Mitchell John T, LeGrand Sara, Hightow-Weidman Lisa B, McKellar Mehri S, Kashuba Angela Dm, Cottrell Mackenzie, McLaurin Tony, Satapathy Goutam, McClernon F Joseph
Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, United States.
Duke Center for Addiction Science and Technology, Durham, NC, United States.
JMIR Mhealth Uhealth. 2018 Sep 10;6(9):e10456. doi: 10.2196/10456.
Pre-exposure prophylaxis (PrEP) provides a strong preventative benefit to individuals at risk for HIV. While PrEP adherence is highly correlated with its efficacy, adherence rates are variable both across and within persons.
The objective of this study was to develop and pilot-test a smartphone-based intervention, known as mSMART, that targets PrEP adherence. mSMART provides contingency management in the form of monetary incentives for daily PrEP adherence based on a real-time adherence assessment using a camera-based medication event-monitoring tool as well as medication reminders, PrEP education, individualized behavioral strategies to address PrEP adherence barriers, and medication adherence feedback.
This was a 4-week open-label, phase I trial in a community sample of young men who have sex with men already on PrEP (N=10).
Although adherence composite scores corresponding to PrEP biomarkers indicated that 90% (9/10) of the sample already had an acceptable baseline adherence in the protective range, by the end of the 4-week period, the scores improved for 30% (3/10) of the sample-adherence did not worsen for any participants. Participants reported mean PrEP adherence rates of 91% via daily entries in mSMART. At the end of the 4-week period, participants indicated acceptable ratings of satisfaction, usability, and willingness to recommend mSMART to others. There were no technical difficulties associated with smartphone compatibility, user misunderstandings about mSMART features that interfered with daily use, or study attrition.
This study is the first to apply contingency management to PrEP adherence. Findings indicated that mSMART is feasible and acceptable. Such an adherence intervention administered via a user-friendly smartphone app can allow for widespread dissemination. Future efficacy trials are needed.
ClinicalTrials.gov NCT02895893; https://clinicaltrials.gov/ct2/show/NCT02895893 (Accessed by Webcite at http://www.webcitation.org/72JskjDJq).
暴露前预防（PrEP）为有感染HIV风险的个体提供了强大的预防作用。虽然PrEP的依从性与其疗效高度相关，但依从率在不同个体之间以及个体内部存在差异。
本研究的目的是开发并进行一项基于智能手机的干预措施（称为mSMART）的试点测试，该措施旨在提高PrEP的依从性。mSMART通过基于摄像头的用药事件监测工具进行实时依从性评估，以金钱奖励的形式为每日坚持服用PrEP提供应急管理，同时还提供用药提醒、PrEP教育、解决PrEP依从性障碍的个性化行为策略以及用药依从性反馈。
这是一项针对已开始服用PrEP的男男性行为年轻人群体的社区样本进行的为期4周的开放标签I期试验（N = 10）。
尽管与PrEP生物标志物对应的依从性综合评分表明，90%（9/10）的样本在基线时就已达到可接受的处于保护范围内的依从性，但在4周结束时，30%（3/10）的样本评分有所提高，且没有任何参与者的依从性变差。参与者通过在mSMART中每日记录报告的PrEP平均依从率为91%。在4周结束时，参与者对满意度、可用性以及向他人推荐mSMART的意愿给出了可接受评分。未出现与智能手机兼容性相关的技术问题、用户对干扰日常使用的mSMART功能的误解或研究损耗。
本研究首次将应急管理应用于PrEP依从性。研究结果表明mSMART是可行且可接受的。通过用户友好的智能手机应用程序进行的这种依从性干预措施能够实现广泛传播。未来需要进行疗效试验。
ClinicalTrials.gov NCT02895893；https://clinicaltrials.gov/ct2/show/NCT02895893（通过Webcite在http://www.webcitation.org/72JskjDJq上访问）
