NCT04542395

Brief Summary

This proposal seeks to enhance acceptability and uptake of COVID-19 testing and vaccination to engage 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 reduce barriers and implement innovate strategies to engage this population in the uptake of COVID-19 testing and vaccination.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

September 3, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 9, 2020

Completed
2.7 years until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

August 19, 2022

Status Verified

August 1, 2022

Enrollment Period

2.5 years

First QC Date

September 3, 2020

Last Update Submit

August 17, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Prevalence of COVID-19 testing, pneumococcal and influenza vaccinations Using Test History Self-Report

    By comparison of pre-, post- intervention, and six-months follow-up data, we anticipate the following compared to baseline: a 30% change in willingness and uptake for testing and vaccination.

    Intervention: 3 months; Follow-up Point: 6 months post-intervention

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

    By comparison of pre-, post- intervention, and six-months follow-up data, we anticipate the following compared to baseline: a 30% change in perceived COVID-19 risk.

    Intervention: 3 months; Follow-up Point: 6 months post-intervention

  • Percentage of Participants Achieving Decreased Levels of COVID-19 Mistrust and Barriers Using the NIH Toolbox Surveys on COVID-19

    By comparison of pre-, post- intervention, and six-months follow-up data, we anticipate the following compared to baseline: a 40% change in mistrust and perceived barriers toward COVID-19 testing and vaccination,

    Intervention: 3 months; Follow-up Point: 6 months post-intervention

Study Arms (1)

Increasing Uptake of COVID-19 Testing and Vaccination

EXPERIMENTAL

This is a pre-experimental "one group pretest-posttest" design to improve COVID-19 associated health outcomes and willingness and uptake toward testing and vaccination among 310 Hispanic and African American 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 COVID-19 health ambassadors 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 Testing and Vaccination

Interventions

Provide/enhance knowledge, modify attitudes, motivate and provide skills and resources to reduce COVID-19 related risk and challenges and increase willingness and uptake in COVID-19 testing and vaccination.

Increasing Uptake of COVID-19 Testing and Vaccination

Eligibility Criteria

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

You may qualify if:

  • Identify as Latino/Hispanic or African American/Black
  • Reside in one of the six collaborating public housing
  • years old and older
  • Speak either English or Spanish

You may not qualify if:

  • Does not self-identify as African American and/or Black
  • Under the age of 18
  • Unable to speak English or Spanish
  • Does not Reside in one of the six collaborating public housing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Housing Authority of Clty of Los Angeles

Los Angeles, California, 90059, United States

Location

MeSH Terms

Conditions

Coronavirus Infections

Interventions

Vaccination

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Immunotherapy, ActiveImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative TechniquesPrimary PreventionPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesCommunicable Disease ControlPublic Health PracticePublic HealthEnvironment and Public Health

Study Officials

  • Mohsen Bazargan, PhD

    Charles R. Drew University of Medicine & Science

    PRINCIPAL INVESTIGATOR
0

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

September 3, 2020

First Posted

September 9, 2020

Study Start

June 1, 2023

Primary Completion

November 30, 2025

Study Completion

November 30, 2025

Last Updated

August 19, 2022

Record last verified: 2022-08

Locations