Telehealth Delivery (Tele-B6)

Emory University

Status: Completed

Conditions: Bisexuality; HIV Seropositivity

Treatments: Behavioral: Tele-B6; Behavioral: Delayed intervention (waitlist control)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05829759

2025P013132 (Other Identifier)

STUDY00003404

R34MH129187-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Male

Ages: 18 to 29 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Black race, inclusive of multiracial identities; male gender, inclusive of transgender 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 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 in other phases

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Tele-B6

Experimental group

Description:

The tele-B6 intervention includes six group sessions delivered over the course of six weeks. Survey assessments for the intervention group will be conducted at enrollment (baseline), 2 months (immediate post-intervention survey), 4 months (interim-survey, post-intervention), and 6 months (endline).

Treatment:

Behavioral: Tele-B6

Wait-list control -delayed intervention

Other group

Description:

Await-list control design to safeguard ethical treatment of participants by ensuring that a potentially impactful intervention will be available to all after a brief waiting period.

Treatment:

Behavioral: Delayed intervention (waitlist control)