COVID-19 Self-testing IMPROVE

NCT06576167 | Completed Results

• 1 other identifier: RADxUP
• Study Type: interventional
• Target: 1,277
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Lifetime Rate of COVID-19 Home Self-Testing Kit Use

  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

Study Arms (3)

Wedge 1

EXPERIMENTAL

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.

Behavioral: IMPROVE

Wedge 2

EXPERIMENTAL

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.

Behavioral: IMPROVE

Wedge 3

EXPERIMENTAL

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.

Behavioral: IMPROVE

Interventions

IMPROVE BEHAVIORAL

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.

Wedge 1; Wedge 2; Wedge 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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,

Sponsors & Collaborators

• Temple University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Center for Asian Health, Lewis Katz School of Medicine, Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Grace X. Ma
• Organization: Center for Asian Health, Lewis Katz School of Medicine, Temple University

grace.ma@temple.edu

215-707-6493

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: stepped wedge clustered-randomized trial

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 28, 2024
• Study Start: June 15, 2023
• Primary Completion: March 15, 2025
• Study Completion: March 15, 2025
• Last Updated: August 20, 2026
• Results First Posted: August 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)