Tough Talks: A Disclosure Intervention for HIV+ Young Men Who Have Sex With Men (YMSM)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Disclosure
- HIV
- HIV/AIDS
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This study includes 3 phases: 1) formative research to refine and enhance Tough Talks with input from YMSM and their social/sexual networks; 2) a technical pilot to optimize functionality and technical performance; and 3) a three-arm RCT to evaluate efficacy and effectiveness of Tough Talks among HIV-infected YMSM. In the RCT, the investigators will conduct a combined efficacy/effectiveness trial to compare the intervention delivered online, in the clinic or standard of care clinic messaging. Primary outcomes will be assessed at intervention completion (1 month) and at 6 months and include HIV viral load and CAI.Masking: Single (Participant)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 16 years and 29 years
- Gender
- Only males
Description
During Phase I of this project, the investigators developed an iPad based virtual reality system that features three avatars, two virtual locations and three disclosure scenarios which represent a variety of common disclosure experiences and contexts experienced by YMSM. In Phase II the investigator...
During Phase I of this project, the investigators developed an iPad based virtual reality system that features three avatars, two virtual locations and three disclosure scenarios which represent a variety of common disclosure experiences and contexts experienced by YMSM. In Phase II the investigators will further enhance Tough Talks and develop a full-feature automated version to test via a multi-site, randomized controlled trial (RCT) through the newly created Center for Innovative Technologies (iTech) across the Prevention and Care Continuum, an NIH-funded center to support adolescent HIV research.
Tracking Information
- NCT #
- NCT03414372
- Collaborators
- Virtually Better, Inc.
- National Institute of Mental Health (NIMH)
- Investigators
- Principal Investigator: Kate Muessig, PhD UNC-Chapel Hill Principal Investigator: Lisa Hightow-Weidman, MD UNC-Chapel Hll
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