NCT05805163

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 7, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

April 7, 2023

Status Verified

March 1, 2023

Enrollment Period

7 months

First QC Date

April 3, 2023

Last Update Submit

April 6, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Return rate

    Ratio of returned tests over total tests provided

    Tests returned within 3 months

Secondary Outcomes (1)

  • Qualitative assessment

    2 months

Study Arms (2)

Control

ACTIVE COMPARATOR

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

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.

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

Interventions

FABI adapted COVID-19 educational pamphlet

Intervention

Standard COVID-19 home-based test kit

ControlIntervention

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2023

First Posted

April 7, 2023

Study Start

September 1, 2023

Primary Completion

April 1, 2024

Study Completion

May 1, 2024

Last Updated

April 7, 2023

Record last verified: 2023-03