RecruitingNot ApplicableNCT05467306

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

Sponsor

University of Washington

Enrollment

1,900 participants

Start Date

May 17, 2023

Study Type

INTERVENTIONAL

Conditions

HIV

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

Sex: FEMALEMin Age: 15 YearsMax Age: 24 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a pharmacy-based model for delivering HIV prevention medication (PrEP) to young women in Kenya who visit pharmacies for contraception. **You may be eligible if...** - You are a female aged 14–24 - You are visiting a retail pharmacy to get contraception - You are not currently taking PrEP - You are willing to be screened for HIV and provide consent **You may NOT be eligible if...** - You are male - You are not seeking contraception at a retail pharmacy - You are younger than 14 or older than 24 - You are currently taking PrEP - You are unwilling to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALNurse-Navigator Enhanced PrEP Support

Pharmacies randomized to the nurse-navigator model will receive tailored support counseling, in addition to receipt of standard PrEP services. Support counseling by nurse-navigators will provide educational messaging tailored to AGYW and actionable advice targeting PrEP persistence and adherence and/or FP topics, and will address participants' questions related to the content. Counseling will include adherence encouragement (IMB domain: motivation), PrEP efficacy and safety (IMB domain: information), self-efficacy for prevention of HIV, support for potential PrEP side effects, behavioral skills (tips for remembering PrEP medications, IMB domain: behavioral skills) and strategies for remembering PrEP refill schedules. During enrollment, the nurse-navigator will explain that support counseling is voluntary and that the nurse will also be available at the pharmacy to address concerns or questions whenever they arise outside of scheduled visits.

Locations(1)

Kenya Medical Research Institute

Kisumu, Kenya

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NCT05467306

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