COVID-19 Self-testing IMPROVE

June 5, 2025 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

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1271

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

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Center for Asian Health, Lewis Katz School of Medicine, Temple University

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).
Behavioral: IMPROVE
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.
Behavioral: IMPROVE
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.
Behavioral: IMPROVE
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
Time Frame
the change in the rate of COVID-19 self-testing
Time Frame: baseline, 1-month follow up, and 3-month follow up
baseline, 1-month follow up, and 3-month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Temple University

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

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)

December 2, 2024

Study Completion (Actual)

December 2, 2024

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)

June 10, 2025

Last Update Submitted That Met QC Criteria

June 5, 2025

Last Verified

June 1, 2025

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.

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