Status:
RECRUITING
PrEP My Way: a Hybrid Type 1 Clinical Effectiveness-implementation Trial to Promote PrEP Persistence Among Young Kenyan Women
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Kenya Medical Research Institute
Jomo Kenyatta University of Agriculture and Technology
Conditions:
HIV/AIDS
Eligibility:
FEMALE
16-24 years
Phase:
NA
Brief 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 se...
Detailed Description
1. Augment PrEP My Way to include choice of PrEP formulation (CAB-LA, dapivirine ring, or oral FTC/ TDF) and adherence support. With a Kenyan design firm, the study team will conduct 28 individual int...
Eligibility Criteria
Inclusion
- young women (age 16-24 years)
- initiating PrEP at the recruitment site (this criterion subsumes all necessary safety assessments for starting PrEP, including HIV-negative status and for those taking FTC/TDF normal renal function and lack of Hepatitis B infection)
- resident in Kisumu County
- phone ownership
- ability to understand KiSwahili, DhoLuo, and/or English
Exclusion
- inability to provide informed consent (e.g., intoxication)
Key Trial Info
Start Date :
March 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06566430
Start Date
March 3 2025
End Date
December 1 2028
Last Update
March 19 2025
Active Locations (1)
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1
Kenya Medical Research Institute
Kisumu, Kenya