Tailored COVID-19 Testing Support Plan for Francophone African Born Immigrants

April 6, 2023 updated by: Texas Woman's University

A Culturally Relevant Communication and Support Plan to Ensure Access to and Use of Covid-19 Testing for Francophone African Born Immigrants

The goal of this clinical trial is to test the effectiveness of a culturally sensitive COVID-19 testing intervention designed for Francophone (French speaking) African Born Immigrants (FABI) . The main question this study aims to answer is whether or not a a culturally sensitive COVID-19 educational pamphlet added to the home-based test will improve testing rates compared to receiving a standard home-based test alone.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Upon consenting, all participants will receive basic COVID-19 testing instructions from trained bilingual/bicultural Francophone African Born Immigrant (FABI) Community Health Workers (CHW's). Next, participants will be randomly assigned to either the control or intervention study arms. In the control condition (n=50) participants will receive a standard COVID-19 home-based test kit. In contrast, those assigned to the intervention condition (n=50) will receive the same COVID-19 home-based test kit plus a FABI culturally sensitive COVID-19 educational pamphlet. Lastly, (n=10) participants from each arm will be randomly selected to participate in qualitative interviews to assess their experiences with CHWs and their test kit.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria: FABI living in Dallas Fort Worth (DFW) -

Exclusion Criteria: None

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Participants will be mailed a standard COVID-19 home-based test kit.
Behavioral: Standard COVID-19 home-based test kit
Standard COVID-19 home-based test kit
Experimental: Intervention
Participants will be mailed a standard COVID-19 home-based test plus the FABI culturally sensitive COVID-19 educational pamphlet.
Behavioral: Standard COVID-19 home-based test kit
Standard COVID-19 home-based test kit
Behavioral: FABI tailored COVID-19 testing pamphlet
FABI adapted COVID-19 educational pamphlet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Return rate
Time Frame: Tests returned within 3 months
Ratio of returned tests over total tests provided
Tests returned within 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative assessment
Time Frame: 2 months
Qualitative assessment of experiences with CHWs, COVID-19 test kit, and FABI culturally sensitive COVID-19 educational pamphlet (if applicable)
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Texas Woman's University

Collaborators

National Institutes of Health (NIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2023

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

April 3, 2023

First Submitted That Met QC Criteria

April 6, 2023

First Posted (Actual)

April 7, 2023

Study Record Updates

Last Update Posted (Actual)

April 7, 2023

Last Update Submitted That Met QC Criteria

April 6, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FY2023-241
  • R0704 (Other Grant/Funding Number: RADx-UP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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