Telehealth Delivery (Tele-B6)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-18

Study Completion Date

2024-11-05

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV Seropositivity Bisexuality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Tele-B6

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).

Group Type EXPERIMENTAL

Tele-B6

Intervention Type BEHAVIORAL

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

Wait-list control -delayed intervention

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.

Group Type OTHER

Delayed intervention (waitlist control)

Intervention Type BEHAVIORAL

Wait-list control participants will be assigned to a group for initiation of the full intervention beginning at month 4 after their enrollment (i.e., beginning after they, and their corresponding intervention group, have completed their intervention and two follow-up surveys). Wait-list control participants will complete surveys at enrollment (baseline), 2 months (pre-intervention), 4 months (preintervention), 6 months (immediate post-intervention), and 8 months (post-intervention).

Interventions

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Tele-B6

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

Intervention Type BEHAVIORAL

Delayed intervention (waitlist control)

Wait-list control participants will be assigned to a group for initiation of the full intervention beginning at month 4 after their enrollment (i.e., beginning after they, and their corresponding intervention group, have completed their intervention and two follow-up surveys). Wait-list control participants will complete surveys at enrollment (baseline), 2 months (pre-intervention), 4 months (preintervention), 6 months (immediate post-intervention), and 8 months (post-intervention).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

29 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No