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.
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
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
Parallel
POC urine TFV test with DLFB
Diagnostic testWomen 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.
Urine TFV assay
To determine the short-term adherence to PrEP between arms, we will look at the difference in the population proportions via a positive result on urine TFV assay over follow-up.
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University of Washington
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
