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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест 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.

Первичные конечные точки

• Urine TFV assay [Срок оценки: Month 6 post-PrEP initiation]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07725679 · STUDY00025989 · R01AI189297

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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