Mustanski Brian, Moskowitz David A, Moran Kevin O, Newcomb Michael E, Macapagal Kathryn, Rodriguez-Díaz Carlos, Rendina H Jonathon, Laber Eric B, Li Dennis H, Matson Margaret, Talan Ali J, Cabral Cynthia
Institute for Sexual and Gender Minority Health and Wellbeing, Northwestern University, Chicago, IL, United States.
Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States.
JMIR Res Protoc. 2020 Aug 11;9(8):e19701. doi: 10.2196/19701.
Adolescent men who have sex with men (AMSM), aged 13 to 18 years, account for more than 80% of teen HIV occurrences. Despite this disproportionate burden, there is a conspicuous lack of evidence-based HIV prevention programs. Implementation issues are critical as traditional HIV prevention delivery channels (eg, community-based organizations, schools) have significant access limitations for AMSM. As such, eHealth interventions, such as our proposed SMART program, represent an excellent modality for delivering AMSM-specific intervention material where youth are.
This randomized trial aimed to test the effectiveness of the SMART program in reducing condom-less anal sex and increasing condom self-efficacy, condom use intentions, and HIV testing for AMSM. We also plan to test whether SMART has differential effectiveness across important subgroups of AMSM based on race and ethnicity, urban versus rural residence, age, socioeconomic status, and participation in an English versus a Spanish version of SMART.
Using a sequential multiple assignment randomized trial design, we will evaluate the impact of a stepped-care package of increasingly intensive eHealth interventions (ie, the universal, information-based SMART Sex Ed; the more intensive, selective SMART Squad; and a higher cost, indicated SMART Sessions). All intervention content is available in English and Spanish. Participants are recruited primarily from social media sources using paid and unpaid advertisements.
The trial has enrolled 1285 AMSM aged 13 to 18 years, with a target enrollment of 1878. Recruitment concluded in June 2020. Participants were recruited from 49 US states as well as Puerto Rico and the District of Columbia. Assessments of intervention outcomes at 3, 6, 9, and 12 months are ongoing.
SMART is the first web-based program for AMSM to take a stepped-care approach to sexual education and HIV prevention. This design indicates that SMART delivers resources to all adolescents, but more costly treatments (eg, video chat counseling in SMART Sessions) are conserved for individuals who need them the most. SMART has the potential to reach AMSM to provide them with a sex-positive curriculum that empowers them with the information, motivation, and skills to make better health choices.
ClinicalTrials.gov Identifier NCT03511131; https://clinicaltrials.gov/ct2/show/NCT03511131.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/19701.
13至18岁的男男性行为青少年（AMSM）占青少年艾滋病毒感染病例的80%以上。尽管负担不成比例，但明显缺乏循证艾滋病毒预防项目。实施问题至关重要，因为传统的艾滋病毒预防传播渠道（如社区组织、学校）对AMSM的接触有很大限制。因此，电子健康干预措施，如我们提议的SMART项目，是在青少年所在之处提供针对AMSM的干预材料的绝佳方式。
这项随机试验旨在测试SMART项目在减少无保护肛交、提高避孕套自我效能、增加避孕套使用意愿以及促进AMSM进行艾滋病毒检测方面的有效性。我们还计划测试SMART在基于种族和族裔、城市与农村居住情况、年龄、社会经济地位以及参与英文或西班牙文版SMART的AMSM重要亚组中是否具有不同的效果。
采用序贯多重分配随机试验设计，我们将评估一系列逐步强化的电子健康干预措施（即通用的、基于信息的SMART性教育；强化程度更高的、有选择性的SMART小组；以及成本更高的、有针对性的SMART课程）的影响。所有干预内容均有英文和西班牙文版本。主要通过付费和免费广告从社交媒体招募参与者。
该试验已招募了1285名13至18岁的AMSM，目标招募人数为1878人。招募工作于2020年6月结束。参与者来自美国49个州以及波多黎各和哥伦比亚特区。正在进行3、6、9和12个月时的干预效果评估。
SMART是首个针对AMSM采用逐步护理方法进行性教育和艾滋病毒预防的网络项目。这种设计表明，SMART为所有青少年提供资源，但将成本更高的治疗（如SMART课程中的视频聊天咨询）保留给最需要的个体。SMART有潜力接触到AMSM，为他们提供一个积极的性教育课程，赋予他们做出更健康选择所需的信息、动力和技能。
ClinicalTrials.gov标识符NCT03511131；https://clinicaltrials.gov/ct2/show/NCT03511131。
国际注册报告标识符（IRRID）：DERR1-10.2196/19701。
