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)：在非洲成功应对艾滋病毒/艾滋病的关键是将艾滋病毒感染患者留在护理中，但登记后的随访损失通常在两年内达到20%-40%，使数百万患者面临预后不良的风险。迫切需要一种在资源限制下优化留存的战略，但首先必须克服两个关键挑战。首先，保留失败可能是由于心理障碍(例如，污名)、结构性障碍(例如，交通)或系统障碍(例如，等待时间较长)。因此，尽管在随机试验(短信、交通凭证和同行导航器)中有三种干预措施显示了保留的一些效果，但每一种干预措施只作用于某些障碍，因此对面临其他障碍的患者无效，并且在现实世界的患者群体中的总体有效性有限。其次，尽管保留不良在非洲是一种危机，但大多数患者仍然在接受治疗，得到的支持很少。因此，即使是最有效的干预措施，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，同时只帮助一些需要帮助的患者。顺序适应战略--一类新的公共卫生方法--可能为这些挑战提供解决方案，同时优化留住努力的效力和效率。候选序贯自适应策略将在所有患者中以较便宜的干预(例如，SMS)开始，然后仅对表现出早期保留不良迹象的患者应用较昂贵和密集的干预(例如，导航器)。根据个人行为改变初始干预可最大限度地减少对初始干预足够的患者的支出(优化效率)，但加强对需要额外或替代帮助的患者的服务(优化有效性)。我们提出了一种序贯多重分配随机试验来评估一系列这样的策略。我们将在肯尼亚Nyanza的六家艾滋病毒诊所随机选择2500名成年人进行(1)常规护理标准教育和咨询(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)将被重新随机分配到(1)单次外展(标准护理)，(2)短信结合代金券，或(3)同行导航器。在目标1中，我们评估了防止留存失误的第一阶段策略(REC、SMS、代金券)的相对有效性。在目标2中，我们评估了第二阶段策略(外展、短信+代金券、导航器)重新接触患者的比较有效性。由于最初的干预改变了失误患者的数量和类型，从而改变了任何第二次干预的效果，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。在研究结束时，我们的主要产出将是一系列适应性保留战略，每一项都伴随着对成本和效果的估计，不同环境中的政策制定者可以利用这些估计来推进艾滋病毒护理和治疗项目在非洲的影响。