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: 10380177
• 负责人: Cathy J Reback
• 金额: $ 41.39万
• 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 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10380177
• 关键词: AIDS prevention; AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Adherence; 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; Subgroup; Technology; Translations; United States National Institutes of Health; Viral Load result; Work; alcohol effect; arm; base; behavior measurement; computerized; condomless anal sex; cultural competence; design; efficacy trial; evidence base; follow-up; health care availability; health disparity populations; 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; pilot test; power analysis; pre-exposure prophylaxis; prospective; randomized trial; response; sex; sexual risk behavior; skills; smartphone Application; social stigma; stimulant use; substance use; theories; transmission process; treatment effect; uptake; urban area; usability; 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）使用甲基苯丙胺（MA）与以下因素的发生率增加有关： 艾滋病毒的流行和传播，以及艾滋病毒预防和护理工作沿着进展不佳 孔蒂努阿男男性行为者使用MA深深融入了社会性网络，包括使用 智能手机应用程序（“app”）和网站来寻找性伴侣。鉴于移动的医疗的发展 技术，不再有必要或合理的限制MA治疗选择的物理网站，聚集在 城市地区，并使用通用的，非定制的内容管理。该项目建立在既定的 我们的手动MA滥用治疗干预的有效性，“下车：行为治疗干预 同性恋和双性恋男性甲基苯丙胺用户，”以及我们成功的非常有希望的发现， 第一阶段概念验证研究，完成Getting Off到跨平台（iOS和Android）的翻译 并在一项科学严谨的随机试验中评估app的疗效和非劣效性。所得物 关闭应用程序，就像之前的基于群体的干预一样，将使用认知行为理论的原则， 改变的阶段，以帮助男男性接触者减少或消除使用MA和艾滋病毒的性风险行为，并增加 沿着艾滋病毒预防或护理连续体的进展（包括艾滋病毒检测的接受， 暴露预防[PEP/PrEP]和对HIV阴性者的PrEP依从性和持久性;抗逆转录病毒疗法 艾滋病毒阳性者的吸收和坚持）。该项目将1）完善和加强前8个 第一阶段根据可行性试点测试制定的摆脱性骚扰治疗干预措施 用户反馈，2）进行形成性研究，以制定其余16个会议的下车MA- 将滥用治疗干预纳入旨在减少MA使用的跨平台计算机化移动的应用程序， 艾滋病毒性风险行为，并增加艾滋病毒预防或护理连续体沿着进展，以及3） 进行随机对照试验，以评估减少MA使用和艾滋病毒性风险行为，并增加进展 沿着艾滋病毒预防或护理连续体，使用三种方法：a）疗效试验-一项双臂随机对照试验， 通过比较立即分娩（ID; n=150）和延迟分娩来确定干预效果 (DD; n=150）组; B）疗效试验-观察到的治疗效果分析，以比较 合并的ID和DD条件（N=300）;和，c）非劣效性试验-两组历史匹配比较 设计用于评价Getting Off应用程序（ID + DD; N=300）相对于匹配样本的结局， 参与者之前参加了基于实体小组的“下车”干预（N~600;总数 N=900）。RCT使用重复测量来评估基线、1-、2-（仅DD条件）、3-、6-、 9个月随访。这项研究可以通过极大地扩大获得公共卫生的影响， 有效的、负担得起的、私人的、文化上有能力的和高度可扩展的MA治疗， 人口