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

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%。在这种情况下，确定新的战略，以优化治疗预防（TasP）是一个顶级的财政年度2014年跨NIH研究优先事项。我们对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将需要比典型治疗方案更高水平的ART依从性。采用交互式短消息服务（SMS）消息的移动的健康（mHealth）方法已经显示出作为改善ART依从性的方法的前景，从而导致血浆HIV RNA的抑制。然而，SMS干预支持关键人群（如FSW）和独特临床场景（如TasP）坚持ART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，我们将测试总体假设，在肯尼亚FSW，一个基于理论的，个性化的，互动的SMS干预，强调坚持治疗的动机，将显着降低可检测的血浆HIV RNA的流行率6个月后，ART启动相比，标准护理。目标1将采用定性研究和社区参与工艺理论为基础的，个性化的，文化上适当的短信接地的信息，动机，行为技能模型的结构。目标2将在一项包括210名FSW的随机对照试验（RCT）中，比较SMS干预与标准治疗在降低ART开始后6个月可检测到血浆HIV RNA的个体比例方面的疗效。目的3将探讨干预的效果的机制，通过比较的支持和动机，坚持ART干预与对照组的受试者使用的LifeWindows信息-动机-行为技能ART依从性问卷的适应。这项工作的一个重要成果将是编写一份程序手册，以便利今后的研究和执行。我们还将进行初步的成本效益分析，以便能够比较与其他治疗和预防干预措施有关的成本和效益。我们的多学科肯尼亚和美国团队拥有在R21提供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合作研究和培训的机会，以建设蒙巴萨县的移动保健能力。肯尼亚国家艾滋病和性传播疾病控制方案将这一地理位置确定为高发区，使其成为艾滋病毒密集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一种有效的策略，以支持治疗和二级艾滋病毒预防FSW。根据初步结果，这些数据将用于为更大（多中心，更大的N）和更长（1-2年随访）的RCT提供资金建议，或制定实施研究建议，以扩大干预措施的规模，同时进一步评估其在现实世界实施环境中的有效性。

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.