National HIV Behavioral Surveillance Among Men Who Have Sex With
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National HIV Behavioral Surveillance System: Heterosexuals at Increased Risk of HIV (NHBS-HET2) Model Surveillance Protocol Behavioral Surveillance Team NCHHSTP/DHAP-SE/BCSB Version: February 5, 2010 ACKNOWLEDGEMENTS These national protocol guidelines for NHBS-HET2 were written by staff of the Behavioral Surveillance Team, Behavioral and Clinical Surveillance Branch (BCSB), Division of HIV/AIDS Prevention—Surveillance and Epidemiology, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention. Prepared by employees of the federal government as part of their official duties, the national HIV behavioral surveillance guidelines is part of the public domain and is not copyright protected under Title 17 of the United States Copyright Code. These protocol guidelines may be copied and shared with others without CDC approval. CONTACTS For inquires about this protocol or the National HIV Behavioral Surveillance System (NHBS), contact the following CDC staff: Protocol Paul Denning, MD Epidemiologist Centers for Disease Control and Prevention 1600 Clifton Rd, Mailstop E-46 Atlanta, Georgia 30333. Telephone: 404.639.2963; E-mail: [email protected] Teresa Jacobs Finlayson, PhD MPH Epidemiologist Centers for Disease Control and Prevention 1600 Clifton Rd, Mailstop E-46 Atlanta, Georgia 30333. Telephone: 404.639.2083; E-mail: [email protected] Isa J. W. Miles, ScD MS Behavioral Scientist Centers for Disease Control and Prevention 1600 Clifton Rd, Mailstop E-46 Atlanta, Georgia 30333. Telephone: 404.639.6304; E-mail: [email protected] NHBS General Inquiries Elizabeth A. DiNenno, PhD Team Leader (Acting), Behavioral Surveillance Centers for Disease Control and Prevention 1600 Clifton Rd, Mailstop E-46 Atlanta, Georgia 30333. Telephone: 404.639.8482; E-mail: [email protected] National HIV Behavioral Surveillance System Among Heterosexuals at Increased Risk of HIV (NHBS-HET2) List of Abbreviations and Acronyms CAB Community Advisory Board CBO Community Based Organization CDC Centers for Disease Control and Prevention DCC Data Coordinating Center DHAP Division of HIV/AIDS Prevention EIA Enzyme Immunoassay FDA Food and Drug Administration GED General Educational Development HAPI ™ Handheld Assisted Personal Interview HET Heterosexuals at Increased Risk of HIV HIV Human Immunodeficiency Syndrome HRA High Risk Area IDU Injecting Drug Users IFA Immunofluorescent Antibody IRB Institutional Review Board MMWR Morbidity and Mortality Weekly Report MSA Metropolitan Statistical Area MSM Men who have Sex with Men NHBS National HIV Behavioral Surveillance System NHBS-HET1 NHBS among Heterosexuals at Increased Risk of HIV (Pilot) NHBS-HET2 NHBS among Heterosexuals at Increased Risk of HIV Round 2 OMB Office of Management and Budget ORP Overall Responsible Party PGP® Pretty Good Protection PRA Paperwork Reduction Act QDS ™ Questionnaire Development System RDS Respondent Driven Sampling RDSAT Respondent Driven Sampling Analysis Tool RDSCM Respondent Driven Sampling Coupon Manager RTA Rapid Testing Algorithm SDN Secure Data Network SES Socio-Economic Status SQL Structured Query Language STD Sexually Transmitted Disease VBS Venue Based Sampling WB Western Blot Contents 1 Introduction................................................................ 1-1 1.1 Purpose of the National HIV Behavioral Surveillance System…… ....... 1-1 1.2 Timeline and Scope of Protocol............................................................... 1-2 1.3 Collaborating Agencies………………………………………………….1-2 1.4 Responsibilities………………………………………………………….1-3 1.5 Justification for NHBS-HET2…………………………………………...1-4 1.6 Description of the Sample……………………………………………….1-5 1.7 General Approach ……………………………………………………….1-8 1.8 Objectives ................................................................................................ 1-9 1.9 Purpose and Use of the NHBS-HET2 Surveillance Protocol…… ....... .. 1-9 2 Formative Research Activities .................................... 2-1 2.1 Definition and Goals of Formative Research........................................... 2-1 2.2 Review of Secondary Data....................................................................... 2-2 2.3 Qualitative Data Collection......................................................................2-3 2.4 Field Site Logistics .................................................................................. 2-5 2.5 Garnering the Support of Community Stakeholders................................ 2-5 2.6 Identification of High Risk Areas (HRAs)………………………………2-6 2.7 Ongoing Formative Research .................................................................. 2-7 NHBS-HET2 Model Surveillance Protocol i Version Date: February 5, 2010 2.8 Development of Local Prevention Questions .......................................... 2-7 3 Data Collection........................................................... 3-1 3.1 Data Collection Instruments .................................................................... 3-1 3.2 Translation of Data Collection Instruments............................................. 3-3 3.3 General Data Collection Procedures........................................................ 3-4 3.4 Monitoring Data Collection..................................................................... 3-6 3.5 Training for Study Personnel................................................................... 3-6 4 Sampling and Recruitment Methods .......................... 4-1 4.1 Overview.................................................................................................. 4-1 4.2 Recruitment, Screening and Interviewing Seeds ..................................... 4-1 4.3 Coupon Redemption and Subsequent Waves of Recruitment ................. 4-4 5 HIV Testing................................................................. 5-1 5.1 Overview.................................................................................................. 5-1 5.2 Procedures/Methods................................................................................. 5-1 5.3 Data Management .................................................................................... 5-5 6 Data Management………………………………................ 6-1 6.1 Data Configuration………………………………………………...........6-1 6.2 NHBS-HET2 Analysis File………………………………………......... .6-2 NHBS-HET2 Model Surveillance Protocol ii Version Date: February 5, 2010 7 Data Analysis and Dissemination ............................... 7-1 7.1 Data Analysis and Dissemination ............................................................ 7-1 7.2 Limitations and Potential Biases.............................................................. 7-2 8 Data Security and Confidentiality............................... 8-1 8.1 HIV/AIDS Surveillance Assurance of Confidentiality............................ 8-1 8.2 Written Data Security Policy ................................................................... 8-1 8.3 Security and Confidentiality Requirements............................................. 8-1 8.4 Breaches in Data Security Procedures ..................................................... 8-5 9 Human Subjects Considerations................................. 9-1 9.1 Institutional Review Board Approval ...................................................... 9-1 9.2 Potential Risks and Anticipated Benefits................................................. 9-1 9.3 Voluntary Participation ...........................................................................9-2 9.4 Vulnerable Populations............................................................................ 9-3 9.5 Informed Consent Process....................................................................... 9-3 9.6 Age of Participants................................................................................... 9-3 9.7 Anonymity and Privacy Protection.......................................................... 9-4 9.8 Reimbursement for Time and Effort........................................................ 9-5 9.9 Adverse Events........................................................................................ 9-6 10 References ……………………………………………………..10-1 NHBS-HET2 Model Surveillance Protocol iii Version Date: February 5, 2010 Appendices A Data Collection Instrument ........................................ A-1 B Model Coupon Form……………………………………..…..B-1 C Justifications…………………………………….............…..C-1 D Model Consent Form ...................................................D-1 E FDA Letter…………………………………………..........……E-1 F Telephone Results…………………………………............ .F-1 G Assurance of Confidentiality for HIV/AIDS Data........G-1 H Guidelines for HIV/AIDS Surveillance........................H-1 I Model Waiver of Documentation of Informed Consent………………………………… ..............I-1 J Required Elements of Informed Consent ....................J-1 K Model Focus Group Consent ....................................... K-1 L Model Key Informant Interview Consent ................... L-1 M Improved Referral to Care for NHBS Participants Using a Rapid Test Algorithm ..................................... M-1 N NHBS-HET2 Partners …………………………………………N-1 O Model Recruiter Script……………………………………...O-1 P HIV Testing Log…………………………………….. ........... P-1 Q Community Key Informant Interview Consent……….Q-1 R CDC Human Research Protection Office Letter……….R-1 NHBS-HET2 Model Surveillance Protocol iv Version Date: February 5, 2010 1 Introduction 1.1 Purpose of the National HIV Behavioral Surveillance (NHBS) System Based on a review in June 1999 of national