PrEP My Way: a Hybrid Type 1 Clinical Effectiveness-implementation Trial to Promote PrEP Persistence Among Young Kenyan Women

NARecruitingINTERVENTIONAL
Enrollment

500

Participants

Timeline

Start Date

March 3, 2025

Primary Completion Date

September 1, 2027

Study Completion Date

December 1, 2028

Conditions
HIV/AIDS
Interventions
BEHAVIORAL

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).

BEHAVIORAL

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).

BEHAVIORAL

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.

Trial Locations (1)

Unknown

RECRUITING

Kenya Medical Research Institute, Kisumu

Sponsors
All Listed Sponsors
collaborator

Kenya Medical Research Institute

OTHER

collaborator

Jomo Kenyatta University of Agriculture and Technology

OTHER

collaborator

Kenya National AIDS & STI Control Programme

OTHER

collaborator

Emory University

OTHER

lead

Massachusetts General Hospital

OTHER