保持健康！：一项电子健康艾滋病预防计划 RCT 的生物医学和行为结果。
Biomedical and Behavioral Outcomes of Keep It Up!: An eHealth HIV Prevention Program RCT.
机构信息
Department of Medical Social Sciences, Feinberg School of Medicine and Institute for Sexual and Gender Minority Health and Wellbeing, Northwestern University, Chicago, Illinois.
Center for HIV Educational Studies and Training, Hunter College and the Graduate Center of the City University of New York, New York, New York.
出版信息
Am J Prev Med. 2018 Aug;55(2):151-158. doi: 10.1016/j.amepre.2018.04.026. Epub 2018 Jun 28.
INTRODUCTION
HIV diagnoses among young men who have sex with men are increasing, but few effective HIV prevention interventions exist for this population. An RCT was conducted of the online Keep It Up! intervention to determine if it significantly reduced condomless anal sex and sexually transmitted infections compared with an HIV knowledge condition.
STUDY DESIGN
From May 2013 to March 2017, a total of 901 participants were enrolled in a double-blinded RCT of Keep It Up! with 1-year follow-up. After completing baseline surveys and sexually transmitted infection testing, participants were randomized by an eHealth platform to the intervention or control condition.
SETTING/PARTICIPANTS: HIV-negative men who have sex with men reporting condomless anal sex, aged 18-29 years, were recruited through advertising and from HIV testing sites and outreach in Atlanta, Georgia; Chicago, Illinois; and New York, New York.
INTERVENTION
Multimedia was used to address HIV knowledge and motivate safer behaviors. The control condition reflected existing online HIV information.
MAIN OUTCOME MEASURES
Primary outcomes were incident gonorrhea or chlamydia at 12-month follow-up and self-reported condomless anal sex with casual partners at 3-, 6-, and 12-month follow-up.
RESULTS
In 2017, data were analyzed from 445 (49%) participants randomized to the intervention and 456 (51%) to the control. Participants were primarily racial/ethnic minorities (63%). Sexually transmitted infections at Month 12 was 40% lower for intervention participants (risk ratio=0.60, 95% CI=0.38, 0.95, p=0.01). For the primary behavioral outcome, both arms showed reductions over time with 44% of control and 37% of intervention participants reporting condomless anal sex at Month 12 (prevalence ratio=0.83, 95% CI=0.70, 0.99, p=0.04).
CONCLUSIONS
The Keep It Up! intervention resulted in significantly lower sexually transmitted infection incidence and a small but significant decrease in condomless anal sex 12 months post-intervention relative to an online HIV knowledge condition. In addition, this study demonstrated the feasibility and acceptability of at-home sexually transmitted infection testing as part of an eHealth intervention.
TRIAL REGISTRATION
This study is registered at www.clinicaltrials.gov NCT01836445.
简介
男男性行为者中的艾滋病毒诊断呈上升趋势，但针对这一人群的有效艾滋病毒预防干预措施很少。对在线保持活力！干预进行了随机对照试验，以确定与艾滋病毒知识条件相比，它是否显著减少了无保护的肛交和性传播感染。
研究设计
从 2013 年 5 月到 2017 年 3 月，共有 901 名参与者参加了保持活力！的双盲 RCT，随访 1 年。在完成基线调查和性传播感染检测后，参与者通过电子健康平台随机分配到干预组或对照组。
地点/参与者：通过广告以及在佐治亚州亚特兰大、伊利诺伊州芝加哥和纽约市的 HIV 检测点和外展活动，招募了年龄在 18-29 岁之间、报告有过无保护肛交、艾滋病毒阴性的男男性行为者。
干预措施
多媒体用于解决艾滋病毒知识问题，并激励更安全的行为。对照组反映了现有的在线艾滋病毒信息。
主要观察指标
主要结局是 12 个月随访时淋病或衣原体感染的发生率，以及 3、6 和 12 个月随访时与偶然伴侣的无保护肛交的自我报告。
结果
2017 年，对随机分配到干预组的 445 名（49%）参与者和分配到对照组的 456 名（51%）参与者的数据进行了分析。参与者主要是少数族裔（63%）。干预组参与者在第 12 个月的性传播感染率降低了 40%（风险比=0.60，95%置信区间=0.38，0.95，p=0.01）。对于主要行为结果，两个组都随着时间的推移而减少，对照组有 44%和干预组有 37%的参与者在第 12 个月报告无保护的肛交（流行率比=0.83，95%置信区间=0.70，0.99，p=0.04）。
结论
与在线艾滋病毒知识条件相比，保持活力！干预导致性传播感染发生率显著降低，干预后 12 个月无保护肛交的发生率也略有显著下降。此外，这项研究证明了在家中进行性传播感染检测作为电子健康干预措施的一部分的可行性和可接受性。
试验注册
本研究在 www.clinicaltrials.gov 注册，编号为 NCT01836445。
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