Human Immunodeficiency Virus

Human Immunodeficiency Virus (Final: May 5, 2014)

I. Background

A. Human Immunodeficiency Virus (HIV) is best described as an infectious disease of the immune system. HIV represents a spectrum of disease that can begin with a brief acute retroviral syndrome that typically transitions to a multiyear chronic and clinically latent illness. Without treatment, this illness eventually progresses to a symptomatic, life-threatening immunodeficiency disease known as AIDS. HIV replication is present during all stages of the infection and progressively depletes CD4 lymphocytes, which are critical for maintenance of effective immune function.

B. The majority of HIV infections in the United States are caused by HIV-1. However, HIV-2 infection should be suspected in persons who have epidemiologic risk factors or an unusual clinical presentation. Factors associated with HIV-2 infection include having lived in or having a sex partner from an HIV-2 endemic area (i.e. West Africa and some European countries such as Portugal, Where HIV-2 prevalence is increasing), having a sex partner known to infected with HIV-2, or having received a blood transfusion or non-sterile injection in an HIV-2 endemic area.

II. Diagnosis

A. History: 1. Social history: high-risk encounter since their last negative HIV test a. Sex with a gay/bisexual man b. IDU c. Sex with a HIV+ partner, prostitute or IDU 2. History of present illness: a. May c/o the following signs or symptoms during acute stage of infection (2-4 weeks after exposure): i. Fever (this is the most common symptom), swollen glands, sore throat, rash, fatigue, muscle and joint aches and pains, headaches b. May c/o the following signs or symptoms when progressing to AIDS: i. Rapid weight loss; recurring fever or profuse night sweats; extreme and unexplained tiredness; prolonged swelling of the lymph glands in the armpits, groin, or neck; diarrhea that lasts for more than a week; sores of the mouth, anus, or genitals; pneumonia; red, brown, pink, or purplish blotches on or under the skin or inside the mouth, nose, or eyelids; memory loss, depression and other neurologic disorders.

B. Examination: Exam often not indicated as patients are most likely asymptomatic or signs/symptoms may be indicative of other illness 1. Constitutional: fever, weight loss, fatigue, night sweats 2. Neurologic: headaches, memory loss, depression 3. ENT: thrush, pharyngitis a. Inspection of the lips, teeth and gums b. Inspection of the oropharynx: oral mucosa, hard and soft palates, tongue, tonsils and posterior pharynx 4. Lymphatic: lymphadenopathy, tenderness of lymph nodes a. Palpation of lymph nodes (neck, axillae, groin)

HIV Protocol - revised 5/5/2014 1 5. Integumentary: rash, sores a. Inspection of the skin if indicated 6. Gastrointestinal: diarrhea 7. Genitourinary: persistent yeast infections a. Males: Inspection of the penis, scrotum, and rectum if indicated b. Females: Pelvic examination if indicated 8. Musculoskeletal: joint pain

C. Laboratory: 1. Alere Determine HIV-1/2 Ag/Ab Combo test – reactive antigen (+Ag/-Ab) OR reactive antibody (-Ag/+Ab) OR reactive Antigen and Antibody (+Ag/+Ab) is considered a preliminary positive for HIV a. Collect venipuncture whole blood (one purple top) on: i. Heterosexual males and females every 12 months (4 week grace period) ii. IDU every 6 months iii. Gay and bisexual males every 3 to 6 months iv. Patients presenting for PEP v. All contacts to HIV

2. Confirmatory testing for all reactive Alere Determine HIV-1/2 Ag/Ab Combo tests (collected by Linkage to Care staff) a. Collect venipuncture whole blood (3 small purple top) for: i. Viral Load confirmatory test ii. In addition, CD4 testing will be done to assist in staging disease b. If anonymous patient, collect venipuncture whole blood (1 large red top) for: i. HIV Antibody/Antigen Combo EIA (State Health Dept Lab) ii. Encourage patient to become confidential client by registering with identification to receive confirmatory test noted in “a.”

III. Procedure for Testing

A. Triage: 1. Nurse should determine whether or not the patient is interested in the Rapid Test and ensure proper consent. a. Consent (opt-out): Patients will be notified that testing will be performed, but given the option to decline or defer testing. 2. Anonymous testing offered if client unwilling to share name/date of birth.

B. Registration: 1. A lab order for a HIV Rapid test (HIV-1/2 Rapid Ab/Ag Combo: STD Stat Lab) will be created in the patient’s visit in HealthDoc 2. The unique serology number on the patient’s Registration form will be entered into the lab order.

C. Phlebotomy: 1. Collect the sample immediately following patient registration 2. Verify that the patient understands that he/she is having a rapid HIV test performed 3. Verify 2 patient identifiers (name/DOB) 4. Draw a small purple-top tube. 5. Apply serology and demographic label to the blood tube

HIV Protocol - revised 5/5/2014 2 6. Deliver specimen to the laboratory immediately after collection for processing

D. Laboratory: 1. The lab tech will perform and record the test results in HealthDoc per usual procedure. 2. If Reactive Determine Ag/Ab Result the lab personnel will: a. Notify the patient’s nurse b. Notify Linkage to Care (LTC) staff c. Notify CDPHE/DIS staff d. These results will never be openly discussed in the lab among the clinicians, under any circumstances, beyond what communication is needed to coordinate efforts to get the result to the patient.

E. Visit: 1. Complete interview and exam as necessary 2. If the patient has tested positive: a. Deliver the results at the end of the visit b. Tailor the visit to meet the needs of the individual c. Refer to LTC staff

IV. Treatment

A. While there is no cure for HIV infection or AIDS, combination anti-retroviral therapy is beneficial in patients with symptomatic HIV infection and may also be helpful in patients with acute HIV infection or asymptomatic infection with a high viral load. All HIV+ patients should be receiving HIV specific medical care and all HIV+ patients in the clinic should be asked about where they are receiving care, what their last T cell count and viral load was, and what medications they are receiving. Those without medical care should be referred to Linkage to Care or the DPH ID clinic.

V. Other considerations

A. All patients with newly diagnosed HIV infection should be interviewed by: 1. CDPHE DIS staff for partner notification purposes 2. Linkage to Care Staff for additional counseling, and referral to services and medical care.

B. Interpretation of Alere Determine HIV-1/2 Ag/Ab Combo Test Results 1. Antibody (HIV 1 or 2) Reactive a. A Reactive test results means that HIV-1 and/or HIV-2 antibodies have been detected in the specimen. The test result is interpreted as Preliminary Positive for HIV-1 and/or HIV-2 antibodies. 2. Antigen (HIV-1 p24) Reactive a. A reactive test result means that HIV-1 p24 antigen has been detected in the specimen. The test result is interpreted as Preliminary positive for HIV-1 p24 antigen. b. A test result that is preliminary positive for HIV-1 p24 antigen in the absence of reactivity for HIV-1 or HIV -2 antibodies may indicate an acute HIV-1 infection. In this case the acute HIV-1 infection is distinguished from an established HIV-1 infection in which antibodies to HIV-1 are present.

HIV Protocol - revised 5/5/2014 3 c. This test does not detect HIV-2 antigen. 3. Antibody Reactive and Antigen (HIV-1 p24) Reactive a. A reactive result is interpreted as preliminary positive for HIV-1 and/or HIV-2 antibodies and HIV-1 p24 antigen. 4. Specimens from individuals with Toxoplasma IgG, human anti-mouse antibodies, rheumatoid factor, elevated triglycerides (above 600mg/dL), herpes simplex virus infection, hospitalized and cancer patients may give false positive test results. 5. A person who has participated in an HIV vaccine study may develop antibodies to the vaccine and may or may not be infected with HIV.

C. Pregnancy 1. The risk for perinatal HIV transmission can be reduced to < 2% through the use of antiretroviral regimens, obstetrical interventions (C-section), and by avoiding breastfeeding.

VI. Counseling

A. Client Readiness to Test and Receive Results: Just because clients request and accept rapid HIV testing does not necessarily mean that they are prepared for the result. It is important that counselors be attentive to client readiness and explores the extent to which clients are prepared to receive results that same day. Counselors may offer the option of returning at a later date to receive their test results if the client is not ready to receive them.

B. Preliminary HIV positive (+): 1. If the test result is preliminary positive (reactive antigen and/or antibody), the counselor should explain the meaning of the reactive test result in simple terms. An example of such a message could be “Your preliminary test result is positive, but we won’t know for sure if you are infected with HIV until we get the results from your confirmatory test. In the meantime, you should take precautions to avoid transmitting the virus.” The counselor should emphasize the importance of confirmatory testing and advise the patient that a staff member (LTC) will schedule a return visit for the confirmatory test results. Counselors should use their best judgment to determine client readiness for this and other forms and referrals. 2. Ongoing medical care dramatically improves quality and length of life for HIV+ patients, although rigorous compliance with treatment is essential. Some people who test positive for HIV infection stay healthy for many years. 3. HIV+ patients should take great care to avoid transmission of their infection to sexual partners a. Patients should inform sexual partners of their HIV infection. b. Patients should avoid exposing sexual partners to their body secretions, especially semen and vaginal fluid, or blood. c. Condoms are effective in reducing HIV transmission, but only if properly used without breakage. d. HIV+ patients on anti-HIV therapy with undetectable viral loads are extremely unlikely to transmit the virus to others, but other factors such as asymptomatic STDs and the patient’s own immune status can impact this. Patients should be encouraged to engage their primary HIV care provider in a risk discussion. e. Having an STD increases risk transmission of HIV. 4. Do not share needles or syringes.

HIV Protocol - revised 5/5/2014 4 5. Professional counseling may be helpful to some persons with known or newly known diagnosed HIV infection, both to discuss issues about communication with current or future sexual partners as well as issues of living with a serious chronic disease. Patients interested in such an option should be referred to linkage to care staff.

C. HIV negative (-): 1. If the test result is nonreactive for Antigen and Antibody, clients should be told that they are not infected with HIV, unless they have had a recent (within 1 month) known or possible exposure to HIV. Retesting should be recommended for clients who have had risk exposure in the preceding month because sufficient time needs to elapse before antigen and/or antibodies develop that can be detected by the test. 2. The most reliable method to prevent acquisition of infection is abstention from sexual intercourse with persons infected with HIV. Permanent, monogamous sexual relationships introduce no new risk for infection provided neither partner is currently infected. 3. Individuals who continue to have multiple sex partners or who initiate new relationships with individuals at increased risk for HIV infection should practice "safe sex" (i.e., avoidance of exchange of bodily secretions or blood during sexual activity). Strong efforts should be made to avoid contact of mucous membranes with blood, semen, pre-ejaculate secretions, and vaginal secretions. Condoms are recommended for all sexual activity that could possibly result in ejaculation. 4. The use of I.V. drugs and especially the sharing of needles and use of unsterilized needles should be avoided. Persons who inject should be made aware of local syringe exchange programs. 5. Having an STD increases the risk of acquiring HIV infection during sex with an HIV+ partner. 6. Individuals with a high-risk HIV exposure should not consider themselves to be HIV-negative until they test negative  3 months after their last such exposure. 7. Persons at ongoing risk for HIV (E.g. an HIV infected partner or routinely not using condoms during intercourse) should be informed that they could consider pre-exposure prophylaxis. 8. Developing a personalized strategy to prevent HIV infection (e.g., a risk reduction plan) is important for all persons wishing to reduce their risk of acquiring HIV and should be discussed with each patient and documented on their chart.

VII. Follow-up

A. All patients with reactive HIV testing should receive post-test counseling (PTC) in 1 week by Linkage to Care Staff.

B. If the patient did not receive the test results at the clinic visit prior to leaving, the patient must return to the clinic with a valid ID for results and PTC. No HIV results should be given over the phone.

VIII. Management of contacts

A. Testing should be performed for all contacts within the preceding year regardless of symptoms. Colorado Department of Public Health and Environment Disease Intervention Staff will provide partner management services.

HIV Protocol - revised 5/5/2014 5 B. Partners who have been exposed to genital secretions and/or blood of an HIV+ partner though sex or injection-drug use within the preceding 72 hours should be offered PEP (Post Exposure Prophylaxis).

IX. References

A. Center for Disease Control and Prevention. Sexually Transmitted Diseases Treatment Guidelines, 2010. MMWR 2010; 59 (No. RR – 12): 14 – 18.

B. Alere North America LLC. Alere Determine HIV-1/2 Ag/Ab Combo, 2013. Yavne, Israel: Orgenics Ltd.

HIV Protocol - revised 5/5/2014 6