Contemporary clinical trials · 2025
Motivational Interviewing for Vaccine Uptake in Latinx Adults (MI Vacuna): Study protocol for a pragmatic multiple-period cluster-randomized crossover trial.
СтатьяПротокол клинического исследованияПоддержка NIH: внешняя программаНазвание и аннотация: Перевод в очереди
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Scrivano Rachel M, van de Water Brittney J, Rueras Nicolle, Alfonso Janin, McManama O'Brien Kimberly H, Soto Ximena, Caumeran Vannah Jiv S, Campos Barbara Mendez, Mancusi Michael, Diehl Brian, Southwick Elizabeth, Moreno Elisabeth, Bora Celia, Armbruster Stephanie, Abuelezam Nadia N, Calvo Rocío, Haneuse Sebastien, Davison Kirsten K
Аннотация
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.
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.