RP7 Impact

RP7 影响

• 批准号: 10595907
• 负责人: Lisa B Hightow-Weidman
• 金额: $ 70.1万
• 依托单位: FLORIDA STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-01-25 至 2029-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10595907
• 关键词: AIDS prevention; Address; Adherence; Administrator; Adolescent Medicine Trials Network; Adolescent and Young Adult; Adoption; Age; Behavior; Behavior Therapy; Behavioral; Biological Markers; Bisexual; Caring; Characteristics; Clinic; Clinical; Cocaine; Cognitive; Cognitive Therapy; Communities; Competence; Consultations; Counseling; Depressed mood; Development; Distress; Educational workshop; Effectiveness; Evidence based intervention; Feedback; Feeling; Funding; Gays; Geography; HIV; HIV risk; HIV/AIDS; HIV/STD; Health; Heterosexuals; Hybrids; Individual; Intervention; Interview; Leadership; Maintenance; Manuals; Measures; Mediating; Mediator; Mental Depression; Methamphetamine; Methods; Modeling; Motivation; Outcome; Participant; Patient Self-Report; Persons; Pharmaceutical Preparations; Prevalence; Primary Care; Professional counselor; Psychological reinforcement; Public Health; Quality-Adjusted Life Years; Random Allocation; Randomized; Randomized, Controlled Trials; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Reporting; Research; Resources; Risk; Risk Reduction; Secure; Sex Behavior; Sexual Transmission; Site; Stimulant; Structure; Testing; Training; Training Activity; Translations; United States; United States National Institutes of Health; Unsafe Sex; Urinalysis; Viral; Viral Load result; antiretroviral therapy; arm; behavioral disinhibition; cisgender; condomless anal sex; cost effectiveness; cost estimate; depressive symptoms; design; economic impact; ecstasy; effectiveness evaluation; effectiveness outcome; effectiveness/implementation trial; evidence base; experience; field study; implementation evaluation; implementation strategy; improved; intervention delivery; intervention effect; life time cost; men who have sex with men; multidisciplinary; non-drug; pilot trial; pleasure; pre-exposure prophylaxis; prevention service; primary outcome; psychosocial; relapse prevention; response; satisfaction; secondary outcome; sex; sexual risk behavior; sexually active; skills; standard of care; stimulant use; substance use; substance use treatment; therapy adherence; translational impact; transmission process; treatment as prevention; treatment services; uptake; virtual

Stimulant drug (e.g., crystal methamphetamine, cocaine, ecstasy, MDMA) use is a substantial public health problem among young gay, bisexual and other men who have sex with men (YGBMSM) in the United States (US). Stimulant use is associated with increased engagement in sexual risk behaviors and decreased use of HIV prevention and treatment services, and as such leads to increased HIV acquisition/transmission. There are currently no evidence-based interventions to reduce stimulant use and concurrent HIV risk among YGBMSM; in response to this urgent need and building of over a decade of NIH-funded formative and pilot research, the proposed hybrid type 2 effectiveness-implementation trial is designed to assess the effectiveness and implementation strategies of Project IMPACT—a HIV status neutral, modular behavioral intervention to reduce HIV risk in YGBMSM who use stimulants in the context of high-risk sex. The intervention incorporates HIV risk reduction counseling (including supporting PrEP and ART use) with behavioral activation (BA)—an evidence-based, easy to administer, cognitive behavioral approach to treat depression that focuses on helping individuals re-engage in activities that generate feelings of enjoyment. Our conceptual model posits that BA will re-engage YGBMSM in pleasurable non-drug use activities that will serve as a natural reinforcement for functional behavior, improve depressed mood when not on stimulants by experiencing increases in pleasure, and decrease overall distress so that YGBMSM who use stimulants can better benefit from HIV risk reduction counseling. The initial pilot trials of Project IMPACT resulted in significant reductions in sexual risk, stimulant use and depressive symptoms. Research Plan Overview: By harnessing the resources, geographic and site diversity, and multidisciplinary expertise of the Adolescent Trials Network (ATN), the current proposal aims to efficiently and rigorously prepare Project IMPACT for rapid translation into real-world practice. Following the RE-AIM Framework, we will test the reach and effectiveness of Project IMPACT (compared to an enhanced Standard of Care condition) in a two-arm, multi-site and multi-format (i.e., in-person and virtual) randomized controlled trial of 360 cisgender YGBMSM who use stimulants in the context of high-risk sex. Participants will be followed for 12 months, and primary outcomes include number of condomless anal sex acts while not protected by PrEP (HIV- YGBMSM) or while not virally suppressed (HIV+ YGBMSM) and stimulant use (via urinalysis). We will also test our multi-faceted implementation strategy by assessing adoption/ accessibility and implementation using mixed-methods assessments that describe and examine characteristics of successful implementation (including differences by intervention delivery format). Finally, we will assess the feasibility of maintenance and sustainment of Project IMPACT by using the well-established CEPAC-AYA model to project its cost effectiveness on HIV transmissions, QALYs, and per person lifetime costs.

刺激性药物（例如，甲基苯丙胺，可卡因，摇头丸，MDMA）的使用是大量公众 年轻同性恋，双性恋和其他与男性发生性关系的男性（YGBMSM）的健康问题 国家（美国）。兴奋剂的使用与增加对性风险行为的参与有关 使用艾滋病毒预防和治疗服务，因此导致艾滋病毒收购/传播增加。 目前尚无基于证据的干预措施来减少兴奋性使用和同时发生的HIV风险 YGBMSM;为了应对这种迫切需求，并建立了十多年的NIH资助的形成和飞行员 研究，拟议的Hybrid 2型有效性实施试验旨在评估 项目影响的有效性和实施策略 - 艾滋病毒状况中立，模块化行为 干预措施以降低在高风险性行为中使用兴奋剂的YGBMSM中的艾滋病毒风险。这 干预措施将艾滋病毒风险降低咨询（包括支持和艺术使用）与 行为激活（BA） - 一种基于证据的，易于管理的认知行为方法 抑郁症的重点是帮助个人重新参与产生乐趣感的活动。 我们的概念模型认为，BA将重新参与YGBMSM愉快的非药水活动 这将是功能行为的自然增强 通过体验愉悦的增加并减少整体困扰，以使使用的YGBMMSM的兴奋剂 兴奋剂可以更好地从艾滋病毒风险降低咨询中受益。项目影响的初步试验试验 导致性风险，刺激性使用和抑郁症状大大减少。 研究计划概述：通过利用资源，地理和场地多样性以及 青少年试验网络（ATN）的多学科专业知识，目前的建议旨在有效， 严格准备的项目影响将快速转化为现实世界实践。遵循重新启示 框架，我们将测试项目影响的影响力和有效性（与增强的标准相比 护理条件）在两臂，多站点和多格式（即面对面和虚拟的）随机控制中 在高风险性别的背景下使用刺激剂的360个sisgender YGBMSM的试验。参与者会 紧随其后的12个月，主要结果包括无避孕套肛交的数量，而不是 受PREP（HIV-YGBMSM）保护或未抑制（HIV+ YGBMSM）和刺激性使用（通过 尿液分析）。我们还将通过评估采用/可访问性来测试多方面的实施策略 并使用混合方法评估来描述和检查的特征 成功实施（包括干预交付格式的差异）。最后，我们将评估 通过使用良好的CEPAC-AYA维护和维持项目影响的可行性 模型将其成本效率投射到HIV传播，Qalys和人均一生成本上。