Telehealth Delivery (Tele-B6)

Last updated: November 25, 2025
Sponsor: Emory University
Overall Status: Completed

Phase

N/A

Condition

Hiv Infections

Hiv/aids

Treatment

Tele-B6

Delayed intervention (waitlist control)

Clinical Study ID

NCT05829759
STUDY00003404
R34MH129187-01
2025P013132
  • Ages 18-29
  • Male

Study Summary

The research team has developed an interventional group program for young men living with HIV and will be adapting it for telehealth delivery. The purpose of the study is to determine whether or not this program can help improve social connections and the health of young men in online delivery and evaluate its potential for implementation in a community setting. The study has three phases: (1) engaging a community advisory board to create and adapt the intervention for online delivery, (2) a randomized clinical trial of the online intervention, and (3) evaluation of the program for community implementation with our partner organization. Participants in the second phase of the study will meet with a study team member to discuss the research process and provide informed consent. The community organization employees will provide consent online prior to completion of a survey and indicate whether they consent to be contacted further for in-depth interviews.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Black race, inclusive of multiracial identities; male gender, inclusive oftransgender men;

  • self-identification as gay, bisexual, or another non-heterosexual orientation,and/or any history of consensual anal or oral sex with men;

  • HIV-positive serostatus;

  • age 18-29 years inclusive;

  • residence in the Atlanta Metropolitan Statistical Area;

  • available and interested to meet for two hours weekly over a six-week period.

Exclusion

Exclusion Criteria:

  • Age < 18 years or > 30 years

  • Unwilling or unable to provide written informed consent

  • Enrollment in one phase of the study is an exclusion criterion for enrollment inother phases

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Tele-B6
Phase:
Study Start date:
April 18, 2023
Estimated Completion Date:
November 05, 2024

Study Description

Subjects will participate in synchronous, online discussion sessions via videoconference for two hours per week over a six-week period. Sessions will include engaging educational components and interactive activities including discussions of case scenarios and sharing of personal experiences where desired. At the end of each videoconference session, participants will be asked to complete a brief session evaluation form in which they will rate the content, facilitation, and overall experience for the week. The long-term goal is to improve engagement across the HIV continuum of care (HIV-CoC) by enhancing individual- and community-level resilience processes among young Black gay, bisexual and other men who have sex with men (YB-GBMSM) living with HIV. To this end, the research team has used community-based participatory research methods to develop Brothers Building Brothers by Breaking Barriers (B6), a novel group-level intervention designed to affirm intersectional identities and augment social capital among YB-GBMSM. The goal of this current study is to adapt and pilot B6 for telehealth delivery (creating tele-B6) within the context of an established community-based organization (CBO), as a strategy for enhancing feasibility and scalability prior to a larger efficacy trial.

Connect with a study center

  • Grady Infectious Diseases Program Clinic

    Atlanta, Georgia 30308
    United States

    Site Not Available

  • Grady Infectious Diseases Program Clinic

    Atlanta 4180439, Georgia 4197000 30308
    United States

    Site Not Available

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