CompletedNot Applicable

Telehealth Delivery (Tele-B6)

United States60 participantsStarted 2023-04-18

Plain-language 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.

Who can participate

Age range

18 Years – 29 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 in meeting for two hours weekly over five weeks. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Acceptability Scale

Timeframe: Study Exit (up to 6 months)

Number of Attended Sessions

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

Number of Participants Reporting Adverse Events (Safety)

Timeframe: During study participation up to 6 months

Trial details

NCT IDNCT05829759

SponsorEmory University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-05

Results submitted2025-12-08

View on ClinicalTrials.gov More HIV Seropositivity trials