NCT04930965

Brief Summary

The purpose of the study is to assess the effectiveness of the HALT COVID Ambassador educational outreach program on increasing likelihood to vaccinate against COVID-19

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable covid19

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable covid19

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

October 5, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
11 months until next milestone

Results Posted

Study results publicly available

January 18, 2024

Completed
Last Updated

January 18, 2024

Status Verified

December 1, 2023

Enrollment Period

1.2 years

First QC Date

June 16, 2021

Results QC Date

December 20, 2023

Last Update Submit

December 20, 2023

Conditions

Keywords

Community Health Worker

Outcome Measures

Primary Outcomes (1)

  • Difference in Proportion of Participants "Likely to Vaccinate" Between Study Arms at Month 1

    Vaccine likelihood will be measured using a single question adapted from the CEAL Common Survey (i.e., "On a scale from 1 to 7, with 1 being 'not at all likely' and 7 being 'very likely', how likely are you to get a COVID-19 vaccine in the next month?"), with "likely to vaccinate" defined as a score of 5-7.

    Month 1 follow-up

Secondary Outcomes (3)

  • Difference in Proportion of Participants "Likely to Vaccinate" Between Study Arms at Month 2

    Month 2 follow-up

  • Difference in Proportion of Participants Who Have Received >=1 Dose of Vaccine Between Study Arms at Month 1

    Month 1 follow-up

  • Difference in Proportion of Participants Who Have Received >=1 Dose of Vaccine Between Study Arms at Month 2

    Month 2 follow-up

Study Arms (2)

Intervention

EXPERIMENTAL
Behavioral: Community health worker engagement

Usual care

NO INTERVENTION

Interventions

3-4 in-person or virtual engagements (individual or group sessions) over 1 month, each engagement lasting 30 minutes to 1 hour

Intervention

Eligibility Criteria

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

You may qualify if:

  • Unlikely to vaccinate in next month
  • Age \>=18 years
  • Self-identification as Black or African American
  • Ability to understand and speak English
  • Willingness to engage with HALT COVID Ambassador via in-person or virtual sessions exploring questions and concerns about vaccines

You may not qualify if:

  • Unable or unwilling to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tulane University Medical Center

New Orleans, Louisiana, 70112, United States

Location

MeSH Terms

Conditions

COVID-19Vaccination Refusal

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesTreatment RefusalTreatment Adherence and ComplianceHealth BehaviorBehavior

Results Point of Contact

Title
Erin Peacock
Organization
Tulane University

Study Officials

  • Marie Krousel-Wood, MD, MSPH

    Tulane University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2021

First Posted

June 18, 2021

Study Start

October 5, 2021

Primary Completion

December 31, 2022

Study Completion

February 28, 2023

Last Updated

January 18, 2024

Results First Posted

January 18, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations