HPTN 075
Feasibility of HIV Prevention Cohort Studies Among MSM in Sub-Saharan Africa
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What is HPTN 075?
HPTN 075 aimed 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).
Who participated in the study?
Men, regardless of HIV infection status, aged 18-44 years living in SSA who reported anal sex with a man in the past three months were recruited at four sites in Kenya, Malawi and South Africa. Transgender women (TGW) were not specifically recruited but were not excluded from recruitment for the study.
Why is HPTN 075 important?
MSM and TGW in SSA are at alarmingly high risk of HIV acquisition and transmission 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 and TGW. Second, in many parts of SSA, MSM and TGW cannot safely seek HIV prevention or treatment services because of the social, cultural, and legal aspects of stigma, discrimination, and criminalization.
What happened during the study?
A total of 401 MSM and TGW, regardless of HIV infection status, were enrolled at four sites in Kenya, Malawi and South Africa. Each participant was followed for 12 months, during which five study visits were conducted. These visits included interviewing participants about behaviors that may put them at risk for HIV infection, medical examinations and collection of blood samples. Of the 401 enrolled, 329 were HIV-negative at the time of enrollment. By the end of the study, 21 of them had become infected with HIV. Incidence rates differed substantially by study site.
What were the key study findings?
Study participants were at an alarming risk of acquiring HIV. The incidence among study participants was substantially higher than the estimated incidence among heterosexual men and women in the general population in the same countries.
Protocol Status
Concluded
Study 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.
Study Design
This 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, identified as male at birth and regardless of HIV infection status, aged 18-44 years and living in SSA who report anal sex with a man in the past 3 months. Transgender women (TGW) will not be targeted for recruitment, but will not be excluded from enrollment.
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.
Treatment Regime
No treatment, this is an observational study.
Primary Objectives
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.
- 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.
Other Objectives
• 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 Documents
HPTN 075 Version 3.0
HPTN 075 Version 2.0
HPTN 075 Version 1.0