Intensive Combination Approach to Rollback the HIV Epidemic in Nigerian Youth (iCARE) Plus Effectiveness / Implementation Hybrid Study

遏制尼日利亚青少年艾滋病毒流行的强化组合方法 (iCARE) 加上有效性/实施混合研究

• 批准号: 10749347
• 负责人: Robert Garofalo
• 金额: $ 141.02万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 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/10749347
• 关键词: AIDS prevention; Acquired Immunodeficiency Syndrome; Adherence; Administrator; Adoption; Agreement; Caring; Child Development; Clinic; Clinical Research; Collaborations; Complex; Continuity of Patient Care; Data; Development; Economics; Effectiveness; Epidemic; Exploration, Preparation, Implementation, and Sustainment; Funding; Goals; Government; HIV; HIV Seronegativity; HIV Seropositivity; HIV Seroprevalence; HIV-1; Health; Human Development; Human immunodeficiency virus test; Hybrids; Incidence; Infection; Intervention; Newly Diagnosed; Nigeria; Nigerian; Participant; Phase; Pilot Projects; Population; Preparation; Prevention; Public Health; Randomized, Controlled Trials; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Research; Risk; Sampling; Services; Structure; Testing; Vertebral column; Viral; Viral Load result; Youth; adolescent HIV prevention; aged; antiretroviral therapy; care systems; case finding; design; effectiveness outcome; effectiveness research; effectiveness testing; effectiveness/implementation study; effectiveness/implementation trial; evidence base; implementation evaluation; implementation intervention; implementation outcomes; implementation research; implementation science; implementation strategy; improved; improved outcome; individualized medicine; innovation; mHealth; men who have sex with men; motivational enhancement therapy; outcome disparities; peer; performance site; pre-exposure prophylaxis; primary outcome; response; same-sex marriage; secondary outcome; social culture; social stigma; standard of care; success; transgender women; uptake; young men who have sex with men

Project Summary Nigeria has the 4th highest global burden of HIV and an uncontrolled epidemic. Among youth aged 15-24, HIV incidence remains high and rates of viral suppression low. The HIV epidemic in Nigeria's youth is highest in men who have sex with men (MSM) and transgender women (TW). Although external (i.e., non-governmental) funders support key population-focused centers to increase access to HIV services for MSM and TW, their reach is limited by dwindling and unsustainable funding. Efforts to improve the capacity of government clinics to reach and care for young MSM (YMSM) and young TW (YTW) as well as to implement effective, scalable, youth-specific interventions with enhanced prevention, improved case-finding, and increased ART access and adherence support for youth living with HIV (YLH) are critical to turn around lagging indicators across the HIV prevention and care continuum. However, to-date, no interventions have undergone rigorous effectiveness and implementation research in Nigeria's complex sociocultural milieu. iCARE Nigeria is a successful NICHD- funded PATC3H research partnership investigating two youth-specific interventions to improve: (1) HIV case- finding and linkage-to-care among YMSM and YTW, and (2) adherence and viral suppression among largely vertically-infected YLH on ART. Each intervention combines evidence-based peer navigation and mHealth strategies adapted to the local context; feasibility and efficacy were shown in a pilot study (UG3). We herein propose iCARE Plus, to scale out and test effectiveness and implementation outcomes on enhanced versions of the iCARE interventions within the newly formed PATC3H-IN. The iCARE Plus Clinical Research Center (CRC) will conduct hybrid effectiveness-implementation trials that will utilize an EPIS (Exploration, Preparation, Implementation, and Sustainment) framework to contextualize intervention implementation in youth aged 15-24 through new Clinical Research Performance Sites (CRPSs) in HIV “hotspots” across Nigeria's six geopolitically distinct zones. Our specific aims are: Aim 1 (Preparation): Implementation preparation will be carried out at selected government clinics in the HIV hotspots, while increasing their capacity and capability to provide services to YMSM and YTW. Aim 2 (Implementation): Test the effectiveness and implementation outcomes of enhanced versions of the iCARE interventions on: 1) HIV case-finding, linkage-to-care and PrEP uptake among YMSM and YTW and 2) viral load suppression in previously unstudied YLH newly-diagnosed and initiating ART. Aim 3 (Sustainment): Promote sustainment of the iCARE initiative and the implementation science capacity development goals of PATC3H-IN by developing a sustainability plan, including economic considerations that leverage ongoing formative research funded by an NICHD supplement, in collaboration with youth, clinic administrators and health ministries and develop IS capacity, building on our Adolescent HIV Prevention and Treatment Implementation Science Alliance (AHISA)-funded iTRAIN project.

项目摘要 尼日利亚的艾滋病毒负担和疫情失控在全球排名第四。在15-24岁的年轻人中，艾滋病毒 发病率仍然很高，病毒抑制率很低。尼日利亚青年中艾滋病毒流行率最高的是#年 与男性发生性关系的男性(MSM)和变性女性(TW)。虽然是外部的(即非政府的) 资助者支持主要的以人口为重点的中心，以增加MSM和TW获得艾滋病毒服务的机会，他们的 覆盖范围受到资金减少和不可持续的限制。致力提高政府诊所的服务能力 为了接触和照顾年轻男男性接触者(YMSM)和年轻TW(YTW)，以及实施有效、可扩展 针对青年的干预措施，加强预防，改进病例发现，增加抗逆转录病毒治疗和 对青年艾滋病毒携带者的坚持支持是扭转艾滋病毒滞后指标的关键 预防和护理连续统一体。然而，到目前为止，没有任何干预措施经历了严格的有效性和 在尼日利亚复杂的社会文化环境中的实施研究。ICARE尼日利亚是一个成功的NICHD- 资助的PATC3H研究伙伴关系调查了两项针对青年的干预措施，以改善：(1)艾滋病毒病例- YMSM和YTW之间的发现和连锁护理，以及(2)大部分患者的依从性和病毒抑制 在ART上垂直感染YLH型。每种干预措施都结合了基于证据的同行导航和mHealth 适应当地情况的战略；试点研究显示了可行性和有效性(UG3)。我们在这里 推荐icare Plus，以横向扩展并测试增强版本的有效性和实施结果 新成立的PATC3H-IN内的ICARE干预措施。ICARE Plus临床研究中心 (CRC)将进行混合有效性实施试验，将利用EPIS(勘探、准备、 实施和可持续)框架，将15-24岁青年干预措施的实施情况纳入背景 通过在尼日利亚六个地缘政治的艾滋病毒热点地区建立新的临床研究绩效网站(CRPS) 不同的区域。我们的具体目标是：目标1(筹备)：将在#年开展执行筹备工作 在艾滋病毒热点地区选定的政府诊所，同时增加其能力和提供 为YMSM和YTW提供的服务。目标2(执行)：测试以下各项的有效性和执行结果 ICARE干预措施的增强版本涉及：1)艾滋病毒病例发现、与护理的联系和PrEP感染 在YMSM和YTW之间，以及2)以前未研究过的YLH新诊断和 启动艺术。目标3(可持续性)：促进维持综合保健方案倡议和执行 PATC3H-IN通过制定可持续发展计划实现科学能力发展目标，包括经济 考虑利用由NICHD附录资助的正在进行的形成性研究 与青年、诊所管理人员和卫生部合作，发展信息和通信技术能力，以青少年艾滋病毒为基础 预防和治疗实施科学联盟(AHISA)资助的iTRAIN项目。