Tailored COVID-19 Testing Support Plan for Francophone African Born Immigrants
Primary Purpose
COVID19 Testing
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FABI tailored COVID-19 testing pamphlet
Standard COVID-19 home-based test kit
Sponsored by
About this trial
This is an interventional screening trial for COVID19 Testing
Eligibility Criteria
Inclusion Criteria: FABI living in Dallas Fort Worth (DFW) - Exclusion Criteria: None -
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
Intervention
Arm Description
Participants will be mailed a standard COVID-19 home-based test kit.
Participants will be mailed a standard COVID-19 home-based test plus the FABI culturally sensitive COVID-19 educational pamphlet.
Outcomes
Primary Outcome Measures
Return rate
Ratio of returned tests over total tests provided
Secondary Outcome Measures
Qualitative assessment
Qualitative assessment of experiences with CHWs, COVID-19 test kit, and FABI culturally sensitive COVID-19 educational pamphlet (if applicable)
Full Information
NCT ID
NCT05805163
First Posted
April 3, 2023
Last Updated
April 6, 2023
Sponsor
Texas Woman's University
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT05805163
Brief Title
Tailored COVID-19 Testing Support Plan for Francophone African Born Immigrants
Official Title
A Culturally Relevant Communication and Support Plan to Ensure Access to and Use of Covid-19 Testing for Francophone African Born Immigrants
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Texas Woman's University
Collaborators
National Institutes of Health (NIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID19 Testing
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Participants will be mailed a standard COVID-19 home-based test kit.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants will be mailed a standard COVID-19 home-based test plus the FABI culturally sensitive COVID-19 educational pamphlet.
Intervention Type
Behavioral
Intervention Name(s)
FABI tailored COVID-19 testing pamphlet
Intervention Description
FABI adapted COVID-19 educational pamphlet
Intervention Type
Behavioral
Intervention Name(s)
Standard COVID-19 home-based test kit
Intervention Description
Standard COVID-19 home-based test kit
Primary Outcome Measure Information:
Title
Return rate
Description
Ratio of returned tests over total tests provided
Time Frame
Tests returned within 3 months
Secondary Outcome Measure Information:
Title
Qualitative assessment
Description
Qualitative assessment of experiences with CHWs, COVID-19 test kit, and FABI culturally sensitive COVID-19 educational pamphlet (if applicable)
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: FABI living in Dallas Fort Worth (DFW) -
Exclusion Criteria: None
-
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Tailored COVID-19 Testing Support Plan for Francophone African Born Immigrants
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