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

• Sponsor: Texas Woman's University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05805163
• Collaborator: National Institutes of Health (NIH) (NIH)
• Enrollment: 100
• Arms: 2
• Anticipated Duration (Months): 8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
COVID19 Testing	Behavioral: FABI tailored COVID-19 testing pamphlet; Behavioral: Standard COVID-19 home-based test kit	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Screening
• Official Title: A Culturally Relevant Communication and Support Plan to Ensure Access to and Use of Covid-19 Testing for Francophone African Born Immigrants
• Anticipated Study Start Date: Sep 1, 2023
• Anticipated Primary Completion Date: Apr 1, 2024
• Anticipated Study Completion Date: May 1, 2024

Arms and Interventions

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: FABI tailored COVID-19 testing pamphlet; FABI adapted COVID-19 educational pamphlet; Behavioral: Standard COVID-19 home-based test kit; Standard COVID-19 home-based test kit

Outcome Measures

Primary Outcome Measures

1. Return rate [Tests returned within 3 months]

   Ratio of returned tests over total tests provided

Secondary Outcome Measures

1. Qualitative assessment [2 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Exclusion Criteria: None

-

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Texas Woman's University
• National Institutes of Health (NIH)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Texas Woman's University
• ClinicalTrials.gov Identifier: NCT05805163
• Other Study ID Numbers: FY2023-241; R0704
• First Posted: Apr 7, 2023
• Last Update Posted: Apr 7, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Apr 7, 2023