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.
Lisa S Meredith, Jonathan N Tobin, Andrea Cassells, Khadesia Howell, Helin Hernandez, Courtney Gidengil, Stephanie Williamson, Lu Dong, George Timmins, Gabriela Alvarado, Tameir Holder, T J Lin, Marielena Lara
{"title":"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.","authors":"Lisa S Meredith, Jonathan N Tobin, Andrea Cassells, Khadesia Howell, Helin Hernandez, Courtney Gidengil, Stephanie Williamson, Lu Dong, George Timmins, Gabriela Alvarado, Tameir Holder, T J Lin, Marielena Lara","doi":"10.1016/j.cct.2025.107848","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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, three, and six months. Outcomes include COVID-19 vaccine (primary) and influenza vaccine (secondary) uptake. The study also evaluates intervention implementation using the RE-AIM model.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Trial registration: </strong>(ClinicalTrials.govNCT06156254).</p>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":" ","pages":"107848"},"PeriodicalIF":2.0000,"publicationDate":"2025-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary clinical trials","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.cct.2025.107848","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
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, three, and six 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.
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.