Intervention Development: Reducing HIV Risk in Vulnerable Youth

干预措施的制定：降低弱势青少年的艾滋病毒风险

• 批准号: 7340031
• 负责人: Robert Garofalo
• 金额: $ 24.16万
• 依托单位: LURIE CHILDREN'S HOSPITAL OF CHICAGO
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-13 至 2010-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7340031
• 关键词: 20 year old; AIDS prevention; AIDS/HIV problem; Adolescence; Adolescent; Adult; African American; Age; Alcohol consumption; Alcohol or Other Drugs use; Alcohols; Attitude; Behavior Therapy; Behavioral; Belief; Centers for Disease Control and Prevention (U.S.); Communities; Consent; Control Groups; Data; Data Analyses; Decision Making; Development; Discrimination; Drug usage; Educational Curriculum; Effectiveness of Interventions; Equilibrium; Esthesia; Feedback; Funding; Future; Goals; Guidelines; HIV; HIV Infections; Health; Homelessness; Human immunodeficiency virus test; Internet; Intervention; Intervention Studies; Intervention Trial; Knowledge; Latino; Life; Literature; Loneliness; Mental Depression; Mental disorders; Mentally Ill Persons; Methods; Minority; Modeling; Outcome; Participant; Partner Communications; Personal Attribute; Pharmaceutical Preparations; Phase; Population; Population Study; Preparation; Prevention program; Primary Prevention; Procedures; Prophylactic treatment; Psychological Stress; Randomized Controlled Trials; Rate; Recruitment Activity; Research Design; Risk; Risk Behaviors; Risk-Taking; Sample Size; Sampling; Sex Behavior; Sexual Partners; Sexually Transmitted Diseases; Site; Specific qualifier value; Staging; Street Youths; Stress; Substance abuse problem; Suggestion; Target Populations; Teenagers; Testing; Well in self; Work; Youth; base; cohort; condoms; design; emotion regulation; experience; follow-up; high risk sexual behavior; information gathering; inner city; innovation; men who have sex with men; peer; pressure; prevent; programs; psychosocial; racial and ethnic; runaway youth; self esteem; sex; size; skills; social; social cognitive theory; therapy development; tool; treatment effect; young adult

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.

描述（由申请人提供）：本探索性/开发性申请 (R34) 请求资金为 16-20 岁的多种族男男性行为青年 (YMSM) 设计和试点艾滋病毒和药物使用预防计划。我们将结合并调整最初为成年 MSM（MIX 项目）、离家出走的青少年（Street Smart）和患有精神疾病的青少年（BALANCE 项目）开发的三个创新型艾滋病毒和药物滥用预防项目。 MIX 项目是联邦政府资助的一项针对吸毒/酗酒的 MSM 的行为干预措施。 Street Smart 被纳入 CDC 实证支持的艾滋病毒预防计划纲要中。 Project BALANCE 是一项针对患有精神疾病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，从重要的年轻成年 HIV+ MSM 线人 (N=21) 收集信息，利用 Project MIX、Street Smart 和 Project BALANCE 为 YMSM 开发独特的定制手动干预措施。在第二阶段，我们将在队列 1 中对干预措施进行试点测试——队列 1 是一个由 20 名不同种族的 YMSM 组成的社区样本（2 组，每组 10 名 YMSM）。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顾问委员会的意见完善课程和学习程序。在第 3 阶段，我们将在试点随机对照试验 (RCT) 中测试修订后的干预措施，样本为 100 YMSM（第 2 组）——实验组 50 YMSM，对照组 50 YMSM。第 1 组将完成基线和 3 个月的后续评估，以评估跟踪和保留策略。第 2 组将完成基线、3 个月和 6 个月的随访，以评估初步治疗效果。干预措施将以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为基础。干预措施将针对 YMSM 特定人群中冒险行为的关键决定因素，包括：心理健康和情绪调节、个人特质、同伴和伴侣关系、性背景变量和性少数压力。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计划参与的函数，以及（b）确定计划对结果变量影响的测试前-测试后效应大小。我们将使用效应大小来确定未来对干预措施进行更明确的测试所需的样本量。我们的目标人群是与 16-20 岁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，但在干预文献中这一群体的代表性严重不足。有了正确的工具，YMSM 将能够更好地做出减少艾滋病毒传播的决策。根据支持干预开发和试点测试早期阶段的 R34 指南，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少年艾滋病毒感染的总体研究计划的一部分。