Achieving HIV viral suppression in refugee settlements in Uganda with Head StART: a cluster randomized trial evaluating the effectiveness of community ART delivery for people newly diagnosed with HIV

通过 Head Start 在乌干达难民安置区实现 HIV 病毒抑制：一项整群随机试验，评估社区 ART 治疗对新诊断出的 HIV 感染者的有效性

• 批准号: 10618071
• 负责人: Kelli Nicole O'Laughlin
• 金额: $ 66.37万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-04-01 至 2028-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10618071
• 关键词: Address; Adherence; Adoption; Affect; Caring; Cessation of life; Client; Clinic; Clinical; Cluster randomized trial; Communities; Data; Diagnosis; Diphosphates; Disclosure; Effectiveness; Eligibility Determination; Ensure; Evaluation; Exclusion; Face; Financial cost; Fostering; Fright; Goals; HIV; HIV diagnosis; Head Start Program; Health; Individual; Intervention; Link; Location; Maintenance; Modeling; Morbidity - disease rate; Motion; Newly Diagnosed; Outcome; Outcome Study; Participant; Perception; Persons; Pilot Projects; Policy Maker; Population; Public Health; Randomized; Randomized, Controlled Trials; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Refugees; Reporting; Research; Rural; Services; Site; Social Network; Social support; Stress; Tenofovir; Testing; Time; Transportation; Travel; Treatment outcome; Uganda; United States National Institutes of Health; Variant; Viral; Viral Load result; Weather; antiretroviral therapy; arm; barrier to care; budget impact; clinical care; community based care; contextual factors; cost; cost comparison; effectiveness evaluation; high risk; implementation framework; implementation research; improved; incremental cost; innovation; intervention cost; intervention delivery; markov model; member; novel; primary outcome; secondary outcome; social; social stigma; standard care; standard of care; therapy adherence

PROJECT SUMMARY Despite freely available HIV services and antiretroviral therapy (ART), people newly diagnosed with HIV in refugee settlements in Uganda have suboptimal rates of ART initiation, adherence, and viral suppression. Refugees face unique barriers to HIV care engagement including long distances to clinic with environmental conditions impacting travel, prohibitive transportation costs with severely limited livelihood opportunities to offset them, disrupted social networks, and guarded HIV status disclosure due to fear of anticipated stigma and reliance on other community members to meet basic survival needs. Innovative strategies to improve engagement in HIV care for this priority population are urgently needed. Community ART delivery, a differentiated ART delivery strategy offered in Uganda for stable clients, reduces time and transportation barriers, fosters social support, and improves engagement in HIV care. Individuals newly diagnosed with HIV, however, are currently excluded from participation in community ART delivery and the impact of this ART delivery strategy has not been evaluated for this group. This is a critical gap in HIV research as the time following initial HIV diagnosis is a vulnerable period with high rates of attrition from care. Preliminary findings from a pilot study in Nakivale Refugee Settlement in southwestern Uganda found that early community ART delivery, implemented at the time of HIV diagnosis, may enhance viral suppression in this setting. The overall objective of this proposal is to conduct a cluster randomized controlled trial to discern the effectiveness of “Head StART,” community ART delivery for those newly diagnosed with HIV, compared to standard care (facility-based ART delivery) to achieve HIV viral suppression. The central hypothesis is that Head StART will be an effective and affordable intervention at refugee health centers across Uganda. Guided by promising preliminary data and supported by the social ecological model, this hypothesis will be tested with these specific aims: 1) To evaluate the effectiveness of Head StART in achieving HIV viral suppression for people newly diagnosed with HIV in refugee settlements in Uganda; 2) To assess Head StART implementation across refugee settlement locations to understand the impact of contextual factors on achieving optimal HIV clinical outcomes; and 3) To estimate the programmatic cost and budget impact of implementing Head StART in refugee settlements in Uganda. The approach is innovative, in that it assesses novel timing of community ART delivery in a humanitarian crisis affected population at high risk of poor clinical outcomes. This proposal is responsive to the NIH priorities for HIV-related research in that it includes assessment of HIV viral suppression among refugees and Ugandan nationals newly diagnosed with HIV, as well as evaluation of an intervention to advance ART delivery. The long-term goal is to devise strategies to optimize HIV outcomes in refugee settlements in Uganda. The proposed research is significant, because it could improve HIV viral suppression in humanitarian contexts globally, advancing progress towards the 95-95-95 UNAIDS targets.

项目摘要 尽管免费可用的艾滋病毒服务和抗逆转录病毒疗法（ART），但新近诊断为艾滋病毒的人 乌干达的难民环境具有次优的艺术倡议，遵守和病毒抑制。 难民面临独特的艾滋病毒护理参与障碍 影响旅行的条件，禁止的运输成本，而生计的机会严重有限 由于担心预期的污名和责任 在其他社区成员中满足基本生存需求。改善艾滋病毒参与的创新策略 迫切需要照顾这种优先人群。社区艺术交付，差异化的艺术品交付 乌干达为稳定客户提供的策略，减少时间和运输障碍，促进社会支持， 并改善参与艾滋病毒护理。但是，目前被排除了新诊断为艾滋病毒的人 尚未评估参与社区艺术交付和这种艺术交付策略的影响 对于这个组。这是艾滋病毒研究中的一个关键差距，因为初次艾滋病毒诊断之后 期间，护理的损耗率很高。 Nakivale难民定居点的试点研究的初步发现 在西南部，乌干达发现，在艾滋病毒诊断时实施的早期社区艺术品， 在这种情况下可能会增强病毒抑制。该提案的总体目的是进行集群 随机对照试验可辨别“头启动”的有效性，为那些人提供社区艺术 与标准护理（基于设施的ART交付）相比，新诊断为HIV，以实现HIV病毒 抑制。中心假设是，在难民中，头部开始是一种有效且负担得起的干预措施 乌干达的卫生中心。以有希望的初步数据为指导，并得到社会生态的支持 模型，该假设将以这些特定目的进行检验：1）评估头开始的有效性 在为乌干达的难民设置中新诊断出患有艾滋病毒的艾滋病毒的人实现艾滋病毒抑制时； 2）到 评估跨难民设置地点的头部开始实施，以了解上下文的影响 实现最佳HIV临床结果的因素； 3）估计程序成本和预算影响 在乌干达的难民环境中实施头部。这种方法是创新的，因为它的评估 在人道主义危机中，社区艺术交付的新时机影响了临床不良风险的高风险 结果。该提案对与HIV相关研究的NIH重点有反应，因为它包括评估 新近诊断为艾滋病毒的难民和乌干达国民之间的艾滋病毒病毒抑制以及评估 干预以推进艺术品。长期目标是制定策略以优化艾滋病毒结果 在乌干达的难民设置中。拟议的研究很重要，因为它可以改善HIV病毒 在全球人道主义背景下的抑制，将进步朝着95-95-95的UNAID目标发展。