Clinical Trials Logo

Clinical Trial Summary

Despite the advent of highly effective prevention tools such as HIV pre-exposure prophylaxis (PrEP), Black men who have sex with men (MSM) continue to have the highest incidence of new HIV diagnoses in the US but are least likely to be engaged in care or to be virally suppressed. Many Black MSM face multiple stigmas but some have found refuge in the House Ball Community (HBC)-a national network of Black LGBT kinship commitments (families) that provide (informal) care giving, affirmation and survival skills-building for its members. The HBC is a large, yet underserved, community within the larger LGBT community. The investigators propose to modify a well-established skills-building and HIV prevention best-evidence, group-level intervention for HIV-negative Black MSM, Many Men Many Voices, into a family-based intervention to focus on asset-building for both HIV-negative and HIV-positive Black MSM within HBC families. Many Men Many Voices (3MV) is a six-session, group-level behavioral intervention and is the only "best evidence" intervention for Black MSM. Family-based interventions have shown HIV prevention efficacy; however, 3MV is not a family-based intervention. In 3MV, HIV-negative Black MSM are recruited into artificial group settings with individuals with whom they may have little social relationship. 3MV neither leverages the connections and commitments nor addresses the variability in HIV-status that exists in house ball families. Because Black MSM in the HBC have closer social relationships, 3MV requires adaptation to be more responsive to this social structure and dynamic. The study's goal in this clinical trial planning grant is to prepare for a cluster randomized controlled trial (CRCT) to test the effectiveness of the modified 3MV vs. standard of care in reducing new HIV infections and increasing rates of viral suppression among Black MSM in HBC families. The study's central hypothesis is that a modified 3MV intervention incorporating family asset-building will have an amplifying effect on HIV prevention and treatment outcomes. This study will provide necessary data to design and conduct a full-scale CRCT effectiveness trial of OFOV on HIV prevention and care outcomes in Black MSM. By precision-tailoring an evidence-based intervention for the HBC, the investigators' research to improve HIV testing and care engagement will complement national efforts to End the Epidemic by 2030, especially among Black MSM-the highest priority group for domestic HIV prevention.


Clinical Trial Description

Although there is access to effective HIV prevention tools such as pre-exposure prophylaxis (PrEP), Black men who have sex with men (MSM) continue to have the highest numbers of new HIV cases in the US and are unlikely to be linked to care or to have their HIV under control. Many Black MSM face many challenges because of racism and homophobia but some have found safety in the House Ball Community -an alternative family network (or houses) for Black LGBT that provide emotional and physical support and care and health information for its members. In this study, the investigators will modify a well-known, six-session group HIV prevention program for HIV-negative Black MSM, called Many Men Many Voices (3MV), and turn it into a family-based program that focuses on Black MSM with and without HIV in House Ball Communities. Family-based group programs have been shown to help prevent individuals from getting HIV; but, 3MV is not a family-based program. And in 3MV, Black MSM without HIV are usually recruited into groups with individuals they have never met before. 3MV doesn't usually use the connections between house ball family members to improve health outcomes and doesn't consider how house ball families have members who are both HIV-negative and HIV-positive. Because Black MSM in the House Ball Community have closer social relationships, 3MV requires modification to better fit the house family structure and how family members interact with each other. The goal in this study is to prepare for a larger study to test if the modified 3MV program works better to reduce new HIV infections and improve the health of HIV-positive Black MSM in the House Ball Community families compared to a no group program. The investigators predict that a modified version of the 3MV group program for the House Ball Community families will work better than the original version of 3MV on HIV prevention and treatment outcomes. This study will provide important information to help us design and conduct a larger study of this modified version of 3MV called "Our Family Our Voices" on HIV prevention and care outcomes in Black MSM. By tailoring a program for the House Ball Community, this research to improve HIV testing and participation in care will better serve Black MSM-the highest priority group for HIV prevention in the United States. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05071378
Study type Interventional
Source State University of New York - Downstate Medical Center
Contact
Status Enrolling by invitation
Phase N/A
Start date September 17, 2020
Completion date November 30, 2021

See also
  Status Clinical Trial Phase
Completed NCT04585737 - Efficacy of Switching to DTG/3TC in Virologically-suppressed Adults Currently on B/F/TAF Phase 4
Not yet recruiting NCT06282783 - Studying Topiramate for Re-Activating the HIV-1 Reservoir Phase 1/Phase 2
Not yet recruiting NCT03622177 - Role of the IL33/Amphiregulin Pathway as a Potential Therapeutic Target in HIV Infection
Recruiting NCT05854381 - To Investigate Safety, Reactogenicity and Immunogenicity of VIR-1388 Compared With Placebo in Participants Without HIV Phase 1
Completed NCT05421806 - A Cohort Study of Use of Doravirine (DOR) Based Regimens in Clinical Practice in Europe DoRavirine Europe Real World/
Completed NCT04568395 - Acute Effects of TCIG vs ECIG in PLWH N/A
Recruiting NCT04887675 - Neuroinflammation and Neurodegeneration in HIV-positive Subjects Switched and Initially Treated With INSTI N/A
Recruiting NCT04820933 - Doravirine Versus Integrase Inhibitors on Backbone of Emtricitabine and Tenofovir Alafenamide in HIV Early Phase 1
Completed NCT03584048 - Charlotte Retention in Care Study
Recruiting NCT06005610 - Estradiol Therapy In Transgender Women to Research Interactions With HIV Therapy Phase 2
Recruiting NCT05947890 - Evaluating the Safety and Immunogenicity of MTBVAC in Adolescents and Adults Living With and Without HIV in South Africa Phase 2
Recruiting NCT05187429 - Low Dose Nivolumab in Adults Living With HIV on Antiretroviral Therapy Phase 1/Phase 2
Active, not recruiting NCT05601128 - A Study Evaluating the Pharmacokinetics, Efficacy, Safety and Tolerability of CABENUVA Phase 3
Completed NCT04675255 - Assessing the Impact of INSTI to PI Switch on Insulin Sensitivity and Fat Metabolism N/A
Recruiting NCT05110963 - Intervention to Improve HIV Care Retention by Addressing Stigma Stigmatized Environments N/A
Completed NCT03986099 - Community Based Antiretroviral Therapy (CBART) Among Children on Chronic ART N/A
Completed NCT04971343 - Access HIV Ag/Ab Combo Assay - European Union (EU) Clinical Trial Protocol
Completed NCT04725877 - VIR-1111: A Prototype Human CMV-based Vaccine for Human Immunodeficiency Virus (HIV) in Healthy Volunteers Phase 1
Recruiting NCT04618198 - Early Empiric Anti-Mycobacterium Tuberculosis Therapy for Sepsis in Sub-Saharan Africa Phase 3
Completed NCT05383456 - The Visceral Adiposity Measurement and Observation Study