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

动机很重要！

• 批准号: 9011546
• 负责人: Raymond Scott McClelland
• 金额: $ 19.37万
• 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 2017-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9011546
• 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; 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; Testing; Time; Training; United States National Institutes of Health; Viral Load result; Work; antiretroviral therapy; base; comparative efficacy; effective therapy; experience; female sex worker; flexibility; follow-up; implementation research; improved; intervention effect; mHealth; mobile computing; multidisciplinary; programs; service intervention; sex; skills; standard care; successful intervention; theories; therapy adherence; training opportunity; 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（由申请人提供）：向 HIV 阳性个体提供抗逆转录病毒治疗 (ART) 可以将传播风险降低 96%。在此背景下，确定优化治疗即预防 (TasP) 的新策略是 2014 财年 Trans-NIH 研究的首要任务。我们对于如何在包括女性性工作者 (FSW) 在内的关键人群中实施 TasP 的知识存在重大差距。有效的 TasP 需要比典型治疗计划更高水平的 ART 依从性。采用交互式短信服务 (SMS) 消息的移动医疗 (mHealth) 方法已显示出作为提高 ART 依从性的方法的前景，从而抑制血浆 HIV RNA。然而，SMS 干预措施支持 FSW 等关键人群和 TasP 等独特临床情况的 ART 依从性的能力尚未得到评估。为了回答这个重要的艾滋病毒治疗和预防问题，我们将测试一个总体假设，即在肯尼亚 FSW 中，基于理论的、个性化的、交互式短信干预强调坚持治疗的动机，将显着降低 6 个月后可检测到的血浆 HIV RNA 的患病率ART 启动与标准护理的比较。目标 1 将采用定性研究和社区参与，以信息-动机-行为技能模型的构建为基础，制作基于理论的、个性化的、适合文化的 SMS 消息。目标 2 将在一项包括 210 名 FSW 的随机对照试验 (RCT) 中比较 SMS 干预与标准护理在降低 ART 开始 6 个月后血浆可检测到 HIV RNA 的个体比例方面的效果。目标 3 将通过使用 LifeWindows 信息 - 动机 - 行为技能 ART 依从问卷的改编，比较干预对象与对照对象对坚持 ART 的支持和动机的看法，从而探索干预效果的机制。这项工作的一个重要成果将是一份程序手册，以促进未来的研究和实施。我们还将进行初步的成本效益分析，以便比较与其他治疗和预防干预措施的成本和效益。我们的肯尼亚和美国多学科团队拥有在 R21 提供的时间范围和预算内进行全面移动医疗试验的经验。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，以建设蒙巴萨县的移动医疗能力。肯尼亚国家艾滋病和性病控制计划将这一地理位置定义为高发区，使其成为强化艾滋病毒预防干预措施的目标地区。成功完成随机对照试验可以证明支持 FSW 治疗和二级艾滋病毒预防的有效策略。根据初步发现，这些数据将用于为更大（多中心、更大 N）和更长（1-2 年随访）RCT 的资助提案的制定提供信息，或制定实施研究提案以带来扩大干预规模，同时进一步评估其在现实世界实施背景下的有效性。