Community-Engaged Research to Improve the COVID-19 Testing Cascade Among Underserved Populations in the US Caribbean Territories

SARS-CoV-2, the virus that causes COVID-19, has ravaged underserved and vulnerable populations in the United States (US), including in the US territories of Puerto Rico (PR) and the US Virgin Islands (USVI). Pre-pandemic data from the Eastern Caribbean Health Outcomes Research Network (ECHORN) Cohort Study (ECS) (NIH/NIMHD U24MD006938; Pl: Nunez-Smith) indicate nearly 61% of the population-based representative sample (n=3000) has at least one chronic condition making them high risk for severe complications from COVID-19. Nearly 30% of ECS participants report food insecurity. These ECS data were recently requested by the Congressional Ways and Means Committee to scope the threat of the COV1D-19 pandemic to the Caribbean US territories. This competitive revision leverages the Yale Transdisciplinary Collaborative Center for Health Disparities Research focused on Precision Medicine (Yale-TCC; NIH/NIMHD U54MD010711; MPI: Nunez-Smith), which supports broader scientific engagement across ECHORN members. ECHORN was founded in 2011 as a consortium of researchers and non-academic stakeholder partners, using a participatory action research approach, to address the epidemic of non-communicable diseases in the region. The Yale-TCC is a community-engaged and stakeholder-driven network with a consortium comprised of 60 individuals representing 35 organizations spanning academia, research, health policy, faith-based organizations, community-based organizations, and civic societies. The Yale-TCC Governing Board guides prioritization. The goal of the proposed community-engaged research was to, in concert with the RADx-UP consortium, understand factors that have led to the disproportionate disease burden and deploy interventions that improve the reach, access, uptake and impact of COVID-19 testing technologies and strategies across FQHCs, local CBOs, and clinical laboratories in the USVl and PR. Rigorous quasi-experimental designs were used to evaluate the proposed testing intervention projects. This was achieved through the following specific aims:
Aim 1: Enhance testing implementation strategies in the USVI and PR utilizing community-based assets and cultural responsiveness to address barriers to full participation in the testing continuum from diagnosis through to seif-isolation. An initial partnership with 3 FQHCs (two in USVI and one in PR) and 2 CBOs (one in USVI and one in PR) was leveraged to refine and implement a multi-component intervention to increase testing, contact tracing, and safe and effective quarantine and isolation, with a focus on the most vulnerable populations. An interrupted time series study design was used to analyze the effect of the intervention on the primary implementation outcome of reach. Secondary Implementation outcomes of adoption, fidelity, acceptability, and sustainability were assessed, as is the secondary effectiveness outcome of ER utilization. Community partners were engaged throughout the intervention refinement, implementation, and evaluation process. Aim 2: Assess the diffusion and uptake of FDA authorized and approved testing technologies across existing and emerging testing models. Through stakeholder and community engagement meetings, intervention components that provide the necessary education/health promotion information, training, and resources that were needed to address barriers at the FQHC, CBO, and community-level to adopt, implement, and disseminate new testing technologies were determined. Sustainability of this model for integration of future technologies or vaccines was addressed and assessed.

新型冠状病毒（SARS-CoV-2）即引发新型冠状病毒肺炎（COVID-19）的病原体，已对美国境内服务不足及弱势人群造成严重冲击，涵盖美属波多黎各（PR）与美属维尔京群岛（USVI）等美国领地。东加勒比健康结局研究网络（ECHORN）队列研究（ECS）的大流行前数据（美国国立卫生研究院/国家少数族裔健康与健康差异研究所U24MD006938项目；项目负责人：Nunez-Smith）显示，在该基于人群的代表性样本（n=3000）中，近61%的个体至少罹患1种慢性疾病，使其面临新冠重症并发症的高风险。近30%的ECS参与者存在粮食不安全问题。美国国会筹款委员会近期请求获取该ECS数据，以评估新冠大流行对加勒比美国领地构成的威胁。
本竞争性修订项目依托耶鲁大学精准医学健康差异研究跨学科合作中心（Yale-TCC；美国国立卫生研究院/国家少数族裔健康与健康差异研究所U54MD010711项目；共同项目负责人：Nunez-Smith）开展，该中心可推动ECHORN成员开展更广泛的科学协作。ECHORN于2011年成立，是由研究人员与非学术利益相关方合作伙伴组成的联盟，采用参与式行动研究方法，旨在应对该地区的非传染性疾病流行问题。耶鲁-TCC是一个社区参与且由利益相关方主导的网络，其联盟包含60名个体，代表了覆盖学术、研究、健康政策、信仰组织、社区组织（CBOs）及公民社团的35家机构。耶鲁-TCC治理委员会负责指导研究优先级制定。
本拟开展的社区参与式研究旨在与RADx-UP联盟协同，明确导致加勒比美国领地出现不成比例疾病负担的影响因素，并部署干预措施，以提升新冠检测技术与策略在美属维尔京群岛、波多黎各的社区健康中心（FQHCs）、本地社区组织及临床实验室中的覆盖范围、可及性、应用率与实施效果。研究采用严格的准实验设计对拟开展的检测干预项目进行评估，具体通过以下2项具体目标实现：
目标1：优化美属维尔京群岛与波多黎各的检测实施策略，利用社区资源与文化适配策略破除从诊断到自我隔离全流程的检测参与障碍。本研究依托与3家社区健康中心（美属维尔京群岛2家、波多黎各1家）及2家社区组织（美属维尔京群岛1家、波多黎各1家）的初步合作关系，细化并实施多组分干预措施，以提升检测覆盖率、接触者追踪效率，以及安全有效的隔离与检疫效果，重点关注最弱势人群。本研究采用间断时间序列研究设计，分析干预措施对主要实施结局——覆盖范围的影响；同时评估采纳率、实施保真度、可接受性与可持续性等次要实施结局，以及急诊就诊率这一次要有效性结局。社区合作伙伴全程参与干预措施的细化、实施与评估过程。
目标2：评估美国食品药品监督管理局（FDA）授权及获批的检测技术在现有与新兴检测模式中的扩散与应用情况。通过利益相关方与社区参与会议，本研究明确了需在社区健康中心、社区组织及社区层面提供的必要宣教/健康促进信息、培训与资源，以破除新型检测技术的采纳、实施与推广障碍。本研究同时对该模式在未来整合新技术或疫苗的可持续性进行了分析与评估。