Adherence challenges with oral tenofovir-based pre-exposure prophylaxis (PrEP) are common. We developed a point-of-care assay to objectively assess tenofovir in urine and conducted a pilot trial examining the impact of counselling informed by use of this urine assay on long-term PrEP adherence. This randomised trial enrolled women not in serodiscordant partnerships 3 months after PrEP initiation at the Kenya Medical Research Institute to compare standard-of-care adherence counselling versus counselling informed by the urine assay (urine-test counselling group) every 3 months for 12 months. In the standard of care group, urine samples were stored and tested at study end without participant feedback. Here we report the adherence primary outcome of hair concentrations of tenofovir at 12 months as a long-term metric (undetectable levels defined long-term non-adherence), as well as urine concentrations of tenofovir at each visit as a short-term adherence metric and acceptability of the assay assessed by quantitative surveys. Data were analysed by randomisation group. This completed trial was registered with (). From March 17, 2021 to Jan 18, 2022 we enrolled 49 women in the urine-test counselling group and 51 in the standard of care group; retention was 86 (86%) of 100. Nine (21%) of 42 in the urine-test counselling group had hair samples at 12 months with tenofovir concentrations below the limit of quantification compared with 15 (37%) of 41 in the standard of care group. The relative odds of long-term non-adherence in the standard of care group compared with urine-test counselling were 3·53 (95% CI 1·03–12·03; p=0·044). Pre-intervention, urine tenofovir was detectable in 65% in the urine-test counselling group and 71% in the standard of care group (p=0·68). At 12 months, 31 (72%) of 43 in the intervention group had detectable urine tenofovir compared with 19 (45%) of 42 in the standard of care group (p=0·0015). 40 (93%) of 43 participants liked the test very much and only one disliked the test. One participant in the standard of care group was withdrawn at the 6-month visit due to HIV seroconversion. A low-cost urine tenofovir assay to inform PrEP counselling resulted in improvement in both short-term and long-term metrics of adherence. This urine tenofovir assay could help to improve long-term PrEP adherence. National Institute of Allergy and Infectious Diseases and National Institutes of Health.

中文翻译：

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护理点尿液替诺福韦检测对肯尼亚女性艾滋病毒暴露前预防依从性的影响：一项随机试点试验


基于口服替诺福韦的暴露前预防 (PrEP) 的依从性挑战很常见。我们开发了一种即时检测方法来客观评估尿液中的替诺福韦，并进行了一项试点试验，检查通过使用这种尿液检测提供的咨询对长期 PrEP 依从性的影响。这项随机试验在肯尼亚医学研究所开始 PrEP 3 个月后招募了未建立血清不一致伙伴关系的女性，以比较标准护理依从性咨询与每 3 个月一次尿液检测（尿液检测咨询组）提供的咨询，持续 12 个月。在标准护理组中，尿液样本在研究结束时被储存和测试，没有参与者反馈。在此，我们报告了 12 个月时头发中替诺福韦浓度的依从性主要结果作为长期指标（检测不到的水平定义为长期不依从），以及每次就诊时的替诺福韦尿液浓度作为短期依从性指标以及通过定量调查评估的测定的可接受性。按随机分组分析数据。该已完成的试验已在 () 处注册。从2021年3月17日到2022年1月18日，我们招募了49名女性参加尿液检测咨询组，51名女性参加标准护理组；保留率为 100 人中的 86 人 (86%)。尿检咨询组中 42 人中有 9 人 (21%) 在 12 个月时的头发样本中替诺福韦浓度低于定量限，而标准组中 41 人中有 15 人 (37%) 的头发样本中替诺福韦浓度低于定量限的护理组。与尿检咨询相比，标准护理组长期不遵守的相对几率为 3·53 (95% CI 1·03–12·03；p=0·044)。干预前，尿液检测咨询组中可检测到替诺福韦的比例为 65%，标准护理组中为 71% (p=0·68)。 12 个月时，干预组 43 人中有 31 人 (72%) 尿液中可检测到替诺福韦，而标准治疗组 42 人中有 19 人 (45%) 尿液可检测到替诺福韦 (p=0·0015)。 43 名参与者中有 40 人（93%）非常喜欢该测试，只有 1 人不喜欢该测试。标准治疗组的一名参与者在 6 个月的访视中因 HIV 血清转化而退出。用于为 PrEP 咨询提供信息的低成本尿液替诺福韦测定可改善短期和长期的依从性指标。这种尿液替诺福韦测定有助于提高长期 PrEP 依从性。国家过敏和传染病研究所和国立卫生研究院。