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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new online program, Tele-B6, can help young men living with HIV feel more connected and improve their health. The program will be compared to a wait-list control, where participants receive the intervention after a short delay. It targets Black men, including transgender men, who identify as gay or bisexual, are HIV-positive, and live in the Atlanta area. Participants should be willing to meet online for two hours each week for six weeks. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance community support and health outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team during the consent process.

What prior data suggests that this telehealth program is safe for young men living with HIV?

Research has shown that the Tele-B6 program, designed for young men living with HIV, has been positively received. Participants found the program acceptable and generally easy to manage. Feedback indicated that they liked the program, though new methods for delivery and implementation might be needed.

The treatment involves telehealth sessions, with no drugs or physical procedures. This typically results in fewer risks or side effects compared to medication-based treatments. While no specific negative effects have been reported, the program's emphasis on social connections and support suggests a low risk of harm.

Overall, current evidence suggests that Tele-B6 is safe for participants, making it a promising option for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Tele-B6 because it offers a unique approach to supporting people with HIV through telehealth technology. Unlike traditional face-to-face counseling or support groups, Tele-B6 provides six group sessions entirely online, making it more accessible for individuals who may face barriers to in-person participation. This method not only facilitates easier access to support but also allows for real-time interaction and feedback in a virtual setting. The convenience and potential for wider reach make Tele-B6 a promising option for enhancing support for people living with HIV.

What evidence suggests that the Tele-B6 program is effective for improving social connections and health in young men with HIV?

Research has shown that telehealth can benefit people with HIV. In one study, 65.3% of patients using telehealth reported satisfaction with how it met their medical needs. Telehealth also reduced missed appointments, which is crucial for managing HIV. In this trial, the Tele-B6 program aims to enhance social connections and health through online group sessions. These sessions are supportive and easy to access, simplifying engagement and connection for young men with HIV. Early results suggest that telehealth programs like Tele-B6 can offer valuable support to this community. ^{3 6 7 8 9}

Who Is on the Research Team?

Sophia A. Hussen, MD, MPH

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

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

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.

I can commit to a 2-hour weekly meeting for six weeks.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05829759/telehealth-delivery-tele-b6

Telehealth Delivery (Tele-B6) | Clinical Research Trial Listing 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 ...

2. rutgershealth.org rutgershealth.org/news/study-finds-telehealth-effective-hiv-patients

Study Finds Telehealth Effective for HIV Patients Of those who used telehealth, 65.3 percent reported being "very happy" or "happy" with how it met their medical care needs, and 92.4 percent ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34140812/

Telemedicine for HIV Care: Current Status and Future ... The study evaluating viral suppression during COVID-19 demonstrated lower rates of virologic suppression and lower rates of missed appointments ...

4. rutgers.edu rutgers.edu/news/study-finds-telehealth-effective-hiv-patients

Study Finds Telehealth Effective for HIV Patients Of those who used telehealth, 65.3 percent reported being "very happy" or "happy" with how it met their medical care needs, and 92.4 percent ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04489667

HIV + Service Delivery and Telemedicine Through Effective ... This study will examine the impact of using a multicomponent intervention (patient reported outcomes, training, and telemedicine) to assist with the ...

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/59/NCT05829759/ICF_000.pdf

Brothers Building Brothers by Breaking Barriers for Telehealth ... Why is this study being done? We have developed a group program for young HIV-positive men and will be adapting it for telehealth delivery.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12480793/

Oral Abstracts from the 2025 Continuum Conference - PMC Using a semi-structured guide, researchers explored current practices for HIV and NCD care and probed for opportunities and challenges related to integration.

8. go.drugbank.com go.drugbank.com/conditions/DBCOND0000267

HIV Seropositivity (DBCOND0000267) Telehealth Delivery (Tele-B6), No drug ... Consequences in Virologically Controlled HIV-infected Patients. Cannabidiol. prevention, 2, completed. NCT05571319.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9677235/

Feasibility and acceptability of B6: a social capital program ... The B6 program was highly acceptable among YB-GBMSM living with HIV; however, innovative program delivery methods and implementation strategies will be needed.