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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-29
SponsorUniversity of Washington

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • POC urine TFV test with DLFB

Treatment groups

400 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

University of Washington

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator