Adaptive Strategies to Prevent and Treat Lapses of Retention in HIV Care for Adolescents (A4A)

摘要 在非洲，14-24岁的青少年和青年艾滋病毒携带者经历了大量的 与成人相比，病毒失败率和艾滋病毒相关死亡率更高。因此，有效的公众 迫切需要为这一年龄段量身定做并在其中进行测试的卫生战略。身体上的， 阿雅面临的心理和社会转型创造了独特的易感性，使人们对流行和 令人敬畏的结构性(例如，交通成本)、社会心理(例如，想要融入同龄人的愿望， 耻辱)和以诊所为基础(例如，不友好的提供者、漫长的等待时间) 公共卫生艾滋病毒治疗设置。障碍的强度和性质的可变性， 然而，这带来了一个关键挑战：如果障碍高度可变，那么就没有单独的干预措施 是所有人都需要的，而他们也无法帮助所有需要帮助的人。适应性策略代表了一种新的 解决这些问题的方法，没有“灵丹妙药”的解决方案，我们假设有这种解决方案 与Aya参与艾滋病毒治疗特别相关。适应性战略通常始于 不那么密集的干预，然后升级为更密集的干预，仅限于 做得不好。对那些做得好的人保持低强度的干预可以节约资源 在Aya的相当一部分不需要额外服务的人中，从而能够实现更多 加大对困难群众的支持力度。而序贯多重分配随机试验 (SMARTS)，用于比较不同的干预序列，已被用于 研究精神疾病、癌症治疗和艾滋病毒治疗，这项建议是第一次应用智能 以解决阿亚参与非洲艾滋病毒治疗的问题。在此设计中，我们将使用 将量身定做具有高有效性潜力的适合发展的干预措施 由Aya预先实施。具体地说，我们将在肯尼亚随机选择880名感染艾滋病毒的Aya患者 (1)以青少年为中心的教育和咨询(关怀标准)与(2)增加短信和同伴 通过电话提供支持、信息和咨询的电子导航员。那些拥有 交战失误将被第二次重新随机分配到三个更高强度的重新 参与干预：(1)护理标准外展和强化咨询，(2) 有条件的现金转账和(3)面对面的同行导航。主要结果将是 访问依从性和病毒载量抑制的组合。这项研究将量化相对的 由有前途的个体组成的几种策略的有效性(和成本效益) 干预措施。我们将评估提供商和患者的体验以及对 使用混合方法进行干预。这项创新性的研究将为公众提供相关证据 卫生规划，以结束艾滋病毒携带者阿亚的艾滋病流行。

Abstract Adolescents and young adults (AYA) aged 14-24 years with HIV in Africa experience substantially higher rates of viral failure and HIV-related mortality as compared to adults. Thus, effective public health strategies tailored for and tested in this age group are urgently needed. The physical, psychological and social transitions faced by AYA create unique susceptibilities to prevalent and formidable structural (e.g., transport costs), psychosocial (e.g., the desire to fit in with peers, stigma) and clinic-based (e.g., unfriendly providers, long waiting times) barriers to engagement in public health HIV treatment settings. The variability in the intensity and the nature of barriers, however, poses a critical challenge: if barriers are highly variable, then no individual interventions are needed by all, while they also fail to help all in need. Adaptive strategies represent a novel approach to such problems with no “silver-bullet” solutions, and which we hypothesize have particular relevance for engagement of AYA in HIV treatment. Adaptive strategies typically begin with a less intensive intervention, and then escalate to a more intensive intervention only in those not doing well. Maintaining lower-intensity interventions in those doing well conserves resources in the substantial fraction of AYA who do not need additional services, thereby enabling more intensive support for those in need. While sequential multiple assignment randomized trials (SMARTs), which are used to compare different sequences of interventions, have been used to study mental illness, cancer therapy and HIV treatment, this proposal is the first to apply a SMART to address engagement of AYA in HIV treatment in Africa. Within this design, we will use developmentally appropriate interventions with high potential for effectiveness that will be tailored by AYA pre-implementation. Specifically, we will randomize 880 AYA with HIV in Kenya to either (1) youth-centered education & counseling (standard of care) vs. (2) addition of a SMS and peer electronic navigator who provides support, information and counseling via phone. Those with a lapse in engagement will be re-randomized a second time to one of three higher-intensity re- engagement interventions: (1) standard of care outreach and intensified counseling, (2) conditional cash transfers and (3) in-person peer navigation. The primary outcome will be a combination of visit adherence and viral load suppression. This study will quantify the relative effectiveness (and cost effectiveness) of several strategies composed of promising individual interventions. We will assess provider and patient experiences and satisfaction with the interventions using mixed methods. This innovative study will offer relevant evidence for public health programming to end the AIDS epidemic for AYA with HIV.