Effect of SMS reminders on PrEP adherence in young Kenyan women (MPYA study): a randomised controlled trial.
Effect of SMS reminders on PrEP adherence in young Kenyan women (MPYA study): a randomised controlled trial.
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DOI：
10.1016/s2352-3018(20)30307-6
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发表时间：
2021-03
期刊：
影响因子：
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通讯作者：
MPYA Study Team
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作者：
Haberer JE;Bukusi EA;Mugo NR;Pyra M;Kiptinness C;Oware K;Garrison LE;Thomas KK;Musinguzi N;Morrison S;Anderson PL;Ngure K;Baeten JM;MPYA Study Team
暴露前预防（PrEP）对预防艾滋病毒感染非常有效。然而，年轻妇女的遵守一直是一个挑战。在某些情况下，短信提醒已被证明可以提高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。因此，我们评估了短信提醒对肯尼亚年轻女性在2年内坚持PrEP的影响。MPYA（在年轻成年女性中监测PrEP）研究是一项随机对照试验，涉及18-24岁的HIV高风险女性（NCT 02915367）。参与者来自大学/职业机构、非正规住区和支持青年妇女的社区组织。PrEP依从性通过实时电子监测器和药房补充来测量。研究人员以1：1的比例将参与者随机分为短信提醒组和无提醒组。提醒最初每天发送，参与者可以切换到“根据需要”提醒（即，仅当他们未按预期打开监视器时才发送）。研究人员知道研究组分配，但对研究者设盲。研究访视分别在1个月、3个月和每季度进行。通过针对研究中心和乳区调整的负二项模型，将SMS提醒对依从性的影响作为主要结局进行评估。我们在2016年12月21日至2018年2月5日期间招募了348名女性。中位年龄为21岁;三分之二的人在基线前一个月报告了无避孕套性行为。我们指定173名参与者每天接收短信提醒（24名[14%]后来选择“根据需要”提醒），175名参与者不接收提醒; 97%（N= 69，291/71，791）的短信提醒按计划发送。在接受PrEP的参与者中（因此可能表明对HIV保护的渴望），电子监测的依从性在24个月内平均为26.8%，各组相似（使用SMS的27.0%;未使用SMS的26.6%;调整后的发病率比为1.16（[95% CI 0.93，1.45; p=0.19]）。我们还发现，在评估电子监测的网站或所有参与者的依从性时，无论在6个月和24个月内是否补充PrEP，都没有显着的干预效果。此外，我们还发现，通过6个月和24个月的药房再填充数据比较研究组时，没有干预效应。没有与试验参与相关的严重不良事件;每个研究组发生5起社会危害，主要与PrEP使用相关。短信提醒在促进肯尼亚年轻妇女坚持PrEP方面无效。鉴于试验的总体依从性较低，需要额外的干预措施来支持该人群使用PrEP。
Pre-exposure prophylaxis (PrEP) is highly effective for preventing HIV acquisition. However, adherence among young women 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 therefore assessed the impact of SMS reminders on PrEP adherence among young women in Kenya over 2 years. The MPYA (Monitoring PrEP among Young Adult women) study was a randomized controlled trial involving 18–24-year-old women with high risk for HIV (NCT02915367). Participants were recruited from colleges/vocational institutions, informal settlements, and community-based organizations supporting young women. PrEP adherence was measured with a real-time electronic monitor and pharmacy refill. Study staff randomized participants 1:1 to SMS reminders versus no reminders. Reminders were initially sent daily and participants could switch to “as needed” reminders (i.e., sent only if they missed opening the monitor as expected) after 1 month. Study arm assignment was known to study staff but masked to investigators. Study visits occurred at 1 month, 3 months, and then quarterly. Effects of SMS reminders on adherence were assessed as the primary outcome by negative binomial models adjusted for study site and quarter. We enrolled 348 women between December 21, 2016 and February 5, 2018. The median age was 21 years; two-thirds reported condomless sex in the month before baseline. We assigned 173 participants to receive daily SMS reminders (24 [14%] later opted for “as needed” reminders) and 175 participants to no reminders; 97% (N=69,291/71,791) of SMS reminders were sent as planned. Among participants picking up PrEP (thus potentially indicating desire for HIV protection), electronically monitored adherence averaged 26.8% over 24 months and was similar by arm (27.0% with SMS; 26.6% without SMS; adjusted incidence rate ratio 1.16 ([95% CI 0.93, 1.45; p=0.19]). We also found no significant intervention effect when assessing electronically monitored adherence by site or for all participants regardless of PrEP refills over both 6 and 24 months. We additionally found no intervention effect when comparing study arms by pharmacy refill data over 6 and 24 months. There were no serious adverse events related to trial participation; 5 social harms occurred in each study arm, primarily related to PrEP use. 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.