乌干达西南部使用 dapivirine 阴道环后风险补偿的评估。
Assessment of risk compensation following use of the dapivirine vaginal ring in southwestern Uganda.
机构信息
Department of HIV Interventions, MRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Uganda
Department of Statistics, MRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Uganda.
出版信息
Sex Transm Infect. 2022 Feb;98(1):32-37. doi: 10.1136/sextrans-2020-054718. Epub 2021 Feb 4.
OBJECTIVES
Participation in HIV prevention trials could trigger risk compensation among participants. We evaluated potential risk compensation following use of a vaginal ring microbicide by women in a phase III trial in southwestern Uganda.
METHODS
We used markers of sexual risk behaviour documented on standardised questionnaires, tested for STIs at baseline and quarterly for 2 years. Risk compensation was defined as a significant increase (trend p<0.05) in the proportion of women reporting risky sexual behaviour or a diagnosed STI between baseline and end of follow-up.
RESULTS
Between September 2013 and December 2016, 197 women (active arm: n=132 and placebo: n=65) were enrolled at the Masaka site. There were decreases in all markers of sexual risk behaviour with statistically significant decreases in only the proportion of women reporting ≥2 sexual partners, p=0.026 and those diagnosed with p<0.001 and or p<0.001 CONCLUSIONS: No evidence of risk compensation was observed in this trial.
TRIAL REGISTRATION NUMBER
NCT01539226.
目的
参与艾滋病毒预防试验可能会引发参与者的风险补偿。我们评估了乌干达西南部一项 III 期试验中女性使用阴道环杀微生物剂后的潜在风险补偿。
方法
我们使用标准问卷记录的性风险行为标志物，在基线和 2 年内每季度进行一次性传播感染检测。风险补偿定义为报告性行为风险或诊断性传播感染的女性比例在基线和随访结束之间显著增加（趋势 p<0.05）。
结果
2013 年 9 月至 2016 年 12 月，在马萨卡地点招募了 197 名女性（实验组：n=132 名和安慰剂组：n=65 名）。所有性风险行为标志物均呈下降趋势，仅报告≥2 个性伴侣的女性比例和诊断为的女性比例具有统计学显著下降，分别为 p=0.026 和 p<0.001 和或 p<0.001。
结论
在这项试验中未观察到风险补偿的证据。
试验注册号
NCT01539226。
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