A Hybrid Effectiveness-Implementation Trial of Urine Point-of-Care Assay to Increase PrEP Adherence Among Women in Kenya
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: POC urine TFV test with DLFB.
- Who it may be relevant to
- Registry conditions: PrEP Adherence Monitoring. Basic parameters: 18 years — 29 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Hybrid Effectiveness-Implementation Trial of a Urine Point-of-Care Assay to Increase PrEP Adherence Among Women in Kenya
Overview
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.
Detailed description
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.
Interventions
- Diagnostic test POC urine TFV test with DLFB
Women 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.
Primary outcome measures
- Urine TFV assay [Time frame: Month 6 post-PrEP initiation]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07725679 · STUDY00025989 · R01AI189297