Pharmacy and Poisons Board
Protocol No: ECCT/25/02/10 Date of Protocol: 09-08-2024
Study Title:

PrEP My Way: A hybrid type 1 clinical effectiveness-implementation trial to promote PrEP persistence among young Kenyan women
Study Objectives:

GENERAL OBJECTIVES

Overall design. We will first augment the initially developed PrEP My Way intervention to include choice of PrEP formulation and choice of adherence support (Aim 1). We will then test the effectiveness of the augmented PrEP My Way intervention (with and without testing for STIs due to cost concerns) on PrEP persistence in women with ongoing HIV prevention needs (i.e., selfreported desire for PrEP, self-reported HIV risk, condomless sex, and/or multiple sexual partners). We will also track implementation, service, and client metrics per Proctor’s framework3 (Aim 2). Finally, we will determine cost-effectiveness of the intervention (Aim 3).

Specific Objectives

1.  To augment the initially developed PrEP My Way intervention to include choice of PrEP formulation (CAB-LA, dapivirine ring, or oral FTC/ TDF) and adherence support. With a Kenyan design firm, we 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. We 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 (NASCOP) will review the design to optimize potential uptake and sustainability in routine care.

2.  To conduct a type 1 effectiveness-implementation trial of PrEP My Way. We 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. Our 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 testing, and family planning use. We will also track implementation, service, and client metrics per Proctor’s framework3.

3.  To determine cost and cost-effectiveness of PrEP My Way. We 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. We will also estimate the incremental costeffectiveness ratio in terms of cost per woman with PrEP persistence. 
Laymans Summary:

The PrEP My Way pilot intervention showed that young women preferred receiving their PrEP pills in a “kit” with other sexual health materials such as HIV tests, sanitary pads, pregnancy tests, etc. In this study, we will adapt the original PrEP My Way kit and delivery systems to include CAB-LA and the dapivirine ring. We will first adapt the original intervention through a series of focus group discussions and in-depth interviews. Then, we will conduct a clinical trial, where participants will be assigned to the enhanced Standard of Care (usual care plus choice of CAB-LA, dapivirine ring, or oral FTC/TDF), the full PrEP My Way intervention, and the intervention without STI testing.
Abstract of Study:
Young women in sub-Saharan Africa are a vulnerable population in terms of HIV acquisition with ~7,000 new infections occurring per week. Oral daily pre-exposure prophylaxis (PrEP) is a highly effective means of HIV prevention when taken regularly during periods of risk. Early experience with the global rollout of PrEP in this population indicates enthusiasm for PrEP, but also barriers to adherence and program retention.
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, our 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, we are 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, routine check-ins and/or WhatsApp groups) to the intervention. We will then test the effectiveness of the augmented PrEP My Way intervention (with and without testing for STIs 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). We will also track implementation, service, and client metrics per Proctor’s framework and determine cost-effectiveness of the intervention.