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.

项目概要 尽管有免费的艾滋病毒服务和抗逆转录病毒治疗 (ART)，但新诊断出的艾滋病毒感染者 乌干达难民安置点的抗逆转录病毒治疗启动率、坚持率和病毒抑制率均不理想。 难民在参与艾滋病毒护理方面面临着独特的障碍，包括距离诊所很远，环境恶劣 影响旅行的条件、令人望而却步的交通成本以及严重有限的生计机会来抵消 他们扰乱了社交网络，并由于担心预期的耻辱和依赖而保守了艾滋病毒状况的披露 帮助其他社区成员满足基本生存需求，以提高艾滋病毒参与度。 迫切需要为这一重点人群提供社区 ART 服务，即差异化的 ART 服务。 乌干达为稳定客户提供的策略，减少时间和交通障碍，促进社会支持， 然而，新诊断出的艾滋病毒感染者目前被排除在外。 参与社区 ART 交付，并且尚未评估该 ART 交付策略的影响 对于这一群体来说，这是艾滋病毒研究的一个关键空白，因为初次艾滋病毒诊断后的时间很脆弱。 纳基瓦尔难民安置点试点研究的初步结果 乌干达西南部发现，在艾滋病毒诊断时实施早期社区抗逆转录病毒疗法， 可能会增强这种情况下的病毒抑制 该提案的总体目标是进行集群。 随机对照试验旨在辨别“Head Start”（针对这些人群的社区抗逆转录病毒疗法）的有效性 新诊断出的艾滋病毒感染者与实现艾滋病毒病毒传播的标准护理（基于设施的抗逆转录病毒治疗）相比 核心假设是，Head Start 将成为针对难民的有效且负担得起的干预措施。 乌干达各地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。 模型中，该假设将通过以下具体目标进行检验： 1) 评估 Head Start 的有效性 为乌干达难民安置点中新诊断出的艾滋病毒患者实现艾滋病毒抑制 2) 评估难民安置地点的 Head Start，以了解具体实施的影响 实现最佳艾滋病毒临床结果的因素；以及 3) 估计规划成本和预算影响 在乌干达难民安置点实施 Head Start 的方法是创新的，因为它进行了评估。 人道主义危机中社区抗逆转录病毒治疗的新时机影响了临床表现不佳的高风险人群 该提案响应了 NIH 艾滋病毒相关研究的优先事项，因为它包括评估。 难民和新诊断出艾滋病毒的乌干达国民的艾滋病毒病毒抑制情况以及评估 促进 ART 实施的干预措施的长期目标是制定优化 HIV 结果的策略。 这项拟议的研究意义重大，因为它可以改善艾滋病病毒的传播。 联合国艾滋病规划署 95-95-95 目标的实现。