A Hybrid Effectiveness-Implementation Trial of Urine Point-of-Care Assay to Increase PrEP Adherence Among Women in Kenya

The goal of this randomized trial study is to learn if drug-level feedback counseling works to improve oral PrEP adherence in adolescent girls and young women. Researchers will compare urine TFV assay positivity between arms. All participants will attend visits on the same schedule, and receive the same SOC counseling for PrEP adherence. Participants in the intervention arm will additionally take POC urine TFV tests and receive drug-level feedback as part of that counseling.

NCT Number	NCT07725679
Lead Sponsor	University of Washington Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Conditions	PrEP Adherence Monitoring
Enrollment	400 participants
Start Date	2027-02-01
Primary Completion	2031-02-01 (estimated)
Study Completion	2031-08-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-24