Mobile Delivery of PrEP at a Syringe Services Program-A Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Intracellular Level of Tenofovir Diphosphate Levels Via Dried Blood Spot at 6-month Follow-up
研究概览
简要总结
The purpose of this study is to see if providing participants with pre-exposure prophylaxis (PrEP) medicine right away at the IDEA Exchange will help participants remain in HIV negative.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •over the age of 18
- •speak either English or Spanish
- •ability to provide informed consent
- •currently enrolled in the syringe services program
- •have a negative HIV rapid test result
- •estimated creatinine clearance > 30 ml/minute
排除标准
- •do not meet the above criteria of inclusion
- •decline to participate
- •test positive for HIV via rapid test
- •are pregnant or plan on becoming pregnant
- •have symptoms acute HIV.
- •Any other comorbidities that at the discretion of the investigator would prevent the participant from participating in the study.
研究组 & 干预措施
Rapid PrEP group
Participants will receive PrEP i.e. Descovy for 12 months at the syringe services program.
干预措施: Descovy 200Mg 25Mg Tablet (Drug)
Rapid PrEP group
Participants will receive PrEP i.e. Descovy for 12 months at the syringe services program.
干预措施: PrEP (Behavioral)
结局指标
主要结局
Intracellular Level of Tenofovir Diphosphate Levels Via Dried Blood Spot at 6-month Follow-up
时间窗: 6 months
Tenofovir diphosphate levels will be quantified using a validated dried blood spot (DBS) assay. The outcome will be reported as the mean intracellular concentration (fmol/punch) at the 6-month follow-up visit. This measure reflects intracellular drug exposure and adherence.
次要结局
- Time to PrEP Initiation Post Negative HIV Rapid Test(up to 12 months)
研究者
Hansel Tookes
Professor of Medicine
University of Miami