Integrated PrEP Interventions for People Who Inject Drugs in Rural Kentucky
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Number of Participants Initiating PrEP
研究概览
简要总结
The overarching goal of this study is to adapt and feasibility test an evidence-based strengths-based case management (SBCM) intervention for pre-exposure prophylaxis (PrEP) initiation, and examine preliminary efficacy of the intervention comparators (SBCM-PrEP) and (Centers for Disease Control (CDC)-PrEP). Within this context, the Specific Aims are to: 1) Assess client, provider, organization, and structural-level facilitators and barriers to integration of a PrEP focused SBCM (SBCM-PrEP) intervention into routine syringe service program (SSP) practice; 2) Adapt an evidence-based SBCM protocol to provide PrEP intervention services for people who inject drugs (PWID) in SSP sites; and, 3) Examine feasibility, acceptability and preliminary efficacy of the adapted SBCM-PrEP. 80 participants will be randomized into: CDC-PrEP (an in-use PrEP intervention based on CDC guidelines) or SBCM-PrEP.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older;
- •HIV-negative status;
- •Past month drug injection;
- •Client of SSP in targeted sites
排除标准
- •HIV-positive status
结局指标
主要结局
Number of Participants Initiating PrEP
时间窗: 6 months post-baseline
Documented PrEP initiation, measured by dispensed PrEP prescription.
次要结局
- Level of Intervention Engagement Assessed by Session Checklist(8 weeks post-baseline)
- Level of Intervention Satisfaction Assessed by the IAQ(8 weeks post-baseline)
研究者
Hilary L Surratt, PhD
Associate Professor
University of Kentucky