HPTN 075: Feasibility of HIV Prevention Cohort Studies Among Men Who Have Sex With Men in Sub-Saharan Africa
Conditions: HIV
Sponsor: HIV Prevention Trials Network

 
HPTN 075 
Feasibility of HIV Prevention Cohort Studies among Men who have Sex with Men in Sub-
Saharan Africa 
 
 
A Study of the HIV Prevention Trials Network 
 
 
 
Sponsored by: 
 
Division of AIDS, US National Institute of Allergy and Infectious Diseases 
US National Institutes of Health 
 
 
 
 
 
 
 
Protocol Chair: 
Theo Sandfort, Ph.D. 
Columbia University 
New York, NY, USA 
 
 
 
 
 
 
Protocol Version 3.0 
15 November 2016 
 
 
 
 
DAIDS Protocol #: 11943 
 
 
 
Non-IND Study 
 

 
HPTN 075,  Protocol Version 3.0 Page 1 of 73 
15 November 2016 
 
HPTN 075 
Feasibility of HIV Prevention Cohort Studies among Men who have Sex with Men 
in Sub-Saharan Africa 
 
TABLE OF CONTENTS 
 
 
List of Abbreviations and Acronyms 
4 
Protocol Team Roster 
6 
Investigator signature page 
10 
Schema 
11 
Overview of Study Design and Randomization Scheme 
13 
 
1.0 
INTRODUCTION........................................................................................................... 14 
1.1 
Background and Prior Research ..................................................................................... 14 
1.2 
Rationale......................................................................................................................... 15 
1.3 
Background and Rationale for Qualitative Component ................................................. 17 
2.0 
STUDY OBJECTIVES AND DESIGN ......................................................................... 18 
2.1 
Primary Objectives ......................................................................................................... 18 
2.2 
Secondary Objectives ..................................................................................................... 18 
2.3 
Exploratory Objective: ................................................................................................... 19 
2.4 
Study Design .................................................................................................................. 19 
2.5 
Study Design for Qualitative component ....................................................................... 21 
2.5.1 
In-Depth Interviews ................................................................................................ 21 
2.5.2 
Focus Group Discussions ........................................................................................ 21 
3.0 
STUDY POPULATION ................................................................................................. 22 
3.1 
Inclusion Criteria ............................................................................................................ 22 
3.2 
Exclusion Criteria ........................................................................................................... 23 
3.3 
Recruitment Process ....................................................................................................... 23 
3.4 
Co-Enrollment Guidelines.............................................................................................. 24 
3.5 
Compensation ................................................................................................................. 24 
3.6 
Participant Retention ...................................................................................................... 24 
3.7 
Participant Withdrawal ................................................................................................... 25 
4.0 
STUDY POPULATION AND SAMPLING FOR QUALITATIVE COMPONENT 26 
4.1 
Study Population for IDIs .............................................................................................. 26 
4.1.1 
Inclusion Criteria for IDIs ....................................................................................... 26 
4.1.2 
Exclusion Criteria for IDIs...................................................................................... 26 
4.2 
Study Population for FGDs ............................................................................................ 26 
4.2.1 
Inclusion Criteria for FGD ...................................................................................... 26 
4.2.2 
Exclusion Criteria for FGD ..................................................................................... 27 
5.0 
STUDY PROCEDURES ................................................................................................ 27 
5.1 
Screening Visit ............................................................................................................... 27 
5.2 
Enrollment Visit ............................................................................................................. 28 
5.3 
Follow-up Visits (Weeks 13 and 39) ............................................................................. 30 
5.4 
Follow-up Visits (Weeks 26 and 52/Exit) ...................................................................... 30 
5.5 
HIV Confirmation Visit ................................................................................................. 31 
5.6 
Behavioral Assessment .................................................................................................. 32 

 
HPTN 075, Protocol Version 3.0 Page 2 of 73 
15 November 2016 
5.7 
Site Recruitment and Retention Monitoring and Reports .............................................. 33 
6.0 
STUDY PROCEDURES FOR THE QUALITATIVE COMPONENT ..................... 33 
6.1 
Study Procedures for IDIs .............................................................................................. 33 
6.1.1 
Recruitment for IDIs ............................................................................................... 33 
6.1.2 
Enrollment for IDIs ................................................................................................. 34 
6.2 
Study Procedures for FGDs............................................................................................ 34 
6.2.1 
Recruitment for FGDs............................................................................................. 34 
7.0 
SAFETY MONITORING AND ADVERSE EVENT REPORTING ........................ 35 
8.0 
STATISTICAL CONSIDERATIONS .......................................................................... 35 
8.1 
Review of Study Design ................................................................................................. 35 
8.2 
Endpoints ........................................................................................................................ 35 
8.2.1 
Primary Endpoints .................................................................................................. 35 
8.2.2 
Secondary Endpoints .............................................................................................. 36 
8.2.3 
Accrual, Follow-up, and Sample Size..................................................................... 36 
8.3 
Data Analysis ................................................................................................................. 37 
8.3.1 
Primary Analyses .................................................................................................... 37 
8.3.2 
Secondary Analyses ................................................................................................ 38 
8.4 
Qualitative Data Analysis............................................................................................... 38 
8.4.1 
Reading ................................................................................................................... 38 
8.4.2 
Coding ..................................................................................................................... 38 
8.4.3 
Data Display and Reduction ................................................................................... 38 
8.4.4 
Analysis of Additional Participant Data ................................................................. 39 
9.0 
ETHICAL CONSIDERATIONS ................................................................................... 39 
10.0 
HUMAN SUBJECTS CONSIDERATIONS ................................................................ 40 
10.1 
Ethical Review ............................................................................................................ 40 
10.2 
Informed Consent ....................................................................................................... 40 
10.3 
Risks ........................................................................................................................... 41 
10.4 
Benefits ....................................................................................................................... 41 
10.5 
Incentives .................................................................................................................... 42 
10.6 
Confidentiality ............................................................................................................ 42 
10.7 
Communicable Disease Reporting Requirements ...................................................... 42 
10.8 
Study Discontinuation ................................................................................................ 43 
11.0 
LABORATORY SPECIMENS AND BIOHAZARD CONTAINMENT .................. 43 
11.1 
Local Laboratory Specimens ...................................................................................... 43 
11.2 
Laboratory Center Specimens .................................................................................... 43 
11.3 
Quality Control and Quality Assurance Procedures ................................................... 44 
11.3.1 QC for HIV Diagnostic Testing .............................................................................. 44 
11.3.2 QC for CD4 Cell Count Determination .................................................................. 45 
11.3.3 QC for HIV Viral Load Determination ................................................................... 45 
11.4 
Specimen Storage and Possible Future Research Testing .......................................... 45 
11.5 
Biohazard Containment .............................................................................................. 45 
12.0 
ADMINISTRATIVE PROCEDURES .......................................................................... 45 
12.1 
Protocol Registration .................................................................................................. 45 
12.2 
Protocol Amendments ................................................................................................ 46 
12.3 
Study Activation ......................................................................................................... 46 
12.4 
Study Coordination ..................................................................................................... 46 
12.5 
Study Monitoring ........................................................................................................ 47 
12.6 
Protocol Compliance .................................................................................................. 47 

 
HPTN 075, Protocol Version 3.0 Page 3 of 73 
15 November 2016 
12.7 
Investigator's Records ................................................................................................. 47 
12.8 
Use of Information and Publications .......................................................................... 48 
13.0 
REFERENCES ................................................................................................................ 49 
14.0 
SCHEDULE OF STUDY VISITS AND PROCEDURES ........................................... 52 
14.1.1 Appendix I: Schedule of Evaluations and Procedures ............................................ 52 
14.1.2 Appendix II: Additional Laboratory Procedures for Men Who Acquire HIV 
Infection During the Study (HIV Confirmation Visit) ......................................................... 54 
14.1.3 Appendix III: Additional Laboratory Procedures for Men Who Have Symptoms of 
Acute HIV Infection During the Study ................................................................................. 55 
15.0 
SAMPLE INFORMED CONSENT FORM ................................................................. 56 
15.1.1 Appendix IV: Sample Screening Consent Form ..................................................... 56 
15.1.2 Appendix V: Sample Enrollment Consent Form .................................................... 60 
15.1.3 Appendix VI: Sample In-Depth Interview Consent Form ...................................... 68 
15.1.4 Appendix VII: Sample Focus Group Discussion Consent Form ............................ 71 
 
 

 
HPTN 075, Protocol Version 3.0 Page 4 of 73 
15 November 2016 
HPTN 075 
Feasibility of HIV Prevention Cohort Studies among Men who have Sex with Men  
in Sub-Saharan Africa 
 
LIST OF ABBREVIATIONS AND ACRONYMS 
 
 
AE 
Adverse Event    
ALT 
Alanine Transaminase 
ART 
Antiretroviral Therapy 
AST 
Aspartate Transaminase 
CAB 
Community Advisory Board 
CASI 
Computer-assisted Self-Interviewing 
CAPI 
Computer-assisted Personal Interviewing  
CBC 
Complete Blood Count 
CD4 
Surface glycoprotein that denoting helper T cells  
CI 
Confidence Interval  
CRM 
Clinical Research Manager 
CRS 
Clinical Research Site  
CT 
Chlamydia  
CTU 
Clinical Trials Unit 
DAIDS 
Division of AIDS  
EC 
Ethics Committee   
EQA 
External Quality Assurance 
GC 
Gonorrhea  
GCP 
Good Clinical Practices 
GEE 
Generalized Estimating Equation   
HBcAb 
Hepatitis B Virus Core Antibody 
HBV 
Hepatitis B Virus  
HBsAb 
Hepatitis B Virus Surface Antibody 
HBsAg 
Hepatitis B Virus Surface Antigen 
HIV 
Human Immunodeficiency Virus  
HPTN 
HIV Prevention Trials Network  
IOR 
Investigator of Record 
IQA 
Internal Quality Assurance 
IRB 
Institutional Review Board    
LC 
Laboratory Center 
LDMS 
Laboratory Data Management System 
LL 
Local Laboratory   
LOC 
Leadership and Operations Center 
MOH 
Ministry of Health 
MSM 
Men who have Sex with Men  
NAAT 
Nucleic Acid Amplification Test 
NIAID 
(United States) National Institute of Allergy and Infectious Diseases 
NIH 
(United States) National Institutes of Health 
QA 
Quality Assurance 
QC 
Quality Control 
PAC 
Protocol Advisory Committee 

 
HPTN 075, Protocol Version 3.0 Page 5 of 73 
15 November 2016 
PEPFAR 
President’s Emergency Plan for AIDS Relief   
PrEP 
Pre-Exposure Prophylaxis   
PRO 
Protocol Registration Office 
PSRC 
Prevention Science Review Committee 
RE 
Regulatory Entity 
RNA 
Ribo-Nucleic Acid   
RSC 
Regulatory Services Center 
SDMC 
(HPTN) Statistical and Data Management Center   
SMS  
Short Message System 
SOC 
Standard-of-Care   
SOP 
Standard Operating Procedures 
SRC 
(HPTN) Scientific Review Committee 
SSA 
Sub-Saharan Africa  
SSP 
Study Specific Procedures  
STI 
Sexually Transmitted Infection  
UK NEQAS 
United Kingdom National External Quality Assessment Service 
VBS 
Venue-Based Sampling  
VQA 
Virology Quality Assurance Program 
WHO 
World Health Organization 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
HPTN 075, Protocol Version 3.0 Page 6 of 73 
15 November 2016 
HPTN 075 
Feasibility of HIV Prevention Cohort Studies among Men who have Sex with 
Men in Sub-Saharan Africa 
 
PROTOCOL TEAM ROSTER 
 
Theo Sandfort, PhD 
Protocol Chair 
Columbia University  
HIV Center for Clinical and 
Behavioral Studies  
1051 Riverside Drive, PI Unit 15 
New York, NY 10032 
United States 
Phone:  (646) 774-6946 
Fax:  (646) 774-6955 
Email: tgs2001@columbia.edu  
 
 
Stefan Baral, MD, MPH 
Protocol Team Member 
Center for Public Health and Human 
Rights 
John Hopkins School of Public 
Health 
Baltimore, MD  21205  
United States 
Phone:  (410) 502-8975 
Fax:  (410) 614-8371 
Email: sbaral@jhsph.edu  
 
Linda-Gail Bekker, MBChB, PhD 
Protocol Team Member 
University of Cape Town, Institute of 
Infectious Disease & Molecular 
Medicine 
PO Box 13801 
Mowbray 
Cape Town, South Africa 
Phone:  +27 021 6506970 
Fax:  +27 021 6506959 
Email: Linda-Gail.Bekker@hiv-
research.org.za 
 
 
 
 
 
Tim Lane, PhD, MPH 
Protocol Team Member 
Center for AIDS Prevention Studies 
University of California, San Francisco, 
CA 
United States 
Phone:  (415) 597-8190 
Fax:  (415) 597-9213  
Email: Tim.Lane@ucsf.edu  
 
Jonathan Paul Lucas, MPH 
HPTN Community Liaison 
FHI 360 
359 Blackwell St Suite 200 
Durham, NC 27701 
United States 
Phone:  (919) 544-7040, x11458 
Fax:  (919) 544-7261 
Email: jlucas@fhi360.org 
 
Lebah Lugalia 
HPTN Laboratory Center 
Johns Hopkins University 
Private Bag A-104 
Lilongwe, Malawi 
Phone: +256-77-4016619  
Fax:  +265-1755954 
Email: llugali1@jhmi.edu  
 
Ernest Moseki, PGD 
Protocol Team Member 
Gaborone Prevention/Treatment Trials 
CRS  
Princess Marina Hospital 
Private Bag BO 320 
Gaborone, Botswana 
Phone:  +267 3975776   
Fax:  +267 3971051 
Email: emoseki@bhp.org.bw  
 
 
 
 

 
HPTN 075, Protocol Version 3.0 Page 7 of 73 
15 November 2016 
Wairimu Chege MD, MPH 
Medical Officer 
LCDR USPHS 
Prevention Sciences Program 
DAIDS, NIAID, NIH, DHHS 
5601 Fishers Lane, Rm 8B38 
Bethesda, MD 20892 
Phone: (240) 292-4786 
Fax: (240) 627- 3465 
Email: wairimu.chege@nih.gov 
 
Ying Qing Chen, PhD  
HPTN Protocol Statistician 
Fred Hutchinson Cancer Research Center  
1100 Fairview Avenue North 
M2-C200 
PO Box 19024 
Seattle, WA 98109 
United States 
Phone:  (206) 667-7051 
Fax:  (206) 667-4812 
Email: yqchen@scharp.org  
 
Vanessa Cummings, BS, MT 
HPTN Laboratory Center QAQC 
Representative 
Pathology  
Pathology Building, Room 306 
600 N. Wolfe Street 
Baltimore, MD 21287 
United States 
Phone:  (410) 502-5296 
Fax:  (410) 614-0430 
Email: vcummin1@jhmi.edu  
 
Vanessa Elharrar, MD, MPH 
Protocol Team Member, NIH 
5601 Fishers Lane, 2E42 
Bethesda, MD 20892 
United States 
Phone:  (240) 669-5557 
Fax:  (301) 828-7322 
Email: vanessa.elharrar@nih.gov  
 
Lynda Emel, PhD 
HPTN SDMC Research Program 
Manager 
Fred Hutchinson Cancer Research Center  
SCHARP-FHCRC  
 
Eduard Sanders, MD, MPH, PhD 
Protocol Team Member 
Kenya Medical Research Institute  
Centre for Geographic Medicine 
Research 
Kilifi, Kenya 
Phone:  +254 041 7522063  
Fax:  +254 041 522390 
Email: ESanders@kilifi.kemri-
wellcome.org  
 
Paul Semugoma, MD 
Protocol Team Member 
African Men for Sexual Health and 
Rights  
27 Clieveden Avenue 
Auckland Park 
Johannesburg, Gauteng 2090 
South Africa 
Phone:  +27 216 740 878 
Fax:  N.A. 
Email: semugoma@gmail.com  
 
Jerome Singh 
Center for the AIDS Programme of 
Research in South Africa (CAPRISA)  
Nelson R. Mandela School of 
Medicine 
Private Bag X7 
Congella 
Durban, South Africa 
Phone:  +27 31 2604555 
Fax:  +27 31 2604566 
Email: singhj9@ukzn.ac.za  
 
Michael J. Stirratt, PhD 
Program Chief 
Adherence to Treatment and 
Prevention Program 
NIMH Division of AIDS Research 
5601 Fishers Lane, Rm 9G28, MSC 
9831 
Bethesda MD 20982 
Phone: (240) 627-3875 
Fax: (240) 627-3107 
Email: stirrattm@mail.nih.gov 
 

 
HPTN 075, Protocol Version 3.0 Page 8 of 73 
15 November 2016 
1100 Fairview Avenue North, E3-129 
PO Box 19024 
Seattle, WA 98109 
United States 
Phone:  (206) 667-5803  
Fax:  (206) 667-4812 
Email: lemel@scharp.org  
 
Susan Eshleman, MD, PhD 
HPTN Laboratory Center Representative 
Johns Hopkins Univ. School of Medicine  
720 Rutland Avenue 
Ross Bldg., Room 646 
Baltimore, MD 21205 
United States 
Phone:  (410) 614-4734 
Fax:  (410) 502-9244 
Email: seshlem@jhmi.edu  
 
Erica Hamilton, MPH 
HPTN Clinical Research Manager 
FHI360  
359 Blackwell St Suite 200 
Durham, NC 27701 
United States 
Phone:  (919) 544-7040, x11295 
Fax:  (919) 544-7261 
Email: ehamilton@fhi360.org 
 
Karen Dominguez 
Desmond Tutu HIV Foundation 
Wernher Beit Building North, N1-16 
UCT Medical School, Anzio Road, 
Observatory, 7925 
Cape Town, South Africa 
Phone: 27 21 650 6969 
Email: kdom@hiv-research.org.za 
 
Josh Kikuvi 
Groote Schuur HIV CRS 
J52 Old Main Building 
Groote Schuur Hospital 
Main Road, Observatory 
Cape Town, South Africa 7925 
Phone: 27 21 650 4191 
Phone: 27 60 488 6482 
Email: Joshua.Kikuvi@hiv-
research.org.za 
 
Patrick Sullivan, DVM, PhD 
Protocol Team Member 
Rollins School of Public Health 
Department of Epidemiology 
Atlanta, GA   
United States 
Phone: (404) 727-2038  
Fax:  (866) 311-8234 
Email: pssulli@emory.edu  
 
Carlos Toledo, PhD 
Protocol Team Member 
Prevention Branch Chief 
CDC, South Africa 
Phone:  +27 12 424 9000 
Fax:  +27 12 346 4286 
Email: toledoc@sa.cdc.gov  
 
Yamikani Mbilizi, MBBS 
Research Physician and Study 
Coordinator 
College of Medicine Johns Hopkins 
Project 
P.O Box 1131 Chipatala Avenue 
Blantyre, Malawi 
Phone: +265 882599589 
Email: ymbilizi@jhu.medcol.mw 
 
Scott Rose, BS 
HPTN Leadership and Operations 
Center 
FHI 360 
359 Blackwell St, Ste 200 
Durham, NC 27701 
United States 
Phone: 919 544 7040 x11378 
Fax: 919 544 0207 
Email: srose@fhi360.org 
 
Ravindre Panchia, MD 
Soweto HPTN CRS 
Chris Hani Baragwanath Hospital 
Chris Hani Road 
Soweto, South Africa 
Phone: 27 11 989 9711 
Fax: 27 11 989 9877 
Email: panchiar@phru.co.za 
 

 
HPTN 075, Protocol Version 3.0 Page 9 of 73 
15 November 2016 
Chris(tie) Heiberg 
Desmond Tutu HIV Foundation 
Wernher Beit Building North, N1-16 
UCT Medical School, Anzio Road, 
Observatory, 7925 
Cape Town, South Africa  
Phone: 27 21 650 6726 
Email: christie.heiberg@hiv-
research.org.za 
 
Laura McKinstry, MPH 
Clinical Data Manager 
Statistical Center for HIV/AIDS 
Research and Prevention (SCHARP) 
Fred Hutchinson Cancer Research 
Center 
1100 Fairview Ave. N., Mail Stop 
E3-129 
Seattle, WA 98109 
Phone: (206) 667-7322 
Fax: (206) 667-4812 
Email: lmckinst@scharp.org 
 
Sufia Dadabhai 
Johns Hopkins University 
Bloomberg School of Public Health 
615 N. Wolfe Street 
E-7132B 
Baltimore, MD 21205 
United States 
Phone: 410 502 9304 
Fax: 443 287 5188 
Email: sdadabha@jhsph.edu 
 
 
 
Arthur Ogendo 
KISUMU CRS 
New Nyanza Provincial General 
Hospital 
Off Kisumu- Kakamego Road 
P.O. Box 1578-40100 
Kisumu, Kenya 
Phone: 254 734 512232 
Email: Aogendo@kemricdc.org 
 
David Schnabel 
KISUMU CRS 
New Nyanza Provincial General 
Hospital 
Off Kisumu- Kakamego Road 
P.O. Box 1578-40100 
Kisumu, Kenya 
Phone: 254 703 485481 
Email: xdh2@cdc.gov 
 
Calvin Mbeda 
KISUMU CRS 
New Nyanza Provincial General 
Hospital 
Off Kisumu- Kakamego Road 
P.O. Box 1578-40100 
Kisumu, Kenya 
Phone: 254 72 3293 051 
Email: CMbeda@kemricdc.org 
 
Noel Kayange 
Chipatala Avenue 
Queen Elizabeth Central Hospital 
PO Box 1131 
Blantyre, Southern Region 
Malawi 
Phone: 265 1 675 129 
Email: nkayange@jhu.medcol.mw 
 
 
 
 
 
 
 
 
 
 

 
HPTN 075, Protocol Version 3.0 Page 10 of 73 
15 November 2016 
HPTN 075 
Feasibility of HIV Prevention Cohort Studies among Men who have Sex with Men 
in Sub-Saharan Africa 
Protocol Version 3.0 / 15 November 2016 
 
 
A Study of the HIV Prevention Trials Network (HPTN) 
 
 
Sponsored by: 
 
US National Institute of Allergy and Infectious Diseases and 
US National Institutes of Health 
 
 
 
 
I, the Investigator of Record, agree to conduct this study in full accordance with the provisions of 
this protocol. I agree to maintain all study documentation for a minimum of three years after 
submission of the site’s final Financial Status Report to the Division of AIDS (DAIDS), unless 
otherwise specified by DAIDS or the HIV Prevention Trials Network (HPTN) Coordinating and 
Operations Center.  Publication of the results of this study will be governed by HPTN policies. 
Any presentation, abstract, or manuscript will be made available by the investigators to the 
HPTN Manuscript Review Committee and DAIDS for review prior to submission. 
 
I have read and understand the information in this protocol and will ensure that all associates, 
colleagues, and employees assisting in the conduct of the study are informed about the 
obligations incurred by their contribution to the study.  
 
 
 
 
 
 
 
 
__________________________________ 
Name of Site Investigator of Record 
 
 
___________________________________________________________________ 
Signature of Site Investigator of Record        Date  
 
 
 

 
HPTN 075, Protocol Version 3.0 Page 11 of 73 
15 November 2016 
HPTN 075 
Feasibility of HIV Prevention Cohort Studies among Men who have Sex with Men in Sub-
Saharan Africa 
 
 
 
SCHEMA 
 
Purpose: This study aims to determine the feasibility of recruiting and retaining men who have 
sex with men (MSM) in a multi-country prospective cohort study in preparation for human 
immunodeficiency virus (HIV) prevention studies in sub-Saharan Africa (SSA). 
 
Design: HPTN 075 is an observational cohort study.  Participants will be accrued over six 
months at four sites in SSA using convenience sampling strategies, with no replacement for 
participants lost to follow-up.  Each participant will be followed for 12 months, during which 
five study visits involving structured HIV behavioral assessments, medical examinations, and 
collection of biological samples will be conducted (including enrollment and quarterly follow-up 
visits). Participants who do not complete 12 months of follow-up will be contacted to explore 
reasons for no longer participating.  
 
Study  
Population:   Men, regardless of HIV infection status, aged 18-44 years living in SSA who report 
anal sex with a man in the past 3 months. 
 
Study Size:   A total of approximately 400 men, about 100 per site, will be enrolled.  Enrollment 
of HIV-infected men will be capped at 20 men per site. 
 
Study   
Duration:   Total study duration in the field is 21 months: 3 months of implementation  preparation, 
6 months of accrual, and 12 months of follow-up. 
 
Primary   
Objective:   To assess study recruitment and retention of a prospective cohort of approximately 400 
MSM in SSA to inform feasibility, power calculations and sample size calculations for future 
HIV prevention studies. 
 
Secondary  
Objectives:  
 To identify factors related to study participation and retention among MSM in SSA, 
including potential barriers for study participation. 
 To assess the experience of MSM in SSA of participating in a cohort study that includes 
biomedical and behavioral assessments. 
 To evaluate the social impact of participating in a biomedical and behavioral cohort study on 
participants. 
 To assess prevalence and incidence of HIV and sexually transmitted infections (STIs), and 
the prevalence of hepatitis B virus (HBV) infection in the study cohort. 

 
HPTN 075, Protocol Version 3.0 Page 12 of 73 
15 November 2016 
 To obtain baseline laboratory data (chemistry and hematology) to evaluate the cohort’s 
suitability for possible future pre-exposure prophylaxis (PrEP) intervention studies. 
 To identify demographic, behavioral, and socioeconomic factors related to prevalence of 
HIV infection, newly diagnosed HIV infection, HBV infection, and STIs.  
 To identify demographic, behavioral, and socioeconomic factors related to uptake of standard 
HIV prevention interventions; accessing HIV- and non-HIV-related care and treatment; as 
well as interest in potential HIV prevention strategies and participation in future HIV 
intervention trials.  
 
To explore the possibility of including female sex partners of MSM participants in future 
HIV intervention trials. 
 
To compare substance use data obtained by self-report to data obtained by retrospective 
testing for substances of abuse in stored urine samples. Note that this objective will only 
apply to sites that have IRB approval for urine storage for substance use testing. 
 
Exploratory  
Objective:   
 To perform secondary laboratory assessments that may include evaluation of factors related 
to HIV infection, hepatitis infection, or STIs; ARV drug use; characterization of HIV in 
infected participants, including phylogenetic analysis; evaluation of the host response to 
infection; and evaluation of laboratory assays and methods related to the study objectives. 
 To explore participant attitudes towards and experiences with PrEP by conducting in-depth 
interviews (IDIs) and focus group discussions (FGDs). 
 
 
Study Sites: 
 
KEMRI/CDC, Kisumu, Kenya 
 
Blantyre CRS, Blantyre, Malawi 
 
Soweto HPTN CRS, Soweto, SA 
 
Groote Schuur HIV CRS (Desmond Tutu HIV), Cape Town SA 

 
HPTN 075, Protocol Version 3.0 Page 13 of 73 
15 November 2016 
HPTN 075 
Feasibility of HIV Prevention Cohort Studies among Men who have Sex with 
Men in Sub-Saharan Africa 
 
OVERVIEW OF STUDY DESIGN 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Screening 
Enrollment 
(~ 100 Participants) 
Week 13 
Short Follow-up 
Week 39 
Short Follow-up 
Week 26 
Follow-up Visit 
Week 52 
Follow-up Visit 

 
HPTN 075, Protocol Version 3.0 Page 14 of 73 
15 November 2016 
1.0 INTRODUCTION  
1.1 
Background and Prior Research   
MSM as a priority for HIV prevention: In all countries where MSM-specific epidemics 
have been studied, MSM have been identified as a key population in HIV epidemics (1-
3).  Even in African countries with generalized epidemics and high HIV prevalence 
overall, the HIV prevalence among MSM is 3-4 times higher than in the general 
population (4). Because of the high levels of bisexual sexual activity and bisexual 
concurrency in this population it has been argued that efforts to address generalized HIV 
epidemics will be unsuccessful unless they also address nested, concentrated HIV 
epidemics among MSM (5).  
 
MSM in SSA are at alarmingly high risk of HIV acquisition and transmission (6-18), and 
face two distinct structural disadvantages to accessing prevention and treatment.  First, 
the major HIV prevention programs in SSA target heterosexual persons and pregnant 
women, and thus do not meet the specific prevention needs of MSM.  Second, in many 
parts of SSA, MSM cannot safely seek HIV prevention or treatment services because of 
the social, cultural, and legal aspects of stigma, discrimination, and criminalization (19-
21).  
 
Relevant previous studies: To date, the vast majority of studies of MSM in SSA have 
been cross-sectional, integrated bio-behavioral surveillance surveys with convenience or 
respondent-driven sampling.  These studies have been largely aimed at describing HIV 
risk behaviors and determining HIV prevalence in these populations (2).  Based on 
existing studies, prevalence of HIV in MSM in SSA is estimated to be 17.9%, compared 
to 5.0% among all adults in the same countries (1).  To date, HIV incidence data for 
MSM in SSA are lacking with the exception of findings from studies in Nairobi and 
Kilifi, Kenya, where an incidence of 9% per 100 person-years was documented for the 
period of 2005-2011 (12, 15).  The scarcity of HIV incidence data in MSM in SSA 
indicates that more work is needed to understand these epidemics (1).  The high HIV 
prevalence and incidence among MSM in SSA indicate an urgent need to identify 
strategies to prevent HIV transmission in this population.  
 
A small, but emerging, body of literature suggests the urgent need to increase access to 
and use of HIV testing (6, 22-24); to increase condom use for anal sex, especially with 
main or regular partners (25, 26); to address and treat STIs (27); and to address structural 
barriers which, if unaddressed, will make it challenging to bring HIV prevention for 
MSM to scale (25, 28-30). 
 
There are also many important but unstudied areas that set the context for feasibility 
studies related to HIV prevention in MSM in SSA.   These include possible social 
consequences of participating in such studies; local/regional heterogeneity of substance 
use patterns and their relationship to risk behaviors; the sexual networks of behaviorally 
bisexual MSM; and the epidemiology of STIs as they relate to HIV acquisition risk.   
 

 
HPTN 075, Protocol Version 3.0 Page 15 of 73 
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These issues are all poorly understood and are central to the ability to mount larger scale 
HIV prevention studies with MSM in SSA.  It is promising that communities of 
providers, MSM, and prevention researchers have engaged in preliminary dialogues 
about providing comprehensive prevention services to MSM in SSA, and that there is 
substantial consensus among stakeholders about the type of services that will be required 
to have substantial impact on HIV prevention (31). 
 
1.2 
Rationale 
HPTN 075 is a multi-site, prospective study that will evaluate the feasibility of enrolling 
and retaining MSM in HIV prevention studies.  Eligible men will be enrolled and 
followed for one year, with regular HIV and STI testing and behavioral assessments.  
Retention at 12 months will be the primary study objective.  
 
There is little information regarding the feasibility, acceptability, or efficacy of HIV 
interventions addressing the HIV prevention needs of MSM in SSA (2).  A recent 
comprehensive literature review indicated that nearly all high-quality efficacy data for 
HIV prevention interventions for MSM have emerged from trials in the global North, 
especially the United States (28). 
 
To date, HIV prevention trials in SSA have enrolled individuals primarily at risk of 
heterosexual transmission; i.e., they have not specifically targeted MSM.  Two important 
exceptions are the Global iPrEX trial, which enrolled a relatively small number of MSM 
in South Africa (N=88 with over 80% non-White participants, (32)) and a Phase I PrEP 
trial, which enrolled 67 MSM in Kenya in 2010 (33).  There are only a few ongoing 
intervention studies among MSM in SSA.  These include: 1) an NIAID-funded Health 
Empowerment study in Mpumalanga Province, South Africa (R01-AI089292), 2) a pilot 
combination prevention study for MSM in Cape Town and Port Elizabeth, South Africa, 
funded through a Methods for Prevention Packages Program (MP3) grant (R01-
AI094575), 3) an operations research prospective cohort study of 1200 MSM, aged 15 
and older, that evaluates the linkage of clients to combination prevention and 
comprehensive HIV and medical services in Nigeria, funded through the President’s 
Emergency Plan for AIDS Relief (PEPFAR), 4) a pilot intervention research project to 
improve ART adherence among Kenyan MSM through provider and peer support (R34-
MH099946 ), and 5) feasibility studies in Malawi and Senegal, funded by USAID. There 
is one well-established cohort of MSM in Africa in Kilifi, Kenya with follow-up since 
2005 (14, 15); behavioral and clinical data have been reported on a clinic-based sample in 
Abuja, Nigeria (27).  Other studies seek to evaluate factors, experiences, and co-
morbidity concerns related to HIV risk behaviors in MSM in Tanzania (R21 -MH090908) 
and South Africa (F31-MH088943 and R01-MH083557). 
 
Relevance to long-term global goals of HPTN: HPTN 075 is particularly relevant to the 
network’s goal of conducting prevention research in populations and geographical 
regions that bear a disproportionate burden of HIV infection.  MSM in SSA clearly meet 
this criterion.  Further, this study will help the HPTN understand the requirements for 
future, larger-scale research studies of HIV prevention interventions in MSM in SSA.  

 
HPTN 075, Protocol Version 3.0 Page 16 of 73 
15 November 2016 
Estimates of retention and HIV incidence (although limited by the small size of this 
study) will inform the design and power calculations for future trials with HIV incidence 
endpoints.  
 
This study will also help the HPTN understand the challenges and opportunities of future, 
multi-site trials of HIV prevention among MSM in SSA. Because MSM typically face 
unique barriers to participation in HIV prevention studies, it is critical to demonstrate the 
feasibility of enrolling and retaining them.  It is also important to understand the biases 
that impact enrollment of MSM in a research study.  Are there some populations of MSM 
who preferentially present for enrollment or avoid presenting for enrollment?   Do some 
MSM present in-authentically, because of desire for study incentives or services?  What 
preparatory steps are key to preparing study sites and communities to engage in research 
with MSM?  Further, understanding more about the relationship of sexual risks with male 
and female partners and the epidemiology of STIs will help evaluate the priority of 
considering these elements in future studies.   
 
Study retention is not only a critical issue for HIV-uninfected MSM, but also for HIV-
infected MSM. Inclusion of HIV-infected MSM in HPTN 075 help identify factors that 
may impact their linkage and retention in care. This information would be helpful for 
design of potential future studies of treatment as prevention in MSM cohorts. Stored 
samples from men who are HIV infected at enrollment could also be tested to obtain 
information about HIV drug resistance and super-infection in this population, and to 
provide a cross-sectional estimate HIV incidence at enrollment. However, these analyses 
may be limited by the small number of HIV-infected men enrolled (up to 20/site, 
maximum of 80).  
 
In the initial consultative phases of developing HPTN 075, stakeholders and concept 
committee members raised issues of social harms and safety.  Evaluating potential social 
harms associated with cohort participation is also critical to the design of future studies 
that are safe for participants, acceptable to communities, and supportable by institutional 
review boards (IRBs)/ethics committees (ECs); especially because future studies are 
likely to include some sites less accustomed to working with MSM.  This pilot study will 
provide insights into the challenges that sites and communities in SSA may need to be 
aware of as they prepare for future, larger studies. In addition to social harms, knowing 
what potential benefits are of participating in a cohort study will contribute to successful 
implementation of future studies. 
 
Critical pathway to efficacy evaluation:  Other ongoing efforts, including an MP3 study, 
are examining the components and composition of a comprehensive HIV prevention 
package for MSM in South Africa.  It is expected that HPTN 075, conducted at four sites, 
will provide information on feasibility of recruiting MSM in several additional settings in 
SSA.  The HPTN 075 study team has connections with the current MP3 project, which 
will provide information on prevention package components and delivery.  In addition, as 
socio-behavioral studies are completed and written up, this additional information will 
inform safe and effective ways to engage MSM in Africa and meaningfully include this 
vulnerable population in prevention research.  It is likely that HPTN 075 and the current 
MP3 study will provide complementary data needed to design and implement a feasible 
and acceptable prevention package for MSM in SSA.   

 
HPTN 075, Protocol Version 3.0 Page 17 of 73 
15 November 2016 
 
A number of African National HIV/AIDS programs (34) are giving attention to specific 
components of a prevention package for a key populations such as MSM. It is thought 
that this may include biomedical interventions such as PrEP. Research that demonstrates 
feasibility and effectiveness will be critical in enabling policy decisions on HIV 
Prevention in MSM to be made.  
 
1.3 
Background and Rationale for Qualitative Component 
Injectable pre‐exposure prophylaxis (PrEP) is a critical addition to the strategies to 
further reduce transmission of human immunodeficiency virus (HIV), particularly among 
populations that engage in high risk sexual practices. Before injectable PrEP can be 
implemented on a large scale, studies are needed to show that it is efficacious and safe, as 
well as what adoption in the real world would look like. It is also important to understand 
this for the benefit of future studies of these agents in the same populations. For such 
studies to be successful, it is critical to understand how PrEP in general, and injectable 
PrEP in particular, are perceived by populations at increased risk, including men who 
engage in sex with men (MSM) in sub-Saharan Africa (SSA).  
 
The main aim of the qualitative component is to assess and understand the knowledge 
and willingness to use PrEP in general, the future acceptability of injectable PrEP, as well 
as the willingness to participate in injectable PrEP trials and demonstration projects. 
Interest in PrEP will be explored in relation to currently available HIV preventive 
strategies.  
 
Study findings will identify issues that need to be addressed before new studies can be 
implemented. There currently is some understanding of the way MSM, predominantly in 
high income countries, perceive PrEP in general. Knowledge regarding injectable PrEP 
and participation in efficacy trials and demonstration projects is practically nil, although 
lessons from vaccine preparedness studies are informative.  
 
It is likely that what is known about PrEP and MSM in high income countries cannot 
automatically be applied to MSM in SSA. There are several reasons why this is the case. 
In general, the social situation in which sub-Saharan African MSM live differs 
substantially from that of MSM in high income countries, due to the criminalization of 
homosexuality, as well as the strong societal rejection. This has consequences for the 
men’s lifestyle, their sexual as well as preventative practices, their thinking about health 
and health care. In addition, acceptability of PrEP in these men is likely to be affected by 
traditional medicine in SSA countries, which interferes with trust in Western medicine. 
 
To address the research questions, we will conduct two focus group discussions (FGDs) 
and twenty in‐depth interviews (IDIs) at each of the four sites involved in HPTN 075. 
Both strategies will deliver complementary information—the FGDs generating an 
assessment of the social climate and the IDIs an understanding from a more personal 
perspective—as well as an opportunity for triangulation. Furthermore, information 
garnered through in‐depth interviews could be linked to a host of behavioral and 

 
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15 November 2016 
psychosocial data collected in the cohort study (in case men are selected for these 
interviews among the HIV-negative cohort participants). The number of focus groups and 
interviews is based on the expectation that they will allow for saturation. The reason for 
involving all four sites is that the acceptability of injectable PrEP will vary across sites; 
involving the four sites will allow exploration of this variety. 
 
 
2.0 STUDY OBJECTIVES AND DESIGN 
2.1 
Primary Objectives 
The primary objective of this study is to assess the feasibility of study recruitment and 
retention of a prospective cohort of approximately 400 MSM in SSA to inform 
feasibility, power calculations, and sample size calculations for future HIV prevention 
studies. 
2.2 
Secondary Objectives 
The secondary objectives of this study are as follows: 
 To identify factors related to study participation and retention among MSM in SSA, 
including potential barriers for study participation; 
 To assess the experience of MSM in SSA of participating in a cohort study that includes 
biomedical and behavioral assessments; 
 To evaluate the social impact of participating in a biomedical and behavioral cohort study on 
participants; 
 To assess prevalence and incidence of HIV and sexually transmitted infections (STIs), and 
the prevalence of hepatitis B virus (HBV) infection in the study cohort; 
 To obtain baseline laboratory data (chemistry and hematology) to evaluate the cohort’s 
suitability for possible future pre-exposure prophylaxis (PrEP) intervention studies; 
 To identify demographic, behavioral, and socioeconomic factors related to prevalence of 
HIV infection, newly diagnosed HIV infection, HBV infection, and STIs; 
 To identify demographic, behavioral, and socioeconomic factors related to uptake of standard 
HIV prevention interventions; accessing HIV- and non-HIV-related care and treatment; as 
well as interest in potential HIV prevention strategies and participation in future HIV 
intervention trials;  
 
To explore the possibility of including female sex partners of MSM participants in future 
studies; 
 
To compare substance use data obtained by self-report to data obtained by retrospective 
testing for substances of abuse in stored urine samples. Note that this objective will only 
apply to sites that have IRB approval for urine storage for substance use testing. 
 

 
HPTN 075, Protocol Version 3.0 Page 19 of 73 
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2.3 
Exploratory Objective:  
 To perform secondary laboratory assessments that may include evaluation of factors 
related to HIV infection, hepatitis infection, or STIs; ARV drug use; characterization of 
HIV in infected participants, including phylogenetic analysis; evaluation of the host 
response to infection; and evaluation of laboratory assays and methods related to the 
study objectives. 
 To explore participant attitudes towards and experiences with PrEP by conducting in-
depth interviews (IDIs) and focus group discussions (FGDs). 
 
2.4 
Study Design 
This is an observational cohort study of approximately 400 MSM - about 100 men at up 
to four clinical research sites (CRSs) in up to four countries in SSA.  The four selected 
sites are: KEMRI/CDC, Kisumu, Kenya, Blantyre CRS, Blantyre, Malawi, Soweto 
HPTN CRS, Soweto, SA, Groote Schuur HIV CRS (Desmond Tutu HIV), Cape Town 
SA.  The cohort will be accrued over a 6-month period, with no replacement for 
participants lost during the 52 weeks (12 months) of follow-up. After Screening, there 
will be five study visits (including enrollment and quarterly follow-up visits). Each visit 
will include physical examinations, collection of biological samples, HIV testing, HIV 
risk reduction counseling, behavioral assessments, and assessment of the social impact 
related to the study participation (see Schedule of Study Visits and Procedures, 
Appendices I-III).  A subset of visits will include STI testing.  The study will be 
implemented according to international guidelines for HIV prevention trials (35, 36) and 
for conducting research with MSM in rights-constrained environments (37).  
 
To obtain a diverse sample of high-risk MSM in high-incidence environments, we will 
design recruitment strategies in collaboration with local MSM communities, making use 
of peer outreach, participant-referral, indirect recruitment (outreach via venues and social 
media), and referral through key figures.  
 
HIV testing will take place at the Screening and, Enrollment visits and, for those who are 
HIV-uninfected at Enrollment, at each of four quarterly visits. In all cases, acquisition of 
HIV infection after Screening will be based on HIV test results obtained on specimens 
collected on two different dates. For participants who are HIV-uninfected at Screening, 
but have a reactive or positive HIV test result at Enrollment or a follow-up visit, the 
second specimen should be collected ideally 2-3 weeks after an initial positive HIV test 
result. If HIV infection is confirmed at the HIV confirmation visit, participants will be 
referred for culturally-competent HIV treatment and care as per national guidelines 
(either on site [external to the study] or elsewhere).  
 
Enrollment of HIV-infected MSM will be capped at 20 per site. These men will be 
maintained in the cohort to assess study retention and to evaluate their engagement in 
HIV care. Participant accrual will be monitored to ensure that no more than 20 HIV-
infected participants are enrolled at each study site. Any additional individuals who have 
one or more reactive/positive HIV test at the Screening visit will be referred for 

 
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culturally-competent HIV treatment and care as per national guidelines. All enrolled men 
who are HIV-infected at Screening or acquire HIV infection after the screening visit will 
have CD4 cell count and HIV viral load testing.  Uptake of care by HIV-infected men 
will be assessed.  HIV-infected men who are already on ART or in care are not eligible 
for enrollment; baseline data on these men will be collected at Screening, even though 
they will not be enrolled.  
 
At Enrollment, all men will have a medical history assessment and complete physical 
examination.  In addition to HIV testing, laboratory testing will include hematology and 
chemistry testing, HBV testing, and STI testing.  STI testing will include testing urine as 
well as rectal and pharyngeal swabs. Referral for appropriate care and treatment will be 
provided as needed.  Also, plasma will be stored for quality assurance (QA) testing and 
other assessments.  Urine will be stored for substance use testing (if permitted by local 
IRBs). 
 
At Screening, Enrollment and subsequent study visits, data will be collected to 1) identify 
barriers and facilitators to study participation, factors that promote study retention, and 
potential social harms and benefits from study participation; 2) evaluate participants’ 
experience of participating in a cohort study and involvement in biomedical and 
behavioral assessments; 3) identify demographic, behavioral, and socioeconomic factors 
related to: prevalence of HIV infection, newly diagnosed HIV infection, HBV infection, 
and STIs; uptake of standard HIV prevention interventions; accessing HIV- and non-
HIV-related care and treatment; and interest in potential HIV prevention strategies and 
participation in future research; and 4) assess explore feasibility of including female sex 
partners in future studies. The behavioral assessment at Screening, Week 13 and 39 
Visits, will be abbreviated and only include a selection of the concepts listed above.  
 
At each visit, all men will be offered a package of clinical and standard-of-care (SOC) 
services as part of their involvement in the study.  This will include HIV risk-reduction 
counseling, and provision of condoms and water-based lubrication (both approved 
according to guidelines from the World Health Organization (WHO)).  In addition to the 
clinic visits, there will be monthly off-site peer-education visits for willing study 
participants to promote retention and elicit timely feedback regarding study 
implementation.   
 
Men who indicate that they wish to withdraw from the study will be asked to complete a 
short assessment survey to assess their reasons for no longer participating in the study. 
Men who do not return for follow-up visits will be contacted to remind them of missed 
visits. 
 
Implementation of the study will be preceded by site preparation and community 
consultation using a standardized framework (37) to ensure readiness for the culturally-
appropriate conduct of the study and availability of culturally-competent care for men 
who are identified as HIV-infected at enrollment or during the study.  Study staff will 
document and evaluate implementation of activities to prepare study sites to optimally 
engage MSM will be documented and evaluated. Ongoing community engagement, 
which is of critical importance for research with this population in SSA settings, will be 
arranged through a Community Advisory Board (CAB) and a Protocol Advisory 

 
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15 November 2016 
Committee (PAC) at each site.  The PAC will consist of members most familiar with 
MSM issues and other members of the MSM community and assist researchers in 
protocol-specific matters such as education and communication materials, appropriate 
study materials, and may provide feedback on proposed study procedures. The CAB will 
advise on general matters. 
 
2.5 
Study Design for Qualitative component 
One time semi-structured in-depth interviews (IDIs) and focus group discussions (FGDs) 
will be conducted with participants at all four HPTN 075 sites. The IDIs are designed to 
gather detailed information on participant experiences with and perceptions of PrEP, 
whereas the FGDs will be used to better understand the context and social climate around 
PrEP in each location.  
 
The qualitative component will assess: 
 Knowledge of PrEP and perceptions of the benefits and concerns about the use of 
PrEP; 
 Product characteristics (e.g., perceived efficacy, attitudes towards injections); 
 Social risks (e.g., receiving HIV medication in a context of high HIV prevalence, 
being misperceived as being HIV positive); 
 Trust in the health care system (in general or specifically in relation to being 
MSM, whether or not related to actual experiences, preference for traditional 
instead of Western medicine); 
 Pragmatic obstacles (e.g., transportation, costs, personal inconvenience); 
 Study design concerns or misunderstandings (e.g. use of placebo control, double‐
blinding, possibility of not getting the real treatment). 
2.5.1 In-Depth Interviews 
IDIs will generate an understanding of PrEP and PrEP use from a more personal 
perspective. Twenty IDIs will be conducted with HPTN 075 participants. 
Demographic information will be collected from participants (e.g., race, age, income, sex, 
education). 
2.5.2 Focus Group Discussions 
Participants from each site will be invited to participate in two FGDs (per site) to explore 
perceptions and experiences around the use of PrEP. Each FGD will be comprised of 5 
participants, one group with men between 18 and 25 years old and one group with men 
older than 25 years. Efforts will be made to include FGD participants representative of 
the diverse range of sites participating in the parent study.  
 
 

 
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3.0 STUDY POPULATION 
The study population will consist of approximately 400 MSM between the ages of 18-44 
years old who report having had anal sex with a man at least once in the past 3 months, 
who are living in SSA, and who are eligible based on the inclusion and exclusion criteria 
listed below. The upper age limit has been chosen to ensure an inclusive assessment of 
SSA MSM.  
 
Site recruitment efforts will ensure that the sample will predominantly be black/African. 
Both HIV-infected and HIV-uninfected men will be enrolled; however, there will be a 
cap on the number of HIV-infected men.  At each site, no more than 20 of the 
participants will be HIV-infected at Enrollment.   
 
3.1 
Inclusion Criteria 
 
Men must meet all of the following criteria to be eligible for inclusion in this study: 
 
Biologically male at birth, according to self-report;  
 
18-44 years old (inclusive); 
 
Willing and able to provide informed consent; 
 
Willing to undergo HIV testing throughout the study and to receive those test results; 
 
Reporting at least one act of anal intercourse in the previous 3 months (12 weeks) with a 
person reported by the participant to be biologically male;  
 
Able to provide complete locator identification for themselves and at least two other personal 
contacts;  
 
Willing to participate in all scheduled study assessments, including specimen collection, 
laboratory assessments, and sample storage;  
 
Committing to not participate in any HIV intervention or vaccine study while participating in 
HPTN 075; 
 
Planning to remain in the study area for at least one year; 
 
For HIV-uninfected men: All HIV test results at the Screening visit must be non-
reactive/negative; 
 
For HIV-infected men: All HIV test results at the Screening visit must be reactive/positive. 
 
Men who are already on PrEP will not be excluded. Additionally, self- or other-identified 
transgender women and male sex workers will not be excluded.  There will, however, be 
no specific effort to recruit these groups.   

 
HPTN 075, Protocol Version 3.0 Page 23 of 73 
15 November 2016 
3.2 
Exclusion Criteria 
Men who meet any of the following criteria will be excluded from this study: 
 
Unwilling to adhere to study procedures; 
 
Past or current participation in a biomedical and/or behavioral HIV/STI 
intervention or cohort study, including HIV vaccine studies; however, 
participation in local/area PrEP demonstration projects does not preclude 
participation in HPTN 075; 
 
HIV-infected men who report that they are already on ART or in HIV care; 
 Any other reason or condition that in the opinion of the Investigator of Record 
(IOR) would interfere with participation, complicate interpretation of study 
outcome data, or otherwise interfere with achieving the study objectives. 
 
Men who have discordant HIV test results at Screening (i.e., at least one reactive or 
positive result and at least one non-reactive or negative result). These men will 
receive HIV counseling and will be referred for further diagnostic tests and care. 
 
3.3 
Recruitment Process 
Each study site will be responsible for enrolling approximately 100 MSM.  
Recruitment procedures will be site-specific because 1) it allows for the 
development of strategies in consultation with community; 2) it allows for 
customization to local circumstances; and 3) it makes it easier to adjust strategies 
if recruitment outcomes lag at specific sites. It is our aim to recruit diverse 
samples that do not necessarily have to be representative for the MSM population.  
The primary aim is to recruit a cohort of high-risk black/African MSM who 
would be likely to participate in future intervention studies. That participants are 
high-risk is safeguarded by the selection criteria and screening process. We expect 
most recruitment efforts to take place in urban contexts; developing strategies in 
consultation with local communities will allow adaptation of strategies to rural 
circumstances if needed. 
 
Sites will develop, in consultation with the community and after collaboratively 
mapping of the variety of MSM expressions in the community, site-specific 
strategies for the promotion of study awareness and acceptability in the 
community, and for recruitment, making use of the following strategies: 
1) Peer outreach: MSM hired and trained as peer outreach workers to approach 
MSM based on their personal connections to and knowledge of the MSM 
population; 
2) Participant referral: eligible participants will be asked to refer their friends to 
participate in the study;  
3) Indirect recruitment: distribution of announcements via actual and virtual “gay” 
venues and events; 
4) Key figures referral: trusted persons with access to MSM networks who can 
distribute study information and encourage MSM to participate. 
 

 
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15 November 2016 
The details of site-specific strategies for the promotion of study awareness and 
acceptability in the community, and for recruitment are included in the SSP 
Manual.  
 
There is little information available to inform an expected screening to enrollment 
ratio. Data from the Cape Town site of the Global iPrEx study showed that a large 
number of men were initially engaged, followed by a pre-screening protocol that 
screened out HIV-infected individuals. Of the initial 629 MSM engaged at 
community level, 20% were finally screened, with a screening to enrollment ratio 
of 1.4:1. Experiences from protocol team members in Africa suggest that about 
50% of the people who are eligible as MSM do not enroll in cohorts. 
 
In relation to the primary objective of this study, we will explore whether the MSM that 
are recruited for this study represent the MSM present in the various communities, or 
whether the cohort of recruited men is biased/selective. This will be assessed through 
ongoing interactions with local communities. As part of the development of the 
recruitment strategies, community representatives will be asked to identify the various 
MSM groups present in the community. Their projections will be used to collaboratively 
review recruitment outcomes.  
3.4 
Co-Enrollment Guidelines 
Men participating in other biomedical and/or behavioral HIV/STI intervention or cohort 
studies will not be eligible for enrollment in HPTN 075; this includes both past and 
current participation in an HIV vaccine study.  In addition, co-enrollment in one or more 
vaccine or device study during the HPTN 075 study will not be permitted and men must 
agree not to enroll in these types of studies while they are participating in HPTN 075. 
However, men may enroll and participate in local PrEP demonstration projects, as it 
would be unethical for HPTN 075 to disallow men from obtaining PrEP in this way. 
 
3.5 
Compensation 
Participants will receive compensation for their time and transportation costs. The exact 
amount might vary per study site and will be determined in consultation with local IRBs 
to ensure that they encourage participation without being coercive. 
 
3.6 
Participant Retention 
Once a participant enrolls in HPTN 075, study staff will make every effort to retain him 
for 52 weeks of follow-up to minimize possible bias associated with loss-to-follow-up.   
Study staff are responsible for developing and implementing local standard operating 
procedures to achieve this goal.  
Retention will be promoted by building trust in the study through the involvement of the 
study community at large before the implementation of the study (38-41) (see also 

 
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15 November 2016 
Section 9). This communication with the community will be ongoing during the study to 
explain the purpose of HIV prevention research and the importance of completing 
research study visits, and to increase awareness about HIV/AIDS more generally. 
On the level of the participant, standard procedures will include: 
 Thorough explanation of the study visit schedule and procedural requirements during the 
informed consent process and re-emphasis at each study visit; 
 Thorough explanation of the importance of individual participation to the overall success 
of the study; 
 Collection of detailed locator information at the study Screening Visit, and active review 
and updating of this information at each subsequent visit; 
 Use of appropriate and timely visit-reminder mechanisms, making use of all available 
contact mechanisms and channels, such as cell phones and short message system (SMS) 
technology; 
 Immediate and multifaceted follow-up on missed visits;  
 
Additionally, retention will be promoted by measures that have proven to be successful in 
other studies and include: emphasizing benefits of participation (e.g., education about 
HIV prevention, provision of condoms and lubrication, treatment of STI if needed), 
providing incentives (and timely payment thereof) and instrumental support, and giving 
control to participants about how and when they are contacted for study participation. 
Structural measures that will promote retention include: maintaining between-assessment 
contacts through monthly off-site peer-education visits for willing study participants, 
fostering supportive staff attitudes (e.g., being respectful, patient yet persistent, flexible) 
resulting in rewarding relationships, establishing a project identity to be developed in 
collaboration with CAB and PAC, maintaining clinical staff and preventing turnover, and 
having a toll-free phone number to participants to increase accessibility to the project. 
 
3.7 
Participant Withdrawal 
Regardless of the participant retention methods described above, participants may 
voluntarily withdraw from the study for any reason at any time.  Should a participant 
indicate that he would like to withdraw, study staff will ask him if he will agree to 
complete a short assessment survey characterizing reasons for withdrawal. 
The IOR also may withdraw participants from the study in order to protect their safety 
and/or if they are unwilling or unable to comply with required study procedures after 
consultation with the Protocol Chair, DAIDS Medical Officer, Statistical and Data 
Management Center (SDMC) Protocol Statistician, and Leadership and Operations 
Center (LOC) Clinical Research Manager (CRM).  
Participants also may be withdrawn if the study sponsor, government or regulatory 
authorities, or site IRBs/ECs terminate the study prior to its planned end date. 

 
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15 November 2016 
Participants who decide to withdraw from the study prior to the Week 52 Visit will be 
asked if they will complete a final evaluation performing the procedures that would have 
been completed at Week 52, but will not be required to do so.  Additionally, study staff 
will record the reason(s) for all withdrawals from the study in participants’ study records 
(regardless of whether participants fill out the short questionnaire) to further understand 
reasons for withdrawal. 
4.0 STUDY POPULATION AND SAMPLING FOR QUALITATIVE 
COMPONENT 
A heterogeneous sample will be used to collect information that is representative of the 
range of experiences, perspectives, and behaviors exhibited throughout the course of the 
study at the various sites involved.  
4.1 
Study Population for IDIs 
At all four sites, IDIs will be conducted with twenty participants per site.  
 
4.1.1 Inclusion Criteria for IDIs 
 Study participants for the qualitative component will be: 
 
Participants who have completed the Week 26 assessment of the parent 
HPTN 075 study,  
 
MSM from the community 
 Having an HIV-negative serostatus. 
 Able and willing to provide informed consent.  
 Able and willing to participate in an hour-long interview. 
 Willing to allow the in-depth interview to be recorded. 
4.1.2 Exclusion Criteria for IDIs 
 Any condition that, in the opinion of the study staff, would make participation in 
the study harmful to the participant, complicate interpretation of study data, or 
otherwise interfere with achieving study objectives, including evidence of altered 
mentality, inebriation, or substance abuse. 
4.2 
Study Population for FGDs 
Each site will conduct two FGDs with five participants per FGD, one group with men 
between 18 and 25 years old and one group with men older than 25 years. 
4.2.1 Inclusion Criteria for FGD 
 Study participants for the qualitative component will be: 
 
Participants who have completed the Week 26 assessment of the parent 
HPTN 075 study,  

 
HPTN 075, Protocol Version 3.0 Page 27 of 73 
15 November 2016 
 
MSM from the community 
 Having an HIV-negative serostatus. 
 Able and willing to provide informed consent. 
 Able and willing to participate in a focus group discussion approximately two 
hours long. 
 Willing to allow the focus group discussion to be recorded. 
4.2.2 Exclusion Criteria for FGD 
 Any condition that, in the opinion of the study staff, would make participation in 
the study harmful to the participant, complicate interpretation of study data, or 
otherwise interfere with achieving study objectives, including evidence of altered 
mentality, inebriation, or substance abuse. 
 
5.0 STUDY PROCEDURES 
An overview of the study visit and procedures schedule is included in Appendices I-III. 
Presented below is additional information for visit-specific study procedures.  Detailed 
instructions to guide and standardize all study procedures across sites will be provided in 
the SSP Manual. 
Visits will take place at Screening, Enrollment, and at Weeks 13, 26, 39 and 52.  
Screening will include administrative procedures, collection of biological samples, and 
HIV testing.  A subset of visits will include STI testing.  Enrollment and the Week 13, 
26, 39 and 52 Visits will include structured behavioral assessments, HIV risk reduction 
counseling, assessment of social impact, collection of biological samples, HIV testing, 
and medical examinations.  ART adherence assessment and counseling will be provided 
as appropriate.  Visit duration is approximately two hours for Enrollment, Week 26 and 
Week 52 Visits.  The Week 13 and Week 39 Visits involve an abbreviated behavioral 
assessment and are expected to last approximately 90 minutes.  
 
5.1 
Screening Visit 
All participants must provide written informed consent for screening before completing 
any other procedures.  Men who are eligible but who do not consent to screening will be 
asked about their reasoning to understand motivations; these reasons will be documented 
without linking it to any personal information. 
 
The following activities will occur during the Screening Visit: 
 
Administrative and Counseling Procedures 
 Obtain informed consent 
 Collect locator information 
 Provide HIV risk reduction counseling 
 Provide condoms and lubricant 

 
HPTN 075, Protocol Version 3.0 Page 28 of 73 
15 November 2016 
 Brief behavioral assessment, including eligibility criteria and risk factors for 
social impact 
 
Clinical Procedures 
 Blood collection 
 HIV rapid testing  
 
Laboratory Procedures 
 Analyses to be performed on blood sample 
o HIV testing (see SSP Manual) 
 Plasma storage (for those who opt in). 
 
Screening will be completed for all participants to be able to assess eligibility. HIV 
counseling and testing will be offered to everyone who consents to screening.  Sites will 
follow the HIV testing algorithm included in the SSP Manual.   
 
HIV-infected: Up to a total of 20 men enrolled at any one site may be HIV-infected.  
Once that cap is reached, men who have reactive HIV rapid tests during Screening will be 
provided HIV counseling and referred for culturally appropriate HIV care.  
 
If screening indicates that an individual is eligible for the study and is interested in 
enrolling in the study, the individual will be asked to return for an Enrollment visit. 
Those who are not eligible will be informed that they do not meet the requirements of 
the study and, if necessary, will be referred for appropriate medical care. The 
Screening and Enrollment visits must be on different days. All HIV test results from 
the Screening visit must be available at the time of the Enrollment visit.  There will 
be no more than 30 calendar days between Screening and Enrollment.  
 
Men who have discordant HIV test results at Screening (at least one reactive or 
positive result and at least one non-reactive or negative result) will not be eligible for 
Enrollment. These men will receive HIV counseling and will be referred for further 
diagnostic tests and care. 
 
5.2 
Enrollment Visit 
Individuals who satisfy all Inclusion and Exclusion Criteria may enroll.  Participants 
must be present at the study site for enrollment.  If more than 30 calendar days have 
passed between Screening and Enrollment, men must be re-screened. Participants are 
allowed to rescreen once only. Enrollment into the study will start with consenting 
participants into the cohort. Men who are eligible but who do not consent to 
participate will be asked about their reasoning to understand motivations not to 
participate; these reasons will be documented and combined with information 

 
HPTN 075, Protocol Version 3.0 Page 29 of 73 
15 November 2016 
provided by the participant during Screening. Participants are considered to be 
enrolled in the study after they have consented.  
 
The following activities will occur during the Enrollment Visit: 
 
Administrative and Counseling Procedures 
 Review locator information 
 Collect demographic information 
 Full behavioral assessment 
 Social impact assessment 
 Provide HIV risk reduction counseling 
 Provide condoms and lubricant 
 
Clinical Procedures 
 Complete medical history, including medications taken in the preceding 3 
months  
 Full physical exam 
 Blood collection 
 Urine collection 
 HIV rapid testing   
 Collection of swabs for STI testing (rectal and pharyngeal) 
 Collection of rectal swabs for storage 
 
Laboratory Procedures (Local Laboratory (LL)) 
 Analyses to be performed on blood sample 
o HIV testing (see SSP Manual) 
o CD4 cell count (if classified as HIV infected at Screening) 
o HIV viral load (if classified as HIV infected at Screening) 
o Hematology (CBC with platelets and differential)* 
o Chemistry (creatinine, phosphate, ALT/AST, bilirubin)* 
o Hepatitis B testing (HBsAg, HBsAb, HBcAb)* 
o Syphilis testing 
 Analyses to performed on urine sample 
o Dipstick for protein and glucose* 
o Gonorrhea/Chlamydia (GC/CT) testing 
 Analyses to be performed on swabs 
o GC/CT testing** 
 Plasma storage  
 Urine storage 
 Rectal swab storage  
 

 
HPTN 075, Protocol Version 3.0 Page 30 of 73 
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* These assessments will be performed to evaluate whether men in the cohort would meet 
criteria for participation in a future PrEP study. 
 
** In some cases, GC/CT testing using swabs will be performed at the HPTN Laboratory 
Center (LC) (e.g., if sites do not have the capacity for this testing or do not have validated 
assays for one or more of the specimen types). 
 
5.3 
Follow-up Visits (Weeks 13 and 39) 
The following procedures will occur during follow-up visits at Weeks 13 and 39: 
 
Administrative and Counseling Procedures 
 Review locator information 
 Abbreviated behavioral assessment 
 Social impact assessment 
 ART adherence assessment and counseling, as appropriate 
 HIV risk reduction counseling 
 Condoms and lubricant provision 
 
Clinical Procedures 
 Interim medical history, including medications 
 Symptom-directed physical exam 
 Blood collection 
 HIV rapid testing  (not required if HIV-infection was confirmed at a 
previous visit, see SSP Manual) 
 
Laboratory Procedures (LL) 
 Analyses to be performed on blood sample 
o HIV testing (not required if HIV-infection was confirmed at a previous 
visit, see SSP Manual) 
 Plasma storage  
 
* In week 13, a participant who tested hepatitis B negative at Enrollment and would like 
to be vaccinated will be referred to an appropriate clinic. 
 
5.4 
Follow-up Visits (Weeks 26 and 52/Exit) 
The following procedures will occur during follow-up visits at Weeks 26 and 52/Exit: 

 
HPTN 075, Protocol Version 3.0 Page 31 of 73 
15 November 2016 
 
Administrative and Counseling Procedures 
 Review locator information 
 Full behavioral assessment  
 Social impact assessment 
 ART adherence assessment and counseling, as appropriate 
 HIV risk reduction counseling 
 Condoms and lubricant provision 
Clinical Procedures 
 Interim medical history, including medications 
 Symptom-directed physical exam 
 Blood collection 
 Urine collection  
 HIV rapid testing  (not required if HIV infection confirmed at a previous 
visit, see SSP Manual) 
 Collection of swabs for STI testing (rectal and pharyngeal) – Week 52 
Visit only  
 
Laboratory Procedures (LL) 
 Analyses to be performed on blood sample 
o HIV testing (not required if HIV-infection was confirmed at a previous 
visit, see SSP Manual) 
o CD4 cell count (if any HIV test is reactive/positive) 
o Syphilis testing  
 Analyses to performed on urine sample 
o GC/CT testing  
 Analyses to performed on swabs – Week 52 Visit only 
o GC/CT testing*  
 Plasma storage 
 Urine storage  
 
* In some cases, GC/CT testing using swabs will be performed at the HPTN Laboratory 
Center (LC) (e.g., if sites do not have the capacity for this testing or do not have validated 
assays for one or more of the specimen types). 
 
5.5 
HIV Confirmation Visit 
Additional procedures are required for men who were HIV-uninfected at Screening and 
have a reactive or positive HIV test at Enrollment or at a follow-up visit.  These 
procedures must be performed on a separate date (see Appendix II). 

 
HPTN 075, Protocol Version 3.0 Page 32 of 73 
15 November 2016 
 
Clinical Procedures 
 Blood collection 
 
Laboratory Procedures (LL) 
 Analyses to be performed on blood sample 
o HIV testing (see SSP Manual) 
o CD4 cell count  
o HIV viral load 
 Plasma storage  
 
All participants with confirmed HIV infection will be referred for culturally-competent 
HIV treatment and care as per national guidelines. The continuum of care (including 
linkage/uptake, retention, and adherence) by HIV-infected men will be assessed.  
 
Note: If a participant has signs or symptoms consistent with acute HIV infection, testing 
will be performed using an HIV RNA test (see Appendix III).  Regardless of whether 
HIV RNA testing is used for diagnostic testing, HIV infection must be confirmed in all 
cases using two independent samples collected on different days. 
 
5.6 
Behavioral Assessment 
Behavioral assessments will be conducted at Screening, Enrollment, Week 13, Week 26, 
Week 39, and Week 52. The length of the assessment as well as the specific content 
varies with the assessment moment (e.g., sexual history will only be assessed at 
Enrollment). The assessment at Screening will focus on basic behavioral characteristics 
and eligibility criteria. Assessment at Week 13 and Week 39 will be abbreviated and 
focus on sexual risk practices. 
 
The behavioral assessment instruments will assess: 1) barriers and facilitators to study 
participation; 2) factors that promote study retention; 3) social harms and benefits from 
study participation; 4) evaluation of cohort participation experience (including 
involvement in biomedical and behavioral assessments); 5) uptake of standard HIV 
prevention interventions; 6) accessing HIV- and non-HIV-related care and treatment; 7) 
interest in potential HIV prevention strategies and participation in future research; and 8) 
demographic, behavioral, and socioeconomic characteristics. The last group of concepts 
includes:  
 
Demographics (e.g., age, education, employment status, income);  
 
Psychosexual characteristics (e.g. sexual and gender identification, preference for 
specific roles in sex, internalized homophobia; sexual practices (e.g., sexual partners, 
number of acts of receptive and insertive anal intercourse, status of partners, use of 
condoms and lubrication, sex under the influence);  
 
Sexual history (e.g., Sexual abuse, forced sex, transactional sex/sex work; 
 
HIV/STI related factors (e.g., perceived HIV risk, testing history, knowledge of STI 

 
HPTN 075, Protocol Version 3.0 Page 33 of 73 
15 November 2016 
symptoms);  
 
Substance use (e.g., frequency and kind of use, alcohol- or drug use related 
problems);  
 
Experienced stigma and discrimination (homophobia and HIV/AIDS stigma); social 
and sexual networks characteristics;  
 
Gay community cohesion and general social capital;  
 
Access to health care and health seeking practices;  
 
Mental health;  
 
Social desirability.  
In addition, men who report current female sexual partners will be asked about the 
possibility of including female sex partners in future studies. 
 
Information will be collected from study participants using a combination of computer-
assisted personal interviewing (CAPI) and computer-assisted self-interviewing (CASI). 
The latter will be offered to participants for the assessment sensitive behaviors, known to 
be underreported in personal interviews. With illiterate persons and persons who do not 
prefer to use CASI, CAPI will be used for the assessment of sensitive behaviors. Sites 
will document whether CASI or CAPI was used. 
5.7 
Site Recruitment and Retention Monitoring and Reports 
Recruitment strategies and outcomes will be monitored allowing the protocol team, 1) to 
see on a regular basis recruitment progress at the sites; 2) to timely identify recruitment 
problems; and 3) to explore these problems and develop solutions and additional 
recruitment strategies. 
 
Because recruitment strategies are site-specific, each site will document recruitment plans 
and activities, as well as how they evolve during study implementation. Additionally, 
because of the need to understand recruitment outcomes, sites will document recruitment 
outcomes per specific implemented strategy throughout the study period. Sites will also 
document planned and implemented retention procedures.  
 
6.0 STUDY PROCEDURES FOR THE QUALITATIVE COMPONENT 
6.1 
Study Procedures for IDIs 
6.1.1 Recruitment for IDIs 
Recruitment of IDIs for this study will be done by site staff in advance of the interviews. 
During the Week 26 follow-up questionnaire, HPTN 075 participants indicate knowledge 
and interest in PrEP as an HIV prevention intervention. At SCHARP, the HPTN 
Statistical and Data Management Center (SDMC), participant identification numbers 
(PTIDs) will be identified by positive/negative responses to certain questions during the 
Week 26 interview. In terms of interest in PrEP, participants will be selected who have 
no or a limited interest in PrEP, as well as men who have a strong interest in PrEP. Those 

 
HPTN 075, Protocol Version 3.0 Page 34 of 73 
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PTIDs will be sent to designated staff at the respective site, who will recruit potential 
participants by PTID via the contact information they have provided.  
6.1.2 Enrollment for IDIs 
The participant will be consented before the interview takes place or any data are 
collected.  
 
During the interview, participants will receive or undergo the following: 
 Informed Consent  
 Confirmation of their parent study participant ID number (PTID) 
 Interview lasting approximately 60 minutes 
6.1.3 Data Collection for IDIs 
IDIs will be conducted over approximately four to six weeks. All IDIs will be conducted 
in a private room at the participant’s research site.  Interviews will be semi-structured and 
will last approximately 60 minutes. Interviewers will be trained data collectors. 
Interviews will be conducted in the local language, digitally recorded, then transcribed 
and subsequently translated into English.  
 
All participants will receive a monetary incentive for their time and travel, which will 
vary by site. 
6.2 
Study Procedures for FGDs 
6.2.1 Recruitment for FGDs 
Recruitment of FGDs for this study will be done by site staff. During the Week 26 
follow-up questionnaire, HPTN 075 participants indicate knowledge and interest in PrEP 
as an HIV prevention intervention. At SCHARP, the HPTN Statistical and Data 
Management Center (SDMC), participant identification numbers (PTIDs) will be 
identified by positive/negative responses to certain questions during the Week 26 
interview. In terms of interest in PrEP, participants will be selected who have no or a 
limited interest in PrEP, as well as men who have a strong interest in PrEP. Those PTIDs 
will be sent to designated staff at the respective site, who will recruit potential 
participants by PTID via the contact information they have provided. 
6.2.2 Enrollment for FGDs 
FGD participants will be consented prior to the start of the focus group. FGDs will last 
approximately two hours. All FGD participants will receive a monetary incentive for 
their time and travel, which will vary by site.  
6.2.3 Data Collection for FGDs 
FGDs will be conducted within a month after training. All FGDs will be conducted at 
participants’ local research site. One facilitator will lead each FGD; facilitators will be 
trained data collectors. All FGDs will be digitally recorded and transcribed. FGDs will be 
conducted in the local language.  
 

 
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7.0 SAFETY MONITORING AND ADVERSE EVENT REPORTING 
The study team will not collect or report Adverse Events (AEs) because there is no 
biomedical intervention.  However, the team will collect and report all social harms that 
are reported to study staff members, using a study-specific incident report form.  This 
form will query common and MSM-specific social harms such as altered personal 
relationships, forced change in housing, and physical violence.  The form will also 
include space for a written narrative to document additional details of any social harm 
experienced.  All research staff will be trained to properly complete the form.  As a part 
of study training, research staff will also be trained on the provision of referrals to 
counseling and social service support.  Reports of social harms will be reviewed by the 
Protocol Chair, DAIDS Medical Officer, Protocol Biostatistician, SDMC Project 
Manager, and LOC CRM quarterly or more often, if indicated, and reported to the 
medical officer together with any actions that are taken.  Social harms will be 
summarized and reported to appropriate IRB(s) following IRB guidelines.  
 
8.0 STATISTICAL CONSIDERATIONS 
8.1 
Review of Study Design 
This is an observational, prospective cohort study, following approximately 400 MSM in 
SSA.  The primary objective of this study is to assess study retention to inform feasibility 
and power and sample size calculations for future combination HIV prevention studies. 
 
8.2 
Endpoints 
8.2.1 Primary Endpoints 
Primary endpoints are:  
1) Recruitment rate within a 6-month period, overall and by site. 
2) Cumulative retention rate, measured by the percent of participants who remain in the 
study at the end of the one-year (Week 52 Visit) follow-up period, overall and by site.  
We expect a recruitment rate of 90% of each site’s recruitment target within a 6-month 
period and a cumulative retention rate of 95%, which is measured by the percent of 
participants who complete the Week 52 Visit (calculated from the moment of informed 
consent at study enrollment).  
We considered a longer follow-up period than one year, more closely reflecting a full 
scale trial and providing more reliable HIV incidence estimates.  However, the primary 
endpoint can be achieved with a shorter follow-up; HIV incidence is a secondary 

 
HPTN 075, Protocol Version 3.0 Page 36 of 73 
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outcome and increase in reliability of incidence estimates through extension would be 
marginal. 
8.2.2 Secondary Endpoints 
The endpoints associated with relevant secondary objectives are as follows:  
 
Completed study visits over the full course of the study; 
 
Self-reported potential barriers to study participation, including internalized 
homophobia, experienced homophobia, limited social capital, alcohol and drug use 
problems, mental distress; 
 
Self-reported experience of study participation, including experienced intrusiveness 
of biomedical procedures, participation burden, and satisfaction with study 
participation; 
 
Self-reported number and types of positive and negative social impact as experienced 
by participants; 
 
Prevalence of HIV infection and STIs at baseline; 
 
Incidence of HIV infection and STIs during follow-up;   
 
Prevalence of HBV infection at baseline; 
 
Frequency of abnormal chemistry or hematology results that might exclude 
participation in a future PrEP study; 
 
Self-reported uptake of standard of HIV prevention interventions and self-reported 
access to HIV- and non-HIV-related care and treatment; 
 
Self-reported interest in future HIV prevention strategies and participation in future 
HIV intervention trials. 
 
8.2.3 Accrual, Follow-up, and Sample Size 
A total of approximately 400 men who report anal sex with a man in the past 3 months 
(12 weeks), ages 18-44 years, and living in SSA, irrespective of HIV status, will be 
followed (approximately 100 per site); enrollment of participants who are HIV-infected 
at Screening will be capped at a maximum of 20 men per study site.  The total study 
duration in the field is 21 months.   There will be 3 months of implementation 
preparation, 6 months of accrual (3 maximum additional months will be allowed for sites 
who are lagging in enrollment), and 12 months of follow-up. 
 
The primary endpoint is the retention rate (95%) at the end of the one-year (52 week) 
follow-up. Table A shows two-sided 95% confidence intervals (CI) for the true retention 
rate based on various possible observed rates, given the sample size of approximately 100 
men at an individual site and the sample size of approximately 400 MSM at all sites 
combined, respectively.  For example, if the retention rate is observed as moderate as 
75% at a particular site, then the 95% CI for the true retention rate for that site is 67%-
83%. 
 
Table A.95% CIs for the True Retention Rate Given Possibly 
Observed Retention Rates 
N 
Observed  
retention rate 
95% CI for true  
retention rate 

 
HPTN 075, Protocol Version 3.0 Page 37 of 73 
15 November 2016 
 
 
 
 
The 
leading secondary endpoint is the incident HIV infection rate per 100 person-years. Table 
B shows two-sided CI for the true HIV infection rate based on various observed number 
of events and retention rate, assuming that the loss to follow-up occurs uniformly during 
the one-year of follow-up.  For example, if a total number 12 incident HIV infections are 
observed among four sites with a retention rate of 75%, then the 95% CI for the true HIV 
infection rate is 2.2%-7.5%. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8.3 
Data Analysis  
8.3.1 Primary Analyses 
Primary data analysis will be performed on all enrolled participants.  Ideally, each 
enrolled participant shall be followed-up for one full year (Week 52 Visit).  Only those 
who are retained at the end of the year will be considered to have reached the endpoint. 
Primary data analysis will tabulate the number of primary endpoints observed during the 
study, and calculate its percentage of the total enrolled participants. Variance will be 
calculated under binomial distributions.  
100 of individual 
site 
50% 
40%, 60% 
75% 
67%, 83% 
85% 
78%, 91% 
95% 
91%, 99% 
400 of all sites 
combined 
50% 
45%, 55% 
75% 
71%, 79% 
85% 
81%, 88% 
95% 
93%, 97% 
Table B. 95% CIs for the True HIV-infection Rate Given Possibly 
Observed HIV Infection Rates* 
Observed retention 
rate (person-years 
expected) 
Observed 
number 
of events 
(infection 
rate) 
95% CI for true 
incidence rate 
50% (60) 
1 (1.7%) 
0.0%, 9.3% 
75% (70) 
3 (4.3%) 
0.8%, 12.5% 
85% (74) 
5 (6.8%) 
2.2%, 15.8% 
95% (78)  
7 (8.9%) 
3.6%, 18.5%  
50% (240) 
4 (1.7%) 
0.4%, 4.2% 
75% (280) 
12 
(4.3%) 
2.2%, 7.5% 
85% (296) 
20 
(6.8%) 
4.2%, 10.4% 
95% ( 312) 
28 (8.9%) 
 6.0%, 13.0% 
*Assumes that 20% of participants are HIV-infected at 
Enrollment. 

 
HPTN 075, Protocol Version 3.0 Page 38 of 73 
15 November 2016 
 
Primary data analysis also will calculate the Kaplan-Meier estimates of the primary 
endpoint taking into account potential loss-to-follow-up during the study.  Their 
variances will be calculated by Greenwood’s formula.  
 
8.3.2 Secondary Analyses 
Secondary data analyses will be performed to characterize the distribution of secondary 
endpoints and their potentially associated predictors.  Exploratory analyses will first be 
performed on both secondary endpoints and their potential associated risk factors.  Time-to-
event secondary endpoints will be analyzed by the Kaplan-Meier estimates, log-rank tests 
and the Cox proportional hazards model.  Binary secondary endpoints will be analyzed 
by chi-square tests and the logistic regression model. Repeated measurements will be 
analyzed by Generalized Estimating Equation (GEE) methods. 
8.4 
Qualitative Data Analysis 
Data collected during IDIs and FGDs will be analyzed using qualitative content analysis 
methods, and qualitative data analysis software that can support team-based analyses. 
Analysis will proceed through steps of reading, coding, data display, and data reduction.  
8.4.1 Reading 
Data analysis will begin as soon as possible after the IDIs or FGDs are conducted and 
transcribed, then translated interviews are sent from the sites to the data analysis team at 
Columbia University. Transcript text will be read by members of the study team in order 
to (1) become familiar with the content of the IDIs and FGDs; (2) identify text that may 
be unclear; (3) point out areas in which interviewing and transcription techniques could 
be improved; and (4) identify recurrent themes. 
8.4.2 Coding  
Using a standardized iterative process, a codebook will be developed for retrieving text 
for key concepts related to the overall objectives, and applied to the data.  A software 
program will be used to organize all qualitative data and prepare it for analysis. Initially, 
double coding will be completed, in order to uncover any discrepancies. Coding 
discrepancies will be discussed by the analysis team, the codebook revised accordingly, 
and recoding performed when necessary to ensure consistent application of codes. 
8.4.3 Data Display and Reduction 
Once all the transcripts have been coded, textual coding reports will be produced. Data 
display matrices and memos will be developed to examine each code in detail for 
subthemes and patterns across interviews, followed by data reduction tables in order to 
summarize primary themes and subthemes. References to verbatim text will support 
interpretation of thematic relationships and provide additional explanation to patterns 
observed.  
 

 
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8.4.4 Analysis of Additional Participant Data 
Comparison groups will be defined by demographic profiles and site location, based on 
the additional participant data collected. Once themes have been synthesized, thematic 
content will then be compared across these groups to assess similarities and differences in 
responses, and explore trends in perceptions and motivators across  different sites. 
Participants’ qualitative responses will be captured and categorized in Dedoose. Coding 
memos will then be used to incorporate contextual descriptions and explanations.  
 
9.0 ETHICAL CONSIDERATIONS 
Because participants engage in sexual practices that are in varying degrees socially 
unacceptable and possibly legally prohibited, they are vulnerable to discrimination as part 
of or as a consequence of study participation.  Staff at the various sites may have 
judgmental attitudes towards study participants and potentially object to study aims and 
engagement of MSM, for example for religious reasons.  Identification of men 
participating in the study as “gay” or “MSM” could result in social sanctions including 
targeted violence (e.g., “gay bashing”) or arrest; a mob attack on a research clinic (Kilifi, 
Kenya) has been documented. Beyond standard procedures to protect study participants 
and staff, and to secure data safety, the following measures will be taken. 
 
 
Study sites will be assessed in terms of readiness of conducting the study and treating 
participants in a culturally competent way; all study staff will receive training to interact 
with study participants in a non-judgmental, MSM-affirming way before the start of the 
study. 
 
There will be an ongoing, dynamic engagement with the MSM community and the 
broader general community, starting before study implementation.   
 
The community will be involved in the study through 1) a CAB, consisting of community 
representatives, including government administrators (e.g., area chief, and police officer), 
religious leaders, health care workers, opinion leaders, representation of MSM 
organizations if possible, and, if available, a human rights lawyer; and 2) a PAC 
consisting of members most familiar with MSM issues and members of the MSM 
community.  The CAB will likely advise on general matters, and the PAC will likely 
assist researchers in protocol-specific matters such as education and communication 
materials, appropriate study materials, and may provide feedback on proposed study 
procedures. 
 
Research staff, CAB, and PAC will collectively identify and share with the study team 
concerns and priorities of the communities hosting the research, explore the study’s 
social impact, and may develop responses for addressing any issues.  To facilitate a direct 
response to study participant- and staff-related emergencies, we will install at each site an 
emergency committee of three persons, consisting of study staff, community 
representation and an on-call security firm. 
 
Each study site will develop and implement in collaboration with the protocol team a site-
specific risk mitigation plan. 
 
Some men may be diagnosed with HIV at Screening, at Enrollment or during the course 
of the study.  All HIV-positive participants will receive standard, comprehensive 
counseling and be referred for culturally competent HIV care and treatment.  

 
HPTN 075, Protocol Version 3.0 Page 40 of 73 
15 November 2016 
 
It is possible that some HPTN 075 participants may also want to join a PrEP 
demonstration project, as these have been rolled out at most of the sites. It would be 
unethical to restrict enrollment to just HPTN 075, in this case. Individual use of PrEP will 
be documented throughout the study.   
 
The sustainability of the services offered to study participants is limited to the study 
duration. It is expected that an increase in cultural competence in servicing MSM is an 
added, sustainable outcome of this study.  We will work with the host-country Ministry 
of Health (MOH) and PEPFAR-supported programs, as appropriate, to increase the 
likelihood of continuity of MSM-affirming services in the study communities. 
 
10.0 
HUMAN SUBJECTS CONSIDERATIONS 
10.1 Ethical Review 
This protocol and the template informed consent forms contained in Appendix IV and V 
— and any subsequent modifications — have been reviewed and approved by the HPTN 
Scientific Review Committee (SRC) and DAIDS Prevention Science Review Committee 
(PSRC) with respect to scientific content and compliance with applicable research and 
human subjects regulations.  
The protocol, site-specific informed consent form, participant education and recruitment 
materials, and other requested documents — and any subsequent modifications — also 
will be reviewed and approved by the ethical review bodies responsible for oversight of 
research conducted at the study site.  
Subsequent to initial review and approval, the responsible IRBs/Ethics Committee (ECs) 
will review the protocol at least annually.  The Investigator will make safety and progress 
reports to the IRBs/ECs at least annually, and within three months of study termination or 
completion.  These reports will include the total number of participants enrolled in the 
study, the number of participants who completed the study, all changes in the research 
activity, and all unanticipated problems involving risks to human subjects or others.  
Study sites will submit documentation of continuing review to the DAIDS Protocol 
Registration Office (PRO), in accordance with the current DAIDS Protocol Registration 
Policy and Procedure Manual. 
 
10.2 Informed Consent 
Written informed consent will be obtained from each study participant.  Each study site is 
responsible for developing a study informed consent form for local use, based on the 
template in Appendix IV and V, which describes the purpose of the study, the procedures 
to be followed, and the risks and benefits of participation, in accordance with all 
applicable regulations.  The study site also is responsible for translating the template form 

 
HPTN 075, Protocol Version 3.0 Page 41 of 73 
15 November 2016 
into local languages, and verifying the accuracy of the translation by performing an 
independent back-translation. 
Literate participants will document their provision of informed consent by signing their 
informed consent forms. Non-literate participants will be asked to document their 
informed consent by marking their informed consent forms (e.g., with an X, thumbprint, 
or other mark) in the presence of a literate third party witness.  (Further details regarding 
DAIDS requirements for documenting the informed consent process with both literate 
and non-literate participants are provided in the DAIDS Standard Operating Procedure 
for Source Documentation.)  Any other local IRB/EC requirements for obtaining 
informed consent from non-literate persons also will be followed.  
Participants will be provided with a copy of their informed consent forms if they are 
willing to receive them.   
10.3 Risks 
Sensitive questions 
The questions we will ask participants about their sexual behavior or drug use may make 
them feel uncomfortable.   
 
Phlebotomy  
Phlebotomy may lead to discomfort, feelings of dizziness or faintness, and/or bruising, 
swelling and/or infection.   
 
HIV Testing Stress 
Participants may become embarrassed, worried, or anxious when completing their HIV 
risk assessment and/or receiving HIV counseling.  They also may become worried or 
anxious while waiting for their HIV test results.  Trained counselors will be available to 
help participants deal with these feelings. 
 
Confidentiality and Discrimination 
Although study sites make every effort to protect participant privacy and confidentiality, 
it is possible that participants' involvement in the study could become known to others, 
and that social harms may result.  For example, participants could be treated unfairly or 
discriminated against, encounter violence, or could have problems being accepted by 
their families and/or communities. Outsiders might think that men are infected with HIV 
or are at high risk for infection with HIV, which could result in having trouble finding or 
keeping a job.   
 
10.4 Benefits 
There may be no direct benefits to participants in this study, however, participants and 
others may benefit in the future from information learned from this study.  Specifically, 

 
HPTN 075, Protocol Version 3.0 Page 42 of 73 
15 November 2016 
information learned in this study may lead to the development of a safe and effective 
intervention that prevents HIV infection.   
In addition, men will receive HIV counseling and testing as part of the study screening 
process, condoms and lubricant (both approved according to WHO guidelines), as well as 
physical exams.  Men enrolled into the study will also be screened for a number of STIs 
and hepatitis B virus infection and referred for care and treatment, as appropriate. 
Participant who are hepatitis B negative and would like to be vaccinated will be referred 
to an appropriate clinic. HIV-infected participants will receive ART adherence 
counseling. 
 
10.5 Incentives 
Pending IRB/EC approval, participants will be compensated for their time and effort in 
this study, and/or be reimbursed for travel to study visits and time away from work.  Site-
specific reimbursement amounts will be specified in the study informed consent forms.  
 
10.6 Confidentiality 
All study-related information will be stored securely at the study site.  All participant 
information will be stored in locked file cabinets in areas with access limited to study 
staff.  All laboratory specimens, reports, study data collection, process, and 
administrative forms will be identified by a coded number only to maintain participant 
confidentiality.  All local databases will be secured with password-protected access 
systems.  Forms, lists, logbooks, appointment books, and any other listings that link 
participant ID numbers to other identifying information will be stored in a separate, 
locked file in an area with limited access. 
Participant’s study information will not be released without the written permission of the 
participant, except as necessary for monitoring by the NIAID and/or its contractors; 
representatives of the HPTN LOC, SDMC, and/or LC; other government and regulatory 
authorities, and/or site IRBs/ECs.   
 
10.7 Communicable Disease Reporting Requirements 
Study staff will comply with all applicable local requirements to report communicable 
diseases identified among study participants to local health authorities.  Participants will 
be made aware of all reporting requirements during the study informed consent process. 
 

 
HPTN 075, Protocol Version 3.0 Page 43 of 73 
15 November 2016 
10.8 Study Discontinuation 
The study may be discontinued at any time by NIAID, the HPTN, other government or 
regulatory authorities, and/or site IRBs/ECs.   
 
11.0  LABORATORY SPECIMENS AND BIOHAZARD CONTAINMENT 
11.1 Local Laboratory Specimens 
As described in Section 5, specimens will be collected for the following tests at the LL:   
 HIV testing (see SSP Manual) 
 CD4 cell count testing 
 HIV viral load 
 Hematology testing (CBC with platelets and differential) 
 Chemistry testing (creatinine, phosphate, ALT/AST, bilirubin) 
 Urine dipstick for protein and glucose 
 HBV serology (HBsAb, HBsAg, HBcAb) 
 Syphilis testing 
 GC/CT testing (urine, rectal swabs, and pharyngeal swabs)* 
 Plasma storage 
 Urine storage for substance use testing 
 Rectal swab storage 
 
* In some cases, GC/CT testing using swabs will be performed at the HPTN LC (e.g., if 
sites do not have the capacity for this testing or do not have validated assays for one or 
more of the specimen types). 
Each study site will adhere to standards of good clinical laboratory practice, and local 
Standard Operating Procedures (SOPs) for specimen management, including proper 
collection, processing, labeling, transport, and storage of specimens to the LL.  Specimen 
collection, testing, and storage at the LL will be documented using the Laboratory Data 
Management System (LDMS) as described in the SSP Manual.   
 
11.2 Laboratory Center Specimens  
As described in Section 5, specimens will be collected for the following testing at the 
HPTN LC: 
 Pharyngeal and rectal swab testing for GC/CT. 
 

 
HPTN 075, Protocol Version 3.0 Page 44 of 73 
15 November 2016 
Retrospective testing: 
 QA for HIV diagnostic testing, including confirmation of HIV 
seroconversion; 
 Other assessments, which may include: HIV incidence testing, HIV resistance 
testing, HIV subtyping, phylogenetic analysis, assessment of HIV super-
infection, characterization of the virus and/or the host response to infection. 
Stored plasma may be tested for the presence of antiretroviral drugs and other 
substances. Stored plasma may also be used for HSV-2 testing; 
 Urine testing for substance use (if permitted); 
 Rectal swab testing for research related to STIs (retrospective, research 
testing). 
 
NOTE: Results of QA and other retrospective testing will not be returned to study sites or 
study participants (with the possible exception of HIV testing, if results differ from 
results obtained at study sites).  At the discretion of the LC, some testing may be 
performed at another institution or at a commercial laboratory, designated by the HPTN 
LC. 
 
11.3 Quality Control and Quality Assurance Procedures 
The study sites will participate in External Quality Assurance (EQA) programs that are 
approved by the HPTN LC.  LC staff will conduct periodic visits to each site to assess the 
implementation of on-site Quality Control (QC) procedures, including proper 
maintenance of laboratory testing equipment and use of appropriate reagents. 
 
The LC will inform site staff of the samples selected for QA testing, and site staff will 
ship the selected specimens to the LC. LC staff will follow-up directly with site staff to 
resolve any problems identified through this process. 
 
11.3.1 QC for HIV Diagnostic Testing 
Before performing HIV diagnostic testing, all sites must validate their testing algorithm, 
and the validation study must be approved by the HPTN LC.  Local laboratories (or 
clinics) will perform testing for HIV diagnosis at Screening, Enrollment, and other 
scheduled visits.  Algorithms for HIV diagnostic testing are provided in the SSP Manual.  
 
Laboratories must participate in an EQA program for HIV testing that is approved by the 
HPTN LC. In addition, the HPTN LC will perform QA for HIV testing. 
 
In addition, if a participant has signs or symptoms consistent with acute HIV infection, 
testing will be performed using an HIV RNA test. Regardless of whether HIV RNA 
testing is used for diagnostic testing, HIV infection must be confirmed in all cases using 
two independent samples collected on different days. 
 

 
HPTN 075, Protocol Version 3.0 Page 45 of 73 
15 November 2016 
11.3.2 QC for CD4 Cell Count Determination 
LLs must be enrolled in the United Kingdom National External Quality Assessment 
Service (UK NEQAS) program through the DAIDS IQA program, with EQA results that 
are deemed satisfactory by the HPTN LC. 
 
11.3.3 QC for HIV Viral Load Determination 
LLs must be enrolled in the Virology Quality Assurance (VQA) program through the 
DAIDS, with EQA results that are deemed satisfactory by the HPTN LC. 
 
11.4 Specimen Storage and Possible Future Research Testing 
Study sites will store all plasma, urine and swab specimens from all enrolled participants 
at least through the end of the study and until all protocol-specified assessments have 
been completed (see Section 11.2 and Appendices I-III). In addition, study participants 
will be asked to provide written informed consent for their specimens to be stored after 
the end of the study for possible future testing; swabs that are sent to the HPTN LC for 
GC/CT testing may also be stored for future testing.  The specimens of participants who 
do not consent to long-term storage and additional testing will be destroyed after all QA 
and protocol-related testing has been performed.  As noted in Section 11.2, results from 
some HPTN LC testing/assessments will not be returned to study sites or study 
participants.  Sites will also store plasma from the subset of men who are screened but 
not enrolled who opt in for sample storage.  
 
11.5 Biohazard Containment 
As the transmission of HIV and other blood-borne pathogens can occur through contact 
with contaminated needles, blood, and blood products, appropriate blood and secretion 
precautions will be employed by all personnel in the drawing of blood and shipping and 
handling of all specimens for this study, as currently recommended by the United States 
Centers for Disease Control and Prevention.  All infectious specimens will be transported 
in accordance with United States regulations (42 CFR 72). 
 
12.0 ADMINISTRATIVE PROCEDURES 
12.1 Protocol Registration 
Prior to implementation of this protocol, and any subsequent full version amendments, 
each site must have the protocol and the protocol consent form(s) approved, as 
appropriate, by their local IRB/ethics committee (EC) and any other applicable regulatory 
entity (RE).  Upon receiving final approval, sites will submit all required protocol 
registration documents to the DAIDS Protocol Registration Office (DAIDS PRO) at the 

 
HPTN 075, Protocol Version 3.0 Page 46 of 73 
15 November 2016 
Regulatory Support Center (RSC).  The DAIDS PRO will review the submitted protocol 
registration packet to ensure that all of the required documents have been received.   
 
Site-specific informed consent forms (ICFs) will not be reviewed and approved by the 
DAIDS PRO. Sites will receive an Initial Registration Notification from the DAIDS PRO 
that indicates successful completion of the protocol registration process.  A copy of the 
Initial Registration Notification should be retained in the site's regulatory files. 
 
12.2 Protocol Amendments 
Upon receiving final IRB/EC and any other applicable RE approval(s) for an 
amendment, sites should implement the amendment immediately.  Sites are required to 
submit an amendment registration packet to the DAIDS PRO at the RSC.  The DAIDS 
PRO will review the submitted protocol registration packet to ensure that all the 
required documents have been received.  Site-specific ICF(s) will not be reviewed and 
approved by the DAIDS PRO, and sites will receive an Amendment Registration 
Notification when the DAIDS PRO receives a complete registration packet.  A copy of 
the final amendment Registration Notification issued by the DAIDS PRO should be 
retained in the site's regulatory files. 
 
For additional information on the protocol registration process and specific documents 
required for initial and amendment registrations, refer to the current version of the 
DAIDS Protocol Registration Manual. 
 
12.3 Study Activation 
Pending successful protocol registration and submission of all required documents, LOC 
staff will “activate” the site to begin study operations. Study implementation may not be 
initiated until a study activation notice is provided to the site. 
 
12.4 Study Coordination 
Study implementation will be directed by this protocol as well as the SSP Manual.  The 
SSP Manual will contain reference copies of the Requirements for Source Documentation 
in DAIDS Funded and/or Sponsored Clinical Trials and will outline procedures for 
conducting study visits; data and forms processing; and other study operations.  
Study case report forms and other study instruments will be developed by the protocol 
team and HPTN SDMC.  Data will be transferred to the HPTN SDMC for data entry, 
cleaning, reporting and analysis.  Quality control reports and queries will be generated 
and distributed to the study sites on a routine schedule for verification and resolution.    

 
HPTN 075, Protocol Version 3.0 Page 47 of 73 
15 November 2016 
Close coordination between protocol team members will be necessary to track study 
progress, respond to queries about proper study implementation, and address other issues 
in a timely manner.  Rates of accrual and retention will be monitored closely by the team 
as well as the HPTN Study Monitoring Committee.  The Protocol Chair, DAIDS Medical 
Officer, Protocol Biostatistician, SDMC Project Manager, and LOC CRM will address 
issues related to study eligibility, documentation, and information-sharing across sites.  
 
12.5 Study Monitoring  
On-site study monitoring will be performed in accordance with DAIDS policies. Study 
monitors will visit the site to: 
 
verify compliance with human subjects and other research regulations and guidelines;  
 
assess adherence to the study protocol, SSP Manual, and local counseling practices; 
and 
 
confirm the quality and accuracy of information collected at the study site and 
entered into the study database.   
 
Site investigators will allow study monitors to inspect study facilities and documentation 
(e.g., informed consent forms, clinic and laboratory records, other source documents, 
case report forms), as well as observe the performance of study procedures.  Investigators 
also will allow inspection of all study-related documentation by authorized 
representatives of the HPTN LOC, SDMC, LC, NIAID, and US and in-country 
government and regulatory authorities.  A site visit log will be maintained at the study 
site to document all visits. 
 
12.6 Protocol Compliance 
The study will be conducted in full compliance with the protocol.  The protocol will not 
be amended without prior written approval by the Protocol Chair and NIAID Medical 
Officer.  All protocol amendments must be submitted to and approved by the relevant 
IRB(s)/EC(s) and the DAIDS RSC prior to implementation. 
 
12.7 Investigator's Records 
The study site IOR will maintain, and store in a secure manner, complete, accurate and 
current study records throughout the study.  The investigator will retain all study records 
for at least three years after submission of the Clinical Trials Unit’s (CTU’s) final 
Financial Status Report to DAIDS, which is due within 90 days after the end of the 
CTU’s cooperative agreement with DAIDS, unless otherwise specified by DAIDS or the 
HPTN LOC.  

 
HPTN 075, Protocol Version 3.0 Page 48 of 73 
15 November 2016 
Study records include administrative documentation — including protocol registration 
documents and all reports and correspondence relating to the study — as well as 
documentation related to each participant screened for and/or enrolled in the study — 
including informed consent forms, locator forms, case report forms, notations of all 
contacts with the participant, and all other source documents. 
12.8 Use of Information and Publications 
Publication of the results of this study will be governed by the HPTN Manual of 
Operations and Policies. Any presentation, abstract, or manuscript will be submitted by 
the Investigator to the HPTN Manuscript Review Committee and DAIDS for review prior 
to submission. 

 
HPTN 075, Protocol Version 3.0 Page 49 of 73 
15 November 2016 
13.0 REFERENCES 
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Global epidemiology of HIV infection in men who have sex with men. Lancet 
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2.Muraguri N, Temmerman M, Geibel S. A decade of research involving men who have 
sex with men in sub-Saharan Africa: Current knowledge and future directions. Sahara J-
Journal of Social Aspects of Hiv-Aids 2012;9(3):137-147. 
3.Beyrer C, World Bank. The global HIV epidemics among men who have sex with men. 
Washington, D.C.: World Bank; 2011. 
4.Beyrer C, Baral SD, Walker D, Wirtz AL, Johns B, Sifakis F. The expanding epidemics 
of HIV Type 1 among men who have sex with men in low- and middle-income countries: 
Diversity and consistency. Epidemiologic Reviews 2010;32(1):137-151. 
5.Imrie J, Hoddinott G, Fuller S, Oliver S, Newell ML. Why MSM in rural South African 
communities should be an HIV prevention research priority. Aids and Behavior 2012. 
6.Baral S, Burrell E, Scheibe A, Brown B, Beyrer C, Bekker L-G. HIV risk and 
associations of HIV infection among men who have sex with men in peri-urban Cape 
Town, South Africa. Bmc Public Health 2011;11(1):766. 
7.Baral S, Sifakis F, Cleghorn F, Beyrer C. Elevated risk for HIV infection among men 
who have sex with men in low- and middle-income countries 2000-2006: a systematic 
review. PLoS Med 2007;4(12):e339. 
8.Burrell E, Mark D, Grant R, Wood R, Bekker LG. Sexual risk behaviours and HIV-1 
prevalence among urban men who have sex with men in Cape Town, South Africa. Sex 
Health 2010;7(2):149-53. 
9.Dahoma M, Johnston LG, Holman A, Miller LA, Mussa M, Othman A, et al. HIV and 
related risk behavior among men who have sex with men in Zanzibar, Tanzania: results 
of a behavioral surveillance survey. AIDS Behav 2011;15(1):186-92. 
10.Lane T, Raymond HF, Dladla S, Rasethe J, Struthers H, McFarland W, et al. High 
HIV prevalence among men who have sex with men in Soweto, South Africa: results 
from the Soweto Men's Study. AIDS Behav 2011;15(3):626-34. 
11.Merrigan M, Azeez A, Afolabi B, Chabikuli ON, Onyekwena O, Eluwa G, et al. HIV 
prevalence and risk behaviours among men having sex with men in Nigeria. Sex Transm 
Infect 2011;87(1):65-70. 
12.Price MA, Rida W, Mwangome M, Mutua G, Middelkoop K, Roux S, et al. 
Identifying at-risk populations in Kenya and South Africa: HIV incidence in cohorts of 
men who report sex with men, sex workers, and youth. J Acquir Immune Defic Syndr 
2012;59(2):185-193. 
13.Rispel LC, Metcalf CA, Cloete A, Reddy V, Lombard C. HIV prevalence and risk 
practices among men who have sex with men in two South African cities. J Acquir 
Immune Defic Syndr 2011;57(1):69-76. 
14.Sanders EJ, Graham SM, Okuku HS, van der Elst EM, Muhaari A, Davies A, et al. 
HIV-1 infection in high risk men who have sex with men in Mombasa, Kenya. Aids 
2007;21(18):2513-2520. 
15.Sanders EJ, Okuku HS, Smith AD, Mwangome M, Wahome E, Fegan G, et al. High 
HIV-1 incidence, correlates of HIV-1 acquisition, and high viral loads following 
seroconversion among MSM. AIDS 2013;27:437-446. 

 
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16.Vuylsteke B, Semde G, Sika L, Crucitti T, Ettiegne Traore V, Buve A, et al. High 
prevalence of HIV and sexually transmitted infections among male sex workers in 
Abidjan, Cote d'Ivoire: need for services tailored to their needs. Sex Transm Infect 
2012;88(4):288-93. 
17.Wade AS, Kane CT, Diallo PAN, Diop AK, Gueye K, Mboup S, et al. HIV infection 
and sexually transmitted infections among men who have sex with men in Senegal. AIDS 
2005;19(18):2133-2140. 
18.Wade AS, Larmarange J, Diop AK, Diop O, Gueye K, Marra A, et al. Reduction in 
risk-taking behaviors among MSM in Senegal between 2004 and 2007 and prevalence of 
HIV and other STIs. ELIHoS Project, ANRS 12139. AIDS Care 2010;22(4):409-14. 
19.Semugoma P, Beyrer C, Baral S. Assessing the effects of anti-homosexuality 
legislation in Uganda on HIV prevention, treatment, and care services. Sahara J-Journal 
of Social Aspects of Hiv-Aids 2012;9(3):173-176. 
20.Human Rights Watch. “Treat Us Like Human Beings”, Discrimination against Sex 
Workers, Sexual and Gender Minorities, and People Who Use Drugs in Tanzania. In: 
Human Rights Watch Report; 2013. 
21.Johnson CA. Off the map. How HIV/AIDS programming is failing same-sex 
practicing people in Africa. New York: International Gay and Lesbian Human Rights 
Commission; 2007. 
22.Baral S, Trapence G, Motimedi F, Umar E, Iipinge S, Dausab F, et al. HIV 
Prevalence, Risks for HIV Infection, and Human Rights among Men Who Have Sex with 
Men (MSM) in Malawi, Namibia, and Botswana. Plos One 2009;4(3):e4997. 
23.Nel JA, Yi H, Sandfort TG, Rich E. HIV-Untested Men Who Have Sex with Men in 
South Africa: The Perception of Not Being at Risk and Fear of Being Tested. Aids and 
Behavior 2013;17(Suppl 1):51-59. 
24.Knox J, Sandfort T, Yi H, Reddy V, Maimane S. Social vulnerability and HIV testing 
among South African men who have sex with men. International Journal of Std & Aids 
2011;22(12):709-713. 
25.Jobson G, de Swardt G, Rebe K, Struthers H, McIntyre J. HIV Risk and Prevention 
Among Men Who Have Sex with Men (MSM) in Peri-Urban Townships in Cape Town, 
South Africa. Aids and Behavior 2013;17(Suppl 1):12-22. 
26.Sandfort T, Yi H, Knox J, Reddy V. Sexual partnership types as determinant of HIV 
Risk in South African MSM: an event-level cluster analysis. Aids and Behavior 
2013;17(Suppl 1):23-32. 
27.Etiebet M, Akolo C, Iwu E, Godwin E, Orazulike I, Blattner M, et al. High HIV-1 
Prevalence, Risk Behaviors, and Viral Loads in MSM Enrolled in a Community-based 
Comprehensive HIV/AIDS Clinic: Nigeria. In: 19th Conference on Retroviruses and 
Opportunistic Infections; 2012; Seattle; 2012. 
28.Sullivan PS, Carballo-Diéguez A, Coates T, Goodreau SM, McGowan I, Sanders EJ, 
et al. Successes and challenges of HIV prevention in men who have sex with men. The 
Lancet 2012;380(9839):388-399. 
29.McIntyre JA, Struthers H. HIV and Men Who Have Sex with Men in South Africa. 
Aids and Behavior 2013;17(Suppl 1):1-3. 
30.Baral S, Adams D, Lebona J, Kaibe B, Letsie P, Tshehlo R, et al. A cross-sectional 
assessment of population demographics, HIV risks and human rights contexts among 
men who have sex with men in Lesotho. Journal of the International Aids Society 
2011;14. 

 
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31.Baral S, Scheibe A, Sullivan P, Trapence G, Lambert A, Bekker L-G, et al. Assessing 
priorities for combination HIV prevention research for men who have sex with men 
(MSM) in Africa. Aids and Behavior 2012:1-10. 
32.Southern African HIV Clinicians Society Consensus Committee. Southern African 
guidelines for the safe use of pre-exposure prophylaxis in men who have sex with men 
who are at risk for HIV infection. Southern African Journal of HIV Medicine 
2012;13:40-55. 
33.Mutua G, Sanders E, Mugo P, Anzala O, Haberer JE, Bangsberg D, et al. Safety and 
adherence to intermittent pre-exposure prophylaxis (PrEP) for HIV-1 in African men who 
have sex with men and female sex workers. Plos One 2012;7(4). 
34.Makofane K, Gueboguo C, Lyons D, Sandfort T. African Aids National Strategic 
Plans inadequately address men who have sex with men. Global Public Health 
2013;8:129-143. 
35.Joint United Nations Programme on HIV/AIDS. Good participatory practice. 
Guidelines for biomedical HIV prevention trials 2011. Geneva: UNAIDS; 2011. 
36.Joint United Nations Programme on HIV/AIDS. Ethical considerations in biomedical 
HIV prevention trials. Geneva: UNAIDS; 2012. 
37.amfAR The Foundation for AIDS Research. Respect, protect, fulfill. Best practices 
guidance in conducting HIV research with gay, bisexual, and other men who have sex 
with men (MSM) in rights-constrained environments; n.d. 
38.Fortune T, Wright E, Juzang I, Bull S. Recruitment, enrollment and retention of young 
black men for HIV prevention research: Experiences from The 411 for Safe Text project. 
Contemporary Clinical Trials 2010;31(2):151-156. 
39.van Loggerenberg F, Mlisana K, Williamson C, Auld SC, Morris L, Gray CM, et al. 
Establishing a cohort at high risk of HIV infection in South Africa: challenges and 
experiences of the CAPRISA 002 acute infection study. Plos One 2008;3(4):e1954. 
40.Yancey AK, Ortega AN, Kumanyika SK. Effective recruitment and retention of 
minority research participants. Annual Review of Public Health 2006;27:1-28. 
41.Robinson KA, Dennison CR, Wayman DM, Pronovost PJ, Needham DM. Systematic 
review identifies number of strategies important for retaining study participants. Journal 
of Clinical Epidemiology 2007;60(8):757-765. 
 
 
 

 
HPTN 075, Protocol Version 3.0 Page 52 of 73 
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14.0 SCHEDULE OF STUDY VISITS AND PROCEDURES 
14.1.1 Appendix I: Schedule of Evaluations and Procedures 
 
Screening 
Enrollment 
Week 13 
Week 26 
Week 39 
Week 
52/Exit 
Administrative and counseling procedures  
Informed consent 
X 
X 
 
 
 
 
Locator information 
X 
 
 
 
 
 
Review locator information 
 
X 
X 
X 
X 
X 
Demographic information 
 
X 
 
 
 
 
Social impact assessment 
 
X 
X 
X 
X 
X 
Abbreviated behavioral assessment 
X 
 
X 
 
X 
 
Full behavioral assessment 
 
X 
 
X 
 
X 
ART adherence assessment & counseling (if applicable) 
 
X 
X 
X 
X 
X 
HIV risk reduction counseling 
X 
X 
X 
X 
X 
X 
Condom and lubricant supply  
X 
X 
X 
X 
X 
X 
Clinical procedures 
Complete medical history including medications 
 
X 
 
 
 
 
Interim medical history including concomitant meds 
 
 
X 
X 
X 
X 
Full physical exam 
 
X 
 
 
 
 
Symptom-directed physical exam 
 
 
X 
X 
X 
X 
Blood collection 
X 
X 
X 
X 
X 
X 
Urine collection  
 
X 
 
X 
 
X 
HIV rapid testing (1) 
X 
X 
X 
X 
X 
X 
Pharyngeal and rectal swab collection for STI testing (2) 
 
X 
 
 
 
X 
Rectal swab collection for storage 
 
X 
 
 
 
 
Laboratory procedures 
HIV testing  (1) 
X 
X 
X 
X 
X 
X 
CD4 cell count (3) 
 
X 
 
X 
 
X 
HIV viral load (4) 
 
X 
 
 
 
 
Hematology (CBC with platelets and differential)  
 
X 
 
 
 
 
Chemistry (creatinine, phosphate, ALT/AST, bilirubin) 
 
X 
 
 
 
 
Urine dipstick for protein and glucose  
 
X 
 
 
 
 
Hepatitis B virus serology (5) 
 
X 
 
 
 
 
Syphilis testing (6) 
 
X 
 
X 
 
X 
Urine testing for GC/CT (2) 
 
X 
 
X 
 
X 
Pharyngeal and rectal swab testing for GC/CT (2) 
 
X 
 
 
 
X 
Plasma storage (7) 
X 
X 
X 
X 
X 
X 
Urine storage (8) 
 
X 
 
X 
 
X 
Rectal swab storage (9) 
 
X 
 
 
 
 
 
(1) The HIV testing algorithm is provided in the Study Specific Procedure (SSP) Manual.  Confirmation of HIV 
acquisition at/after Enrollment requires HIV testing at two different study visits (different days). Additional laboratory 
procedures are required for men who acquire HIV infection during the study (see Appendix II). HIV testing is not 
required after HIV infection is confirmed. 
(2) GC/CT testing will be performed using Nucleic Acid Amplification Tests (NAAT). In some cases, swab testing for 
GC/CT will be performed at the HPTN LC. 
(3) At Enrollment, CD4 cell count testing will only be performed for participants who were classified as HIV-infected at 
Screening. At subsequent visits, CD4 cell count testing will be performed only for men with confirmed HIV infection 

 
HPTN 075, Protocol Version 3.0 Page 53 of 73 
15 November 2016 
(this includes men who were HIV-infected at Enrollment and men who acquire HIV during the study). CD4 cell counts 
will be obtained at multiple visits to provide data related to cross-sectional HIV incidence estimation.  
(4) At Enrollment, HIV viral load testing will only be performed for participants who were classified as HIV-infected at 
the Screening visit. 
(5) HBV testing will include hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), and hepatitis 
B core antibody (HBcAb) tests. This testing will be performed using blood specimens. 
(6) Syphilis testing will be performed using blood specimens according to local standards.  
(7)Stored plasma will be used for Quality Assurance testing and other assessments at the HPTN LC that may include: 
HIV incidence testing, HIV resistance testing, HIV subtyping, phylogenetic analysis, assessment of HIV super-
infection, characterization of the virus and/or the host response to infection. Stored plasma may also be tested for the 
presence of antiretroviral drugs and other substances. Stored plasma may also be tested for HSV-2. These assessments 
will be performed retrospectively; results will not be returned to study sites or participants (with the possible exception 
of HIV diagnostic testing, if results obtained at the HPTN LC differ from site results). Individuals may opt out of 
sample storage at the Screening visit. 
(8)Stored urine will be tested for substance abuse (if permitted by local IRBs). These assessments will be performed 
retrospectively; results will not be returned to study sites or participants. 
(9) Rectal swabs will be stored for possible future testing at the HPTN LC; this may include testing for pathogens such 
as HSV1/2 and HPV. These assessments will be performed retrospectively; results will not be returned to study sites or 
participants. 
 
 
 

 
HPTN 075, Protocol Version 3.0 Page 54 of 73 
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14.1.2 Appendix II: Additional Laboratory Procedures for Men Who Acquire HIV 
Infection During the Study (HIV Confirmation Visit) 
 
 
Confirmation 
of HIV 
infection 
Clinical procedures 
 
Blood collection  
X 
Laboratory procedures 
 
HIV testing (1) 
X 
CD4 cell count  
X 
HIV viral load 
X 
Additional plasma storage (2) 
X 
 
(1) The HIV testing algorithm is provided in the SSP Manual.   
(2) Stored plasma will be used for Quality Assurance testing and other assessments that may include: incidence testing, 
HIV resistance testing, HIV subtyping, phylogenetic analysis, assessment of HIV super-infection, characterization of 
the virus and/or the host response to infection. Stored plasma may also be tested for the presence of antiretroviral drugs 
and other substances. Stored plasma may also be tested for HSV-2. These assessments will be performed 
retrospectively; results will not be returned to study sites or participants (with the possible exception of HIV diagnostic 
testing, if results obtained at the HPTN LC differ from site results). 

 
HPTN 075, Protocol Version 3.0 Page 55 of 73 
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14.1.3 Appendix III: Additional Laboratory Procedures for Men Who Have 
Symptoms of Acute HIV Infection During the Study 
 
 
HIV 
Testing  
Clinical procedures 
 
Blood collection  
X 
Laboratory procedures 
 
HIV RNA testing 
X 
Additional plasma storage (1) 
X 
 
(1) Stored plasma will be used for Quality Assurance testing and other assessments that may include: HIV incidence 
testing, HIV resistance testing, HIV subtyping, phylogenetic analysis, assessment of HIV super-infection, 
characterization of the virus and/or the host response to infection. Stored plasma may also be tested for the presence of 
antiretroviral drugs and other substances. Stored plasma may also be tested for HSV-2. These assessments will be 
performed retrospectively; results will not be returned to study sites or participants (with the possible exception of HIV 
diagnostic testing, if results obtained at the HPTN LC differ from site results). 

 
HPTN 075, Protocol Version 3.0 Page 56 of 73 
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15.0 SAMPLE INFORMED CONSENT FORM  
15.1.1 Appendix IV: Sample Screening Consent Form 
 
HPTN 075: Feasibility of HIV Prevention Cohort Studies among Men who have Sex 
with Men in Sub-Saharan Africa 
 
Protocol Version 3.0 
15 November 2016 
DAIDS Document ID: 11943 
 
Study Implementers: TBD   
 
Study Sponsors: National Institutes of Health (NIH), US National Institute of Allergy 
and Infectious Diseases (NIAID), Division of AIDS (DAIDS) 
 
PRINCIPAL INVESTIGATOR: [Insert Name] 
PHONE:  [Insert Number] 
 
INTRODUCTION 
You are being asked to take part in a screening process to find out if you are eligible to 
take part in the research study named above. The goal of the study is to find out if 
African men who have sex with men are willing to participate in a 1 year-long research 
study. 
 
Before you decide if you want to be a part of this screening, we want you to know about 
the study.  This consent form will give you information about the screening process.  The 
study staff will discuss the screening with you, and you are free to ask any questions.  
After the screening has been fully explained to you, you can decide whether or not you 
want to participate.  This process is called informed consent.  If you decide to participate 
in the screening, you will be asked to sign this consent form or make your mark in front 
of someone.  You will be offered a copy to keep.  
 
What will happen during the Screening visit?  
Screening visit: The first study visit (today) is called the Screening visit.  The Screening 
visit will take about 60-90 minutes and will help us to know if you are eligible to join the 
study.  During this visit, you will be asked questions about your health, sexual practices, 
and personal life to see if you are eligible to participate.  Study staff will ask your name 
and contact information so that we can keep in touch with you during the study.   
 
At this visit, we will draw ~XX mL of blood (about X tablespoons) and your blood will 
be tested for HIV infection. If tests show that you have HIV infection, you may still be 
able to participate and will be referred for counseling. We are inviting HIV positive men 
and HIV negative men to participate in this study, but we are enrolling fewer HIV 
positive men. We will also counsel you about HIV infection and risks you may be taking.  
You will be given condoms and lubrication.  
 

 
HPTN 075, Protocol Version 3.0 Page 57 of 73 
15 November 2016 
The data collected at the Screening visit will be analyzed to learn more about the HIV 
epidemic among men who have sex with men in Africa. 
 
Leftover samples 
Some blood samples will be leftover after the testing for this visit has been completed. 
We will ask you if we may store these samples. If you agree to store your samples but 
change your mind later, you can contact study staff.  We will then destroy your samples. 
Stored samples may be sent to laboratories in the United States for testing. Stored 
samples will not be sold or used for commercial reasons. The samples may be tested for 
drugs used to treat HIV infection or other substances. If you are HIV-infected, the 
samples may also be used to study the HIV virus or your body’s response to HIV 
infection. Some of this work may involve studying how HIV spreads within the 
community. Results from testing stored blood samples will not be returned to the study 
site or you. If you agree to have your samples stored, we will ask you to initial the end of 
this form.   
 
What are your rights as a research participant? 
 Your participation in the screening is entirely voluntary.   
 You may decide not to take part in the screening tests or to leave at any time without 
losing the benefits of your standard medical care or other services.  You will be 
treated the same no matter what you decide. 
 If you decide not to participate in the screening, you cannot participate in this 
research study. 
 Even if you agree to participate in the screening, it does not mean you have agreed to 
participate in the research study.  
 We will tell you about new information from this or other studies that may affect your 
health, welfare or willingness to stay in this study.   
 
What are the risks/discomforts of this screening? 
Taking blood may cause pain and bruising at the place where the blood is taken.  Sometimes, drawing 
blood causes people to feel lightheaded or even faint.  The questions about your sexual activity might 
make you uncomfortable or embarrassed.  Getting an HIV test may cause you anxiety.  
 
We will make every effort to protect your privacy and confidentiality while you are in 
this screening.  However, it is possible that you could have problems if people learn that 
you are here for this screening.  People may think that you are infected with HIV or at 
risk of HIV because of sexual behavior.  If you are infected with HIV, you may have 
problems finding or keeping a job.  Others may treat you unfairly, including your family 
and community.   
 
Are there potential benefits to screening? 
These screening tests may or may not be of direct benefit to you.  If you take part in this 
screening, you will learn information about HIV and your HIV status.  
 
What about confidentiality? 
All efforts will be made to keep your personal information confidential to the extent permitted by law, 
but we cannot promise complete confidentiality.  On your screening records, a code will be used 

 
HPTN 075, Protocol Version 3.0 Page 58 of 73 
15 November 2016 
instead of your name.  Only the study staff will know this code.  The study staff will not give out any 
information that identifies you without your written consent.  However, the clinic’s Ethics Committee 
or Institutional Review Board, NIAID and or its contractors, representatives of the HPTN LOC, 
SDMC, and/or LC, and other government and regulatory authorities may review your screening 
records for study purposes.   
(Insert local requirements for reporting of communicable diseases) 
 
A description of this study will be available on www.ClinicalTrials.gov. This web site will not include 
information that can identify you. At most the web site will include a summary of the results. You 
can search this web site at any time. 
 
What are the costs or payments to you? 
There will be no cost to you for these visits, examinations, laboratory tests or other procedures.  
 
What should you do if you have problems or questions about the screening? 
For questions about this screening or a research-related injury, contact: 
 [Name, physical address, phone number of the investigator or other study staff] 
 
For questions about your rights as a research subject, contact: 
 [Name, title, and contact information of person on the Institutional Review Board (IRB) 
or other organization appropriate for the site] 
 
STATEMENT OF CONSENT 
 
I have read (or someone has read and explained to me) this consent form.  I understand 
the purpose of the screening, the procedures to be followed, and the risks and benefits as 
described in this consent form.  I voluntarily agree to be screened for my potential 
participation in this research study.   
 
 
____________________________________________________________________ 
Participant’s Name (print) Participant’s            Signature or Thumbprint and Date 
 
 
For staff:  I have explained the purpose of the screening to the volunteer and have 
answered all of his/her questions.  To the best of my knowledge, he/she understands the 
purpose, procedures, risks and benefits of this study screening. 
 
___________________________________________________________ 
Study Staff ConductingStudy Staff Signature and Date 
Consent Discussion (print) 
 
 
For witnesses for illiterate volunteers:  I attest that the information contained in this 
written consent form has been read and explained to the participant.  He/she appears to 
understand the purpose, procedures, risks and benefits of the study screening and has 
voluntarily accepted to participate in this screening. 

 
HPTN 075, Protocol Version 3.0 Page 59 of 73 
15 November 2016 
 
For those placing thumbprint only:  I attest that the participant who states that his/her 
name is   _________________________ has placed his/her thumbprint on this consent 
form of his/her own free will on this day _________________. 
 
 
____________________________________________________________ 
Witness’ Name (print)                                      Witness’ Signature and Date 
 
 
Please initial below to indicate whether you agree to have your leftover samples from this 
visit stored.   
 
____  My initials indicate that my leftover samples from this visit may be stored for 
study-related testing. 
 
____  I do not agree to allow leftover samples from this visit to be stored for study-
related testing. 
 
 

 
HPTN 075, Protocol Version 3.0 Page 60 of 73 
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15.1.2 Appendix V: Sample Enrollment Consent Form 
 
HPTN 075: Feasibility of HIV Prevention Cohort Studies among Men who have Sex 
with Men in Sub-Saharan Africa 
 
Protocol 
Version 3.0 
15 November 2016 
DAIDS Document ID: 11943 
 
Study Implementers: TBD   
 
Study Sponsors: National Institute of Health (NIH), US National Institute of Allergy and 
Infectious Diseases (NIAID), Division of AIDS (DAIDS) 
 
PRINCIPAL INVESTIGATOR: [Insert Name] 
PHONE:  [Insert Number] 
 
INTRODUCTION 
You are being asked to take part in a research study.  About 400 men in southern Africa 
will participate in this study. The goal of the study is to find out if African men who have 
sex with men are willing to participate in a 1 year-long research study.  Whether you join 
the study or not is up to you.  If you choose to join the study, you may stop taking part at 
any time.   
 
There may be no direct benefits for you if you participate in this study.  There may be 
some risks with taking part in the study.  Before you can make an informed decision 
about whether to take part in this study, you should understand the possible risks and 
potential benefits of being in this study.  This document, an informed consent form, will 
describe what will take place during the study.  This consent form might contain some 
words that are not familiar to you.  Please ask us to explain anything that you do not 
understand before you sign this form.  If you tell us that you understand the study and 
have decided that you want to participate, you will be asked to read, sign, and date this 
form.  You will also be offered a copy of this form to keep. 
 
What happens if you do not want to join the study? 
Before you learn more about the study it is important that you know the following: 
 You do not have to be in this study if you do not want to and you can stop taking part in the study 
at any time without affecting the services you get at [insert clinic]. 
 If you decide to stop taking part in the study, you may still join another study if one is available 
and you qualify. 
 During the study, you may be told of important new information about the study that may affect 
your original decision to join.  It will be up to you to decide if you want to continue in the study.  
If you decide to stay in the study, we may ask you to sign an updated informed consent form.   
 If you or your doctor decides that you should withdraw from the study we may ask you to come in 
for a final visit.   
 

 
HPTN 075, Protocol Version 3.0 Page 61 of 73 
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What will happen if I want to join this study? 
You are reading this form because you are eligible to participate in the study.  If you 
decide to join the study, you will need to agree to: 
 
 come to 5 study visits at this clinic over the course of 1 year (12 months); 
 get tested for HIV infection, hepatitis B infection, and other sexually transmitted 
infections by us, and receive the test results; 
 answer some personal questions related to ways that HIV is spread; 
 not participate in other HIV research studies, other than local PrEP demonstration 
projects, while you are in this study. 
 
What will happen during the study visits?  
 
Enrollment visit: The Enrollment visit will take about 2 hours.  During the Enrollment 
visit, study staff will confirm your name and update your contact information.  We will 
ask you about anything that has happened as a result of your study participation thus far.    
 
We will draw ~XX mL of blood (about X tablespoons). Your blood will be tested for 
HIV, to see if you have a new HIV infection (if your tests were negative at the Screening 
visit) or to confirm that you are infected (if your HIV tests were positive at the Screening 
visit). Your blood will also be tested for hepatitis B virus and syphilis, and to learn more 
about your general health. We will also collect a urine sample (up to XX mL).  We will 
test the urine for sexually transmitted infections and for tests of kidney function. We will 
also collect swabs (of your throat and rectum) during the visit to test for sexually 
transmitted infections. Some of the blood, urine and swab samples collected at this visit 
will be stored for other testing which is described below. At this visit, you will be asked 
about your sexual practices and other things that might impact the spread of HIV.  We 
will counsel you about HIV infection, risks you may be taking, and how to avoid getting 
or giving others HIV.  If you are taking HIV medication (ART) we will talk to you about 
taking your medicine.  You will be asked questions about any changes in your health and 
medications and we will give you a full physical exam.   
 
Study staff will inform you of the results of the tests performed at this visit. You will be 
given condoms and lubrication. 
 
Follow-up Visits: Each follow-up visit (4 visits at week 13, 26, 39, 52) will take about 
1.5 to 2 hours.  Study staff will confirm your name and update your contact information.  
We will ask you about anything that has happened as a result of your study participation.  
You will be asked about your sexual practices and other things that might impact the 
spread of HIV.  
 
We will draw blood ~XX mL of blood (about X tablespoons). If you have not been 
confirmed to have HIV infection, your blood will be tested to see if you have HIV 
infection. Your blood will also be tested for syphilis at some of the follow-up visits.  We 
will also collect a urine sample at some follow-up visits (up to XX mL).  We will test the 
urine for sexually transmitted infections. We will also collect swabs (of your throat and 
rectum) at the last study visit to test for sexually transmitted infections. Some of the 

 
HPTN 075, Protocol Version 3.0 Page 62 of 73 
15 November 2016 
blood, urine and swab samples collected at follow-up visits will be stored for other 
testing which is described below. 
 
We will counsel you about HIV infection, risks you may be taking, and how to avoid 
getting or giving others HIV.  If you have started taking HIV medication (ART) we will 
talk to you about taking your medicine.  You will be asked questions about any changes 
in your health and medications and we will give you a physical exam if you report 
symptoms.  If the tests indicate that you may be infected with HIV, you may be asked to 
come back to the clinic again for additional testing to confirm the results. 
 
You will be given condoms and lubrication. 
 
What will happen if you have a positive test result during the study?  
 
What if your blood shows that you may have HIV? 
 
If you do not have HIV infection at Screening, and tests from this visit or a later visit 
indicate that you may have been infected with HIV, we will need to do additional HIV 
testing and you will need to return to the clinic for this testing.  If the additional tests 
show that you have HIV infection, we will do lab tests to see how well your body can 
fight off infections, and we will measure the amount of HIV virus in your blood. This 
will help us to learn more about HIV infection and the HIV epidemic in African men who 
have sex with men. We will also need to do additional HIV testing if you tested HIV 
positive at the screening visit, but the HIV test from Enrollment visit is negative; if this 
happens, additional testing will be performed to determine if you are or are not infected.  
If testing shows that you are HIV infected, we will also refer you for HIV treatment and 
care. 
 
 
What if a test result shows that you have hepatitis B or a sexually transmitted infection? 
If a test results shows that you have hepatitis B or a sexually transmitted infection, you 
may still participate in the study.  We will refer you for appropriate medical care and 
treatment. 
 
Stored Samples 
Some of the blood, urine and swab samples collected at the enrollment and follow-up 
visits will be used for other testing as part of this study. Samples may be tested for drugs 
used to treat HIV infection or other substances. If you have HIV infection, the stored 
blood may also be used to study the HIV virus or your body’s response to HIV infection. 
Some of this work may involve studying how HIV spreads within the community. Stored 
rectal swab samples may be tested to learn more about sexually transmitted infections in 
your community.  Stored urine samples may be tested for substances you may be using. 
Results from testing stored blood, urine and swab samples will not be returned to the 
study site or you. 
 
Storage of Samples 
There may be some blood, urine or swab samples left over after all of the study testing 
has been completed.  We would like to use these samples for future research studies to 

 
HPTN 075, Protocol Version 3.0 Page 63 of 73 
15 November 2016 
develop new HIV tests, HIV vaccines and treatments or to learn more about HIV 
infection.  If you agree for us to use the samples, you will be asked to sign this form.   
If you do not agree to have your samples stored, you can still be in this study.  If you 
agree to store your samples but change your mind later, you can contact study staff.  We 
will then destroy your samples.   
 
If you agree to this use of your samples, we will ask you to initial the end of this form.  
Your blood, urine or swab samples will be sent to designated laboratories in the United 
States for further testing.  Your samples may be stored indefinitely [insert local 
guidelines].  Any future use or the ability to store your samples longer needs to be 
reviewed and approved by the NIH and local authorities.  If these studies involve other 
laboratories, we will need approval from your local authorities to store or transfer them 
elsewhere.  Your left over samples will not be sold or used for commercial reasons. 
What are the possible risks or discomforts? 
Sensitive questions 
The questions we will ask you about your sexual behavior or drug use may make you feel 
uneasy.  However, you do not have to answer any question that you do not want to and 
you can stop answering the questions at any time.  You might also feel some discomfort 
such as gagging as a result of the throat swab and embarrassment during the genital 
exams.  
 
Blood samples 
Taking blood samples may cause some pain, bruise your arm, or make you feel 
lightheaded.  In rare cases, you may faint.  There is also a slight chance of infection when 
blood is drawn.   
 
HIV Testing Stress 
You may be nervous while you are waiting for your HIV test result.  If the tests show that 
you have HIV, you may worry about your health and future.  You will receive counseling 
before and after the test to help address your concerns.   
 
Confidentiality 
We will make every effort to protect your confidentiality during the study.  The study staff will not 
give out any information that identifies you without your written consent.  However, the clinic’s 
Ethics Committee or Institutional Review Board, NIAID and or its contractors, representatives of the 
HPTN LOC, SDMC, and/or LC, and other government and regulatory authorities may review your 
screening records for study purposes.   
 
(Insert local requirements for reporting of communicable diseases)  
 
It is possible that others may think that you are “gay” or that you like to have sex with 
men.   They may also learn that you are part of this study and they may think that you are 
infected with HIV or are at high risk for infection with HIV.  Because of this you could 
have trouble finding or keeping a job.  You could also have problems with your family, 
friends and community.   
 

 
HPTN 075, Protocol Version 3.0 Page 64 of 73 
15 November 2016 
A description of this study will be available on www.ClinicalTrials.gov. This web site 
will not include information that can identify you. At most the web site will include a 
summary of the results. You can search this web site at any time. 
 
What are the potential benefits? 
At study visits we will check to see if you have HIV infection, hepatitis B infection, or 
other sexually transmitted infections.  If you do not have a hepatitis B infection and 
would like to be vaccinated against hepatitis B, we will refer you for that.  The 
counseling you get during this study may help you to avoid HIV, hepatitis B, and other 
sexually-transmitted infections.  If tests show that you have HIV, hepatitis B virus, or 
another sexually transmitted infection, counseling we provide may help you to learn how 
to better care for yourself and avoid passing an infection to your sexual partners.  We will 
refer you for care and/or treatment of an infection.   
 
During the study you will have tests to check on the health of your blood, liver, and 
kidneys.  If any health problems are found, you will be referred for care.   
 
At every visit you will be offered condoms and lubricant free of charge.   
 
What are some reasons you may be withdrawn from the study without your 
consent? 
You may be withdrawn from the study without your consent for the following reasons: 
 The research study is stopped or canceled, for instance by local authorities, such as 
the ethical review committee, or by other agencies, such as the study sponsor or other 
oversight agencies. 
 The study staff feels that staying in the study would be harmful to you. 
 The study investigators identify other reasons that they believe would prevent you 
from continuing in the study. 
 
What are the alternatives to participating in this study? 
You do not have to join this study. 
 
[Sites to amend as applicable]  There may be other studies going on at this study clinic or 
in the community for which you may be eligible.  If you wish, we will tell you about 
other studies that we know about.  There may also be other places where you can go for 
HIV counseling and testing.  We will tell you about those places if you wish.   
 
How will your privacy be protected? 
All the information you give us as part of this study will be kept confidential.  All your 
laboratory test results will also be kept confidential.  You will get a unique study 
identification number that will be used instead of your name on your documents.  
However, at every study visit we will ask you to identify yourself.  This is to make sure 
that it is you who provides samples and information to us.  Also we want to make sure 
that no other person than you can get your confidential laboratory test results.  Only the 
study staff will be able to see records that identify you by name.  This information will 
not be shared with others.  All records will be stored in locked file cabinets at the study 
clinic.  Results of your laboratory tests will be made available only to you when you visit 

 
HPTN 075, Protocol Version 3.0 Page 65 of 73 
15 November 2016 
the clinic.  Your name will never be used in any publication or presentation about the 
study. 
 
Your records may be reviewed by the sponsor of the study, the US National Institutes of Health 
(NIH), and their representatives, [insert name of site] IRB/EC, study staff, study monitors and 
[insert applicable local regulatory authorities]. 
 
What happens if you are injured by this research? 
Taking part in this study may put you at risk for personal injury. 
 
It is unlikely that you will be physically injured by any study activities that are conducted at the 
clinic.  If you are injured, the [institution] will give you the treatment needed for your injuries.  
You [will/will not] have to pay for this treatment.  You will be told where you can get additional 
treatment for your injuries.  There is no program to pay money or give other forms of 
compensation for such injuries.  You do not give up any legal rights by signing this consent 
form. 
 
Who can you contact if you have any questions? 
We are happy to answer any questions that you may have.  It may be that you have 
questions about your rights as a study participant or that you think you have been injured 
because you were in this study.  In this case you can contact [insert name of the 
investigator or other study staff] at [[insert telephone number and physical address].   
 
If you have any questions or concerns about whether you should join this study, or your 
rights as a research participant, you should contact [insert name ore title of person on the 
IRB/EC or other organization appropriate for the site] at [insert physical address and 
telephone number].     
 
What is the cost of study participation? 
There is no cost to you for being in this study.  You will receive [insert local amount] for 
your time, effort, and travel to and from the clinic for each study visit.  You will be given 
condoms and lubricants, free of charge at each visit. 
 
What should you do if you have problems or questions about the study? 
For questions about this study or a research-related injury, contact: 
 [Name, physical address, and phone number of the investigator or other study staff] 
 
For questions about your rights as a research subject, contact: 
 [Name, title, and contact information of person on the Institutional Review Board (IRB) or other 
organization appropriate for the site] 

 
HPTN 075, Protocol Version 3.0 Page 66 of 73 
15 November 2016 
HPTN 075: Feasibility of HIV Prevention Cohort Studies among Men who have Sex 
with Men in Sub-Saharan Africa 
 
Protocol Version 3.0 
15 November 2016 
DAIDS Document ID: 11943 
 
US National Institute of Allergy and Infectious Diseases (NIAID) 
US National Institutes of Health (NIH) 
Sponsor: NIH, NIAID, DAIDS 
 
ENROLLMENT INFORMED CONSENT FORM 
 
INVESTIGATOR OF RECORD:[insert name] 
PHONE: [insert number] 
 
SIGNATURE PAGE 
Study Participation 
If you have read this consent form, or had it read and explained to you, and you 
understand the information, and you voluntarily agree to join the study, please sign your 
name or make your mark below. 
 
____________________        _______________________       _______________ 
Participant Name (print)         Participant Signature                   Date 
 
___________________           _______________________     ________________ 
Study Staff Conducting           Study Staff Signature                  Date 
Consent Discussion (print) 
 
For witnesses for illiterate volunteers:  I attest that the information contained in this 
written consent form has been read and explained to the participant.  He/she appears to 
understand the purpose, procedures, risks and benefits of the study screening and has 
voluntarily accepted to participate in this screening. 
 
For those placing thumbprint only:  I attest that the participant who states that his/her 
name is   _________________________ has placed his/her thumbprint on this consent 
form of his/her own free will on this day _________________. 
 
 
____________________________________________________________ 
Witness’ Name (print)                                      Witness’ Signature and Date 
 
 
 
 
 
 
 

 
HPTN 075, Protocol Version 3.0 Page 67 of 73 
15 November 2016 
Samples Stored for Future Testing 
 
Blood: 
____  My initials indicate that my blood samples may be stored for future testing after 
study-related testing has been completed. 
 
____  I do not agree to allow my blood samples to be saved for long-term storage and 
future testing after study-related testing has been completed. 
 
Urine 
____ My initials indicate that my urine samples may be stored for future testing after 
study-related testing has been completed. 
____ I do not agree to allow my urine samples to be saved for long term storage and 
future testing after study-related testing has been completed. 
 
Swabs: 
____ My initials indicate that my swabs may be stored for future testing after study-
related testing has been completed. 
____ I do not agree to allow my swabs to be saved for long term storage and future 
testing after study-related testing has been completed. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
HPTN 075, Protocol Version 3.0 Page 68 of 73 
15 November 2016 
 
15.1.3 Appendix VI: Sample In-Depth Interview Consent Form 
 
Interests in PrEP and PrEP-related Studies—In-depth Interviews 
 
Purpose and Overview 
 
You are being asked to take part in an extra portion of HPTN 075. The goal of this part is 
to find out how MSM feel about PrEP (pre-exposure prophylaxis). PrEP is a new way to 
stop the spread of the human immunodeficiency virus, or HIV. The main purpose of this 
part is to understand what some men in the HPTN 075 study think about PrEP and about 
studies that look at whether various forms of PrEP work. For this part, we will be 
conducting interviews and group discussions. You have been invited to participate in an 
interview. About 20 men who have sex with men (MSM) at [insert clinic] will participate 
in this part of the study. 
 
Voluntary 
Whether you join the study or not is up to you.  If you choose to join this study, you may 
stop taking part at any time.  If you decide not to participate or to withdraw from the 
study, it has no consequences for the services you receive here. 
 
Procedures 
Your participation will consist of a one-on-one interview with an interviewer in a private 
room about your thoughts about and experiences with PrEP. This is called an in-depth 
interview. The interview will last approximately 1 hour. The interview will be recorded. 
If you do not want the interview to be recorded, you cannot participate in this part of the 
study. 
 
Risks and Inconveniences 
Some questions we will ask you may make you feel uncomfortable and some of the 
information we would like you to share with us is of a sensitive nature. You may decline 
to answer any question. You may also stop the interview at any time.  
 
Benefits  
There may be no direct benefits for you if you participate in this study.  You might find it 
interesting to share your thoughts and experiences with an interviewer. What you and 
other men tell us will help us improve HIV prevention for men who have sex with men 
and design better studies. 
 
Confidentiality  
An exact record of what you say during the interview will be recorded.  Your name will 
not be on the recording. The interview will be transcribed [and then translated into 
English]. All information that might identify you or anybody else will be deleted from the 
transcription. The recording of your interview will be destroyed once the interview is 
transcribed and checked, no later than six months after the interview took place. The 
transcripts will be sent to the Principal Investigator of this study in New York for 
analysis.  

 
HPTN 075, Protocol Version 3.0 Page 69 of 73 
15 November 2016 
 
All the information you give us as part of this study will be kept confidential. Your 
unique study identification number from HPTN 075 will be used instead of your name on 
your documents for this study. Only study staff here at [fill in] will be able to see records 
that identify you by name. This information will not be shared with others. All records 
will be stored in locked file cabinets at the study clinic. In New York, the translated 
transcript of your interview will be stored on pass-word protected computers. Your name 
will never be used in any publication or presentation about the study.  
 
Your records may be reviewed by the sponsor of the study, the US National Institutes of 
Health (NIH), and their representatives, [insert name of site] IRB/EC, study staff, study 
monitors and [insert applicable local regulatory authorities]. 
 
A description of this study will be available on www.ClinicalTrials.gov. This web site 
will not include information that can identify you. At most the web site will include a 
summary of the results. You can search this web site at any time. 
 
Study Compensation  
You will receive XXXX in cash to compensate you for your participation in the study 
and XXXX to cover transportation expenses. 
 
Questions 
I am happy to answer any questions about the study before we start the interview. If 
questions come up after the study, you can contact [insert name of the investigator or 
other study staff] at [insert telephone number and physical address].   
 
If you have any questions about your rights as a research participant, want to provide 
feedback, or have a complaint, you may call [insert name ore title of person on the 
IRB/EC or other organization appropriate for the site] at [insert physical address and 
telephone number]. (An IRB is a committee that protects the rights of participants in 
research studies).  

 
HPTN 075, Protocol Version 3.0 Page 70 of 73 
15 November 2016 
Interests in PrEP and PrEP-related Studies 
 
Protocol Version 3.0 
15 November 2016 
 
Sponsor: US National Institutes of Health (NIH), US National Institute of Mental 
Health (NIMH) 
 
IN-DEPTH INTERVIEW INFORMED CONSENT FORM 
 
INVESTIGATOR OF RECORD:[insert name] 
PHONE:[insert number] 
 
SIGNATURE PAGE 
Study Participation 
If you have read this consent form, or had it read and explained to you, and you 
understand the information, and you voluntarily agree to join the study, please sign your 
name or make your mark below. 
 
 
___________________        ________________      _______________________ 
Participant Name (print)      Participant Signature      Date 
 
 
___________________      __________________      _____________________ 
Study Staff Conducting       Study Staff Signature      Date 
Consent Discussion (print) 
 
 
For witnesses for illiterate volunteers:  I attest that the information contained in this 
written consent form has been read and explained to the participant.  He/she appears to 
understand the purpose, procedures, risks and benefits of the study screening and has 
voluntarily accepted to participate in this screening. 
 
 
For those placing thumbprint only:  I attest that the participant who states that his/her 
name is   _________________________ has placed his/her thumbprint on this consent 
form of his/her own free will on this day _________________. 
 
 
__________________      _______________      _________________________ 
Witness’ Name (print)      Witness’ Signature       Date 
 
 
 
 
 
 

 
HPTN 075, Protocol Version 3.0 Page 71 of 73 
15 November 2016 
15.1.4 Appendix VII: Sample Focus Group Discussion Consent Form 
 
Interests in PrEP and PrEP-related Studies—Group Discussions 
 
Purpose and Overview 
 
You are being asked to take part in an extra portion of HPTN 075. The goal of this part is 
to find out how MSM feel about PrEP (pre-exposure prophylaxis). PrEP is a new way to 
stop the spread of the human immunodeficiency virus, or HIV. The main purpose of this 
research study is to understand what some men in the HPTN 075 study think about PrEP 
and about studies that look at whether various forms of PrEP work. For this part of the 
study we will be conducting interviews and group discussions. You have been invited to 
participate in a group discussion. About 10 men who have sex with men (MSM) at [insert 
clinic] will participate in this part of the study. 
 
Voluntary 
Whether you join the study or not is up to you.  If you choose to join this study, you may 
stop taking part at any time.  If you decide not to participate or to withdraw from the 
study, it has no consequences for the services you receive here. 
 
Procedures 
You will have a discussion with a group of other men who participate in HPTN 075. This 
is called a focus group. The discussion will focus on sexual risk and HIV prevention, and 
PrEP in particular. PrEP is a way of reducing the risk of HIV transmission by using 
specific drugs. The discussion will last approximately 2 hours. The discussion will be 
recorded so we have an exact record of what everyone says, as there is too much 
information to write down during the discussion. If you do not want the interview to be 
recorded, you cannot participate in this part of the study.  
 
Risks and Inconveniences 
Some questions we will ask you may make you feel uncomfortable and some of the 
information we would like you to share with us is of a sensitive nature. You may decline 
to answer any question. You may also stop participating in the group discussion at any 
time.  
 
Benefits  
There may be no direct benefits for you if you participate in this study.  You might find it 
interesting to share your thoughts and experiences with other participants. What you and 
other men tell us will help us improve HIV prevention for men who have sex with men 
and design better studies. 
 
Confidentiality  
Because you will take part in a group discussion, the other people in the group will also 
hear your responses. We ask that everyone respect the confidentiality of the other 
participants. If you decide to participate, please do not discuss what is shared in this 
group with anyone outside of the group. 
 

 
HPTN 075, Protocol Version 3.0 Page 72 of 73 
15 November 2016 
An exact record of what is said in the group discussion will be recorded.  Your name will 
not be on the recording. The discussion will be transcribed [and then translated into 
English]. All information that might identify you or anybody else will be deleted from the 
transcription. The recording of the discussion will be destroyed once the discussion is 
transcribed and checked, no later than six months after the discussion took place. The 
transcript of the discussion will be sent to the Principal Investigator of this study in New 
York for analysis.  
 
All the information you give us as part of this portion of the study will be kept 
confidential. Your unique study identification number from HPTN 075 will be used 
instead of your name on your documents for this part. Only study staff here at [fill in] 
will be able to see records that identify you by name. This information will not be shared 
with others. All records will be stored in locked file cabinets at the study clinic. In New 
York, the translated transcript of your interview will be stored on pass-word protected 
computers. Your name will never be used in any publication or presentation about the 
study.  
 
Your records may be reviewed by the sponsor of the study, the US National Institutes of 
Health (NIH), and their representatives, [insert name of site] IRB/EC, study staff, study 
monitors and [insert applicable local regulatory authorities]. 
 
A description of this study will be available on www.ClinicalTrials.gov. This web site 
will not include information that can identify you. At most the web site will include a 
summary of the results. You can search this web site at any time. 
 
Study Compensation  
You will receive XXXX in cash to compensate you for your participation in the study 
and XXXX to cover transportation expenses. 
 
Questions 
I am happy to answer any questions about the study before we start the group discussion. 
If questions come up after this portion of the study, you can contact [insert name of the 
investigator or other study staff] at [insert telephone number and physical address].   
 
If you have any questions about your rights as a research participant, want to provide 
feedback, or have a complaint, you may call [insert name ore title of person on the 
IRB/EC or other organization appropriate for the site] at [insert physical address and 
telephone number]. (An IRB is a committee that protects the rights of participants in 
research studies).  

 
HPTN 075, Protocol Version 3.0 Page 73 of 73 
15 November 2016 
Interests in PrEP and PrEP-related Studies 
 
 
Protocol Version 3.0 
15 November 2016 
 
Sponsor: US National Institutes of Health (NIH), US National Institute of Mental 
Health (NIMH) 
 
GROUP DISCUSSION INFORMED CONSENT FORM 
 
INVESTIGATOR OF RECORD:[insert name] 
PHONE:[insert number] 
 
SIGNATURE PAGE 
Study Participation 
If you have read this consent form, or had it read and explained to you, and you 
understand the information, and you voluntarily agree to join the study, please sign your 
name or make your mark below. 
 
 
___________________      _________________      ______________________ 
Participant Name (print)      Participant Signature      Date 
 
 
___________________      _________________       ______________________ 
Study Staff Conducting       Study Staff Signature      Date 
Consent Discussion (print) 
 
 
For witnesses for illiterate volunteers:  I attest that the information contained in this 
written consent form has been read and explained to the participant.  He/she appears to 
understand the purpose, procedures, risks and benefits of the study screening and has 
voluntarily accepted to participate in this screening. 
 
 
For those placing thumbprint only:  I attest that the participant who states that his/her 
name is   _________________________ has placed his/her thumbprint on this consent 
form of his/her own free will on this day _________________. 
 
 
__________________________________________________________ 
Witness’ Name (print)Witness’ Signature Date