Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06614361
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
Community-based Behavioral Intervention to Increase COVID-19 and Influenza Vaccination for African American Black and Latino Persons An Optimization Randomized Controlled Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Community-based Behavioral Intervention to Increase COVID-19 and Influenza Vaccination for African American Black and Latino Persons An Optimization Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The proposed study responds to the need for community-engaged interventions to increase vaccine uptake among populations experiencing health disparities We focus on COVID-19 and influenza vaccination both of which now require annual vaccines Among those at highest risk for morbidity hospitalization and mortality are African AmericanBlack and Latino ABBL persons who are not up-to-date on these vaccinations Only 20-28 of adult AABL persons are up-to-date on COVID-19 vaccination compared to 31 of White persons and only 30-40 of AABL persons receive the influenza vaccine annually compared to ampgt55 among White persons AABL experience serious impediments to COVID-19 and to a lesser extent influenza vaccination at individual- eg distrust insufficient knowledge low perceived risk cognitive biases social- eg peer norms and structural-levels of influence eg poor access Taken together these comprise multi-level vaccine hesitancy Factors that promote vaccination include trusted AABL health educators peers nurses tapping into altruism and collective responsibility circumventing cognitive biases and reducing structural barriers Without efforts to address multi-level vaccine hesitancy rates of COVID-19 and influenza vaccination will remain unacceptably low and racialethnic health disparities in infectious disease morbidity and mortality will persist The proposed study is led by a collaborative team at New York University and the Northern Manhattan Improvement Corporation It uses the multiphase optimization strategy MOST an engineering-inspired framework to test effects of individual candidate intervention components in a factorial design and then optimize a multi-component intervention made up of the most cost-effective combination of components Staying up-to-date with COVID-19 vaccination confirmed with documentary evidence is the primary outcome and influenza vaccination is the secondary outcome We have identified four promising candidate components with an emphasis on brevity low-touch and future scalability A nurse-led shared decision making B a text message intervention C modest lottery prizes for vaccination and D peer navigation to vaccination appointments Participants will be N560 community-residing adult English and Spanish-speaking AABL persons who are not up-to-date on COVID-19 and influenza vaccinations but with at least one COVID-19 vaccine dose
Detailed Description:
The proposed study responds to the need for community-engaged interventions to increase vaccine uptake among populations experiencing health disparities We focus on COVID-19 and influenza vaccination both of which now require annual vaccines Among those at highest risk for morbidity hospitalization and mortality are African AmericanBlack and Latino ABBL persons who are not up-to-date on these vaccinations Only 20-28 of adult AABL persons are up-to-date on COVID-19 vaccination compared to 31 of White persons and only 30-40 of AABL persons receive the influenza vaccine annually compared to ampgt55 among White persons AABL experience serious impediments to COVID-19 and to a lesser extent influenza vaccination at individual- eg distrust insufficient knowledge low perceived risk cognitive biases social- eg peer norms and structural-levels of influence eg poor access Taken together these comprise multi-level vaccine hesitancy Factors that promote vaccination include trusted AABL health educators peers nurses tapping into altruism and collective responsibility circumventing cognitive biases and reducing structural barriers Without efforts to address multi-level vaccine hesitancy rates of COVID-19 and influenza vaccination will remain unacceptably low and racialethnic health disparities in infectious disease morbidity and mortality will persist The proposed study is led by a collaborative team at New York University and the Northern Manhattan Improvement Corporation It uses the multiphase optimization strategy MOST an engineering-inspired framework to test effects of individual candidate intervention components in a factorial design and then optimize a multi-component intervention made up of the most cost-effective combination of components Staying up-to-date with COVID-19 vaccination confirmed with documentary evidence is the primary outcome and influenza vaccination is the secondary outcome We have identified four promising candidate components with an emphasis on brevity low-touch and future scalability A nurse-led shared decision making B a text message intervention C modest lottery prizes for vaccination and D peer navigation to vaccination appointments Participants will be N560 community-residing adult English and Spanish-speaking AABL persons who are not up-to-date on COVID-19 and influenza vaccinations but with at least one COVID-19 vaccine dose Specific aims are Aim 1 identify which of four components contribute meaningfully to improvement in the outcomes Aim 2 identify mediators eg altruism norms and moderators eg sociodemographic characteristics distrust of the effects of each component and Aim 3 build the most cost-effective intervention packages Participants will be randomly assigned to an experimental condition and assessed at 3- and 6-months post-baseline N45 participants will engage in qualitative in-depth interviews We will also uncover describe and plan for implementation issues so the optimized intervention can be rapidly scaled up by community-based and outpatient health organizations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None