Implementation Science to Understand and Design Stakeholder Informed Innovative Interventions to Improve Adolescent and Youth HIV Prevention and Care Continuums in Rural and Urban Uganda

项目摘要：青少年和青壮年(Aya)艾滋病毒发病率高，结果差。 与成年人相比，整个艾滋病毒预防和护理的级联效应。尽管艾滋病毒负担很高，但这两种情况下 在年青人中，口服PrEP(HIV阴性)和实现病毒抑制(HIV阳性)的效果并不理想 撒哈拉以南非洲。在乌干达青年中，口服PrEP的接受率和持久性较低，原因如下 停药包括：服药负担，艾滋病毒严重程度较低，需要伴侣或父母批准，艾滋病毒- 相关的污名、对副作用的恐惧和卫生设施障碍。 卡替格列韦是一种新型长效抗逆转录病毒药物 (CAB-LA) 和高效的PrEP选择，可以减少日常口服PrEP的障碍。我们建议 评价以证据为基础的艾滋病毒预防和护理干预措施，以改善以下方面的实施成果 乌干达的高危Aya(15-24岁)。这项研究涵盖了连续护理，将使用新的筛选 艾滋病毒风险的方法，将涉及在以年轻人为重点的临床试验方面经验丰富的团队， 实施科学(IMS)，将实施卫生部批准的社区差异化服务交付模式 对于交付CAB-LA，将评估搜索青年(SY)的实施情况，这是一个多组成部分 包括基于生命阶段的评估和支持的干预措施，以增加高危人群的病毒抑制 Aya感染艾滋病毒，并将使用混合有效性实施设计来评估这些基于证据的 干预措施。我们的目标包括：目标1：使用执行研究综合框架， 我们将确定两项创新的潜在实施成功的决定因素：CAB-LA和SY 在乌干达5个不同地理位置的社区、诊所、提供者和患者层面实施。 目标2a：使用混合有效性实施类型II设计，我们将评估吸收和持久性 卡巴-洛杉矶。我们会进行一项随机前瞻性研究，以评估提供CAB的成效- 洛杉矶属于高危人群，阿亚。有效性结果将是启动CAB-LA的研究对象的比例 并持续了18个月的跟踪调查，比较了设施和社区的交付方式。实施 结果将是使用RE-AIM的可行性、可接受性、采用率和维护性。目标2b：使用混合动力 我们将评估实施的有效性实施类型III设计(可行性、采用率、保真度和 持续)和SY干预在增加长期病毒学抑制方面的有效性(&lt；200毫升) 在18个月的随访中，5个CRPS使用RE-AIM。目标3：我们将使用目标1和2中的平台来加强 加强国际监测系统的能力，并将调查结果转化为政策和指导方针。我们的研究涉及到坚实的社区和 建立机构伙伴关系，建立一支在创新方法方面经验丰富的强大多学科团队 和撒哈拉以南非洲的实施科学。该项目建立在PATC3H和AHISA的基础上，具有响应性 对于世卫组织，乌干达卫生部的优先事项是为高度脆弱的阿亚提供艾滋病毒服务方面的差距。它将测试一个 新的、可扩展的和综合的方法，以启动和维持对LMIC中高风险的Aya的支持。

PROJECT SUMMARY: Adolescents and young adults (AYA) have a high HIV incidence and poor outcomes along the entire HIV prevention and care cascades compared to adults. Despite the high HIV burden, both uptake of oral PrEP (HIV negatives) and achieving viral suppression (HIV positives) are sub-optimal among youth in Sub-Saharan Africa. Among youth in Uganda, uptake and persistence on oral PrEP is low, with reasons for discontinuation including: pill burden, low perceived severity of HIV, need for partner or parental approval, HIV- related stigma, fear of side-effects and health facility barriers. Cabotegravir, a is new long-acting antiretroviral (CAB-LA) and highly efficacious PrEP choice that can mitigate barriers to use of daily oral PrEP. We propose to evaluate evidence-based HIV prevention and care interventions to improve implementation outcomes among high-risk AYA (15-24 years) in Uganda. The study covers the continuum of care, will use novel screening methods for HIV risk, will involve teams that are highly experienced in youth-focused clinical trials and implementation science (ImS), will implement MOH approved community differentiated service delivery models for delivery CAB-LA, will evaluate the implementation of the SEARCH-Youth (SY), a multi-component intervention comprising of life-stage based assessment and support to increase viral suppression in high-risk AYA with HIV, and will use hybrid effectiveness implementation designs to assess these evidence-based interventions. Our aims include: Aim 1: Using the consolidated framework for implementation research (CFIR), we will identify determinants of potential implementation success of two innovations: CAB-LA and SY implementation at the community, clinic, provider, and patient levels in 5 geographically distinct sites in Uganda. Aim 2a: Using a hybrid effectiveness implementation type II design, we will assess the uptake and persistence of CAB-LA. We will conduct a randomized prospective study to assess effectiveness for the provision of CAB- LA among high risk AYA. Effectiveness outcome will be proportion of study subjects who have initiated CAB-LA and persisted at 18 months of follow-up comparing facility and community delivery options. Implementation outcomes will be feasibility, acceptability, adoption and maintenance using RE-AIM. Aim 2b: Using a hybrid effectiveness implementation type III design we will assess implementation (feasibility, adoption, fidelity, and sustainment) and effectiveness of the SY intervention in increasing long-term virologic suppression (<200 c/mL) at 18 months of follow-up in 5 CRPS using RE-AIM. Aim 3: We will use platforms in aims 1 and 2 to strengthen capacity of ImS and to translate findings into policy and guidelines. Our study involves solid community and institutional partnerships and builds on a strong multi-disciplinary team highly experienced in innovative methods and implementation science in sub-Saharan Africa. The project, building on PATC3H and AHISA, is responsive to WHO’s, Uganda’s MoH priorities regarding the gap in HIV services for highly vulnerable AYA. It will test a novel, scalable and integrated approach to initiate and sustain support for high-risk AYA in LMIC.