Center for Global Health, Massachusetts General Hospital, Boston, MA, USA; Department of Medicine, Harvard Medical School, Boston, MA, USA.
Centre for Microbiology Research, Kenya Medical Research Institute, Kisumu, Kenya; Department of Global Health, University of Washington, Seattle, WA, USA.
Lancet HIV. 2021 Mar;8(3):e130-e137. doi: 10.1016/S2352-3018(20)30307-6.
BACKGROUND: Pre-exposure prophylaxis (PrEP) is highly effective for preventing HIV acquisition. However, adherence among young women (aged 18-24 years) has been challenging. SMS reminders have been shown to improve adherence to antiretroviral therapy in some contexts, including in combination with real-time adherence monitoring. We aimed to determine the effect of SMS reminders on PrEP adherence among young women in Kenya over a 2-year period. METHODS: The monitoring PrEP among young adult women (MPYA) study was an open label randomised controlled trial involving young adult women at high risk of HIV in Thika and Kisumu, Kenya. Participants were recruited from colleges, vocational institutions, informal settlements, and community-based organisations supporting young women. Women had to be aged 18-24 years and at high risk of HIV acquisition (defined as a VOICE risk score of 5 or higher, or being in a serodiscordant relationship). Study staff randomly assigned participants (1:1) to receive either SMS reminders (SMS reminder group) or no reminders (no SMS reminder group). Study group assignment was known to trial staff but masked to investigators. Reminders were initially sent daily and participants could switch to as-needed reminders (ie, sent only if they missed opening the monitor as expected) after 1 month. Study visits occurred at 1 month, 3 months, and then quarterly (ie, every 3 months). The primary outcome was PrEP adherence over 24 months measured with a real-time electronic monitor and assessed by negative binomial models adjusted for the study site and quarter among participants who collected PrEP. This trial is registered with ClinicalTrials.gov, NCT02915367. FINDINGS: Of 642 women initially approached, 348 eligible women were enrolled between Dec 21, 2016, and Feb 5, 2018. Participants were randomly assigned to either the SMS reminder group (n=173) or the no SMS reminder group (n=175). The median age was 21 years (IQR 19-22) and 228 (66%) of the 348 participants reported condomless sex in the month before baseline. 24 (14%) of the 173 participants assigned to receive daily SMS reminders later opted for as-needed reminders. 69 291 (97%) of 71 791 SMS reminders were sent as planned. Among participants collecting PrEP (thus potentially suggesting a desire for HIV protection), electronically monitored adherence averaged 26·8% over 24 months and was similar by study group (27·0% with SMS, 26·6% without SMS, adjusted incidence rate ratio 1·16 [95% CI 0·93-1·45], p=0·19). There were no serious adverse events related to trial participation; five social harms occurred in each study group, primarily related to PrEP use. INTERPRETATION: SMS reminders were ineffective in promoting PrEP adherence among young Kenyan women. Given the overall low adherence in the trial, additional interventions are needed to support PrEP use in this population. FUNDING: US National Institute of Mental Health.
背景:暴露前预防(PrEP)对预防 HIV 感染非常有效。然而,年轻女性(年龄在 18-24 岁之间)的依从性一直是一个挑战。短信提醒已被证明可以提高某些情况下抗逆转录病毒治疗的依从性,包括与实时依从性监测相结合。我们旨在确定短信提醒在肯尼亚年轻女性中预防 PrEP 依从性方面的作用,为期 2 年。
方法:监测年轻成年女性 PrEP(MPYA)研究是一项开放标签的随机对照试验,涉及肯尼亚蒂卡和基苏木高危 HIV 的年轻成年女性。参与者是从大学、职业学校、非正规住区和支持年轻女性的社区组织招募的。女性必须年龄在 18-24 岁之间,并且有感染 HIV 的高风险(定义为 VOICE 风险评分 5 分或更高,或处于血清不一致的关系中)。研究人员随机将参与者(1:1)分配到接受短信提醒(短信提醒组)或不接受提醒(无短信提醒组)。研究组的分配对试验工作人员是已知的,但对研究人员是保密的。提醒最初每天发送,参与者在 1 个月后可以切换到按需提醒(即仅在预期未打开监测器时发送)。研究访问在 1 个月、3 个月和每 3 个月(即每 3 个月)进行。主要结果是使用实时电子监测器测量的 24 个月 PrEP 依从性,通过在收集 PrEP 的参与者中调整研究地点和季度的负二项式模型进行评估。这项试验在 ClinicalTrials.gov 注册,NCT02915367。
结果:在最初接触的 642 名女性中,有 348 名符合条件的女性于 2016 年 12 月 21 日至 2018 年 2 月 5 日之间入组。参与者被随机分配到短信提醒组(n=173)或无短信提醒组(n=175)。中位数年龄为 21 岁(IQR 19-22),348 名参与者中有 228 名(66%)在基线前一个月报告有过无保护性行为。173 名被分配接受每日短信提醒的参与者中有 24 名(14%)后来选择了按需提醒。计划发送了 69291 条(97%)短信提醒中的 69 条。在收集 PrEP 的参与者中(因此可能表示希望预防 HIV),电子监测的依从性平均为 24 个月 26.8%,且两组间相似(短信组 27.0%,无短信组 26.6%,调整后的发病率比 1.16[95%CI 0.93-1.45],p=0.19)。试验参与无严重不良事件;每个研究组都发生了 5 起社会危害事件,主要与 PrEP 的使用有关。
解释:短信提醒在促进肯尼亚年轻女性 PrEP 依从性方面无效。考虑到试验中整体依从性较低,需要采取额外的干预措施来支持该人群使用 PrEP。
资助:美国国立精神卫生研究所。
Lancet HIV. 2019-9-23