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Telehealth Support for HIV
N/A
Waitlist Available
Led By Sophia A. Hussen, MD, MPH
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 2, 4, 6, 8* months
Awards & highlights
No Placebo-Only Group
Summary
This trial will assess a program to help young men living with HIV in online delivery to improve social connections and their health. It has 3 phases, engaging a community, a randomized clinical trial, and evaluation. Participants will meet with a study team and provide consent.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this is a behavioral intervention delivered via telehealth focusing on social support rather than medication, there are no direct medical side effects expected from participating in this trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0, 2, 4, 6, 8* months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 2, 4, 6, 8* months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acceptability
Change in Recruitment Rates
Change in retention
+3 moreSecondary study objectives
Change in Perception of HIV stigma
Change in Perception of Structural Racism and Discrimination.
Change in Perception of discrimination
+12 moreOther study objectives
Changes in HIV viral load
Rate of retention care
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Wait-list control -delayed interventionExperimental Treatment1 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-B6Experimental Treatment1 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).
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Who is running the clinical trial?
National Institute of Mental Health (NIMH)NIH
2,918 Previous Clinical Trials
2,739,905 Total Patients Enrolled
Emory UniversityLead Sponsor
1,697 Previous Clinical Trials
2,603,858 Total Patients Enrolled
Sophia A. Hussen, MD, MPHPrincipal InvestigatorEmory University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am either younger than 18 or older than 30.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.I am HIV positive.I am between 18 and 29 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Wait-list control -delayed intervention
- Group 2: Tele-B6
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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