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

描述（由申请人提供）：向艾滋病毒阳性个体提供抗逆转录病毒治疗（ART）可将传播风险降低96%。在这种背景下，确定新的策略来优化治疗作为预防（TasP）是2014财政年度Trans- NIH研究的首要任务。我们在如何在包括女性性工作者在内的关键人群中实施TasP方面的知识存在重大差距。与典型治疗方案相比，有效的TasP需要更高水平的ART依从性。采用交互式短信息服务（SMS）信息的移动健康（mHealth）方法已显示出改善抗逆转录病毒治疗依从性的希望，从而抑制血浆HIV RNA。然而，SMS干预措施支持关键人群（如FSWs）和特殊临床情况（如TasP）坚持抗逆转录病毒治疗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，我们将测试肯尼亚fsw的总体假设，一个基于理论的、个性化的、互动的短信干预强调坚持治疗的动机，与标准治疗相比，在抗逆转录病毒治疗开始6个月后显著降低可检测到的血浆HIV RNA的流行。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、适合文化的短信。目的2将在一项随机对照试验（RCT）中比较SMS干预与标准护理在抗逆转录病毒治疗开始6个月后降低可检测血浆HIV RNA个体比例的疗效，该试验包括210名fsw。目的3将通过使用lifewindow信息-动机-行为技能ART依从性问卷，比较干预组与对照组对支持和坚持ART的动机的看法，探讨干预效果的机制。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，以便与其他治疗和预防干预措施进行成本和效益比较。我们的多学科肯尼亚和美国团队在R21提供的时间框架和预算范围内进行全面的移动健康试验。这项工作将为肯尼亚合作伙伴提供合作研究和培训机会，以在蒙巴萨县建立移动医疗能力。肯尼亚国家艾滋病和性传播疾病控制规划将这一地理位置确定为高发聚集区，使其成为加强艾滋病毒预防干预的目标地区。这项随机对照试验的成功完成可以证明，这是一项有效的策略，可以支持家庭服务场所的治疗和艾滋病毒的二级预防。根据初步发现，这些数据将用于为更大（多地点、更大N）和更长的随机对照试验（1-2年随访）制定资助建议，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实际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.