Intervention Development: Reducing HIV Risk in Vulnerable Youth

描述(由申请人提供)：这项探索性/发展性申请(R34)要求提供资金，为16-20岁的不同种族、与男性发生性行为的年轻男子(YMSM)设计和试验艾滋病毒和药物使用预防计划。我们将结合和调整最初为成年男男性接触者(项目组合)、离家出走的青少年(街道智能)和精神病青少年(项目平衡)开发的三个创新的艾滋病毒和药物使用预防项目。Mix项目是一项由联邦政府资助的针对吸毒/酗酒的MSM的行为干预。街道智能在疾控中心经验性支持的艾滋病毒预防计划纲要中。平衡项目是为患有精神障碍的青少年正在进行的艾滋病毒预防计划。在第一阶段，我们将与我们的顾问委员会合作，从主要的年轻成人HIV+MSM信息者(N=21)那里收集信息，以利用Project Mix、Street Smart和Project Balance为YMSM开发一种独特的量身定制的手动干预措施。在第二阶段，我们将用队列1--一个以社区为基础的样本，对20名不同种族的YMSM(两组10名YMSM)进行干预试验。我们将检查干预措施的可行性、可接受性和耐受性，并将评估我们的跟踪和保留策略。我们将根据参与者的反馈和咨询委员会的意见来完善课程和学习程序。在第三阶段，我们将在试点随机对照试验(RCT)中测试修订的干预措施，样本为100名YMSM(队列2)-50名YMSM(实验组)和50名YMSM(对照组)。第1组将完成基线和3个月的后续评估，以评价跟踪和保留战略。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。这项干预将借鉴社会学习理论和以前应用于高危青少年的性行为和吸毒行为的社会-个人框架。这项干预将针对我们特定的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、性背景变量和性少数群体压力。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的影响的前后效应大小。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。我们的目标人群是与16-20岁的男性发生性关系的年轻男性，他们是美国感染艾滋病毒/艾滋病的最高风险群体之一，但可悲的是，在干预文献中这一群体的比例偏低。有了正确的工具，YMSM将更好地做出减少艾滋病毒传播的决定。与R34指南一致，以支持干预开发和试点测试的早期阶段，最终产品将构成YMSM全面干预试验的基础。这项研究是旨在了解和预防高危青年感染艾滋病毒的总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.