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