论文部分内容阅读
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 investigate the cohort maintenance and its predictors in men who have sex with men (MSM) pre-exposure prophylaxis (PrEP) clinical trials. Methods A total of 167 subjects were enrolled and screened by non-probabilistic sampling method. Randomized into 1: 1 ratio, patients were divided into daily medication group and intermittent medication group. At 0 (baseline), 4, 8, 12, , 24,28 weeks (± 5 days) were followed up and questionnaires. Survival curves based on Kaplan-Meier estimates were used to describe the cohort retention probabilities of different groups. Cox regression was used to analyze the cohort maintenance predictors. Results 80.2% of the subjects completed at least 1 follow-up after medication, 59.9% completed the 28-week cohort. Intermittent drug use (ARR = 0.60, 95% CI: 0.36 to 0.99), age> 24 years (ARR = 0.46, 95% CI: 0.25-0.83), median income relative to high income (ARR = 0.45, 95% CI: 0.21 to 0.96). Participants who participated in the trial (ARR = 0.59, 95% CI: 0.36 to 0.99) in hopes of promoting an AIDS-preventing drug had lower rates of loss, higher cohort retention, Subjects who participated in the trial (ARR = 1.90, 95% CI: 1.13 to 3.21) had higher rates of missed, lower cohort retention, because of the availability of free preventive drugs. Conclusions The retention of PrEP clinical trial cohort in MSM is not high, and the cohort retention of intermittent medication cohort is higher than that of daily medication. In the further clinical trials of PrEP, corresponding strategies should be developed to improve the cohort retention.