Multicomponent Intervention to Reduce Sexual Risk and Substance Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- Number of Unprotected Sex Acts in the Past 90 Days
研究概览
简要总结
The objective is to expand and refine an intervention for transgender women (TW) into a 7-session individual- and group-based intervention that is scalable for community settings to reduce sexual risk and substance use and to increase stigma-coping and risk-buffering behaviors among TW in NYC. The investigators will pilot test the intervention with 20 TW and subsequently, conduct a randomized controlled trial with 240 TW to compare the intervention to a wait list control condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older
- •Identify as a transgender woman (assigned male at birth and currently identify as female)
- •Report 3 or more acts of unprotected anal or vaginal sex in the past 90 days and at least 1 in the past 30 days
- •Report 5 or more days of illicit drug use in the past 90 days and at least 2 in the past 30
- •Provide contact information
- •Reside in the NYC metropolitan area
- •Able to complete a survey in English (Spanish-language assistance can be provided by bilingual staff)
- •Provide informed consent
排除标准
- •Unstable, serious psychiatric symptoms
- •Current suicidal/homicidal ideation
- •Evidence of gross cognitive impairment
- •Currently enrolled in a drug abuse treatment or enrolled in an HIV risk or drug use intervention study
研究组 & 干预措施
Wait List Control Condition
MI + CBST Intervention
Seven sessions of Motivational Interviewing and Cognitive Behavioral Skills Training
干预措施: MI + CBST Intervention (Behavioral)
结局指标
主要结局
Number of Unprotected Sex Acts in the Past 90 Days
时间窗: every 4 months over the course of 8 months
Decreases from Baseline in the Number of Unprotected Sex Acts in the past 90 days at 4 and 8 months
Number of Days of Drug Use in the Past 90 Days
时间窗: every 4 months over the course of 8 months
Decreases from Baseline in the Number of Days of Drug Use in the past 90 days at 4 and 8 months
次要结局
未报告次要终点
研究者
H. Jonathon Rendina
Assistant Professor
Hunter College of City University of New York