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

Starting soon · Not applicable

Conditions studied: PrEP Adherence Monitoring

In brief

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.

Key facts

Study ID

NCT07725679

Run by

University of Washington

People needed

400

Starts

2027-02-01

Expected to finish

2031-08-01

Last updated by the study team

2026-07-24

Who can join

Age: 18 and older, up to 29. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• HIV uninfected
• Received daily oral PrEP one month prior, with a negative result on a urine assay one-month post PrEP initiation
• Currently attending or willing to attend one of the study clinics for PrEP refills
• Interest in continuing on oral PrEP despite adherence challenges
• No known sero-discordant relationships
• Living in Kiambu County and not planning to relocate for the next year

You may not qualify if…

• Inadequate capacity to consent or complete planned study procedures
• Do not speak English or Kiswahili
• Test positive for HIV at screening
• Concomitant participation in another PrEP adherence support study

Full record on ClinicalTrials.gov

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