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 尽管免费提供艾滋病毒服务和抗逆转录病毒疗法， 乌干达的难民定居点的抗逆转录病毒治疗启动率、坚持率和病毒抑制率都不理想。 难民在接受艾滋病毒护理方面面临独特的障碍，包括距离诊所很远， 影响旅行的条件，高昂的运输费用，以及严重有限的生计机会， 他们，扰乱了社交网络，并由于担心预期的耻辱和依赖而保护艾滋病毒状况的披露 以满足其他社区成员的基本生存需求。改进艾滋病毒防治工作的创新战略 迫切需要照顾这一优先群体。社区抗逆转录病毒治疗，差异化的抗逆转录病毒治疗 在乌干达为稳定客户提供的战略，减少了时间和交通障碍，促进了社会支持， 并改善艾滋病护理的参与度。然而，新诊断出的艾滋病毒感染者目前被排除在外 参与社区抗逆转录病毒疗法的实施，尚未评估该抗逆转录病毒疗法实施战略的影响 此群组的。这是艾滋病毒研究中的一个关键空白，因为最初艾滋病毒诊断后的时间是一个脆弱的因素。 护理流失率高的时期。Nakivale难民安置点试点研究的初步结果 在乌干达西南部，发现在艾滋病毒诊断时进行早期社区抗逆转录病毒治疗， 可以增强这种情况下的病毒抑制。本建议的总体目标是进行一次分组 一项随机对照试验，以确定“头部开始”的有效性，为那些 新诊断为艾滋病毒感染者，与标准护理（基于设施的ART提供）相比， 镇压核心假设是，Head StART将是难民署有效和负担得起的干预措施， 乌干达各地的医疗中心。以有希望的初步数据为指导，以社会生态为支持， 模型，这一假设将与这些具体目标进行测试：1）为了评估头部StART的有效性 在乌干达难民定居点为新诊断的艾滋病毒感染者实现艾滋病毒抑制; 2） 评估各难民安置点的首席StART实施情况，以了解 实现最佳艾滋病毒临床结果的因素;以及3）估计项目成本和预算影响 在乌干达的难民安置点实施Head StART。该方法是创新的，因为它评估了 在受人道主义危机影响的人群中，社区ART提供的新时机具有临床不良风险 结果。这项建议是响应国家卫生研究院艾滋病毒相关研究的优先事项，因为它包括评估 新诊断感染艾滋病毒的难民和乌干达国民中艾滋病毒病毒抑制情况的评估， 进行干预以推进ART的实施。长期目标是制定战略，优化艾滋病毒成果 在乌干达的难民安置点。这项拟议中的研究意义重大，因为它可以改善艾滋病毒的 在全球范围内，在人道主义背景下进行镇压，推动实现艾滋病规划署95 - 95-95目标的进展。