A Self-Assessment Intervention for Young Adult Polydrug Users at Risk for HIV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 750
- 试验地点
- 2
- 主要终点
- Days drug use in the past 90 days
研究概览
简要总结
The proposed study is a three-armed randomized clinical trial. A total of 750 clients will be randomly assigned (using a random number table) to the interviewer-administered intervention, the self-administered intervention, and waitlist control conditions upon completion of screening, informed consent, HIV pretest counseling and test administration, and collection of baseline risk behavior data. Outcomes will be measured at 3, 6 and 12 months.
详细描述
The specific aims of the 5-year study are to:
- identify the covariates of baseline substance abuse and sexual risks (including demographics, social risk measures, peer norms, abuse history, and mental health status) among a sample of 750 heterosexually active, not-in-treatment, club and prescription drug users ages 18 to 39 in Miami, Florida.
- evaluate, through random assignment, the relative effectiveness of two intervention conditions and a waitlist control in reducing sex risks and drug use, as measured at 3-, 6- and 12-month follow-ups:
- Arm 1, an interviewer-administered comprehensive health and social risk assessment intervention (CAPI Intervention) similar to the baseline instrument used in the parent grant;
- Arm 2, an identical self-administered comprehensive assessment intervention (ACASI Intervention); and
- Arm 3, a waitlist control condition (Control). Outcome measures, including past 90-day counts of unprotected sex acts and days' drug use, will be obtained from brief risk behavior inventories at baseline and follow-ups.
- conduct qualitative process evaluation research with 40 participants in each study arm to contextualize the study findings and intervention outcomes.
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 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •heterosexually active
- •ongoing club and prescription drug use
- •between 18-39 years of age
- •must go to local clubs at least two times per month
排除标准
- •no current working phone number or e-mail address
- •no intention to remain in South Florida for the next 12 months
- •new HIV diagnosis in the past 90 days
- •currently participating in a drug treatment program (excluding 12-step programs such as Alcoholics Anonymous)
研究组 & 干预措施
CAPI Intervention
an interviewer-administered comprehensive health and social risk assessment intervention
干预措施: Trans-theoretical Process of Change Model - interviewer (Behavioral)
ACASI Intervention
self-administered comprehensive health and social risk assessment intervention
干预措施: Trans-theoretical Process of Change Model-self (Behavioral)
Control
waitlist control condition
结局指标
主要结局
Days drug use in the past 90 days
时间窗: 12 months
unprotected sexual intercourse events outside of primary relationships
时间窗: 3 months
unprotected sexual intercourse events outside of primary relationship
时间窗: 12 months
次要结局
未报告次要终点
研究者
Steven Kurtz, Ph.D.
Professor
Nova Southeastern University