Behavioral Intervention for HIV/AIDS Prevention in Black MSM

Overseen By Henna Budhwani, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Not black, Not male, Not MSM, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

59 Participants Needed

Trial Summary

What is the purpose of this trial?

The overall goal of this 5-year Mentored Research Scientist Development K01-Award is to support Henna Budhwani, PhD, MPH to become an independent implementation science investigator in the field of HIV prevention. The proposed project seeks to address the HIV crisis in Alabama, where rates of undiagnosed HIV in black young men who have sex with men (YMSM, 18-29 years) exceed 20%. This project will adapt and test a behavioral intervention to promote HIV rapid testing in the community, deliver culturally appropriate prevention education, offer sociostructural support, and refer eligible participants for pre-exposure prophylaxis (PrEP). Four training objectives are proposed that are in lockstep with three specific aims.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Adapted Brothers Saving Brothers (aBSB) for HIV/AIDS prevention in Black MSM?

Research shows that behavioral interventions for men who have sex with men (MSM) can reduce unprotected sex by up to 27%, which is a key factor in preventing HIV transmission. Additionally, interventions like peer case management have shown potential in improving HIV care retention and viral suppression among Black MSM, suggesting that similar approaches in aBSB could be effective. ^{1 2 3 4 5}

Is the behavioral intervention for HIV/AIDS prevention in Black MSM safe for humans?

The research articles reviewed do not provide specific safety data for the behavioral intervention, but they do not report any safety concerns, suggesting it is generally safe for human participants. ^{2 3 6 7 8}

How is the Adapted Brothers Saving Brothers (aBSB) treatment different from other HIV prevention treatments for Black MSM?

The Adapted Brothers Saving Brothers (aBSB) treatment is unique because it is specifically tailored for Black men who have sex with men (MSM), focusing on behavioral interventions to reduce HIV risk. It adapts existing community-based outreach methods to better address the specific needs and vulnerabilities of this group, which are often not fully addressed by standard HIV prevention programs. ^{1 2 5 6 9}

Eligibility Criteria

This trial is for Black young men (18-29 years old) in Alabama who have sex with other men, can speak and read English, are sexually active, and either conduct or oversee community outreach and HIV testing. They must be willing to give informed consent.

Inclusion Criteria

You regularly spend time with children.

You help spread awareness about HIV and provide HIV testing in local communities.

I am biologically male.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Qualitative Research

Conduct in-depth interviews and focus groups to inform intervention adaptation

6 months

Multiple visits for interviews and focus groups

Intervention Adaptation

Iteratively adapt the Brothers Saving Brothers (BSB) intervention using intervention mapping

6-12 months

Pilot Testing

Conduct a hybrid type 1 effectiveness-implementation pilot study of the adapted intervention

6 months

Pre-intervention, post-intervention, 3-month, and 6-month follow-up visits

Follow-up

Participants are monitored for acceptability, feasibility, and HIV prevention outcomes

6 months

Treatment Details

Interventions

• Adapted Brothers Saving Brothers (aBSB)
• Standard Street Outreach

Trial Overview The study is testing a behavioral intervention called Adapted Brothers Saving Brothers (aBSB), compared to standard street outreach methods. The goal is to increase HIV rapid testing, provide prevention education, support services, and refer eligible individuals for PrEP.

Participant Groups

Group I: aBSB Experimental Treatment 1 Intervention

aBSB is the adaptation of BSB. BSB a two part intervention to improve rates of community-based HIV testing and prevention education in black young MSM (YMSM). BSB was developed on Information Motivation Behavioral Skills (IMB) theory. The first part of BSB uses Motivational Interviewing in a culturally appropriate way to encourage participants to accept testing and return for test results. The second part is conducted after the participant has received his result, assuming it was not reactive and offers prevention education.

Group II: Street Outreach Active Control 1 Intervention

Standard street outreach was used as the control in the original BSB trial.

Adapted Brothers Saving Brothers (aBSB) is already approved in United States for the following indications:

Approved in United States as Adapted Brothers Saving Brothers (aBSB) for:

• HIV prevention and education for black young men who have sex with men (YMSM)

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Florida State University

Lead Sponsor

Trials

234

Recruited

41,100+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

Findings from Research

A new behavioral intervention aimed at reducing HIV sexual risk behaviors among HIV-infected men who have sex with men (MSM) was developed and initially tested at Fenway Community Health in Boston, emphasizing community and stakeholder involvement.

The intervention is based on the Information, Motivation, and Behavioral Skills (IMB) model and is now ready for further testing in a randomized controlled trial, highlighting its potential effectiveness in integrating prevention into HIV care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing an HIV-prevention intervention for HIV-infected men who have sex with men in HIV care: project enhance. Knauz, RO., Safren, SA., O'Cleirigh, C., et al.[2022]

A year-long study involving Black men who have sex with men (MSM) in North Carolina showed significant reductions in risky sexual behaviors, including a 44.1% decrease in unprotected receptive anal intercourse and a 35.2% decrease in unprotected insertive anal intercourse by 12 months.

The intervention also led to increased condom use, with a 30.3% rise in the percentage of participants reporting always using condoms for receptive anal intercourse, demonstrating the efficacy of adapting existing HIV prevention strategies for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an HIV prevention intervention adapted for Black men who have sex with men. Jones, KT., Gray, P., Whiteside, YO., et al.[2022]

The BROTHERS Project successfully used a sexual partner referral approach to recruit African American MSM (men who have sex with men) with characteristics that are often associated with higher HIV infection rates, such as lower income and education levels, and higher rates of unemployment and incarceration.

This method of recruitment highlighted significant structural barriers faced by referred partners, suggesting that sexual partner referral can effectively reach individuals who might not be accessible through traditional recruitment methods, thereby improving HIV prevention efforts in underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparison of Referred Sexual Partners to Their Community Recruited Counterparts in The BROTHERS Project (HPTN 061). Hall, G., Li, K., Wilton, L., et al.[2018]

A peer case management intervention called Building Brothers Up (2BU) was implemented with 69 Black men who have sex with men (BMSM) to improve their retention in HIV primary care and support them in achieving viral suppression.

While the results did not reach full statistical significance, there was a trend suggesting that increased attendance to the peer sessions may improve the odds of achieving full viral suppression, highlighting the potential effectiveness of tailored support for this high-risk group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer Case Management Promoting Advancement Along the HIV Care Continuum Among Black Men Who Have Sex with Men Living with HIV: Building Brothers Up. Kisler, KA., Fletcher, JB., Reback, CJ.[2023]

A systematic review of 54 behavioral HIV prevention interventions involving 16,224 participants showed that these interventions significantly reduced unprotected sex among men who have sex with men (MSM) by 27% compared to minimal or no interventions.

Even when compared to standard HIV prevention methods, 16 interventions still managed to reduce unprotected sex by 17%, highlighting the effectiveness of targeted behavioral strategies in HIV prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HIV intervention research for men who have sex with men: a 7-year update. Johnson, WD., Holtgrave, DR., McClellan, WM., et al.[2018]

Face-to-face group interventions and community-level programs targeting men who have sex with men have proven effective in promoting safer behaviors to reduce the risk of HIV infection.

There is a critical need for ongoing development of tailored HIV prevention strategies that can sustain behavior changes and reach vulnerable populations, particularly young and minority men who have sex with men.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HIV prevention interventions with gay or bisexual men and youth. Kelly, JA.[2007]

In a study involving 337 young men of color who have sex with men, the Many Men, Many Voices (3MV) intervention led to significant decreases in HIV risk behaviors at both 3 and 6 months post-intervention.

Participants reported reduced instances of unprotected sex, including with multiple partners and with partners of unknown HIV status, indicating that 3MV may effectively lower HIV risk in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduced Sexual Risk Behaviors Among Young Men of Color Who Have Sex with Men: Findings from the Community-Based Organization Behavioral Outcomes of Many Men, Many Voices (CBOP-3MV) Project. Stein, R., Shapatava, E., Williams, W., et al.[2022]

The adapted intervention 'No Excuses/Sin buscar excusas' significantly reduced unprotected intercourse among 370 at-risk Latino MSM, with 59% reporting a decrease compared to 39% in the control group at three months follow-up.

Participants in the intervention group also reported increased condom use at last intercourse, indicating the effectiveness of the adaptation in promoting safer sexual practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting the VOICES HIV behavioral intervention for Latino men who have sex with men. O'Donnell, L., Stueve, A., Joseph, HA., et al.[2021]

Behavioral interventions are crucial for preventing the spread of HIV, particularly among homosexual and bisexual men, highlighting the need for targeted strategies to promote safer practices.

The review emphasizes the importance of accurately identifying factors that influence behavior change and critically evaluating interventions to ensure they are effective before widespread implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral interventions for the primary prevention of HIV infection among homosexual and bisexual men. Peterson, PL., Ostrow, DG., McKirnan, DJ.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Developing an HIV-prevention intervention for HIV-infected men who have sex with men in HIV care: project enhance. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Evaluation of an HIV prevention intervention adapted for Black men who have sex with men. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A Comparison of Referred Sexual Partners to Their Community Recruited Counterparts in The BROTHERS Project (HPTN 061). [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Peer Case Management Promoting Advancement Along the HIV Care Continuum Among Black Men Who Have Sex with Men Living with HIV: Building Brothers Up. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

HIV intervention research for men who have sex with men: a 7-year update. [2018]

6. England pubmed.ncbi.nlm.nih.gov

HIV prevention interventions with gay or bisexual men and youth. [2007]

7. United States pubmed.ncbi.nlm.nih.gov

Reduced Sexual Risk Behaviors Among Young Men of Color Who Have Sex with Men: Findings from the Community-Based Organization Behavioral Outcomes of Many Men, Many Voices (CBOP-3MV) Project. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Adapting the VOICES HIV behavioral intervention for Latino men who have sex with men. [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Behavioral interventions for the primary prevention of HIV infection among homosexual and bisexual men. [2021]