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Telehealth Delivery (Tele-B6)

NCT05829759 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-04-20

Study results available
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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

Interventions

BEHAVIORAL

Tele-B6

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).

BEHAVIORAL

Delayed intervention (waitlist control)

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).

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Emory University

    lead OTHER

Principal Investigators

  • Sophia A. Hussen, MD, MPH · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
29 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-18
Primary Completion
2024-11-05
Completion
2024-11-05

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05829759 on ClinicalTrials.gov