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

NCT07725679 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-07-24

No results posted yet for this study

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.

Conditions

  • PrEP Adherence Monitoring

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.

Sponsors & Collaborators

Principal Investigators

  • Jennnifer Velloza, PhD, MPH · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
29 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2027-02-01
Primary Completion
2031-02-01
Completion
2031-08-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07725679 on ClinicalTrials.gov