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 尼日利亚是全球艾滋病毒负担第四高的国家，而且艾滋病疫情不受控制。在15至24岁的青年中， 发病率仍然很高，病毒抑制率很低。尼日利亚青年中的艾滋病毒流行率最高， 男男性行为者（MSM）和跨性别女性（TW）。虽然外部（即，非政府组织） 资助者支持以人口为中心的主要中心，以增加男男性行为者和TW获得艾滋病毒服务的机会， 由于资金不断减少和不可持续，援助范围受到限制。努力提高政府诊所的能力 接触和照顾年轻男同性恋者（YMSM）和年轻女同性恋者（YTW），并实施有效的，可扩展的， 针对青年的干预措施，加强预防，改善病例发现，增加抗逆转录病毒疗法的获得， 对艾滋病毒感染者青年（YLH）的依从性支持对于扭转艾滋病毒感染者的滞后指标至关重要 预防和护理连续体。然而，迄今为止，没有任何干预措施取得了严格的成效， 尼日利亚复杂社会文化环境中的实施研究。iCARE尼日利亚是一个成功的NICHD- 由PATC3H资助的研究伙伴关系，调查两项针对青年的干预措施，以改善：（1）艾滋病毒病例- YMSM和YTW之间的发现和护理联系，以及（2）在很大程度上， 垂直感染YLH的ART。每种干预措施都结合了基于证据的同伴导航和移动健康 适应当地情况的战略;可行性和有效性已在试点研究中得到证明（UG3）。我们在此 提出iCARE Plus，以扩展和测试增强版本的有效性和实施成果 新成立的PATC3H-IN中的iCARE干预措施。iCARE Plus临床研究中心 (CRC)将利用EPIS（勘探，准备， 实施和维持）框架，以便在15 - 24岁青年中实施干预措施 通过在尼日利亚六个地缘政治上的艾滋病毒"热点"建立新的临床研究绩效站点（CRPS）， 不同的区域我们的具体目标是：目标1（准备）：实施准备将在 在艾滋病毒热点地区选定政府诊所，同时提高其提供 为YMSM和YTW提供服务。目标2（执行）：测试 iCARE干预措施的增强版本：1）艾滋病毒病例发现、与护理的联系和PrEP吸收 在YMSM和YTW之间，2）在先前未研究的新诊断的YLH中的病毒载量抑制， 启动ART目标3（可持续性）：促进iCARE倡议的可持续性， 通过制定可持续发展计划，实现PATC3H-IN的科学能力发展目标， 考虑利用由NICHD补充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，发展信息系统能力， 预防和治疗实施科学联盟（AHISA）资助的iTRAIN项目。