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

This will be a randomized trial conducted in four public clinic facilities in Kiambu County. We will enroll 400 AGYW ages 15-29 who have been using oral PrEP for one month and will randomize them 1:1 to our DLFB intervention or standard-of-care (SOC). Enrolled AGYW will return for follow-up two months after enrollment and quarterly thereafter through 12 months. Intervention participants will receive DLFB counseling using our urine TFV assay at all visits. SOC arm participants will receive standard counseling; urine will be collected longitudinally but will be tested at study end. We will collect behavioral data via computer assisted self-interviewing (CASI) surveys. Our primary outcome will be the proportion of positive urine assays at each visit. We will compare urine TFV assay positivity between arms using a repeated measures mixed effects logistic regression model.

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