Intervention Development: Reducing HIV Risk in Vulnerable Youth

描述（由申请人提供）：本探索性/发展性申请（R34）要求资金用于为16-20岁的不同种族的男男性行为青年（YMSM）设计和试点艾滋病毒和药物使用预防计划。我们将结合和调整三个创新的艾滋病毒和药物使用预防方案，这些方案最初是为成年男男性行为者（MIX项目）、离家出走青年（Street Smart项目）和精神病青少年（BALANCE项目）开发的。MIX项目是由联邦政府资助的针对吸毒/酗酒的男男性行为者的行为干预。“街头智慧”是美国疾病控制与预防中心经验支持的艾滋病预防项目纲要之一。BALANCE项目是一项针对患有精神疾病的青少年的HIV预防项目。在第一阶段，我们将与咨询委员会合作，从主要的年轻艾滋病毒阳性男男性行为者（N=21）那里收集信息，根据MIX项目、Street Smart项目和BALANCE项目，为男男性行为者制定独特的定制化干预措施。在第二阶段，我们将在队列1中对干预进行试点测试，队列1是一个基于社区的样本，包括20名不同种族的YMSM（两组10名YMSM）。我们将检查干预措施的可行性、可接受性和容忍度，并评估我们的跟踪和保留策略。我们会根据参加者的意见和谘询委员会的意见，完善课程和学习程序。在第三阶段，我们将在100名YMSM（队列2）样本的随机对照试验（RCT）中测试修订后的干预措施-实验组50名YMSM，对照组50名YMSM。队列1将完成基线和3个月的随访评估，以评估跟踪和保留策略。队列2将完成基线、3个月和6个月的随访，以评估初步治疗效果。社会学习理论和先前应用于高危青少年性行为和吸毒行为的社会-个人框架将为干预提供信息。干预将针对我们的特定YMSM人群中风险承担的关键决定因素，包括：心理健康和情绪调节、个人属性、同伴和伴侣关系、性环境变量和性少数派压力。数据分析将(a)评估青少年危险性行为和药物滥用的变化作为项目参与的函数，以及(b)确定项目对结果变量影响的前测后测试效应大小。我们将使用效应大小来确定未来对干预进行更明确测试所需的样本量。我们的目标人群是16-20岁的男男性行为者，他们是美国艾滋病毒/艾滋病感染风险最高的人群之一，但在干预文献中，这一人群的代表性很低。有了正确的工具，青年男性群体将更有能力做出减少艾滋病毒传播的决定。根据R34指南支持干预措施开发的早期阶段和试点测试，最终产品将构成对YMSM进行全面干预试验的基础。这项研究是旨在了解和预防高危青少年感染艾滋病毒的整体研究计划的一部分。

DESCRIPTION (provided by applicant): This exploratory/developmental application (R34) requests funds to design and pilot an HIV and substance use prevention program for 16-20 year-old ethnically-diverse, young men who have sex with men (YMSM). We will combine and adapt three innovative HIV and substance use prevention programs originally developed for adult MSM (Project MIX), runaway youth (Street Smart), and mentally ill adolescents (Project BALANCE). Project MIX is a federally-funded behavioral intervention for MSM who use drugs/alcohol. Street Smart is in the CDC compendium of empirically supported HIV prevention programs. Project BALANCE is an ongoing HIV prevention program for teens with psychiatric disorders. In stage 1, we will work with our advisory board and gather information from key young adult HIV+ MSM informants (N=21) to develop a uniquely tailored manualized intervention for YMSM drawing on Project MIX, Street Smart, and Project BALANCE. In stage 2, we will pilot test the intervention with cohort 1 -- a community-based sample of 20 ethnically-diverse YMSM (2 groups of 10 YMSM). We will examine the intervention's feasibility, acceptability and tolerability, and we will evaluate our tracking and retention strategies. We will refine the curriculum and study procedures based on participant feedback and advisory board input. In stage 3, we will test the revised intervention in a pilot randomized controlled trial (RCT) in a sample of 100 YMSM (cohort 2) - 50 YMSM in the experimental group and 50 YMSM in a control group. Cohort 1 will complete baseline and 3-month follow-up assessments to evaluate tracking and retention strategies. Cohort 2 will complete baseline, 3-, and 6-month follow-up to evaluate preliminary treatment effects. The intervention will be informed by social learning theory and a social- personal framework previously applied to the sexual and drug use behavior of at-risk youth. The intervention will target key determinants of risk taking among our specific population of YMSM, including: psychological well- being and emotion regulation, personal attributes, peer and partner relationships, sexual context variables, and sexual minority stress. Data analyses will (a) evaluate change in adolescent risky sexual behavior and substance abuse as a function of program participation, and (b) determine the pretest-posttest effect size of program impact on the outcome variables. We will use the effect size to determine the sample size needed for a more definitive test of the intervention in the future. Our target population, young men who have sex with men age 16-20, is one of the highest U.S. risk groups for HIV/AIDS acquisition, yet one that is woefully under-represented in the intervention literature. Empowered with the right tools, YMSM will be better equipped to make decisions that reduce the spread of HIV. Consistent with R34 guidelines to support the early phase of intervention development and pilot testing, the final product will form the basis for a full-scale intervention trial for YMSM. This study is part of an overall program of research designed to understand and prevent HIV infection among high-risk youth.