500
Participants
Start Date
March 3, 2025
Primary Completion Date
September 1, 2027
Study Completion Date
December 1, 2028
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.
RECRUITING
Kenya Medical Research Institute, Kisumu
Collaborators (1)
Kenya Medical Research Institute
OTHER
Jomo Kenyatta University of Agriculture and Technology
OTHER
Kenya National AIDS & STI Control Programme
OTHER
Emory University
OTHER
Massachusetts General Hospital
OTHER