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COVID-19 Self-testing IMPROVE

Project IMPROVE: Implementing Community-Engaged Intervention Research to Increase Rapid SARS-CoV-2 Self-Testing Among Diverse Underserved and Vulnerable Asian Americans

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06576167
Enrollment
1277
Registered
2024-08-28
Start date
2023-06-15
Completion date
2025-03-15
Last updated
2026-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

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

Interventions

BEHAVIORALIMPROVE

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.

Sponsors

Temple University
Lead SponsorOTHER
National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SCREENING
Masking
NONE

Intervention model description

stepped wedge clustered-randomized trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

\-

Design outcomes

Primary

MeasureTime frameDescription
Lifetime Rate of COVID-19 Home Self-Testing Kit Usebaseline, 1-month follow up, and 3-month follow upLifetime 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.

Countries

United States

Baseline characteristics

Characteristic
Age, Continuous61.13 years
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
361 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
0 Participants
Sex: Female, Male
Female
290 Participants
Sex: Female, Male
Male
133 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 1,2770 / 1,2770 / 1,060
other
Total, other adverse events
0 / 1,2770 / 1,2770 / 1,060
serious
Total, serious adverse events
0 / 1,2770 / 1,2770 / 1,060

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 21, 2026