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

适应性预防策略

• 批准号: 8732203
• 负责人: Elvin H. Geng
• 金额: $ 63.5万
• 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/8732203
• 关键词: AIDS/HIV problem; Absenteeism at work; 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; Enrollment; Expenditure; Experimental Designs; Face; Family; Fright; Funding; Guilt; HIV; Health Benefit; Individual; Intervention; Joints; Kenya; 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; Solutions; Staging; 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 relevance; randomized trial; response; social; social stigma; standard of care; success; 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）：保留艾滋病毒感染的患者对非洲的艾滋病毒/艾滋病的成功反应至关重要，但是入学后对随访的损失通常在两年左右达到20％-40％，使数百万患者面临不良结果的风险。迫切需要一种优化在资源限制内保留的策略，但必须首先克服两个关键挑战。首先，保留的失误可能是由于心理（例如柱头），结构性（例如，运输）或系统（例如，较长的等待时间）障碍，因此，三个干预措施在随机试验中保留了一定的疗效，在随机试验中保留了一定的疗效（SMS文本信息，每种障碍，因此在某些情况下，限制了其他障碍，因此是其他障碍，是其他障碍，是其他有效的效果现实世界中的患者人群。其次，尽管保留率差是非洲的危机，但大多数患者仍在提供最少的支持。结果，即使是统一应用的方法，即使是这些干预措施中最有效的方法，也会浪费对不需要帮助的患者的资源，同时仅帮助一些有需要的患者。顺序自适应策略 - 一种新颖的公共卫生方法 - 可能提供解决这些挑战的解决方案，并同时优化保留工作的有效性和效率。候选的顺序自适应策略将从所有患者的较便宜的干预措施（例如SMS）开始，然后仅对显示保留率不佳的早期迹象的患者进行更为昂贵，更密集的策略（例如，导航器）。根据个人行为的响应，改变初始干预措施可以最大程度地减少初始干预足够的患者的支出（优化效率），但会加强需要其他需要其他或替代帮助的人（优化有效性）的服务。我们提出了一项顺序多次分配随机试验，以评估此类策略的家庭。我们将在肯尼亚Nyanza的六家HIV诊所中随机将2500名成年人随机，以（1）（1）医疗标准常规教育和咨询（REC），（2）SMS短信或（3）运输代金券。保留率较弱的早期迹象的患者（定义为第一次延迟迟到14天）将被重新融合到（1）（1）一次外展（护理标准），（2）SMS与凭证合并或（3）同行导航员。在AIM 1中，我们评估了第一阶段策略（REC，SMS，代金券）的比较有效性，以防止保留失误。在AIM 2中，我们评估了第二阶段策略（外展，SMS +代金券，导航器）的比较有效性，以重新吸引患者。由于最初的干预措施都会改变流失的患者数量和类型，从而改变了任何第二次干预的影响，因此在AIM 3中，我们评估了测序的预防和重新参与策略的共同有效性和成本效益。在研究结论中，我们的主要产出将是保留自适应策略的菜单，伴随着成本和有效性的估计，在不同环境中的决策者可以使用这些策略来推动非洲艾滋病毒护理和治疗计划的影响。