COUNCIL OF STATE AND TERRITORIAL EPIDEMIOLOGISTS HIVSURVEILLANCE TRAINING MANUAL November 2012 Acknowledgements This training manual was based on a manual used at the Florida Department of Health. Some sections of that document were so useful that only minor changes were made for inclusion in this manual. CSTE acknowledges the contribution of the CSTE workgroup: Marie Antoinette Bernard, Tina Brubaker, Sharon Carter, Melissa English, Douglas Frye, Kelly Gallagher, Joan Greene, Catina James, Bonnie Krampe, Benjamin Laffoon, Martin Ngokion, Luke Shouse, Stephanie Townsell, and Jeff Turner as well as CSTE National Office staff member Lauren Rosenberg. CSTE also acknowledges technical editor Karen Foster for her contributions to the project. The primary author is Michael Campsmith, CSTE consultant. This publication was supported by Cooperative Agreement Number 5U38HM000414 from CDC. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of CDC. Table of Contents TABLE OF CONTENTS INTRODUCTION ............................ 5 MODULE 1 ................................ 15 HIV Case Definition and the Human Immune System MODULE 2 ................................ 65 HIV Case Report Forms MODULE 3 ................................ 81 Managing Collection of Surveillance Data MODULE 4 ................................ 101 Presenting Surveillance Data MODULE 5 ................................ 133 Risk Ascertainment MODULE 6 ................................ 155 eHARS MODULE 7 ................................ 175 Evaluating HIV Surveillance Programs TABLE OF CONTENTS Introduction INTRODUCTION HIV Surveillance Training Manual Objectives OBJECTIVES: 1. Explain the spectrum of events through the course of HIV infection. 2. Describe the background and purpose of public health surveillance. 3. Outline key events in the timeline of HIV surveillance. 4. Provide information about where to find more in-depth information about topics related to HIV and HIV surveillance. INTRODUCTION Introduction Introduction The purpose of an HIV surveillance program is to promote the systematic and ongoing collection, analysis, evaluation, and dissemination of epidemiologic data of the highest possible quality. In turn, public health surveillance data are used to plan, implement, and evaluate HIV programs and interventions. Public health surveillance activities identify HIV-related conditions at various points along the spectrum of HIV disease (Table I.1)—from reporting of HIV infection in otherwise asymptomatic people to periodic clinical evaluations of immune system status (e.g., CD4 tests) to AIDS diagnosis through low CD4 value/ diagnosis of qualifying opportunistic illnesses to death certificate review for HIV-related mortality. Table I.1 HIV/AIDS surveillance: monitoring the spectrum of infection SENTINEL EVENTS HIV Exposure (children) HIV Infection 1st Positive Confidential 1st CD4+ HIV T-Cell Test Count 1st Viral Load 1st CD4+ Test T-Cell <200 cells AIDS-OI per µL Death In the past, surveillance for HIV-related diseases focused on opportunistic infections, cancers, and conditions that are known to occur late in the course of HIV disease. When the condition that became known as AIDS was first recognized in 1981, the underlying cause of the disease was unknown, and surveillance focused on a group of specific conditions associated with severe immunosuppression (e.g., Pneumocystis carinii pneumonia [now known as Pneumocystis jiroveci pneumonia], Kaposi sarcoma). In addition, persons with severe manifestations of HIV disease sought medical care and therefore came to the attention of health-care providers who could report cases to local and state health departments. Finally, because all HIV infected people eventually developed severe diseases, AIDS case finding through review of hospital records and AIDS-related deaths provided a relatively complete representation of the demographic and risk groups affected by the epidemic. National surveillance for AIDS began with identification of the initial cases in 1981. However, not until the first HIV-antibody diagnostic tests were licensed in 1985 could public health surveillance be conducted on conditions of HIV infection before a clinical diagnosis of AIDS. To properly monitor the HIV epidemic, surveillance staff need to collect accurate information about key events from the time HIV infection is first diagnosed in a person until death. This information is collected from many sources and documents, such as health-care providers (adult and pediatric case report forms), laboratories (laboratory reports), and vital records offices (birth and death certificates). Increased use of diagnostic laboratory testing and of electronic reporting have led to an increased number of documents introduction HIV Surveillance Training Manual | 7 Introduction in the HIV surveillance system. Historically, consolidated information from all documents has been used to create a single case record for each HIV-infected person. As technology and the epidemic have evolved, the Centers for Disease Control and Prevention (CDC) has developed a document-based data management system to better track information received from HIV surveillance programs and to better monitor HIV disease progression. Information about the spectrum of HIV disease assists CDC and state and local health departments in better understanding the direction of the epidemic, including populations most affected and in need of prevention and care services. After licensing of HIV diagnostic tests in 1985, many public health programs implemented surveillance for HIV infection (along with continuation of regular AIDS surveillance). However, several jurisdictions had concerns (e.g., confidentiality, stigma, discrimination) about surveillance for HIV infections before an AIDS diagnosis and until recently did not adopt integrated surveillance for the spectrum of HIV disease. HIV surveillance data are used to monitor trends in the epidemic. Active case finding is conducted by state and local health departments throughout the United States, and uniform reporting methods with timely transmission of data to CDC have enabled CDC to disseminate HIV surveillance data for public health monitoring and planning purposes. Because HIV surveillance is the largest population-based system for monitoring the epidemic nationally, it has become the basis for allocation of federal, state, and local resources for prevention and patient care. Surveillance for AIDS provides data at the late stage of HIV disease. One disadvantage of examining late- stage disease is that secondary prevention activities, such as referrals for early treatment interventions or partner notification, cannot be facilitated by health departments early in the course of infection when they are most beneficial. For this reason, as of April 2008, public health surveillance programs in all states and territories have expanded their surveillance case finding activities to also include persons in whom HIV infection is diagnosed before development of AIDS. To ensure maximum efficiency of surveillance activities and optimum quality of resulting data, HIV surveillance program staff need to understand theconcepts of public health surveillance. After that understanding, they then need to implement those concepts in a standardized manner. The goal of this training manual is to present the basic concepts of an effective HIV surveillance system in a manner that staff with various levels of experience can use in their activities. Proper application of the principles of public health surveillance will result in a successful HIV surveillance program. By design this manual presents the basics of HIV surveillance activities. For more in-depth material, the reader is directed to the references at the end of this introduction. In addition, this manual is designed to provide a broad overview of HIV surveillance activities and practices. Because local surveillance programs might have developed policies and procedures specific to their own programs, some of the material in this manual might not apply to individual HIV surveillance systems. 8 | HIV Surveillance Training Manual introduction Introduction Background and Purpose Infectious disease surveillance was initiated in the United States in the late 1800s as a method of quarantine control to prevent the spread of conditions such as cholera, smallpox, yellow and fever. In 1961, CDC assumed responsibility for the collection and publication of data on nationally notifiable diseases. However, reporting of diseases to CDC by states is voluntary; reporting is mandated (i.e., by legislation or regulation) only at the state level. Periodically, the list of nationally notifiable diseases is recommended for revision on the basis of consultation with various public health partners, including the Council of State and Territorial Epidemiologists (CSTE). HIV surveillance staff should contact their state department of public health or office of general council about specific laws, statutes, and regulations authorizing the collection and reporting of public health information in their jurisdiction. HIPAA AND PUBLIC HEALTH SURVEILLANCE The national Health Insurance Portability and Accountability Act (HIPAA) was enacted in 1996. Title II of HIPAA, known as the Administrative Simplification provision, addresses the security and privacy of health data. The standards are intended to improve the efficiency and effectiveness of the nation’s health-care system while maintaining