Clinical trial NCT03414372: Tough Talks: A Disclosure Intervention for HIV+ Young Men Who Have Sex With Men (YMSM)
Official title: Tough Talks: A Disclosure Intervention for HIV+ Young Men Who Have Sex With Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hiv
HIV/AIDS
Disclosure
Keywords: MSM
HIV
disclosure
eHealth
virtual reality
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Virtually Better, Inc.
name: National Institute of Mental Health (NIMH)
First posted: 2018-01-29
Enrollment: 156
Sex: MALE
Minimum age (years): 16
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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) (n=8) a technical pilot to optimize functionality and technical performance; and 3) (n=156) 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 condomless anal intercourse (CAI).
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 16-29 years
* assigned male at birth
* male identified
* HIV infected
* Owns a mobile device or has access to a laptop or desktop computer
* able to understand, read, and speak English
* Reports 1 or more episodes of anal intercourse with a male partner in the last 6 months

Exclusion Criteria:

* HIV negative
* assigned female at birth
* 15 or younger
* 30 or older

Primary outcomes:
measure: Number of Participants With Suppressed Viral Load
timeFrame: Month 6
Secondary outcomes:
measure: Number of Participants Who Had Condomless Anal Intercourse With a Potentially Susceptible Partner
timeFrame: Month 6
measure: Mean Intention to Disclose Score
timeFrame: Month 6
measure: Mean Disclosure Self-Efficacy Score
timeFrame: Month 6
measure: Mean Consequences of Disclosure (Cost) Score
timeFrame: Month 6
measure: Mean Consequences of Disclosure (Rewards) Score
timeFrame: Month 6
measure: Mean Disclosure Self-Regulation (Family) Score
timeFrame: Month 6
measure: Mean Disclosure Self-Regulation (Peers) Score
timeFrame: Month 6
measure: Mean Disclosure Self-Regulation (Sexual Partners) Score
timeFrame: Month 6
measure: Mean Disclosure Outcome Expectations (Self-Evaluative) Score
timeFrame: Month 6
measure: Mean Disclosure Outcome Expectations (Hedonistic) Score
timeFrame: Month 6
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Chapel Hill
state: North Carolina
Study officials:
affiliation: UNC-Chapel Hill
name: Kate Muessig, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UNC-Chapel Hll
name: Lisa Hightow-Weidman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hightow-Weidman LB, Muessig K, Soberano Z, Rosso MT, Currie A, Adams Larsen M, Knudtson K, Vecchio A. Tough Talks Virtual Simulation HIV Disclosure Intervention for Young Men Who Have Sex With Men: Development and Usability Testing. JMIR Form Res. 2022 Sep 8;6(9):e38354. doi: 10.2196/38354.