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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
Texas Woman's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for COVID19 Testing

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    April 3, 2023
    Last Updated
    April 6, 2023
    Sponsor
    Texas Woman's University
    Collaborators
    National Institutes of Health (NIH)
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    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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