Telehealth Support for HIV

Overseen By Andres Camacho-Gonzalez, MD, MsC

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Age, Consent, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Sophia A. Hussen, MD, MPH

Principal Investigator

Emory University

Eligibility Criteria

This trial is for young Black men, including transgender men, aged 18-29 living with HIV in the Atlanta area. Participants must identify as gay or bisexual or have a history of sex with men and be able to meet weekly online for six weeks.

Inclusion Criteria

Black race, inclusive of multiracial identities

I identify as a male, including being a transgender man.

I identify as gay, bisexual, or another non-heterosexual orientation and/or have had consensual anal or oral sex with men.

Exclusion Criteria

Enrollment in one phase of the study is an exclusion criterion for enrollment in other phases

Unwilling or unable to provide written informed consent

Timeline

Community Engagement

Engaging a community advisory board to create and adapt the intervention for online delivery

Not specified

Treatment

Participants receive the tele-B6 intervention, which includes six group sessions delivered over six weeks

6 weeks

6 online sessions

Evaluation

Evaluation of the program for community implementation with partner organization

Not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Tele-B6

Trial Overview The study tests an online group program designed to improve social connections and health outcomes for young men with HIV. It involves adapting the program for telehealth delivery, randomizing participants into immediate or delayed intervention groups, and evaluating it for community use.

Participant Groups

Group I: Wait-list control -delayed intervention Experimental Treatment 1 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 II: Tele-B6 Experimental Treatment 1 Intervention

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).

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+