COVID19 TestingNCT05805163
Tailored COVID-19 Testing Support Plan for Francophone African Born Immigrants
A study testing FABI tailored COVID-19 testing pamphlet and Standard COVID-19 home-based test kit in people with COVID19 Testing, run by Texas Woman's University.
Trial 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) . Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID19 Testing
- What is being tested?
- FABI tailored COVID-19 testing pamphlet and Standard COVID-19 home-based test kit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -
About this study
Official title: 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.
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.
- Conditions
- COVID19 Testing
- Being tested
- FABI tailored COVID-19 testing pamphlet, Standard COVID-19 home-based test kit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FABI tailored COVID-19 testing pamphletBehavioural
FABI adapted COVID-19 educational pamphlet
Standard COVID-19 home-based test kitBehavioural
Standard COVID-19 home-based test kit
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Participants will be mailed a standard COVID-19 home-based test kit. Receives: Behavioral: Standard COVID-19 home-based test kit |
| Intervention | Experimental | Participants will be mailed a standard COVID-19 home-based test plus the FABI culturally sensitive COVID-19 educational pamphlet. Receives: Behavioral: FABI tailored COVID-19 testing pamphlet; Behavioral: Standard COVID-19 home-based test kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return rate
Ratio of returned tests over total tests provided
Measured: 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)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study startSep 2023 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID19 TestingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Woman's University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05805163
- Sponsor's protocol ID
- FY2023-241
- Other IDs
- R0704
- Status last verified
- Mar 2023
- First submitted
- 3 Apr 2023
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Culturally Relevant Communication and Support Plan to Ensure Access to and Use of Covid-19 Testing for Francophone African Born Immigrants
- ClinicalTrials.gov ID
- NCT05805163
- Acronym / sponsor ID
- FY2023-241
- Conditions
- COVID19 Testing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Texas Woman's UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Sep 2023 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Standard COVID-19 home-based test kitParticipants will be mailed a standard COVID-19 home-based test kit. |
| Intervention | Experimental | Behavioral: FABI tailored COVID-19 testing pamphlet, Behavioral: Standard COVID-19 home-based test kitParticipants will be mailed a standard COVID-19 home-based test plus the FABI culturally sensitive COVID-19 educational pamphlet. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FABI tailored COVID-19 testing pamphletFABI adapted COVID-19 educational pamphlet | Behavioural | Intervention |
| Standard COVID-19 home-based test kitStandard COVID-19 home-based test kit | Behavioural | Control, Intervention |
Primary outcome
Return rate
Time frame: Tests returned within 3 months
Ratio of returned tests over total tests provided
1 secondary outcome
Qualitative assessment
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Individual participant dataSharing planned: Undecided
Related trials for COVID19 Testing
Active, not recruitingPhase 2
COVID-19 Rapid Test-to-Treat With African American Churches (Faithful Response II)
COVID-19 Testing Behaviors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing FABI tailored COVID-19 testing pamphlet and Standard COVID-19 home-based test kit in people with COVID19 Testing, run by Texas Woman's University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return rate (time frame: Tests returned within 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023; AzTrials last refreshed its copy on 3 Nov 2026.