Tough Talks: A Disclosure Intervention for HIV+ Young Men Who Have Sex With Men (YMSM)
Condition: Hiv; HIV/AIDS; Disclosure
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

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.
    

Intervention name(s): Tough Talks Online; Tough Talks Clinic; Standard of Care
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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.; 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.; 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.
Other intervention name(s): Tough Talks
Allocation: Randomized
Intervention model: Parallel Assignment
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).
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: MSM; HIV; disclosure; eHealth; virtual reality