HPTN 061

Feasibility Study of a Community-Level, Multi-Component Intervention for Black Men Who Have Sex with Men: A Study of the HIV Prevention Trials Network

The purpose of this study was 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. This was 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 was recruited for qualitative interviews and focus groups.

This study focused on sexually active Black MSM living in select cities in the United

States (US), and will include nationally, approximately 2418 participants (403 per site at each of six sites, including Emory University).

  • Men enrolling for this study were 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 was 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 were 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 was 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 were recruited from the main study to participate in focus groups (approximately 18-24 participants per site, or 108-134 participants overall) and qualitative interviews (between 10 and 30 participants at each site, or 60-180 participants overall).

The intervention components provided to participants included:

  • 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.
  • Counseling and referral for care offered to participants for issues such as substance use and mental health
  • Engagement with peer health care system navigators (PHNs) to facilitate uptake of health care and other services.

The primary objective of this study was to obtain the information needed to design a full, community-wide randomized trial.  Specific areas of interest included:

  • 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

The total duration of the study was two years.  This timeline includes 12 months for  

participant accrual and up to 12 months of follow-up for each participant.