PrEP My Way: A Hybrid Type 1 Clinical Effectiveness-implementation Trial to Promote PrEP Persistence Among Young Kenyan Women
NCT Number: NCT06566430
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: HIV/AIDS
Interventions: BEHAVIORAL: PrEP My Way intervention|BEHAVIORAL: PrEP My Way intervention without STI testing|BEHAVIORAL: Enhanced standard of care
Sponsor: Massachusetts General Hospital
Collaborators: Kenya Medical Research Institute|Jomo Kenyatta University of Agriculture and Technology|Kenya National AIDS & STI Control Programme|Emory University
Sex: FEMALE
Age: CHILD, ADULT
Enrollment: 500
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-10-01
Completion Date: 2028-12-01

Summary:
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

Primary Outcome Measures: Months of PrEP persistence, 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., 9 months
Secondary Outcome Measures: Months of prevention-effective persistence, 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. Data will only be considered for those reporting ongoing HIV prevention needs., 9 months