Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jun 13, 2019
Open Peer Review Period: Jun 17, 2019 - Jul 1, 2019
Date Accepted: Aug 28, 2019
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Testing a Real-Time Tenofovir Urine Adherence Assay for Monitoring and Providing Feedback to PrEP in Kenya (the PUMA study): A Pilot Randomized Clinical Trial
ABSTRACT
Background:
Worldwide expansion of pre-exposure prophylaxis (PrEP) with oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) will be critical to ending the HIV epidemic. However, maintaining daily adherence to PrEP can be difficult and the accuracy of self-reported adherence is often limited by social desirability bias. Pharmacologic adherence monitoring (measuring drug levels in a biomatrix) has been critical to the interpretation of the PrEP trials, but testing usually requires expensive equipment and skilled personnel. We have recently developed a point-of-care (POC) immunoassay to measure tenofovir in urine, allowing real-time adherence monitoring for the first time.
Objective:
To study a point-of-care adherence metric in PrEP to support and increase adherence via an RCT
Methods:
The paper describes the protocol for a pilot randomized trial to test the acceptability, feasibility, and impact on long-term adherence of implementing a POC urine tenofovir test to provide real-time adherence feedback among women on PrEP in Kenya. Eligible women (n=100) will be HIV-negative, ≥18 years old, and recruited from a clinic in Kenya providing PrEP. Participants will be randomized 1:1 to the intervention of providing real-time feedback via the urine assay versus standard-of-care adherence counseling. Acceptability will be assessed by a quantitative survey of participants at the end of the study, as well as by qualitative data collected via in-depth interviews (n=20) and focus group discussions (n=4 groups of 5-10 women each). Feasibility will be assessed by the proportion of women retained in the study, the mean number of missed visits, the proportion of planned urine assessments completed and messages delivered, while in-depth interviews with providers will explore the ease of administering the urine test. Tenofovir levels in hair serve as the long-term metric of adherence. A linear mixed effects linear regression model will estimate the effect of the intervention versus standard-of-care on logarithmically transformed levels of tenofovir in hair.
Results:
We expect to see increases in adherence via a long-term measure using a novel point-of-care method to monitor and deliver feedback on adherence.
Conclusions:
A novel urine assay to measure and deliver information on adherence to PrEP in real-time will be tested for the first time in this trial planned among women on PrEP in Kenya. Study findings will inform a larger-scale PrEP trial assessing the impact of real-time monitoring/feedback via the urine tenofovir assay on HIV prevention. Improving adherence to PrEP will have long-term implications for the efforts to end the HIV epidemic worldwide. Clinical Trial: Clinicaltrials.gov NCT03935464
Citation
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Copyright
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