COVID-19 Self-testing IMPROVE
July 29, 2026 updated by: Temple University
Project IMPROVE: Implementing Community-Engaged Intervention Research to Increase Rapid SARS-CoV-2 Self-Testing Among Diverse Underserved and Vulnerable Asian Americans
The study aims to engage community partners to implement IMPROVE intervention and promote (COVID-19) rapid testing among vulnerable Asian Americans in the Greater Philadelphia Area and New York City
Study Overview
Study Type
Interventional
Enrollment (Actual)
1277
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19140
- Center for Asian Health, Lewis Katz School of Medicine, Temple University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- (1) self-identified as Asian from one of the subgroups: Chinese, Korean, Vietnamese, Filipino, or other South Asian Americans,
- (2) aged 18 and above,
- (3) living in the Greater Philadelphia or NYC areas,
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Wedge 1
The earliest group to implement the IMPROVE intervention ( in 4-9 study months).
Clusters assigned to this sequence remained in the control condition for 3 months, received the intervention for 6 months, and completed follow-up assessments for 3 months.
|
IMPROVE is a CBHN-led intervention.
The study team delivered comprehensive training to CHNs to let them be well-prepared for intervention delivery.
CHNs lead an in-person start-up group education session that consists of 4 modules: 1) a 6-minutes video of a health care provider delivering information on COVID-19 to help participants better understand the disease; 2) using educational slides, CHNs discuss the importance of COVID-19 testing and mitigation adherence; 3) CHNs conduct live demonstration of how to use rapid COVID-19 self-test kit correctly and distribute two COVID-19 self-testing kits to each participant.
4) CHNs guide interactive discussions with participants to enable them to reflect and reinforce what they learned.
In addition, CHNs will help participants identify their navigation needs in reducing hesitancy of self-testing and mitigation practices.
CHNs will also schedule check-in calls with participants.
|
|
Experimental: Wedge 2
Following the wedge 1 group, the wedge 2 group started the intervention in the study months 7-12.
Clusters assigned to this sequence remained in the control condition for 6 months, received the intervention for 6 months, and completed follow-up assessments for 3 months.
|
IMPROVE is a CBHN-led intervention.
The study team delivered comprehensive training to CHNs to let them be well-prepared for intervention delivery.
CHNs lead an in-person start-up group education session that consists of 4 modules: 1) a 6-minutes video of a health care provider delivering information on COVID-19 to help participants better understand the disease; 2) using educational slides, CHNs discuss the importance of COVID-19 testing and mitigation adherence; 3) CHNs conduct live demonstration of how to use rapid COVID-19 self-test kit correctly and distribute two COVID-19 self-testing kits to each participant.
4) CHNs guide interactive discussions with participants to enable them to reflect and reinforce what they learned.
In addition, CHNs will help participants identify their navigation needs in reducing hesitancy of self-testing and mitigation practices.
CHNs will also schedule check-in calls with participants.
|
|
Experimental: Wedge 3
The wedge 3 group started the intervention in the study months 10-15.
Clusters assigned to this sequence remained in the control condition for 9 months, received the intervention for 6 months, and completed follow-up assessments for 3 months.
|
IMPROVE is a CBHN-led intervention.
The study team delivered comprehensive training to CHNs to let them be well-prepared for intervention delivery.
CHNs lead an in-person start-up group education session that consists of 4 modules: 1) a 6-minutes video of a health care provider delivering information on COVID-19 to help participants better understand the disease; 2) using educational slides, CHNs discuss the importance of COVID-19 testing and mitigation adherence; 3) CHNs conduct live demonstration of how to use rapid COVID-19 self-test kit correctly and distribute two COVID-19 self-testing kits to each participant.
4) CHNs guide interactive discussions with participants to enable them to reflect and reinforce what they learned.
In addition, CHNs will help participants identify their navigation needs in reducing hesitancy of self-testing and mitigation practices.
CHNs will also schedule check-in calls with participants.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lifetime Rate of COVID-19 Home Self-Testing Kit Use
Time Frame: baseline, 1-month follow up, and 3-month follow up
|
Lifetime use defined as self-report of ever using a COVID-19 rapid antigen home self-test kit at least once.
Baseline was collected before IMPROVE implementation for all participants.
The 1-month and 3-month follow-up assessments were collected after participants received the IMPROVE intervention, according to their wedge rollout schedule.
Cleaned dataset with corrected data collection dates was used to update the results.
|
baseline, 1-month follow up, and 3-month follow up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 15, 2023
Primary Completion (Actual)
March 15, 2025
Study Completion (Actual)
March 15, 2025
Study Registration Dates
First Submitted
August 27, 2024
First Submitted That Met QC Criteria
August 27, 2024
First Posted (Actual)
August 28, 2024
Study Record Updates
Last Update Posted (Actual)
August 20, 2026
Last Update Submitted That Met QC Criteria
July 29, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RADxUP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.