NCT03414372

Tough Talks: A Disclosure Intervention for HIV+ Young Men Who Have Sex With Men (YMSM)

Tough Talks: A Disclosure Intervention for HIV+ Young Men Who Have Sex With Men

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: Male
• Age: 16 Years – 29 Years
• Healthy volunteers: Not accepted

Summary

Tough Talks is a virtual reality based HIV disclosure intervention that allows HIV+ individuals to practice disclosing to romantic partners. Tough Talks allows participants to have the opportunity to practice disclosing using a variety of strategies and experience different outcomes including acceptance, confusion, lack of HIV knowledge, and rejection.

Detailed 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 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.

Conditions

• Hiv
• HIV/AIDS
• Disclosure

Interventions

Type	Name	Description
BEHAVIORAL	Tough Talks Online	Those randomized to the online condition will receive information about how to access Tough Talks online and be given their unique log-in and password information and information on how to contact study personnel for any technical issues. Arm 1 participants will have 24-hour access to all of the intervention features and will be able to access the program for additional sessions at any time. Study staff will provide reminders using text or email (participant preference) if they have not accessed the intervention at the specified time intervals.
BEHAVIORAL	Tough Talks Clinic	Those randomized to the in-clinic condition (Arm 2) will immediately begin the Tough Talks intervention. Study staff will ensure participants are logged on and will also be available to answer technical issues should they arise. After completion, those in this arm will have an in-person follow-up visit scheduled for approximately two weeks. The in-person sessions were adapted to be delivered via Zoom or a similar HIPAA compliant platform due to the COVID-19 pandemic.
BEHAVIORAL	Standard of Care	Those randomized to the control arm (SOC) will receive a paper-based disclosure informational packet based on available Centers of Disease Control (CDC) guidance. At one-month, all participants will complete an online survey to assess intervention acceptability as well as to assess Social Cognitive Theory (SCT model) constructs.

Timeline

• Start date: 2019-05-07
• Primary completion: 2022-04-07
• Completion: 2022-04-07
• First posted: 2018-01-29
• Last updated: 2023-03-06
• Results posted: 2023-03-06

Locations

1 site across 1 country: United States