Acceptability and feasibility of a urine-based tenofovir adherence assay for monitoring and providing feedback on PrEP adherence in Kenya.

Objective measures of oral PrEP adherence - especially point-of-care (POC) measures that enable real-time assessment, intervention, and feedback - have the potential to improve adherence. Our team previously developed and validated a novel urine-based POC metric of PrEP adherence. In this study, we sought to determine whether this assay is acceptable and feasible among women taking PrEP and PrEP providers in Kenya. We conducted a trial comparing PrEP adherence counseling using the assay (intervention) versus standard-of-care counseling. We conducted in-depth interviews (IDIs) with intervention-arm participants (n = 20), and focus group discussions (n = 18) after the final (12-month) follow-up visit. We also conducted IDIs with purposively-sampled healthcare providers (HCPs) (n = 8) who administered the assay. The assay was highly acceptable among participants and HCPs as it was perceived to be accurate, could provide evidence of adherence, provides real-time results, and improves participant and provider relationship. HCPs reported that the assay facilitated counseling, seemed to increase adherence, and would be feasible to implement in routine care settings. Both participants and HCPs reported concerns about the assay related to the fear of being stigmatized for negative results, and test accessibility. Future studies should evaluate the impact of this novel test on adherence patterns over time in diverse populations.Trial registration: ClinicalTrials.gov identifier: NCT03935464.