Sexual risk behavior among HIV-uninfected men who have sex with men participating in a tenofovir preexposure prophylaxis randomized trial in the United States.
Sexual risk behavior among HIV-uninfected men who have sex with men participating in a tenofovir preexposure prophylaxis randomized trial in the United States.
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DOI：
10.1097/qai.0b013e31828f097a
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发表时间：
2013-09-01
期刊：
影响因子：
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通讯作者：
Buchbinder SP
中科院分区：
文献类型：
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作者：
Liu AY;Vittinghoff E;Chillag K;Mayer K;Thompson M;Grohskopf L;Colfax G;Pathak S;Gvetadze R;Oʼhara B;Collins B;Ackers M;Paxton L;Buchbinder SP
评估参与PrEP试验的男男性行为者与每日服药相关的性行为变化。随机、双盲、安慰剂对照试验。参与者在入组时或延迟9个月后随机接受富马酸替诺福韦二氧吡酯或安慰剂，随访24个月。在旧金山、亚特兰大和波士顿招募了400名在过去12个月内报告与男性肛交并符合其他资格标准的hiv阴性男男性行为者。性风险评估在基线和季度访问使用音频计算机辅助自我访谈。使用逻辑回归和负二项回归对重复测量评估服药与性行为的关系。在随访期间，行为风险的总体指标下降或保持稳定。报告无保护肛交（UAS）的平均伴侣数量和比例在随访期间下降（p<0.05），平均UAS发作保持稳定。在最初的9个月里，立即服药组和延迟服药组在风险实践方面的变化是相似的。在延迟组开始服药或在立即组继续用药后，这些风险指标没有显著差异。使用罂粟花、安非他明和提高性能力的药物与性风险的一个或多个指标独立相关。在这项临床试验中，没有证据表明未感染艾滋病毒的男男性行为者之间存在风险补偿。既然PrEP已被证明对男男性行为者和其他人群有效，应继续监测风险补偿，并将在开放标签试验和其他情况下提供。
To evaluate for changes in sexual behaviors associated with daily pill-use among MSM participating in a PrEP trial. Randomized, double-blind, placebo-controlled trial. Participants were randomized 1:1:1:1 to receive tenofovir disoproxil fumarate or placebo at enrollment or after a 9-month delay and followed for 24 months. 400 HIV-negative MSM reporting anal sex with a man in the past 12 months and meeting other eligibility criteria enrolled in San Francisco, Atlanta, and Boston. Sexual risk was assessed at baseline and quarterly visits using Audio Computer-Assisted Self-Interview. The association of pill-taking with sexual behavior was evaluated using logistic and negative-binomial regression for repeated measures. Overall indices of behavioral risk declined or remained stable during follow-up. Mean numbers of partners and proportion reporting unprotected anal sex (UAS) declined during follow-up (p<0.05), and mean UAS episodes remained stable. During the initial 9 months, changes in risk practices were similar in the group that began pills immediately vs. those in the delayed arm. These indices of risk did not differ significantly after initiation of pill-use in the delayed arm or continuation of study medication in the immediate arm. Use of poppers, amphetamines, and sexual performance-enhancing drugs were independently associated with one or more indices of sexual risk. There was no evidence of risk compensation among HIV-uninfected MSM in this clinical trial. Monitoring for risk compensation should continue now that PrEP has been shown to be efficacious in MSM and other populations and will be provided in open-label trials and other contexts.