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及预测因子分析

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

目的了解男男性行为人群（men who have sex with men，MSM）艾滋病暴露前预防用药（pre-exposure prophylaxis，PrEP）临床试验中队列的保持情况及其预测因子。方法采用非概率抽样的方法招募并筛选出167例受试对象，按1∶1比例随机分配进入每日服药组或间歇服药组，在第0（基线）、4、8、12、16、20、24、28（±5 d内）周进行临床随访和问卷调查，采用基于Kaplan-Meier估计的生存曲线描述不同试验组队列保持概率，单因素和多因素Cox回归分析队列保持的预测因子。结果80.2%的受试对象完成了至少1次服药后随访，59.9%完成了28周的队列随访。间歇用药组（ARR=0.60，95% CI：0.36～0.99）、年龄〉24岁（ARR=0.46，95% CI：0.25～0.83）、中等收入相对于高收入（ARR=0.45，95%CI：0.21～0.96）、因希望能够推广一种预防艾滋病的药物而参加试验（ARR=0.59，95% CI：0.36～0.99）的参与者有更低的脱失率，即更高的队列保持力，因为能获得免费的预防药物而参加试验（ARR=1.90，95% CI：1.13～3.21）的受试者有更高的脱失率，即更低的队列保持力。结论MSM人群PrEP临床试验队列保持力不高，间歇服药组的队列保持力高于每日服药组，在进一步的PrEP临床试验中需制定相应策略以提高试验队列保持力。

Objective To understand the cohort retention and its predictors in pre-exposure prophylaxis （PrEP） clinical trial among men who have sex with men （MSM）. Methods Using non-probability sampling methods, 167 eligible subjects were recruited and then assigned to a daily dose arm or an intermittent dose arm randomly at the proportion of 1∶1. Follow-up and questionnaire were carried out in weeks 0 （baseline）, 4, 8, 12, 16, 20, 24, and 28. Survival curve based on the Kaplan-Meier estimation was conducted to describe the cohort retention rates of different trial arms. Univariate and multivariate logistic regression procedures were conducted to analyze the predictors of cohort retention. Results Overall, 80.2% of the subjects completed at least one follow-up after taking medicine, and 59.9% completed a 28-week follow-up. Intermittent dose arm （ARR=0.60, 95% CI：0.36-0.99）, age of 24 years and older （ARR=0.46, 95% CI：0.25-0.83）, middle income （ARR=0.45, 95% CI：0.21-0.96）, and participants who attended the experiment wishing to spread a kind of medication to prevent the infection of human immunodeficiency virus （HIV） （ARR=0.59, 95% CI：0.36～0.99） showed lower attrition, namely higher cohort retention. Those who attended the experiment for free medication （ARR=1.90, 95% CI：1.13-3.21） had higher attrition, namely lower cohort retention. Conclusion The cohort retention of PrEP clinical trial is not high. The cohort retention rate is higher in the intermittent dose arm than in the daily dose arm. Appropriate strategies are needed to promote the cohort retention in the further PrEP clinic trial.