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

描述（由申请人提供）：在非洲，将感染艾滋病毒的患者留在护理中对于成功应对艾滋病毒/艾滋病至关重要，但在登记后的两年内，随访损失往往达到20%-40%，使数百万患者面临预后不良的风险。迫切需要一项在资源限制范围内优化留用的战略，但必须首先克服两个关键挑战。首先，滞留时间的缺失可能是由于心理（例如，羞辱）、结构（例如，交通）或系统（例如，漫长的等待时间）障碍造成的。因此，尽管三种干预措施在随机试验中（短信、交通券和同伴导航员）显示出一定的滞留效果，但每种干预措施只对一些障碍起作用，因此对面临其他障碍的患者无效，在现实世界的患者群体中总体有效性有限。第二，尽管住院率低是非洲的一个危机，但大多数患者仍在接受治疗，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，也会浪费资源在不需要帮助的患者身上，而只帮助一些需要帮助的患者。序贯适应策略——一类新的公共卫生方法——可能为这些挑战提供解决方案，同时优化留用工作的效力和效率。候选的顺序适应策略将从对所有患者进行成本较低的干预（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成本较高且强化的干预（例如导航仪）。根据个人的行为改变最初的干预措施，使最初的干预措施对那些已经足够的患者的支出最小化（优化效率），但对那些需要额外或替代帮助的患者加强服务（优化有效性）。我们提出了一个顺序的多任务随机试验来评估一系列这样的策略。我们将在肯尼亚Nyanza的6家艾滋病诊所随机抽取2500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。保留力减弱的早期迹象（定义为患者第一次迟到14天）的患者将被重新随机分配到(1)单次外展（标准护理），(2)短信与代金券相结合，或(3)同伴导航员。在目标1中，我们评估了第一阶段策略（REC， SMS，凭证）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）的相对有效性，以重新吸引患者。由于最初的干预改变了死亡患者的数量和类型，从而改变了任何第二次干预的效果，因此在Aim 3中，我们评估了顺序预防和再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份适应性保留策略的菜单，每一项都附有成本和效果的估计，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项目的影响。

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.