Ukrainian Institute on Public Health Policy, Kyiv, Ukraine.
International Charitable Foundation "Alliance for Public Health", Kyiv, Ukraine.
Int J Drug Policy. 2024 Jan;123:104284. doi: 10.1016/j.drugpo.2023.104284. Epub 2023 Dec 6.
BACKGROUND: The efficacy of daily oral pre-exposure prophylaxis (PrEP) in preventing HIV transmission among people who inject drugs (PWID) was demonstrated over a decade ago. However, only a few studies among PWID have since measured PrEP adherence using laboratory markers. METHODS: In this trial, we randomized recently injecting PWID in Kyiv, Ukraine, to receive daily oral TDF/FTC with or without SMS reminders. Enrollment and PrEP initiation took place at an HIV clinic. Subsequent visits at months 1, 3, and 6 were conducted at a community harm reduction center and included a structured interview, adherence counseling, PrEP dispensing, and dried blood spot collection. PrEP adherence was assessed using standard self-reported measures and TDF/FTC biomarkers. RESULTS: A total of 199 PWID (99 SMS, 100 No-SMS) were enrolled, of whom 24 % were women, with a median age of 37. At month 6, 79.4 % (158/199) of participants were retained, with 84 % (133/158) reporting opioid injection and 20 % (31/158) reporting stimulant injection in the past 30 days. 77 % (122/158) reported taking >95 % of PrEP doses in the past month, and 87 % reported taking the last dose within 2 days. Tenofovir diphosphate was detected in 17 % (28/158) of participants, and emtricitabine triphosphate was detected in 25 % (40/158). Only 3 % (5/158) had metabolite levels indicative of consistent PrEP uptake at 4+ doses per week. There was no association between the SMS intervention and TDF/FTC metabolite detection. CONCLUSION: Adherence to daily oral PrEP among actively injecting PWID, without daily supervision or incentives, was extremely low, despite supportive counseling and SMS reminders. We also observed a high rate of discordance between self-report and classification by a validated biomarker of adherence. Given the scarcity of evidence and emerging data suggesting low oral PrEP adherence among PWID, additional implementation studies with TDF/FTC biomarkers are needed to study whether a sufficient level of adherence to daily PrEP is attainable among PWID, especially as long-acting injectable PrEP offers a promising alternative.
背景：十多年前，每日口服暴露前预防（PrEP）在预防注射吸毒者（PWID）中的 HIV 传播方面的疗效得到了证实。然而，此后只有少数 PWID 研究使用实验室标志物来衡量 PrEP 的依从性。
方法：在这项试验中，我们在乌克兰基辅对最近开始注射吸毒的 PWID 进行了随机分组，分别接受每日口服替诺福韦/恩曲他滨（TDF/FTC）加或不加短信提醒。入组和 PrEP 起始均在一家 HIV 诊所进行。随后在第 1、3 和 6 个月在社区减少伤害中心进行随访，包括结构化访谈、依从性咨询、PrEP 配给和干血斑采集。使用标准的自我报告措施和 TDF/FTC 生物标志物评估 PrEP 的依从性。
结果：共有 199 名 PWID（99 名短信组，100 名无短信组）入组，其中 24%为女性，中位年龄为 37 岁。在第 6 个月，199 名参与者中有 79.4%（158/199）保留，84%（133/158）报告过去 30 天内有阿片类药物注射，20%（31/158）报告有兴奋剂注射。77%（122/158）报告过去一个月内服用了>95%的 PrEP 剂量，87%报告在过去两天内服用了最后一剂。在 158 名参与者中，有 17%（28/158）检测到替诺福韦二磷酸盐，有 25%（40/158）检测到恩曲他滨三磷酸盐。只有 3%（5/158）的代谢物水平表明每周至少服用 4 剂 PrEP，且依从性一致。短信干预与 TDF/FTC 代谢物检测之间没有关联。
结论：在没有每日监督或激励的情况下，积极注射吸毒的 PWID 每日口服 PrEP 的依从性极低，尽管提供了支持性咨询和短信提醒。我们还观察到自我报告和经过验证的依从性生物标志物分类之间存在很高的不一致性。鉴于 PWID 中口服 PrEP 依从性的证据稀缺，且新出现的数据表明其依从性低，需要进行更多使用 TDF/FTC 生物标志物的实施研究，以研究 PWID 是否能够达到每日 PrEP 足够的依从性，特别是因为长效注射型 PrEP 提供了一种很有前景的替代方案。
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