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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to reduce HIV rates among young Black men who have sex with men in Alabama. It will test a program called Adapted Brothers Saving Brothers (aBSB), which provides motivational support and education to encourage HIV testing and prevention. Participants will also receive standard street outreach services for comparison. The trial seeks young Black men aged 18-29 who have male sexual partners, have not taken an HIV test in the past six months, and are not on PrEP (a preventative HIV medication). As an unphased trial, this study offers participants the chance to contribute to innovative HIV prevention strategies tailored to their community.

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 prior data suggests that this behavioral intervention is safe for participants?

Research has shown that the Adapted Brothers Saving Brothers (aBSB) program has not raised any safety concerns in past studies. Although specific safety data is unavailable, the absence of reported issues suggests it is well-tolerated. This program aims to encourage HIV testing and prevention education among young Black men who have sex with men. It employs motivational interviewing, a method that helps individuals agree to testing and follow up on their results. No negative effects have been reported, making it a safe choice for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard approaches of medication and traditional counseling for HIV prevention, the Adapted Brothers Saving Brothers (aBSB) intervention stands out by using Motivational Interviewing tailored specifically for Black young men who have sex with men (YMSM). This culturally sensitive technique engages participants more personally, encouraging them to undergo HIV testing and to return for results. Additionally, aBSB focuses on empowering individuals through prevention education after they receive negative test results, an approach designed to reduce future risk. Researchers are excited about aBSB because it not only boosts testing rates but also builds a stronger foundation for long-term prevention through culturally relevant methods.

What evidence suggests that this trial's treatments could be effective for HIV prevention in Black MSM?

Research has shown that the Brothers Saving Brothers (BSB) program successfully increased HIV testing and prevention counseling among young Black men who have sex with men. This program uses motivational interviewing to encourage open conversation and help individuals make positive health decisions. In this trial, participants may receive the updated version, called aBSB, which includes tools like quick HIV tests and information about PrEP, a medication that helps prevent HIV. Early results suggest that this new version not only increases testing but also provides culturally relevant education and support. The aim is to make it easier for participants to access and use these preventive measures. Another group in this trial will receive Standard Street Outreach, which serves as the active comparator. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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