PrEP My Way: A Hybrid Type 1 Clinical Effectiveness-implementation Trial to Promote PrEP Persistence Among Young Kenyan Women
概览
- 阶段
- 不适用
- 干预措施
- PrEP My Way intervention
- 疾病 / 适应症
- HIV/AIDS
- 发起方
- Massachusetts General Hospital
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Months of PrEP persistence
- 状态
- 招募中
- 最后更新
- 10天前
概览
简要总结
PrEP My Way is a novel PrEP delivery system consisting of clinic-based PrEP initiation, followed by peer-delivered kits for HIV self-testing, PrEP refills, vaginal swabs for gonorrhea and chlamydia self-sampling, pregnancy tests, and contraception refills, if desired. Based on Social Cognitive Theory, the overall hypothesis is that PrEP My Way will overcome critical stigma and structural barriers that currently limit PrEP use and thus empower young women to promote their sexual health.
Preliminary testing of PrEP My Way in Kisumu, Kenya found it to be highly feasible and acceptable, but PrEP use as an oral medication was lower than expected. Now that newer PrEP formulations are becoming available, the team is adding choice of PrEP formulation (i.e., oral tenofovir/emtricitabine, injectable cabotegravir-long acting [CAB-LA], or dapivirine ring) as well as choice of adherence support from peers (e.g., SMS [short message service], routine check-ins and/or WhatsApp groups) to the intervention. The study team will then test the effectiveness of the augmented PrEP My Way intervention (with and without testing for gonorrhea and chlamydia due to cost concerns) on PrEP persistence in women with ongoing HIV prevention needs (i.e., self-reported desire for PrEP, self-reported HIV risk, condomless sex, and/or multiple sexual partners). The team will also track implementation, service, and client metrics per Proctor's framework and determine cost-effectiveness of the intervention
详细描述
1. Augment PrEP My Way to include choice of PrEP formulation (CAB-LA, dapivirine ring, or oral FTC/ TDF) and adherence support. With a Kenyan design firm, the study team will conduct 28 individual interviews and 2 workshops with young women, young men (as sexual partners), caregivers, nurses, and community health workers to adapt the kit, product guides, and delivery systems. The study team will use a nurse-delivered model for injections per Kenya regulations and a peer-delivered model for rings/oral PrEP. The Kenya National AIDS/STI Control Program will review the design to optimize potential uptake and sustainability in routine care. 2. Conduct a type 1 effectiveness-implementation trial of PrEP My Way. The study team will enroll 432 women (age 16-24) in Kisumu, Kenya, and randomize them 1:1:1 to the full intervention vs the intervention without STI testing (i.e., to assess marginal impact of the most costly kit component beyond PrEP) vs enhanced standard of care. Women in the intervention will choose bimonthly (CAB-LA) or quarterly (ring/oral) delivery. The primary outcome will be PrEP persistence by recorded injection (CAB-LA) or drug levels (ring/oral) at 9 months in women with ongoing HIV prevention needs (i.e., self-reported desire for PrEP, self-reported HIV risk, condomless sex, and/or multiple sexual partners). Secondary/additional outcomes will be persistence and adherence at other time points and with alternative definitions of HIV prevention needs, STI (sexually transmitted infection) testing, and family planning use. Investigators will also track implementation, service, and client metrics per Proctor's framework. 3. Determine cost and cost-effectiveness of PrEP My Way. Analysts will conduct micro-costing analyses through time and motion studies and use published cost data, internal reports, and supply-chain data to determine the cost of delivering each PrEP formulation and support option and the marginal cost of STI testing. The team will also estimate the incremental cost-effectiveness ratio in terms of cost per woman with PrEP persistence.
研究者
Jessica Haberer, MD
Professor of Medicine, Director of Research
Massachusetts General Hospital
入排标准
入选标准
- •young women (age 16-24 years)
- •initiating PrEP at the recruitment site (this criterion subsumes all necessary safety assessments for starting PrEP, including HIV-negative status and for those taking FTC/TDF normal renal function and lack of Hepatitis B infection)
- •resident in Kisumu County
- •phone ownership
- •ability to understand KiSwahili, DhoLuo, and/or English
排除标准
- •inability to provide informed consent (e.g., intoxication)
研究组 & 干预措施
PrEP My Way intervention
PrEP My Way is an intervention that involves peer-delivery of a kit containing PrEP and other sexual health services. Participants will be offered PrEP (if HIV-negative) per a point-of-care test, pregnancy testing, vaginal swabs for gonorrhea and chlamydia testing, condoms, and/or self-injection medroxyprogesterone, as desired. Prior to randomization, participants will decide which form of PrEP they would like to take (oral FTC/TDF, dapivirine ring, injectable cabotegravir) and adherence support.
干预措施: PrEP My Way intervention
PrEP My Way intervention without STI testing
PrEP My Way is an intervention that involves peer-delivery of a kit containing PrEP and other sexual health services. Participants will be offered PrEP (if HIV-negative) per a point-of-care test, pregnancy testing, condoms, and/or self-injection medroxyprogesterone, as desired. Prior to randomization, participants will decide which form of PrEP they would like to take (oral FTC/TDF, dapivirine ring, injectable cabotegravir) and adherence support.
干预措施: PrEP My Way intervention without STI testing
Enhanced standard of care
Prior to randomization, participants will decide which form of PrEP they would like to take (oral FTC/TDF, dapivirine ring, injectable cabotegravir).
干预措施: Enhanced standard of care
结局指标
主要结局
Months of PrEP persistence
时间窗: 9 months
We will consider receipt of CAB-LA injections as count data, we will analyze the amount of dapivirine loaded in the ring minus the residual ring level, and we will analyze the TFV-DP concentrations from dried blood spots in those participants who took oral PrEP. Each measure reflects \~8 weeks of drug coverage, such that an equivalent measure is available for all formulations.
次要结局
- Months of prevention-effective persistence(9 months)