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PrEP My Way: a Hybrid Type 1 Clinical Effectiveness-implementation Trial to Promote PrEP Persistence Among Young Kenyan Women
Sponsor: Massachusetts General Hospital
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
Key Details
Gender
FEMALE
Age Range
16 Years - 24 Years
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2025-03-03
Completion Date
2028-12-01
Last Updated
2025-03-19
Healthy Volunteers
Yes
Conditions
Interventions
PrEP My Way intervention
Intervention components may be modified pending the input from Aim 1. As currently planned, the peer delivering the PrEP My Way kit will be trained to provide basic education and support use of the kit components. The peer will also have a smart phone to show an instructional video. Participants will communicate with peers via mobile phones (e.g., SMS, WhatsApp) to arrange for kit delivery at Months 1, 3, 6, 9, and 12 for those choosing the oral or ring formulations of PrEP. If the participant chooses to use injections, she will communicate with the peers to arrange for kit delivery at Months 1, 3, 5, 7, 9, 11, and 12. All deliveries will be made via unmarked vehicles at home or a preferred safe site during reasonable hours. Two-way mobile phone communication will also be used to convey test results and provide on-going support and empowerment. Follow-up with the clinic will occur at Month 12 and as needed (e.g., treatment for positive tests).
PrEP My Way intervention without STI testing
Intervention components may be modified pending the input from Aim 1. As currently planned, the peer delivering the PrEP My Way kit will be trained to provide basic education and support use of the kit components. This kit will not contain STI testing. The peer will also have a smart phone to show an instructional video. Participants will communicate with peers via mobile phones (e.g., SMS, WhatsApp) to arrange for kit delivery at Months 1, 3, 6, 9, and 12 for those choosing the oral or ring formulations of PrEP. If the participant chooses to use injections, she will communicate with the peers to arrange for kit delivery at Months 1, 3, 5, 7, 9, 11, and 12. All deliveries will be made via unmarked vehicles at home or a preferred safe site during reasonable hours. Two-way mobile phone communication will also be used to convey test results and provide on-going support and empowerment. Follow-up with the clinic will occur at Month 12 and as needed (e.g., treatment for positive tests).
Enhanced standard of care
These participants will receive PrEP (choice of oral, ring, or injection formulation), STI testing, and family planning at the clinic, as requested.
Locations (1)
Kenya Medical Research Institute
Kisumu, Kenya