NCT04779138

Brief Summary

This proposal seeks to enhance uptake and completion of COVID-19 vaccination among African American and Latinx public housing residents in South Los Angeles. Given the multiple disparities experienced by public housing residents, the investigators will utilize a theoretically-based, multidisciplinary and culturally tailored intervention to provide education at multiple levels and implement innovate strategies to engage this population in the uptake of COVID-19 vaccination.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
462

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

September 11, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

April 24, 2024

Status Verified

February 1, 2024

Enrollment Period

2.2 years

First QC Date

February 27, 2021

Last Update Submit

April 23, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of vaccination uptake for COVID-19, influenza, and pneumonia using Vaccination History Self Report

    1\. By comparison of pre-, post- intervention, and 9- and 18-months follow-up data, we anticipate the following compared to baseline: a 40% change in completion of COVID-19 vaccination series

    Intervention: 4 months; Follow-up Point: 3 months post-intervention

Secondary Outcomes (2)

  • Percentage of Participants Achieving Decreased Vaccine Hesitancy Levels of COVID-19 vaccine Using the NIH Toolbox Surveys on COVID-19

    Intervention: 4 months; Follow-up Point: 3 months post-intervention

  • Percentage of Participants Achieving Increased Level of Behavior Change toward COVID-19 Vaccination Using the NIH Toolbox Surveys on COVID-19

    Intervention: 4 months; Follow-up Point: 3 months post-intervention

Study Arms (1)

Increasing Uptake of COVID-19 Vaccination

EXPERIMENTAL

This is a pre-experimental "one group pretest-posttest" design to increase COVID-19 vaccine uptake and completion among African American and Latinx public housing residents in South Los Angeles. The proposed intervention will employ (1) culturally sensitive, (2) theoretically based intervention that will be jointly delivered by our ACTIVATE triad leaders and our researchers. We will use the Information, Motivation, and Behavioral Skills (IMB) model and the Transtheoretical Model to implement the intervention.

Behavioral: Increasing Willingness and Uptake of COVID-19 Vaccination

Interventions

Provide/enhance knowledge, modify attitudes, motivate and provide skills and resources to reduce COVID-19 vaccine hesitancy and increase willingness and uptake in COVID-19 vaccination.

Increasing Uptake of COVID-19 Vaccination

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • identify as Latinx or African American
  • age 18 or older
  • reside in one of the six collaborating public housing area
  • Speak either English or Spanish

You may not qualify if:

  • Not a resident at one of the collaborating public housing areas
  • Does not self-identify as African American or Latinx
  • Age 17 and younger
  • Unable to speak either English or Spanish
  • Aim 3:
  • identify as Latinx or African American
  • age 18 or older
  • reside in one of the six collaborating public housing area
  • Speak either English or Spanish
  • Report vaccine hesitancy
  • Not a resident at one of the collaborating public housing areas
  • Does not self-identify as African American or Latinx
  • Age 17 and younger
  • Unable to speak either English or Spanish
  • Received all recommended vaccines for COVID-19
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charles R. Drew University of Medicine & Science

Los Angeles, California, 90059, United States

Location

MeSH Terms

Conditions

Coronavirus InfectionsVaccination Refusal

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsTreatment RefusalTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Sharon Cobb

    Charles R. Drew University of Medicine & Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2021

First Posted

March 3, 2021

Study Start

September 11, 2021

Primary Completion

November 30, 2023

Study Completion

April 1, 2024

Last Updated

April 24, 2024

Record last verified: 2024-02

Locations