Randomized Controlled Trial of a Mobile Health Intervention to Promote Retention and Adherence to Preexposure Prophylaxis Among Young People at Risk for Human Immunodeficiency Virus: The EPIC Study
Randomized Controlled Trial of a Mobile Health Intervention to Promote Retention and Adherence to Preexposure Prophylaxis Among Young People at Risk for Human Immunodeficiency Virus: The EPIC Study
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DOI：
10.1093/cid/ciy810
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发表时间：
2019-06-15
影响因子：
11.8
通讯作者：
Fuchs, Jonathan D.
中科院分区：
文献类型：
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作者：
Liu, Albert Y.;Vittinghoff, Eric;Fuchs, Jonathan D.
背景男男性行为的青年男子最容易感染人体免疫机能丧失病毒（艾滋病毒）。虽然暴露前预防（PrEP）已被证明是有效的，但在年轻人中的依从性和保留率很低。我们进行了一项随机对照试验，以评估针对年轻人的双向短信干预（PrEPmate）对研究保留和PrEP依从性的影响。在芝加哥安全网系统内启动PrEP的HIV风险年轻人以2：1的比例随机接受PrEPmate或标准护理（SoC）36周。主要保留结果是研究访视完成，主要依从性结果是在第4、12、24和36周评估的二磷酸替诺福韦酯（TFV-DP）浓度≥ 700 fmol/punch（与≥ 4剂/周一致）。使用具有稳健标准误的广义估计方程logistic模型评估PrEPmate对保留和依从性的影响。从2015年4月到2016年3月，121名参与者入组（平均年龄24岁; 27%黑人，36%拉丁美洲人）。接受PrEPmate的参与者更有可能参加研究访视（86% PrEPmate vs. 71% SoC，比值比[OR] = 2.62，95%置信区间[CI] 1.24-5.54），并且TFV-DP水平与≥ 4剂/周一致（72% PrEPmate vs. 57% SoC，OR = 2.05，95% CI 1.06-3.94）。PrEPmate的疗效在年龄、种族/民族、教育或保险方面没有显著差异。总体而言，88%的人报告PrEPmate非常/有点帮助，92%的人会向其他人推荐PrEPmate。交互式短信干预具有很高的可接受性，并显着增加研究访视保留和PrEP依从性的年轻人在艾滋病毒感染的风险。
Background. Young men who have sex with men are among the most vulnerable to human immunodeficiency virus (HIV) infection. Although preexposure prophylaxis (PrEP) has demonstrated effectiveness, adherence and retention have been low among youth.Methods. We conducted a randomized controlled trial to evaluate the impact of a youth-tailored, bidirectional text-messaging intervention (PrEPmate) on study retention and PrEP adherence. Young individuals at risk for HIV initiating PrEP within Chicago's safety-net system were randomized 2: 1 to receive PrEPmate or standard of care (SoC) for 36 weeks. The primary retention outcome was study-visit completion, and the primary adherence outcome was tenofovir diphosphate (TFV-DP) concentrations >= 700 fmol/punch (consistent with >= 4 doses/week) assessed at 4, 12, 24, and 36 weeks. The impact of PrEPmate on retention and adherence was evaluated using generalized estimating equation logistic models with robust standard errors.Results. From April 2015 to March 2016, 121 participants enrolled (mean age 24; 27% black, 36% Latino). Participants who received PrEPmate were more likely to attend study visits (86% PrEPmate vs. 71% SoC, odds ratio [OR] = 2.62, 95% confidence interval [CI] 1.24-5.54) and have TFV-DP levels consistent with >= 4 doses/week (72% PrEPmate vs. 57% SoC, OR = 2.05, 95% CI 1.06-3.94). PrEPmate efficacy did not differ significantly by age, race/ethnicity, education, or insurance. Overall, 88% reported PrEPmate to be very/somewhat helpful, and 92% would recommend PrEPmate to others.Conclusions. An interactive text-messaging intervention had high acceptability and significantly increased study-visit retention and PrEP adherence among young individuals at risk for HIV acquisition.