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

University of North Carolina (UNC)

Status: Completed

Conditions: Disclosure; Hiv; HIV/AIDS

Treatments: Behavioral: Tough Talks Clinic; Behavioral: Standard of Care; Behavioral: Tough Talks Online

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT03414372

2R44MH104102-03 (U.S. NIH Grant/Contract)

14-0345

Details and patient eligibility

About

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.

Full 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.

Enrollment: 156 patients

Sex: Male

Ages: 16 to 29 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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156 participants in 3 patient groups, including a placebo group

Tough Talks Online

Experimental group

Description:

Participants will use Tough Talks Online

Treatment:

Behavioral: Tough Talks Online

Tough Talks Clinic

Experimental group

Description:

Participants will use receive Tough Talks in a clinic

Treatment:

Behavioral: Tough Talks Clinic

Standard of Care

Placebo Comparator group

Description:

Participants will receive the standard of care (SOC).

Treatment:

Behavioral: Standard of Care