IPrEP, Study #2: Evaluating the Effectiveness, Feasibility and Acceptability of Enhanced Pre-exposure Prophylaxis (PrEP) Packages for Young Female Sex Workers in Kisumu, Kenya
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- PrEP Adherence between PS and RRT arms
研究概览
简要总结
This is an open-label randomized controlled trial (n=200) in which HIV-negative young female sex workers (FSW) will be randomized to receive oral PrEP combined with specific behavioral and structural adherence interventions, either: (1) Intensive Peer Support (PS) or (2) Reminders and Resource Transfer (RRT).Respondent-driven sampling (RDS) will be used to recruit FSW as potential study participants.The study adherence interventions will be delivered over the first 12-month period in conjunction with PrEP. Thereafter, the study-specific adherence interventions will be withdrawn and PrEP continued for an additional 12 months with standard support as per national guidelines. Trial participants will be followed for a total of 24 months and attend 11 study visits over this period.
详细描述
The overall aim of the proposed study is to compare the effectiveness, feasibility and acceptability of two adherence support interventions, peer support (PS) and reminders plus resource transfer (RRT), in combination with daily oral pre-exposure prophylaxis (PrEP) to optimize PrEP adherence among young in Kisumu, Kenya. Pre-exposure prophylaxis (PrEP) is a promising biomedical HIV prevention intervention. Findings from placebo-controlled efficacy trials highlight the need for adherence support to achieve PrEP efficacy and public health impact.
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 24 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Report no previous diagnosis of HIV infection
- •Report being a cisgender female or transgender female
- •Report being between 18-24 years of age
- •Report living or working in study area
- •Report intention to stay in study area for 24 months
- •Report exchange sex with men for goods, money, favors or other services in past 3 months
- •Report no previous or recent (within the last 3 months) PrEP use
- •Able to complete study procedures in English, Kiswahili or Dholuo
- •Willingness to be randomized and adhere to study interventions according to eligibility, including PrEP
排除标准
- •Ineligible for PrEP according to Guidelines on Use of Antiretroviral Drugs for Treating and Preventing HIV Infection in Kenya - 2018 Edition (National AIDS and STI Control Program, 2018)
- •Unable to provide informed consent for study procedures
- •Any medical, psychiatric, or social condition, or occupational or other responsibility that, in the judgment of the principle investigators, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
- •Reports plan to leave area in the next 24 months
研究组 & 干预措施
Peer Support PS)
Participants randomized to the PS arm will be assigned a trained peer supporter (PSr) to enhance adherence to PrEP.
干预措施: Peer Support (PS) (Behavioral)
Peer Support PS)
Participants randomized to the PS arm will be assigned a trained peer supporter (PSr) to enhance adherence to PrEP.
干预措施: daily oral PrEP (emtricitabine 200 mg/tenofovir 300 mg) [FTC/TDF] (Drug)
Reminders and Resource Transfer (RRT)
Participants randomized to the RRT arm will receive weekly SMS text messages and resource transfers to enhance adherence to PrEP.
干预措施: Reminder and Resource Transfer (RRT) (Behavioral)
Reminders and Resource Transfer (RRT)
Participants randomized to the RRT arm will receive weekly SMS text messages and resource transfers to enhance adherence to PrEP.
干预措施: daily oral PrEP (emtricitabine 200 mg/tenofovir 300 mg) [FTC/TDF] (Drug)
结局指标
主要结局
PrEP Adherence between PS and RRT arms
时间窗: 12 months
Proportion of participants with ARV in plasma at 12-month visit
次要结局
- PrEP Adherence between PS and RRT arms, any visit(At all visits)
- PrEP adherence across PS and RRT arms(18 and 24 months)
- Feasibility of PS and RRT interventions, study visit retention(24 months)
- Scaled perception of PrEP, PS and RRT(24 months)
- Safety of PrEP including social harms(24 months)
- Discontinuation of PrEP(24 months)
- HIV risk behavior during PrEP use, unprotected sex(Baseline, 6, 12, 18, and 24 months)
- Completion of study visits between PS and RRT(12, 18 and 24 months)
- PrEP Adherence between PS and RRT arms, self-report(At all visits)
- HIV risk behavior during PrEP use, propensity score(Baseline, 6, 12, 18, and 24 months)
- Feasibility of PS and RRT interventions, intervention delivery(24 months)