Pilot Testing a Behavioral Intervention to Incorporate Advances in HIV Prevention for Black Young MSM in Alabama

NCT03680729 | Completed Results DMC

• 1 other identifier: 520558
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV/AIDS

Keywords

Prevention; HIV/AIDS; MSM; Alabama

Outcome Measures

Primary Outcomes (2)

• Acceptability as Assessed by Participant Self-rated Satisfaction With the Intervention

  Participants rate their satisfaction with the intervention by positive response to "I like this app," scale of 1-4. Scores across participants in each arm were averaged to produce a mean score. Higher scores indicate higher acceptability.

  36 months

• Did the Study Participant Accept a Rapid HIV Test After the Delivery of the Kings or Standard Outreach Intervention?

  This information will be assessed by the return of an HIV test result.

  18 months

Secondary Outcomes (1)

• Did the Study Participant Secure a Prescription for PrEP?

  6 months

Study Arms (2)

aBSB

EXPERIMENTAL

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.

Behavioral: Adapted Brothers Saving Brothers (aBSB)

Street Outreach

ACTIVE COMPARATOR

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

Behavioral: Standard Street Outreach

Interventions

Adapted Brothers Saving Brothers (aBSB) BEHAVIORAL

This information is listed in the arm description.

aBSB

Standard Street Outreach BEHAVIORAL

This information is listed in the arm description.

Street Outreach

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: For part of the study, tentatively, only males will be eligible.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Minimally 18 years and 0 months of age
• Interacts with youth routinely
• Conducts or supervises community outreach and community-based HIV testing
• English speaking
• Can read English text
• Able and willing to provide informed consent
• Youth aged 18 years, 0 months to 29 years, 11 months
• Identifies as Black (or African American)
• Identifies as biologically male
• Is sexually active with male partners (MSM)
• Hasn't taken an HIV test in 6-months
• Is not currently on PrEP
• English speaking
• Able and willing to provide informed consent

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

University of Alabama at Birmingham (UAB)

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

• Budhwani H, Kiszla BM, Outlaw AY, Oster RA, Mugavero MJ, Johnson MO, Hightow-Weidman LB, Naar S, Turan JM. Adapting a Motivational Interviewing Intervention to Improve HIV Prevention Among Young, Black, Sexual Minority Men in Alabama: Protocol for the Development of the Kings Digital Health Intervention. JMIR Res Protoc. 2022 Jul 13;11(7):e36655. doi: 10.2196/36655.

  PMID: 35830245 RESULT

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Professor
• Organization: Florida State University

hbudhwani@fsu.edu

(850) 296-7509

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: September 21, 2018
• Study Start: February 24, 2020
• Primary Completion: January 11, 2025
• Study Completion: January 11, 2025
• Last Updated: February 9, 2026
• Results First Posted: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)