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

实施科学以理解和设计利益相关者知情的创新干预措施，以改善乌干达农村和城市青少年艾滋病毒预防和护理的连续性

• 批准号: 10749472
• 负责人: Philippa Musoke
• 金额: $ 91.44万
• 依托单位: MU-JHU CARE
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-08 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10749472
• 关键词: AIDS prevention; Adherence; Adolescent; Adolescent and Young Adult; Adoption; Adult; Africa South of the Sahara; Anti-Retroviral Agents; Area; Attitude; Awareness; Caring; Catchment Area; Clinic; Clinical Trials; Collaborations; Communities; Consolidated Framework for Implementation Research; Continuity of Patient Care; Country; Development; Effectiveness; Enrollment; Evidence based intervention; Female Adolescents; Focus Groups; Friends; Fright; Geography; Guidelines; HIV; HIV Seronegativity; HIV Seropositivity; HIV risk; HIV/STD; Health; Health Personnel; Health care facility; Incidence; Individual; Institution; Intervention; Interview; Knowledge; Leadership; Life; Location; Maintenance; Male Adolescents; Methods; Modeling; Oral; Outcome; Participant; Patients; Policies; Policy Maker; Population; Prospective Studies; Provider; Randomized; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Readiness; Research; Research Personnel; Resources; Risk; Rural; Service delivery model; Services; Severities; Site; Solid; Study Subject; Testing; Translating; Translations; Treatment outcome; Trust; Uganda; Viral; Work; Youth; aged; care systems; clinical implementation; design; effectiveness evaluation; effectiveness outcome; effectiveness/implementation design; effectiveness/implementation hybrid; epidemic response; evidence base; experience; follow-up; high risk; high risk sexual behavior; high-risk adolescents; implementation barriers; implementation evaluation; implementation framework; implementation outcomes; implementation science; improved; informant; innovation; low and middle-income countries; member; multi-component intervention; multidisciplinary; novel; peer; performance site; pill; pre-exposure prophylaxis; prevention service; preventive intervention; primary outcome; programs; recruit; routine care; screening; service delivery; sex; side effect; social; social stigma; success; testing uptake; uptake; vulnerable adolescent

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.

项目摘要：青少年和年轻人（aya）有很高的艾滋病毒事件，结果不佳 与成年人相比，沿着整个HIV预防和护理级联。尽管伯恩伯恩（Hiv Burnen）高，但两者都吸收 口服准备（HIV负）和实现病毒抑制（HIV阳性）在青年中是最佳的 撒哈拉以南非洲。在乌干达的青年中，口服准备的吸收和持续性很低，原因是 中断包括：伯恩药丸，艾滋病毒的认知严重程度低，需要伴侣或父母批准，艾滋病毒 - 相关的污名，对副作用和医疗设施障碍的恐惧。 Cabotegravir，A是新的长效抗逆转录病毒 （驾驶室） 以及高效的准备选择，可以减轻日常口服准备的障碍。我们建议 评估基于证据的HIV预防和护理干预措施，以改善 乌干达的高风险Aya（15-24岁）。该研究涵盖了护理的连续性，将使用新颖的筛选 艾滋病毒风险的方法将涉及在以青年为中心的临床试验中经验丰富的团队 实施科学（IMS）将实施MOH认可的社区差异化服务交付模型 对于交付驾驶室，将评估搜索-Youth（SY）的实施，这是一个多组件 干预基于生命阶段的评估和支持以增加高风险的病毒抑制 AYA患有艾滋病毒，并将使用混合有效性实施设计来评估这些循证 干预措施。我们的目标包括：目标1：使用合并框架进行实施研究（CFIR）， 我们将确定两项创新的潜在实施成功的决定者：CAB-LA和SY 在乌干达的5个地理上不同地理位置上的社区，诊所，提供者和患者水平的实施。 AIM 2A：使用混合有效性实施II型设计，我们将评估吸收和持久性 Cab-la。我们将进行一项随机的前瞻性研究，以评估提供CAB-的有效性 洛杉矶高风险aya。有效性结果将是启动CAB-LA的研究对象的比例 并坚持在18个月的随访中比较设施和社区交付选择。执行 结果将是可行性，可接受性，采用和使用Re-Aim的维护。 AIM 2B：使用混合动力 有效性实施III型设计我们将评估实施（可行性，采用，忠诚度和 维持）和SY干预对增加长期病毒学抑制的有效性（<200 c/ml） 在5个月后，使用Re-Aim进行了18个月的随访。目标3：我们将在目标1和2中使用平台来加强 IMS的能力并将发现转化为政策和准则。我们的研究涉及扎实的社区和 机构合作伙伴关系，并建立在一个强大的多学科团队中，在创新方法方面经验丰富 和撒哈拉以南非洲的实施科学。该项目建立在PATC3H和AHISA上，反应迅速 乌干达对谁的卫生部优先事项，涉及艾滋病毒的差距高度脆弱的aya。它将测试 新颖，可扩展和综合的方法来启动和维持对LMIC的高风险AYA的支持。