Adaptive Strategies for Preventing & Treating Lapses of Retention in Care (AdaPT)

适应性预防策略

• 批准号: 9315217
• 负责人: Elvin H. Geng
• 金额: $ 67.52万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-07-24 至 2019-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9315217
• 关键词: AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Address; Adherence; Adult; Affect; Africa; Appointment; Behavior; Caring; Characteristics; Clinic; Clinical; Communities; Complex; Computerized Medical Record; Counseling; Cues; Dementia; Economics; Education; Effectiveness; Effectiveness of Interventions; Eligibility Determination; Enrollment; Expenditure; Experimental Designs; Face; Family; Fright; Funding; Guilt; HIV; Health Benefit; Individual; Intervention; Joints; Kenya; Logistics; Mental Depression; Morbidity - disease rate; National Institute of Mental Health; Outcome; Output; Patient Rights; Patients; Policy Maker; Population; Pregnancy; Prevention; Preventive Intervention; Primary Health Care; Productivity; Provider; Psychosocial Factor; Public Health; Randomized; Reporting; Research; Research Infrastructure; Research Personnel; Resources; Risk; Services; Shame; System; Text; Time; Transportation; Travel; United States National Institutes of Health; Viral; Visit; Work; addiction; arm; comparative effectiveness; cost; cost effectiveness; design; effective intervention; evidence base; follow-up; mortality; novel; novel strategies; outreach; patient population; peer; prevent; programs; psychologic; public health intervention; public health relevance; randomized trial; response; retention rate; routine care; social; social stigma; standard of care; success; survival outcome; treatment program; voucher

DESCRIPTION (provided by applicant): Retaining HIV-infected patients in care is critical to a successful response to HIV/AIDS in Africa, but loss to follow-up after enrollment often reaches 20%-40% by two years, placing millions of patients at risk of poor outcomes. A strategy to optimize retention within resource constraints is urgently needed, but must first overcome two critical challenges. First, lapses in retention may be due to psychological (e.g., stigma), structural (e.g., transportation) or systems (e.g., long waiting times) barriers Therefore, althoug three interventions have shown some efficacy for retention in randomized trials (SMS text messages, transport vouchers and peer navigators), each acts only on some barriers and is therefore is ineffectual for patients facing other barriers and is of limited overall effectivenessin real-world patient populations. Second, although poor retention is a crisis in Africa, most patients remain in care with minimal support. As a result, even the most effective of these interventions if applied uniformly as a one-size-fits-all approach will squander resources on patients who do not need help while helping only some patients in need. Sequential adaptive strategies - a novel class of public health approaches - may offer a solution to these challenges and simultaneously optimize both the effectiveness and efficiency of retention efforts. A candidate sequential adaptive strategy would start with a less expensive intervention (e.g., SMS) in all patients and then apply a more costly and intensive one (e.g., navigator) only to patients who show early signs of poor retention. Altering the initial intervention in response to a individual's behavior minimizes expenditures for patients for whom the initial intervention is sufficient (optimizing efficiency), but intensifies services for those who need additional or alternative help (optimizing effectiveness). We propose a sequential multiple assignment randomized trial to evaluate a family of such strategies. We will randomize 2,500 adults at six HIV clinics in Nyanza, Kenya to (1) standard of care routine education and counseling (REC), (2) SMS text messages, or (3) transport vouchers. Patients with early signs of weakening retention (defined as the first time a patient is 14 days late for an appointment) will be re-randomized to (1) a single episode of outreach (standard of care), (2) SMS combined with vouchers, or (3) a peer navigator. In Aim 1, we assess the comparative effectiveness of first-stage strategies (REC, SMS, voucher) to prevent lapses in retention. In Aim 2, we assess the comparative effectiveness of second stage strategies (outreach, SMS + voucher, navigator) to re-engage patients. Because the initial intervention changes both the numbers and types of patients who lapse and thereby the effect of any second intervention, in Aim 3 we assess the joint effectiveness and cost-effectiveness of sequenced prevention and re-engagement strategies. At study conclusion, our primary output will be a menu of adaptive strategies for retention, each accompanied by estimates of cost and effectiveness, which policy makers in different settings can use to advance the impact of HIV care and treatment programs in Africa.

描述（由申请人提供）：将艾滋病毒感染者留在护理中对于非洲成功应对艾滋病毒/艾滋病至关重要，但入组后两年内失访率往往达到 20%-40%，导致数百万患者陷入困境面临不良结果的风险。迫切需要在资源限制下优化保留的策略，但必须首先克服两个关键挑战。首先，记忆力下降可能是由于心理（例如，耻辱）、结构（例如，交通）或系统（例如，长时间等待）障碍造成的。因此，尽管三种干预措施在随机试验中显示出对记忆力有一定的功效（短信） 、交通券和同伴导航器），每种方法仅对某些障碍起作用，因此对于面临其他障碍的患者无效，并且在现实世界的患者群体中整体有效性有限。其次，尽管保留率低是非洲的一个危机，但大多数患者仍在接受护理，但支持很少。因此，即使是这些干预措施中最有效的，如果作为一刀切的方法统一应用，也会将资源浪费在不需要帮助的患者身上，而只帮助一些有需要的患者。序贯适应性策略——一类新型的公共卫生方法——可以为这些挑战提供解决方案，同时优化保留工作的有效性和效率。候选序贯适应性策略将从对所有患者进行较便宜的干预（例如短信）开始，然后仅对早期表现出保留不良迹象的患者应用成本更高且强度更大的干预（例如导航）。根据个人行为改变初始干预措施可以最大限度地减少初始干预措施已足够的患者的支出（优化效率），但可以加强对需要额外或替代帮助的患者的服务（优化有效性）。我们提出了一项序贯多重分配随机试验来评估一系列此类策略。我们将在肯尼亚尼安萨的 6 个 HIV 诊所随机抽取 2,500 名成年人接受 (1) 标准护理常规教育和咨询 (REC)、(2) 短信或 (3) 交通券。有早期保留减弱迹象的患者（定义为患者第一次预约迟到 14 天）将被重新随机分配至 (1) 单次外展（标准护理），(2) 短信与代金券相结合，或 (3) 对等导航器。在目标 1 中，我们评估了第一阶段策略（REC、SMS、优惠券）的相对有效性，以防止保留失误。在目标 2 中，我们评估了第二阶段策略（外展、短信 + 代金券、导航）重新吸引患者的相对有效性。由于初始干预会改变失效患者的数量和类型，从而改变任何第二次干预的效果，因此在目标 3 中，我们评估了顺序预防和重新参与策略的联合有效性和成本效益。在研究结论中，我们的主要成果将是一系列保留的适​​应性策略，每项策略都附有成本和有效性的估计，不同环境下的政策制定者可以利用这些策略来提高非洲艾滋病毒护理和治疗计划的影响。