Drain Paul, Ngure Kenneth, Mugo Nelly, Spinelli Matthew, Chatterjee Purba, Bacchetti Peter, Glidden David, Baeten Jared, Gandhi Monica
University of Washington, Seattle, WA, United States.
Jomo Kenyatta University of Agriculture and Technology, Nairobi, Kenya.
JMIR Res Protoc. 2020 Apr 2;9(4):e15029. doi: 10.2196/15029.
The worldwide expansion of preexposure prophylaxis (PrEP) with oral tenofovir-disoproxil-fumarate/emtricitabine 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 interpreting 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.
The goal of this study is to examine a point-of-care adherence metric in PrEP to support and increase adherence via a randomized controlled trial.
The paper describes the protocol for a pilot randomized controlled trial to test the acceptability, feasibility, and impact on long-term adherence of implementing a POC urine test to provide real-time adherence feedback among women on PrEP. Eligible women (n=100) will be HIV-negative, ≥18 years old, and recruited from a clinic in Kenya that provides PrEP. Participants will be randomized 1:1 to the intervention of providing real-time feedback via the assay versus standard of care adherence counseling. Acceptability by participants will be assessed by a quantitative survey, as well as by qualitative data collected via in-depth interviews (n=20) and focus group discussions (n=4 groups, 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 (n=8) will explore the ease of administering the urine test. Tenofovir levels in hair will serve as long-term adherence metrics. A linear mixed-effects model will estimate the effect of the intervention versus standard of care on logarithmically transformed levels of tenofovir in hair.
This study has been funded by the National Institute of Health, approved by the Kenya Medical Research Institute Institutional Review Board, and will commence in June 2020.
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 trial assessing the impact of real-time adherence monitoring/feedback on HIV prevention. Improving adherence to PrEP will have long-term implications for efforts to end the HIV epidemic worldwide.
ClinicalTrials.gov NCT03935464; https://clinicaltrials.gov/ct2/show/NCT03935464.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/15029.
口服替诺福韦酯/恩曲他滨暴露前预防（PrEP）在全球范围内的推广对于终结艾滋病流行至关重要。然而，坚持每日服用PrEP可能具有挑战性，且自我报告的服药依从性准确性常常受到社会期望偏差的限制。药物依从性监测（测量生物基质中的药物水平）对于解读PrEP试验至关重要，但检测通常需要昂贵的设备和专业人员。我们最近开发了一种即时检验（POC）免疫测定法来检测尿液中的替诺福韦，从而首次实现了实时依从性监测。
本研究的目的是通过一项随机对照试验，检验PrEP中的即时检验依从性指标，以支持并提高依从性。
本文描述了一项试点随机对照试验的方案，该试验旨在测试实施POC尿液检测以向接受PrEP的女性提供实时依从性反馈的可接受性、可行性及其对长期依从性的影响。符合条件的女性（n = 100）将为HIV阴性，年龄≥18岁，从肯尼亚一家提供PrEP的诊所招募。参与者将按1:1随机分配至通过检测提供实时反馈的干预组和标准护理依从性咨询组。将通过定量调查以及通过深入访谈（n = 20）和焦点小组讨论（n = 4组，每组5 - 10名女性）收集的定性数据来评估参与者的可接受性。可行性将通过研究中保留的女性比例、错过就诊的平均次数、完成的计划尿液评估比例和发送的信息来评估，同时对提供者进行深入访谈（n = 8）将探讨尿液检测的操作便利性。头发中的替诺福韦水平将作为长期依从性指标。线性混合效应模型将估计干预措施与标准护理对头发中替诺福韦对数转换水平的影响。
本研究已获得美国国立卫生研究院的资助，经肯尼亚医学研究所机构审查委员会批准，并将于2020年6月开始。
一种用于测量并实时提供PrEP依从性信息的新型尿液检测方法将在本次针对肯尼亚接受PrEP的女性进行的试验中首次进行测试。研究结果将为评估实时依从性监测/反馈对艾滋病预防影响的更大规模试验提供参考。提高PrEP的依从性对于全球终结艾滋病流行的努力具有长期意义。
ClinicalTrials.gov NCT03935464；https://clinicaltrials.gov/ct2/show/NCT03935464。
国际注册报告识别码（IRRID）：PRR1-10.2196/15029。
