Importance Adolescents represent a key population for implementing preexposure prophylaxis (PrEP) interventions worldwide, yet tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) for PrEP is only licensed for adults. Objective To examine the safety of and adherence to PrEP along with changes in sexual risk behavior among adolescent men who have sex with men (MSM). Design, Setting, and Participants Adolescent Medicine Trials Network for HIV/AIDS Interventions 113 (Project PrEPare) was a PrEP demonstration project that evaluated the safety, tolerability, and acceptability of TDF/FTC and patterns of use, rates of adherence, and patterns of sexual risk behavior among healthy young MSM aged 15 to 17 years. Participants were recruited from adolescent medicine clinics and their community partners in 6 US cities, had negative test results for human immunodeficiency virus (HIV) but were at high risk for acquiring an infection, and were willing to participate in a behavioral intervention and accept TDF/FTC as PrEP. Exposures All participants completed an individualized evidence-based behavioral intervention and were provided with daily TDF/FTC as PrEP for 48 weeks. Main Outcomes and Measures The main objectives were to: (1) provide additional safety data regarding TDF/FTC use among young MSM who had negative test results for HIV; (2) examine the acceptability, patterns of use, rates of adherence, and measured levels of tenofovir diphosphate in dried blood spots; and (3) examine patterns of risk behavior when young MSM were provided with a behavioral intervention in conjunction with open-label TDF/FTC. Results Among 2864 individuals screened (from August 2013 to September 2014), 260 were eligible and 78 were enrolled (mean [SD] age, 16.5 [0.73] years), of whom 2 (3%) were Asian/Pacific Islander, 23 (29%) were black/African American, 11 (14%) were white, 16 (21%) were white Hispanic, and 26 (33%) were other/mixed race/ethnicity. Over 48 weeks of PrEP use, 23 sexually transmitted infections were diagnosed in 12 participants. The HIV seroconversion rate was 6.4 (95% CI: 1.3-18.7) per 100 person-years. Tenofovir diphosphate levels consistent with a high degree of anti-HIV protection (>700 fmol/punch) were found in 42 (54%), 37 (47%), 38 (49%), 22 (28%), 13 (17%), and 17 (22%) participants at weeks 4, 8, 12, 24, 36, and 48, respectively. Conclusions and Relevance Adolescent Medicine Trials Network for HIV/AIDS Interventions 113 enrolled a diverse sample of adolescent MSM at risk for HIV who consented to study participation. Approximately half achieved protective drug levels during the monthly visits, but adherence decreased with quarterly visits. Youth may need additional contact with clinical staff members to maintain high adherence. Trial Registration clinicaltrials.gov Identifier: NCT01769456

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在美国与 15 至 17 岁男性发生性关系的青少年男性进行抗逆转录病毒暴露前预防的安全性和可行性

重要性 青少年是全球实施暴露前预防 (PrEP) 干预措施的关键人群，但富马酸替诺福韦酯/恩曲他滨 (TDF/FTC) 仅获准用于成人。目的检查与男性发生性关系的青春期男性 (MSM) 的安全性和依从性以及性风险行为的变化。艾滋病毒/艾滋病干预青少年医学试验网络 113（PrEPare 项目）的设计、设置和参与者是一个评估 TDF/FTC 的安全性、耐受性和可接受性以及使用模式、依从性和模式的 PrEP 示范项目15 至 17 岁健康年轻 MSM 的性风险行为。参与者是从美国 6 个城市的青少年医学诊所及其社区合作伙伴招募的，人类免疫缺陷病毒 (HIV) 检测结果呈阴性，但感染风险高，愿意参与行为干预并接受 TDF/FTC 作为 PrEP。暴露 所有参与者都完成了个性化的循证行为干预，并在 48 周内每天接受 TDF/FTC 作为 PrEP。主要结果和措施 主要目标是： (1) 提供关于 HIV 检测结果呈阴性的年轻 MSM 使用 TDF/FTC 的额外安全数据；(2) 检查干血斑中替诺福韦二磷酸酯的可接受性、使用模式、依从率和测量水平；(3) 检查当年轻 MSM 接受行为干预并结合开放标签 TDF/FTC 时的风险行为模式。结果 在筛查的 2864 人中（2013 年 8 月至 2014 年 9 月），260 人符合条件，78 人入选（平均 [SD] 年龄，16.5 [0.73] 岁），其中 2 人（3%）是亚洲/太平洋岛民，23 29% 是黑人/非裔美国人，11 (14%) 是白人，16 (21%) 是西班牙裔白人，26 (33%) 是其他/混血/种族。使用 PrEP 超过 48 周，12 名参与者被诊断出 23 次性传播感染。HIV 血清转化率为每 100 人年 6.4（95% CI：1.3-18.7）。在 42 (54%)、37 (47%)、38 (49%)、22 (28%)、13 (17) 中发现与高度抗 HIV 保护 (>700 fmol/pun) 一致的替诺福韦二磷酸盐水平%) 和 17 (22%) 名参与者分别在第 4、8、12、24、36 和 48 周。结论和相关性 HIV/AIDS 干预青少年医学试验网络 113 招募了一个不同的样本，其中包括同意参与研究的处于 HIV 感染风险的青少年 MSM。大约一半在每月访问期间达到了保护性药物水平，但依从性随着季度访问而下降。青少年可能需要与临床工作人员进行额外接触以保持高度依从性。试验注册clinicaltrials.gov 标识符：NCT01769456