Boost your health (Refuerza tu Salud): Design of a randomized controlled trial of a community health worker intervention to reduce inequities in COVID-19 and influenza vaccinations

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-02-16 DOI:10.1016/j.cct.2025.107848

Lisa S. Meredith , Jonathan N. Tobin , Andrea Cassells , Khadesia Howell , Helin G. Hernandez , Courtney Gidengil , Stephanie Williamson , Lu Dong , George Timmins , Gabriela Alvarado , Tameir Holder , Jacqueline Cortez Lainez , T.J. Lin , Marielena Lara

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引用次数: 0

Abstract

Introduction

Low-income and underserved populations, especially racial and ethnic minorities, experience health disparities linked to social determinants. The COVID-19 pandemic amplified these disparities, necessitating effective strategies to address structural racism and related factors. Vaccination, crucial for mitigating infectious diseases, including COVID-19 and influenza, remains challenging among underserved populations. Community health worker (CHW) interventions show promise in addressing these disparities but have not undergone rigorous evaluation with a randomized controlled trial to increase vaccination uptake among underserved populations. This study develops and evaluates a CHW vaccination behavior (CHW-VB) intervention to increase COVID-19 and influenza vaccination among adult patients in primary care settings.

Methods

Tailoring of the Boost Your Health (Refuerza tu Salud) intervention is grounded in behavior change theory and integrates input from a Community Advisory Board. The study employs a patient randomized controlled trial design to test the effectiveness the CHW-VB intervention compared with usual care across six Federally Qualified Health Centers (FQHCs) in New York. Patients are being screened for eligibility (vaccinated but not up to date with the COVID-19 vaccine and have at least one of seven common chronic illnesses) and 800 are assessed at baseline and three months. Outcomes include COVID-19 vaccine (primary) and influenza vaccine (secondary) uptake. The study also evaluates intervention implementation using the RE-AIM model.

Conclusion

Boost Your Health aims to increase COVID-19 and influenza vaccination among racially/ethnically diverse, underserved populations with chronic illness through the CHW-VB intervention, targeting critical gaps in vaccination uptake to reduce health disparities and increase health equity.

Trial registration: (ClinicalTrials.gov NCT06156254).

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增进健康：设计一项社区卫生工作者干预措施的随机对照试验，以减少COVID-19和流感疫苗接种方面的不公平现象。

引言：低收入和得不到充分服务的人口，特别是种族和族裔少数群体，经历着与社会决定因素有关的健康差距。2019冠状病毒病大流行扩大了这些差距，需要采取有效战略来解决结构性种族主义和相关因素。疫苗接种对于减轻COVID-19和流感等传染病至关重要，但在服务不足的人群中仍然具有挑战性。社区卫生工作者（CHW）干预措施有望解决这些差异，但尚未通过随机对照试验进行严格评估，以增加服务不足人群的疫苗接种率。本研究开发并评估了CHW疫苗接种行为（CHW- vb）干预措施，以增加初级保健机构成年患者的COVID-19和流感疫苗接种。方法：“促进健康”（Refuerza tu Salud）干预措施以行为改变理论为基础，并整合了社区咨询委员会的意见。本研究采用患者随机对照试验设计，在纽约六家联邦合格医疗中心（fqhc）比较CHW-VB干预与常规护理的有效性。正在对患者进行资格筛查（接种过疫苗但未及时接种COVID-19疫苗，并且患有七种常见慢性疾病中的至少一种），并在基线、3个月和6个月时对800名患者进行评估。结果包括COVID-19疫苗（一级）和流感疫苗（二级）接种。该研究还使用RE-AIM模型评估干预措施的实施情况。结论：Boost Your Health旨在通过CHW-VB干预措施，在不同种族/民族、服务不足的慢性病人群中增加COVID-19和流感疫苗接种，针对疫苗接种方面的关键差距，以缩小健康差距，增加卫生公平。试验注册：（ClinicalTrials.govNCT06156254）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.