"PrEP My Way": A Novel PrEP Delivery System to Meet the Needs of Young African Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- PrEP Adherence
研究概览
简要总结
The investigators will first develop, tailor, and refine PrEP My Way for use with young women in Kisumu, Kenya (Aim 1). The design firm will use a client-centered, iterative approach, involving up to 15 individual interviews and two focus group discussions (with up to 5 women each) to optimally design the PrEP My Way kit (with instructional materials) and peer delivery system (including communication and kit delivery plans). The investigators will then test the intervention for feasibility, acceptability, and preliminary impact on PrEP adherence and program retention (Aim 2). The study team will randomize 100 Kenyan women to PrEP My Way versus standard of care (i.e., clinic-based delivery of PrEP and sexual health services) and follow them for 6 months. Feasibility will be assessed by receipt of the kit at 1, 3, and 6 months and ability to use its components per protocol. Acceptability will be determined through a mixed-methods interview at 6 months. Preliminary impact will be evaluated by dried blood spot tenofovir levels (adherence) and kit use/clinic attendance at 6 months (retention) as primary outcomes. Mediators and moderators of PrEP use (e.g., empowerment and mental health) will be explored through questionnaires at baseline and 6 months.
详细描述
- Develop PrEP My Way. Using a client-centered approach, the study team will iteratively conduct individual interviews and focus group discussions with up to 25 Kenyan women (age 16-24) to optimally design PrEP My Way (the kit with instructional materials) and peer delivery system (including phone communication and kit delivery plans).
- Assess PrEP My Way for feasibility, acceptability, and preliminary impact on PrEP adherence and program retention. The investigators will randomize 100 Kenyan women (age 16-24) to PrEP My Way versus standard of care (i.e., clinic-based delivery of PrEP and sexual health services) and follow them for 6 months. Feasibility will be assessed by receipt of the kit at 1, 3, and 6 months and ability to use its components per protocol. Acceptability will be determined through a mixed-methods interview. Preliminary impact will be evaluated by dried blood spot tenofovir levels (adherence) and kit use/clinic attendance at 6 months (retention). Potential influencing and mediating socio-behavioral factors will be explored with questionnaires at 0 and 6 months.
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
- 16 Years 至 24 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Young woman (age 16-24 years); we will enroll emancipated minors (e.g., those who have not yet attained the age of legal competency as defined by state law, but who are entitled to treatment as if they had by virtue of assuming adult responsibilities, such as self-support, marriage, or procreation) per Kenyan national guidelines [39]) or 16-17 year-olds with parental consent
- •Reported sexual activity within the past 3 months
- •Interest in taking PrEP (actual PrEP uptake is not a requirement for Aim 1)
- •Residence in the Kisumu region
- •Phone ownership
- •Ability to understand KiSwahili, DhoLuo, and/or English
排除标准
- •Inability to provide informed consent (e.g., intoxication, mental disability)
结局指标
主要结局
PrEP Adherence
时间窗: Six months
PrEP adherence as measured by detectable tenofovir-diphosphate (TFV-DP) in dried blood spots
次要结局
- Self-reported PrEP Adherence in the Past 30 Days(Months 1, 3, 6 (intervention arm))
- Number of Participants With PrEP Persistence (Kit Delivery/Pharmacy Refill)(At 6 months)
- Rates of STI Testing(Months 1, 3, and 6)
- Rates of Hormonal Contraception(Months 1, 3, and 6)
- Prevention-effective Adherence at 6 Months(Measured at 6 months)
研究者
Jessica Haberer, MD
Director of Research, Center for Global Health
Massachusetts General Hospital