Getting Off: A Theory-based mHealth Intervention for Methamphetamine-using MSM

下车：针对使用甲基苯丙胺的 MSM 的基于理论的移动健康干预

• 批准号: 9920698
• 负责人: Cathy J Reback
• 金额: $ 46.92万
• 依托单位: FRIENDS RESEARCH INSTITUTE, INC.
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-07-15 至 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9920698
• 关键词: AIDS prevention; AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Adherence; Alcohol or Other Drugs use; Behavior Therapy; Behavioral; Bisexual; Caring; Cognitive; Cognitive Therapy; Communities; Continuity of Patient Care; Data Pooling; Development; Discrimination; Evaluation; Exposure to; Face; Feedback; Feeling; Focus Groups; Food; Funding; Gays; Growth; HIV; HIV Infections; HIV Seronegativity; HIV Seropositivity; Health Technology; Homophobia; Housing; Human immunodeficiency virus test; Individual; Interruption; Intervention; Measures; Methamphetamine; Modeling; National Institute of Drug Abuse; Outcome; Participant; Pharmaceutical Preparations; Pilot Projects; Population; Prevalence; Privatization; Prophylactic treatment; Public Health; Randomized; Reporting; Research; Research Priority; Risk; Sampling; Severities; Sexual Partners; Sexual and Gender Minorities; Site; Structure; Subgroup; Technology; Testing; Translations; United States National Institutes of Health; Viral Load result; Work; alcohol effect; arm; base; behavior measurement; computerized; condomless anal sex; design; efficacy trial; evidence base; follow-up; health care availability; health disparity; high risk population; improved; individualized medicine; innovation; innovative technologies; intervention effect; mHealth; male; men who have sex with men; methamphetamine abuse; methamphetamine use; methamphetamine user; mobile application; mobile computing; mortality; power analysis; pre-exposure prophylaxis; prospective; randomized trial; response; sex; sexual risk behavior; skills; smartphone Application; social stigma; stimulant use; theories; transmission process; treatment effect; uptake; urban area; usability; virology; web site

Abstract Methamphetamine (MA) use among men who have sex with men (MSM) is associated with increased rates of HIV prevalence and transmission, as well as substandard advancement along the HIV Prevention and Care Continua. MA use among MSM is deeply integrated into socio-sexual networks including the use of smartphone applications (“app”) and websites to find sexual partners. Given the growth of mobile health technology, it is no longer necessary or reasonable to limit MA treatment options to physical sites, clustered in urban areas, and administered using generic, non-tailored content. The project builds upon the established efficacy of our manualized MA-abuse treatment intervention, “Getting Off: A Behavioral Treatment Intervention for Gay and Bisexual Male Methamphetamine Users,” and the highly promising findings from our successful Stage I proof-of-concept study, to complete translation of Getting Off into a cross-platform (iOS and Android) app and assess the app’s efficacy and non-inferiority in a scientifically rigorous randomized trial. The Getting Off app, like the group-based intervention before it, will use the principles of Cognitive Behavioral Theory and Stages of Change to help MSM reduce or eliminate MA use and HIV sexual risk behaviors, and increase advancement along the HIV Prevention or Care Continuum (including uptake of HIV testing, pre-, and post- exposure prophylaxis [PEP/PrEP] and PrEP adherence and persistence for those who are HIV negative; ART uptake and adherence for those who are HIV positive). This project will 1) refine and enhance the first 8 sessions of the Getting Off MA-abuse treatment intervention developed in Stage I based on feasibility pilot test user feedback, 2) conduct formative research to develop the remaining 16 sessions of the Getting Off MA- abuse treatment intervention into a cross-platform computerized mobile app targeted to reduce MA use and HIV sexual risk behaviors, and increase advancement along the HIV Prevention or Care Continuum, and 3) conduct a RCT to evaluate reductions of MA use and HIV sexual risk behaviors, and increased advancement along the HIV Prevention or Care Continuum, using three approaches: a) Efficacy Trial – a two-arm RCT to determine intervention effects through comparison of the Immediate Delivery (ID; n=150) and Delayed Delivery (DD; n=150) arms; b) Efficacy Trial – an observed treatment effects analysis to compare pre/post data from the pooled ID and DD conditions (N=300); and, c) Non-inferiority Trial – a two-arm historical matched comparison design to evaluate the outcomes of the Getting Off app (ID + DD; N=300) relative to a matched sample of participants having previously attended the brick-and-mortar group-based Getting Off intervention (N~600; total N=900). The RCT uses repeated measures to assess participants at baseline, 1-, 2- (DD condition only), 3-, 6-, and 9-month follow-up. This study could have significant public health impact by greatly expanding access to effective, affordable, private, culturally competent and highly scalable MA treatment to this very high-risk population.

摘要 男男性行为者(MSM)中使用甲基苯丙胺(MA)与 艾滋病毒的流行和传播，以及艾滋病毒预防和护理工作进展不达标 康涅瓦。男男性接触者中的MA使用深度融入了社会-性网络，包括使用 智能手机应用程序(APP)和寻找性伴侣的网站。鉴于移动医疗的增长 技术，不再有必要或合理地将MA治疗选项限制在物理站点、聚集在 城市地区，并使用通用的、非定制的内容进行管理。该项目建立在已建立的 我们的人工MA滥用治疗干预的有效性，《下车：一种行为治疗干预》 对于同性恋和双性恋男性甲基苯丙胺吸毒者来说，“和我们的成功发现非常有希望 第一阶段概念验证研究，以完成跨平台(iOS和Android)的转换 并在一项科学严谨的随机试验中评估该应用程序的有效性和非劣性。得到的东西 Off APP，就像它之前的基于群体的干预一样，将使用认知行为理论和 改变的阶段，以帮助MSM减少或消除MA使用和HIV性危险行为，并增加 在艾滋病毒预防或护理连续过程中取得进展(包括在艾滋病毒检测之前和之后 暴露预防[PEP/PrEP]以及对艾滋病毒阴性者的PrEP坚持和坚持；ART 艾滋病毒阳性者的接受和坚持)。该项目将1)完善和增强前8 基于可行性中试的第一阶段制定的戒除滥用药物治疗干预的会议 用户反馈，2)进行形成性研究，以开发剩余的16个脱手MA会话- 将虐待治疗干预纳入跨平台计算机化移动应用程序，旨在减少MA的使用和 艾滋病毒性危险行为，并在艾滋病毒预防或护理连续过程中提高进展，以及3) 开展随机对照试验，评估吸毒者和HIV性危险行为的减少，以及进步的增加 在艾滋病毒预防或护理连续过程中，使用三种方法：a)疗效试验--双臂随机对照试验 通过比较即时分娩(ID；n=150)和延迟分娩来确定干预效果 (DD；n=150)ARMS；b)疗效试验--一项观察的治疗效果分析，以比较来自 合并ID和DD条件(N=300)；以及，c)非劣势试验--双臂历史配对比较 设计以评估相对于匹配样本的脱机应用程序(ID+DD；N=300)的结果 参与者之前参加过基于实体小组的脱机干预(N~600；总计 N=900)。随机对照试验在基线、1-、2-(仅限DD情况)、3-、6-、 并进行9个月的随访。这项研究可能会通过极大地扩大对 针对这一非常高风险的有效、负担得起的、私人的、有文化能力的、高度可扩展的MA治疗 人口。