Motivation matters! RCT of theory-based, SMS to support TASP in high-risk women

动机很重要！

• 批准号: 8807554
• 负责人: Raymond Scott McClelland
• 金额: $ 19.42万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-02-10 至 2016-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8807554
• 关键词: AIDS prevention; Access to Information; Acquired Immunodeficiency Syndrome; Address; Adherence; Africa; Area; Back; Behavior; Behavioral; Budgets; Caring; Clinic; Clinical; Collaborations; Community Participation; Cost Effectiveness Analysis; Costs and Benefits; Country; County; Data; Development; Effectiveness; Female; Funding; General Population; Generations; Geographic Locations; HIV; HIV Infections; HIV Seropositivity; Health; Health Benefit; High Prevalence; High Risk Woman; Hour; Incidence; Individual; Information Theory; Institution; Intervention; Kenya; Knowledge; Language; Manuals; Methods; Modeling; Motivation; Names; Outcome; Participant; Patients; Perception; Plasma; Population; Prevalence; Prevention; Prevention approach; Preventive Intervention; Procedures; Provider; Public Health; Publishing; Qualitative Research; Questionnaires; RNA; Randomized Controlled Trials; Reporting; Research Priority; Research Proposals; Research Training; Resistance; Risk; Services; Site; Target Populations; Technology; Testing; Time; Training; United States National Institutes of Health; Viral Load result; Work; antiretroviral therapy; base; comparative efficacy; effective therapy; experience; flexibility; follow-up; implementation research; improved; intervention effect; mHealth; multidisciplinary; programs; public health relevance; service intervention; sex; skills; standard care; successful intervention; theories; therapy adherence; transmission process; treatment as usual; treatment program

DESCRIPTION (provided by applicant): Antiretroviral therapy (ART) provided to HIV-positive individuals can reduce transmission risk by 96%. In this context, identifying new strategies to optimize treatment as prevention (TasP) is a top Fiscal Year 2014 Trans- NIH Research Priority. There are important gaps in our knowledge of how to implement TasP in key populations including female sex workers (FSW). Effective TasP will require higher levels of ART adherence than those achieved in typical treatment programs. Mobile Health (mHealth) approaches employing interactive short message service (SMS) messages have shown promise as a method for improving ART adherence, leading to suppression of plasma HIV RNA. However, the ability of SMS interventions to support ART adherence in key populations like FSWs and unique clinical scenarios such as TasP has yet to be evaluated. To answer this important HIV treatment and prevention question, we will test the overarching hypothesis that in Kenyan FSWs, a theory-based, individualized, interactive SMS intervention emphasizing motivation to adhere to treatment will significantly reduce the prevalence of detectable plasma HIV RNA 6 months following ART initiation compared to standard care. Aim 1 will employ qualitative research and community participation to craft theory-based, individualized, culturally appropriate SMS messages grounded in constructs of the information-motivation-behavioral skills model. Aim 2 will compare the efficacy of the SMS intervention versus standard care for reducing the proportion of individuals with detectable plasma HIV RNA 6 months after ART initiation in a randomized, controlled trial (RCT) including 210 FSWs. Aim 3 will explore the mechanism of the intervention's effect by comparing perceptions of support and motivation to adhere to ART in intervention versus control subjects using an adaptation of the LifeWindows Information - Motivation - Behavioral Skills ART Adherence Questionnaire. An important product of this work will be a procedural manual to facilitate future research and implementation. We will also conduct a preliminary cost effectiveness analysis to enable comparison of costs and benefits in relation to other treatment and prevention interventions. Our multidisciplinary Kenyan and US team has experience conducting full-scale mHealth trials within the time frame and budget afforded by an R21. This work will provide collaborative research and training opportunities with Kenyan partners to build mHealth capacity in Mombasa County. This geographic location is defined by Kenya's National AIDS and STD Control Programme as a high-incidence cluster, making it a target area for intensive HIV prevention interventions. Successful completion of the RCT could demonstrate an efficacious strategy to support treatment and secondary HIV prevention in FSWs. Depending on the initial findings, these data will be used to inform development of funding proposals for a larger (multi-site, larger N) and longer (1-2 year follow-up) RCT, or to develop an implementation research proposal to bring the intervention to scale while further evaluating its effectiveness in a real-world implementation context.

描述(申请人提供)：向艾滋病毒阳性患者提供抗逆转录病毒治疗(ART)可以将传播风险降低96%。在这种背景下，确定新的战略以优化治疗作为预防(TasP)是2014财年跨NIH研究的首要优先事项。我们在如何在包括女性性工作者(FSW)在内的关键人群中实施TasP的知识方面存在着重大差距。与典型的治疗方案相比，有效的TasP需要更高水平的ART依从性。使用交互式短消息服务(SMS)消息的移动健康(MHealth)方法已经显示出作为一种改善ART依从性的方法的前景，从而导致抑制血浆HIV RNA。然而，短信干预在关键人群(如暗娼)和独特临床方案(如TasP)中支持抗逆转录病毒治疗的能力尚未得到评估。为了回答这一重要的艾滋病毒治疗和预防问题，我们将测试压倒一切的假设，即在肯尼亚FSWs中，与标准护理相比，强调坚持治疗动机的基于理论的、个性化的互动短信干预将显著降低ART开始后6个月可检测到的血浆HIV RNA的患病率。目标1将利用定性研究和社区参与，在构建信息-动机-行为技能模型的基础上，制定基于理论的、个性化的、适合文化的短信。目的2将在一项包括210名暗娼的随机对照试验(RCT)中，比较短信干预和标准护理在ART启动6个月后降低可检测到血浆HIV RNA的个体比例方面的效果。目的3采用改编的生活视窗信息-动机-行为技能艺术依从性问卷，通过比较干预组和对照组受试者对支持和坚持艺术的动机的知觉，来探讨干预效果的机制。这项工作的一个重要成果将是一本程序手册，以便利今后的研究和实施。我们还将进行初步的成本效益分析，以便将成本和收益与其他治疗和预防干预措施进行比较。我们的多学科肯尼亚和美国团队拥有在R21的时间框架和预算内进行全面mHealth试验的经验。这项工作将提供与肯尼亚合作伙伴的合作研究和培训机会，以在蒙巴萨县建设移动卫生能力。这一地理位置被肯尼亚国家艾滋病和性病控制方案定义为高发聚集区，使其成为密集艾滋病毒预防干预的目标地区。RCT的成功完成可以证明一种有效的战略，以支持暗娼的治疗和艾滋病毒二级预防。根据最初的调查结果，这些数据将被用于为更大规模(多地点、更大N)和更长时间(1-2年后续行动)的区域工作队的供资建议提供信息，或者用于制定实施研究建议，以使干预措施具有规模，同时进一步评估其在现实世界实施背景下的有效性。