A Hybrid Effectiveness-Implementation Trial of Urine Point-of-Care Assay to Increase PrEP Adherence Among Women in Kenya | NCT07725679

NCT07725679

Overview

NCT ID: NCT07725679
Lead Sponsor: University of WashingtonOTHER
Official Title: A Hybrid Effectiveness-Implementation Trial of a Urine Point-of-Care Assay to Increase PrEP Adherence Among Women in Kenya
Brief 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

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: Inclusion Criteria:

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

Exclusion Criteria:

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