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的第四高负担，也是不受控制的流行病。在15-24岁的艾滋病毒的青年中 发病率保持较高，病毒抑制率低。尼日利亚青年时期的艾滋病毒流行最高 与男人发生性关系（MSM）和跨性别女性（TW）的男性。尽管外部（即非政府） 资金支持关键人口的关键中心，以增加MSM和TW的艾滋病毒服务的机会 覆盖范围受到限制和不可持续的资金。努力提高政府诊所的能力 达到和照顾年轻MSM（YMSM）和Young TW（YTW），并实施有效，可扩展， 通过增强预防，改善案例调查以及增加艺术访问和增加的艺术品的干预措施 对艾滋病毒（YLH）青年的依从性支持对于扭转艾滋病毒的滞后指标至关重要 预防和护理仍在继续。但是，迄今为止，没有干预措施经历了严格的效力 尼日利亚复杂社会文化环境的实施研究。尼日利亚ICARE是成功的Nichd- 资助的PATC3H研究合作伙伴关系调查了两项针对青年的干预措施以改进：（1）HIV病例 - 在YMSM和YTW之间找到和联系，以及（2）在很大程度上遵守和病毒抑制 垂直感染了艺术的YLH。每个干预组合基于证据的同行导航和MHealth 适应当地环境的策略；在一项初步研究（UG3）中显示了可行性和效率。我们在这里 提案Icare Plus，扩展并测试有效性和实施结果 新形成的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，该试验将使用EPIS（探索，准备， 实施和维持框架，以将15-24岁的青年的干预实施背景化 通过尼日利亚六个地球上的HIV“热点”中的HIV“热点”中的新临床研究表现站点（CRPS） 不同的区域。我们的具体目的是：目标1（准备）：实施准备将在 在艾滋病毒热点中精选的政府诊所，同时提高其提供的能力和能力 YMSM和YTW的服务。目标2（实施）：测试有效性和实施结果 ICARE干预措施的增强版本：1）HIV案例调查，链接到护理和准备吸收 在YMSM和YTW中以及2）以前未研究的YLH新诊断的病毒载荷抑制和 发起艺术。目标3（维持）：促进ICARE倡议的维持和实施 通过制定包括经济的可持续性计划，PATC3H-IN的科学能力发展目标 考虑由NICHD补充资助的正在进行的形成性研究的考虑，合作 在我们的青春期艾滋病毒的基础上，有了青年，诊所管理人员和卫生部并发展的能力 预防和治疗实施科学联盟（AHISA）资助了ITRAIN项目。