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
HIV and Black MSM in the U.S.
What is HPTN 061?
Protocol Status: Participants Off Study & Primary Analysis Complete
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 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.
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
Brewer RA, Magnus M, Kuo I, Wang L, Liu TY, Mayer KH. Exploring the relationship between incarceration and HIV among Black men who have sex with men in the United States. J Acquir Immune Defic Syndr. 2013, 65: 218-25 PMCID: 3898433.
Dyer TP, Regan R, Wilton L, Harawa NT, Ou SS, Wang L, Shoptaw S. Differences in Substance Use, Psychosocial Characteristics and HIV-Related Sexual Risk Behavior Between Black Men Who Have Sex with Men Only (BMSMO) and Black Men Who Have Sex with Men and Women (BMSMW) in Six US Cities. J Urban Health. 2013, 90: 1181-93 PMCID:3853182.
Hussen SA, Stephenson R, Del Rio C, Wilton L, Wallace J, Wheeler D; HPTN 061 Protocol Team. HIV Testing Patterns among Black Men Who Have Sex with Men: A Qualitative Typology. PLoS One. 2013, 8: e75382 PMCID: 3777907.
Koblin BA, Mayer KH, Eshleman SH, Wang L, Mannheimer S, del Rio C, Shoptaw S, Magnus M, Buchbinder S, Wilton L, Liu TY, Cummings V, Piwowar-Manning E, Fields SD, Griffith S, Elharrar V, Wheeler D; HPTN 061 Protocol Team. Correlates of HIV acquisition in a cohort of Black men who have sex with men in the United States: HIV prevention trials network (HPTN) 061. PLoS One. 2013, 8: e70413 PMCID: 3724810.
Konikoff J, Brookmeyer R, Longosz AF, Cousins MM, Celum C, Buchbinder SP, Seage GR 3rd, Kirk GD, Moore RD, Mehta SH, Margolick JB, Brown J, Mayer KH, Koblin BA, Justman JE, Hodder SL, Quinn TC, Eshleman SH, Laeyendecker O. Performance of a limiting-antigen avidity enzyme immunoassay for cross-sectional estimation of HIV incidence in the United States. PLoS One. 2013, 8: e82772.
Brewer RA, Magnus M, Kuo I, Wang L, Liu TY, Mayer KH. The high prevalence of incarceration history among black men who have sex with men in the United States: associations and implications. Am J Public Health. 2014, 104: 448-54 PMCID: 3953792.
Chen I, Cummings V, Fogel JM, Marzinke MA, Clarke W, Connor MB, Griffith S, Buchbinder S, Shoptaw S, Rio CD, Magnus M, Mannheimer S, Wheeler DP, Mayer KH, Koblin BA, Eshleman SH. Low-level Viremia Early in HIV Infection. J Acquir Immune Defic Syndr. 2014, Epub: PMCID in process.
Cousins MM, Konikoff J, Laeyendecker O, Celum C, Buchbinder SP, Seage GR 3rd, Kirk GD, Moore RD, Mehta SH, Margolick JB, Brown J, Mayer KH, Koblin BA, Wheeler D, Justman JE, Hodder SL, Quinn TC, Brookmeyer R, Eshleman SH. HIV diversity as a biomarker for HIV incidence estimation: including a high-resolution melting diversity assay in a multiassay algorithm. J Clin Microbiol. 2014, 52: 115-21.
Cousins MM, Konikoff J, Sabin D, Khaki L, Longosz AF, Laeyendecker O, Celum C, Buchbinder SP, Seage GR 3rd, Kirk GD, Moore RD, Mehta SH, Margolick JB, Brown J, Mayer KH, Kobin BA, Wheeler D, Justman JE, Hodder SL, Quinn TC, Brookmeyer R, Eshleman SH. A comparison of two measures of HIV diversity in multi-assay algorithms for HIV incidence estimation. PLoS One. 2014, 9: e101043.
Harawa N, Wilton L, Wang L, Mao C, Kuo I, Penniman T, Shoptaw S, Griffith S, Williams JK, Cummings V, Mayer K, Koblin B; HPTN 061 Study Team. Types of Female Partners Reported by Black Men Who Have Sex with Men and Women (MSMW) and Associations with Intercourse Frequency, Unprotected Sex and HIV and STI Prevalence. AIDS Behav. 2014, 18: 1548-59 PMCID: 4169287.
Irvin R, Wilton L, Scott H, Beauchamp G, Wang L, Betancourt J, Lubensky M, Wallace J, Buchbinder S. A Study of Perceived Racial Discrimination in Black Men Who Have Sex with Men (MSM) and Its Association with Healthcare Utilization and HIV Testing. AIDS Behav. 2014, 18: 1272-8 PMCID: In process.
Magnus M, Franks J, Griffith S, Arnold MP, Goodman K, Wheeler DP; for the HPTN 061 Study Group. Engaging, Recruiting, and Retaining Black Men Who Have Sex With Men in Research Studies: Don't Underestimate the Importance of Staffing-Lessons Learned From HPTN 061, the BROTHERS Study. J Public Health Manag Pract. 2014, Epub: PMCID: In Process.
Mannheimer S, Wang L, Wilton L, Tieu HV, Del Rio C, Buchbinder S, Fields S, Glick S, Conor MB, Cummings V, Eshleman SH, Koblin B, Mayer KH. Infrequent HIV Testing and Late HIV Diagnosis Are Common Among US Black Men Who Have Sex with Men (BMSM). J Acquir Immune Defic Syndr. 2014, Epub: PMID: 25197830.
Marzinke MA, Clarke W, Wang L, Cummings V, Liu TY, Piwowar-Manning E, Breaud A, Griffith S, Buchbinder S, Shoptaw S, del Rio C, Magnus M, Mannheimer S, Fields SD, Mayer KH, Wheeler DP, Koblin BA, Eshleman SH, Fogel JM. Nondisclosure of HIV status in a clinical trial setting: antiretroviral drug screening can help distinguish between newly diagnosed and previously diagnosed HIV infection. Clin Infect Dis. 2014, 58: 117-20 PMCID: 3864502.
Mayer KH, Wang L, Koblin B, Mannheimer S, Magnus M, del Rio C, Buchbinder S, Wilton L, Cummings V, Watson CC, Piwowar-Manning E, Gaydos C, Eshleman SH, Clarke W, Liu TY, Mao C, Griffith S, Wheeler D; HPTN061 Protocol Team. Concomitant socioeconomic, behavioral, and biological factors associated with the disproportionate HIV infection burden among Black men who have sex with men in 6 U.S. cities. PLoS One. 2014, 9: e87298 PMCID: 3909083.
Piwowar-Manning E, Fogel JM, Laeyendecker O, Wolf S, Cummings V, Marzinke M, Clarke W, Breaud A, Wendel S, Wang L, Swanson P, Hackett J, Jr., Mannheimer S, del Rio C, Kuo I, Harawa NT, Koblin BA, Moore R, Blankson JN, Eshleman SH. Failure to identify HIV-infected individuals in a clinical trial using a single HIV rapid test for screening. HIV Clin Trials. 2014, 15: 62-8 PMCID: 4167641.
Chen I, Connor MB, Clarke W, Marzinke MA, Cummings V, Breaud A, Fogel JM, Laeyendecker O, Fields SD, Donnell D, Griffith S, Scott HM, Shoptaw S, Rio CD, Magnus M, Mannheimer S, Wheeler DP, Mayer KH, Koblin BA, Eshleman SH. Antiretroviral drug use and HIV drug resistance among HIV-infected Black men who have sex with men: HIV Prevention Trials Network 061. J Acquir Immune Defic Syndr. 2015, : .
Hall G, Li K, Wilton L, Wheeler D, Fogel J, Wang L, Koblin B,. A Comparison of Referred Sexual Partners to Their Community Recruited Counterparts in The BROTHERS Project (HPTN 061). AIDS and Behavior. 2015, 19: 2214-23.
Irvin R, Vallabhaneni S, Scott H, Williams JK, Wilton L, Li X, Buchbinder S; HPTN 061. Examining Levels of Risk Behaviors among Black Men Who Have Sex with Men (MSM) and the Association with HIV Acquisition. PLoS One. 2015, 10: .
Tieu HV, Liu TY, Hussen S, Connor M, Wang L, Buchbinder S, Wilton L, Gorbach P, Mayer K, Griffith S, Kelly C, Elharrar V, Phillips G, Cummings V, Koblin B, Latkin C; HPTN 061. Sexual Networks and HIV Risk among Black Men Who Have Sex with Men in 6 U.S. Cities. PLoS One. 2015, 10: e0134085.
Williams JK, Wilton L, Magnus M, Wang L, Wang J, Dyer TP, Koblin BA, Hucks-Ortiz C, Fields SD, Shoptaw S, Stephenson R, O'Cleirigh C, Cummings V; HIV Prevention Trials Network 061 Study Team. Relation of Childhood Sexual Abuse, Intimate Partner Violence, and Depression to Risk Factors for HIV Among Black Men Who Have Sex With Men in 6 US Cities. Am J Public Health. 2015, 105: 2473-81.
Nelson LE, Wilton L, Moineddin R, Zhang N, Siddiqi A, Sa T, Harawa N, Regan R, Dyer TP, Watson CC, Koblin B, Del Rio C, Buchbinder S, Wheeler DP, Mayer KH; HPTN 061 Study Team. Economic, Legal, and Social Hardships Associated with HIV Risk among Black Men who have Sex with Men in Six US Cities. J Urban Health. 2016, : .