An HIV Preexposure Prophylaxis Demonstration Project and Safety Study for Young MSM.
An HIV Preexposure Prophylaxis Demonstration Project and Safety Study for Young MSM.
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DOI：
10.1097/qai.0000000000001179
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发表时间：
2017-01-01
期刊：
影响因子：
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通讯作者：
Adolescent Trials Network (ATN) for HIVAIDS Interventions
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文献类型：
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作者：
Hosek SG;Rudy B;Landovitz R;Kapogiannis B;Siberry G;Rutledge B;Liu N;Brothers J;Mulligan K;Zimet G;Lally M;Mayer KH;Anderson P;Kiser J;Rooney JF;Wilson CM;Adolescent Trials Network (ATN) for HIVAIDS Interventions
男男性行为者（YMSM）是实施PrEP干预措施的关键人群。这项开放标签研究检查了PrEP的依从性，并评估了美国12个城市YMSM不同样本的性行为。研究对象为18-22岁未感染HIV的MSM，在过去6个月内有HIV传播危险行为。每天向参与者提供TDF/FTC（Truvada®）。研究访视在基线时进行，每月一次，直至第12周，然后每季度一次，直至第48周。连续收集干血斑（DBS）用于定量替诺福韦二磷酸盐（TFV-DP）。2013年3月至9月，接触了2186人，发现400人初步符合条件。在这400例受试者中，277例计划进行面对面筛选访视，200例入组（平均年龄=20.2岁; 54.5%黑人，26.5%拉丁裔）。基线时性传播感染（STI）的诊断率为22%，包括尿道和直肠衣原体/淋球菌感染和梅毒，并且在各次访视期间仍然很高。第4周时，56%的受试者的TFV-DP水平与≥4片/周一致。到第48周，34%的受试者的TFV-DP水平与≥4片/周一致，在第24周出现明显下降。研究期间发生了4例HIV血清转换（3.29/100人-年）。>80%的参与者报告了无安全套性行为，与最后一个伴侣无安全套肛交与较高的TFV-DP水平相关。PrEP的可接受性很高，大多数参与者在每月访问期间达到保护性药物水平。随着访问频率的降低，依从性也降低了。美国的YMSM可能需要在对青年友好的环境中获得PrEP，并提供量身定制的依从性支持和可能增加的访问时间表。
Young men who have sex with men (YMSM) are a key population for implementation of PrEP interventions. This open-label study examined adherence to PrEP and assessed sexual behavior among a diverse sample of YMSM in 12 U.S. cities. Eligible participants were 18–22 year old HIV-uninfected MSM who reported HIV transmission risk behavior in the past 6 months. Participants were provided daily TDF/FTC (Truvada®). Study visits occurred at baseline, monthly through week 12, then quarterly through week 48. Dried blood spots (DBS) were serially collected for the quantification of tenofovir diphosphate (TFV-DP). Between March-September 2013, 2186 individuals were approached and 400 were found to be preliminarily eligible. Of those 400, 277 were scheduled for an in-person screening visit and 200 were enrolled (mean age=20.2; 54.5% Black, 26.5% Latino). Diagnoses of sexually transmitted infections (STIs), including urethral and rectal chlamydial/gonococcal infection and syphilis, at baseline was 22% and remained high across visits. At week 4, 56% of participants had TFV-DP levels consistent with ≥4 pills/week. By week 48, 34% of participants had TFV-DP levels consistent with ≥4 pills/week, with a noticeable drop-off occurring at Week 24. Four HIV seroconversions occurred on study (3.29/100 person-years). Condomless sex was reported by >80% of participants and condomless anal sex with last partner was associated with higher TFV-DP levels. Acceptability of PrEP was high and most participants achieved protective drug levels during monthly visits. As visit frequency decreased, so did adherence. YMSM in the US may need PrEP access in youth-friendly settings with tailored adherence support and potentially augmented visit schedules.