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Recruiting NCT05467306

Enhancing PrEP Outcomes Among Kenyan Adolescent Girls and Young Women With a Novel Pharmacy-based PrEP Delivery Platform

Trial Parameters

Condition Hiv
Sponsor University of Washington
Study Type INTERVENTIONAL
Phase N/A
Enrollment 1,900
Sex FEMALE
Min Age 15 Years
Max Age 24 Years
Start Date 2023-05-17
Completion 2026-03-31
Interventions
Nurse-Navigator Enhanced PrEP Support

Brief Summary

The investigators will conduct a cluster RCT in Kisumu, Kenya to determine the effect of nurse-navigators on PrEP initiation, persistence, and adherence among AGYW seeking contraception within a pharmacy-based PrEP delivery model. The study will randomize 20 retail pharmacies offering PrEP (10 pharmacies per randomization arm) and will enroll 1900 AGYW seeking contraception. All participants will be enrolled following purchase of a contraceptive method, offered PrEP (daily oral PrEP or the DPV-VR) and followed for 10 months. The study will quantify and compare PrEP initiation, persistence, and adherence at the pharmacy-level between randomization arms, in addition to several secondary and exploratory outcomes.

Eligibility Criteria

Inclusion Criteria: * Female gender * Seeking contraception (EC, OCP, injectables, implants, and condoms) from the retail pharmacy site * Age between ≥14 and \<25 years old * Willingness to receive PrEP screening per national guidelines including HIV testing * Not currently taking PrEP * Able and willing to provide informed consent for participation Exclusion Criteria: * Male gender * Not seeking contraception (EC, OCP, injectables, implants, and condoms) from the retail pharmacy site * Age \<14 and \>24 years old * Not willing to receive PrEP screening per national guidelines including HIV testing * Currently taking PrEP * Not able and/or willing to provide informed consent for participation

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