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

描述（由申请人提供）：保留HIV感染患者的护理对于成功应对非洲的HIV/AIDS至关重要，但入组后的随访损失通常在两年内达到20%-40%，使数百万患者面临不良结局的风险。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，记忆力下降可能是由于心理因素（例如，柱头），结构（例如，运输）或系统（例如，因此，尽管三种干预措施在随机试验中显示出一定的保留效果（SMS文本消息、运输凭证和同伴导航器），但每种干预措施仅对某些障碍起作用，因此对面临其他障碍的患者无效，并且在现实世界患者群体中的总体有效性有限。第二，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，得到的支持最少。因此，即使是这些干预措施中最有效的，如果作为一种一刀切的方法统一应用，也会浪费资源在不需要帮助的病人身上，而只帮助一些需要帮助的病人。序贯适应性战略-一种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。候选顺序适应策略将以较便宜的干预开始（例如，SMS），然后应用更昂贵和密集的方法（例如，导航员）仅适用于表现出早期保留不良迹象的患者。根据个人的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经足够的患者的支出（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（优化效率）。我们提出了一个序贯多分配随机试验，以评估家庭这样的策略。我们将在肯尼亚尼扬扎的六个艾滋病诊所随机抽取2,500名成年人，接受（1）护理标准常规教育和咨询（REC），（2）短信，或（3）交通券。具有记忆力减弱早期体征的患者（定义为患者首次约会迟到14天）将被重新随机分配至（1）单次外展（标准治疗），（2）SMS联合代金券，或（3）同行导航。在目标1中，我们评估了第一阶段策略（REC，SMS，代金券）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，SMS +代金券，导航器）重新吸引患者的相对有效性。由于初始干预改变了失效患者的数量和类型，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份保留的适应性策略菜单，每一项都附有成本和有效性的估计，不同环境中的政策制定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。

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.