CClinicalTrials.gg
Status unknownNCT05805163Updated Apr 7, 2023

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

An interventional study of FABI tailored COVID-19 testing pamphlet and Standard COVID-19 home-based test kit in COVID19 Testing, sponsored by Texas Woman's University. Status unknown. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-07.

Sponsored by Texas Woman's University · Not applicable, Interventional, and Screening

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • COVID19 Testing

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03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Texas Woman's University is the lead sponsor of 82 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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

Exclusion Criteria: None

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Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Control

    Participants will be mailed a standard COVID-19 home-based test kit.

    Behavioral: 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: FABI tailored COVID-19 testing pamphlet · Behavioral: Standard COVID-19 home-based test kit

Interventions

  • BehavioralFABI tailored COVID-19 testing pamphlet

    FABI adapted COVID-19 educational pamphlet

  • BehavioralStandard COVID-19 home-based test kit

    Standard COVID-19 home-based test kit

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What researchers measure

Primary outcomes

  1. Return rate

    Ratio of returned tests over total tests provided

    Time frame: Tests returned within 3 months

Secondary outcomes

  1. Qualitative assessment

    Qualitative assessment of experiences with CHWs, COVID-19 test kit, and FABI culturally sensitive COVID-19 educational pamphlet (if applicable)

    Time frame: 2 months

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05805163
Lead sponsor
Texas Woman's University
Collaborators
National Institutes of Health (NIH)
Responsible party
Sponsor
First posted
Apr 7, 2023
Start date
Sep 2023 (estimated)
Primary completion
Apr 2024 (estimated)
Completion
May 2024 (estimated)
Last update
Apr 7, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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