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
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What
is HPTN 061?
Protocol Status:
In Development
Study
Summary
Study Purpose: To ascertain the feasibility and acceptabiliity of an 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: Multi-site, community-level feasibility study
Study Population: Sexually active Black MSM living in the United States
Study Size: Approximately 2136 "first wave" participants (267 per site at eight sites) and approximately 400 referred partners (50 per site at eight sites).
There will be no limit on enrollment of participants referred by "index" participants already in the study (according to the referring scheme in the protocol). Index participants are defined later in the protocol, but can be generally described as those newly identified with HIV infection, those with previously diagnosed HIV infection who are not receiving HIV care, and certain HIV negative participants.
Men enrolling for this study who have not been referred by an index participant will be called "first wave" participants. Enrollment of first wave participants will cease when 200 first wave participants eligible for longitudinal follow up have been enrolled.
Enrollment of certain sub-categories of first wave participants will be limited according to criteria detailed in the protocol.
Study Duration: Two years total.
Twelve months for participant accrual with up to 12 months of follow up for each participant
Treatment Regimen: The intervention components provided to participants include:
HIV risk-reduction counseling, testing and referral for care
STI testing and referral for care
Screening for substance use and mental health issues, and provision of counseling and referral for care (if indicated)
Engagement with peer-health navigators to facilitate uptake of healthcare and other services
Enumeration of up to 20 social and sexual network members by all participants and referral of up to 5 sexual partners by index participants for enrollment into the study
Primary Objectives: To obtain information needed to design the full community-randomized trial, particularly in the areas of:
recruitment of black MSM
satisfaction of Black MSM with intervention components
uptake of the intervention components by Black MSM, including:
Proportion of enrolled participants who agree to HIV testing
Proportion of participants who agree to STI testing
Proportion of participants who utilize peer navigator referrals
Proportion of HIV infected participants entering HIV care
Increase in condom use in all participants from enrollment to week 52
Decrease in viral load among HIV infected participants from initiation of HAART to week 52
Decrease in STIs among all participants from enrollment to week 52
Secondary Objectives: To collect samples, behavioral data and HIV test results to improve laboratory measures of HIV incidence based on samples derived from cross-sectional studies
To estimate the HIV incidence rate and the effect of the intervention on the incidence rate through mathematical modeling
To describe characteristics of sexual network members of black MSM who are newly diagnosed with HIV infection, or previously diagnosed but not in care
To assess attitudes of black MSM toward other prevention interventions
To describe social and sexual networks of Black MSM within cities to inform decisions about what constitutes a randomizable unit for a future trial of the intervention
CORE Protocol Specialist:
Sam Griffith
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| This study is early in its development. No information is available here. |
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