Motivational Interviewing for Vaccine Uptake in Latinx Adults (MI Vacuna): Study protocol for a pragmatic multiple-period cluster-randomized crossover trial

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-06-14 DOI:10.1016/j.cct.2025.107987

Rachel M. Scrivano , Brittney J. van de Water , Nicolle Rueras , Janin Alfonso , Kimberly H. McManama O'Brien , Ximena Soto , Vannah Jiv S. Caumeran , Barbara Mendez Campos , Michael Mancusi , Brian Diehl , Elizabeth Southwick , Elisabeth Moreno , Celia Bora , Stephanie Armbruster , Nadia N. Abuelezam , Rocío Calvo , Sebastien Haneuse , Kirsten K. Davison

{"title":"Motivational Interviewing for Vaccine Uptake in Latinx Adults (MI Vacuna): Study protocol for a pragmatic multiple-period cluster-randomized crossover trial","authors":"Rachel M. Scrivano , Brittney J. van de Water , Nicolle Rueras , Janin Alfonso , Kimberly H. McManama O'Brien , Ximena Soto , Vannah Jiv S. Caumeran , Barbara Mendez Campos , Michael Mancusi , Brian Diehl , Elizabeth Southwick , Elisabeth Moreno , Celia Bora , Stephanie Armbruster , Nadia N. Abuelezam , Rocío Calvo , Sebastien Haneuse , Kirsten K. Davison","doi":"10.1016/j.cct.2025.107987","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>While vaccines are safe and effective, vaccine hesitancy negatively impacts Latinx adults and adults with mental illness, resulting in low vaccination rates. Evidence suggests that Motivational interviewing (MI) may reduce vaccine hesitancy among underserved populations. This trial evaluates the effectiveness of MI integrated into behavioral health on vaccine hesitancy and COVID-19 and influenza vaccination among Latinx adults with mental illness.</div></div><div><h3>Methods</h3><div>Implemented in partnership with NeighborHealth, a Federally Qualified Health Center (FQHC) in a predominantly-Latinx community, Motivational Interviewing for Vaccine Uptake in Latinx Adults (MI Vacuna) is a novel intervention, comprised of Motivational Interviewing (MI) and a warm handoff, implemented by behavioral health (BH) clinicians to address vaccine hesitancy in their patients. Utilizing a pragmatic multiple-period, cluster-randomized crossover trial design this study: 1) tests the effectiveness of MI Vacuna on COVID-19 and influenza vaccine uptake among Latinx adults with mental illness; 2) investigates moderators of intervention effects including patient-provider ethno-language concordance and country of origin; and 3) examines theory-based elements on the causal pathway between the intervention and vaccine uptake. Primary outcomes include patient COVID-19 and influenza vaccine uptake extracted from electronic health records. Secondary outcomes include vaccine hesitancy and provider trust, evaluated using patient surveys and interviews. Implementation outcomes are measured using multiple data sources.</div></div><div><h3>Discussion</h3><div>This novel study tests the effect of MI within the context of BH on COVID-19 and influenza vaccine hesitancy and uptake among Latinx adults. Results inform the sustainability and scale-up of MI Vacuna and BH-centered efforts to target patient vaccine hesitancy.</div><div><strong>Trial Registration:</strong> <span><span>clinicaltrials.gov</span><svg><path></path></svg></span>, <span><span>NCT06062056</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"155 ","pages":"Article 107987"},"PeriodicalIF":1.9000,"publicationDate":"2025-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary clinical trials","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1551714425001818","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

Background

While vaccines are safe and effective, vaccine hesitancy negatively impacts Latinx adults and adults with mental illness, resulting in low vaccination rates. Evidence suggests that Motivational interviewing (MI) may reduce vaccine hesitancy among underserved populations. This trial evaluates the effectiveness of MI integrated into behavioral health on vaccine hesitancy and COVID-19 and influenza vaccination among Latinx adults with mental illness.

Methods

Implemented in partnership with NeighborHealth, a Federally Qualified Health Center (FQHC) in a predominantly-Latinx community, Motivational Interviewing for Vaccine Uptake in Latinx Adults (MI Vacuna) is a novel intervention, comprised of Motivational Interviewing (MI) and a warm handoff, implemented by behavioral health (BH) clinicians to address vaccine hesitancy in their patients. Utilizing a pragmatic multiple-period, cluster-randomized crossover trial design this study: 1) tests the effectiveness of MI Vacuna on COVID-19 and influenza vaccine uptake among Latinx adults with mental illness; 2) investigates moderators of intervention effects including patient-provider ethno-language concordance and country of origin; and 3) examines theory-based elements on the causal pathway between the intervention and vaccine uptake. Primary outcomes include patient COVID-19 and influenza vaccine uptake extracted from electronic health records. Secondary outcomes include vaccine hesitancy and provider trust, evaluated using patient surveys and interviews. Implementation outcomes are measured using multiple data sources.

Discussion

This novel study tests the effect of MI within the context of BH on COVID-19 and influenza vaccine hesitancy and uptake among Latinx adults. Results inform the sustainability and scale-up of MI Vacuna and BH-centered efforts to target patient vaccine hesitancy.

Trial Registration: clinicaltrials.gov, NCT06062056

查看原文本刊更多论文

拉丁裔成人接种疫苗的动机性访谈（MI Vacuna）：一项实用的多期集群随机交叉试验的研究方案。

背景：虽然疫苗是安全有效的，但疫苗犹豫对拉丁裔成年人和患有精神疾病的成年人产生了负面影响，导致疫苗接种率低。有证据表明，动机性访谈（MI）可以减少服务不足人群对疫苗的犹豫。本试验评估了将MI纳入行为健康对患有精神疾病的拉丁裔成人疫苗犹豫和COVID-19和流感疫苗接种的有效性。方法：与NeighborHealth合作实施，这是一个主要是拉丁裔社区的联邦合格健康中心（FQHC），拉丁裔成人疫苗摄取动机访谈（MI Vacuna）是一种新的干预措施，由动机访谈（MI）和温暖移交组成，由行为健康（BH）临床医生实施，以解决患者的疫苗犹豫问题。本研究采用实用的多期、集群随机交叉试验设计：1)测试MI Vacuna对拉丁裔成年精神疾病患者COVID-19和流感疫苗接种的有效性；2)研究干预效果的调节因素，包括患者-提供者民族语言一致性和原籍国；3)检查干预和疫苗摄取之间因果途径的理论基础要素。主要结局包括从电子健康记录中提取的患者COVID-19和流感疫苗接种情况。次要结局包括疫苗犹豫和提供者信任，通过患者调查和访谈进行评估。使用多个数据源衡量实施结果。讨论：这项新研究测试了BH背景下心肌梗死对拉丁裔成年人COVID-19和流感疫苗犹豫和吸收的影响。结果提示了MI Vacuna和以bh为中心的针对患者疫苗犹豫的可持续性和规模。试验注册：clinicaltrials.gov, NCT06062056。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

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.