While oral pre-exposure prophylaxis (PrEP) has proven efficacious for HIV prevention, consistent use is necessary to achieve its intended impact. We compared effectiveness of enhanced PrEP (enPrEP) adherence support to standard of care (sPrEP) among Black MSM and TGW attending a community clinic in Harlem, NY. EnPrEP included peer navigation, in-person/online support groups, and SMS messages. Self-reported adherence over previous 30 days, collected in quarterly interviews, was defined as ≥ 57%. Crude and adjusted analyses examined factors associated with adherence. A total of 204 participants were enrolled and randomized; 35% were lost to follow-up. PrEP adherence was 30% at 12-months; no intervention effect was observed (p = 0.69). Multivariable regression analysis found that lower adherence was associated with low education and depressive symptoms. We found that an enhanced adherence intervention did not improve PrEP adherence. Findings point to the need for innovative methods to improve PrEP adherence among Black MSM and TGW.Clinical Trial Registration NCT02167386, June 19, 2014.

中文翻译：

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在纽约州哈莱姆市的社区环境中坚持与男性发生性关系的黑人和变性妇女的暴露前预防措施。

虽然口服暴露前预防（PrEP）已被证明对HIV预防有效，但必须持续使用以达到预期效果。我们比较了在纽约哈林区社区诊所就诊的黑人MSM和TGW中增强的PrEP（enPrEP）依从支持对护理标准（sPrEP）的有效性。EnPrEP包括对等导航，亲自/在线支持组和SMS消息。在季度访问中收集的过去30天的自我报告依从性被定义为≥57％。粗略和调整后的分析检查了与依从性相关的因素。共有204名参与者参加了研究并进行了随机分组。35％失去随访。在12个月时PrEP依从性为30％；没有观察到干预效果（p = 0.69）。多变量回归分析发现，较低的依从性与低学历和抑郁症状有关。我们发现增强的依从性干预不能改善PrEP依从性。研究结果表明需要创新方法来提高Black MSM和TGW之间PrEP的依从性。临床试验注册NCT02167386,2014年6月19日。