Telehealth Delivery (Tele-B6)

NCT05829759 | Completed Results

• 3 other identifiers: STUDY00003404R34MH129187-012025P013132
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Seropositivity; Bisexuality

Keywords

black; Multiracial identity

Outcome Measures

Primary Outcomes (3)

• Acceptability Scale

  Post-session evaluation forms were administered after each intervention session and were evaluated collectively at the end of the study. This evaluation form included 7 statements (examples: "I felt comfortable in this virtual space", "I am confident I can apply the tools we learned today to my life") to be answered on a 5-point Likert scale (e.g., 5=strongly agree, 4=agree, 3=neutral, 2=disagree, 1=strongly disagree) as well as open ended questions (e.g., what did you like most?)

  Study Exit (up to 6 months)

• Number of Attended Sessions

  Attendance was assessed using session logs recorded at each intervention visit, capturing the number of sessions attended during the five-week intervention period. For the immediate intervention arm (Tele-B6), attendance was recorded from baseline through completion of the five-week intervention (up to 2 months post-enrollment). For the delayed intervention (wait-list control) arm, attendance was recorded during the five-week intervention delivered between months 2 and 4 of study participation.

  During intervention sessions up to 5 weeks (5 weeks total)

• Number of Participants Reporting Adverse Events (Safety)

  Review of Adverse Event Tracking Forms during study participation up to six months.

  During study participation up to 6 months

Secondary Outcomes (6)

• The Material Resources Survey

  0, 2, 4, 6 months

• Everyday Discrimination Scale

  0, 2, 4 months

• Perception of HIV Stigma Scale

  0, 2, 4, 6 months

• Personal Social Capital Scale

  0, 2, 4, 6 months

• Number of Participants With Studies Depression Scale Greater Than 16

  0, 2, 4, 6 months

Other Outcomes (10)

• Qualitative Description of Intersectional Stigma

  Exit of study (up to 6 months)

• Qualitative Description of Logistical Barriers

  Exit of study (up to 6 months)

• Perception of Individual Resilience Process: Identity Affirmation

  0, 2, 4, 6 months

Study Arms (2)

Tele-B6

EXPERIMENTAL

The tele-B6 intervention includes five group sessions delivered over the course of five 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).

Behavioral: Tele-B6

Wait-list control -delayed intervention

OTHER

A wait-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.

Behavioral: Delayed intervention (waitlist control)

Interventions

Tele-B6 BEHAVIORAL

Participants will be part of the Tele-B6 intervention that includes five group sessions delivered over the course of five 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).

Tele-B6

Delayed intervention (waitlist control) BEHAVIORAL

Wait-list control participants will be assigned to initiate the full intervention at month 2 after their enrollment (i.e., after they and their corresponding intervention group have completed their intervention and one follow-up survey). Wait-list control participants will complete surveys at enrollment (baseline), 2 months (pre-intervention), 4 months (immediate post-intervention), and 6 months (endline).

Wait-list control -delayed intervention

Eligibility Criteria

• Age: 18 Years - 29 Years
• Gender Eligibility Details: male gender, inclusive of transgender men
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 in meeting for two hours weekly over five weeks.

You may not qualify if:

• Age \< 18 years or \> 30 years
• Unwilling or unable to provide written informed consent

Sponsors & Collaborators

• Emory University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Grady Infectious Diseases Program Clinic

Atlanta, Georgia, 30308, United States

Location

Related Publications (1)

• Reed MO, Bullock M, Newman A Jr, Dutta S, Opara SCO, Tewodros T, Doraivelu K, Camacho-Gonzalez A, Murden R, Gamarel K, Harper GW, Hussen SA. Brothers Building Brothers by Breaking Barriers: Protocol for a Pilot Trial of a Telehealth Social Capital Intervention for Young Black Sexual Minority Men Living With HIV. JMIR Res Protoc. 2025 Dec 1;14:e69961. doi: 10.2196/69961.

  PMID: 41325601 DERIVED

MeSH Terms

Conditions

HIV Seropositivity; Bisexuality

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; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Sexuality; Sexual Behavior; Behavior

Results Point of Contact

• Title: Sophia A. Hussen, MD, MPH
• Organization: Emory University

shussen@emory.edu

404-616-2440

Study Officials

• Sophia A. Hussen, MD, MPH

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Public Health and Medicine

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: April 26, 2023
• Study Start: April 18, 2023
• Primary Completion: November 5, 2024
• Study Completion: November 5, 2024
• Last Updated: April 20, 2026
• Results First Posted: April 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: The de-identified dataset will be available after the study and data analysis are complete.
• Access Criteria: All requests should be sent by email to the principal investigator.

Locations

US (1)