HPTN 061
Feasibility of a community-level, multi-component intervention for Black MSM in preparation for a Phase IIB community-level randomized trial to test the efficacy of the intervention in reducing HIV incidence among Black MSM
What is HPTN 061?
Protocol Status: Closed to Follow Up
Study Purpose: To determine the feasibility and acceptability of a multifaceted intervention among Black men who have sex with men (MSM), to prepare for a community-level randomized trial to test the efficacy of the intervention in reducing HIV incidence among Black MSM.
Study Design: A multi-site, community-level feasibility study, with longitudinal data collected for the majority of participants and only baseline cross-sectional data collected for a minority of participants. A subset of participants will also be recruited for qualitative interviews and focus groups.
Study Population: Sexually active Black MSM living in select cities in the United States (US).
Study Size: Approximately 2418 participants (403 per site at each of six sites) Men enrolling for this study will be recruited in one of two ways- either directly from the community ("community recruited" participants) or as sexual network partners referred by participants ("referred" participants). Enrollment of certain sub-categories of community recruited participants will be limited according to criteria detailed in the protocol. Enrollment of community-recruited participants at a site will cease when 250 community-recruited participants who agree to HIV testing have been enrolled. A subset of community-recruited and referred participants will be considered "index" participants. Index participants are those who are newly identified with HIV infection, those with previously diagnosed HIV infection who are not receiving HIV care, and a random sample of HIV-negative participants. Index participants will be asked to refer sexual partners. There will be no cap on the number of referred participants enrolled into the study, however enrollment of referred participants will stop two months after closure of enrollment of community-recruited participants. A subset of participants will be recruited from the main study to participate in focus groups (approximately 18-24 participants per site, or 108-134 participants overall) and qualitative interviews (up to 30 participants at each site, or 180 participants overall).
Study Duration: The total duration of the study will be two years. This timeline includes 12 months for participant accrual and up to 12 months of follow-up for each participant.
Treatment Regimen: The intervention components provided to participants include: Referral of up to five sexual partners by index participants for enrollment into the study. HIV risk reduction counseling, testing, and referral for care STI testing and referral for care. Screening for substance use, mental health issues, partner and/or homophobic violence, and (if indicated) provision of counseling and referral for care. Engagement with peer health care system navigators (PHNs) to facilitate uptake of health care and other services.
Primary Objectives: To obtain the information needed to design a full, community-wide randomized trial. Specific areas of interest include: Recruitment of Black MSM. Uptake of the intervention components by Black MSM, including the proportion of enrolled participants who: Agree to HIV testing. Agree to STI testing. Use peer navigation. Estimating the following in the course of the study: Proportion of participants who are newly diagnosed with HIV at enrollment. Increase in condom use from enrollment to week 52. Decrease in viral load at week 52 among HIV-infected participants who initiate HAART during their study participation. Decrease in prevalence of STIs from enrollment to week 52. Satisfaction of Black MSM with intervention components
Secondary Objectives: To collect samples, behavioral data, and HIV test results to improve laboratory measures of HIV incidence in cross-sectional surveys. To estimate the HIV incidence rate under intervention conditions. To estimate the effect of the intervention on HIV incidence through mathematical modeling. To describe the social and sexual networks of Black MSM based on individually self-reported network data. To describe risk behaviors of sexual network members of Black MSM, especially of those who are newly diagnosed with HIV infection, or previously diagnosed but not in care. To assess attitudes of Black MSM toward other HIV prevention interventions. To use qualitative research methods to: Examine individual, interpersonal, cultural, institutional, and geographic-specific processes that influence study participation and uptake of intervention components. Understand how and to what extent stigma and discrimination (and other emergent themes) influence HIV testing and access to care by geographic region.
SDMC Protocol Specialist: Corey L. Kelly get info
Protocol Statistician: Lei Wang get info
Protocol Co-Chair: Darrell Wheeler get info
Protocol Co-Chair: Darrell Wheeler get info
Protocol Co-Chair: Kenneth H. Mayer get info
Protocol Chair: Beryl Koblin get info
DAIDS Medical Officer: Vanessa Elharrar get info
CORE Protocol Specialist: Erica Hamilton get info
CORE Protocol Specialist: Sam Griffith get info
| Site |
Target Enrollment |
Cumulative Enrollment |
Implementation Status |
More Info |
|---|---|---|---|---|
|
5802 Atlanta, United States |
0 |
|
Closed to Follow Up |
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|
31602 Boston, United States |
403 |
237 |
Closed to Follow Up |
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|
Hope Clinic of the Emory Vaccine Center CRS 31440 Decatur, United States |
403 |
292 |
Closed to Follow Up |
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|
31607 Los Angeles, United States |
403 |
283 |
Closed to Follow Up |
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|
Harlem Prevention Ctr. CRS (El-Sadr CTU) 30276 New York, United States |
202 |
154 |
Closed to Follow Up |
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|
New York Blood Center/Union Square CRS 31605 New York, United States |
202 |
156 |
Closed to Follow Up |
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|
San Francisco Vaccine and Prevention CRS 30305 San Francisco, United States |
403 |
204 |
Closed to Follow Up |
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|
31608 Washington, United States |
403 |
227 |
Closed to Follow Up |
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