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?
HPTN 061 was a research study conducted to examine certain strategies which may show promise for slowing the spread of HIV among Black gay, bisexual and other MSM. The study also sought to better understand the lives of Black MSM and how factors in their lives relate to HIV risk. The study began enrolling participants in July 2009 and completed follow up in December 2011.
Who participated in the study?
A total of 1553 MSM and transgender persons, both HIV infected and uninfected, who were 18 years old or older and self-identified as Black, enrolled in six cities. These cities (and the local name of the study) were: Atlanta, GA (BROTHERS), Boston, MA (Project SOS), New York, NY (Brothers’ Project), Los Angeles, CA (The Brothers’ Project), San Francisco, CA (Unity), and Washington, DC (061).
What happened during the study?
Most participants had three visits spaced out over a year. At these visits, participants were asked questions about their past and current lives. They were offered testing for HIV and other sexually-transmitted infections, as well as an opportunity to work with a “peer health navigator” who could assist them in getting connected to resources available in their community, such as medical care and social services.
Results
Initial analyses of the data revealed greatly elevated HIV infection rates among young Black MSM in the U.S. The study was first to determine the rate of new HIV infection among such a large prospective cohort of U.S. Black MSM (referred to as HIV incidence). Other early analyses showed that HIV infection in this study population was associated with high rates of sexually transmitted infections, poverty and low and/or delayed rates of HIV testing.
A key question at the beginning of the study was whether Black MSM would agree to participate in this research. The number of men enrolled clearly shows that Black MSM were willing to volunteer their time, information and samples for an HIV study. In addition, more than 350 men worked with a peer health counselor at one or more study sites, and over 97% of men enrolled were willing to have an HIV test. This success speaks to the generosity of the participants and the dedication and support of staff and community partners at each site.
Protocol Status
Concluded
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 six U.S.cities: Atlanta, Boston, Los Angeles, New York City, San Francisco, and Washington, DC
Study Size
1,553 participants were enrolled. Men were either recruited directly from the community ("community recruited" participants) or as sexual network partners referred by participants ("referred" participants).
Study Duration
The study began enrolling participants in July 2009 and completed follow up in December 2011.
Treatment Regime
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.