男男性行为人群艾滋病暴露前预防用药临床试验队列保持力分析

Cohort retention in HIV pre-exposure prophylaxis clinical trial among men who have sex with men

摘要:

目的：了解男男性行为者（men who have sex with men，MSM）在艾滋病暴露前预防用药（pre-exposure prophylaxis，PrEP）临床试验中的队列保持力及其影响因素。方法：采用非概率抽样法招募并筛选出297名MSM进入研究，随机分为每日用药组、高危行为前后用药组和空白对照组，每3月进行临床随访和问卷调查。利用Kaplan-Meier 估计的生存曲线描述不同试验组的累积队列保持率，单因素和多因素Cox回归用于分析队列保持的影响因素。结果：43.1%（128/297）的MSM完成了本研究的随访，队列平均保持时间（5.85±3.99）月。高危行为前后用药组相对空白对照组（AHR=0.62，95%CI=0.42~0.91）、年龄30岁以上（AHR=0.65，95%CI=0.47～0.90）的MSM有更高的队列保持力。结论：本研究中MSM人群PrEP临床试验队列保持力不高，在后期研究中需加强空白对照组和低年龄MSM的队列管理，以提高临床试验的队列保持力。

Abstract:

Objective：To explore cohort retention and associated factors in HIV pre-exposure prophylaxis（PrEP） clinical trial among men who have sex with men（MSM）. Methods：Totally 297 MSM were enrolled by non-probability sampling methods and then as－signed to daily dose，intermittent dose and blank control arms randomly. Clinical follow-up and questionnaire were carried out every 3 months. Cumulative cohort retention rates of different arms were described by Kaplan-Meier estimation. Univariate and multivariate Cox regression were used to analyze associated factors of cohort retention. Results：43.1%（128/297） of participants completed the fol－low-up in this study and the mean retention time was （5.85±3.99） months. Those who were in intermittent dose arm（AHR=0.62，95%CI＝0.42 to 0.91） and older than 30 years（AHR=0.65，95%CI＝0.47 to 0.90） showed higher cohort retention. Conclusion：The co－hort retention of PrEP clinical trial among MSM in this study is not high. Effective measures should be taken to improve the cohort re－tention of MSM in blank control arm and younger age.