risks of participating in an HIV/AIDS clinical trial are explained to study volunteers before they decide whether to participate in a study.  Use the AIDSinfo clinical trial search to find HIV/AIDS studies looking for volunteer participants. Some HIV/AIDS clinical trials enroll only people who have HIV. Other studies enroll people who don’t have HIV.

What is a clinical trial?

A clinical trial is a research study done to evaluate new medical approaches in people. New approaches can include:

 new medicines or new combinations of medicines 35

 new surgical procedures or devices  new ways to use an existing medicine or device

Clinical trials are the fastest way to determine whether new medical approaches are safe and effective in people.

What is an HIV/AIDS clinical trial?

HIV/AIDS clinical trials help researchers find better ways to prevent, detect, or treat HIV/AIDS. All the medicines used to treat HIV/AIDS in the United States were first studied in clinical trials.

Examples of HIV/AIDS clinical trials under way include:

 studies of new medicines to treat HIV  studies of vaccines to prevent or treat HIV  studies of medicines to treat infections related to HIV 36

Can anyone participate in an HIV/AIDS clinical trial?

It depends on the study. Some HIV/AIDS clinical trials enroll only people who have HIV. Other studies include people who don’t have HIV. 37

Other factors such as age, gender, HIV treatment history, or other medical conditions may also restrict who can participate in an HIV/AIDS clinical trial.

What are the benefits of participating in an HIV/AIDS clinical trial?

Participating in an HIV/AIDS clinical trial can provide benefits. For example, many people participate in HIV/AIDS clinical trials because they want to contribute to HIV/AIDS research. They may have HIV or know someone who has HIV.

People with HIV who participate in an HIV/AIDS clinical trial may benefit from new HIV medicines before they are widely available. HIV medicines being studied in clinical trials are called investigational drugs. To learn more, read the AIDSinfo What is an Investigational HIV Drug? fact sheet.

Participants in clinical trials can receive regular and careful medical care from a research team that includes doctors and other health professionals. Often the medicines and medical care are free of charge.

Sometimes people get paid for participating in a clinical trial. For example, they may receive money or a gift card. They may be reimbursed for the cost of meals or transportation.

Are HIV/AIDS clinical trials safe?

Researchers try to make HIV/AIDS clinical trials as safe as possible. However, volunteering to participate in a study that is testing an experimental treatment for HIV can involve risks of varying degrees. Risks can include unpleasant, serious, or even life-threatening side effects from the treatment being studied.

In a process called informed consent, study volunteers are informed of the possible risks and benefits of a clinical trial. Understanding the risks and benefits helps volunteers decide whether to participate in the study.

If I decide to participate in an HIV/AIDS clinical trial, will my personal information be shared? 38

The privacy of study volunteers is important to everyone involved in an HIV/AIDS clinical trial. The informed consent process includes an explanation of how a study volunteer’s personal information is protected.

How can I find an HIV/AIDS trial in which to participate?

To find an HIV/AIDS clinical trial looking for volunteers, use the AIDSinfo clinical trial search. For help with your search, call an AIDSinfo health information specialist at 1-800-448-0440 or email [email protected].

This fact sheet is based on information from the following sources:

 From the National Institutes of Health (NIH):  Learn About Clinical Studies 39

 NIH Clinical Research Trials and You: The Basics  A Patient’s Guide to Clinical Trials  From the National Cancer Institute at NIH:  Clinical Trials Information for Patients and Caregivers

HIV Prevention

The Basics of HIV Prevention

Key Points

 HIV is spread only in certain body fluids from a person infected with HIV. These fluids are blood, semen, pre-seminal fluids, rectal fluids, vaginal fluids, and breast milk.  In the United States, HIV is spread mainly by having sex or sharing injection drug equipment, such as needles, with someone who has HIV.  To reduce your risk of HIV infection, use condoms correctly every time you have vaginal, oral, or anal sex. Don’t inject drugs. If you do, use only sterile injection equipment and water and never share your equipment with others.  If you don’t have HIV but are at high risk of becoming infected with HIV, talk to your health care provider about pre-exposure prophylaxis (PrEP). PrEP involves taking a specific HIV medicine every day to reduce the risk of HIV infection.

How is HIV spread?

The person-to-person spread of HIV is called HIV transmission. HIV is transmitted (spread) only in certain body fluids from a person infected with HIV:

 Blood 40

 Semen  Pre-seminal fluids  Rectal fluids  Vaginal fluids  Breast milk

HIV transmission is only possible if these fluids come in contact with a mucous membrane or damaged tissue or are directly injected into the bloodstream (from a needle or syringe). Mucous membranes are found inside the rectum, the vagina, the opening of the penis, and the mouth.

In the United States, HIV is spread mainly by:

 Having anal or vaginal sex with someone who has HIV without using a condom or taking medicines to prevent or treat HIV  Sharing injection drug equipment ("works"), such as needles, with someone who has HIV

HIV can also spread from an HIV-infected woman to her child during pregnancy, childbirth (also called labor and delivery), or breastfeeding. This spread of HIV is called mother-to-child transmission of HIV.

In the past, some people were infected with HIV after receiving a blood transfusion or organ or tissue transplant from an HIV-infected donor. Today, this risk is very low because donated blood, organs, and tissues are carefully tested in the United States.

You can’t get HIV from casual contact with a person infected with HIV, for example from a handshake, a hug, or a closed-mouth kiss. And you can’t get HIV from contact with objects such as toilet seats, doorknobs, or dishes used by a person infected with HIV. Use the AIDSinfo You Can Safely Share…With Someone With HIV infographic to spread this message.

How can I reduce my risk of getting HIV?

Anyone can get HIV, but you can take steps to protect yourself from HIV infection. 41

 Get tested and know your partner’s HIV status. Talk to your partner about HIV testing and get tested before you have sex. Use this testing locator from the Centers for Disease Control and Prevention (CDC) to find an HIV testing location near you.  Have less risky sex. HIV is mainly spread by having anal or vaginal sex without a condom or without taking medicines to prevent or treat HIV.  Use condoms. Use a condom correctly every time you have vaginal, anal, or oral sex. Read this fact sheet from CDC on how to use condoms correctly.  Limit your number of sexual partners. The more partners you have, the more likely you are to have a partner with HIV whose HIV is not well controlled or to have a partner with a sexually transmitted disease (STD). Both of these factors can increase the risk of HIV transmission. If you have more than one sexual partner, get tested for HIV regularly.  Get tested and treated for STDs. Insist that your partners get tested and treated too. Having an STD can increase your risk of becoming infected with HIV or spreading it to others.  Talk to your health care provider about pre-exposure prophylaxis (PrEP). PrEP is an HIV prevention option for people who don’t have HIV but who are at high risk of becoming infected with HIV. PrEP involves taking a specific HIV medicine every day. For more information, read the AIDSinfo fact sheet on Pre-Exposure Prophylaxis (PrEP).  Don’t inject drugs. But if you do, use only sterile drug injection equipment and water and never share your equipment with others.

I am HIV positive but my partner is HIV negative. How can I protect my partner from HIV?

Take HIV medicines daily. Treatment with HIV medicines (called antiretroviral therapy or ART) helps people with HIV live longer, healthier lives. ART can’t cure HIV infection, but it can reduce the amount of HIV in the body. Having less HIV in your body will reduce your risk of passing HIV to your partner during sex. You can also talk to your partner about taking PrEP.

To protect your partner, use condoms correctly every time you have sex. Even someone who is taking HIV medicines and has an undetectable viral load can still potentially transmit HIV to a partner. So even if you are taking HIV medicines, it’s still important to use condoms.

If you inject drugs, don’t share your needles, syringes, or other drug equipment with your partner.

To learn more, read this webpage from AIDS.gov on Mixed-Status Couples. 42

Are HIV medicines used in other situations to prevent HIV infection?

Yes, HIV medicines are also used for post-exposure prophylaxis (PEP) and to prevent mother-to-child transmission of HIV.

 Post-exposure prophylaxis (PEP) PEP is the use of HIV medicines to reduce the risk of HIV infection soon after a possible exposure to HIV. PEP may be used, for example, after a person has sex without a condom with a person who is infected with HIV or after a health care worker is accidentally exposed to HIV in the workplace. To be effective, PEP must be started within 3 days after the possible exposure to HIV. PEP involves taking HIV medicines each day for 28 days. For more information, read the AIDSinfo fact sheet on Post-Exposure Prophylaxis (PEP).  Prevention of mother-to-child transmission of HIV Women with HIV take HIV medicines during pregnancy and childbirth to reduce the risk of passing HIV to their babies. Their newborn babies also receive HIV medicine for 4 to 6 weeks after birth. The HIV medicine reduces the risk of infection from any HIV that may have entered a baby’s body during childbirth. For more information, read the AIDSinfo fact sheet on Preventing Mother-to- Child Transmission of HIV.

How can I learn more about preventing HIV?

Browse through the following information. This fact sheet is based on this information.

From CDC:

 HIV Transmission  HIV Prevention  PrEP  PEP

From the Department of Health and Human Services:

 Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States:  General Principles Regarding Use of Antiretroviral Drugs During Pregnancy: Overview 43

 Postpartum Care: Infant Antiretroviral Prophylaxis

Preventing Mother-to-Child Transmission of HIV

Key Points

 Mother-to-child transmission of HIV is the spread of HIV from an HIV-infected woman to her child during pregnancy, childbirth (also called labor and delivery), or breastfeeding (through breast milk). Mother-to-child transmission is the most common way that children become infected with HIV.  Pregnant women with HIV receive HIV medicines during pregnancy and childbirth to prevent mother-to-child transmission of HIV. In some situations, a woman with HIV may have a scheduled cesarean delivery (sometimes called a C-section) to prevent mother-to- child transmission of HIV during delivery.  Babies born to women with HIV receive HIV medicine for 4 to 6 weeks after birth. The HIV medicine reduces the risk of infection from any HIV that may have entered a baby’s body during childbirth.  Because HIV can be transmitted in breast milk, women with HIV living in the United States should not breastfeed their babies. In the United States, baby formula is a safe and healthy alternative to breast milk.  If a woman takes HIV medicines during pregnancy and childbirth and her baby receives HIV medicine for 4 to 6 weeks after birth, the risk of transmitting HIV can be lowered to 1% or less.

What is mother-to-child transmission of HIV?

Mother-to-child transmission of HIV is the spread of HIV from an HIV-infected woman to her child during pregnancy, childbirth (also called labor and delivery), or breastfeeding (through breast milk). Mother-to-child transmission of HIV is also called perinatal transmission of HIV.

Mother-to-child transmission is the most common way that children become infected with HIV. 44

Can mother-to-child transmission of HIV be prevented?

Yes. Because of the use of HIV medicines and other strategies, the risk of mother-to-child transmission can be lowered to 1% or less. The risk of mother-to-child transmission of HIV is low when:

 HIV is detected as early as possible during pregnancy (or before a woman gets pregnant).  Women with HIV receive HIV medicine during pregnancy and childbirth and, in certain situations, have a scheduled cesarean delivery (sometimes called a C-section).  Babies born to women with HIV receive HIV medicines for 4 to 6 weeks after birth and are not breastfed.

Is HIV testing recommended for pregnant women?

The Centers for Disease Control and Prevention (CDC) recommends that all women who are pregnant or planning to become pregnant get tested for HIV as early as possible—before, if possible, and during every pregnancy.

Pregnant women with HIV receive HIV medicines to reduce the risk of mother-to-child transmission of HIV and to protect their own health. HIV medicines are recommended for everyone infected with HIV. HIV medicines help people with HIV live longer, healthier lives and reduce the risk of transmission of HIV.

How do HIV medicines prevent mother-to-child transmission of HIV?

HIV medicines work by preventing HIV from multiplying, which reduces the amount of HIV in the body. Having less HIV in the body reduces a woman's risk of passing HIV to her child during pregnancy and childbirth. Having less HIV in the body also protects the woman's health.

Some of the HIV medicine passes from the pregnant woman to her unborn baby across the placenta (also called the afterbirth). This transfer of HIV medicine protects the baby from HIV infection, especially during a vaginal delivery when the baby passes through the birth canal 45

and is exposed to any HIV in the mother’s blood or other fluids. In some situations, a woman with HIV may have a cesarean delivery (sometimes called a C-section) to reduce the risk of mother-to-child transmission of HIV during delivery.

Babies born to women with HIV receive HIV medicine for 4 to 6 weeks after birth. The HIV medicine reduces the risk of infection from any HIV that may have entered a baby’s body during childbirth.

Are HIV medicines safe to use during pregnancy?

Most HIV medicines are safe to use during pregnancy. In general, HIV medicines don’t increase the risk of birth defects. Health care providers talk with HIV-infected women about the benefits and risks of specific HIV medicines to help the women decide which HIV medicines to use during pregnancy.

Are there other ways to prevent mother-to-child transmission of HIV?

Because HIV can be transmitted in breast milk, HIV-infected women in the United States should not breastfeed their babies. In the United States, baby formula is a safe and healthy alternative to breast milk.

There are reports of children becoming infected with HIV by eating food that was previously chewed by a person infected with HIV. To be safe, babies should not be fed pre-chewed food.

How can I learn more about preventing mother-to-child transmission of HIV?

Read the following AIDSinfo fact sheets:

 HIV Medicines During Pregnancy and Childbirth  Preventing Mother-to-Child Transmission of HIV After Birth

This fact sheet is based on information from the following sources: 46

From CDC:

 HIV Among Pregnant Women, Infants, and Children

From the Department of Health and Human Services:

 Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States:  Introduction  General Principles Regarding Use of Antiretroviral Drugs During Pregnancy: Overview and Teratogenicity  Postpartum Care: Infant Antiretroviral Prophylaxis

Post-Exposure Prophylaxis (PEP)

Key Points

 Post-exposure prophylaxis (PEP) involves taking antiretroviral (ARV) medicines very soon after a possible exposure to HIV to prevent becoming infected with HIV.  PEP should be started as soon as possible to be effective and always within 72 hours (3 days) after a possible exposure to HIV.  If your health care provider thinks PEP is right for you, you’ll take 3 or more ARV medicines every day for 28 days.

What is PEP?

PEP stands for “post-exposure prophylaxis.” The word “prophylaxis” means to prevent or protect from an infection or disease. PEP involves taking antiretroviral (ARV) medicines very soon after a possible exposure to HIV to prevent becoming infected with HIV.

There are 2 types of PEP: oPEP and nPEP. oPEP stands for “occupational post-exposure prophylaxis.” It’s when a health care worker takes PEP because of a possible on-the-job exposure to HIV, such as during a needlestick injury. 47

The other type of PEP is called nPEP, and it stands for “non-occupational post-exposure prophylaxis.” It’s when someone takes PEP because of a possible HIV exposure that happened outside of the person’s work, such as during sex or injection drug use.

Who should consider taking PEP?

PEP might be prescribed for you if you are HIV negative or don’t know your HIV status, and in the last 72 hours you:

 Think you were exposed to HIV during your work, for example from a needlestick injury  Think you were exposed to HIV during sex  Shared needles or drug preparation equipment (“works”)  Were sexually assaulted

Your health care provider will help to determine whether you should receive PEP.

PEP is intended for emergency situations. It is not meant for regular use by people who may be exposed to HIV frequently. Another HIV prevention method, called pre-exposure prophylaxis or PrEP, is when people at high risk for HIV take a specific HIV medicine daily to prevent getting HIV. For more information on PrEP, see the AIDSinfo fact sheet on Pre-Exposure Prophylaxis (PrEP).

What should I do if I think I was recently exposed to HIV?

If you think you were exposed to HIV, immediately contact your health care provider or go to an emergency room, urgent care clinic, or local HIV clinic right away. You will have an HIV test and other tests done. Your health care provider or emergency room doctor will help to decide whether you should receive PEP.

When should PEP be taken?

PEP should be started as soon as possible to be effective and always within 72 hours (3 days) after a possible exposure to HIV. According to research, PEP will most likely not prevent HIV infection if it is taken 72 hours after a person is exposed to HIV. 48

How long is PEP taken for?

PEP involves taking 3 or more ARV medicines every day for 28 days. You will need to return to your health care provider at certain times while taking PEP and after you finish taking PEP for HIV testing and other tests.

What HIV medicines are used for PEP?

The Centers for Disease Control and Prevention (CDC) provides information on recommended ARV medicines for PEP. CDC also provides PEP recommendations for specific groups of people, including children, pregnant women, and people with kidney problems. The most recent PEP recommendations can be found on CDC’s PEP Guidelines webpage. Your health care provider or emergency room doctor will determine which medicines you should take as part of PEP.

Does PEP work?

PEP is effective in preventing HIV infection when it’s taken correctly, but it’s not 100% effective. The sooner you start PEP after a possible HIV exposure, the better. While taking PEP, it’s important to keep using condoms with sex partners and to continue safe drug injection practices. Read this fact sheet from CDC for information on how to use condoms correctly.

Does PEP cause side effects?

The ARV medicines in PEP may cause side effects. The side effects can be treated and aren’t life threatening. Talk to your health care provider if you have any side effect that bothers you or that does not go away.

PEP medicines may also interact with other medicines that people are taking (known as a drug interaction). Because of potential drug interactions, it’s important to tell your health care provider about any other medicines that you take.

How can I learn more about PEP? 49

Visit the websites below from CDC to learn more about PEP. This fact sheet is based on information from these sources:

 HIV Basics: PEP  PEP Resources

Pre-Exposure Prophylaxis (PrEP)

Key Points

 Pre-exposure prophylaxis (PrEP) can help prevent HIV infection in people who don’t have HIV but who are at high risk of becoming infected with HIV.  PrEP involves taking a specific HIV medicine every day. PrEP is most effective when taken consistently each day.  According to the Centers for Disease Control and Prevention (CDC), by taking PrEP every day, a person can lower their risk of getting HIV from sex by more than 90% and from injection drug use by more than 70%.

What is PrEP?

PrEP stands for “pre-exposure prophylaxis.” The word “prophylaxis” means to prevent or protect from an infection or disease.

PrEP can help prevent HIV infection in people who don’t have HIV but who are at high risk of becoming infected with HIV. PrEP involves taking a specific HIV medicine every day. If a person is exposed to HIV, having the HIV PrEP medicine in the person’s bloodstream can help stop HIV from setting up a permanent infection in the body.

What HIV medicine is used for PrEP?

The HIV medicine currently prescribed for PrEP is a combination pill called Truvada. Truvada is made up of two HIV medicines: tenofovir disoproxil fumarate (brand name: Viread) and emtricitabine (brand name: Emtriva). Truvada was approved by the U.S. Food and Drug Administration (FDA) to treat HIV in 2004, and it was approved by FDA for use as PrEP in July 2012. 50

Other medicines are being studied for possible use as PrEP. These medicines are called investigational drugs, and none of them have been approved by FDA yet. To find out more about investigational HIV drugs, read the AIDSinfo What is an Investigational HIV Drug?fact sheet.

Who should consider taking PrEP?

PrEP is for people who don’t have HIV but who are at high risk of becoming infected with HIV through sex or injection drug use.

You may want to consider PrEP if you are not infected with HIV and you are in an ongoing sexual relationship with an HIV-positive partner.

Other people who may want to consider PrEP include:

 Gay or bisexual men who are not in a monogamous relationship with a recently tested, HIV-negative partner, who have either 1) had anal sex without a condom in the past 6 months, or 2) been diagnosed with a sexually transmitted disease (STD) in the past 6 months.  Heterosexual men or women who are not in a monogamous relationship with a recently tested, HIV-negative partner, and who do not always use condoms during sex with partners whose HIV status is unknown and who are at high risk of HIV infection (for example, people who inject drugs or have bisexual male partners).  People who, in the last 6 months, have injected drugs and have either 1) shared needles or injection equipment, or 2) been in a drug treatment program.

The above are some examples of people who may benefit from PrEP. If you think PrEP may be right for you, talk to your health care provider.

Does PrEP work?

PrEP is most effective when taken consistently each day. According to the Centers for Disease Control and Prevention (CDC), by using PrEP every day, you can lower your risk of getting HIV from sex by more than 90% and from injection drug use by more than 70%. Adding other strategies, such as condom use, along with PrEP can reduce a person’s risk even further. 51

Does PrEP cause side effects?

Most people taking PrEP do not have any serious side effects from the medicine. Some people taking PrEP may have nausea, but this usually goes away over time. Talk to your health care provider if you have any side effect that bothers you or that does not go away.

What should I do if I think PrEP could help me?

If you think you may be at high risk for HIV and that you might benefit from PrEP, talk to your health care provider. If you and your health care provider agree that PrEP might reduce your risk of getting HIV, the next step is a physical examination, an HIV test, and other blood tests. If the tests show that PrEP is likely to be safe for you and that you might benefit from PrEP, your health care provider can give you a prescription.

Many health insurance plans cover the cost of PrEP. A commercial medication assistance program can help eligible people pay for PrEP.

What happens once I start PrEP?

Once you start PrEP, you will need to take PrEP every day. If you don’t take PrEP every day, there may not be enough medicine in your bloodstream to block HIV. Studies have shown that PrEP is much less effective if it is not taken every day.

You should keep using condoms while taking PrEP. Taking PrEP daily can protect you against HIV infection, but it is not 100% effective. Continued use of condoms can help reduce your risk of HIV infection even further. PrEP also does not reduce the risk of getting any other STDs. Read this fact sheet from CDC for information on how to use condoms correctly.

If you are having trouble taking PrEP every day or if you want to stop taking PrEP, talk to your health care provider.

How can I learn more about PrEP?

Visit the websites below from CDC to learn more about PrEP. This fact sheet is based on information from these sources: 52

 HIV Basics: PrEP  PrEP Resources  Preexposure Prophylaxis for the Prevention of HIV Infection in the United States – 2014 Clinical Practice Guideline 

HIV Treatment

HIV Treatment: The Basics

Key Points

 Antiretroviral therapy (ART) is the use of HIV medicines to treat HIV infection. People on ART take a combination of HIV medicines (called an HIV regimen) every day.  ART is recommended for everyone infected with HIV. People infected with HIV should start ART as soon as possible. ART can’t cure HIV, but HIV medicines help people infected with HIV live longer, healthier lives. ART also reduces the risk of HIV transmission.  Potential risks of ART include unwanted side effects from HIV medicines and drug interactions between HIV medicines or between HIV medicines and other medicines a person is taking. Poor adherence—not taking HIV medicines every day and exactly as prescribed—can lead to drug resistance and treatment failure.

What is antiretroviral therapy?

Antiretroviral therapy (ART) is the use of HIV medicines to treat HIV infection. People on ART take a combination of HIV medicines (called an HIV regimen) every day.

ART is recommended for everyone infected with HIV. ART can’t cure HIV, but HIV medicines help people with HIV live longer, healthier lives. ART also reduces the risk of HIV transmission. 53

How do HIV medicines work?

HIV attacks and destroys the infection-fighting CD4 cells of the immune system. Loss of CD4 cells makes it hard for the body to fight off infections and certain HIV-related cancers.

HIV medicines prevent HIV from multiplying (making copies of itself), which reduces the amount of HIV in the body. Having less HIV in the body gives the immune system a chance to recover. Even though there is still some HIV in the body, the immune system is strong enough to fight off infections and certain HIV-related cancers.

By reducing the amount of HIV in the body, HIV medicines also reduce the risk of HIV transmission.

When is it time to start taking HIV medicine?

People infected with HIV should start ART as soon as possible. In people with the following conditions, it’s especially important to start ART right away: pregnancy, AIDS, certain HIV-related illnesses and coinfections, and early HIV infection. (Early HIV infection is the period up to 6 months after infection with HIV.)

Read the AIDSinfo When to Start Antiretroviral Therapy fact sheet to learn more about why it’s important for people with these conditions to start ART as soon as possible.

What HIV medicines are included in an HIV regimen?

There are many HIV medicines available for HIV regimens. The HIV medicines are grouped into six drug classes according to how they fight HIV. A person’s initial HIV regimen usually includes three HIV medicines from at least two different HIV drug classes.

Selection of an HIV regimen depends on several factors, including possible side effects of HIV medicines and potential drug interactions between medicines. Because the needs of people with HIV vary, there are several HIV regimens to choose from. 54

What are risks of taking HIV medicines?

Potential risks of ART include side effects from HIV medicines and drug interactions between HIV medicines or between HIV medicines and other medicines a person is taking. Poor adherence—not taking HIV medicines every day and exactly as prescribed—increases the risk of drug resistance and treatment failure. 55

Side effects Side effects from HIV medicines can vary depending on the medicine and the person taking the medicine. People taking the same HIV medicine can have very different side effects. Some side effects, like headaches or occasional dizziness, may not be serious. Other side effects, such as swelling of the throat and tongue or liver damage, can be life-threatening.

Drug interactions HIV medicines can interact with other HIV medicines in an HIV regimen. They can also interact with other medicines, vitamins, nutritional supplements, and herbal products. A drug interaction can reduce or increase a medicine's effect on the body. Drug interactions can also cause unwanted side effects.

Drug resistance When HIV multiplies in the body, the virus sometimes mutates (changes form) and makes variations of itself. Variations of HIV that develop while a person is taking HIV medicines can lead to drug-resistant strains of HIV. HIV medicines that previously controlled a person’s HIV are not effective against the new, drug-resistant HIV. In other words, the person’s HIV continues to multiply.

Poor adherence to an HIV regimen increases the risk of drug resistance and treatment failure.

Where can I learn more about ART?

Read the other fact sheets in the AIDSinfo HIV Treatment series to learn more about ART. Topics covered in this series include:

 When to Start Antiretroviral Therapy  What to Start: Choosing an HIV Regimen  HIV Medication Adherence  Drug Resistance  What is a Drug Interaction?

This fact sheet is based on information from the following sources: 56

 From the Department of Health and Human Services: Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents  From the Department of Veterans Affairs: Treatment Decisions for HIV  From the National Institute of Allergy and Infectious Diseases: HIV/AIDS Treatment

Just Diagnosed: Next Steps After Testing Positive for HIV

Key Points

 Testing positive for HIV often leaves a person overwhelmed with questions and concerns. It’s important to remember that HIV is a manageable disease that can be treated with HIV medicines. HIV medicines can’t cure HIV, but they help people with HIV live longer, healthier lives.  The first step after testing HIV positive is to see a health care provider, even if you don’t feel sick. Prompt medical care and treatment with HIV medicines as soon as possible is the best way to stay healthy.  It is recommended that people with HIV start taking HIV medicines as soon as possible. Deciding when to start HIV medicines and what medicines to take begins with an HIV baseline evaluation.  An HIV baseline evaluation includes a review of the person’s health and medical history, a physical exam, and lab tests.

What is the next step after testing positive for HIV?

Testing positive for HIV often leaves a person overwhelmed with questions and concerns. It’s important to remember that HIV is a manageable disease that can be treated with HIV medicines.

The first step after testing positive is to see a health care provider, even if you don’t feel sick. People with HIV work closely with their health care providers to decide when to start HIV medicines and what HIV medicines to take.

The use of HIV medicines to treat HIV infection is called antiretroviral therapy (ART). ART involves taking a combination of HIV medicines (called an HIV regimen) every day. ART can’t cure HIV, but it helps people with HIV live longer, healthier lives and reduces the risk of HIV transmission. 57

It is recommended that people with HIV start ART as soon as possible. Deciding when to start ART and what HIV medicines to take begins with an HIV baseline evaluation.

What is an HIV baseline evaluation?

An HIV baseline evaluation includes all the information collected during a person’s initial visits with a health care provider. The HIV baseline evaluation includes a review of the person’s health and medical history, a physical exam, and lab tests.

The purpose of an HIV baseline evaluation is to:

 Determine how far a person’s HIV infection has progressed. Treatment with HIV medicines can prevent HIV from advancing to AIDS. AIDS is the final stage of HIV infection.  Evaluate whether the person is ready to start lifelong treatment with HIV medicines.  Collect information to decide what medicines to start.

During an HIV baseline evaluation, the health care provider explains the benefits and risks of HIV treatment and discusses ways to reduce the risk of passing HIV to others. The health care provider also takes time to answer any questions.

What are some questions people typically ask during their first visits with an HIV health care provider?

People newly diagnosed with HIV infection have many questions. If you’ve just tested HIV positive you may have some of the following questions:

 Because I have HIV, will I eventually get AIDS?  What can I do to stay healthy and avoid getting other infections?  How can I prevent passing HIV to others?  How will HIV treatment affect my lifestyle?  How should I tell my partner that I have HIV?  Is there any reason to tell my employer and those I work with that I have HIV?  Are there support groups for people with HIV? 58

Many people find it helpful to write down questions before a medical appointment. Some people bring a family member or friend to their HIV appointments to remind them of questions to ask and to write down the answers.

What lab tests are included in an HIV baseline evaluation?

The following lab tests are included in an HIV baseline evaluation.

CD4 count A CD4 count measures the number of CD4 cells in a sample of blood. CD4 cells are infection-fighting cells of the immune system. HIV destroys CD4 cells, which damages the immune system. A damaged immune system makes it hard for the body to fight off infections. Treatment with HIV medicines prevents HIV from destroying CD4 cells. The higher a person’s CD4 count is, the better.

ART is recommended as soon as possible for everyone with HIV, no matter how high or low their CD4 count is. However, a low CD4 count (below 200 cells/mm3) increases the urgency to start ART.

The CD4 count is also used to monitor the effectiveness of HIV medicines once ART is started.

Viral load A viral load test measures how much virus is in the blood (HIV viral load). A goal of HIV treatment is to keep a person’s viral load so low that the virus can’t be detected by a viral load test.

Drug-resistance testing Drug-resistance testing identifies which, if any, HIV medicines will not be effective against a person’s strain of HIV. Health care providers consider a person’s drug resistance test results when recommending an HIV regimen.

Testing for sexually transmitted infections (STIs) Coinfection with another STI can cause HIV infection to advance faster and increase the risk of HIV transmission to a sexual partner. STI testing makes it possible to detect and treat any STIs promptly. 59

An HIV baseline evaluation also includes other tests, such as a blood cell count, kidney and liver function tests, blood glucose and blood fat level tests, and tests for hepatitis.

To learn more, view the AIDSinfo infographic: What do my lab results mean?

How does an HIV baseline evaluation help determine if a person is ready to start HIV treatment?

Before starting treatment, people with HIV must be prepared to take HIV medicines every day for the rest of their lives. A baseline evaluation can help to identify any issues that can make it difficult to take HIV medicines every day and exactly as prescribed (called medication adherence).

Issues, such as lack of health insurance or alcohol or drug abuse, can make medication adherence difficult. Health care providers can recommend resources to help people deal with any issues before they start taking HIV medicines.

How can I find more resources for a person who has just tested HIV positive?

The following are resources to share with someone newly diagnosed with HIV:

 How to Find HIV Treatment Services, a fact sheet listing HIV-related resources including resources to help find a health care provider and get help paying for HIV medicines, from AIDSinfo.  Question Builder, a tool to use to create a list of questions to ask a health care provider, from the Agency for Healthcare Research and Quality.  Do You Have to Tell? A webpage with tips on how to share an HIV diagnosis with others, from AIDS.gov.

This fact sheet is based on information from these sources:

 From the Department of Veterans Affairs: Just Diagnosed  From the Health Resources and Services Administration: Guide for HIV/AIDS Clinical Care/Testing and Assessment  From the Department of Health and Human Services: Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents: Baseline Evaluation and Initiation of Antiretroviral Therapy 60

When to Start Antiretroviral Therapy

Key Points

 Antiretroviral therapy (ART) is the use of HIV medicines to treat HIV infection. ART is recommended for everyone infected with HIV. ART helps people with HIV live longer, healthier lives.  People with HIV should start ART as soon as possible. In HIV-infected people with the following conditions, it’s especially important to start ART right away: pregnancy, AIDS, certain HIV-related illnesses and coinfections, and early HIV infection. (Early HIV infection is the period up to 6 months after infection with HIV.)  Before starting ART, people with HIV discuss the benefits and risks of ART with their health care providers. They also discuss the importance of medication adherence—taking HIV medicines every day and exactly as prescribed.

When is it time to start taking HIV medicine?

Treatment with HIV medicines (called antiretroviral therapy or ART for short) is recommended for everyone infected with HIV. ART helps people with HIV live longer, healthier lives and reduces the risk of HIV transmission.

The Department of Health and Human Services (HHS) guidelines on the use of HIV medicines in adults and adolescents recommend that people with HIV start ART as soon as possible. In HIV-infected people with certain conditions, it’s especially important to start ART right away.

What conditions increase the urgency to start ART?

The following conditions increase the urgency to start ART:

 Pregnancy  AIDS  Certain HIV-related illnesses and coinfections  Early HIV infection 61

Pregnancy All pregnant women with HIV should take HIV medicines to prevent mother-to-child transmission of HIV. The HIV medicines will also protect the health of the pregnant woman.

All pregnant women with HIV should start taking HIV medicines as soon as possible during pregnancy. In general, women who are already taking HIV medicines when they become pregnant should continue taking HIV medicines throughout their pregnancies. When HIV infection is diagnosed during pregnancy, ART should be started right away.

AIDS Acquired immunodeficiency syndrome (AIDS) is the most advanced stage of HIV infection. People with AIDS should start ART immediately.

A diagnosis of AIDS is based on the following criteria:

 A CD4 count less than 200 cells/mm3. A low CD4 count is a sign that HIV has severely damaged the immune system.

OR

 Illness with an AIDS-defining condition. AIDS-defining conditions are infections and cancers that are life-threatening in people with HIV. Certain forms of cervical cancer and tuberculosis are examples of AIDS-defining conditions.

HIV-related illnesses and coinfections Some illnesses that develop in people infected with HIV increase the urgency to start ART. These illnesses include HIV-related kidney disease and certain opportunistic infections (OIs). OIs are infections that develop more often or are more severe in people with weakened immune systems, such as people with HIV.

Coinfection is when a person has two or more infections at the same time. Coinfection with HIV and certain other infections, such as hepatitis B or hepatitis C virus infection, increases the urgency to start ART. 62

Early HIV infection Early HIV infection is the period up to 6 months after infection with HIV. During early HIV infection, the level of HIV in the body (called viral load) is very high. A high viral load damages the immune system and increases the risk of HIV transmission.

ART helps people with HIV live longer, healthier lives. Studies suggest that these benefits begin even when ART is started in early HIV infection. In addition, starting ART during early HIV infection reduces the risk of HIV transmission.

Once a person starts ART, why is medication adherence important?

ART is a life-long treatment that helps people with HIV live longer, healthier lives. Before starting ART, people with HIV discuss the benefits and risks of ART with their health care providers. They also discuss the importance of medication adherence—taking HIV medicines every day and exactly as prescribed. Adherence to an HIV regimen prevents HIV from multiplying and destroying the immune system. Taking HIV medicines every day also reduces the risk of HIV transmission.

Before starting ART, it’s important to address issues that can make adherence difficult. For example, a busy schedule or lack of health insurance to cover the cost of HIV medicines can make it hard to take HIV medicines consistently. Health care providers can recommend resources to help people deal with any issues that may interfere with adherence.

Read the following AIDSinfo fact sheets to learn more about medication adherence:

 HIV Medication Adherence  Following an HIV Regimen: Steps to Take Before and After Starting HIV Medicines

This fact sheet is based on information from the following sources:

From the U.S. Department of Health and Human Services: 63

 Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents: Initiation of Antiretroviral Therapy and Acute and Recent (Early) HIV Infection  Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States: Recommendations for Use of Antiretroviral Drugs During Pregnancy: Overview, HIV-Infected Pregnant Women Who Are Currently Receiving Antiretroviral Therapy, and Pregnant Women Living with HIV Who Have Never Received Antiretroviral Drugs (Antiretroviral Naive)

What to Start: Choosing an HIV Regimen

Key Points

 The use of HIV medicines to treat HIV infection is called antiretroviral therapy (ART). People on ART take a combination of HIV medicines (called an HIV regimen) every day.  HIV medicines are grouped into six drug classes according to how they fight HIV. The six drug classes include more than 25 HIV medicines.  In general, a person’s first HIV regimen includes three HIV medicines from at least two different drug classes.  The choice of HIV medicines to include in an HIV regimen depends on a person's individual needs. When choosing an HIV regimen, people with HIV and their health care providers consider many factors, including possible side effects of HIV medicines and potential drug interactions.

What is an HIV regimen?

An HIV regimen is a combination of HIV medicines used to treat HIV infection. HIV treatment (also called antiretroviral therapy or ART) begins with choosing an HIV regimen. People on ART take the HIV medicines in their HIV regimens every day. ART helps people with HIV live longer, healthier lives and reduces the risk of HIV transmission.

There are more than 25 HIV medicines approved by the U.S. Food and Drug Administration (FDA) to treat HIV infection. Some HIV medicines are available in combination (in other words, two or more different HIV medicines combined in one pill). 64

The U.S. Department of Health and Human Services (HHS) provides guidelines on the use of HIV medicines. In general, the guidelines recommend starting ART with a regimen that includes three HIV medicines from at least two different drug classes.

What are the HIV drug classes?

HIV medicines are grouped into six drug classes according to how they fight HIV. The six drug classes are:

 Non-nucleoside reverse transcriptase inhibitors (NNRTIs)  Nucleoside reverse transcriptase inhibitors (NRTIs)  Protease inhibitors (PIs)  Fusion inhibitors  CCR5 antagonists (CCR5s) (also called entry inhibitors)  Integrase strand transfer inhibitors (INSTIs)

In general, a person's first HIV regimen includes two NRTIs plus an INSTI, an NNRTI, or a PI boosted with cobicistat (brand name: Tybost) or ritonavir (brand name: Norvir). Cobicistat or ritonavir increase (boost) the effectiveness of the PI.

Click here to see the AIDSinfo fact sheet that lists the FDA-approved HIV medicines by drug class.

What factors are considered when choosing an HIV regimen?

The choice of HIV medicines to include in an HIV regimen depends on a person’s individual needs. When choosing an HIV regimen, people with HIV and their health care providers consider the following factors:

 Other diseases or conditions that the person with HIV may have, for example heart disease or pregnancy.  Possible side effects of HIV medicines.  Potential interactions between HIV medicines or between HIV medicines and other medicines the person with HIV is taking.  Results of drug-resistance testing (and other tests). Drug-resistance testing identifies which, if any, HIV medicines won’t be effective against a person’s HIV. 65

 Convenience of the regimen. For example, a regimen that includes two or more HIV medicines combined in one pill is convenient to follow.  Any issues that can make it difficult to follow an HIV regimen. For example, a busy schedule can make it hard to take HIV medicines consistently every day.  Cost of HIV medicines.

The HHS guidelines on the use of HIV medicines in adults and adolescents recommend several regimens for people starting ART. The best regimen for a person depends on their individual needs.

How long does it take for ART to work?

Viral load is the amount of HIV in a person’s blood. A main goal of ART is to reduce a person’s viral load to an undetectable level. An undetectable viral load means that the level of HIV in the blood is too low to be detected by a viral load test.

Once effective ART is started, it usually takes 3 to 6 months for a person’s viral load to reach an undetectable level. Having an undetectable viral load doesn’t mean a person’s HIV is cured. But although there is still some HIV in the person’s body, an undetectable viral load shows that ART is working effectively. Effective ART helps people with HIV live longer, healthier lives and reduces the risk of HIV transmission.

This fact sheet is based on information from the following sources:

 From the Department of Health and Human Services: Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents: Treatment Goals and What to Start: Initial Combination Regimens for the Antiretroviral-Naive Patient  From the Department of Veterans Affairs: Treatment Decisions

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FDA-Approved HIV Medicines

Treatment with HIV medicines is called antiretroviral therapy (ART). ART is recommended for everyone with HIV. People on ART take a combination of HIV medicines (called an HIV regimen) every day. A person's initial HIV regimen generally includes three HIV medicines from at least two different drug classes.

ART can’t cure HIV, but HIV medicines help people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission.

The following table lists HIV medicines approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in the United States. The HIV medicines are listed according to drug class and identified by generic and brand names. Click on a drug name to view information on the drug from the AIDSinfo Drug Database. Or download the AIDSinfo Drug Database app to view the information on your Apple or Android devices.

To see a timeline of all FDA approval dates for HIV medicines, view the AIDSinfo FDA Approval of HIV Medicines infographic.

FDA-Approved HIV Medicines

FDA Generic Name Brand Drug Class Approval (Other names and acronyms) Name Date Nucleoside Reverse Transcriptase Inhibitors (NRTIs) NRTIs block reverse transcriptase, abacavir Ziagen December an enzyme HIV needs to make (abacavir sulfate, ABC) 17, 1998 copies of itself. Videx October 9, 1991 67

FDA-Approved HIV Medicines

FDA Generic Name Brand Drug Class Approval (Other names and acronyms) Name Date didanosine Videx EC October 31, (delayed-release didanosine, dideoxyinosine, enteric-coated (enteric- 2000 didanosine, ddI, ddI EC) coated) emtricitabine Emtriva July 2, 2003 (FTC) lamivudine Epivir November (3TC) 17, 1995 stavudine Zerit June 24, (d4T) 1994 tenofovir disoproxil Viread October 26, fumarate 2001 (tenofovir DF, TDF) zidovudine Retrovir March 19, (azidothymidine, AZT, ZDV) 1987 Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) NNRTIs bind to and later alter efavirenz Sustiva September reverse transcriptase, an enzyme (EFV) 17, 1998 HIV needs to make copies of itself. etravirine Intelence January 18, (ETR) 2008 nevirapine Viramune June 21, (extended-release nevirapine, NVP) 1996 68

FDA-Approved HIV Medicines

FDA Generic Name Brand Drug Class Approval (Other names and acronyms) Name Date Viramune March 25, XR 2011 (extended release) rilpivirine Edurant May 20, (rilpivirine hydrochloride, RPV) 2011 Protease Inhibitors (PIs) PIs block HIV protease, an enzyme atazanavir Reyataz June 20, HIV needs to make copies of itself (atazanavir sulfate, ATV) 2003 darunavir Prezista June 23, (darunavir ethanolate, DRV) 2006 fosamprenavir Lexiva October 20, (fosamprenavir calcium, FOS-APV, FPV) 2003 indinavir Crixivan March 13, (indinavir sulfate, IDV) 1996 nelfinavir Viracept March 14, (nelfinavir mesylate, NFV) 1997 ritonavir Norvir March 1, (RTV) 1996 69

FDA-Approved HIV Medicines

FDA Generic Name Brand Drug Class Approval (Other names and acronyms) Name Date

*Although ritonavir is a PI, it is generally used as a pharmacokinetic enhancer as recommended in the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection. saquinavir Invirase December 6, (saquinavir mesylate, SQV) 1995 tipranavir Aptivus June 22, (TPV) 2005 Fusion Inhibitors Fusion inhibitors block HIV from enfuvirtide Fuzeon March 13, entering the CD4 cells of (T-20) 2003 the immune system. Entry Inhibitors Entry inhibitors block proteins on maraviroc Selzentry August 6, the CD4 cells that HIV needs to (MVC) 2007 enter the cells. Integrase Inhibitors 70

FDA-Approved HIV Medicines

FDA Generic Name Brand Drug Class Approval (Other names and acronyms) Name Date Integrase inhibitors block HIV dolutegravir Tivicay August 13, integrase, an enzyme HIV needs to (DTG, dolutegravir sodium) 2013 make copies of itself. elvitegravir Vitekta September (EVG) 24, 2014 raltegravir Isentress October 12, (raltegravir potassium, RAL) 2007 Isentress HD May 26, 2017 Pharmacokinetic Enhancers Pharmacokinetic enhancers are cobicistat Tybost September used in HIV treatment to increase (COBI) 24, 2014 the effectiveness of an HIV medicine included in an HIV regimen. Combination HIV Medicines Combination HIV medicines abacavir and lamivudine Epzicom August 2, contain two or more HIV (abacavir sulfate / lamivudine, ABC / 3TC) 2004 medicines from one or more drug classes. abacavir, dolutegravir, and lamivudine Triumeq August 22, (abacavir sulfate / dolutegravir sodium / lamivudine, ABC / DTG 2014 / 3TC) 71

FDA-Approved HIV Medicines

FDA Generic Name Brand Drug Class Approval (Other names and acronyms) Name Date abacavir, lamivudine, and zidovudine Trizivir November (abacavir sulfate / lamivudine / zidovudine, ABC / 3TC / ZDV) 14, 2000 atazanavir and cobicistat Evotaz January 29, (atazanavir sulfate / cobicistat, ATV / COBI) 2015 darunavir and cobicistat Prezcobix January 29, (darunavir ethanolate / cobicistat, DRV / COBI) 2015 efavirenz, emtricitabine, and tenofovir disoproxil fumarate Atripla July 12, 2006 (efavirenz / emtricitabine / tenofovir DF, EFV / FTC / TDF) elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide Genvoya November 5, fumarate 2015 (elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide, EVG / COBI / FTC / TAF) elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil Stribild August 27, fumarate 2012 (QUAD, EVG / COBI / FTC / TDF) emtricitabine, rilpivirine, and tenofovir alafenamide Odefsey March 1, (emtricitabine / rilpivirine / tenofovir AF, emtricitabine / 2016 rilpivirine / tenofovir alafenamide fumarate, emtricitabine / rilpivirine hydrochloride / tenofovir AF, emtricitabine / rilpivirine hydrochloride / tenofovir alafenamide, emtricitabine / rilpivirine hydrochloride / tenofovir alafenamide fumarate, FTC / RPV / TAF) 72

FDA-Approved HIV Medicines

FDA Generic Name Brand Drug Class Approval (Other names and acronyms) Name Date emtricitabine, rilpivirine, and tenofovir disoproxil fumarate Complera August 10, (emtricitabine / rilpivirine hydrochloride / tenofovir disoproxil 2011 fumarate, emtricitabine / rilpivirine / tenofovir, FTC / RPV / TDF) emtricitabine and tenofovir alafenamide Descovy April 4, 2016 (emtricitabine / tenofovir AF, emtricitabine / tenofovir alafenamide fumarate, FTC / TAF) emtricitabine and tenofovir disoproxil fumarate Truvada August 2, (emtricitabine / tenofovir DF, FTC / TDF) 2004 lamivudine and zidovudine Combivir September (3TC / ZDV) 27, 1997 lopinavir and ritonavir Kaletra September (ritonavir-boosted lopinavir, LPV/r, LPV / RTV) 15, 2000

This fact sheet is based on information from the following sources:

 From FDA: Antiretroviral Drugs Used in the Treatment of HIV Infection  From the National Institute of Allergy and Infectious Diseases: Drugs That Fight HIV-1  From the National Library of Medicine: Drug information from the DailyMed website

73

Drug Resistance

Key Points

 As HIV multiplies in the body, the virus sometimes mutates (changes form) and produces variations of itself. Variations of HIV that develop while a person is taking HIV medicines can lead to drug-resistant strains of HIV.  With drug resistance, HIV medicines that previously controlled a person’s HIV are not effective against new, drug-resistant HIV. In other words, the HIV medicines can't prevent the drug-resistant HIV from multiplying. Drug resistance can cause HIV treatment to fail.  A person can initially be infected with drug-resistant HIV or develop drug-resistant HIV after starting HIV medicines.  Drug-resistance testing identifies which, if any, HIV medicines won’t be effective against a person’s HIV. Drug-resistance testing results help determine which HIV medicines to include in an HIV treatment regimen.  Medication adherence—taking HIV medicines every day and exactly as prescribed—reduces the risk of drug resistance.

What is HIV drug resistance?

Once a person becomes infected with HIV, the virus begins to multiply (make copies of itself) in the body. As HIV multiplies, it sometimes mutates (changes form) and produces variations of itself. Variations of HIV that develop while a person is taking HIV medicines can lead to drug-resistant strains of HIV.

With drug resistance, HIV medicines that previously controlled the person’s HIV are not effective against the new, drug-resistant HIV. In other words, the HIV medicines can’t prevent the drug-resistant HIV from multiplying. Drug resistance can cause HIV treatment to fail.

Drug-resistant HIV can spread from person to person. People initially infected with drug-resistant HIV have drug resistance to one or more HIV medicines even before they start taking HIV medicines.

How does poor medication adherence increase the risk of drug resistance? 74

Medication adherence means taking HIV medicines every day and exactly as prescribed. HIV medicines prevent HIV from multiplying. Skipping HIV medicines allows HIV to multiply, which increases the risk that the virus will mutate and produce drug-resistant HIV.

As a result of drug resistance, one or more HIV medicines in a person’s HIV regimen may no longer be effective.

What is cross resistance?

Cross resistance is when resistance to one HIV medicine causes resistance to other medicines in the same HIV drug class. (HIV medicines are grouped into drug classes according to how they fight HIV.) As a result of cross resistance, a person’s HIV may be resistant even to HIV medicines that the person has never taken. Cross resistance limits the number of HIV medicines available to include in an HIV regimen.

What is drug-resistance testing?

Drug-resistance testing is done to identify which, if any, HIV medicines won’t be effective against a person’s strain of HIV. Drug-resistance testing is done using a sample of blood.

Drug-resistance testing is done when a person first begins receiving care for HIV infection. Resistance testing should be done whether the person decides to start taking HIV medicines immediately or to delay treatment. If treatment is delayed, resistance testing may be repeated when HIV medicines are started.

Drug-resistance testing done before a person starts HIV medicines for the first time can show whether the person was initially infected with a drug-resistant strain of HIV. Drug-resistance testing results are used to decide which HIV medicines to include in a person’s first HIV regimen. 75

After treatment is started, drug-resistance testing is repeated if viral load testing indicates that a person’s HIV regimen isn’t controlling the virus. If drug-resistance testing shows that the HIV regimen isn’t effective because of drug resistance, the test results can be used to select a new HIV regimen.

Drug-resistance testing is also recommended for all HIV-infected pregnant women before starting HIV medicines and also in some pregnant women already taking HIV medicines. Pregnant women will work with their health care providers to decide if drug-resistance testing is needed.

How can a person taking HIV medicines reduce the risk of drug resistance?

Adherence to an effective HIV treatment regimen reduces the risk of drug resistance.

Here are some tips on medication adherence for people living with HIV:

 Once you decide to start treatment, work closely with your health care provider to choose an HIV regimen that suits your needs. A regimen that meets your needs will make adherence easier. Tell your health care provider about any issues that can make adherence difficult. For example, tell your health care provider if you have a busy schedule that makes it hard to take medicines on time or lack health insurance to cover the cost of HIV medicines. Your health care provider can recommend resources to help you address any issues before you start taking HIV medicines.  When you start treatment, closely follow your HIV regimen. Take your HIV medicines every day and exactly as prescribed. Use medication aids such as a 7-day pill box or pill diary to stay on track. Download the AIDSinfo Drug Database app to set daily pill reminders.  Keep your medical appointments so that your health care provider can monitor your HIV treatment. Appointments are a good time to ask questions and ask for help to manage problems that make it hard to follow an HIV regimen.

How can I learn more about drug resistance?

 Read about HIV resistance testing.  Get more tips on HIV medication adherence.  View the AIDSinfo drug resistance infographic. 76

This fact sheet is based on information from the following sources:

 From the Department of Health and Human Services: Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents/Drug-Resistance Testing  From the Health Resources and Services Administration: Guide for HIV/AIDS Clinical Care/Resistance Testing  From the National Institute of Allergy and Infectious Diseases: HIV/AIDS Treatment

HIV Medication Adherence

Key Points

 Medication adherence means sticking firmly to an HIV regimen—taking HIV medicines every day and exactly as prescribed.  HIV medicines prevent HIV from multiplying, which protects the immune system and reduces the risk of both drug resistance and HIV treatment failure. Medication adherence lets HIV medicines do their job!  Adherence can be difficult for many reasons. For example, side effects from some HIV medicines can make it hard to stick to an HIV regimen, or a medication dosing schedule might not fit well into a person’s routine.  Strategies to help maintain adherence include using a 7-day pill box and setting daily pill reminders on a smartphone. For more tips on medication adherence, read the AIDSinfo fact sheet: Following an HIV Regimen: Steps to Take Before and After Starting HIV Medicines.

What is medication adherence?

Adherence means “to stick firmly.” So for people with HIV, medication adherence means sticking firmly to an HIV regimen—taking HIV medicines every day and exactly as prescribed.

Why is adherence to an HIV regimen important?

Adherence to an HIV regimen gives HIV medicines the chance to do their job: to prevent HIV from multiplying and destroying the immune system. HIV medicines help people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission. 77

Poor adherence to an HIV regimen allows HIV to destroy the immune system. A damaged immune system makes it hard for the body to fight off infections and certain cancers. Poor adherence also increases the risk of drug resistance and HIV treatment failure.

What is drug resistance?

Drug resistance can develop as HIV multiplies in the body. When HIV multiplies, the virus sometimes mutates (changes form) and makes variations of itself. Variations of HIV that develop while a person is taking HIV medicines can lead to new, drug-resistant strains of HIV. With drug resistance, HIV medicines that used to suppress the person’s HIV are not effective against the new drug-resistant HIV. In other words, the person’s HIV continues to multiply.

Once drug-resistant HIV develops, it remains in the body. Drug resistance limits the number of HIV medicines available to include in a current or future HIV regimen.

What is the connection between medication adherence and drug resistance?

Taking HIV medicines every day prevents HIV from multiplying, which reduces the risk that HIV will mutate and produce drug-resistant HIV. Skipping HIV medicines allows HIV to multiply, which increases the risk of drug-resistant HIV developing.

Research shows that a person’s first HIV regimen offers the best chance for long-term treatment success. So adherence is important from the start—when a person first begins taking HIV medicines.

Why is medication adherence sometimes difficult?

Adherence to an HIV regimen can be difficult for several reasons. For example, side effects from some HIV medicines, such as nausea or diarrhea, can make it hard to follow an HIV regimen. When an HIV regimen includes several HIV medicines, it’s easy to forget how many pills to take and when to take them.

The following factors can also make medication adherence difficult: 78

 Side effects from interactions between HIV medicines and other medicines a person may take  Trouble swallowing pills or other difficulty taking medicines  A busy schedule, shift work, or travel away from home that makes it hard to take medicines on time  Having an unstable living or housing situation  Illness or depression  Alcohol or drug use that interferes with the activities of daily life  Fear of disclosing one’s HIV-positive status to others  Lack of health insurance to cover the cost of HIV medicines

Before starting HIV medicines, it helps to have strategies in place to maintain adherence. Strategies may include using a 7-day pill box or using an app, such as the AIDSinfo Drug Database app, to set daily pill reminders. Also, health care providers can provide helpful referrals and resources for anticipated adherence challenges. People can work with their health care providers to select an HIV regimen that works best for their needs and lifestyle.

To get more tips on adherence, read the AIDSinfo fact sheet: Following an HIV Regimen: Steps to Take Before and After Starting HIV Medicines.

This fact sheet is based on information from the following sources.

 From the Department of Health and Human Services: Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents/Adherence to Antiretroviral Therapy  From the Health Resources and Services Administration: Guide for HIV/AIDS Clinical Care: HIV Treatment/Adherence

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Following an HIV Regimen: Steps to Take Before and After Starting HIV Medicines

Key Points

 An essential part of following an HIV regimen is medication adherence. Medication adherence means sticking firmly to an HIV regimen—taking HIV medicines every day and exactly as prescribed.  Medication adherence reduces the risk of drug resistance and treatment failure.  Before starting an HIV regimen, tell your health care provider about any issues that can make adherence difficult, such as lack of health insurance or alcohol or drug abuse.  After starting an HIV regimen, medication aids such as pill boxes, pill reminders, and medication diaries can help to maintain long- term medication adherence.

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Before starting an HIV regimen, talk to your health care provider about medication adherence.

Talking with your health care provider will help you understand why you’re starting HIV treatment and why medication adherence is important. Medication adherence means sticking firmly to an HIV regimen—taking HIV medicines every day and exactly as prescribed.

Your health care provider will explain that taking HIV medicines every day can protect your health and prevent your HIV infection from advancing to AIDS. The HIV medicines will also reduce your risk of passing HIV to another person during sex. Your health care provider will emphasize that adherence to an HIV regimen reduces the risk of drug resistance and treatment failure.

Information that you share with your health care provider will make it easier to select an HIV regimen that suits your needs. The information will also help you and your health care provider plan ahead for any issues that may make adherence difficult.

What should I tell my health care provider before starting an HIV regimen?

Tell your health care provider about other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Other medicines you take may interact with the HIV medicines in your HIV regimen. A drug interaction can reduce or increase the effect of a medicine or cause side effects.

Tell your health care provider about any issues that can make adherence difficult. Issues such as lack of health insurance or alcohol or drug use can make it hard to follow an HIV regimen. If needed, your health care provider can recommend resources to help you address any issues before you start treatment.

Describe your schedule at home and at work to your health care provider. Working together, you can arrange your HIV medication schedule to match your day-to-day routine.

Ask your health care provider for written instructions on how to follow your HIV regimen. The instructions should include the following details: 81

 Each HIV medicine included in your regimen  How much of each medicine to take  When to take each medicine  How to take each medicine (for example, with or without food)  Possible side effects from each medicine, including serious side effects  How to store each medicine

Use small candies to practice following the instructions. The practice will help you identify and address problems with adherence before you start your HIV regimen.

After you start an HIV regimen, use a variety of strategies to maintain adherence.

To maintain adherence over the long term, try some of the following strategies:

 Use a 7-day pill box. Once a week, fill the pill box with your HIV medicines for the entire week.  Take your HIV medicines at the same time every day.  Set the alarm on your cell phone to remind you to take your medicines. (An alarm clock or timer works too.) Or download the AIDSinfo Drug App to bookmark your HIV medicines, make notes, and set daily pill reminders.  Ask your family members, friends, or coworkers to remind you to take your medicines.  Keep your medicines nearby. Keep a back-up supply of medicines at work or in your purse or briefcase.  Plan ahead for changes in your daily routine, including weekends and holidays. If you’re going away, pack enough medicine to last the entire trip.  Use an app or an online or paper medicine diary to stay on track. Enter the name of each medicine; include the dose, number of pills to take, and when to take them. Record each medicine as you take it. Reviewing your diary will help you identify the times that you’re most likely to forget to take your medicines.  Keep all of your medical appointments. Use a calendar to keep track of your appointments. If you run low on medicines before your next appointment, call your health care provider to renew your prescriptions.  Get additional tips on adherence by joining a support group for people living with HIV.

What should I do if I forget to take my HIV medicines? 82

Unless your health care provider tells you otherwise, take the medicine you missed as soon as you realize you skipped it. But if it’s almost time for the next dose of the medicine, don’t take the missed dose and instead just continue on your regular medication schedule. Don’t take a double dose of a medicine to make up for a missed dose.

Discuss medication adherence at each appointment with your health care provider.

Tell your health care provider if you’re having difficulty following your regimen. Don’t forget to mention any side effects you’re having. Side effects from HIV medicines are a major reason why medication adherence can be difficult.

Let your health care provider know if your regimen is too complicated to follow. Your health care provider may simplify your regimen by including fewer HIV medicines or by reducing the number of times a day you need to take your HIV medicines.

Discuss any issues that are causing you to skip medicines. Your health care provider can recommend resources to help you deal with the issues.

Learn more about adherence.

 Read this fact sheet on adherence.  Get tools and resources to help with medication adherence.

This fact sheet is based on information from the following sources:

 From the Department of Health and Human Services: Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents: Adherence to Antiretroviral Therapy  From the Health Resources and Services Administration: Guide for HIV/AIDS Clinical Care: HIV Treatment/Adherence

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HIV and Immunizations

Key Points

 Vaccines protect people from diseases such as chicken pox, flu, and polio. Vaccines are given by needle injection (a shot), by mouth, or sprayed into the nose. The process of getting a vaccine is called vaccination or immunization.  There are no vaccines to prevent or cure HIV, but people with HIV can benefit from vaccines against other diseases. The following vaccines are recommended for all people with HIV: hepatitis B; influenza (flu); human papillomavirus (HPV) (for those up to age 26); pneumococcal (pneumonia); and tetanus, diphtheria, and pertussis (a single vaccine that protects against the three diseases). Every 10 years, a repeat vaccine against tetanus and diphtheria is also recommended. Other vaccines may be recommended for some people with HIV.  In general, people with HIV should not get live, attenuated vaccines unless the benefit outweighs the risk.  Because HIV medicines strengthen the immune system and reduce HIV viral load, whenever possible people with HIV may want to start taking HIV medicines before getting immunizations.

What are vaccines?

Vaccines protect people from diseases such as chicken pox, flu, and polio. Vaccines are given by needle injection (a shot), by mouth, or sprayed into the nose. The process of getting a vaccine is called vaccination or immunization.

Most vaccines are designed to prevent a person from ever having a particular disease or to result in a person having only a mild case of the disease. When a person gets a vaccine, the body responds by mounting an immune response against the particular disease. An immune response includes all the actions of the immune system to defend the body against the infection.

Vaccines not only protect individuals from disease, they protect communities as well. When most people in a community get immunized against a disease, there is little chance of a disease outbreak.

Is there a vaccine against HIV? 84

Testing is underway on experimental vaccines to prevent and treat HIV/AIDS, but no HIV vaccines are approved for use outside of clinical trials. For more information about these vaccines, read the AIDSinfo fact sheets What is a Preventive HIV Vaccine? and What is a Therapeutic HIV Vaccine?

Even though there are no vaccines to prevent or cure HIV, people with HIV can benefit from vaccines against other diseases.

Can HIV infection affect the safety and effectiveness of vaccines?

Yes. Damage to the immune system due to HIV can reduce the body’s immune response to a vaccine. A weakened immune response makes a vaccine less effective. In general, vaccines work best when an HIV-infected person’s CD4 count is above 200 copies/mm3.

By stimulating the immune system, vaccines may also cause a person’s HIV viral load to increase temporarily.

Because HIV medicines strengthen the immune system and reduce HIV viral load, people with HIV may want to start antiretroviral therapy (ART) before getting vaccinated whenever possible. In some situations, however, immunizations should be given even if ART has not been started. For example, it’s important for people with HIV to get vaccinated against the flu at the time of year when the risk of flu is greatest.

Are all types of vaccines safe for people with HIV?

The design of a vaccine depends on several factors, such as how a microbe infects the body and how the immune system responds. For this reason, there are several types of vaccines, including live, attenuated vaccines and inactivated vaccines.

Live, attenuated vaccines: A live, attenuated vaccine contains a weakened but live form of a disease-causing microbe. Although the attenuated (weakened) microbe cannot cause the disease (or can cause only mild disease), the vaccine can still trigger an immune response. 85

Inactivated vaccines: Inactivated vaccines are made from microbes that have been killed with chemicals, heat, or radiation. There is no chance that an inactivated vaccine can cause the disease it was designed to prevent.

In general, to be safe, people with HIV should get inactivated vaccines to avoid even the remote chance of getting a disease from a live, attenuated vaccine. However, for some diseases, only live, attenuated vaccines are available. In this case, the protection offered by the live vaccine may outweigh the risks. Vaccines against chicken pox and shingles are examples of live, attenuated vaccines that, in certain situations, may be recommended for people with HIV.

Do vaccines cause side effects?

Side effects from vaccines are generally minor (for example, soreness at the location of an injection or a low-grade fever) and go away within a few days. Severe reactions to vaccines are rare. Before getting a vaccine, talk to your health care provider about the benefits and risks of the vaccine and possible side effects.

Which vaccines are recommended for people with HIV?

The following vaccines are recommended for people with HIV:

 Hepatitis B  Influenza (flu)  Pneumococcal (pneumonia)  Tetanus, diphtheria, and pertussis (whooping cough). A single vaccine called Tdap protects adolescents and adults against the three diseases. Every 10 years, a repeat vaccine against tetanus and diphtheria (called Td) is recommended.  Human papillomavirus (HPV) (for those up to age 26)

Additional vaccines may be recommended based on an HIV-infected person’s age, previous vaccinations, risk factors for a particular disease, or certain HIV-related factors. For more details, read this information from the Centers for Disease Control and Prevention (CDC): HIV Infection and Adult Vaccination. 86

What about travel and immunizations?

Regardless of destination, all travelers should be up to date on routine vaccinations. Those traveling to destinations outside the United States may need immunizations against diseases present in other parts of the world, such as cholera or yellow fever.

If you have HIV, talk to your health care provider about any vaccines you may need before you travel.

 If a required immunization is available only as a live, attenuated vaccine, your health care provider can give you a letter that excuses you from getting the vaccine.  If your CD4 count is less than 200 copies/mm3, your health care provider may recommend that you delay travel to give your HIV medicines time to strengthen your immune system.  To prepare for your trip, read information from CDC on Travelers with Weakened Immune Systems.  This fact sheet is based on information from the following sources:  From CDC, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America: Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents  From the Health Resources and Services Administration: Guide for HIV/AIDS Clinical Care/Immunizations for HIV-Infected Adults and Adolescents  From the National Institute of Allergy and Infectious Diseases: Vaccines

What is a Drug Interaction?

Key Points

 A drug interaction is a reaction between two (or more) drugs or between a drug and a food or beverage.  A drug interaction can decrease or increase the action of a drug or cause unwanted side effects.  Having an existing medical condition can also cause a drug interaction. For example, taking a nasal decongestant if you have high blood pressure may cause an unwanted reaction.  Treatment with HIV medicines (called antiretroviral therapy or ART) helps people with HIV live longer, healthier lives. But drug interactions can complicate HIV treatment. 87

 To avoid drug interactions, tell your health care provider about all prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

What is a drug interaction?

A drug interaction is a reaction between two (or more) drugs (called a drug-drug interaction) or between a drug and a food or beverage (called a drug-food interaction). An existing medical condition can make certain drugs potentially harmful (called a drug-condition interaction). For example, taking a nasal decongestant if you have high blood pressure may cause an unwanted reaction.

Medicines help us feel better and stay healthy. But drug interactions can cause problems by reducing or increasing the action of a medicine or causing adverse (unwanted) side effects.

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Are drug interactions a problem for people with HIV?

Treatment with HIV medicines (called antiretroviral therapy or ART) helps people with HIV live longer, healthier lives. But drug interactions, especially drug-drug interactions, can complicate HIV treatment.

Drug-drug interactions between HIV medicines are common. Interactions between HIV medicines may reduce or increase the concentration of an HIV medicine in the blood. The change in concentration can make the affected HIV medicine less effective, more effective, or so strong that it causes dangerous side effects.

Drug-drug interactions between HIV medicines and other medicines are also common. For example, some HIV medicines may make hormonal birth control less effective. Women using hormonal contraceptives may need to use an additional or different method of birth control to prevent pregnancy. For more information about using birth control and HIV medicines at the same time, view the AIDSinfoHIV and Birth Control infographic.

Can drug-food interactions and drug-condition interactions affect people with HIV?

Yes, the use of HIV medicines can lead to both drug-food interactions and drug-condition interactions.

Food or beverages can affect the absorption of some HIV medicines and increase or reduce the concentration of the medicine in the blood. Depending on the HIV medicine, the change in concentration may be helpful or harmful. Instructions for HIV medicines affected by food specify whether to take the medicine with or without food. (HIV medicines not affected by food can be taken with or without food.)

Pregnancy is a condition that can affect how the body processes HIV medicines. Because of these pregnancy-related changes, dosing of an HIV medicine may change during different stages of pregnancy. But pregnant women should always consult with their health care providers before making any changes to their HIV regimens.

How can I avoid drug interactions? 89

You can take the following steps to avoid drug interactions:

 Tell your health care provider about all prescription and nonprescription medicines you are taking or plan to take. Also tell your health care provider about any vitamins, nutritional supplements, and herbal products you take.  Before taking a medicine, ask your health care provider or pharmacist the following questions:  What is the medicine used for?  How should I take the medicine?  While taking the medicine, should I avoid any other medicines or certain foods or beverages?  Can I take this medicine safely with the other medicines that I am taking? Are there any possible drug interactions I should know about? What are the signs of those drug interactions?  In the case of a drug interaction, what should I do?  Take medicines according to your health care provider’s instructions. Always read the information and directions that come with a medicine. Drug labels and package inserts include important information about possible drug interactions.  Tell your health care provider if you have any side effect that bothers you or that does not go away.

Learn more about drug interactions.Read the Food and Drug Administration’s (FDA’s) Drug Interactions: What You Should Know webpage.

Browse the AIDSinfo Drug Database to find information on FDA-approved and investigational HIV/AIDS-related drugs, including information on drug interactions.

This fact sheet is based on information from the following sources:

 From the U.S. Department of Health and Human Services: Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents:  Considerations for Antiretroviral Use in Special Patient Populations: HIV-Infected Women  Considerations for Antiretroviral Use in Special Patient Populations: HIV and the Older Patient  Drug Interactions: Overview  From FDA: Avoiding Drug Interactions  From the National Institutes of Health (NIH) SeniorHealth.gov: Taking Medicines Last Reviewed: August 22, 2017 HIV Among Hispanics/Latinos August 2017

Fast Facts • Hispanics/Latinos are disproportionately affected by HIV.a • About 7 in 10 new HIV diagnoses among Hispanics/Latinos occur in gay and bisexual men.b • About half of Hispanics/Latinos living with HIV have achieved viral suppression.

HIV continues to be a serious threat to the health of the Hispanic/Latino community. In 2015, Hispanics/Latinos accounted for about one quarter of all new diagnoses of HIV in the United States, despite representing about 18% of the total US population. The Numbers HIV Diagnoses in the United States and 6 Dependent New HIV Infections Areas for the Most-Affected Subpopulations, 2015 From 2010 to 2014, estimated annual

HIV infections increased 14% (from 6,400 Black, Male-to- 10 ,318 to 7,300) among Hispanic/Latino gay, Male Sexual Contact bisexual, and other men who have sex White, Male-to- Male Sexual Contact 7,572 with men.c Hispanic/Latino, Male-to- 7,271 HIV and AIDS Diagnosesc Male Sexual Contact Black Women, 4,146 • In 2015, Hispanics/Latinos accounted Heterosexual Contact for 24% (9,798) of the 40,040 new Black Men, 1,926 diagnoses of HIV infection in the Heterosexual Contact Hispanic United States and 6 dependent Hispanic/Latina Women, 1,096 Heterosexual Contact Other areas.d Of those, 87% (8,563) were in men, and 12% (1,223) were 0 2000 4000 6000 8000 10000 12000 14000 in women. • Gay and bisexual men accounted Source: CDC. Diagnoses of HIV infection in the United States and dependent areas, 2015 (https://www.cdc.gov/hiv/pdf/ for 85% (7,271) of the HIV diagnoses library/reports/surveillance/cdc-hiv-surveillance-report-2015-vol-27.pdf). HIV Surveillance Report 2016;27. among Hispanic/Latino men in 2015. • Among Hispanic women/Latinas, 90% (1,096) of the diagnosed HIV infections were attributed to heterosexual contact.e • From 2010 to 2014, HIV diagnoses increased 2% among all Hispanics/Latinos, but trends varied among subgroups. ºº Diagnoses among Hispanic women/Latinas declined steadily (16%). ºº Diagnoses among all Hispanic/Latino gay and bisexual men increased (13%). ºº Diagnoses among young Hispanic/Latino gay and bisexual men (aged 13 to 24) increased 16%, a slower increase than in previous years. Living With HIV and Deaths • At the end of 2014, an estimated 235,600 Hispanics/Latinos were living with HIV in the United States. Of these, an estimated 17% were living with undiagnosed HIV. • Among all Hispanics/Latinos living with HIV in 2014, 83% had received a diagnosis, 58% received HIV medical care in 2014, 48% were retained in HIV care, and 48% had a suppressed viral load.f

a Hispanics/Latinos can be of any race. b The term male-to-male sexual contact is used in CDC surveillance systems. It indicates a behavior that transmits HIV infection, not how individuals self-identify in terms of their sexuality. This fact sheet uses the term gay and bisexual men. c Estimated annual HIV infections are the estimated number of new infections (HIV incidence) that occurred in a particular year, regardless of when those infections were diagnosed. HIV and AIDS diagnoses indicate when a person is diagnosed with HIV or AIDS, not when the person was infected. d Dependent areas: American Samoa, Guam, the Northern Mariana Islands, Puerto Rico, the Republic of Palau, and the US Virgin Islands. e Heterosexual contact with a person known to have, or be at high risk for, HIV infection. f People are considered retained in care if they get two viral load or CD4 tests at least 3 months apart in a year. (CD4 cells are the cells in the body’s immune system that are destroyed by HIV.) Viral suppression is based on the most recent viral load test.

National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Division of HIV/AIDS Prevention • In 2014, 916 deaths among Hispanics/Latinos were attributed directly to HIV. Prevention Challenges Why are Hispanics/Latinos at higher risk? In all communities, lack of awareness of HIV status contributes to HIV transmission. People who do not know they have HIV cannot take advantage of HIV care and treatment and may unknowingly pass HIV to others. • A number of challenges contribute to the higher rates of HIV infection among Hispanics/Latinos: • More Hispanics/Latinos are living with HIV than some other races/ethnicities. • Hispanics/Latinos have higher rates of some STDs than some other races/ethnicities. Having another STD can increase a person’s chance of getting or transmitting HIV. • Though not unique to Hispanics/Latinos, stigma, fear, discrimination, and homophobia impact Hispanic/Latino lives. These issues may put many Hispanics/Latinos at higher risk for HIV infection. • Poverty, migration patterns, lower educational level, and language barriers may make it harder for Hispanics/Latinos to get HIV testing and care. • Undocumented Hispanics/Latinos may be less likely to use HIV prevention services, get an HIV test, or get treatment if HIV-positive because of concerns about being arrested and deported. What CDC Is Doing CDC and its partners are pursuing a high-impact prevention approach to advance national HIV prevention goals and maximize the effectiveness of current HIV prevention methods. Activities include • Support and technical assistance to health departments and community-based organizations (CBOs) to deliver effective prevention interventions for Hispanics/Latinos: ºº Starting in 2012, CDC has awarded at least $330 million each year under the current funding opportunity (https://www.cdc. gov/hiv/funding/announcements/ps12-1201/index.html) for health departments to direct resources to the populations and geographic areas of greatest need and prioritize the HIV prevention strategies that will have the greatest impact. ºº In 2017, CDC awarded nearly $11 million per year for 5 years to 30 CBOs to provide HIV testing to young gay and bisexual men of color and transgender youth of color, with the goals of identifying undiagnosed HIV infections and linking those who have HIV to care and prevention services. • The Act Against AIDS (https://www.cdc.gov/actagainstaids/) initiative, which raises awareness about HIV through multiple campaigns and partnerships such as ºº Let’s Stop HIV Together (https://www.cdc.gov/actagainstaids/campaigns/lsht/index.html)(Detengamos Juntos el VIH (https://www. cdc.gov/actagainstaids/spanish/campaigns/together/index.html)), which raises awareness about HIV and its impact on the lives of all Americans. ºº Doing It (https://www.cdc.gov/actagainstaids/campaigns/doingit/) (Lo Estoy Haciendo / La Prueba del VIH (https://www.cdc.gov/ actagainstaids/spanish/campaigns/doingit/index.html)), which motivates individuals to get tested for HIV and know their status. ºº Start Talking. Stop HIV. (https://www.cdc.gov/actagainstaids/campaigns/starttalking/) (Inicia la conversación. Detén el VIH. (https:// www.cdc.gov/actagainstaids/spanish/campaigns/starttalking/index.html)), which encourages open discussion about a range of HIV prevention strategies and related sexual health issues between sex partners.

ºº Partnering and Communicating Together (PACT) (https://www.cdc.gov/actagainstaids/partnerships/ Additional Resources pact.html), a 5-year partnership with organizations such as the National Hispanic Medical CDC-INFO Association to raise awareness about testing, prevention, and retention in care among populations 1-800-CDC-INFO (232-4636) disproportionately affected by HIV, including Hispanics/Latinos. www.cdc.gov/info CDC HIV Website www.cdc.gov/hiv CDC Act Against AIDS Campaign www.cdc.gov/actagainstaids

Page 2 of 2 HIV Among African Americans February 2017

Fast Facts • African Americans are the racial/ethnic group most affected by HIV in the United States. • Gay and bisexual men account for a majority of new HIV diagnoses among African Americans. • There are promising signs of progress, especially among women and those who inject drugs.

Blacks/African Americansa account for a higher proportion of new HIV diagnoses, those living with HIV, and those ever diagnosed with AIDS, compared to other races/ethnicities. In 2015, African Americans accounted for 45% of HIV diagnoses, though they comprise 12% of the US population.b The Numbers HIV and AIDS Diagnosesc In 2015: • 17,670 African Americans were diagnosed with HIV in the United States (13,070 men and 4,524 women). • More than half (58%, 10,315) of African Americans diagnosed with HIV were gay or bisexual men.d • Among African American gay and bisexual men diagnosed with HIV, 38% (3,888) were young men aged 13 to 24. • 48% (8,702) of those diagnosed with AIDS in the United States were African Americans. From 2005 to 2014: • The number of HIV diagnoses HIV Diagnoses in the United States for the Most-Affected Subpopulations, 2015 among African American women fell 42%, though it is still high compared to women of other Black MSM 10,315 races/ethnicities. In 2015, 4,524 White MSM 7,570 African American women were diagnosed with HIV, compared Hispanic/Latino MSM 7,013 with 1,131 Hispanic/Latino women Black Women, 4,142 and 1,431 white women. Heterosexual Contact Black Men, 1,926 Blacks/ • HIV diagnoses among African Heterosexual Contact African Americans American gay and bisexual men Hispanic/Latina Women, 1,010 Other Races/ increased 22%. But diagnoses Heterosexual Contact Ethnicities stabilized in recent years, White Women, 968 Heterosexual Contact increasing less than 1% since 2010. • HIV diagnoses among young 02,000 4,000 6,000 8,000 10,000 12,000 African American gay and bisexual Source: CDC. Diagnoses of HIV infection in the United States and dependent areas, 2015. HIV Surveillance Report 2016;27 men (aged 13 to 24) increased (https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-report-2015-vol-27.pdf). Subpopulations 87%. But that trend has leveled off representing 2% or less of HIV diagnoses are not reflected in this chart. Abbreviation: MSM, men who have sex with men. recently, with diagnoses declining 2% since 2010. Living With HIV and Deaths • At the end of 2013, 498,400 African Americans were living with HIV (40% of everyone living with HIV in the US), and 1 in 8 did not know they were infected. • Of African Americans diagnosed with HIV in 2014, 72% were linked to HIV medical care within 1 month.e • Of African Americans diagnosed with HIV in 2012 or earlier, 54% were retained in continuous HIV care and 49% had a suppressed viral load (virus at low enough levels to stay healthy and reduce transmission risk).e • In 2014, 3,591 African Americans died of HIV or AIDS, accounting for 53% of total deaths attributed to the disease that year. Prevention Challenges In all communities, lack of awareness of HIV status contributes to HIV risk. People who do not know they have HIV cannot take advantage of HIV care and treatment and may unknowingly pass HIV to others.

National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Division of HIV/AIDS Prevention A number of challenges contribute to the higher rates of HIV infection among African Americans. The greater number of people living with HIV (prevalence) in African American communities and the fact that African Americans tend to have sex with partners of the same race/ethnicity mean that African Americans face a greater risk of HIV infection with each new sexual encounter. Some African American communities continue to experience higher rates of other sexually transmitted diseases (STDs) than other racial/ethnic communities in the United States. Having another STD can significantly increase a person’s chance of getting or transmitting HIV. The poverty rate is higher among African Americans than other racial/ethnic groups. The socioeconomic issues associated with poverty—including limited access to high-quality health care, housing, and HIV prevention education—directly and indirectly increase the risk for HIV infection and affect the health of people living with and at risk for HIV. These factors may explain why African Americans have worse outcomes on the HIV continuum of care, including lower rates of linkage to care and viral suppression. Stigma, fear, discrimination, and homophobia may also place many African Americans at higher risk for HIV. What CDC Is Doing CDC and its partners are pursuing a high-impact prevention approach to advance the goals of the National HIV/AIDS Strategy: Updated to 2020 (https://www.aids.gov/federal-resources/national-hiv-aids-strategy/overview/) and maximize the effectiveness of current HIV prevention methods. Some of CDC’s activities include: • Support for health departments and community-based organizations to deliver effective prevention interventions for African Americans and other populations. ºº Comprehensive HIV Prevention Programs for Health Departments (https://www.cdc.gov/hiv/funding/announcements/ps12-1201/ index.html), an HIV prevention initiative for health departments in states, territories, and select cities, including those serving African American clients. Starting in 2012, CDC has awarded at least $330 million each year ($343.7 million in 2015) under this funding opportunity. ºº Support (http://www.cdc.gov/hiv/funding/announcements/ps15-1509/index.html) for health departments to develop comprehensive models of prevention, care, and social services for gay and bisexual men of color living with or at risk for HIV, as well as training and technical assistance (https://www.cdc.gov/hiv/funding/announcements/ps15-1510/index.html) to implement and sustain those models. ºº A new funding opportunity (https://www.cdc.gov/hiv/funding/announcements/ps17-1704/index.html) beginning in 2017 to implement comprehensive HIV prevention programs for young gay and bisexual men of color. • Two new projects to help health departments reduce HIV infections and improve HIV medical care among gay and bisexual men of color. These funding opportunity announcements (FOAs) will increase gay and bisexual men’s access to pre-exposure prophylaxis (PrEP) (http://www.cdc.gov/hiv/risk/prep/index.html), increase health departments’ surveillance capacity, and support effective models of prevention and care for gay and bisexual men of color. • The Act Against AIDS (http://www.cdc.gov/actagainstaids/) campaigns, including ºº Let’s Stop HIV Together (http://www.cdc.gov/actagainstaids/campaigns/lsht/index.html), which raises HIV awareness and fights stigma among all Americans and provides many stories about people living with HIV; ºº Doing It (http://www.cdc.gov/actagainstaids/campaigns/doingit/index.html), a national HIV testing and prevention campaign that encourages all adults to know their HIV status and protect themselves and their community by making HIV testing a part of their regular health routine; ºº Start Talking. Stop HIV. (http://www.cdc.gov/actagainstaids/campaigns/starttalking/index.html) helps gay and bisexual men communicate about safer sex, testing, and other HIV prevention issues. ºº HIV Treatment Works (http://www.cdc.gov/actagainstaids/campaigns/hivtreatmentworks/index.html), which shows how people living with HIV have overcome barriers to stay in care and provides resources on how to live well with HIV; and ºº Partnering and Communicating Together (PACT) to Act Against AIDS (http://www.cdc.gov/actagainstaids/partnerships/pact.html), a 5-year partnership with organizations such as the National Black Justice Coalition, the National Urban League, and the Black Men’s Xchange to raise awareness about testing, prevention, and retention in care among populations disproportionately affected by HIV, including African Americans.

Additional Resources CDC-INFO 1-800-CDC-INFO (232-4636) www.cdc.gov/info a Referred to as African Americans in this fact sheet. CDC HIV Website b Does not include African Americans who are Hispanic/Latino. www.cdc.gov/hiv c HIV and AIDS diagnoses indicate when a person is diagnosed with HIV infection or AIDS, not when the person was infected. d IThe term male-to-male sexual contact is used in CDC surveillance systems. It indicates a behavior that transmits HIV infection, not how CDC Act Against AIDS individuals self-identify in terms of their sexuality. This fact sheet uses the term gay and bisexual men. Campaign e In 32 states and the District of Columbia (the areas with complete lab reporting by December 2015). www.cdc.gov/actagainstaids

Page 2 of 2 HIV Among Asians May 2017

Fast Facts • The number of HIV diagnoses among Asians in the United States increased in recent years. • Among Asians, gay and bisexual men are most affected by HIV. • Around 1 in 5 Asians living with HIV in the United States do not know they have it.

Between 2010 and 2014, the Asian populationa in the United States grew around 11%, more than three times as fast as the total U.S. population. During the same period, the number of Asians receiving an HIV diagnosis increased by 36%, driven primarily by an increase in HIV diagnoses among Asian gay and bisexual men.b Asians, who make up 6% of the population, continue to account for only a small percentage of new HIV diagnoses in the United States and 6 dependent areas. The Numbers HIV and AIDS Diagnosesc • Asians accounted for 2% (959) of the 40,040 new HIV diagnoses in the United States and 6 dependent areas in 2015.d • Of Asians diagnosed with HIV infection in 2015, 86% (820) were men and 14% (132) were women. • Gay and bisexual men accounted for 89% (729) of all HIV diagnoses among Asian men in 2015. Among Asian women, 95% (125) of HIV diagnoses were attributed to heterosexual contact.e • From 2010 to 2014, HIV diagnoses increased by 47% among Asian gay and bisexual men in the United States. • In 2015, 326 Asians were diagnosed with AIDS, representing 2% of the 18,538 AIDS diagnoses in the United States and 6 dependent areas. Living With HIV • Of the 16,200 Asians estimated to be living with HIV in the United States in 2013, 22% (3,500) were undiagnosed, the highest rate of undiagnosed HIV among any race/ethnicity. By comparison, 13% of all persons living with HIV in the United States were undiagnosed. • Of Asians diagnosed with HIV in 2014, 80% were linked to HIV medical care within 1 month of diagnosis, compared to 75% of all persons diagnosed with HIV that year.f • Of Asians who had been living with diagnosed HIV for at least a year at the end of 2013, 56% were retained in care (receiving continuous HIV medical care), and 60% had achieved viral suppression,g slightly higher than the overall rate (55%) of viral suppression among all races/ethnicities. HIV Diagnoses Among Adult and Adolescent Asians in the United States and 6 Dependent Areas by Transmission Category and Sex, 2015

Male-to-Male Sexual Contact/IDU (17) 2%

† † IDU (20) 2% Other (2) <1% IDU (6) 5% Heterosexual Contact (53) 6%

Male-to-Male Sexual Contact Heterosexual contact (729) 89% (125) 95%

Males (N=820)* Females (N=132)* * Due to rounding, percentages might not total 100%. † Injection drug use. Source: CDC. Diagnoses of HIV infection in the United States and dependent areas, 2015(https://www.cdc.gov/hiv/pdf/ library/reports/surveillance/cdc-hiv-surveillance-report-2015-vol-27.pdf). HIV Surveillance Report 2016;27.

National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Division of HIV/AIDS Prevention Prevention Challenges There are some behaviors that put everyone at risk for HIV. These include having vaginal or anal sex without a condom or without being on medicines that prevent HIV, or sharing injection drug equipment with someone who has HIV. Other factors that affect Asians particularly include: • Undiagnosed HIV. People living with undiagnosed HIV cannot obtain the care they need to stay healthy and may unknowingly transmit HIV to others. • Cultural factors. Some Asians may avoid seeking testing, counseling, or treatment because of language barriers or fear of discrimination, the stigma of homosexuality, immigration issues, or fear of bringing shame to their families. • Limited research. Limited research about Asian health and HIV infection has resulted in few targeted prevention programs and behavioral interventions in this population. • Data limitations. The reported number of HIV cases among Asians may not reflect the true HIV diagnoses in this population because of race/ethnicity misidentification. This could lead to the underestimation of HIV infection in this population. What CDC Is Doing CDC and its partners are pursuing a high-impact prevention (https://www.cdc.gov/hiv/policies/hip/hip.html) approach to maximize the effectiveness of current HIV prevention methods, and improve surveillance among Asians. Funding state, territorial, and local health departments is CDC’s largest investment in HIV prevention. • CDC provides support and technical assistance to health departments and community-based organizations to deliver prevention programs for Asians, such as The Banyan Tree Project (http://banyantreeproject.org/wp2014/). • Capacity Building Assistance for High-Impact HIV Prevention (https://www.cdc.gov/hiv/funding/announcements/ps14-1403/index. html) provides technical assistance in capacity building to the Asian and Pacific Islander American Health Forum (http://www.apiahf. org) and the Asian and Pacific Islander Wellness Center (http://apiwellness.org/site/). • The CDC publication Effective HIV Surveillance Among Asian Americans and Native Hawaiians and Other Pacific Islanders (https://www. cdc.gov/hiv/pdf/policies_13_238558_HIVSurveillance_NHAS_v6_508.pdf) outlines successful HIV surveillance activities for health departments in states with high concentrations of Asians. • CDC is raising awareness through the Act Against AIDS campaigns (https://www.cdc.gov/actagainstaids/index.html), including ºº Doing It (https://www.cdc.gov/actagainstaids/campaigns/doingit/index.html), a new national HIV testing and prevention campaign that encourages all adults to know their HIV status and protect themselves and their community by making HIV testing a part of their regular health routine; ºº Let’s Stop HIV Together (https://www.cdc.gov/actagainstaids/campaigns/lsht/index.html), which raises HIV awareness and fights stigma among all Americans and provides many stories about people living with HIV; and ºº HIV Treatment Works (https://www.cdc.gov/actagainstaids/campaigns/hivtreatmentworks/index.html), which highlights how men and women who are living with HIV have overcome barriers.

Additional Resources CDC-INFO a A person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent including, for 1-800-CDC-INFO (232-4636) example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam. www.cdc.gov/info b The term male-to-male sexual contact is used in CDC surveillance systems. It indicates a behavior that transmits HIV infection, not how CDC HIV Website individuals self-identify in terms of their sexuality. This fact sheet uses the term gay and bisexual men. www.cdc.gov/hiv c Dependent areas include American Samoa, Guam, the Northern Mariana Islands, Puerto Rico, the Republic of Palau, and the US CDC Act Against AIDS Virgin Islands. Campaign d HIV and AIDS diagnoses indicate when a person was diagnosed with HIV infection or AIDS, not when the person was infected. www.cdc.gov/actagainstaids e Heterosexual contact with a person known to have, or to be at high risk for, HIV infection. f Data for medical care and viral suppression are from 32 states and the District of Columbia (the areas with complete lab reporting by December 2015). g A person who has a suppressed viral load has a very low level of the virus. That person can stay healthy and has a dramatically reduced risk of transmitting the virus to others.

Page 2 of 2 HIV Among American Indians and Alaska Natives March 2017

Fast Facts • HIV affects AIs/ANs in ways that are not always obvious because of their small population sizes. • Over the last decade, annual diagnoses increased 63% among AI/AN gay and bisexual men. • AIs/ANs face HIV prevention challenges, including poverty, high rates of STIs, and stigma.

HIV is a public health issue among American Indians and Alaska Natives (AIs/ANs), who represent about 1.2%a of the U.S. population. Overall, diagnosed HIV infections among AIs/ANs are proportional to their population size. Compared with other racial/ethnic groups, AIs/ANs ranked fifth in rates of HIV diagnoses in 2015, with a lower rate than blacks/African Americans, Hispanics/Latinos,b Native Hawaiians/Other Pacific Islanders, and people reporting multiple races, but a higher rate than Asians and whites. The Numbers HIV and AIDS Diagnosesc • Of the 39,513 HIV diagnoses in the United States in 2015, 1% (209) were among AIs/ANs. Of those, 73% (152) were men and 26% (55) were women. • Of the 152 HIV diagnoses among AI/AN men in 2015, most (79%; 120) were among gay and bisexual men.d • Most of the 55 HIV diagnoses among AI/AN women in 2015 were attributed to heterosexual contact (73%; 40). • From 2005 to 2014, the annual number of HIV diagnoses increased 19% (from 172 to 205) among AIs/ANs overall and 63% among AI/AN gay and bisexual men (from 81 to 132). • In 2015, 96 AIs/ANs were diagnosed with AIDS. Of them, 59% (57) were men and 41% (39) were women.

Living With HIV and Deaths HIV Diagnoses Among American Indians/Alaska Natives • Of the 3,600 AIs/ANs estimated to in the US by Transmission Category and Sex, 2015 be living with HIV in 2013, 18% (630) Heterosexual Contact (11) were undiagnosed. By comparison, Male-to-Male 7% Sexual Contact/IDU (11) 13% of everyone living with HIV were 7% undiagnosed. IDU† (10) 7% • Of AIs/ANs diagnosed with HIV in 2014, 78% were linked to medical care IDU† (15) 27% within 1 month.e • At the end of 2013, 53% of AIs/ANs Male-to-Male who had been living with diagnosed Sexual Contact (120) Heterosexual Contact (40) 73% HIV for at least a year were retained in 79% care (receiving continuous HIV medical care), and 52% had achieved viral suppression. • During 2014, 51 AIs/ANs died from HIV Males (N-152) Females (N-55)

or AIDS. †Injection drug use The terms male-to-male sexual contact and male-to-male sexual contact and injection drug use are used in CDC surveillance systems. They indicate the behaviors that transmit HIV infection, not how individuals self-identify in terms of their sexuality.

Source: CDC. Diagnoses of HIV infection in the United States and dependent areas, 2015 (https://www.cdc. a Percentage of AIs/ANs reporting only one race. gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-report-2015-vol-27.pdf). HIV Surveillance Report b Hispanics/Latinos can be of any race. 2016;27. c HIV and AIDS diagnoses indicate when a person is diagnosed with HIV infection or AIDS, but do not indicate when the person was infected. d The term gay and bisexual men, referred to as men who have sex with men in CDC surveillance systems, indicates how individuals self-identify in terms of their sexuality, not a behavior that transmits HIV infection. e In 32 states and the District of Columbia (the areas with complete lab reporting by December 2015).

National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Division of HIV/AIDS Prevention Prevention Challenges • Sexually transmitted diseases (STDs). From 2011 to 2015, AIs/ANs had the second highest rates of chlamydia and gonorrhea among all racial/ethnic groups. Having another STD increases a person’s risk for getting or transmitting HIV. • Lack of awareness of HIV status. Almost 1 in 5 AIs/ANs who were living with HIV at the end of 2013 were unaware of their status. People who do not know they have HIV cannot take advantage of HIV care and treatment and may unknowingly pass HIV to others. • Stigma. AI/AN gay and bisexual men may face culturally based stigma and confidentiality concerns that could limit opportunities for education and HIV testing, especially among those who live in rural communities or on reservations. • Cultural diversity. There are over 560 federally recognized AI/AN tribes, whose members speak over 170 languages. Because each tribe has its own culture, beliefs, and practices, creating culturally appropriate prevention programs for each group can be challenging. • Socioeconomic issues. Poverty, including limited access to high-quality housing, directly and indirectly increases the risk for HIV infection and affects the health of people living with and at risk for HIV infection. Compared with other racial/ethnic groups, AIs/ ANs have higher poverty rates, have completed fewer years of education, are younger, are less likely to be employed, and have lower rates of health insurance coverage. • Alcohol and illicit drug use. Alcohol and substance use can impair judgment and lead to behaviors that increase the risk of HIV. Injection drug use can directly increase the risk of HIV through sharing contaminated needles, syringes, and other equipment. Compared with other racial/ethnic groups, AIs/ANs tend to use alcohol and drugs at a younger age and use them more often and in higher quantities. • Data limitations. Racial misidentification of AIs/ANs may lead to the undercounting of this population in HIV surveillance systems and may contribute to the underfunding of targeted services for AI/AN. What CDC Is Doing CDC and its partners are pursuing a high-impact prevention approach to advance the goals of the National HIV/AIDS Strategy, maximize the effectiveness of current HIV prevention methods, andimprove surveillance among AI/AN. Activities include: • Working with the Indian Health Service (IHS) and tribal leaders of the CDC Tribal Consultation Advisory Committee to discuss methods for developing and implementing scalable, effective prevention approaches that reach those at greatest risk for HIV, including young gay and bisexual AI/AN men. • Providing support and technical assistance to health departments and community-based organizations to deliver effective prevention interventions (https://effectiveinterventions.cdc.gov/en/Home.aspx). • Ensuring that capacity-building assistance providers incorporate cultural competency, linguistics, and educational appropriateness into all services delivered. • Providing capacity building assistance directly to the IHS so it can strengthen its support for HIV activities, including HIV testing capacity; We R Native, a comprehensive health resource for Native youth; and the Red Talon Project, which works to achieve a more coordinated national and Northwest tribal response to STDs/HIV. • Collaborating with National Association of State and Territorial AIDS Directors to release an issue brief, Native Gay Men and Two Spirit People: HIV/AIDS and Viral Hepatitis Programs and Services (https://www.nastad.org/sites/default/files/Issue-Brief-Two-Spirit- Final-03-14-13.pdf). • Raising awareness through the Act Against AIDS campaigns (http://www.cdc.gov/actagainstaids/index.html), including ºº Doing It (http://www.cdc.gov/actagainstaids/campaigns/doingit/index.html), a national HIV testing and prevention campaign that encourages all adults to get tested for HIV and know their status; ºº Let’s Stop HIV Together (http://www.cdc.gov/actagainstaids/campaigns/lsht/index.html), which raises HIV awareness and fights stigma among all Americans and provides many stories about people living with HIV; and ºº HIV Treatment Works (http://www.cdc.gov/actagainstaids/campaigns/hivtreatmentworks/index.html), which highlights how men and women who are living with HIV have overcome barriers. The campaign provides resources and encourages people living with HIV to Get In Care (http://www.cdc.gov/actagainstaids/campaigns/ hivtreatmentworks/getincare/index.html), Stay In Care (http://www.cdc.gov/actagainstaids/ Additional Resources campaigns/hivtreatmentworks/stayincare/index.html), and Live Well (http://www.cdc.gov/ CDC-INFO 1-800-CDC-INFO (232-4636) actagainstaids/campaigns/hivtreatmentworks/livewell/index.html). www.cdc.gov/info In addition, the Office for State, Tribal, Local, and Territorial Support (OSTLTS) serves as the primary link CDC HIV Website www.cdc.gov/hiv between CDC, the Agency for Toxic Substance and Disease Registry, and tribal governments. OSTLTS’s CDC Act Against AIDS tribal support activities are focused on fulfilling CDC’s supportive role in ensuring that AI/AN communities Campaign receive public health services that keep them safe and healthy. www.cdc.gov/actagainstaids

Page 2 of 2 HIV Among Native Hawaiians and Other Pacific Islanders in the United States May 2017

Fast Facts • NHOPI represented less than 1% of new HIV diagnoses in the United States in 2015. • From 2010 to 2014, the annual number of HIV diagnoses declined 22% among NHOPI. • Nearly 20% of adult and adolescent NHOPI living with HIV do not know it.

Although Native Hawaiians and Other Pacific Islanders (NHOPI) account for a very small percentage of new HIV diagnoses, HIV affects NHOPI in ways that are not always apparent because of their small population sizes. The Numbers HIV and AIDS Diagnosesa • In 2015, 79 NHOPI were diagnosed with HIV, representing less than 1% of new HIV diagnoses in the United States. NHOPI make up 0.2% of the population. • NHOPI had the third-highest rate of HIV diagnoses (14.1 per 100,000 people) by race/ethnicity in 2015, behind blacks/African Americans and Hispanics/Latinos.b • Gay and bisexual menc accounted for 78% (62) of HIV Diagnoses of HIV Infection among Adult and Adolescent diagnoses among NHOPI in 2015. Native Hawaiians/Other Pacific Islanders, by Transmission Category, 2015 – United States • The annual number of HIV diagnoses among NHOPI declined 22% from 2010 to 2014. • In 2015, 22 NHOPI were diagnosed with AIDS in the United States. Living With HIV • In 2013, an estimated 1,200 NHOPI were living with HIV in the United States. Of those, nearly 20% had not been diagnosed. By comparison, 13% of all Americans living with HIV are undiagnosed. • Among NHOPI who were diagnosed with HIV in 2014, 84% were linked to care within 1 month.d • Among NHOPI diagnosed with HIV in 2012 or earlier and alive at the end of 2013, 47% were retained in HIV care, and 55% had a suppressed viral load.e Prevention Challenges Some behaviors put everyone at risk for HIV, including NHOPI. These behaviors include having vaginal or anal sex without a condom or without medicines to prevent or treat HIV, or sharing injection drug equipment with someone who has HIV. Other factors particularly affect NHOPI: • Lack of awareness of HIV status can affect HIV rates in communities. People who do not know they have HIV cannot take advantage of HIV care and treatment and may unknowingly pass HIV to others. • Socioeconomic factors such as poverty, inadequate or no health care coverage, language barriers, and lower Source: CDC. Diagnoses of HIV infection in the United States and dependent areas, educational attainment among NHOPI may contribute to 2015 (https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance- lack of awareness about HIV risk and higher-risk behaviors. report-2015-vol-27.pdf). HIV Surveillance Report 2016;27. • Cultural factors may affect the risk of HIV infection. NHOPI National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Division of HIV/AIDS Prevention cultural customs, such as not talking about sex across generations, may stigmatize sexuality in general, and homosexuality specifically, as well as interfere with HIV risk-reduction strategies, such as condom use. • Limited research about NHOPI health and HIV infection and small population numbers have resulted in a lack of targeted prevention programs and behavioral interventions for this population. • The low reported number of HIV cases among NHOPI may not reflect the true burden of HIV in this population because of race/ ethnicity misidentification that could lead to an underestimation of HIV infection. What CDC Is Doing CDC and its partners are pursuing a high-impact prevention (https://www.cdc.gov/hiv/policies/hip/hip.html) approach to maximize the effectiveness of current HIV prevention methods. • CDC provides support and technical assistance to health departments and community-based organizations to deliver prevention programs for NHOPI, such as The Banyan Tree Project (http://banyantreeproject.org/wp2014/). • HIV Prevention Projects for Community-Based Organizations funds The Asian Pacific AIDS Intervention Team (http://apaitonline. org) and the Asian and Pacific Islander Wellness Center (http://apiwellness.org/site/), which provide an array of culturally sensitive services, including HIV care and testing, HIV education, counseling, behavioral health, substance abuse, and social support services. • Capacity Building Assistance for High-Impact HIV Prevention (https://www.cdc.gov/hiv/funding/announcements/ps14-1403/index. html) provides technical assistance in capacity building to the Asian and Pacific Islander American Health Forum (http://www.apiahf. org) and the Asian and Pacific Islander Wellness Center (http://apiwellness.org/site/). • The CDC publication Effective HIV Surveillance Among Asian Americans and Native Hawaiians and Other Pacific Islanders (https:// www.cdc.gov/hiv/pdf/policies_13_238558_HIVSurveillance_NHAS_v6_508.pdf) outlines successful HIV data collection activities for health departments in states with high concentrations of NHOPI. • Through its Act Against AIDS (https://www.cdc.gov/actagainstaids/) campaigns, CDC provides messages about HIV treatment and prevention. For example, ºº Doing It (https://www.cdc.gov/actagainstaids/campaigns/doingit/index.html) encourages all adults to get tested for HIV and know their status. ºº Let’s Stop HIV Together (https://www.cdc.gov/actagainstaids/campaigns/lsht/index.html) raises awareness about HIV and fights stigma. ºº HIV Treatment Works (https://www.cdc.gov/actagainstaids/campaigns/hivtreatmentworks/index.html) encourages people living with HIV to stay in care. Additional Resources CDC-INFO 1-800-CDC-INFO (232-4636) a HIV and AIDS diagnoses indicate when a person received an HIV or AIDS diagnosis, not when the person was infected. www.cdc.gov/info b Hispanics/Latinos can be of any race. c The term male-to-male sexual contact is used in CDC surveillance systems. It indicates a behavior that transmits HIV infection, not how CDC HIV Website www.cdc.gov/hiv individuals self-identify in terms of their sexuality. This fact sheet uses the term gay and bisexual men. d In 32 states and the District of Columbia (the areas with complete lab reporting by December 2015). CDC Act Against AIDS e A person with a suppressed viral load has a very low level of the virus. That person can stay healthy and has a dramatically reduced risk Campaign www.cdc.gov/actagainstaids of transmitting the virus to others.

Page 2 of 2 CDC HIV Incidence: Estimated Annual FACT Infections in the U.S., 2008-2014 SHEET Overall and by Transmission Route

Estimated annual HIV infections in the U.S. declined 18% from 2008-2014

56% 36% 26% 18% decline decline decline decline

among among among gay and among gay and people who heterosexuals bisexual men bisexual men inject drugs aged 35-44 years aged 13-24 years

HIV infections are declining in the U.S. After remaining stable since the mid-1990s, the estimated number of annual HIV infections in the U.S. fell nearly 20% between 2008-2014 (from 45,700 to 37,600). A new analysis of trends in infections by transmission route demonstrates particular progress in several groups:

Some gay and bisexual men Heterosexuals (from 13,400 to 8,600) n 13- to 24-year-old gay and bisexual men (9,400 to 7,700) People who inject drugs (from 3,900 to 1,700) n 35- to 44-year-old gay and bisexual men (5,800 to 4,300) n White gay and bisexual men (9,000 to 7,400) Progress remains uneven HIV remains a serious health problem in the U.S., Gay and bisexual men remain most affected with gay and bisexual men bearing the greatest burden by risk group. Gay and bisexual men were the only group that did not experience Heterosexuals 23% 8,600 infections an overall decline in annual HIV infections from 2008 to 2014: annual infections remained stable at about 26,000 per year. People who inject drugs 37,600 1,700 infections Infections were also stable among black gay New HIV 5% and bisexual men, at about 10,000 per year. Infections Gay and bisexual men 3% This stabilization is an encouraging in 2014 who inject drugs 1,100 infections sign after more than a decade of increases in these populations, but progress must be accelerated. 70% Gay and bisexual men 26,200 infections

U.S. Department of Health and Human Services Centers for Disease Control and Prevention

FEBRUARY 2017 Additionally, concerning trends have emerged among gay and Annual HIV infections are falling among bisexual males by age and ethnicity. While annual infections gay and bisexual men aged 13-24, but have declined among white men, they remain high and stable rising among those aged 25-34 years among black men, and are now increasing among Latino men. Black Hispanic White 13-24 25-34 35-44 45-54 ≥55 Stable12,000 among black gay and bisexual men (from 10,100 to 12,000 10,100) 10,000 10,000 20% increase among Latino gay and bisexual men (from 8,000 8,000 6,100 to 7,300) 6,000 6,000

And,4,000 by age, as infections have declined among young men 4,000 ages 13-24 and men ages 35-44, they have increased among 2,000 2,000 men ages 25-34. 0 0 2008 2009 2010 2011 2012 2013 2014 2008 2009 2010 2011 2012 2013 2014

Current burden and trends by state Another new analysis examines current burden and trends in infections by state. The study reveals:

Southern states bear the greatest burden of Annual HIV infections declined substantially HIV, accounting for 50% of new infections and statistically significantly in some states and in 2014 Washington, D.C.: In the jurisdictions where they could be estimated,* n Washington, D.C. 10% per year annual infections in all states decreased or remained n Maryland about 8% per year stable from 2008-2014 n Pennsylvania about 7% per year n Georgia about 6% per year n New York and North Carolina each about 5% per year *35 states and Washington, D.C. n I llinois about 4% per year n Texas about 2% per year

CD4 methodology CD4 cells are a type of white blood cell that help in protecting the body from infections, but they are also targeted by HIV. CD4 cell counts can be used to determine the stage of HIV infection in a person. As HIV stays in the body longer, CD4 cells decrease. CDC used CD4 cell counts from the time of HIV diagnosis to estimate when an infection occurred and to estimate HIV incidence for 2008-2014. The CD4 model was based on data reported to the National HIV Surveillance System. The new methodology was applied first to these new analyses presented at the Conference on Retroviruses and Opportunistic Infections. Additional analyses will be available over time.

If you are a member of the news media and need more information, please visit www.cdc.gov/nchhstp/newsroom or contact the News Media Line at CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention 404-639-8895 or [email protected].

FEBRUARY 2017 2 HIV Infection: Detection, Counseling, and Referral

 Detection of HIV Infection: Screening  Diagnosing HIV Infection  Counseling for Persons with HIV Infection and Referral to Support Services  Management of Sex Partners and Injection-Drug Partners  STD Testing During HIV Care  Special Considerations

HIV infection typically begins with a brief acute retroviral syndrome, transitions to a multi-year chronic illness that progressively depletes CD4 T- lymphocytes critical for maintenance of effective immune function, and ends with symptomatic, life-threatening immunodeficiency. This late stage of infection, known as acquired immunodeficiency syndrome (AIDS), develops over months to years with an estimated median time of approximately 11 years (289). In the absence of treatment, virtually all persons with AIDS will die from AIDS-related causes; however with antiretroviral therapy, persons provided early effective treatment can expect to live a near normal lifespan (290-292). Early diagnosis of HIV infection and linkage to care are essential not only for the patients’ own health but also to reduce the risk for transmitting HIV to others. As of March 2012, U.S. guidelines recommend all persons with HIV infection diagnoses be offered effective antiretroviral therapy (70).

As of 2011, approximately 16% of the estimated 1.2 million persons with HIV infection in the United States are unaware of their infection (Monitoring Selected National HIV Prevention and Care Objectives by Using HIV Surveillance Data). Knowledge of HIV-infection status has important clinical implications, because HIV infection alters the immune system and thereby affects the diagnosis, evaluation, treatment, and follow-up of some other STDs. Diagnosing HIV infection during the acute phase of disease is particularly important (see Acute HIV Infection). Persons with acute HIV infection are highly infectious, because HIV concentrations are extremely high in plasma and genital secretions following initial infection (293-296). However, tests for HIV antibodies are often negative during this phase of infection, causing persons to mistakenly believe they are uninfected and unknowingly continue to engage in behaviors associated with HIV transmission. Of persons with acute HIV infection, 50%–90% are symptomatic, many of whom seek medical care (297,298). Because persons with no HIV-associated symptoms might present for assessment or treatment of a concomitantly acquired STD, providers serving persons at risk for STDs are in a position to diagnose HIV infection in persons during the acute phase of infection. Despite the availability of effective antiretroviral therapy, many cases of HIV infection continue to be diagnosed at advanced stages, as evidenced by low CD4 cell counts. Nationally, the proportion of patients who receive AIDS diagnoses at or within 12 months of their HIV diagnosis in 2010 was 32% (299). Since 2006, CDC has recommended efforts to increase HIV testing by streamlining the consent process and expanding opt-out testing to all health-care settings, including those serving persons at risk for STDs (122). HIV testing facilitates early diagnosis, which reduces the spread of disease, extends life expectancy, and reduces costs of care. However, rates of testing remain low: CDC estimates that in 2008, only 45% of adults aged 18–64 years had ever been tested (300), and that during 2006–2009 approximately 41% of persons with newly diagnosed HIV infection had never been previously tested (301).

Comprehensive HIV treatment services are usually not available in facilities focusing primarily on STD treatment (e.g., STD clinics). In such settings, patients with a new diagnosis of HIV infection or those with an existing diagnosis of HIV infection who are not engaged in regular on-going care should be linked promptly to a health-care provider or facility experienced in caring for HIV-infected patients (70). Providers working in STD clinics should be knowledgeable about the treatment options available in their communities, educate HIV-infected persons about their illness, and link these patients to HIV-related care and support services. Provision of care also should include behavioral and psychosocial services, especially for alcohol and drug addiction and for mental health problems.

A detailed discussion of the complex issues required for the management of HIV infection is beyond the scope of this report; however this information is available elsewhere (17, 70,247). These HIV care and management resources are updated frequently, and the most current versions are available online (see URLs accompanying each reference). These resources provide additional information about the diagnosis, medical management, and counseling of persons with HIV infection, referral for support services, and management of sex and injection-drug partners in STD-treatment facilities. In addition, subsequent sections of this report briefly discuss HIV infection during pregnancy and among infants and children.

Detection of HIV Infection: Screening

All persons who seek evaluation and treatment for STDs should be screened for HIV infection. Screening should be routine, regardless of whether the patient reports any specific behavioral risks for HIV infection. Persons at high risk for HIV infection with early syphilis, gonorrhea, or chlamydia should be screened at the time of the STD diagnosis, even if an HIV test was recently performed. Some STDs, especially rectal gonorrhea and syphilis, are a risk marker for HIV acquisition (142, 145,156).

CDC recommends HIV screening for patients aged 13–64 years in all health-care settings (122). Persons should be notified that testing will be performed, but retain the option to decline or defer testing (an opt-out approach) (302). Consent for HIV screening should be incorporated into the general informed consent for medical care in the same manner as other screening or diagnostic tests. A separate consent form for HIV testing is not recommended.

Providing prevention counseling in conjunction with HIV diagnostic testing or as part of HIV screening programs should not be required in health-care settings. However, some persons might be more likely to think about HIV and consider their risk-related behavior when undergoing an HIV test. HIV testing presents providers with an opportunity to conduct HIV/STD prevention counseling and communicate risk-reduction messages.

Top of Page Diagnosing HIV Infection

HIV infection can be diagnosed by serologic tests that detect antibodies against HIV-1 and HIV-2 and by virologic tests that detect HIV antigens or ribonucleic acid (RNA). Testing begins with a sensitive screening test, usually an antigen/antibody combination or antibody immunoassay (IA). Available serologic tests are both highly sensitive and specific and can detect all known subtypes of HIV-1. Most can also detect HIV-2 and uncommon variants of HIV-1 (e.g., group O and group N). Rapid HIV tests enable clinicians to make a preliminary diagnosis of HIV infection within 30 minutes. However, most rapid antibody assays become reactive later than conventional laboratory-based antibody or combination antigen/antibody serologic assays, and thus can produce negative results in recently infected persons.

The recommended diagnostic algorithm for HIV infection consists of a laboratory-based immunoassay, which if repeatedly reactive is followed by a supplemental test (e.g., an HIV-1/HIV-2 antibody differentiation assay, Western blot, or indirect immunofluorescence assay). However, available HIV laboratory antigen/antibody immunoassays detect HIV infection earlier than these supplemental tests. Therefore, during very early stages of HIV infection, discordant HIV test results (reactive immunoassay results with negative supplemental test results) have been erroneously interpreted as negative (303). This problem is minimized by use of a combination HIV-1/HIV-2 antigen-antibody (Ag/Ab) immunoassay, which if reactive is followed by an HIV-1/HIV-2 antibody differentiation assay (304). This algorithm confers an additional advantage, as it can detect HIV-2 antibodies after the initial immunoassay. Although HIV-2 is uncommon in the United States, accurate identification is important because monitoring and therapy for HIV-2 differs from that for HIV-1 (305). RNA testing is performed on all specimens with reactive immunoassay but negative supplemental antibody test results to determine whether the discordance represents acute HIV infection.

The following are specific recommendations that apply to testing for HIV infection.

 HIV screening is recommended for all persons who seek evaluation or treatment for STDs. This testing should be performed at the time of STD diagnosis (e.g., early syphilis, gonorrhea, and chlamydia) in populations at high risk for HIV infection.  HIV testing must be voluntary and free from coercion. Patients must not be tested without their knowledge.  Opt-out HIV screening (notifying the patient that an HIV test will be performed, unless the patient declines) is recommended in all health-care settings.  Specific signed consent for HIV testing should not be required. General informed consent for medical care is considered sufficient to encompass informed consent for HIV testing.  Use of Ag/Ab combination tests is encouraged unless persons are unlikely to receive their HIV test results.  Preliminary positive screening tests for HIV infection must be followed by additional testing to definitively establish the diagnosis.  Providers should be alert to the possibility of acute HIV infection and perform an antigen/antibody immunoassay or HIV RNA in conjunction with an antibody test. Persons suspected of recently acquired HIV infection should be referred immediately to an HIV clinical- care provider.

Acute HIV Infection

Health-care providers should be knowledgeable about the symptoms and signs of acute retroviral syndrome, which develops in 50%–90% of persons within the first few weeks after they become infected with HIV (298). Acute retroviral syndrome is characterized by nonspecific symptoms, including fever, malaise, lymphadenopathy, and skin rash. Suspicion of acute retroviral syndrome should prompt urgent assessment with an antigen/antibody immunoassay or HIV RNA in conjunction with an antibody test. If the immunoassay is negative or indeterminate, then testing for HIV RNA should follow. Clinicians should not assume that a laboratory report of a negative HIV antibody test result indicates that the necessary RNA screening for acute HIV infection has been conducted. Further, HIV home-testing kits only detect HIV antibodies and therefore will not detect acute HIV infection.

Persons with acute HIV infection are highly infectious because the concentration of virus in plasma and genital secretions is extremely elevated during this stage of infection (294,306). Antiretroviral therapy during acute HIV infection is recommended, because it substantially reduces infectiousness to others, improves laboratory markers of disease, may decrease severity of acute disease, lowers viral set-point, reduces the size of the viral reservoir, decreases rate of viral mutation by suppressing replication, and preserves immune function (70). Persons who receive an acute HIV infection diagnosis should be referred immediately to an HIV clinical-care provider, provided prevention counseling (e.g., advised to reduce number of partners and to use condoms correctly and consistently), and screened for STDs. Information should be provided on the availability of postexposure prophylaxis for sexual and needle-sharing partners not known to have HIV infection if the most recent contact was within the 72 hours preceding HIV diagnosis (www.cdc.gov/hiv).

After Establishing a New HIV Diagnosis

Persons with newly diagnosed HIV infection should be informed about 1) the importance of promptly initiating medical care for their own health and to reduce further transmission of HIV, 2) the effectiveness of HIV treatments, and 3) what to expect as they enter medical care for HIV infection (70). They should be linked promptly to a health-care provider or facility experienced in caring for patients with HIV. Persons with symptoms or signs that suggest advanced HIV infection (e.g., fever, weight loss, diarrhea, cough, shortness of breath, and oral candidiasis) should be immediately evaluated or referred for evaluation. Persons experiencing psychologic distress should be referred accordingly (see Counseling for Persons with HIV Infection and Referral to Support Services). Detailed and regularly updated recommendation for the initial management of persons with HIV infection can be found elsewhere (17,70,247).

Top of Page

Counseling for Persons with HIV Infection and Referral to Support Services

Providers should expect persons with HIV infection to be distressed when first informed of a positive test result. Such persons face multiple major adaptive challenges, including coping with the reactions of others to a stigmatizing illness, developing and adopting strategies for maintaining physical and emotional health, initiating changes in behavior to prevent HIV transmission to others, and reducing the risk for acquiring additional STDs. Many persons will require assistance with making reproductive choices, gaining access to health services, and coping with changes in personal relationships. Therefore, behavioral and psychosocial services are an integral part of health care for persons with HIV infection.

Persons testing positive for HIV infection have unique needs. Some require referral for specific behavioral interventions (e.g., a substance abuse program), mental health disorders (e.g., depression), and emotional distress, while others require assistance with securing and maintaining employment and housing. Women should be counseled or appropriately referred regarding reproductive choices and contraceptive options, and persons with multiple psychosocial problems might be candidates for comprehensive risk-reduction counseling and other support services.

The following are specific recommendations for HIV counseling and linkage to services that should be offered to patients before they leave the testing site.

 Persons who test positive for HIV should be counseled, either on-site or through referral, concerning the behavioral, psychosocial, and medical implications of HIV infection.  Health-care providers should assess the need for immediate medical care and psychosocial support.  Providers should link persons with newly diagnosed HIV infection to services provided by health-care personnel experienced in the management of HIV infection. Additional services that might be needed include substance abuse counseling and treatment, treatment for mental health disorders or emotional distress, reproductive counseling, risk-reduction counseling, and case management. Providers should follow up to ensure that patients have received services for any identified needs.  Persons with HIV infection should be educated about the importance of ongoing medical care and what to expect from these services.

Several successful, innovative interventions to assist persons with HIV infection reduce the possibility of transmission to others have been developed for diverse at-risk populations, and these can be locally replicated or adapted (12, 15,307-310). Involvement of nongovernment and community-based organizations might complement such efforts in the clinical setting.

Top of Page Management of Sex Partners and Injection-Drug Partners Clinicians providing services to persons with HIV infection should determine whether any partners should be notified concerning possible exposure to HIV (122, 311). In the context of HIV management, “partner” includes sex partners and persons with whom syringes or other injection equipment is shared. Partner notification is an important component of disease management, because early diagnosis and treatment of HIV infection reduces risk for HIV transmission, decreases individual morbidity and mortality risk, and provides the opportunity to modify risk behaviors. Partner notification for HIV infection should be confidential. Specific guidance regarding spousal notification varies by jurisdiction. Detailed recommendations concerning identification, notification, diagnosis, and treatment of exposed partners are available in CDC’s Recommendations for Partner Services Programs for HIV Infection, Syphilis, Gonorrhea, and Chlamydial Infections (See Partner Services) (311).

The following are specific recommendations for implementing partner-notification procedures:

 Health-care providers should inform persons with HIV infection about partner services including processes, benefits, and risks.  Persons with HIV infection should be encouraged to notify their partners and to refer them for counseling and testing.  Health-care providers should assist in the partner-notification process, either directly or by referral to health department partner-notification programs, which might attempt to contact them.  If persons with HIV infection are unwilling to notify their partners or cannot ensure their partners will seek counseling, HIV care staff or health department personnel should use confidential partner notification procedures. Health department staff are trained to employ public health investigation strategies to confidentially locate persons who are hard to reach, whereas most clinical providers do not have the time or expertise to conduct this type of partner notification.  Partners who have been reached and are not known to have HIV infection should be offered postexposure prophylaxis with combination antiretrovirals if they were exposed to genital secretions or blood of a partner with HIV infection though sex or injection-drug use within the preceding 72 hours (312).

STD Testing During HIV Care

At the initial HIV care visit, providers should test all sexually active persons with HIV infection for curable STDs (e.g., syphilis, gonorrhea, and chlamydia) and perform testing at least annually during the course of HIV care (12). Specific testing includes syphilis serology and NAAT for N. gonorrhoeae and C. trachomatis at the anatomic site of exposure, as the preferred approach. Women with HIV infection should also be screened for trichomonas at the initial visit and annually thereafter. Women should be screened for cervical cancer precursor lesions by cervical Pap tests per existing guidelines (247).

More frequent screening for curable STDs might be appropriate depending on individual risk behaviors and the local epidemiology of STDs. Many STDs are asymptomatic, and their diagnosis might indicate risk behavior that should prompt referral for partner services and prevention counseling (10). Pathogen-specific sections of this document provide more detailed information on screening, testing, and treatment.

Top of Page Special Considerations

Pregnancy

All pregnant women should be tested for HIV infection during the first prenatal visit. A second test during the third trimester, preferably at <36 weeks’ gestation, should be considered for all pregnant women and is recommended for those known to be at high risk for acquiring HIV, those who receive health care in jurisdictions with elevated incidence of HIV or AIDS among women, and women seen in clinical settings in which prenatal screening identifies at least one pregnant women with HIV infection per 1,000 women screened (122). Diagnostic algorithms for HIV infection in pregnant women are not different than those for nonpregnant women (See Diagnosis, HIV Infection). Pregnant women should be informed about being tested for HIV as part of the panel of prenatal tests (103, 122); for women who decline, providers should address concerns that pose obstacles to testing and encourage testing at subsequent prenatal visits. Women who decline testing because they have had a previous negative HIV test result should be informed about the importance of retesting during each pregnancy. Women with no prenatal care should be tested for HIV at the time of delivery.

Testing pregnant women is important not only because knowledge of infection status can help maintain the health of the woman, but because it enables receipt of interventions (i.e., antiretroviral and obstetrical) that can substantially reduce the risk for perinatal transmission of HIV. After a pregnant woman has been identified as having HIV infection, she should be educated about the benefits of antiretroviral treatment for her health and for reducing the risk for transmission to her infant. In the absence of antiretroviral treatment, a mother’s risk of transmitting HIV to her neonate is approximately 30% but can be reduced to <2% through antiretroviral treatment, obstetrical interventions (i.e., elective cesarean section at 38 weeks of pregnancy), and breastfeeding avoidance (105). Pregnant women who have HIV infection should be linked to an HIV care provider and given appropriate antenatal and postpartum treatment and advice. Detailed and regularly updated recommendations for the initial management of persons with HIV infection and pregnancy are available in existing guidance at http://aidsinfo.nih.gov/guidelines.

HIV Infection Among Neonates, Infants, and Children

Diagnosis of HIV infection in a pregnant woman indicates the need to evaluate and manage the HIV- exposed neonate and consider whether the woman’s other children might be infected. Detailed recommendations regarding diagnosis and management of HIV in neonates and children of mothers with HIV infection are beyond the scope of this report and can be found at http://aidsinfo.nih.gov/guidelines. Exposed neonates and children with HIV infection should be referred to physicians with such expertise.

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CDC A-Z INDEX 2015 Sexually Transmitted Diseases Treatment Guidelines

2015 STD Treatment Guidelines

** USPSTF recommends screening in adults and adolescents ages 15-65 Chlamydia

Women  Sexually active women under 25 years of age1  Sexually active women aged 25 years and older if at increased risk2  Retest approximately 3 months after treatment3 Pregnant  All pregnant women under 25 years of age1 Women  Pregnant women, aged 25 and older if at increased risk2  Retest during the 3rd trimester for women under 25 years of age or at risk3,4  Pregnant women with chlamydial infection should have a test-of- cure 3-4 weeks after treatment and be retested within 3 months1

Men  *Consider screening young men in high prevalence clinical settings5 or in populations with high burden of infection (e.g. MSM)6

Men Who  At least annually for sexually active MSM at sites of contact have Sex (urethra, rectum) regardless of condom use6 With Men (MSM)  Every 3 to 6 months if at increased risk7

Persons with  For sexually active individuals, screen at first HIV evaluation, and HIV at least annually thereafter8  More frequent screening for might be appropriate depending on individual risk behaviors and the local epidemiology8

Gonorrhea

Women  Sexually active women under 25 years of age1  Sexually active women age 25 years and older if at increased risk9  Retest 3 months after treatment10

Pregnant  All pregnant women under 25 years of age and older women if at Women increased risk11  Retest 3 months after treatment10

Men Who  At least annually for sexually active MSM at sites of contact have Sex (urethra, rectum, pharynx) regardless of condom use10 With Men  Every 3 to 6 months if at increased risk7 (MSM)

Persons with  For sexually active individuals, screen at first HIV evaluation, and HIV at least annually thereafter10  More frequent screening for might be appropriate depending on individual risk behaviors and the local epidemiology10

Syphilis

Pregnant  All pregnant women at the first prenatal visit11 Women  Retest early in the third trimester and at delivery if at high risk12

Men Who  At least annually for sexually active MSM13 have Sex  Every 3 to 6 months if at increased risk7 With Men (MSM)

Persons with  For sexually active individuals, screen at first HIV evaluation, and HIV at least annually thereafter14,15,16  More frequent screening might be appropriate depending on individual risk behaviors and the local epidemiology13

Trichomonas

Women  *Consider for women receiving care in high-prevalence settings (e.g., STD clinics and correctional facilities) and for women at high risk for infection (e.g., women with multiple sex partners, exchanging sex for payment, illicit drug use, and a history of STD)17

Persons with  Recommended for sexually active women at entry to care and at HIV least annually thereafter14 Herpes

Women  *Type-specific HSV serologic testing should be considered for women presenting for an STD evaluation (especially for women with multiple sex partners)17

Pregnant  *Evidence does not support routine HSV-2 serologic screening Women among asymptomatic pregnant women. However, type-specific serologic tests might be useful for identifying pregnant women at risk for HSV infection and guiding counseling regarding the risk for acquiring genital herpes during pregnancy17

Men  *Type-specific HSV serologic testing should be considered for men presenting for an STD evaluation (especially for men with multiple sex partners)17

Men Who  *Type-specific serologic tests can be considered if infection status have Sex is unknown in MSM with previously undiagnosed genital tract With Men (MSM) infection17

Persons with  *Type-specific HSV serologic testing should be considered for HIV persons presenting for an STD evaluation (especially for those persons with multiple sex partners), persons with HIV infection, and MSM at increased risk for HIV acquisition17

HIV

Women  All women aged 13-64 years (opt-out)**18  All women who seek evaluation and treatment for STDs19 Pregnant  All pregnant women should be screened at first prenatal visit (opt- Women out)20  Retest in the third trimester if at high risk21

Men  All men aged 13-64 (opt-out)**18  All men who seek evaluation and treatment for STDs19

Men Who  At least annually for sexually active MSM if HIV status is unknown have Sex or negative and the patient himself or his sex partner(s) have had With Men (MSM) more than one sex partner since most recent HIV test22

Cervical Cancer

Women  Women 21-29 years of age every 3 years with cytology  Women 30-65 years of age every 3 years with cytology, or every 5 years with a combination of cytology and HPV testing23,24,25

Pregnant  Pregnant women should be screened at same intervals as Women nonpregnant women23,24,25

Persons with  Women should be screened within 1 year of sexual activity or HIV initial HIV diagnosis using conventional or liquid-based cytology; testing should be repeated 6 months later26

Hepatitis B Screening

Women  Women at increased risk27 Pregnant  Test for HBsAg at first prenatal visit of each pregnancy regardless Women of prior testing; retest at delivery if at high risk27,28

Men  Men at increased risk27

Men Who  All MSM should be tested for HBsAg27 have Sex With Men (MSM)

Persons with  Test for HBsAg and anti-HBc and/or anti-HBs27 HIV

Hepatitis C Screening

Women  Women born between 1945-196529,30  Other women If risk factors are present30

Pregnant  Pregnant women born between 1945-196529,30 Women  Other pregnant women if risk factors are present30

Men  Men born between 1945-196529,30  Other men If risk factors are present30

Men Who  MSM born between 1945-196529 have Sex  Other MSM if risk factors are present30 With Men (MSM)  Annual HCV testing in MSM with HIV infection31

Persons with  Serologic testing at initial evaluation32,33 HIV  Annual HCV testing in MSM with HIV infection31

Recommendations for HIV Prevention with Adults and Adolescents with HIV

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The Recommendations for HIV Prevention with Adults and Adolescents with HIV in the United States, 2014 (published December 11, 2014) updates and expands the 2003 guideline, Incorporating HIV prevention into the medical care of persons living with HIV. This guideline is a compilation of longstanding and new federal recommendations on biomedical, behavioral, and structural prevention interventions that can help reduce the risk of HIV transmission from persons with HIV – thus advancing the goals of the 2010 National HIV/AIDS Strategy (NHAS). The guideline does not provide comprehensive guidance on all prevention and care services for persons with HIV. The guideline is accompanied by three companion summaries, one for each of the guideline’s three primary audiences:

 Summary for Clinical Providers – for persons who provide individual level HIV prevention and care services in healthcare settings such as clinics and hospitals.  Summary for Nonclinical Providers – for persons who provide individual level HIV prevention and care services in non-healthcare settings, such as shelters, churches, and other community-based organizations.  Summary for Health Departments and HIV Planning Groups – for health department and HIV planning group staff who provide population-level HIV prevention and care services, such as HIV surveillance and community HIV education.  Implementation Resources

A comprehensive library of online resources including tools, webinars, trainings, factsheets, and recent publications on related topics. More The guideline may also interest persons with HIV; partners of persons with HIV; specialists in HIV planning, service delivery, policy, and legislation; and managers of medical assistance programs, health insurance plans, and health systems that serve persons with HIV.

The 2014 guideline and its companion summaries have been amended in December 2016 to fix errata, outdated or dysfunctional URLs, and missing references or footnotes (the above links to these documents will take the reader to the amended versions). The recommendations and other content have not been updated. For the most current versions of the guidelines on HIV prevention cited in the 2014 guideline please refer to the following guideline databases or websites:

 CDC’s HIV Prevention Guidelines: Guidelines and recommendations on prevention, screening, diagnosis, treatment, and management of HIV infection and HIV-related diseases.  CDC’s 2015 Sexually Transmitted Diseases Treatment Guidelines: The current CDC STD guidelines and related resources.  AIDSinfo Clinical Guidelines Portal: Administered by the National Library of Medicine, the AIDSinfo portal contains federally approved HIV/AIDS medical practice guidelines.  HRSA Clinical Care Guidelines and Resources: Database of HHS HIV clinical care and treatment guidelines and clinical protocols and practices that provide detailed information on the effective delivery of HIV care.  National HIV/AIDS Strategy for the United States: Updated to 2020: This updated Strategy reflects the hard work accomplished and the lessons learned since the original Strategy was released in 2010. The Update allows for opportunities to refresh the ongoing work in HIV prevention, care and research.

References

* Please note that portions of this table marked with an asterisk are considerations and should not be interpreted as formal recommendations.

** USPSTF recommends screening in adults and adolescents ages 15-65

1. LeFevre ML. Screening for Chlamydia and Gonorrhea: U.S. Preventive Services Task Force Recommendation

Statement. Annals of internal medicine. Sep 23 2014.

2. Those who have a new sex partner, more than one sex partner, a sex partner with concurrent partners, or a sex

partner who has a sexually transmitted infection. Screening for Chlamydia and Gonorrhea: U.S. Preventive

Services Task Force Recommendation Statement. Annals of internal medicine. Sep 23 2014.

3. Centers for Disease Control and Prevention. Sexually Transmitted Diseases Treatment Guidelines, 2015.

4. e.g., those with a new sex partner, more than one sex partner, a sex partner with concurrent partners, or a sex

partner who has a sexually transmitted infection. Centers for Disease Control and Prevention. Sexually

Transmitted Diseases Treatment Guidelines, 2015.

5. Adolescent clinics, correctional facilities, and STD clinics. Centers for Disease Control and Prevention. Sexually

Transmitted Diseases Treatment Guidelines, 2015.

6. Centers for Disease Control and Prevention. Sexually Transmitted Diseases Treatment Guidelines, 2015.

7. More frequent STD screening (i.e., for syphilis, gonorrhea, and chlamydia) at 3–6-month intervals is indicated for

MSM, including those with HIV infection if risk behaviors persist or if they or their sexual partners have multiple

partners. Centers for Disease Control and Prevention. Sexually Transmitted Diseases Treatment Guidelines,

2015.

8. Centers for Disease Control and Prevention. Sexually Transmitted Diseases Treatment Guidelines, 2015.

9. Those who have a new sex partner, more than one sex partner, a sex partner with concurrent partners, or a sex

partner who has an STI. Additional risk factors for gonorrhea include inconsistent condom use among persons

who are not in mutually monogamous relationships; previous or coexisting sexually transmitted infections; and

exchanging sex for money or drugs. Clinicians should consider the communities they serve and may opt to

consult local public health authorities for guidance on identifying groups that are at increased risk. Screening for Chlamydia and Gonorrhea: U.S. Preventive Services Task Force Recommendation Statement. Annals of internal

medicine. Sep 23 2014.

10. Centers for Disease Control and Prevention. Sexually Transmitted Diseases Treatment Guidelines, 2015.

11. US Preventive Services Task Force. Screening for syphilis infection in pregnancy: reaffirmation recommendation

statement. Annals of internal medicine. 5/19/2009 2009;150(10):705-709.

12. American Academy of Pediatrics, American College of Obstetricians and Gynecologists, and March of Dimes

Birth Defects Foundation. Guidelines for Perinatal Care. 6th ed. Elk Grove Village, IL: American Academy of

Pediatrics; 2007

13. Centers for Disease Control and Prevention. Sexually Transmitted Diseases Treatment Guidelines, 2015.

14. CDC, Health Resources and Services Administration, National Institutes of Health, HIV Medicine Association of

the Infectious Diseases Society of America, HIV Prevention in Clinical Care Working Group. Recommendations

for incorporating human immunodeficiency virus (HIV) prevention into the medical care of persons living with

HIV. Clin Infect Dis. Jan 1 2004;38(1):104-121.

15. Aberg JA, Gallant JE, Ghanem KG et al. Primary Care Guidelines for the Management of Persons Infected With

HIV: 2013 Update by the HIV Medicine Association of the Infectious Diseases Society of America. CID. Jan 1

2014;58: e1-e34.

16. Centers for Disease Control and Prevention, Health Resources and Services Administration, National Institutes

of Health, American Academy of HIV Medicine, Association of Nurses in AIDS Care, International Association of

Providers of AIDS Care, the National Minority AIDS Council, and Urban Coalition for HIV/AIDS Prevention

Services. Recommendations for HIV Prevention with Adults and Adolescents with HIV in the United States,

2014. 2014. http://stacks.cdc.gov/view/cdc/26062. December 11, 2014.

17. Centers for Disease Control and Prevention. Sexually Transmitted Diseases Treatment Guidelines, 2015.

18. CDC. Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care

settings. MMWR. 9/22/2006 2006;55(No. RR-14):1-17.

19. Centers for Disease Control and Prevention. Sexually Transmitted Diseases Treatment Guidelines, 2015.

20. Moyer VA, US Preventive Services Task Force. Screening for HIV: US Preventive Services Task Force

Recommendation Statement. Annals of internal medicine. 2013;159:51–60.

21. Women who use illicit drugs, have STDs during pregnancy, have multiple sex partners during pregnancy, live in

areas with high HIV prevalence, or have partners with HIV infection. Centers for Disease Control and Prevention.

Sexually Transmitted Diseases Treatment Guidelines, 2015.

22. Centers for Disease Control and Prevention. Sexually Transmitted Diseases Treatment Guidelines, 2015.

23. Moyer VA. Screening for cervical cancer: US Preventive Services Task Force recommendation statement.

Annals of internal medicine. Jun 19 2012;156(12):880-891, W312. 24. American College of Obstetricians and Gynecologists (ACOG). Screening for cervical cancer. ACOG Practice

Bulletin Number 131. Obstet Gynecol. Nov 2012;120(5):1222-1238.

25. Saslow D, Solomon D, Lawson HW, et al. American Cancer Society, American Society for Colposcopy and

Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and

early detection of cervical cancer. CA Cancer J Clin. May-Jun 2012;62(3):147-172.

26. Panel on Opportunistic Infections in HIV-Infected Adults and Adolescents. Guidelines for prevention and

treatment of opportunistic infections in HIV-infected adults and adolescents: recommendations from the Centers

for Disease Control and Prevention, the National Institutes of Health, and the HIV Medicine Association of the

Infectious Diseases Society of America.Available at: http://aidsinfo.nih.gov/contentfiles/lvguidelines/adult_oi.pdf

27. Those at increased risk include persons born in regions of high endemicity (>=2% prevalence), IDU, MSM,

persons on Immunosuppresive therapy, Hemodialysis patients, HIV positive individuals, and others. For detailed

recommendations refer to: Centers for Disease Control and Prevention. Recommendations for Identification and

Public Health Management of Person swith Chronic Hepatitis B Virus Infection,2008. MMWR September 19th,

2008; 57(RR-8);1-21. Available at: https://www.cdc.gov/mmwr/pdf/rr/rr5708.pdf

28. U.S. Preventive Services Task Force. Screening for Hepatitis B Virus Infection in Pregnancy: U.S. Preventive

Services Task Force Reaffirmation Recommendation Statement. Ann Intern Med 2009;150:869-73

29. Smith BD, Morgan RL, Beckett GA, et al. Recommendations for the identification of chronic hepatitis C virus

infection among persons born during 1945-1965. MMWR. Aug 17 2012;61(No. RR-4):1-32.

30. Past or current injection drug use, receipt of blood transfusion before 1992, long term hemodialysis, born to

mother with Hep. C, intranasal drug use, receipt of an unregulated tattoo, and other percutaneous exposures.

Moyer VA. Screening for hepatitis C virus infection in adults: US Preventive Services Task Force

recommendation statement. Annals of internal medicine. Sep 3 2013;159(5):349-357.

31. Centers for Disease Control and Prevention. Sexually Transmitted Diseases Treatment Guidelines, 2015.

32. Panel on Opportunistic Infections in HIV-Infected Adults and Adolescents. Guidelines for prevention and

treatment of opportunistic infections in HIV-infected adults and adolescents: recommendations from the Centers

for Disease Control and Prevention, the National Institutes of Health, and the HIV Medicine Association of the

Infectious Diseases Society of America.Available at: http://aidsinfo.nih.gov/contentfiles/lvguidelines/adult_oi.pdf

33. Aberg JA, Gallant JE, Ghanem KG et al. Primary Care Guidelines for the Management of Persons Infected With

HIV: 2013 Update by the HIV Medicine Association of the Infectious Diseases Society of America. CID. Jan 1

2014;58: e1-e34.

 Page last updated: August 22, 2016  Content source: o Division of STD Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention

 1600 Clifton Road Atlanta, GA 30329-4027 USA 800-CDC-INFO (800-232-4636), TTY: 888-232-6348 Email CDC-INFO

U.S. Department of Health & Human Services HHS/Open USA.gov

Recommendations for HIV Prevention with Adults and Adolescents with HIV in the United States,

Centers for Disease Control and Prevention

Health Resources and Services Administration

National Institutes of Health

American Academy of HIV Medicine

Association of Nurses in AIDS Care

International Association of Providers of AIDS Care

National Minority AIDS Council

Urban Coalition for HIV/AIDS Prevention Services first published 2014 updated 2016

Correspondence Email: [email protected].

Suggested citation Centers for Disease Control and Prevention, Health Resources and Services Administration, National Institutes of Health, American Academy of HIV Medicine, Association of Nurses in AIDS Care, International Association of Providers of AIDS Care, the National Minority AIDS Council, and Urban Coalition for HIV/AIDS Prevention Services. Recommendations for HIV Prevention with Adults and Adolescents with HIV in the United States, 2014. http://stacks.cdc.gov/view/cdc/26062. This document is not protected by the Copyright Act, and copyright ownership cannot be transferred. It may be used and reprinted without special permission. Disclosures and disclaimers The contributors to this report (Appendix C) declared no interests regarding the commercial products discussed herein. The report describes the use of certain drugs, tests, and procedures for some indications that do not reflect labeling approved by the U.S. Food and Drug Administration (FDA) at the time of publication. Information about such drugs, tests, or procedures is noted in the relevant sections. What’s New in the Recommendations? The December 11, 2014, version of Recommendations for HIV Prevention with Adults and Adolescents with HIV in the United States, 2014, and its companion summaries have been amended in December 2016 to correct errata, outdated or broken hyperlinks, and missing references or footnotes.

Page 1 of 238 Section 7. Risk Screening and Risk-reduction Interventions

Section 7. Risk Screening and Risk-reduction Interventions Background Risk screening is the collection of information to determine a person’s risk of transmitting HIV to others. In this report, risk screening is defined as a brief evaluation of behavioral factors that may affect the risk of exposing others to HIV (e.g., unprotected* sex or sharing drug-injection equipment) and biomedical or biologic factors that influence HIV viral load, viral shedding, and infectiousness (e.g., antiretroviral treatment [ART] use, ART adherence, sexually transmitted disease [STD], and pregnancy). Risk screening† is used to identify behavioral or biomedical risk-reduction interventions suited to a specific individual.1-4

Behavioral risk-reduction interventions include various services provided in clinical settings‡ and nonclinical settings§ that have been shown to promote safer behaviors and reduce the risk of exposing others to HIV. Many interventions address psychological, social, or structural factors that influence sexual, drug-injection, and reproductive behaviors. Some aim to provide information, build knowledge, and improve skills that lead to safer behaviors. Others increase motivation to adopt safer behaviors or modify social norms. Some interventions involve a structural component, such as increasing access to condoms. Behavioral risk-reduction interventions can be offered to individuals or groups through counseling, discussion, role plays, or exercises; through print media, such as brochures and posters; and through interactive media, such as computers, telephones, and mobile devices.5

This section addresses risk screening and behavioral risk-reduction interventions that can promote safer sexual and drug-injection behavior over a lifetime. Quality improvement** and program monitoring and evaluation†† methods can determine if the interventions described in this section are implemented as intended, yield the expected outcomes, or warrant changes in delivery methods (see Section 13, Quality Improvement). Because risk screening and risk-reduction interventions are central to HIV prevention with persons with HIV, other sections also describe behavioral and biomedical strategies to reduce the risk of HIV transmission: linkage to and retention in care (Section 4), antiretroviral treatment (Section 5), ART

* Unprotected sex or unprotected sexual contact is sexual activity without using a physical barrier (i.e., penile sex without using a male condom; vaginal sex without using a male or female condom; oral-anal contact without using a dental dam or other barrier device; vaginal- digital contact without using a female condom, latex glove, or finger cot; or rectal-digital contact without using a latex glove or finger cot). † Risk screening is the collection of information to determine a person’s risk of transmitting HIV to others. In this report, risk screening is defined as a brief evaluation of behavioral factors that may affect the risk of exposing others to HIV (e.g., unprotected sex or sharing drug- injection equipment) and biomedical factors that influence HIV viral load, viral shedding, and infectiousness (e.g., antiretroviral treatment [ART] use, ART adherence, sexually transmitted disease [STD], and pregnancy). Information gathered during this screening can be used to identify suitable behavioral or biomedical risk-reduction interventions. ‡ Clinical settings are health care facilities in which medical diagnostic, treatment, and disease prevention services are routinely provided. § Nonclinical settings are facilities that provide prevention, education, screening and interventions for risk behaviors, and referrals for medical and social services. Some nonclinical settings may also provide health promotion services and screening for HIV and some STD. ** Quality improvement is an approach to the continuous study and improvement of the processes of providing services that meet or exceed established professional standards and user expectations. †† Monitoring and evaluation is a process that involves the repeated, ongoing collection and review of information about program activities, characteristics, and outcomes in order to assess program implementation, coverage, acceptability, cost, and effectiveness.

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adherence (Section 6), partner services‡‡ (Section 8), STD services (Section 9), reproductive health care (Section 10), pregnancy services (Section 11), and services for other medical conditions and social factors that influence HIV transmission (Section 12).

Recommendations

BOX 7. RECOMMENDATIONS—RISK SCREENING AND RISK-REDUCTION INTERVENTIONS

For nonclinical and clinical providers (including health department staff who provide individual-level services to persons with HIV) Organizational-level interventions  Establish infrastructure to support routine risk screening and brief risk-reduction interventions (i) (see Box 7-A)  Train staff to create a trusting, supportive, and nonjudgmental atmosphere that encourages persons with HIV to be honest, to voluntarily disclose sex and drug-use behaviors and health information, and to ask questionsa (ii) Individual-level risk screening services  Screen persons with HIV at initial and later encounters (at least yearly or more frequently as needed) for these risk factors: (i, ii, iii, iv, v, vi) (see Box 7-B)  Behavioral characteristics that affect their risk of exposing others to HIV (e.g., unprotected sex, sharing drug-injection equipment)b,c,d  Biologic or biomedical characteristics that affect their level of infectiousness, (e.g., use of and adherence to antiretroviral treatment (ART), viral load level, sexually transmitted disease [STD] diagnoses, pregnancy)b,c,d,e,f,g,h  Characteristics of partners that affect the partner’s risk of acquiring HIV or STD, when information available (e.g., use of preexposure prophylaxis [PrEP]i or nonoccupational postexposure prophylaxis [nPEP]j)b,c,d,e,f,g,h  Offer positive reinforcement to persons who report safer behaviors and use of biomedical strategies that reduce their level of infectiousness to motivate their continued use (ii, iv, vii)

‡‡ Partner services include an array of voluntary services for persons with HIV or STD and their sex and drug-injection partners that are intended to reduce HIV transmission: interviewing persons with HIV to obtain information to contact or locate their sex and drug-injection partners; notifying partners of possible HIV exposure; offering testing for HIV, sexually transmitted diseases, and other infections; providing condoms, prevention information, and counseling; and providing help in obtaining risk-reduction services, HIV medical care, and other medical and social services.

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BOX 7. RECOMMENDATIONS—RISK SCREENING AND RISK-REDUCTION INTERVENTIONS (cont) Individual-level risk-reduction services  Use information collected during risk screening to identify risk-reduction messages and interventions that address the person’s risk of exposing others to HIV, level of infectiousness, and partners’ risks of acquiring HIV (i, ii, iii, iv, v, vi, vii, viii, ix, x)  Offer risk-reduction information and interventions that are tailored to risks of the person with HIV (and of partners they refer) specifically:  Information about • behavioral interventions that can reduce the risk of exposing others to HIV (e.g., brief or intensive risk-reduction strategies that encourage safer sex and use of sterile drug-injection equipment, substance use treatment)d,l (i, ii, iii, iv, vi, vii, viii) (see Box 7-C) • biomedical interventions that can reduce viral load or HIV shedding (e.g., HIV medical care, ART use,e STD services,f special reproductive and pregnancy servicesg,h) (i, ii, iii, iv, vii, viii, ix, x) (see Box 7-C) • strategies for uninfected partners to reduce their risk of acquiring HIV (e.g., partner notification,c PrEP,i nPEPj) (i, ii, iii, vii, viii) (see Box 7-C)  Correcting misconceptions regarding HIV transmission, acquisition, or prevention methodsk (i, ii, iii, v) (see Box 7-C)  Providing or making referrals for specialized behavioral counseling and psychosocial support to members of HIV-discordant couples,m if availablea (ii)  Offering latex or polyurethane male and/or female condomsa (ii, iii)  Providing or making referrals for new, sterile syringes through syringe services programsn, pharmacists, physicians, or other legal methods to persons who lack consistent access to sterile drug-injection equipment (ii, iv, vi) For staff of health departments and HIV planning groups who provide population-level HIV prevention and care services

 Support efforts to monitor HIV risk behaviors in community (see Box 7-D)  Facilitate partnerships between clinical and nonclinical providers that provide services and programs to promote safer behaviors (xi) (see Box 7-D)  Make available online directories of organizations that offer services to promote safer behaviors (xi) (see Box 7-D)  Make available information about minors’ access to and consent to risk-reduction services and devices (e.g., condoms) in the jurisdiction (xii)

Note. In this report, nonclinical providers are defined as persons who work in community-based organizations or health departments operating outside of health care facilities and who provide HIV testing, health education, risk-reduction interventions, partner services, case management, or assistance with linkage or referral to medical and social services. These persons include HIV testing providers, peer and professional health educators, counselors, service linkage facilitators, partner services specialists, case managers, and social workers. Clinical providers are defined as persons who work in health care facilities and who provide risk assessments, health education, counseling, screening, diagnosis, treatment, and other health-related services. These providers include physicians, registered nurses, advance practice nurses, physician assistants, dentists, mental health providers, pharmacists, health educators, case managers, social workers, and counselors. Some may be employees or contractors of health departments. Some of the federal guidelines cited in the Recommendation boxes may have been updated. For current federal recommendations, please refer to http://www.cdc.gov/hiv/guidelines/personswithhiv.html. Note. Persons with HIV may include members of HIV-discordantm or HIV-concordant couples.

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BOX 7. RECOMMENDATIONS—RISK SCREENING AND RISK-REDUCTION INTERVENTIONS (cont) a The cited source guidance that supports this recommendation was intended for health care providers. Based on opinions of the Project Workgroup, the section writing group concluded that it would be beneficial and feasible for other types of providers to implement this recommendation. b See the Implementation Resources topic in this section for a link to examples of risk-screening tools. c See Section 8, Partner Services. d See Section 12, Other Medical and Social Services. e See Section 5, Antiretroviral Treatment. f See Section 9, STD Services, for recommendations on screening for STD with laboratory tests and treating persons diagnosed with STD. g See Section 10, Reproductive Health Care. h See Section 11, Pregnancy. i PrEP is the daily, continuous use of a select regimen of antiretroviral medications for a period of time by an HIV-uninfected person to achieve levels of drug in the blood and anal and genital mucosa sufficient to reduce the risk of HIV acquisition.6 In July 2012, FDA approved one PrEP drug regimen for preventing sexual transmission. Although HHS recommendations in May 2014 advised use of this same regimen for persons who inject drugs, the product label only addresses use for preventing sexual transmission. j nPEP is the use of selected antiretroviral medications by HIV-uninfected persons within 72 hours after isolated, nonoccupational exposures to body fluids potentially containing HIV, such as after unprotected sexual intercourse or condom breakage, in order to reduce the risk of HIV acquisition.7 Use of antiretroviral medication for nPEP does not reflect labeling approved by FDA. k Common misconceptions relate to perceptions of the relative, per-act risk of HIV transmission for various types of sexual contact; how behavioral, biologic, and viral factors influence transmission risk; whether ART use can reduce the risk of HIV transmission; and whether use of PrEP or nPEP with antiretroviral medications can reduce the risk of HIV acquisition by HIV-uninfected partners. l Evidence-based interventions are individual-, group-, or population-level interventions that have been shown to promote safer behaviors or reduce HIV or STD transmission in research studies, program evaluations, or theory-based intervention experience. CDC has compiled and regularly updates a list of effective, evidence-based behavioral risk-reduction interventions that have been shown to be cost-effective for populations with similar HIV risk behaviors at http://www.cdc.gov/hiv/prevention/research/compendium/. m An HIV-discordant couple consists of one HIV-infected person and one HIV-uninfected person. n Syringe services programs provide free, new, sterile syringes and needles in exchange for used syringes and needles to reduce transmission of bloodborne pathogens among people who inject drugs. Sources i. CDC. Recommendations for partner services programs for HIV infection, syphilis, gonorrhea, and chlamydial infection. MMWR 2008;57(RR-9). http://stacks.cdc.gov/view/cdc/7074. Accessed November 3, 2014. ii. HRSA. Guide for HIV/AIDS Clinical Care—2014 Edition. U.S. Department of Health and Human Services; 2014. http://hab.hrsa.gov/sites/default/files/hab/clinical-quality-management/2014guide.pdf. Accessed December 23, 2016. iii. CDC. Sexually transmitted diseases treatment guidelines, 2015. MMWR 2015;64(RR-3). http://www.cdc.gov/std/tg2015/. Accessed December 21, 2016. iv. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1–infected adults and adolescents. 2014. http://aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescent-treatment-guidelines/0/. Accessed July 7, 2014. v. CDC. Effectiveness of prevention strategies to reduce the risk of acquiring or transmitting HIV: serosorting for HIV-negative persons. Updated January 7, 2016. http://www.cdc.gov/hiv/risk/estimates/preventionstrategies.html. Accessed June 22, 2016. vi. CDC. Integrated prevention services for HIV infection, viral hepatitis, sexually transmitted diseases, and tuberculosis for persons who use drugs illicitly: summary guidance from CDC and the U.S. Department of Health and Human Services. MMWR 2012;61(RR-5). http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6105a1.htm?s_cid=rr6105a1_w. Accessed November 3, 2014. vii. CDC. Revised guidelines for HIV counseling, testing, and referral and Revised recommendations for HIV screening of pregnant women. MMWR 2001;50(RR-19). http://stacks.cdc.gov/view/cdc/7281. Accessed November 3, 2014. viii. CDC. Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. MMWR 2006;55(RR- 14). http://stacks.cdc.gov/view/cdc/7316. Accessed November 3, 2014. ix. CDC. Antiretroviral postexposure prophylaxis after sexual, injection-drug use, or other nonoccupational exposure to HIV in the United States: recommendations from the U.S. Department of Health and Human Services. MMWR 2005;54(RR-2). http://stacks.cdc.gov/view/cdc/7303. Accessed November 3, 2014. x. CDC, et al. Preexposure prophylaxis for the prevention of HIV infection in the United States—2014: a clinical practice guideline. May 14, 2014. http://stacks.cdc.gov/view/cdc/23109. Accessed May 15, 2014. xi. Patient Protection and Affordable Care Act, Public Law 111-148, 111th Congress. March 23, 2010. http://www.gpo.gov/fdsys/pkg/PLAW- 111publ148/pdf/PLAW-111publ148.pdf. Accessed February 7, 2014. xii. Centers for Medicare and Medicaid Services, et al. Joint CMCS and HRSA informational bulletin: coordination between Medicaid and Ryan White HIV/AIDS programs. May 1, 2013. http://hab.hrsa.gov/sites/default/files/hab/Global/medicaidinfobulletin.pdf. Accessed December 30, 2016.

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Box 7-A. Examples of strategies to improve infrastructure for risk screening and risk- reduction services

 Develop written procedures about staff members’ responsibilities for providing risk screening and risk- reduction interventions  Provide staff training and tools that describe  methods to assess both behavioral and biologic risk information (e.g., condom use, viral load, concurrent STDs)a  characteristics that influence risk screening and risk-reduction services, such as age, sexual orientation, health literacy, and cultural attitudes about health care  methods to offer risk-reduction interventions that emphasize healthy sexuality, avoiding substance abuse, and sustained high adherence to ART  state laws and regulations about confidentiality protections, HIV disclosure and possible consequences of exposing others to HIV, minors’ access to risk-reduction services, and ways to access legal, sterile drug- injection equipment  how to increase skills in serving persons with various ages, gender identities, sexual orientations, cultural backgrounds, education levels, and health literacy levels  In settings that can monitor persons with HIV receiving risk-reduction services over time  establish monitoring systems that incorporate behavioral and medical information (e.g., viral load, recent STD diagnosis) to allow for more accurate risk assessment and more tailored risk-reduction interventions  provide reminders about periodic risk screening and track delivery of risk screening and risk-reduction interventions  Establish agreements or contracts to link persons with HIV to risk-reduction interventions that are not provided onsite a See Section 6, ART Adherence, for more information on viral load and Section 9, STD Services, for more information on STD screening.

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Box 7-B. Recommended topics to cover during risk screening

 Sexual behaviors  Sexual practices (e.g., vaginal, penile, anal, or oral sex; insertive vs. receptive sex, including recent condom use)  Sex partners (e.g., number, age, gender, HIV status, drug-use history, and recent STD diagnoses of partners; whether a partner is new or committed; where partners met; intimate partner violence)  Sexual activity that may expose others to blood (e.g., sexual abuse, sex during menses, or use of sexual aids, devices, or toys that cause anal or genital trauma, inflammation, or irritation)  Use of serosortinga and seropositioningb  Alcohol and drug-use behaviors  Recent and ever use of substances for health or recreational purposes (e.g., alcohol, methamphetamine, ecstasy, ketamine, nitrites, marijuana, cocaine)  Use of these substances before, during, or after sexual activity  Sharing drug-injection equipment (e.g., needles, syringes, cotton, cooker, water)  Drug-injection partners (e.g., number of partners, partners’ HIV infection status)  Use of new, sterile syringes and other drug-injection equipment, including sources of equipment  Biomedical and biologic factors that may influence infectiousness or the risk of HIV transmission  Recent diagnosis of acute HIV infectionc based on HIV test results or clinical evaluationd  Recent use of ARTe  Recent diagnosis of STD and STD treatmentf  Recent condom use  Contraceptive useg  Current or planned pregnancyh  Use of special conception methodsg  Biomedical and biologic factors that may influence the risk of acquiring HIV by partners or the fetus or infant of a woman with HIV  Recent condom use  Recent diagnoses of STDf,i  Current or planned pregnancyg,h,i  Contraceptive useg  Male circumcision  Inconsistent use of sterile drug-injection equipment  Use of PrEP or nPEP with antiretroviral medicationse,i

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Box 7-B. Recommended topics to cover during risk screening (cont) a The practice of limiting unprotected sex (i.e., sexual activity without using a physical barrier) to partners believed to have the same HIV infection status (e.g., persons with HIV only have unprotected sex with persons believed to be HIV-infected). b The practice of modifying sexual activity based on beliefs about the partner’s HIV infection status and the per-act risk of HIV transmission for a given type of contact (e.g., persons with HIV practice receptive fellatio [i.e., the practice of receiving a partner’s penis in one’s mouth] with HIV-uninfected partners because they believe this type of contact is less likely to transmit HIV than insertive fellatio [i.e., the practice of inserting one’s penis into a partner’s mouth], anal sex, or vaginal sex). c Acute HIV infection is the period between initial HIV infection and the expression of HIV antibodies that can be detected by HIV antibody tests. This period is characterized by high levels of HIV in the blood and a vigorous immune response. d A recent diagnosis may be based HIV test result indicative of acute infection (i.e., positive HIV antigen or nucleic acid amplification test or HIV antibody result indicative of recent seroconversion) and/or clinical evaluation of symptoms or signs of acute retroviral syndrome (e.g., fever, pharyngitis, rash, myalgia, arthralgia, diarrhea, headache, lymphadenopathy). e See Section 5, Antiretroviral Treatment, for recommendations on the use of ART to reduce the infectiousness of persons with HIV and to reduce the risk of their HIV-uninfected partners’ acquiring HIV. f See Section 9, STD Services, for recommendations on STD screening and treatment to reduce the infectiousness of persons with HIV and the role of STD in facilitating HIV transmission. g See Section 10, Reproductive Health Care, for recommendations on family planning to prevent unintended pregnancy and special conception methods that reduce the risk of HIV transmission or acquisition. h See Section 11, Pregnancy, for recommendations on reducing the risk of sexual and perinatal transmission or acquiring HIV during pregnancy and the postpartum period. i See Section 8, Partner Services, for recommendations on reducing the risk of acquiring HIV by HIV-uninfected partners, including STD screening and treatment, PrEP and nPEP, and reproductive and pregnancy services.

Box 7-C. Important topics when informing persons with HIV about how to prevent transmission of HIV to others

General topics  How HIV is spread (e.g., exchange of body fluid) and not spread (e.g., handshake)  How sustained high adherence to ART suppresses viral load and reduces the risk of transmitting HIV  How preventing or treating symptomatic and asymptomatic STDs can improve health and decrease the risk of transmitting HIV  How avoiding drugs and alcohol can improve health and may promote safer drug-use or sexual behaviors  Benefits of support from family, friends, or partners to encourage safer behaviors  Benefits and risks of selectively disclosing HIV infection to others (e.g., those at a heightened risk of HIV exposure, health care providers) and methods that minimize the risk of negative consequences of disclosurea  Benefits of knowing the HIV-infection status of sex and drug-injection partners  How serosorting may result in HIV transmission if assumptions about partners’ HIV status are incorrect or may result in acquiring STDs and, more rarely, new HIV strains from infected partners  Characteristics of HIV-uninfected sex and drug-injection partners that increase their risk of HIV acquisition (e.g., sharing nonsterile drug-injection equipment, STDs)  Availability of PrEP and nPEP for HIV-uninfected partners when clinically indicated to prevent HIV acquisitionb,c  Availability of voluntary, confidential, and usually free health department services to notify sex or drug-injection partners of possible HIV exposured

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Box 7-C. Important topics when informing persons with HIV about how to prevent transmission of HIV to others (cont)

Topics related to sexual transmission (or perinatal transmission if pregnant woman becomes HIV infected through sexual contact)e,f  Communicating with partners to foster healthy sexuality (e.g., noncoercive sexual contact, negotiating safer behaviors)  Methods that HIV-discordant couples can use to reduce the risk of sexual HIV transmission, including the following:  Using latex and polyurethane male and female condoms: negotiating with partner to use; reminders to use; correct and consistent use  Using dental dams or other physical barriers while having oral-vaginal or oral-rectal sex  Using sexual positioning that lowers a partner’s risk of acquiring HIV (order from lowest to highest risk: insertive fellatio, receptive fellatio, insertive penile-vaginal sex, receptive penile-vaginal sex, insertive anal sex, receptive anal sex)g  Practicing mutual masturbation and digital penetration and using clean sex toys that do not cause anal or genital bleeding or traumah  Avoiding exposing partner to blood, semen, vaginal secretions, and other body fluids that are visibly contaminated with blood  Avoiding sexual intercourse with HIV-infected persons after invasive anal or genital procedures until healing is complete,i or when anal or genital bleeding, inflammation, or trauma may be present (e.g., if infected with STD or when using irritating sexual aids)h  Using only water-based spermicides and lubricants that do not contain nonoxynol-9  Avoiding contact with body fluids of HIV-infected persons after invasive oral or dental procedures  Reducing the number of sex partners  Risk of acquiring STDs in genital and nongenital sites if having genital, anal, or oral sexual contacte  Presence of symptomatic or asymptomatic STD in persons with HIVe  Presence of symptomatic or asymptomatic STD in HIV-uninfected partners, which may increase their risk of acquiring HIV and may indicate a substantial risk for HIV that is a clinical indication for PrEPc  Methods to prevent unintended pregnancye  Conception options that reduce the risk of HIV transmissionf  Interventions to reduce the risk of perinatal transmissionf  Evidence that male circumcision may reduce a man’s risk of acquiring HIV from a female partner with HIVj

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Box 7-C. Important topics when informing persons with HIV about how to prevent transmission of HIV to others (cont)

Topics related to transmission resulting from substance use and sharing drug-injection equipmentk  Health benefits of abstaining from or reducing substance use  The relation between use of some recreational drugs and higher risk sexual practices (e.g., methamphetamines)  Risk of transmitting HIV when sharing drug-injection equipment  Benefits of completing substance use treatment (that may include relapse prevention and opioid substitution programs)  Methods to reduce the risk of transmitting HIV if drug injection continues, including the following:  Reducing the number of drug-injection partners  Using new, sterile equipment from reliable sources (pharmacies, SSPs)  Using sterile needles, syringes, fluids, cookers, and cotton each time to prepare and inject drugs  Using sterile water (preferable) or fresh tap water when preparing drugs  Never sharing or reusing drug-injection or preparation equipment  Cleaning injection sites with alcohol swabs before injection  Disposing needles and syringes in safe places after each use

Note. Providers can address topics relevant to each person with HIV using print, audiovisual materials, or discussion over one or more encounters. The Implementation Resources topic in this section includes a link to print, audiovisual, and online risk-reduction interventions and materials that can be used in nonclinical and clinical settings. a See Section 3, Context of Prevention. b Preexposure prophylaxis (PrEP) is the daily, continuous use of a select regimen of antiretroviral medications for a period of time by an HIV-uninfected person to achieve levels of drug in the blood and anal and genital mucosa sufficient to reduce the risk of HIV acquisition.6 In July 2012, FDA approved one PrEP drug regimen for preventing sexual transmission. Although HHS recommendations in May 2014 advised use of this same regimen for persons who inject drugs, the product label only addresses use for preventing sexual transmission. nPEP is the use of selected antiretroviral medications by HIV-uninfected persons within 72 hours after isolated, nonoccupational exposures to body fluids potentially containing HIV, such as after unprotected sexual intercourse or condom breakage, in order to reduce the risk of HIV acquisition. Use of antiretroviral medication for nPEP does not reflect labeling approved by FDA. c See Section 5, Antiretroviral Treatment, for more information regarding the use of PrEP and nPEP.6,7 d See Section 8, Partner Services, for more information. e See Section 10, Reproductive Health Care, for more information on contraception and conception options. f See Section 11, Pregnancy, for more information on interventions to reduce the risk of perinatal HIV transmission. g Estimated risk of acquiring HIV from an HIV-infected partner (in order of lowest to highest risk): insertive fellatio, receptive fellatio, insertive vaginal sex, receptive vaginal sex, insertive anal sex, receptive anal sex.8,9 h Including penile piercing devices, constrictive penile rings, or other sex aids, devices, or toys that have touched the blood or genital secretions of HIV-infected persons (see the Evidence topic in this section for additional information). i Examples include tubal ligation; vasectomy; dilatation and curettage; and removal of vaginal, cervical, and penile warts, polyps, and precancerous lesions. j CDC has disseminated information from African trials showing that adult male circumcision may reduce a man’s risk of acquiring HIV from an infected female partner.1,10 k More detailed CDC guidance on methods to reduce the risk of injection-related HIV transmission is found in other sources.11

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Box 7-D. Examples of population-level strategies for health departments to support risk screening and risk-reduction services

 Monitor prevalence of HIV risk behaviors in jurisdiction through behavioral surveillance or special projects  Support programs that increase access to risk-reduction information, condoms, and legal, sterile syringes, if allowed in the jurisdiction  Make available directories of:  risk-reduction services sites  condom distribution sites  legal sources of sterile syringes  substance abuse treatment programs  Provide technical assistance to clinical and nonclinical providers about these topics:  how to access and strengthen risk-reduction services networks  financial and reimbursement issues  protecting confidentiality and data  security during the referral process

How These Recommendations Differ from Previous Recommendations These recommendations are consistent with other current federal guidance that advises conducting routine, periodic risk screening; providing accurate information about HIV transmission risk; offering behavioral risk-reduction information; providing risk-reduction interventions tailored to an individual’s risks onsite or through referrals;§§ encouraging safe and voluntary disclosure of HIV-positive status to partners; and informing partners about biomedical and behavioral methods to reduce their risk of acquiring HIV.1,6,7,12-17 These recommendations are also generally consistent with the latest guidance about these topics from several nongovernmental organizations.18-23

However, these recommendations differ from the 2003 Recommendations for Incorporating HIV Prevention into HIV Medical Care by

 summarizing new evidence published since 2003 about behavioral and biologic risk screening and behavioral risk-reduction interventions  advising regular screening for behavioral, biologic, and biomedical factors that may influence the risk of transmission of HIV or acquisition of HIV by uninfected partners  advising the use of both behavioral and biomedical strategies to reduce the risk of HIV transmission when providing risk-reduction messages and interventions  engaging clinical and nonclinical providers to provide risk-reduction services tailored to HIV- discordant couples that might include behavioral counseling and psychosocial support  advising providers of HIV risk-reduction services to encourage persons with HIV to start, continue, or reengage in HIV medical care

§§ Referral is a process to help persons identify and access needed services by offering the service provider’s address, phone number, directions, hours of operation, and other basic information.

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 engaging clinical and nonclinical providers to inform persons with HIV about biomedical interventions (e.g., preexposure prophylaxis [PrEP]*** and nonoccupational postexposure prophylaxis [nPEP]†††) for HIV-uninfected partners when clinically indicated to reduce their risk of HIV acquisition  providing additional guidance on developing infrastructure to support risk screening and risk- reduction interventions

Methods The section writing group based these recommendations on

 a review of several current Centers for Disease Control and Prevention (CDC) and U.S. Department of Health and Human Services (HHS) guidelines about risk screening, risk reduction, and sexual practices that may influence HIV transmission1,6,7,12-15,24,25  published systematic reviews that included 2 meta-analyses26,27 and a qualitative systematic review about the effectiveness of risk-reduction interventions28  a systematic review of 48 behavioral risk-reduction interventions for persons with HIV that were conducted in the United States and published between 1988 and 2012.29 (Section 2, Methods, describes how these interventions were identified through the CDC HIV/AIDS Prevention Research Synthesis Project’s cumulative HIV/AIDS/STD prevention database.) Fourteen of the interventions met established criteria‡‡‡ for the CDC compendium of evidence-based interventions§§§ (EBIs).5,29 These criteria were related to a study design with a low risk of bias, rigor of implementation and analysis, and a statistically significant effect size on outcomes of reported unprotected sex or acquisition of bacterial STDs.5  a narrative review of published literature in PubMed related to ****  types and effectiveness of interventions to reduce risk behaviors related to substance use in studies from the United States that were published between 2000 and 2012. Search terms included injection drug use and HIV risk; drug substitution; methamphetamine; and opioid substitution.  use of syringe services programs in studies from the United States and other countries that were published between 1997 and 2012. Search terms included sterile syringe access, syringe services programs, syringe exchange programs, needle exchange programs, and HIV.  influence of sexual practices on the risk of sexual transmission in studies from the United States that were published between 2000 and 2012. Search terms included HIV risk and sexual act; serosorting;†††† sex toys; lubricants; and spermicides.

*** PrEP is the daily, continuous use of a select regimen of antiretroviral medications for a period of time by an HIV-uninfected person to achieve levels of drug in the blood and anal and genital mucosa sufficient to reduce the risk of HIV acquisition.6 ††† nPEP is the use of selected antiretroviral medications by HIV-uninfected persons within 72 hours after isolated, nonoccupational exposures to body fluids potentially containing HIV, such as after unprotected sexual intercourse or condom breakage, in order to reduce the risk of HIV acquisition.7 ‡‡‡ For the current number of evidence-based interventions and other updates, please refer to the CDC Compendium of Evidence-based Interventions and Best Practices for HIV Prevention (http://www.cdc.gov/hiv/research/interventionresearch/compendium/). §§§ Evidence-based interventions are individual-, group-, or population-level interventions that have been shown to promote safer behaviors or reduce HIV or STD transmission in research studies, program evaluations, or theory-based intervention experience. **** Risk behaviors are behaviors that can result in transmitting HIV to others or acquiring HIV through sexual contact, drug use, or during pregnancy (e.g., anal or vaginal intercourse without a barrier, sharing nonsterile drug-injection equipment). †††† Serosorting is the practice of limiting unprotected sex to partners believed to have the same HIV-infection status (e.g., persons with HIV have unprotected sex only with persons believed to be HIV-infected).

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 male circumcision and risk of HIV acquisition in studies from the United States and Africa that were published between 2000 and 2012. Search terms included male circumcision and HIV.  a cost-effectiveness analysis of risk-reduction interventions for gay, bisexual, and other men who have sex with men (MSM); persons who inject drugs (PWID); and heterosexual persons with HIV in which per-client cost estimates and intervention effects were based on 5 effective interventions included in CDC compendium of EBIs5,30

To describe the prevalence of sexual and drug-injection risk behaviors in persons with HIV in the United States, the writing group also conducted a narrative review of articles published in PubMed database between 2010 and March 2014 that were indexed with these terms: HIV, risk behavior, and HIV transmission.

Evidence Supporting the Recommendations This topic summarizes evidence that supports recommendations on risk screening, several behavioral interventions, and one biomedical intervention (male circumcision). Other sections summarize the evidence that support recommendations about other biomedical interventions: antiretroviral treatment (Section 5), ART adherence (Section 6), partner services (Section 8), STD services (Section 9), reproductive health care (Section 10), pregnancy services (Section 11), and services for other medical conditions and social factors that influence HIV transmission (Section 12).

The role of risk screening for behavioral and biomedical factors that influence HIV transmission in guiding the content of risk-reduction interventions Accurate information on behavioral and biologic risks of HIV transmission is needed to identify the most appropriate risk-reduction interventions. However, it can be difficult to accurately estimate a person’s risk of HIV transmission because risk varies depending on the type and frequency of sexual and drug-injection behaviors, ART use and adherence, HIV viral load, concurrent STDs, pregnancy, partners’ HIV status, and other factors over time. Moreover, the results of risk screening may be inaccurate due to31

 poor recall  misunderstanding about risks associated with specific behaviors  previous negative experience with disclosing risk behaviors  fear of or experience with negative judgments, criticism, or stigmatization  desire for social approval  concerns about legal consequences of reporting risk behaviors  doubts about confidentiality protections  poor rapport with providers

Studies show that some persons who have been diagnosed with an acute bacterial STD—an objective marker of unprotected sexual activity—deny having unprotected sex.1 However, providers who conduct risk screening using a nonjudgmental approach that stresses confidentiality may encourage trust and elicit more honest responses.32,33 Most clinical providers and some nonclinical providers can access biomedical

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information, such as a recent STD diagnosis, that can help to validate the accuracy of reported risk behaviors.1

Three controlled clinical studies2-4 found that information elicited during risk screening guided the content of motivational interviews and led to statistically significant reductions in the amount or frequency of unprotected anal or vaginal sex. By periodically screening for both behavioral and biologic factors that influence HIV transmission, providers can identify a wider range of risk-reduction options that are acceptable to persons with HIV and their partners.34 For example, some persons with HIV may prefer lifelong ART use with high adherence rather than lifelong condom use. Other persons with HIV may urge partners to reduce their risk of exposure or biologic susceptibility to HIV by using condoms, taking PrEP, or seeking screening and treatment for STDs.

The role of behavioral risk-reduction interventions in promoting safer sexual behavior or reducing HIV or STD transmission Characteristics of behavioral risk-reduction interventions associated with unprotected sex and STD acquisition in persons with HIV Two 2006 meta-analyses evaluated a total of 18 different controlled trials of behavioral risk-reduction interventions conducted in the United States, Puerto Rico, and Canada after ART became available in 1996.26,27 The interventions involved single or multiple sessions in clinical or nonclinical settings.

Both meta-analyses concluded that behavioral risk-reduction interventions were effective in reducing the frequency or number of unprotected sex acts and/or the risk of acquisition of STDs by persons with HIV.26,27 Several intervention characteristics were significantly associated with a lower frequency of unprotected sex (i.e., 95% confidence intervals did not include 1.0). These characteristics included the following:

 based on cognitive behavioral theory26 (OR=0.52)  used motivational enhancement27 (OR=0.32)  offered skills building (e.g., correct use of male and female condoms, role play for negotiating condom use)26 (OR=0.59)  focused on HIV transmission behaviors in more than two-thirds of sessions26 (OR=0.49)  delivered to individuals with HIV26 (OR=0.49)  delivered by health care providers or professional counselors26 (OR=0.52)  delivered in settings where persons with HIV receive routine services or medical care and addressed mental health, medication adherence, and HIV risk behavior26 (OR=0.41)  involved ≥20 hours of total session time (OR=0.25) or a duration of >3 months26 (OR=0.43)

Behavioral risk-reduction interventions in clinical or nonclinical settings Several studies have shown that persons with HIV tend to report safer sexual activity after having received behavioral risk-reduction interventions in clinical or nonclinical settings. These studies include a demonstration project in public-sector HIV clinics35 and 14 interventions that CDC classified as EBIs‡‡‡‡

‡‡‡‡ Fifteen EBIs have met the established criteria as of April 2016, but the current version of this guideline has not been updated to reflect that number.

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(see the Methods topic in this section).5,29 These EBIs were conducted in clinical (n=8) or nonclinical (n=6) settings and involved single or multiple sessions of varied duration.5,29 Each intervention included at least one of the characteristics associated with intervention effectiveness listed above.

Brief prevention counseling messages during routine medical visits Three interventions classified as EBIs found that adults who received brief prevention counseling messages from clinical providers (or from actors portraying physicians in a video) during all routine HIV medical visits were significantly less likely to report unprotected sex than adults who did not receive these repeated messages.2,3,36 These prevention messages were tailored to the patient’s reported risk and/or focused on self-protection, partner protection, and HIV disclosure. All 3 interventions also included posters and/or patient brochures that reinforced the prevention messages provided by clinical providers.

Additionally, findings of an evaluation35 of observational data from 13 clinics funded by the Health Resources and Services Administration (HRSA) were consistent with the 3 EBIs. Brief risk-reduction counseling sessions (lasting about 3–5 minutes) during all routine HIV care visits were associated with a significant reduction in the number of reported acts of unprotected vaginal and anal sex.35

Intensive risk-reduction interventions during routine HIV care visits Five randomized control trials classified as EBIs found that patients who participated in a series of several interactive prevention sessions, each lasting 40 to 120 minutes, had a significant reduction in the reported number of unprotected sex acts with partners at risk for acquiring HIV when compared with patients who received standard of care (e.g., basic HIV information) or non-HIV health promotion interventions (e.g., advice about nutrition or cancer prevention).37-42 The interventions used various approaches:

 MSM with HIV serving as peer advocates offered MSM 4 individual counseling sessions and 2 follow-up sessions that focused on reducing unprotected sex with partners with negative or unknown infection status.40  Trained facilitators offered 2 individual and 5 group sessions that focused on ART, adherence to ART, and sexual decision making under various hypothetical conditions related to substance use, HIV status disclosure, treatment status, viral load, social relationships, and mood. The intervention was also associated with improved adherence to ART.39  Trained counselors offered individual, monthly sessions over 4 consecutive months. Sessions included motivational interviewing, CDs, and booklets that contained information about safer sex tailored to patients’ risks, and 4 follow-up letters that reinforced the content of the preceding session.37,38  Trained female peer educators with HIV and professional health educators offered 4 group sessions to women with HIV. Sessions focused on gender pride, social support, healthy sexual relationships, and skills to negotiate safer sex.41  Trained male and female facilitators offered 23 sessions (two sessions per week over 6 months) to groups of adolescents with HIV. Sessions focused on coping with an HIV diagnosis, HIV disclosure, participating in health care decisions, identifying factors that triggered risk behaviors, skills to negotiate safer sex, implementing daily routines to stay healthy, and reducing substance use and unprotected sex.42

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Intensive behavioral risk-reduction interventions in nonclinical settings In 6 EBIs,5 peer educators or health educators led a series of interactive intervention sessions for individuals, small groups, or heterosexual HIV-discordant couples with varied demographic characteristics.29,43-50 Sessions focused on coping with an HIV diagnosis, building condom-use skills, negotiating safer sex behaviors, avoiding drug use that might increase the risk of HIV transmission, and other topics. Compared with groups who did not receive the interventions, participants of all 6 interventions were significantly less likely to report unprotected sex acts during the 3 to 12 months after sessions ended. The magnitude of reductions varied by intervention.29

Condom distribution in clinical and nonclinical settings A meta-analysis of 21 studies found that programs that increased the acceptability and accessibility of condoms in several sites used by persons with HIV and persons at high risk for HIV.51 These sites included: publicly-funded health care facilities (e.g., health clinics, mental health centers, substance abuse treatment centers), local businesses (e.g., hotels, bars, bathhouses, brothels), schools (e.g., outside classrooms and nurses’ offices), and organized public events. The analysis of 20 studies reported significantly increased condom use among persons who access these sites (OR=1.81, 95% CI: 1.51, 2.17). An analysis of 5 studies found that condom distribution programs were associated with a reduced incidence of HIV and STD among persons who access these sites (OR=0.69, 95% CI: 0.53, 0.91).51

The cost-effectiveness of behavioral risk-reduction interventions A recent cost-effectiveness analysis evaluated 5 individual- and group-level interventions shown to reduce unprotected sex in 3 hypothetical populations of persons with HIV (MSM, heterosexual persons, and PWID).30 The evaluation found that providing these interventions to prevent HIV transmission was cost-saving compared with not providing the interventions and that the intervention cost per new case of HIV averted for a hypothetical population of MSM (~$150,000)30 was substantially lower than the lifetime cost of HIV treatment (>$400,000).52 When these same estimates of intervention cost and intervention effectiveness were applied to hypothetical populations of heterosexual persons with HIV and PWID, these interventions were cost-effective in preventing HIV transmission (with a cost per quality- adjusted life year gained of ~$550 for heterosexual persons and ~$16,000 for PWID) compared with not providing the interventions. However, the intervention cost per new case of HIV averted was slightly greater than the lifetime cost of HIV treatment for both populations.30

The relation between sexual practices and risk of sexual transmission Type of sexual activity Seropositioning is the practice of modifying sexual activity based on beliefs about the partner’s HIV infection status and the per-act risk of HIV transmission for a given type of contact. A recent study found the estimated relative risk of acquiring HIV varies by the type of sexual activity.8 The risk is highest for receptive anal sex, and decreases in the following order: insertive anal sex, receptive vaginal sex, insertive vaginal sex, receptive fellatio,§§§§ and insertive fellatio.***** (The risk associated with

§§§§ The practice of receiving a partner’s penis in one’s mouth. ***** The practice of inserting one’s penis into a partner’s mouth.

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cunnilingus††††† was not examined.) By extension, persons with HIV are most likely to transmit HIV to their uninfected partners when practicing insertive anal sex (person with HIV inserts his penis into partner’s anus), followed in order by receptive anal sex (person with HIV receives partner’s penis in his/her anus), insertive penile-vaginal sex (person with HIV inserts penis into partner’s vagina), receptive penile-vaginal sex (person with HIV receives partner’s penis in her vagina), insertive fellatio (person with HIV receives oral stimulation of his penis by partner), and receptive fellatio (person with HIV orally stimulates penis of partner).8

Serosorting is the practice of having unprotected sex only with partners believed to have the same HIV infection status. Persons with HIV who have sex only with infected partners cannot transmit HIV to uninfected persons only if assumptions about partner infection status are correct. Serosorting among persons with HIV may rarely cause HIV superinfection,53 the acquisition of another HIV strain that may reduce the effectiveness of HIV treatment if new, drug-resistant HIV strains are acquired.54 Serosorting does not protect persons with HIV from acquiring hepatitis C virus infection or STDs, including STDs that may facilitate HIV transmission.1,13,55

Practices that result in anal or genital trauma, inflammation, or bleeding Some sex toys and products that contain nonoxynol-9 (lubricants and spermicides) may occasionally cause anal or genital trauma, bleeding, irritation, or inflammation that may increase the risk of HIV transmission, especially if these products are used frequently or for long duration.1,24,25,56-58

Longstanding recommendations to inform women with HIV that unprotected sex during menses poses a potential risk of HIV transmission were based on evidence that menstrual fluid and female genital secretions may contain HIV.59-61 The HIV viral load in menstrual fluids of women who have high adherence to effective ART is substantially lower than the viral load in menstrual fluids of women not taking ART.60,61 However, plasma viral load may not reflect the HIV viral load in female genital secretions and women with HIV can shed HIV even if their plasma viral load is undetectable.62 One nested case-control study of risk factors for prevalent HIV infection among uncircumcised Kenyan men, found that having sex with a partner during menses increased the odds of becoming HIV-infected about two-fold (OR 2.1, 95% CI: 1.1–3.7) after controlling for all other factors that were associated with prevalent HIV infection.63 However, a longitudinal study of European HIV-discordant couples (in which either the man or woman was infected) who inconsistently used condoms did not report an association between sex during menses and HIV transmission.64

Use of recreational drugs before or during sex A 2012 systematic review of 61 studies among MSM with HIV found that those who used methamphetamine were more likely to engage in higher-risk sexual behaviors (e.g., having unprotected anal intercourse, group sex, sex with multiple partners, sex with casual partners, sex with PWID, sex with HIV-uninfected partners) than MSM with HIV who do not use this drug.65 One U.S. study found that use of inhaled nitrites (“poppers”) was associated with engaging in unprotected anal intercourse.66 Several

††††† Oral stimulation of the female genitals.

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studies have shown that use of erectile dysfunction medications was associated with unprotected anal sex among MSM, including MSM with HIV.67-70

Male circumcision Three well-designed clinical trials in African countries found that circumcision of HIV-uninfected men reduced their risk of acquiring HIV from women by 50% to 60%.71-74 Observational studies in heterosexual, HIV-uninfected persons have found that male circumcision reduced a man’s risk of acquiring STDs that facilitate HIV transmission or acquisition (e.g., syphilis, HSV-2) and reduced a female sex partner’s risk of acquiring STDs that facilitate HIV transmission or acquisition (i.e., female genital ulceration, bacterial vaginosis, and trichomoniasis)75-78 (see Section 9, STD Services). A meta- analysis of the 7 well-designed studies conducted in African countries (1 randomized controlled trial [RCT] and 6 longitudinal analyses) found that female partners of circumcised men did not have a lower risk of acquiring HIV (RR 0.80, 95% CI 0.53–1.36).79

Most HIV transmission in the United States occurs among MSM, most of whom practice both insertive and receptive anal sex.70,80,81 A recent Cochrane Review conducted pooled analyses of data from 20 observational studies of MSM that included more than 65,000 participants from low-, middle-, and high-income countries, most of whom were circumcised as infants.82 Pooled analyses of data from all MSM and the subset of MSM reporting receptive anal sex found that circumcision had no protective effect. The authors concluded that this evidence was insufficient to support a recommendation that adolescent or adult MSM undergo circumcision as an HIV prevention strategy.82

The American Academy of Pediatrics (with endorsement by the American College of Obstetricians and Gynecologists [ACOG]), the American Academy of Family Physicians (AAFP), and the American Urological Association (AUA) stated that neonatal circumcision has potential health benefits, such as prevention of urinary tract infections, penile cancer, and some sexually transmitted infections, including HIV.83-86 Although the AAP, ACOG, and AAFP concluded that these health benefits were not sufficient to recommend routine neonatal circumcision for health reasons, they stated that the benefits of neonatal circumcision are sufficient to justify access to this procedure, including third-party payment, for families that choose it. The AAFP and AUA have cautioned that African studies showing that circumcision substantially reduces the risk of men acquiring HIV from women with HIV may not necessarily be extrapolated to men in the U.S. The AAFP list of recommended clinical indications for adult circumcision (penile abnormalities and diseases) does not include preventing HIV acquisition.87 The AUA recommends presenting circumcision to men in the U.S. as one possible strategy to prevent HIV acquisition that should be used with other prevention methods such as safe sexual practices.86,87

The role of risk-reduction interventions in promoting safer drug- injection behaviors Behavioral interventions Studies are too few to determine if behavioral interventions can promote safer drug-injection behaviors (e.g., needle cleaning) in persons with HIV who continue to inject drugs.26

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However, several studies have shown that many PWID with HIV stop injecting drugs or inject less frequently after they obtain substance use treatment.88-90

Syringe services programs Using nonfederal funds, many U.S. communities distribute sterile drug-injection equipment and/or information about the benefits of sterile syringes to PWID through syringe services programs (SSPs),‡‡‡‡‡ outreach workers, or vending machines.91,92 Several reviews of evidence from North America, including one systematic review conducted in the United States in 1997, found that SSPs lead to safer injecting behaviors and can be effective in reducing HIV transmission among PWID when part of comprehensive HIV prevention programs.93-98 The Institute of Medicine’s evaluation of SSPs in the United States and other countries found that SSPs were associated with reductions in drug-use and injection-related risk behaviors (such as sharing injection equipment). However, it concluded that evidence of the effect of SSPs on HIV incidence was inconclusive.93 A study from San Francisco that included about 100 PWID, including persons with HIV, found that many PWID relied on syringes from SSPs or pharmacies that sold sterile syringes, and that PWID were more likely to share injection equipment when access to these syringe sources was limited.99

Legal access to syringes through physicians and pharmacists Sterile syringes are sold in pharmacies in some states to reduce the risk of transmitting HIV and other bloodborne pathogens;§§§§§ some states require a physician’s prescription to purchase syringes.100,101 A CDC report concluded that physician prescribing authority may not have a large-scale, population-level impact on HIV incidence, but this method offers PWID with HIV a safe means to obtain sterile syringes.102 A 2006 national physician survey found that fewer than 1% of participants reported prescribing syringes for PWID, including persons with HIV, but 60% reported a willingness to prescribe syringes for PWID.100 Physicians with certain characteristics were more likely to report being willing to prescribe syringes: they served PWID, asked PWID about syringe sharing, believed that PWID share syringes because of lack of access to sterile syringes, knew that syringes were legally available in their community, and knew other physicians who prescribed syringes.100 The effectiveness of physician prescribing authority as a strategy to promote safer injection behaviors and reduce HIV incidence has not been evaluated at a population level.

Oral opioid maintenance programs A 2011 Cochrane systematic review assessed the influence of opioid substitution programs on injection and sexual behaviors. The review evaluated 38 studies, including many from the United States, involving more than 12,000 participants. The studies consistently found that oral methadone or buprenorphine maintenance treatment by opioid-dependent PWID was associated with statistically significant reductions (i.e., 95% confidence intervals did not include 1.0) in subgroups with these characteristics103:

 used opioids (relative risk ranged from 0.37 to 0.81)  used drug-injection equipment (relative risk ranged from 0.45 to 0.87)

‡‡‡‡‡Syringe services programs provide free, new, sterile syringes and needles in exchange for used syringes and needles to reduce transmission of bloodborne pathogens among people who inject drugs. They may be called syringe exchange programs or needle exchange programs. §§§§§ At the time of the review, these activities were not supported by federal funds. Check with your state health department for latest information on funding opportunities.

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 shared drug-injection equipment (relative risk ranged from 0.37 to 0.49)  had multiple sex partners (relative risk = 0.37)  exchanged sex for drugs or money (relative risk ranged from 0.62 to 0.65)

Issues that Influence Implementation of the Recommendations Implementation progress, challenges, and opportunities Abstinence from penetrative sexual intercourse is the most effective method to reduce the risk of sexual HIV transmission. However, many persons with HIV remain sexually active and use other methods to reduce their risk of HIV transmission after their diagnosis.104-106 An analysis of 2009 surveillance data found that among about 600,000 persons with HIV with unsuppressed viral load, 20% engaged in unprotected, HIV-discordant risk behavior,****** resulting in an estimated transmission rate of 23.13%.107-109 A meta-analysis of 30 U.S. studies that included more than 18,000 MSM with HIV estimated that the prevalence of unprotected anal sex was considerably higher with partners with HIV (30%, 95% CI: 25%-36%) than with partners of unknown HIV infection status (16%, 95% CI: 13%–21%) or HIV-uninfected partners (13%, 95% CI: 10%-16%).80

Abstinence from sharing drug-injection equipment with HIV-uninfected persons is the most effective method to reduce injection-related HIV transmission but many persons who are addicted to injected drugs continue to share injection equipment after their HIV diagnosis. In 2012, an estimated 3,456 reported cases of HIV were related to injection drug use, not including cases among MSM who injected drugs.110 Many cases occurred in areas where substance use treatment and legal sources of sterile syringes are available to PWID.

Baseline data from an ongoing RCT that enrolled 1,100 HIV-infected PWID found that 39.7% engaged in both sharing drug-injection equipment and unprotected sex.109 In 2009, 25% of the estimated 165,900 PWID with HIV had unsuppressed viral load and reported unprotected sex with persons of different HIV infection status.109 Of the 179 cases of perinatally infected infants diagnosed in 15 areas during 2005– 2008, several were born to women who became infected after having sex or sharing drug-injection equipment late in pregnancy with a person with HIV.111

Whenever possible, most persons with HIV should receive some risk-reduction counseling from their health care providers when they start HIV medical care. Nationally representative data indicate that only about 45% of persons receiving outpatient HIV medical care reported receiving HIV prevention counseling†††††† from a health care provider during the preceding year.112 Evaluations of patients receiving HIV primary care through the Ryan White HIV/AIDS Program in 9 states found that 53% of all patients and 65% of PWID reported having discussed safer sex and HIV prevention methods with their providers during their last visit.113,114 Some clinical providers who provide HIV risk-reduction counseling at initial visits do not provide it at later visits. In one study, 60% of providers reported providing risk-reduction counseling to more than 90% of their newly diagnosed patients, but only 14% of providers reported such counseling to more than 90% of their returning patients.115 A study of patients with HIV in 15 Ryan

****** HIV-discordant risk behavior is engaging in unprotected sex or sharing drug-injection equipment with a person with a different HIV infection status. †††††† HIV prevention counseling is an interactive process between client or patient and counselor aimed at reducing sexual, drug-use, and reproductive behaviors that pose a risk of HIV transmission or acquisition.

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White-funded clinics in 12 states and Washington, DC, showed that providers reported counseling 69% of new patients but only 52% of returning patients.116

Lack of time and staff and competing priorities are common barriers to providing risk screening and risk- reduction interventions in clinical settings, community-based organizations, and health departments.117,118 Intensive, multisession interventions are generally more effective in promoting safer behaviors among persons with HIV than brief interventions (see the Evidence topic in this section). However, intensive interventions are impractical without trained staff and dedicated space and they may appeal only to persons who will commit to attending several sessions. Some clinical providers may defer risk screening and risk-reduction interventions because they do not 1) have the needed skills or comfort, 2) believe that interventions will change behaviors, or 3) provide periodic STD screening that might identify patients with objective markers of unprotected sex.113,115,119-123

A qualitative systematic review of 30 behavioral risk-reduction interventions found that several factors enabled provision of brief or intensive risk-reduction interventions in clinical settings28:

 Securing buy-in from clinical providers before introducing the intervention  Addressing provider attitudes and beliefs about risk reduction  Overcoming resistance from providers who are uncomfortable with risk-reduction counseling  Providing training in selected risk-reduction counseling techniques  Anticipating changes in clinic flow due to the intervention  Clarifying responsibilities of all members of the care team to provide or reinforce risk-reduction messages

At least three studies found that training and decision-support tools can enhance providers’ comfort, skill, efficiency, and motivation to provide risk screening and risk-reduction interventions.120,122,124 Brief provider- or patient-administered risk-screening tools and computer-based and video-based risk-reduction interventions may be practical alternatives for both clinical and nonclinical providers when time is limited (see the Implementation Resources topic below).26,29 By offering accurate, self-collected STD screening tests that do not require provider time for specimen collection, providers can routinely use positive test results as markers of unprotected sex (see Section 9, STD Services).

Clear billing procedures, adequate reimbursement, and formal referral agreements with other providers of risk-reduction interventions also promote delivery of risk-reduction interventions.113 The Patient Protection and Affordable Care Act (ACA) enables clinical and nonclinical providers to bill risk screening and risk-reduction services.125 Some health departments are exploring third-party reimbursement for risk-reduction services.126,127

Policy, legal, and ethical considerations Laws about HIV confidentiality protections, HIV disclosure, and duty to inform others about possible HIV exposure vary by jurisdiction. Providers who are aware of these laws are better equipped to fulfill their own obligations to notify persons of possible HIV exposure and to inform persons with HIV about their rights and responsibilities regarding HIV disclosure. (See Section 3, Context of Prevention, and Section 8, Partner Services, for details on the legal and ethical issues related to HIV exposure.)

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In some jurisdictions, persons with HIV may hesitate to carry condoms or sterile drug-injection equipment in public settings if possessing these devices could result in charges of illegal sex work or drug use.128,129 Laws about the distribution and prescription authority for sterile drug-injection equipment vary by jurisdiction; some states do not authorize legal access to sterile equipment through medical care providers, pharmacists, or SSPs.130 (See Section 12, Other Medical and Social Services, for details on referring persons with HIV to these services.)

Special populations Some persons with HIV continue to practice behaviors that can transmit HIV despite risk-reduction interventions because of personal choice; substance abuse; mental illness; lack of access to new, sterile drug-injection equipment; reliance on sex work for financial survival; misconceptions that risk behaviors do not pose a risk of HIV transmission; and other factors (see Section 12, Other Medical and Social Services). These persons include adults and adolescents who are MSM, homeless, and incarcerated. Persons who continue risk behaviors or have a detectable viral load despite interventions may benefit from more intensive interventions and specialty services, such as substance use treatment (see Section 12, Other Medical and Social Services). Some persons with HIV require additional risk screening and risk- reduction services to reduce the risk of transmission during intervals when viral load is high (due to lapses in adherence to ART), when attempting conception through unprotected sex, or during pregnancy. (See Section 6, ART Adherence; Section 10, Reproductive Health Care; and Section 11, Pregnancy, for additional information.)

Implementation Resources Resources to support implementation of these recommendations are available at http://www.cdc.gov/hiv/guidelines/implementationresources.html. These include risk-screening tools, training materials, and packaged information on evidence-based risk-reduction interventions.5

References 1. Centers for Disease Control and Prevention [Workowski K; Bolan G]. Sexually transmitted diseases treatment guidelines, 2015. MMWR 2015;64(RR-3):1-137. http://www.cdc.gov/std/tg2015/. Accessed December 2016. 2. Fisher JD, et al. Clinician-delivered intervention during routine clinical care reduces unprotected sexual behavior among HIV-infected patients. J Acquir Immune Defic Syndr 2006;41(1):44-52. 3. Gilbert P, et al. Interactive “Video Doctor” counseling reduces drug and sexual risk behaviors among HIV- positive patients in diverse outpatient settings. PLoS ONE 2008;3(4):e1988. 4. Lightfoot M, et al. Efficacy of brief interventions in clinical care settings for persons living with HIV. J Acquir Immune Defic Syndr 2010;53(3):348-356. 5. Centers for Disease Control and Prevention. Compendium of evidence-based interventions and best practices for HIV prevention: Risk Reduction chapter. 2014. http://www.cdc.gov/hiv/prevention/research/compendium/rr/. Accessed April 8, 2014. 6. Centers for Disease Control and Prevention, et al. Preexposure prophylaxis for the prevention of HIV infection in the United States—2014: a clinical practice guideline. 2014. http://stacks.cdc.gov/view/cdc/23109. Accessed May 15, 2014. 7. Centers for Disease Control and Prevention. Antiretroviral postexposure prophylaxis after sexual, injection- drug use, or other nonoccupational exposure to HIV in the United States: recommendations from the U.S. Department of Health and Human Services. MMWR 2005;54(RR-2):1-20. 8. Patel P, et al. Estimating per-act HIV transmission risk: a systematic review. AIDS 2014;28(10):1509-1519.

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9. Centers for Disease Control and Prevention. HIV Transmission Risk. 2014. http://www.cdc.gov/hiv/basics/transmission.html. Accessed October 15, 2014. 10. Centers for Disease Control and Prevention. Male circumcision and risk for HIV transmission and other health conditions: implications for the United States. 2008. http://stacks.cdc.gov/view/cdc/13545. Accessed September 28, 2016. 11. Centers for Disease Control and Prevention. Questions and Answers: HIV Prevention—how can I prevent getting HIV from drug use? 2014. http://www.cdc.gov/hiv/basics/prevention.html. Accessed October 15, 2014. 12. Centers for Disease Control and Prevention. Recommendations for partner services programs for HIV infection, syphilis, gonorrhea, and chlamydial infection. MMWR 2008;57(RR-9):1-83. 13. Centers for Disease Control and Prevention. Effectiveness of prevention strategies to reduce the risk of acquiring or transmitting HIV: serosorting for HIV-negative persons. 2016. http://www.cdc.gov/hiv/risk/estimates/preventionstrategies.html. Accessed June 23, 2016. 14. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1–infected adults and adolescents. 2014. http://www.aidsinfo.nih.gov/guidelines/html/1/adult-and- adolescent-treatment-guidelines/0. Accessed July 7, 2014. 15. Health Resources and Services Administration. Guide for HIV/AIDS Clinical Care—2014 Edition. 2014. http://hab.hrsa.gov/sites/default/files/hab/clinical-quality-management/2014guide.pdf. Accessed October 17, 2016. 16. Centers for Disease Control and Prevention. Revised guidelines for HIV counseling, testing, and referral. MMWR 2001;50(RR-19):1-58. 17. Centers for Disease Control and Prevention. Integrated prevention services for HIV infection, viral hepatitis, sexually transmitted diseases, and tuberculosis for persons who use drugs illicitly: summary guidance from CDC and the U.S. Department of Health and Human Services. MMWR 2012;61(RR-5):1-40. 18. World Health Organization (WHO). Essential prevention and care interventions for adults and adolescents living with HIV in resource-limited settings. Boothroyd J (Ed.); 2008. http://www.who.int/hiv/pub/prev_care/OMS_EPP_AFF_en.pdf. Accessed February 23, 2012. 19. New York State Department of Health AIDS Institute, et al. Prevention with positives: integrating HIV prevention into HIV primary care. 2011. http://www.hivguidelines.org/wp-content/uploads/2012/10/prevention- with-positives-10-08-2012.pdf. Accessed September 26, 2016. 20. Institute of Medicine. Clinical Preventive Services for Women: Closing the Gaps. Washington, DC: The National Academies Press; 2011. 21. Aberg JA, et al. Primary care guidelines for the management of persons infected with HIV: 2013 update by the HIV Medicine Association of the Infectious Diseases Society of America. Clin Infect Dis 2014;58(1):e1-e34. 22. Marrazzo JM, et al. HIV prevention in clinical care settings: 2014 recommendations of the International Antiviral Society–USA Panel. JAMA 2014;312(4):390-409. 23. Thompson MA, et al. Antiretroviral treatment of adult HIV infection: 2012 recommendations of the International Antiviral Society-USA Panel. JAMA 2012;308(4):387-402. 24. Centers for Disease Control and Prevention. Nonoxynol-9 spermicide contraception use—United States, 1999. MMWR 2002;51(18):389-392. 25. Centers for Disease Control and Prevention. Notice to readers: CDC statement on study results of product containing nonoxynol-9. MMWR 2000;49(31):717-718. 26. Crepaz N, et al. Do prevention interventions reduce HIV risk behaviours among people living with HIV? A meta-analytic review of controlled trials. AIDS 2006;20(2):143-157. 27. Johnson BT, et al. Sexual risk reduction for persons living with HIV: research synthesis of randomized controlled trials, 1993 to 2004. J Acquir Immune Defic Syndr 2006;41(5):642-650. 28. Gilliam PP, et al. Prevention with positives: a review of published research, 1998-2008. J Assoc Nurses AIDS Care 2009;20(2):92-109. 29. Crepaz N, et al. A systematic review of interventions for reducing HIV risk behaviors among people living with HIV in the United States, 1988–2012. AIDS 2014;28(5):633-656. 30. Lin F, et al. Cost effectiveness of HIV prevention interventions in the U.S. Am J Prev Med 2016. http://www.sciencedirect.com/science/article/pii/S0749379716000374. Accessed March 4, 2016. 31. Obermeyer CM, et al. Facilitating HIV disclosure across diverse settings: a review. Am J Public Health 2011;101(6):1011-1023. 32. Chen WT, et al. Engagement with health care providers affects self-efficacy, self-esteem, medication adherence and quality of life in people living with HIV. Journal of AIDS & clinical research 2013;4(11):256.

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33. Teixeira PA, et al. HIV patients' willingness to share personal health information electronically. Patient Educ Couns 2011;84(2):e9-12. 34. Kitahata MM, et al. Cohort profile: the Centers for AIDS Research Network of Integrated Clinical Systems. Int J Epidemiol 2008;37(5):948-955. 35. Myers JJ, et al. Interventions delivered in clinical settings are effective in reducing risk of HIV transmission among people living with HIV: results from the Health Resources and Services Administration (HRSA)’s special projects of national significance initiative. AIDS Behav 2010;14(3):483-492. 36. Richardson JL, et al. Effect of brief safer-sex counseling by medical providers to HIV-1 seropositive patients: a multi-clinic assessment. AIDS 2004;18(8):1179-1186. 37. Golin CE, et al. SafeTalk, a multicomponent, motivational interviewing-based, safer sex counseling program for people living with HIV/AIDS: a qualitative assessment of patients' views. AIDS Patient Care STDS 2010;24(4):237-245. 38. Golin CE, et al. Longitudinal effects of SafeTalk, a motivational interviewing-based program to improve safer sex practices among people living with HIV/AIDS. AIDS Behav 2012;16(5):1182-1191. 39. Kalichman SC, et al. Integrated behavioral intervention to improve HIV/AIDS treatment adherence and reduce HIV transmission. Am J Public Health 2011;101(3):531-538. 40. McKirnan DJ, et al. The Treatment Advocacy Program: a randomized controlled trial of a peer-led safer sex intervention for HIV-infected men who have sex with men. J Consult Clin Psychol 2010;78(6):952-963. 41. Wingood GM, et al. A randomized controlled trial to reduce HIV transmission risk behaviors and sexually transmitted diseases among women living with HIV: the WiLLOW Program. J Acquir Immune Defic Syndr 2004;37(Suppl 2):S58-67. 42. Rotheram-Borus MJ, et al. Efficacy of a preventive intervention for youths living with HIV. Am J Public Health 2001;91(3):400-405. 43. Rotheram-Borus MJ, et al. Prevention for substance-using HIV-positive young people: telephone and in-person delivery. J Acquir Immune Defic Syndr 2004;37(Suppl 2):S68-77. 44. Kalichman SC, et al. Effectiveness of an intervention to reduce HIV transmission risks in HIV-positive people. Am J Prev Med 2001;21(2):84-92. 45. Kalichman SC, et al. Group intervention to reduce HIV transmission risk behavior among persons living with HIV/AIDS. Behav Modif 2005;29(2):256-285. 46. Sikkema KJ, et al. Effects of a coping intervention on transmission risk behavior among people living with HIV/AIDS and a history of childhood sexual abuse. J Acquir Immune Defic Syndr 2008;47(4):506-513. 47. Wolitski RJ, et al. Effects of a peer-led behavioral intervention to reduce HIV transmission and promote serostatus disclosure among HIV-seropositive gay and bisexual men. AIDS 2005;19(Suppl 1):S99-109. 48. El-Bassel N, et al. National Institute of Mental Health Multisite Eban HIV/STD Prevention Intervention for African American HIV Serodiscordant Couples: a cluster randomized trial. Arch Intern Med 2010;170(17):1594-1601. 49. NIMH Multisite HIV/STD Prevention Trial for African American Couples Group. Methodological overview of an African American couple-based HIV/STD prevention trial. J Acquir Immune Defic Syndr 2008;49(Suppl 1):S3-14. 50. Healthy Living Project Team. Effects of a behavioral intervention to reduce risk of transmission among people living with HIV: the healthy living project randomized controlled study. J Acquir Immune Defic Syndr 2007;44(2):213-221. 51. Charania MR, et al. Efficacy of structural-level condom distribution interventions: a meta-analysis of U.S. and international studies, 1998-2007. AIDS Behav 2011;15(7):1283-1297. 52. Farnham PG, et al. Updates of lifetime costs of care and quality of life estimates for HIV-infected persons in the United States: late versus early diagnosis and entry into care. J Acquir Immune Defic Syndr 2013;64(2):183- 189. 53. Blish CA, et al. Human immunodeficiency virus type 1 superinfection occurs despite relatively robust neutralizing antibody responses. J Virol 2008;82(24):12094-12103. 54. Smith DM, et al. HIV drug resistance acquired through superinfection. AIDS 2005;19(12):1251-1256. 55. Cotte L, et al. Sexually transmitted HCV infection and reinfection in HIV-infected homosexual men. Gastroenterol Clin Biol 2009;33(10-11):977-980. 56. Begay O, et al. Identification of personal lubricants that can cause rectal epithelial cell damage and enhance HIV type 1 replication in vitro. AIDS Res Hum Retroviruses 2011;27(9):1019-1024. 57. Lee SH, et al. Trauma to male genital organs: a 10-year review of 156 patients, including 118 treated by surgery. BJU Int 2008;101(2):211-215.

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58. Rinard K, et al. Cross-sectional study examining four types of male penile and urethral "play". Urology 2010;76(6):1326-1333. 59. Centers for Disease Control and Prevention. HIV/AIDS among women who have sex with women. 2006. http://img.thebody.com/cdc/2006/wsw.pdf. Accessed September 26, 2016. 60. Cu-Uvin S, et al. Effect of highly active antiretroviral therapy on cervicovaginal HIV-1 RNA. AIDS 2000;14(4):415-421. 61. Debiaggi M, et al. Viral excretion in cervicovaginal secretions of HIV-1–infected women receiving antiretroviral therapy. Eur J Clin Microbiol Infect Dis 2001;20(2):91-96. 62. Cu-Uvin S, et al. Genital tract HIV-1 RNA shedding among women with below detectable plasma viral load. AIDS 2010;24(16):2489-2497. 63. Mattson CL, et al. A nested case-control study of sexual practices and risk factors for prevalent HIV-1 infection among young men in Kisumu, Kenya. Sex Transm Dis 2007;34(10):731-736. 64. de Vincenzi I. A longitudinal study of human immunodeficiency virus transmission by heterosexual partners. European Study Group on Heterosexual Transmission of HIV. N Engl J Med 1994;331(6):341-346. 65. Rajasingham R, et al. A systematic review of behavioral and treatment outcome studies among HIV-infected men who have sex with men who abuse crystal methamphetamine. AIDS Patient Care STDS 2012;26(1):36-52. 66. Drumright LN, et al. Associations between substance use, erectile dysfunction medication and recent HIV infection among men who have sex with men. AIDS Behav 2009;13(2):328-336. 67. Brewer DD, et al. Unsafe sexual behavior and correlates of risk in a probability sample of men who have sex with men in the era of highly active antiretroviral therapy. Sex Transm Dis 2006;33(4):250-255. 68. Chu PL, et al. Viagra use in a community-recruited sample of men who have sex with men, San Francisco. J Acquir Immune Defic Syndr 2003;33(2):191-193. 69. Kim AA, et al. Increased risk of HIV and sexually transmitted disease transmission among gay or bisexual men who use Viagra, San Francisco 2000-2001. AIDS 2002;16(10):1425-1428. 70. Mansergh G, et al. Methamphetamine and sildenafil (Viagra) use are linked to unprotected receptive and insertive anal sex, respectively, in a sample of men who have sex with men. Sex Transm Infect 2006;82(2):131- 134. 71. Auvert B, et al. Randomized, controlled intervention trial of male circumcision for reduction of HIV infection risk: the ANRS 1265 trial. PLoS Med 2005;2(11):e298. 72. Bailey RC, et al. Male circumcision for HIV prevention in young men in Kisumu, Kenya: a randomised controlled trial. Lancet 2007;369(9562):657-666. 73. Gray RH, et al. Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial. Lancet 2007;369(9562):657-666. 74. Siegfried N, et al. Male circumcision for prevention of heterosexual acquisition of HIV in men. Cochrane Database Syst Rev 2009;(2):CD003362. 75. Wetmore CM, et al. Randomized controlled trials of interventions to prevent sexually transmitted infections: learning from the past to plan for the future. Epidemiol Rev 2010;32(1):121-136. 76. Tobian AA, et al. Male circumcision for the prevention of HSV-2 and HPV infections and syphilis. N Engl J Med 2009;360(13):1298-1309. 77. Alanis MC, et al. Neonatal circumcision: a review of the world’s oldest and most controversial operation. Obstet Gynecol Surv 2004;59(5):379-395. 78. Weiss HA, et al. Male circumcision and risk of syphilis, chancroid, and genital herpes: a systematic review and meta-analysis. Sex Transm Infect 2006;82(2):101-109. 79. Weiss HA, et al. Male circumcision and risk of HIV infection in women: a systematic review and meta- analysis. Lancet Infect Dis 2009;9(11):669-677. 80. Crepaz N, et al. Prevalence of unprotected anal intercourse among HIV-diagnosed MSM in the United States: a meta-analysis. AIDS 2009;23(13):1617–1629. 81. Fisher MP, et al. Risk behaviors among HIV-positive gay and bisexual men at party-oriented vacations. J Stud Alcohol Drugs 2013;74(1):158-167. 82. Wiysonge CS, et al. Male circumcision for prevention of homosexual acquisition of HIV in men. Cochrane Database Syst Rev 2011;(6):CD007496. 83. American Academy of Family Physicians. Neonatal circumcision. 2013. http://www.aafp.org/about/policies/all/neonatal-circumcision.html. Accessed October 24, 2014. 84. American Academy of Pediatrics Task Force on Circumcision. Circumcision policy statement. Pediatrics 2012;130(3):585-586.

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85. American College of Obstetricians and Gynecologists. Frequently asked questions: newborn circumcision. 2012. http://www.acog.org/Patients/FAQs/Newborn-Circumcision. Accessed October 24, 2014. 86. American Urological Association. Policy statement: circumcision. 2007. http://www.auanet.org/about/policy- statements/circumcision.cfm. Accessed October 24, 2014. 87. Holman JR, et al. Adult circumcision. Am Fam Physician 1999;59(6):1514-1518. http://www.aafp.org/afp/1999/0315/p1514.html. Accessed October 24, 2014. 88. Altice FL, et al. Treatment of medical, psychiatric, and substance-use comorbidities in people infected with HIV who use drugs. Lancet 2010;376(9738):367-387. 89. Klinkenberg WD, et al. Mental disorders and drug abuse in persons living with HIV/AIDS. AIDS Care 2004;16(Suppl 1):S22-42. 90. Lucas GM. Substance abuse, adherence with antiretroviral therapy, and clinical outcomes among HIV-infected individuals. Life Sci 2011;88(21-22):948-952. 91. Kaiser Family Foundation. State Health Facts: Sterile Syringe Exchange Programs, 2014. 2014. http://kff.org/hivaids/state-indicator/syringe-exchange-programs/. Accessed September 26, 2016. 92. National Alliance of State and Territorial AIDS Directors, et al. Syringe Services Program (SSP) Development and Implementation Guidelines for State and Local Health Departments. 2012:1-52. http://www.nastad.org/Docs/055419_NASTAD%20UCHAPS%20SSP%20Guidelines%20August%202012.pdf . Accessed October 11, 2012. 93. Institute of Medicine. Preventing HIV Infection among Injecting Drug Users in High Risk Countries: An Assessment of the Evidence. Washington, DC: The National Academies Press; 2006. 94. Palmateer N, et al. Evidence for the effectiveness of sterile injecting equipment provision in preventing hepatitis C and human immunodeficiency virus transmission among injecting drug users: a review of reviews. Addiction 2010;105(5):844-859. 95. Hurley SF, et al. Effectiveness of needle-exchange programmes for prevention of HIV infection. Lancet 1997;349(9068):1797-1800. 96. National Institutes of Health. Interventions to prevent HIV risk behaviors—NIH consensus statement. 1997;15(2):1-41. http://consensus.nih.gov/1997/1997PreventHIVRisk104html.htm. Accessed October 11, 2012. 97. Gibson DR, et al. Effectiveness of syringe exchange programs in reducing HIV risk behavior and HIV seroconversion among injecting drug users. AIDS 2001;15(11):1329-1341. 98. United States General Accounting Office. Needle exchange programs: research suggests promise as an AIDS prevention strategy. 1993. http://www.gao.gov/assets/220/217594.pdf. Accessed October 11, 2012. 99. Riley ED, et al. Access to sterile syringes through San Francisco pharmacies and the association with HIV risk behavior among injection drug users. J Urban Health 2010;87(4):534-542. 100. Macalino GE, et al. A national physician survey on prescribing syringes as an HIV prevention measure. Subst Abuse Treat Prev Policy 2009;4(1):13. 101. Centers for Disease Control and Prevention. State and local policies regarding IDUs' access to sterile syringes. 2005. http://www.cdc.gov/idu/facts/aed_idu_pol.htm. Accessed October 24, 2014. 102. Centers for Disease Control and Prevention. Physician prescription of sterile syringes to injection drug users. 2005. http://www.cdc.gov/idu/facts/Physician.htm. Accessed May 24, 2012. 103. Gowing L, et al. Oral substitution treatment of injecting opioid users for prevention of HIV infection. Cochrane Database Syst Rev 2011;(8):CD004145. 104. Marks G, et al. Estimating sexual transmission of HIV from persons aware and unaware that they are infected with the virus in the USA. AIDS 2006;20(10):1447–1450. 105. Donnell D, et al. Heterosexual HIV-1 transmission after initiation of antiretroviral therapy: a prospective cohort analysis. Lancet 2010;375(9731):2092-2098. 106. Quinn TC, et al. Viral load and heterosexual transmission of human immunodeficiency virus type 1. Rakai Project Study Group. N Engl J Med 2000;342(13):921-929. 107. Centers for Disease Control and Prevention. Clinical and behavioral characteristics of adults receiving medical care for HIV infection—Medical Monitoring Project, United States, 2007. MMWR 2011;60(SS-11):1-20. 108. Hall HI, et al. HIV transmission in the United States: considerations of viral load, risk behavior, and health disparities. AIDS Behav 2013;17(5):1632-1636. 109. Holtgrave DR, et al. Estimating number of diagnosed persons living with HIV in the United States engaged in unprotected serodiscordant risk behavior with unsuppressed viral load. J Acquir Immune Defic Syndr 2014;65(3):e125-128.

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110. Centers for Disease Control and Prevention. Diagnoses of HIV infection in the United States and dependent areas, 2012. HIV Surveillance Report 2014;24. http://www.cdc.gov/hiv/library/reports/surveillance/. Accessed November 24, 2014. 111. Whitmore SK, et al. Correlates of mother-to-child transmission of HIV in the United States and Puerto Rico. Pediatrics 2012;129(1):e74-81. 112. Centers for Disease Control and Prevention. Vital Signs: HIV prevention through care and treatment—United States. MMWR 2011;60(47):1618–1623. 113. Morin SF, et al. Missed opportunities: prevention with HIV-infected patients in clinical care settings. J Acquir Immune Defic Syndr 2004;36(4):960-966. 114. Wilkinson JD, et al. Providers' HIV prevention discussions with HIV-seropositive injection drug users. AIDS Behav 2006;10(6):699-705. 115. Metsch LR, et al. Delivery of HIV prevention counseling by physicians at HIV medical care settings in 4 US cities. Am J Public Health 2004;94(7):1186–1192. 116. Myers JJ, et al. Helping clinicians deliver consistent HIV prevention counseling to their HIV-infected patients. AIDS Care 2013;25(5):640-645. 117. Drainoni ML, et al. HIV medical care provider practices for reducing high-risk sexual behavior: results of a qualitative study. AIDS Patient Care STDS 2009;23(5):347-356. 118. Ryan GW, et al. Data-driven decision-making tools to improve public resource allocation for care and prevention of HIV/AIDS. Health Aff (Millwood) 2014;33(3):410-417. 119. Bluespruce J, et al. HIV prevention in primary care: impact of a clinical intervention. AIDS Patient Care STDS 2001;15(5):243-253. 120. Gardner LI, et al. Frequency of discussing HIV prevention and care topics with patients with HIV: influence of physician gender, race/ethnicity, and practice characteristics. Gend Med 2008;5(3):259-269. 121. Myers JJ, et al. Sex, risk and responsibility: provider attitudes and beliefs predict HIV transmission risk prevention counseling in clinical care settings. AIDS Behav 2007;11(5 Suppl):S30-S38. 122. Thrun M, et al. Improved prevention counseling by HIV care providers in a multisite, clinic-based intervention: positive STEPs. AIDS Educ Prev 2009;21(1):55-66. 123. Steward WT, et al. Provider fatalism reduces the likelihood of HIV-prevention counseling in primary care settings. AIDS Behav 2006;10(1):3-12. 124. Rose CD, et al. HIV intervention for providers study: a randomized controlled trial of a clinician-delivered HIV risk-reduction intervention for HIV-positive people. J Acquir Immune Defic Syndr 2010;55(5):572-581. 125. Patient Protection and Affordable Care Act, 111-148, 111th Congress, 2010 Cong. Rec. 2010. http://www.gpo.gov/fdsys/pkg/PLAW-111publ148/pdf/PLAW-111publ148.pdf. Accessed February 10, 2012. 126. National Network of STD/HIV Prevention Training Centers. HIV partner counseling and referral services capacity needs assessment. 2008. http://www.stdpreventiononline.org/assets/resources/63200797_1735.pdf. Accessed January 28, 2014. 127. National Alliance of State and Territorial AIDS Directors. Billing and reimbursement. Issue Brief 2013. http://nastad.org/docs/NASTAD-Issue-Brief-Billing-April-2013.pdf. Accessed March 24, 2014. 128. Blankenship K, et al. Criminal law, policing policy, and HIV risk in female street sex workers and injection drug users. J Law Med Ethics 2002;30(4):548-559. 129. Shannon K, et al. Violence, condom negotiation, and HIV/STI risk among sex workers. JAMA 2010;304(5):573-574. 130. North American Syringe Exchange Network. US Syringe Exchange Program Database. 2014. http://www.nasen.org/programs/. Accessed March 24, 2014.

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Section 8. HIV Partner Services Background HIV partner services comprise an array of voluntary services intended to reduce HIV transmission. They are provided to 1) persons with HIV (described as index patients*) who have been newly diagnosed in clinical settings† or nonclinical settings;‡ represent a case of infection that is reported to health departments; or have been previously diagnosed and also pose a high risk of exposing others to HIV (e.g., a recently diagnosed STD that indicates unprotected sex§ or may facilitate HIV transmission or sharing drug-injection equipment**); and 2) their sex and drug-injection partners. The core components include interviewing persons with HIV to obtain information to contact or locate their sex and drug- injection partners; notifying partners of possible HIV exposure; offering testing for HIV, sexually transmitted disease (STD), and other infections; providing condoms, prevention information, and counseling; and providing help in obtaining risk-reduction services, HIV medical care, and other medical and social services.1 This proactive approach can hasten the diagnosis of HIV and other infections; can prompt treatment before symptoms appear; and can reduce the transmission, burden, and costs of these communicable diseases in communities.

Reporting of cases of HIV, syphilis, gonorrhea, and chlamydial infection†† is required in all states, the District of Columbia, and U.S. territories.2 In many jurisdictions, receipt of a laboratory or clinical case report of HIV or STD by a health department or its HIV or STD surveillance program will activate a health department’s legal authority to provide partner services.1 Cases of HIV identified at anonymous testing sites cannot be reported by name to health departments. Most health departments initiate HIV partner services after receiving reports of confirmed cases of HIV. However, some may initiate contact with “presumptive” index patients upon receiving reports of positive preliminary test results3,4 but defer notifying partners until additional testing of the index patient confirms HIV infection. Health departments can adopt this practice if they apply the 2014 Centers for Disease Control and Prevention (CDC) revised HIV surveillance case definition that allows routine reporting of positive preliminary HIV test results before confirmatory test results are available.5 CDC’s revised surveillance case definition also recommends routine reporting of cases of acute infection diagnosed by HIV antigen or nucleic acid amplification tests.5 In states that adopt this case definition, health departments can rapidly identify acutely infected persons who are likely to be highly infectious and who warrant being offered expedited partner services. Some clinical and nonclinical providers contact health department partner services

* A person with diagnosed HIV or STD and whose diagnosis prompts an investigation to identify other persons (known as partners) who may have become infected through sexual contact or exposure to blood or other body fluids of the index patient. † Clinical settings are health care facilities in which medical diagnostic, treatment, and disease prevention services are routinely provided. ‡ Nonclinical settings are facilities that provide prevention, education, screening and interventions for risk behaviors, and referrals for medical and social services. Some nonclinical settings may also provide health promotion services and screening for HIV and some STD. § Sexual activity without using a physical barrier (i.e., penile sex without using a male condom; vaginal sex without using a male or female condom; oral-anal contact without using a dental dam or other barrier device; vaginal-digital contact without using a female condom, latex glove, or finger cot; or rectal-digital contact without using a latex glove or finger cot). ** Drug-injection equipment includes needles and syringes; drug preparation equipment, such as cookers, mixing containers, spoons, and filters; swabs; and water or some other liquid used for preparing a drug solution or for rinsing drug equipment. †† Another document describes partner services that are prompted by the diagnosis of bacterial STD in index patients who are not infected with HIV.1

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specialists immediately after they identify persons with positive HIV tests—particularly persons with acute infection—rather than wait for receipt of a surveillance case report to activate partner services.1,3,4,6

In the United States, most HIV partner services are provided by health department partner services specialists who are highly trained in providing voluntary, confidential partner services and can be engaged through routine case reporting, provider referral, and requests by persons with HIV.1 Nevertheless, methods of delivering partner services may vary by jurisdiction. Partner elicitation‡‡ can be done by health department specialists, HIV testing providers, and other clinical or nonclinical providers who are trained and authorized to conduct partner elicitation.1,6 Partner notification§§ can be performed by health department specialists; physicians; nurse practitioners, and physician assistants who work under the authority of a physician; other clinical and nonclinical providers who are trained and authorized to provide partner notification; and index patients.1 Some jurisdictions use hybrid methods in which 1) trained clinical providers or nonclinical HIV testing providers elicit partner information from index patients, but defer partner notification to health department specialists; 2) index patients give partner contact information to health department specialists, who in turn notify the partners; 3) index patients and health department specialists or other providers jointly notify the partners; and 4) index patients make verbal contracts with health department specialists to notify partners within a specific time frame, and if this fails, the specialists attempt to notify partners.7-9

Health department partner services are voluntary and confidential and usually involve no cost to index patients or partners; specialists notify partners of possible HIV exposure without revealing the index patient’s name or other potentially identifying information.1 These specialists contact index patients and partners by phone, letter, email, or text message or in person at HIV testing sites, HIV clinical settings, STD clinics, homes, or other community settings where private communication is possible. In some health departments, specialists also use “screen names” or other information provided by index patients to contact partners who were found through Internet dating sites, “chat rooms,” mobile device applications, or social networking*** tools.1,3,10 Specialists may also help index patients use Internet††† or social media sites to directly notify partners about possible HIV exposure.11 In a national survey of 57 state or local health departments, two-thirds reported using Internet-based partner notification.9

Because partner services specialists routinely offer HIV testing to partners, they offer a form of targeted, community-based HIV screening for persons at high risk for HIV. Some partner services programs offer venue-based HIV testing in sites frequented by index patients or partners.1 They also use social network‡‡‡ or “cluster” approaches in which health department specialists encourage index patients or partners to recruit friends, family members, or others for HIV testing.1 In some cases, specialists will actively link

‡‡ Partner elicitation is an early step of voluntary, confidential partner services in which a health department partner services specialist or other provider interviews or reinterviews a person with HIV or STD to collect names, descriptions, and locating and contact information of persons who are sex or drug-injection partners so the partners can be notified of possible HIV or STD exposure. §§ Partner notification is a step of voluntary, confidential partner services that involves locating and confidentially notifying sex and drug- injection partners of persons infected with HIV or STD of possible exposure to HIV or STD. *** Social networking is a strategy to recruit persons for HIV testing or prevention services in which high-risk individuals use their personal influence to recruit peers they believe are at high risk for HIV infection. ††† Recent information on Internet partner services can be found at http://www.cdc.gov/std/program/ips/default.htm (Introducing Technology into Partner Services toolkit for programs was published December 2015 and was not available at the time of initial publication of this report [December 2014]). ‡‡‡ A social network is a group of persons connected by social relationships, such as friends, family, sex and drug-injection partners, or persons who frequent the same physical or virtual venues.

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index patients or partners with HIV to HIV medical care.12,13 In addition, some health care providers provide HIV testing to partners who are referred by their patients with HIV.6

This section addresses partner services prompted by a diagnosis of HIV or the diagnosis of an STD in a person previously diagnosed with HIV. Other federal guidance describes partner services for HIV- uninfected persons diagnosed with STDs.1 Quality improvement§§§ and program monitoring and evaluation**** can determine if the services described in this section are implemented as intended, yield the expected outcomes, or warrant changes in delivery methods (see Section 13, Quality Improvement). Section 9, STD Services, provides more information about STD screening, treatment, and counseling of index patients and management of partners. Section 5, Antiretroviral Treatment, describes the use of nonoccupational postexposure prophylaxis (nPEP)†††† for HIV-uninfected partners with very recent HIV exposure, and preexposure prophylaxis (PrEP)‡‡‡‡ for HIV-uninfected partners at substantial risk for acquiring HIV infection.

Recommendations

BOX 8. RECOMMENDATIONS—HIV PARTNER SERVICES

For nonclinical and clinical providers (not including health department partner services specialists)  Develop infrastructure, policies, and procedures that enable persons who warrant HIV partner services (index patients) to obtain services through the health department or other authorized providers (i) (see Box 8-A)  Collaborate with health department staff to reinforce knowledge and skills about the following topics (i):  Methods to ensure that partner services are voluntary and confidential (see Box 8-B)  Elements of partner services (see Box 8-B)  Roles, responsibilities, and legal authority of nonclinical providers, clinical providers, and health department staff to provide partner services to index patients and inform their partners of possible HIV exposure  Laws, regulations, requirements, procedures, and guidelines in the jurisdiction (e.g., data confidentiality and security, index patient’s and provider’s duty to inform exposed partners, laws regarding prosecution for intentional HIV exposure)a  Identify index patients with HIV who warrant partner services and offer expedited interviews to those with the following characteristics (i, ii, iii, iv, v):  Acute HIV infectionb based on laboratory tests (e.g., positive result on HIV p24 antigen test, HIV nucleic acid amplification test, or HIV viral load test; or HIV antibody results indicative of recent seroconversion), or clinical evaluation (i.e., symptoms or signs of acute retroviral syndrome) that is associated with a high risk of HIV transmission  High HIV viral load that is associated with a high risk of HIV transmission  Newly reported or newly diagnosed HIV infection (based on preliminary and/or confirmatory HIV test results as allowed by the jurisdiction)

§§§ Quality improvement is an approach to the continuous study and improvement of the processes of providing services that meet or exceed established professional standards and user expectations. **** Monitoring and evaluation is a process that involves the repeated, ongoing collection and review of information about program activities, characteristics, and outcomes in order to assess program implementation, coverage, acceptability, cost, and effectiveness. †††† nPEP is the use of selected antiretroviral medications by HIV-uninfected persons within 72 hours after isolated, nonoccupational exposure to body fluids potentially containing HIV, such as after unprotected sexual intercourse or condom breakage, in order to reduce the risk of HIV acquisition. ‡‡‡‡ PrEP is the daily, continuous use of a specific regimen of antiretroviral medications for a period of time by an HIV-uninfected person to achieve levels of drug in the blood and anal and genital mucosa sufficient to reduce the risk of HIV acquisition.14

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BOX 8. RECOMMENDATIONS—HIV PARTNER SERVICES (cont)

 Newly diagnosed sexually transmitted diseases (STDs) that indicate recent unprotected sex (i.e., sexual activity without using a physical barrier) and facilitate HIV transmission—primary and secondary syphilis; gonorrhea and chlamydial infection (including rectal infection); herpes simplex virus type 2 (HSV-2); and trichomoniasis (in women)c  Increased risk of HIV transmission due to pregnancyd  Behaviors that pose a high risk of exposing others to HIV (e.g., multiple, anonymous partners; having unprotected sex with persons with negative or unknown HIV-infection status; sharing drug-injection equipment)e  A specific request for partner services  Ask index patients if they have disclosed their HIV infection to all sex and drug-injection partners and if self- notification would pose any risks (i, ii, v)  Promptly refer index patients to health department partner services directly or through HIV case reporting according to the methods of the jurisdiction (i, ii, iii, iv, v, vi) (see Box 8-B)  If the index patient declines referral for health department assistance, offer partner services as appropriate to the provider’s legal authority and skills and the index patient’s preferences (i, ii, iii, iv, v) (see Box 8-B)  Offer services to partners who are referred by index patients as appropriate to provider’s legal authority and skills (i, ii, v) (see Box 8-B) For health department partner services specialists  Provide partner services information, resources, advice, and assistance to HIV testing providers in nonclinical and clinical settings as allowed by professional authority and skills (i, vi) (see Box 8-A)  Establish a partner services program with the following principles (i, vi, vii): (see Box 8-A)  Adheres to the laws, regulations, and standards of the jurisdiction and protects confidentiality  Promptly identifies index patients who warrant being offered partner services through HIV and STD case surveillance information, referring providers, or other methods allowed in the jurisdiction  Efficiently uses a well-trained workforce that demonstrates culturally appropriate interactions with community members  Expedites services to the highest risk index patients and partners  Considers innovative, evidence-based methods to notify partners (e.g., Internet, social media)  Monitors program effectiveness to guide quality improvementc,f  Contact index patients and offer essential services (i, vi) (see Box 8-B)  Notify partners and offer essential partner services (i, vi) (see Box 8-B)

Note. In this report, nonclinical providers are defined as persons who work in community-based organizations or health departments operating outside of health care facilities and who provide HIV testing, health education, risk-reduction interventions, partner services, case management, or assistance with linkage or referral to medical and social services. These persons include HIV testing providers, peer and professional health educators, counselors, service linkage facilitators, partner services specialists, case managers, and social workers. In this section, recommendations for health department partner services specialists are listed separately from recommendations for other nonclinical providers because state and local laws and regulations influence their roles and responsibilities. Clinical providers are defined as persons who work in health care facilities and who provide risk assessments, health education and counseling; disease screening, diagnosis, and treatment; and other health-related services. These providers include physicians, registered nurses, advance practice nurses, physician assistants, dentists, mental health providers, pharmacists, health educators, case managers, social workers, and counselors. Some may be employees or contractors of health departments. Most states authorize physicians to provide partner services as part of their duty to inform persons of possible exposure to HIV or STD. Some jurisdictions authorize other clinical providers to provide partner services because they work under the authority of a physician (e.g., nurse practitioners and physician assistants) or have been trained and authorized by health departments to provide partner services. Some of the federal guidelines cited in the Recommendation boxes may have been updated. For current federal recommendations, please refer to http://www.cdc.gov/hiv/guidelines/personswithhiv.html.

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BOX 8. RECOMMENDATIONS—HIV PARTNER SERVICES (cont) a See Section 3, Context of Prevention, for more information on HIV disclosure. b Acute HIV infection is the period between initial HIV infection and the expression of HIV antibodies that can be detected by HIV antibody tests. This period is characterized by high levels of HIV in the blood and a vigorous immune response. c See Section 9, STD Services, for more information on STDs that may facilitate HIV transmission. d See Section 11, Pregnancy, for more information on how pregnancy influences HIV transmission. e See Section 7, Risk Screening and Risk Reduction, for more information on risk behaviors. f See Section 13, Quality Improvement, for more information. Sources i. CDC. Recommendations for partner services programs for HIV infection, syphilis, gonorrhea, and chlamydial infection. MMWR 2008;57(RR-9). http://stacks.cdc.gov/view/cdc/7074. Accessed November 3, 2014. ii. CDC. Sexually transmitted diseases treatment guidelines, 2015. MMWR 2015;64(RR-3). http://www.cdc.gov/std/tg2015/. Accessed December 21, 2016. iii. CDC. Revised guidelines for HIV counseling, testing, and referral. MMWR 2001;50(RR-19). http://stacks.cdc.gov/view/cdc/7281. Accessed November 3, 2014. iv. CDC. Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. MMWR 2006;55(RR-14). http://stacks.cdc.gov/view/cdc/7316. Accessed November 3, 2014. v. HRSA. Guide for HIV/AIDS Clinical Care—2014 Edition. U.S. Department of Health and Human Services; 2014. http://hab.hrsa.gov/sites/default/files/hab/clinical-quality-management/2014guide.pdf. Accessed December 23, 2016. vi. HRSA. The Ryan White Care Act; Section 2631 [300ff-38]. Grants for Partner Notification Programs. October 30, 2009. http://hab.hrsa.gov/livinghistory/issues/confidentiality_8.htm. Accessed December 23, 2016. vii. CDC. Data security and confidentiality guidelines for HIV, viral hepatitis, sexually transmitted disease, and tuberculosis programs: standards to facilitate sharing and use of surveillance data for public health action. 2011. http://www.cdc.gov/nchhstp/programintegration/docs/PCSIDataSecurityGuidelines.pdf. Accessed March 15, 2013.

Box 8-A. Recommended strategies to establish infrastructure for HIV partner services

For nonclinical and clinical providers (not including health department partner services specialists)  Establish clear policies and procedures that are consistent with laws and regulations in the jurisdiction and that relate to the following topics (i, ii, iii, iv, v, vi):  Strategies to notify the health department about index patients who warrant partner services, including those with acute HIV infectiona or other characteristics who should be offered expedited interviews (see Box 8)  Methods to protect and transfer confidential information about index patients and partners to health departments  Methods to help index patients notify partners  Methods to elicit partner information, notify partners, and provide testing and presumptive STD treatment to partners  Informing index patients and partners about the availability of preexposure prophylaxis (PrEP) b and nonoccupational postexposure prophylaxis (nPEP)c when clinically indicated for HIV-uninfected persons to reduce their risk of HIV acquisitiond  Routinely provide verbal, print, or audiovisual materials to index patients that describe partner services’ benefits, potential risks, procedures, and the availability of voluntary, confidential health department assistance (i, ii, iii)  Periodically assess partner services to guide quality improvemente (i)

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Box 8-A. Recommended strategies to establish infrastructure for HIV partner services (cont)

For health department partner services specialists  Offer information, resources, advice, and assistance to nonclinical and clinical providers who provide HIV, STD, and viral hepatitis services, such as the followingf (i, ii, vi):  Provider and patient education materials that describe health department partner services and how they can be engaged  Decision-support tools or protocols that describe how to contact the health department regarding index patients who should be expedited for interviewing (e.g., those with acute HIV infection)  Staffing arrangements that expedite partner services at high-volume, high-prevalence HIV testing sites (e.g., assigning health department specialists to work onsite or on an on-call basis)  Information about state or local regulations regarding • legal interpretation of any provider responsibilities regarding the duty to inform partners of possible HIV exposure • reporting new cases of HIV or STD infection by health care providers and laboratories  Provide or obtain ongoing training on effective partner services methods that are informed by local epidemiology, jurisdiction requirements, and CDC guidelines on the following topics (i):  Confidential, respectful, culturally sensitive communication  Assessing the risk of partner violence  Handling of complex or threatening situations in the field  Rights of minors  The effect of changes in health department staffing, HIV testing methods, and HIV surveillance case definitions on partner services priorities  Innovative, effective methods to reach index patients and partners (e.g., Internet and social media sites)  Methods to expedite HIV testing of partners (e.g., rapid, point-of-service tests)  Establish and use systems to integrate or routinely match HIV and STD surveillance data to identify index patients who are coinfected with HIV and other STDs (i)  Establish criteria to expedite offering interviews to index patients with the following characteristics (i, ii)  Acute HIV infection based on laboratory tests (e.g., positive result on HIV p24 antigen test, HIV nucleic acid amplification test, or HIV viral load test; or HIV antibody results indicative of recent seroconversion), or clinical evaluation (i.e., symptoms or signs of acute retroviral syndrome) that is associated with a high risk of HIV transmission  High HIV viral load that is associated with a high risk of HIV transmission  Newly reported or newly diagnosed HIV infection (based on preliminary and/or confirmatory HIV test results as allowed by the jurisdiction)  Newly diagnosed sexually transmitted diseases (STDs) that indicate recent unprotected sex (i.e., sexual activity without using a physical barrier) and facilitate HIV transmission—primary and secondary syphilis; gonorrhea and chlamydial infection (including rectal infection); herpes simplex virus type 2 (HSV-2); and trichomoniasis (in women)g  Increased risk of HIV transmission due to pregnancyh  Behaviors that pose a high risk of exposing others to HIV (e.g., multiple, anonymous partners; having unprotected sex with persons with negative or unknown HIV-infection status; sharing drug-injection equipment)i  A specific request for partner services

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Box 8-A. Recommended strategies to establish infrastructure for HIV partner services (cont)

 Establish criteria for partners who warrant expedited notification with the following characteristics (i, ii):  Likely to be infected with HIV or STD but unaware of their infection  Had contact with index patients in the 3 months before their HIV diagnoses  Warrant STD testing and presumptive STD treatment because the index patients are coinfected with STD  Spouses, long-term partners, and other partners who had contact with index patient in the past 12 months  Establish protocols regarding methods and preferred timeframes to expedite the following partner services (i):  Communicating with index patients (preferably within 2–3 working days of identifying the index patient) and follow-up communication if the index patient did not provide partner information at the initial encounter (preferably within 2 weeks of the initial encounter)  Notifying partners in person or by phone, letter, email, or other means (preferably within 2–3 working days of obtaining partner locating information)  Providing index patients STD and viral hepatitis screening, reproductive health services, and relevant support services onsite or by linking to another provider (preferably within 2 weeks of initial encounter)f  Providing partners screening for HIV, STD, and viral hepatitis, evaluation for HIV prophylaxis, and other medical and social services onsite or by linking to another providerf  Periodically evaluate the partner services program to guide quality improvemente (i)

Note. Another document describes additional recommendations on infrastructure.1 a Acute HIV infection is the period between initial HIV infection and the expression of HIV antibodies that can be detected by HIV antibody tests. This period is characterized by high levels of HIV in the blood and a vigorous immune response. b PrEP is the daily, continuous use of a specific regimen of antiretroviral medications for a period of time by an HIV-uninfected person to achieve levels of drug in the blood and anal and genital mucosa sufficient to reduce the risk of HIV acquisition. In July 2012, FDA approved one PrEP regimen (tenofovir/emtricitabine) for preventing sexual transmission. Although HHS recommendations in May 2014 advised use of this same regimen for persons who inject drugs, the product label only addresses use for preventing sexual transmission. c nPEP is the use of selected antiretroviral medications by HIV-uninfected persons within 72 hours after isolated, nonoccupational exposures to body fluids potentially containing HIV, such as after unprotected sexual intercourse or condom breakage, in order to reduce the risk of HIV acquisition. Use of antiretroviral medication for nPEP does not reflect labeling approved by FDA. d See Section 5, Antiretroviral Treatment, for more information about HIV prophylaxis for HIV-uninfected partners of persons with HIV. e See Section 13, Quality Improvement, for more information. f Viral hepatitis testing (and treatment of infected persons) has not been shown to influence HIV transmission but is included here because it is often offered in combination with HIV and STD testing for individual and public health benefits. This section does not address services for partners exposed to viral hepatitis by persons with HIV who are coinfected with viral hepatitis. g See Section 9, STD Services, for more information on STDs that may facilitate HIV transmission. h See Section 11, Pregnancy, for more information on how pregnancy influences HIV transmission. Sources i. CDC. Recommendations for partner services programs for HIV infection, syphilis, gonorrhea, and chlamydial infection. MMWR 2008;57(RR-9). http://stacks.cdc.gov/view/cdc/7074. Accessed November 3, 2014. ii. CDC. Sexually transmitted diseases treatment guidelines, 2015. MMWR 2015;64(RR-3). http://www.cdc.gov/std/tg2015/. Accessed December 21, 2016. iii. HRSA. Guide for HIV/AIDS Clinical Care—2014 Edition. U.S. Department of Health and Human Services; 2014. http://hab.hrsa.gov/sites/default/files/hab/clinical-quality-management/2014guide.pdf. Accessed December 23, 2016. iv. CDC. Antiretroviral postexposure prophylaxis after sexual, injection-drug use, or other nonoccupational exposure to HIV in the United States: recommendations from the U.S. Department of Health and Human Services. MMWR 2005;54(RR-2). http://stacks.cdc.gov/view/cdc/7303. Accessed November 3, 2014. v. CDC, et al. Preexposure prophylaxis for the prevention of HIV infection in the United States—2014: a clinical practice guideline. May 14, 2014. http://stacks.cdc.gov/view/cdc/23109. Accessed May 15, 2014. vi. HRSA. The Ryan White Care Act; Section 2631 [300ff-38]. Grants for Partner Notification Programs. October 30, 2009. http://hab.hrsa.gov/livinghistory/issues/confidentiality_8.htm. Accessed December 23, 2016.

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Box 8-B. Essential elements of HIV partner services

General principles (i, ii)  Inform index patients and partners referred by index patients that partner services  have potential benefits and risks  are voluntary and confidential  can be provided in several ways, including through health department specialists  Consider various methods to notify partners based on the preferences of index patients and their partners’ characteristics (e.g., found through the Internet, risk of adverse reaction), including self-notification and assistance from health departments and providers  Protect the confidentiality of the index patient and partners and the privacy of their health informationa  Communicate in a nonjudgmental, culturally appropriate, and sensitive manner  Monitor and adhere to changes in jurisdiction regulations that may affect partner services, especially these issues:  Any duty of index patients or providers to inform spouses or other persons of possible HIV exposurea  Intimate partner violence, sexual assault, or child or elder abuse when index patients or partners report abuse or when abuse is suspecteda  Rights of minorsa Services for index patients  Offer voluntary, confidential partner notification assistance through health department partner services specialists and explain the notification process, the role of health department specialists, and confidentiality protections (i, iii, iv, v, vi)  If the index patient accepts health department partner notification assistance, the health department specialist should take the following steps (i, iii):  Explain the rationale for notifying partners of possible HIV exposure (i.e., partners who had contact with the index patient in the 12 months before HIV diagnoses), with priority given to partners who had contact during the 3 months before HIV diagnosis or during the previous month if the index patient has acute HIV infection or high viral load  Ask the index patient which sex and drug-injection partners have already been notified of possible HIV exposure  Collect contact and other information, using CDC-recommended methods, about sex and drug-injection partners who have not been notifiedb  Collect information about physical venues and Internet sites frequented by the index patient or members of his or her social network if using venue-based or social network HIV testing methods  Assess barriers and risks to partner notification for each named partner (e.g., physical or verbal abuse), offer advice and services to reduce this risk (e.g., describe measures to prevent partner violence), and defer notification if a risk is apparent  Notify the index patient’s partners using CDC-recommended methodsb  Recognize that some index patients prefer to self-notify some partners but request assistance to notify other partners  If the index patient declines referral to health department partner services by a nonclinical or nonclinical, the provider should take the following steps (i, iii, iv, vi):  Help the index patient develop a plan to notify partners directly or with provider assistance, as allowed by the jurisdiction  Offer assistance in testing partners for HIV, STDs, and viral hepatitisc,d,e

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Box 8-B. Essential elements of HIV partner services (cont)

 If the index patient seeks partner notification assistance from a nonclinical or clinical provider who is trained and authorized to provide partner services, the provider should take these steps (i, iii, iv):  Explain the rationale for notifying partners of possible HIV exposure (i.e., partners who had contact with the index patient in the 12 months before HIV diagnoses), with priority given to partners who had contact during the 3 months before HIV diagnosis or during the previous month if the index patient has acute HIV infection or high viral load  Ask the index patient which sex and drug-injection partners have already been notified of possible HIV exposure  Collect contact and other information, using CDC-recommended methods, about sex and drug-injection partners who have not been notified  Assess barriers and risks to partner notification for each named partner (e.g., physical or verbal abuse), offer advice and services to reduce this risk (e.g., describe measures to prevent partner violence), and defer notification if a risk is apparent  Notify the index patient’s partners using CDC-recommended methods as appropriate to legal authority and skillsb  Recognize that some index patients prefer to self-notify some partners but request assistance to notify other partners  If the index patient chooses to self-notify any partner without assistance, the provider should describe (i, iii, iv, vii):  Possible challenges of self-notification, such as partner violence, and discourage self-notification if a risk is apparent  Self-notification methods for known partners (e.g., in person) and anonymous partners (e.g., established Internet notification programs)  Methods to improve the effectiveness of self-notification (e.g., focus on partners over the previous 3 months or, if diagnosed with acute HIV infection or high viral load, focus on partners over the previous month; use a private, safe setting; anticipate and respond to negative partner reactions; seek provider assistance if questions arise)  Key messages for partners (e.g., how to obtain HIV, STD, and viral hepatitis testing and evaluation in facilities that link partners with positive tests to health care providers or to home HIV testing if the partners decline other testing options)c,d,e  If the index patient declines any partner services through the health department, provider or self-notification, re-offer partner services at the next encounter and/or notify the HIV care provider serving the index patient that partner services should be offered at the HIV care visit, when appropriate (i)  Regardless of the partner notification method, the provider should promptly offer index patients the following prevention and care services onsite or through linkage, if not recently provided:  HIV medical carec (i, iii, iv, vi, viii, ix)  STD and viral hepatitis testing, evaluation, treatment, vaccination, and counselingc,d,e (i, iii, vi)  Risk-reduction services and devices (e.g., behavioral information, counseling, risk-reduction interventions, latex or polyurethane condoms)f,g (i, iii, iv, vi, ix)  Information about the availability of PrEP and nPEP for HIV-uninfected partners when clinically indicated to reduce their risk of HIV acquisitionh,i (i, x, xi)  Other medical or social services that influence HIV transmission (e.g., substance use treatment, mental health services)j (i, iii, iv, vi, ix)

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Box 8-B. Essential elements of HIV partner services (cont)

Services for sex and drug-injection partners  Notify the partner about possible HIV exposure (and STD exposure if the index patient is coinfected with STD) without disclosing the identity of the index patient, using CDC-recommended methods (i, vi, viii)  Provide information about HIV, STD, and viral hepatitis infections (i, vi)  Promptly offer the following services onsite or through linkage:  HIV testing if the partner is not known to be HIV-infected (followed by verification of test results)k (i, iii, iv, ix)  HIV care, treatment, and partner services if a preliminary or confirmatory HIV test is positivec (i, iii, vi)  Screening for STD and viral hepatitis if partner is asymptomatic, using tests recommended by CDCd,e (i, iii)  Presumptive STD treatment (while awaiting results of STD testing or clinical evaluation) if the partner was exposed to STDd (iii)  Testing and clinical evaluation for STD and viral hepatitis if partner has relevant symptomsd,e (i, iii)  STD and viral hepatitis care and treatment if the partner is diagnosed with these conditionsd,e (i, iii, ix)  Risk-reduction services and devices (e.g., behavioral information, counseling, risk-reduction interventions, latex or polyurethane condoms)f,g (i, iii)  Information about the availability of PrEP and nPEP for HIV-uninfected persons when clinically indicated to reduce the risk of HIV acquisitioni and referrals to clinical providers who offer prophylaxis (x, xi)  Other medical and social services that influence HIV transmission (e.g., substance use treatment, mental health services)j (i, iii)  Collect information about members of the partners’ social network (including physical and virtual venues frequented), using CDC-recommended methods (i)

Note. Another document describes additional recommendations on how to conduct partner services.1 a See Section 3, Context of Prevention. b See source i (below) for details on CDC recommended methods. c See Section 4, Linkage to and Retention in Care. d See Section 9, STD Services. e Viral hepatitis testing (and treatment of infected persons) has not been shown to influence HIV transmission but is included here because it is often offered in combination with HIV and STD testing for individual and public health benefits. This section does not address services for partners exposed to viral hepatitis by persons with HIV who are coinfected with viral hepatitis. f See Section 7, Risk Screening and Risk Reduction. g All these source guidance documents advise providing information and counseling about condom use; Health Resources and Services Administration (HRSA) guidance for persons attending publicly funded clinics specifies providing condoms. h The cited source guidance that supports this recommendation was intended for clinicians. Based on the opinions of the Project Workgroup, the section writing group concluded that it would be beneficial and feasible for other types of providers to implement this recommendation. i See Section 5, Antiretroviral Treatment, for more information about PrEP and nPEP. j See Section 12, Other Medical and Social Services. k Partners who are unlikely to obtain prompt HIV testing in clinical settings should be linked to HIV testing at community-based organizations or home.

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Box 8-B. Essential elements of HIV partner services (cont)

Sources i. CDC. Recommendations for partner services programs for HIV infection, syphilis, gonorrhea, and chlamydial infection. MMWR 2008;57(RR-9). http://stacks.cdc.gov/view/cdc/7074. Accessed November 3, 2014. ii. CDC. Data security and confidentiality guidelines for HIV, viral hepatitis, sexually transmitted disease, and tuberculosis programs: standards to facilitate sharing and use of surveillance data for public health action. 2011. http://www.cdc.gov/nchhstp/programintegration/docs/PCSIDataSecurityGuidelines.pdf. Accessed March 15, 2013. iii. CDC. Sexually transmitted diseases treatment guidelines, 2015. MMWR 2015;64(RR-3). http://www.cdc.gov/std/tg2015/. Accessed December 21, 2016. iv. CDC. Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. MMWR 2006;55(RR-14). http://stacks.cdc.gov/view/cdc/7316. Accessed November 3, 2014. v. HRSA. The Ryan White Care Act; Section 2631 [300ff-38]. Grants for Partner Notification Programs. October 30, 2009. http://hab.hrsa.gov/livinghistory/issues/confidentiality_8.htm. Accessed December 23, 2016. vi. HRSA. Guide for HIV/AIDS Clinical Care—2014 Edition. U.S. Department of Health and Human Services; 2014. http://hab.hrsa.gov/sites/default/files/hab/clinical-quality-management/2014guide.pdf. Accessed December 23, 2016. vii. CDC. Home Tests: Testing—HIV/AIDS. http://www.cdc.gov/hiv/testing/hometests.html. Accessed January 12, 2014. viii. CDC. HIPAA privacy rule and public health: guidance from CDC and the U.S. Department of Health and Human Services. MMWR 2003;52(S-1). http://stacks.cdc.gov/view/cdc/12138. Accessed November 3, 2014. ix. CDC. Revised guidelines for HIV counseling, testing, and referral. MMWR 2001;50(RR-19). http://stacks.cdc.gov/view/cdc/7281. Accessed November 3, 2014. x. CDC. Antiretroviral postexposure prophylaxis after sexual, injection-drug use, or other nonoccupational exposure to HIV in the United States: recommendations from the U.S. Department of Health and Human Services. MMWR 2005;54(RR-2). http://stacks.cdc.gov/view/cdc/7303. Accessed November 3, 2014. xi. CDC, et al. Preexposure prophylaxis for the prevention of HIV infection in the United States—2014: a clinical practice guideline. May 14, 2014. http://stacks.cdc.gov/view/cdc/23109. Accessed May 15, 2014.

How These Recommendations Differ from Previous Recommendations The 2003 Recommendations for Incorporating HIV Prevention into HIV Medical Care15 (hereafter called the 2003 Recommendations) were based on CDC partner services guidelines published in 1998 and 2001.16,17 The updated recommendations in this section are consistent with 2008 CDC recommendations for partner services1 and other current federal guidance about partner services.6,14,18-22 They are also consistent with the latest comparable guidance about notifying partners of patients with HIV from the International Antiviral Society-USA Panel.23 They are also generally consistent with guidance about 1) social network, cluster, and Internet-based partner notification methods; 2) integrating and matching HIV and STD surveillance data to identify index patients eligible for partner services; and 3) collaborations among health departments, community-based organizations, and health care providers from the National Network of STD/HIV Prevention Training Centers,9 the National Coalition of STD Directors,10 and the National Alliance of State and Territorial AIDS Directors.24

Compared with the 2003 Recommendations,15 these updated recommendations

 advise that health department specialists provide partner services whenever possible because of evidence that these specialists provide more efficient, effective, and cost-effective services than other providers  stress building relationships between health departments and HIV testing, prevention, and health care providers (especially those serving a large number of persons with HIV) to expedite partner services to index patients who have been newly diagnosed with HIV or are at high risk of exposing others to HIV

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 advise expediting interviews of index patients with laboratory or clinical evidence of acute HIV infection§§§§ who may be highly infectious  stress actively helping index patients and partners with positive HIV tests to start or resume HIV medical care  advise informing index patients about the availability of PrEP and nPEP for HIV-uninfected partners when clinically indicated to reduce their risk of HIV acquisition  encourage health departments to consider using innovative methods to locate and notify partners (e.g., Internet)

Methods The section writing group based most of these recommendations on the 2008 CDC recommendations for partner services that were based on a systematic literature review and expert opinion (that the writing group did not reexamine).1,25 Some recommendations were based on 1) other federal guidance about partner services and HIV case reporting published from January 2001 to May 20146,14,18-22 and 2) scientific evidence from articles identified through a narrative review.

The writing group’s narrative review included articles about partner services in the United States published in English from January 2007 through January 2014 retrieved from PubMed, Google Scholar, the Cochrane Database, and MEDLINE. They used these search terms in various combinations: United States, HIV, sexually transmitted disease, chlamydial infection, gonorrhea, syphilis, reinfection, partner services, partner notification, disclosure, self-disclosure, nondisclosure, contact tracing, sexual networks, Internet partner notification, text notification, surveillance, self-referral, patient referral, partner referral, provider-assisted referral, contract referral, dual referral, index patient, patient-delivered partner treatment/therapy, disease intervention specialists, recurrence, partners and risk behavior, cost, and cost-effectiveness. The writing group found additional articles by manually searching references in articles identified by the database search. This narrative literature review yielded many recent articles, including a systematic review of partner notification from several countries (including the United States),26 a review of Internet-based partner notification,27 evidence-based guidance on partner services from an expert panel on community-based preventive services in the United States,28 and 2 studies of the cost-effectiveness of HIV partner services.29,30

Evidence Supporting the Recommendations The literature review yielded new evidence about the relative effectiveness of health department partner services, the benefits of timely partner services, new methods to notify partners, and the cost- effectiveness of partner services.

Several studies confirmed earlier findings that health department partner services specialists contacted more partners with unrecognized HIV infection per index patient than other types of partner services providers.31-34 Specialized training and field experience may enable health department specialists to elicit more accurate information about partners from index patients35 and to identify more partners per index patient.31 In contrast, several studies indicate that many health care providers or HIV testing providers

§§§§ Acute HIV infection is the period between initial HIV infection and the expression of HIV antibodies that can be detected by HIV antibody tests. This period is characterized by high levels of HIV in the blood and a vigorous immune response.

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may not 1) understand health department partner services procedures; 2) routinely advise patients to notify their partners about possible HIV exposure; 3) routinely refer patients for health department assistance; or 4) have the skills or time to elicit, notify, or manage partners.31,36-38 Some providers do not inform persons newly diagnosed with HIV that case reporting required by health care providers and laboratories may activate health departments to offer partner services.1

Several recent studies found that assigning health department specialists to work in clinics, hospitals, and private medical practices that provide a high-volume of HIV testing were more effective than traditional, offsite partner services.3,12,37,39,40 Assigning health department specialists to work in testing sites can also increase the proportion of index patients who receive partner services and shorten the interval between diagnosis and interview. This approach can also increase the proportion of partners who were located, were newly diagnosed with HIV infection, and obtained treatment.3,12,39,40

Some health departments routinely use HIV surveillance data to identify persons with acute infection or routinely integrate or match HIV and STD surveillance systems to identify HIV-infected persons who have new STD diagnoses and warrant being offered expedited interviews.41-45 Surveys of state and city health departments indicate that partner services programs that routinely access name-based HIV case reports and surveillance data can serve a higher proportion of index patients than health departments without such access.9,46

Several studies found that partner services were more productive when they were offered to persons shortly after their HIV diagnoses or to persons diagnosed with acute HIV infection.34,47-49 A small study in San Francisco evaluated the effort to find 1 newly identified HIV-infected partner; health department partner services specialists had to interview only 8 HIV-infected index patients if their interviews occurred within 2 weeks after diagnosis, but had to interview 21 HIV-infected index patients if their interviews occurred more than 2 weeks after diagnosis (p=0.008).48 A study in North Carolina compared interview outcomes of persons with acute HIV infection and persons with established infection: persons with acute infection named 2.5 times more partners (95% confidence interval: 2.1 to 3.0) and named 1.9 times more partners who were newly diagnosed with HIV infection (95% confidence interval: 1.1 to 3.5).34 A study in 2 large cities evaluated partner notification services for 48 persons with acute HIV infection; 23 of the 72 named partners underwent HIV testing and 5 (21.7%) had positive test results.49 A study in New York City found that after health department partner services specialists began to offer rapid, point-of-service HIV testing to partners, the proportion of partners who underwent testing rose from 52% to 76% (p<0.001) and the program identified more than twice the number of partners with newly diagnosed HIV infection than it had before rapid testing started.50

At least 5 recent evaluations examined partner notification using electronic technologies. Three evaluations assessed ecards (using inSPOT software) sent by index patients to notify partners as a means to supplement traditional partner notification. Although most evaluations used indirect methods to estimate partners’ receipt of ecards or to estimate follow-up HIV testing (because they did not know the identity of ecard recipients), these evaluations found that awareness and use of inSPOT was limited and resulted in few partners obtaining HIV testing.27,51,52 A few studies evaluated the acceptability of Internet- based partner notification. One found that gay, bisexual, or other men who have sex with men (MSM) were willing to receive or initiate emails about partner notification, regardless of their HIV infection status.53 The investigators concluded that health departments considering Internet methods should use

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culturally sensitive social marketing campaigns to increase awareness and acceptability of these methods. A study of MSM found that responders would be less likely to seek care and to notify partners if notified by anonymous ecards than if notified directly by their partner.54

Studies in 2 states evaluated the cost and effectiveness of partner services programs that included counseling and rapid HIV testing.30 When fixed program costs were excluded, the estimated cost per partner notified of a new HIV diagnosis was $11,626 in Colorado and $2,545 in Louisiana. A cost- effectiveness analysis assessed a set of partner services provided by health department specialists to 3 different hypothetical populations: MSM, persons who inject drugs (PWID), and heterosexuals. The services included HIV testing, referring HIV-infected partners to HIV care, and behavioral risk-reduction information.29 These partner services were cost-saving compared with no intervention. Moreover, the intervention cost per new case of HIV averted in a partner (ranging from ~$116,000 for MSM, ~$263,000 for PWID, and ~$349,000 for heterosexuals) was lower than the lifetime cost of HIV treatment (>$400,000).55

Other sections of this report cite evidence that supports recommendations about PrEP and nPEP (Section 5, Antiretroviral Treatment) and STD screening and treatment (Section 9, STD Services).

Issues that Influence Implementation of the Recommendations Implementation progress, challenges, and opportunities A 2006 survey of more than 51 health departments in the United States found that 43% of persons with newly reported HIV infection received health department partner services; this was a significant increase from the proportion reported in a 2001 health department survey (32%).46 According to a survey and interviews of staff of health departments from 51 states/territories and 6 large cities published in 2008,***** health departments offered partner services to 47% to 79% of index patients with HIV.9 Health department partner services programs serving jurisdictions with low HIV morbidity and name-based HIV reporting were more likely than programs serving jurisdictions with high HIV morbidity without name- based reporting to report routinely use HIV surveillance to activate partner services, serve index patients diagnosed in private health systems, and notify a high proportion of partners. Many survey respondents reported that high caseloads in high-morbidity areas and unlinked or incompatible HIV surveillance and partner services information systems hindered partner services.

In general, persons diagnosed with HIV in public-sector clinics and HIV testing sites affiliated with health departments are more likely to receive health department partner services than persons diagnosed elsewhere.56 These public-sector sites are more likely to routinely refer index patients to health department partner services specialists or to invite these specialists to work onsite. To increase use of partner services, some health departments have marketed their services to private-sector HIV testing providers or assigned partner services specialists to work in large HIV care practices.1,9,12,39,57 Since the passage of the Patient Protection and Affordable Care Act, some health departments are exploring third- party reimbursement to enhance program capacity.9,58

***** Most recent nationally reported data is available at http://www.cdc.gov/hiv/library/reports/evaluation.html.

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Although partner services can benefit all persons with HIV, high caseloads or staffing shortages force most health departments to prioritize the order of interviewing index patients and partners.1 Most health departments expedite interviewing of index patients who have newly reported and newly diagnosed HIV infection. The 2014 CDC revised HIV surveillance case definition recommends that laboratories and HIV testing providers report cases of acute HIV infection or preliminary positive HIV test results to expedite partner services.5,59 Some health departments also expedite interviewing of index patients with established HIV infection who have been recently diagnosed with STD (particularly infectious primary or secondary syphilis and rectal gonorrhea among MSM). Patients who are coinfected with HIV and STD are easier to identify if HIV surveillance and STD surveillance systems are integrated or routinely matched.3,42

Policy, legal, and ethical considerations Well-implemented partner services balance the interests of infected persons, their partners, and the community. Because partner services are voluntary and confidential, it is unethical to coerce, deceive, or withhold information from index patients when attempting to elicit partner information or notify partners. Index patients who feel pressured to provide partner information may not provide accurate partner information. Several studies show that most persons with HIV, their partners, and their health care providers accept partner services, including the involvement of health departments and Internet-based partner notification, and consider partner services a valuable service rather than an imposition.53,60-62 Developing standard referral procedures and interagency agreements that protect confidentiality may improve the acceptability of partner services and improve communication and collaboration between HIV testing providers and health departments1,9,10 (see the Implementation Resources topic below).

State and local laws and public health regulations generally protect the confidentiality of all HIV and STD information, including information obtained from or about index patients.1 Persons who fear that partner notification might cause stigma; provoke physical or verbal abuse; harm relationships; or expose illegal activity may choose confidential partner notification (that does not reveal the identity of the index patient) over self-notification.63-66 Confidentiality is subject to practical limits when a person has a single, identifiable partner and when couples seek joint HIV testing and post-test counseling. Although there is growing interest in couple-based HIV testing and counseling after joint consent, some providers hesitate to offer this service because of concerns about violating HIV-related confidentiality protections.67,68

Despite the longstanding practice of confidential health department partner services, some clinicians, HIV testing providers, and persons with HIV may be unaware of or doubt these confidentiality protections. Some individuals and communities do not favor health department access to personal health information for public health purposes because they distrust public health authorities or fear the information might be stigmatizing, provoke negative partner reactions, or have legal ramifications.1,62,69,70 Nevertheless, real or perceived breaches of confidentiality during provision of partner services appear to be rare. Several studies conducted from the late 1990s to 2011, most of which involved heterosexual partners, found that the risk of violence due to partner notification was low71-74 and that partner notification itself did not increase rates of partnership dissolution.62,71,75

Some jurisdictions have laws that require or allow public health officials or health care providers to notify partners who may have been exposed to HIV infection, even when index patients object.1 Persons who misunderstand these laws may believe that all partner notification is mandatory or nonconfidential. To

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minimize negative attitudes about partner services, providers can reassure index patients that partner services are strictly voluntary and confidential, are usually provided at no cost to index patients and partners, and are deferred if there is a risk of partner retribution.

Section 3, Context of Prevention, and Section 9, STD Services, provide further information on policy, legal, and ethical aspects of partner services.

Special populations Some adolescents, undocumented immigrants, sexual assault survivors, prisoners, and other vulnerable or medically marginalized persons with HIV may resist health department partner services. Adolescents who do not know that these services are confidential, voluntary, and do not require parental consent in many states may appreciate careful explanations of consent and confidentiality procedures. Immigrants may believe that partner services conflict with their cultural norms or may prompt deportation or other legal action. Some immigrants may require partner services information in their own language.1 Rapid, point- of-care HIV testing is useful when screening transient partners, such as migrant workers1 (see Section 12, Other Medical and Social Services).

Implementation Resources Additional information and resources to support implementation of these recommendations can be found at http://www.cdc.gov/hiv/guidelines/.

References 1. Centers for Disease Control and Prevention. Recommendations for partner services programs for HIV infection, syphilis, gonorrhea, and chlamydial infection. MMWR 2008;57(RR-9):1-83. 2. Council of State and Territorial Epidemiologists. State Reportable Conditions Websites. 2007. http://www.cste.org/?page=StateReportable. Accessed October 15, 2014. 3. Bernstein KT, et al. Partner services as targeted HIV screening—changing the paradigm. Public Health Rep 2014;129(Supplement 1):50-55. 4. New York State Department of Health. Releasing preliminary positive results for standard HIV testing: Fact Sheet. 2009. http://www.health.ny.gov/diseases/aids/providers/testing/preliminary_positive/fact_sheet.htm. Accessed January 16, 2014. 5. Centers for Disease Control and Prevention. Revised surveillance case definition for HIV infection—United States, 2014. MMWR 2014;63(RR-3):1-10. 6. Centers for Disease Control and Prevention [Workowski K; Bolan G]. Sexually transmitted diseases treatment guidelines, 2015. MMWR 2015;64(RR-3):1-137. http://www.cdc.gov/std/tg2015/. Accessed December 2016. 7. New York State Department of Health. HIV Reporting and Partner Notification Questions and Answers. 2013. http://www.health.ny.gov/diseases/aids/providers/regulations/reporting_and_notification/question_answer.htm. Accessed January 16, 2014. 8. State of Louisiana Department of Health and Hospitals. HIV/AIDS Program, HIV Partner Services, Partner Elicitation Protocol for Community-based Organizations Counseling and Testing Staff. 2008. http://new.dhh.louisiana.gov/assets/oph/HIVSTD/CBO_CT_Partner_Elicitation_Protocol.doc. Accessed January 16, 2014. 9. National Network of STD/HIV Prevention Training Centers. HIV partner counseling and referral services capacity needs assessment. 2008. http://www.stdpreventiononline.org/assets/resources/63200797_1735.pdf. Accessed January 28, 2014. 10. National Coalition of STD Directors. National Guidelines for Internet-based STD and HIV Prevention: accessing the power of the Internet for public health. 2010. http://www.ncsddc.org/Internet_Guidelines. Accessed January 12, 2014.

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11. Internet Sexuality Information Services Inc. (I.S.I.S). inSPOT—[STD] Internet notification service for partners or tricks. 2014. http://www.inspot.org. Accessed January 16, 2014. 12. Udeagu CC, et al. Impact of a New York City Health Department initiative to expand HIV partner services outside STD clinics. Public Health Rep 2012;127(1):107-114. 13. Udeagu CC, et al. Lost or just not following up: public health effort to re-engage HIV-infected persons lost to follow-up into HIV medical care. AIDS 2013;27(14):2271-2279. 14. Centers for Disease Control and Prevention, et al. Preexposure prophylaxis for the prevention of HIV infection in the United States—2014: a clinical practice guideline. 2014. http://stacks.cdc.gov/view/cdc/23109. Accessed May 15, 2014. 15. Centers for Disease Control and Prevention, et al. Incorporating HIV prevention into the medical care of persons living with HIV: recommendations of CDC, the Health Resources and Services Administration, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. MMWR 2003;52(RR-12):1-24. 16. Centers for Disease Control and Prevention. HIV partner counseling and referral services guidance. 1998. http://stacks.cdc.gov/view/cdc/5150/. Accessed January 28, 2013. 17. Centers for Disease Control and Prevention. Program operations guidelines for STD prevention: partner services. 2001. http://www.cdc.gov/std/program/partners.pdf. Accessed May 24, 2012. 18. Health Resources and Services Administration. Guide for HIV/AIDS Clinical Care—2014 Edition. 2014. http://hab.hrsa.gov/sites/default/files/hab/clinical-quality-management/2014guide.pdf. Accessed October 17, 2016. 19. Centers for Disease Control and Prevention. Antiretroviral postexposure prophylaxis after sexual, injection- drug use, or other nonoccupational exposure to HIV in the United States: recommendations from the U.S. Department of Health and Human Services. MMWR 2005;54(RR-2):1-20. 20. Centers for Disease Control and Prevention. Revised guidelines for HIV counseling, testing, and referral. MMWR 2001;50(RR-19):1-58. 21. Centers for Disease Control and Prevention. Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. MMWR 2006;55(RR-14):1-24. 22. Centers for Disease Control and Prevention. Improving sexually transmitted disease programs through assessment, assurance, policy development, and prevention strategies (STD AAPPS). 2013. http://www.cdc.gov/std/foa/aapps/default.htm. Accessed April 4, 2014. 23. Marrazzo JM, et al. HIV prevention in clinical care settings: 2014 recommendations of the International Antiviral Society–USA Panel. JAMA 2014;312(4):390-409. 24. National Alliance of State and Territorial AIDS Directors. NASTAD technical assistance meeting report: reaching gay men using the Internet. 2009. http://www.cdc.gov/nchhstp/programintegration/docs/PCSI_April24_09_MeetingReport_FINAL-508C-2.pdf. Accessed July 22, 2014. 25. Hogben M, et al. The effectiveness of HIV partner counseling and referral services in increasing identification of HIV-positive individuals: a systematic review. Am J Prev Med 2007;33(2S):S89-S100. 26. Ferreira A, et al. Strategies for partner notification for sexually transmitted infections, including HIV. Cochrane Database Syst Rev 2013;(10):CD002843. 27. Plant A, et al. Evaluation of inSPOTLA.org: an Internet partner notification service. Sex Transm Dis 2012;39(5):341-345. 28. Community Preventive Services Task Force. The Guide to Community Preventive Services. March 11, 2013. http://www.thecommunityguide.org/hiv/. Accessed October 15, 2014. 29. Lin F, et al. Cost effectiveness of HIV prevention interventions in the U.S. Am J Prev Med 2016. http://www.sciencedirect.com/science/article/pii/S0749379716000374. Accessed March 4, 2016. 30. Shrestha RK, et al. Costs and effectiveness of partner counseling and referral services with rapid testing for HIV in Colorado and Louisiana, United States. Sex Transm Dis 2009;36(10):637-641. 31. Malave MC, et al. Human immunodeficiency virus partner elicitation and notification in New York City: public health does it better. Sex Transm Dis 2008;35(10):869-876. 32. Cohen MS, et al. Human immunodeficiency virus infection and partner services: a monumental missed opportunity. Sex Transm Dis 2010;37(8):476-477. 33. Golden MR, et al. A controlled study of the effectiveness of public health HIV partner notification services. AIDS 2009;23(1):133-135.

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34. Moore ZS, et al. Number of named partners and number of partners newly diagnosed with HIV infection identified by persons with acute versus established HIV infection. J Acquir Immune Defic Syndr 2009;52(4):509-513. 35. Torrone EA, et al. Glen or Glenda: reported gender of sex partners in two statewide HIV databases. Am J Public Health 2010;100(3):525-530. 36. Swendeman DT, et al. HIV partner notification: predictors of discussion and agreements from provider reports. AIDS Behav 2009;13(3):573-581. 37. Udeagu CC, et al. Provider and client acceptance of a health department enhanced approach to improve HIV partner notification in New York City. Sex Transm Dis 2010;37(4):266-271. 38. Mackellar DA, et al. Exposure to HIV partner counseling and referral services and notification of sexual partners among persons recently diagnosed with HIV. Sex Transm Dis 2009;36(3):170-177. 39. Rudy ET, et al. Community-embedded disease intervention specialist program for syphilis partner notification in a clinic serving men who have sex with men. Sex Transm Dis 2012;39(9):701-705. 40. Taylor MM, et al. Improving partner services by embedding disease intervention specialists in HIV-clinics. Sex Transm Dis 2010;37(12):767-770. 41. Bodach S, et al. Integrating acute HIV infection within routine public health surveillance practices in New York City. Public Health Rep 2012;127(4):451-459. 42. Fitz Harris LF, et al. Program collaboration and service integration activities among HIV programs in 59 U.S. health departments. Public Health Rep 2014;129(Suppl 1):33-42. 43. Skinner JM, et al. Trends in reported syphilis and gonorrhea among HIV-infected people in Arizona: implications for prevention and control. Public Health Rep 2014;129(Suppl 1):85-94. 44. Taylor MM, et al. Gonorrhea infections diagnosed among persons living with HIV/AIDS: identifying opportunities for integrated prevention services in New York City, Washington, DC, Miami/Dade County, and Arizona. J Acquir Immune Defic Syndr 2013;64(1):115-120. 45. Udeagu CC, et al. Outcomes of HIV partner services for people with HIV and STD coinfection versus new HIV diagnosis: implications for HIV prevention strategies. Sex Transm Dis 2011;38(9):887-888. 46. Katz DA, et al. Increasing public health partner services for human immunodeficiency virus: results of a second national survey. Sex Transm Dis 2010;37(8):469-475. 47. Golden MR, et al. An evaluation of HIV partner counseling and referral services using new disposition codes. Sex Transm Dis 2009;36(2):95-101. 48. Marcus JL, et al. Updated outcomes of partner notification for human immunodeficiency virus, San Francisco, 2004-2008. AIDS 2009;23(8):1024-1026. 49. Patel P, et al. Detecting acute human immunodeficiency virus infection using 3 different screening immunoassays and nucleic acid amplification testing for human immunodeficiency virus RNA, 2006-2008. Arch Intern Med 2010;170(1):66-74. 50. Renaud TC, et al. The effect of HIV field-based testing on the proportion of notified partners who test for HIV in New York City. Am J Public Health 2011;101(7):1168-1171. 51. Kerani RP, et al. A randomized, controlled trial of inSPOT and patient-delivered partner therapy for gonorrhea and chlamydial infection among men who have sex with men. Sex Transm Dis 2011;38(10):941-946. 52. Rietmeijer CA, et al. Evaluation of an online partner notification program. Sex Transm Dis 2011;38(5):359-364. 53. Mimiaga MJ, et al. HIV and STD status among MSM and attitudes about Internet partner notification for STD exposure. Sex Transm Dis 2008;35(2):111-116. 54. Kerani RP, et al. Acceptability and intention to seek medical care after hypothetical receipt of patient-delivered partner therapy or electronic partner notification postcards among men who have sex with men: the partner's perspective. Sex Transm Dis 2013;40(2):179-185. 55. Farnham PG, et al. Updates of lifetime costs of care and quality of life estimates for HIV-infected persons in the United States: late versus early diagnosis and entry into care. J Acquir Immune Defic Syndr 2013;64(2):183- 189. 56. Golden MR, et al. HIV partner notification in the United States: a national survey of program coverage and outcomes. Sex Transm Dis 2004;31(12):709–712. 57. Taylor HA, et al. The ethical review of health care quality improvement initiatives: findings from the field. Issue Brief (The Commonwealth Fund) 2010;95:1-12. 58. Patient Protection and Affordable Care Act, 111-148, 111th Congress, 2010 Cong. Rec. 2010. http://www.gpo.gov/fdsys/pkg/PLAW-111publ148/pdf/PLAW-111publ148.pdf. Accessed February 10, 2012. 59. Centers for Disease Control and Prevention, et al. Laboratory testing for the diagnosis of HIV infection: updated recommendations. June 27, 2014. http://stacks.cdc.gov/view/cdc/23447. Accessed July 14, 2014.

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60. Ahrens K, et al. HIV partner notification outcomes for HIV-infected patients by duration of infection, San Francisco, 2004 to 2006. J Acquir Immune Defic Syndr 2007;46(4):479-484. 61. Golden MR, et al. Support among persons infected with HIV for routine health department contact for HIV partner notification. J Acquir Immune Defic Syndr 2003;32(2):196-202. 62. Passin WF, et al. A systematic review of HIV partner counseling and referral services: client and provider attitudes, preferences, practices, and experiences. Sex Transm Dis 2006;33(5):320-328. 63. Golub SA, et al. Partner serostatus and disclosure stigma: implications for physical and mental health outcomes among HIV-positive adults. AIDS Behav 2009;13(6):1233-1240. 64. Smith R, et al. A meta-analysis of disclosure of one’s HIV-positive status, stigma and social support. AIDS Care 2008;20(10):1266-1275. 65. Frye V, et al. Managing identity impacts associated with disclosure of HIV status: a qualitative investigation. AIDS Care 2009;21(8):1071-1078. 66. Sowell RL, et al. Understanding and responding to HIV/AIDS stigma and disclosure: an international challenge for mental health nurses. Issues Ment Health Nurs 2010;31(6):394-402. 67. Purcell DW, et al. Incorporating couples-based approaches into HIV prevention for gay and bisexual men: opportunities and challenges. Arch Sex Behav 2014;43(1):35-46. 68. Stephenson R, et al. Attitudes toward couples-based HIV testing among MSM in three US cities. AIDS Behav 2011;15(Suppl 1):S80-87. 69. Klitzman R, et al. Naming names: perceptions of name-based HIV reporting, partner notification, and criminalization of non-disclosure among persons living with HIV. Sex Res Soc Policy 2004;1(3):38-57. 70. Tobin KE, et al. HIV seropositive drug users' attitudes towards partner notification (PCRS): results from the SHIELD study in Baltimore, Maryland. Patient Educ Couns 2007;67(1-2):137-142. 71. Kissinger PJ, et al. Partner notification for HIV and syphilis: effects on sexual behaviors and relationship stability. Sex Transm Dis 2003;30(1):75-82. 72. Koenig LJ, et al. Women, violence, and HIV: a critical evaluation with implications for HIV services. Matern Child Health J 2000;4(2):103-109. 73. Koenig LJ, et al. Violence during pregnancy among women with or at risk for HIV infection. Am J Public Health 2002;92(3):367-370. 74. Thurman AR, et al. Partner notification of sexually transmitted infections: a large cohort of Mexican American and African American women. Sex Transm Dis 2008;35(2):136-140. 75. Hoxworth T, et al. Changes in partnerships and HIV risk behaviors after partner notification. Sex Transm Dis 2003;30(1):83-88.

Page 146 of 238 Appendix C. Organizations and Persons Contributing to this Report

Columbia; Norma Rolfsen,* RN, FNP, MS, AACRN, Michael Reese Center, Chicago, Illinois; Beirne Roose-Snyder,* JD, Center for Health and Gender Equity, Washington, District of Columbia (formerly with Center for HIV Law and Policy, New York, New York); Jill M. Sabatine,* MSW, National Association of Social Workers, Providence, Rhode Island; Carl E. Schmid II, MBA, BA, The AIDS Institute, Washington, District of Columbia; Scott Schoettes, JD, Lambda Legal Defense and Education Fund; John W. Senterfitt, PhD, RN, MPH, Los Angeles County Department of Public Health, Los Angeles, California; Michael D. Siever,* PhD, San Francisco AIDS Foundation, San Francisco, California; Jane M. Simoni, PhD, University of Washington, Seattle, Washington; Neena Smith- Bankhead, MS, AID Atlanta, Inc., Atlanta, Georgia; Javid Syed,* MPH, Treatment Action Group, New York, New York; Tyler A. TerMeer,* MS, Ohio AIDS Coalition, Columbus, Ohio (formerly with the National Alliance of State and Territorial AIDS Directors, Washington, District of Columbia); Tim Vincent, MS, MFCC, University of California, San Francisco, California; Aimee Wilkin, MD, MPH, Wake Forest University School of Medicine, Winston-Salem, North Carolina; Ron Wilcox,* MD, Louisiana State University Health Sciences Center, New Orleans, Louisiana; Margaret Wolfe,* MPH, Puerto Rico Department of Health, San Juan, Puerto Rico; Barry Zingman, MD, Montefiore Medical Center, Bronx, New York.

External Peer Reviewers A. Cornelius Baker, National Black Gay Men’s Advocacy Coalition, Washington, District of Columbia; Carlos del Rio, MD, MPH, Emory University, Atlanta, Georgia; Seth C. Kalichman, PhD, University of Connecticut, Storrs, Connecticut; Jeanne M. Marrazzo, MD, MPH, University of Washington, Seattle, Washington; Mark W. Thrun, MD, Denver Public Health, Denver, Colorado; Rochelle Walensky, MD, MPH, Brigham and Women’s and Massachusetts General Hospital, Boston, Massachusetts.

Editorial, Information Science, and Graphical Support CDC: Michael Friend, ABJ; Mary Mullins, MLS; Robin Moseley, MAT; Kim Distel, MS, MLIS; Richard Noegel, BA; Marie S. Morgan, BA, ELS; Jarrad Hogg, BFA.

American Institutes for Research, Frederick, Maryland. Graphic design.

Administrative Support CDC: Marquita Dawson; Angela Glenn; Summer Terry, MPA.

Declarations of Interest None of the contributors who submitted declaration of interest forms reported financial interests related to commercial products described in this report during their review of drafts or consultation participation.

Acknowledgments The Project Workgroup thanks staff and members of the HIV Medicine Association of the Infectious Diseases Society of America, Arlington, Virginia, for their invaluable comments on several drafts.

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