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.

项目概要 尼日利亚的艾滋病毒负担位居全球第四，并且在 15 至 24 岁的青少年中，艾滋病毒流行不受控制。 尼日利亚青年人的艾滋病毒流行率仍然很高，而病毒抑制率却很低。 男男性行为者 (MSM) 和变性女性 (TW) 尽管是外部的（即非政府的）。 资助者支持主要以人口为中心的中心，以增加 MSM 和 TW 获得艾滋病毒服务的机会，他们的 提高政府诊所能力的努力受到资金减少和不可持续的限制。 接触和照顾年轻的 MSM (YMSM) 和年轻的 TW (YTW)，并实施有效的、可扩展的、 针对青少年的干预措施，包括加强预防、改进病例发现、增加抗逆转录病毒治疗的获取和 对青年艾滋病毒感染者 (YLH) 的依从性支持对于扭转艾滋病毒感染的滞后指标至关重要 然而，迄今为止，还没有任何干预措施取得严格的有效性和有效性。 iCARE 尼日利亚是一个成功的 NICHD- 实施研究。 资助 PATC3H 研究伙伴关系，调查两项针对青年的干预措施，以改善：(1) HIV 病例- YMSM 和 YTW 之间的发现和护理联系，以及 (2) 大多数人的依从性和病毒抑制 ART 上垂直感染的 YLH 的每项干预措施都结合了基于证据的同伴导航和移动医疗。 适合当地情况的策略；试点研究（UG3）显示了可行性和有效性。 提出 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 iCARE Plus 临床研究中心内的 iCARE 干预措施。 (CRC) 将利用 EPIS（探索、准备、 实施和维持）框架，以在 15-24 岁青少年中实施干预措施 通过尼日利亚六个地缘政治艾滋病毒“热点”的新临床研究绩效网站（CRPS） 我们的具体目标是： 目标 1（准备）：实施准备工作将在 在艾滋病毒热点地区选定政府诊所，同时提高其提供服务的能力和能力 目标 2（实施）：测试 YMSM 和 YTW 的有效性和实施结果。 iCARE 干预措施的增强版：1) HIV 病例发现、护理联系和 PrEP 吸收 YMSM 和 YTW 之间的病毒载量抑制以及 2) 先前未研究过的 YLH 新诊断和 启动 ART 目标 3（维持）：促进 iCARE 倡议的维持和实施 PATC3H-IN 的科学能力发展目标是通过制定可持续发展计划，包括经济 利用 NICHD 补充资助的持续形成性研究的考虑因素，合作 与青年、诊所管理人员和卫生部合作，以我们的青少年艾滋病毒为基础，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。