HIV I InfectionNCT05071378
Leveraging Family-Based Assets for Black MSM In House Ball Communities
A study testing Our Family, Our Voices in people with HIV I Infection, run by State University of New York - Downstate Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV I Infection
- What is being tested?
- Our Family, Our Voices
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2020to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
HEAT Program/SUNY Downstate Medical Center
Brooklyn, New York, 11203
About this study
Official title: Leveraging Family-Based Assets for Black MSM In House Ball Communities (Our Family, Our Voices-"OFOV)
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.
Read the detailed 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.
- Conditions
- HIV I Infection
- Being tested
- Our Family, Our Voices
- Keywords
- Men, House ballroom community, transgender
- Medical subject headings
- Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Our Family, Our VoicesBehavioural
Also called an adaptation of Many Men, Many Voices
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | This arm will be enrolled in the intervention prior to any data collection Receives: Behavioral: Our Family, Our Voices |
| Wait listed control | No intervention | This arm will receive the intervention after all study data is collected |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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: 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: 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: 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: measured at time 0, 3 months and 6 months
Secondary outcomes (6)
Family based assets 1: Sense of Community Scale
The change in the aggregate scores of all study participants across the 3 times points as a secondary measurement to study impact of the intervention
Measured: measured at time 0, 3 months and 6 months
Family based assets 2: READY Tool
The change in the aggregate scores of all study participants across the 3 times points as a secondary measurement to study impact of the intervention
Measured: measured at time 0, 3 months and 6 months
Family based assets 3: Asset Inventory
The change in the Asset Inventory scores of all study participants across the 3 times points as a secondary measurement to study impact of the intervention
Measured: measured at time 0, 3 months and 6 months
Brief Resilience Scale
The change in the aggregate scores of all study participants across the 3 times points as a secondary measurement to study impact of the intervention
Measured: measured at time 0, 3 months and 6 months
Condomless anal intercourse
The change in the relative frequency = # times condoms used during anal sex / total # episodes of anal sex in the past 3 months among all study participants across the 3 times points as a secondary measurement to study impact of the intervention
Measured: measured at time 0, 3 months and 6 months
Number of sexual partners
The change in the total number of sexual partners in the past 3 months among all study participants across the 3 times points as a secondary measurement to study impact of the intervention
Measured: measured at time 0, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start17 Sep 2020
- Primary completion30 Nov 2021 (estimated)
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV I InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York - Downstate Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Jeffrey Birnbaum MD MPH, State University of New York - Downstate Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05071378
- Sponsor's protocol ID
- 1555461
- Other IDs
- 1R34MH124082-01
- Status last verified
- Sep 2021
- First submitted
- 21 May 2021
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Family-Based Assets for Black MSM In House Ball Communities (Our Family, Our Voices-"OFOV)
- ClinicalTrials.gov ID
- NCT05071378
- Acronym / sponsor ID
- 1555461
- Conditions
- HIV I Infection
- Keywords
- Men, House ballroom community, transgender
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- State University of New York - Downstate Medical CenterUniversity, hospital or other
- Collaborators
- Yale University, National Institute of Mental Health (NIMH)
- Study start
- 17 Sep 2020 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 8 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Our Family, Our VoicesThis arm will be enrolled in the intervention prior to any data collection |
| Wait listed control | No intervention | –This arm will receive the intervention after all study data is collected |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Our Family, Our VoicesAlso: an adaptation of Many Men, Many VoicesMany 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. | Behavioural | Intervention Group |
Primary outcome
HIV testing
Time frame: measured at time 0, 3 months and 6 months
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
HIV testing
Time frame: measured at time 0, 3 months and 6 months
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
PrEP use
Time frame: measured at time 0, 3 months and 6 months
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
HIV care engagement
Time frame: measured at time 0, 3 months and 6 months
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
Taking ARV treatment
Time frame: measured at time 0, 3 months and 6 months
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
Viral load measurement
Time frame: measured at time 0, 3 months and 6 months
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
6 secondary outcomes
Family based assets 1: Sense of Community Scale
Time frame: measured at time 0, 3 months and 6 months
Family based assets 2: READY Tool
Time frame: measured at time 0, 3 months and 6 months
Family based assets 3: Asset Inventory
Time frame: measured at time 0, 3 months and 6 months
Brief Resilience Scale
Time frame: measured at time 0, 3 months and 6 months
Condomless anal intercourse
Time frame: measured at time 0, 3 months and 6 months
Number of sexual partners
Time frame: measured at time 0, 3 months and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Our Family, Our Voices in people with HIV I Infection, run by State University of New York - Downstate Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV testing (time frame: measured at time 0, 3 months and 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.