Leveraging Family-Based Assets for Black MSM In House Ball Communities

NCT05071378 | Unknown

• 2 other identifiers: 15554611R34MH124082-01
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV I Infection

Keywords

Men; House ballroom community; transgender

Outcome Measures

Primary Outcomes (6)

• HIV testing

  primary outcome for HIV-negative participants: the change in the proportion of those who are HIV-negative having been tested for HIV at the three time point s

  measured at time 0, 3 months and 6 months

• HIV testing

  primary outcome for HIV-negative participants: total change in the number of HIV test results among those who are HIV-negative and have been tested for HIV at the 3 time points

  measured at time 0, 3 months and 6 months

• PrEP use

  primary outcome for HIV-negative participants: the change in the proportion of those who are HIV-negative who report taking PrEP at the three time points

  measured at time 0, 3 months and 6 months

• HIV care engagement

  primary outcome for participants living with HIV: the change in the proportion of those living with HIV who report medical visits at the three time points

  measured at time 0, 3 months and 6 months

• Taking ARV treatment

  primary outcome for participants living with HIV: the change in the proportion of those living with HIV who report taking ARV treatment at the three time points

  measured at time 0, 3 months and 6 months

• Viral load measurement

  primary outcome for participants living with HIV: the change in the proportion of those living with HIV with undetectable HIV viral loads among those taking ARV treatment at the 3 time points

  measured at time 0, 3 months and 6 months

Secondary Outcomes (6)

• Family based assets 1: Sense of Community Scale

  measured at time 0, 3 months and 6 months

• Family based assets 2: READY Tool

  measured at time 0, 3 months and 6 months

• Family based assets 3: Asset Inventory

  measured at time 0, 3 months and 6 months

• Brief Resilience Scale

  measured at time 0, 3 months and 6 months

• Condomless anal intercourse

  measured at time 0, 3 months and 6 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

This arm will be enrolled in the intervention prior to any data collection

Behavioral: Our Family, Our Voices

Wait listed control

NO INTERVENTION

This arm will receive the intervention after all study data is collected

Interventions

Our Family, Our Voices BEHAVIORAL

Many Men, Many Voices (3MV) is a seven-session, group-level intervention developed to prevent HIV and sexually transmitted diseases (STDs) among black men who have sex with men (MSM) who may or may not identify themselves as gay. The intervention addresses factors that influence the behavior of black MSM: cultural, social, and religious norms; interactions between HIV and other STDs; sexual relationship dynamics; and the social influences that racism and homophobia have on HIV risk behaviors. Our Family, Our Voices seeks to create an adaptation of Many Men, Many Voices specifically tailored to young people who are members of the house ball community by incorporating elements of family support and resilience afforded to participants in the intervention.

Also known as: an adaptation of Many Men, Many Voices

Intervention Group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Gender Eligibility Details: At least half of the participating house members must be Black men who have sex with men. Black MSM must also currently self-identify as cisgender or transgender man, report anal sex with another man at least once within the previous six months (note: other HBC family members can identify as any gender).
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Eligibility for the study will be determined primarily at the family-level. At least 12 members of the same HBC family must be willing to participate together, of which at least half the participating members must be Black MSM.
• Participating family members must reside in the New York City metro area.
• Black MSM participants must be at least 18 years old.

You may not qualify if:

• Not being a member of a house ballroom community family
• Residing outside the New York City
• Being a member of a house ballroom community family that has been established less than 12 months

Sponsors & Collaborators

• State University of New York - Downstate Medical Center: lead
• Yale University: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

HEAT Program/SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

MeSH Terms

Conditions

Multiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Model Details: The investigators will determine the feasibility, acceptability and a preliminary estimate of effect size of an evidence-based HIV prevention intervention for Black MSM adapted for HIV status-neutral use with families in the HBC (called: OFOV). The eight-step ADAPT-ITT framework will guide the approach to enhance intervention content to incorporate an asset-building framework. Aim 1 will lead to the combined multi-level intervention adapted to improve congruence with the realities of HBC families. Aim 2 will assess the feasibility and acceptability of conducting a cluster randomized controlled trial of OFOV with a standard of care wait-listed control group. Data collected from the CRCT will be used to estimate the effect size of OFOV on HIV testing and PrEP use (primary outcome for HIV-negative participants), HIV care engagement and use of ARV treatment (primary outcome for PLHIV), as well as number of family-based assets and sexual health measures (status-neutral secondary outcomes).

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: October 8, 2021
• Study Start: September 17, 2020
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: October 8, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)