Clinical trial NCT05829759: Telehealth Delivery (Tele-B6)
Official title: Brothers Building Brothers by Breaking Barriers for Telehealth Delivery (Tele-B6)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Seropositivity
Bisexuality
Keywords: black
Multiracial identity
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-04-26
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability
timeFrame: Study Exit (up to 8* months)
measure: Change in the Acceptability Surveys
timeFrame: 2, 4, 6, up to 8* months
measure: Change in Recruitment Rates
timeFrame: 2, 4, 6, up to 8* months
measure: Change in retention
timeFrame: 2, 4, 6, up to 8* months
measure: Change in the intervention fidelity
timeFrame: 2, 4, 6, up to 8* months
measure: Safety (adverse events)
timeFrame: During study participation up to 8* months
Secondary outcomes:
measure: Change in Perception of Structural Racism and Discrimination.
timeFrame: 0, 2, 4, 6, 8* months
measure: Change in Perception of discrimination
timeFrame: 0, 2, 4, 6, up to 8* months
measure: Change in Perception of HIV stigma
timeFrame: 0, 2, 4, 6, up to 8* months
measure: Change in Perception of internalized homonegativity inventory
timeFrame: 0, 2, 4, 6, up to 8* months
measure: Qualitative description of intersectional stigma
timeFrame: Exit of study (up to 8 months)
measure: Change in intersectional stigma
timeFrame: Exit of study (up to 8 months)
measure: Change in logistical barriers
timeFrame: 0, 2, 4, 6, up to 8* months
measure: Qualitative description of logistical barriers
timeFrame: Exit of study (up to 8 months)
measure: Changes in perception of individual resilience process: Identity Affirmation
timeFrame: 0, 2, 4, 6, up to 8* months
measure: Qualitative description individual resilience process: Identity Affirmation
timeFrame: Exit of study (up to 8 months)
measure: Changes in the community resilience process: social capital
timeFrame: 0, 2, 4, 6, up to 8* months
measure: Qualitative description of the community resilience process: social capital
timeFrame: Exit of study (up to 8 months)
measure: Changes in the perception of minority stress: depression
timeFrame: 0, 2, 4, 6, up to 8* months
measure: Changes in the perception of minority stress: general well-being
timeFrame: 0, 2, 4, 6, up to 8* months
measure: Qualitative description of the minority stress
timeFrame: Exit of study (up to 8 months)
Other outcomes:
measure: Changes in HIV viral load
timeFrame: 0 and 6 months
measure: Rate of retention care
timeFrame: 0 and 6 months
Locations:
city: Atlanta
country: United States
facility: Grady Infectious Diseases Program Clinic
state: Georgia
Study officials:
affiliation: Emory University
name: Sophia A. Hussen, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: