Tough Talks: A Disclosure Intervention for HIV+ Young Men Who Have Sex With Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Number of Participants With Suppressed Viral Load
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 29 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •HIV negative
- •assigned female at birth
- •15 or younger
- •30 or older
研究组 & 干预措施
Tough Talks Clinic
Participants will use receive Tough Talks in a clinic
干预措施: Tough Talks Clinic (Behavioral)
Tough Talks Online
Participants will use Tough Talks Online
干预措施: Tough Talks Online (Behavioral)
Standard of Care
Participants will receive the standard of care (SOC).
干预措施: Standard of Care (Behavioral)
结局指标
主要结局
Number of Participants With Suppressed Viral Load
时间窗: Month 6
Chart review or drawn for study. Viral load suppression will be defined as HIV RNA \< lower limit of detection as per the laboratory at each clinical site.
次要结局
- Mean Intention to Disclose Score(Month 6)
- Mean Disclosure Self-Efficacy Score(Month 6)
- Mean Disclosure Self-Regulation (Family) Score(Month 6)
- Mean Disclosure Outcome Expectations (Self-Evaluative) Score(Month 6)
- Mean Disclosure Outcome Expectations (Hedonistic) Score(Month 6)
- Mean Consequences of Disclosure (Rewards) Score(Month 6)
- Mean Disclosure Self-Regulation (Peers) Score(Month 6)
- Mean Disclosure Self-Regulation (Sexual Partners) Score(Month 6)
- Number of Participants Who Had Condomless Anal Intercourse With a Potentially Susceptible Partner(Month 6)
- Mean Consequences of Disclosure (Cost) Score(Month 6)