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NOT YET RECRUITING
NCT07725679
NA

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

Sponsor: University of Washington

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 29 Years

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2027-02-01

Completion Date

2031-08-01

Last Updated

2026-07-24

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

POC urine TFV test with DLFB

Women randomized to the intervention arm will take POC urine TFV tests and will receive drug level feedback (DLFB) alongside SOC counseling at each visit until exit.