CClinicalTrials.gg
CompletedNCT06576167Updated Aug 20, 2026Results posted

COVID-19 Self-testing IMPROVE

An interventional study of IMPROVE in COVID-19, sponsored by Temple University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by Temple University · Not applicable, Interventional, and Screening

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Jun 2023, registered Aug 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
1,277
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • COVID-19

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03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 1,277 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Temple University is the lead sponsor of 219 studies on the registry; 30 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 7 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

Exclusion Criteria:

-

05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
1,277 participants (actual)

Study arms

  • 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.

    Behavioral: IMPROVE

  • 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.

    Behavioral: IMPROVE

  • 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.

    Behavioral: IMPROVE

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.

06

What researchers measure

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.

    Time frame: baseline, 1-month follow up, and 3-month follow up

07

Results

Posted Aug 20, 2026

Participant flow

Control and Baseline Phase
Participant flow — Control and Baseline Phase
MilestoneWedge 1Wedge 2Wedge 3
Started389527361
Completed389527361
Not completed000
IMPROVE Phase
Participant flow — IMPROVE Phase
MilestoneWedge 1Wedge 2Wedge 3
Started389527361
Completed389527361
Not completed000
Follow-Up Phase
Participant flow — Follow-Up Phase
MilestoneWedge 1Wedge 2Wedge 3
Started389527361
Completed309453298
Not completed807463
Withdrew: Lost to follow-up807463

Outcome measures

PrimaryLifetime 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.

Time frame:
baseline, 1-month follow up, and 3-month follow up
Reported as:
Count of participants · Participants
Lifetime Rate of COVID-19 Home Self-Testing Kit Use
ParticipantsControlIMPROVE
Baseline (Control Period)4300
1-month follow up0583
3-month follow up0732

Adverse events

Collected over Adverse events were monitored from enrollment through completion of post-intervention follow-up assessments, up to 15 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Control0/1,277 (0%)0/1,277 (0%)0/1,277 (0%)
IMPROVE0/1,277 (0%)0/1,277 (0%)0/1,277 (0%)
Follow Up0/1,060 (0%)0/1,060 (0%)0/1,060 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Wedge 1Wedge 2Wedge 3Total
Mean62.51 (19 to 94)59.63 (18 to 99)61.85 (18 to 94)61.13 (18 to 99)
Sex: Female, Male
Sex: Female, Male(Participants)Wedge 1Wedge 2Wedge 3Total
Female290363210863
Male78153133364
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Wedge 1Wedge 2Wedge 3Total
American Indian or Alaska Native0000
Asian3895273611277
Native Hawaiian or Other Pacific Islander0000
Black or African American0000
White0000
More than one race0000
Unknown or Not Reported0000
08

Study locations

1 site
  • Center for Asian Health, Lewis Katz School of Medicine, Temple University
    Philadelphia, Pennsylvania 19140, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Feb 22, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06576167
Lead sponsor
Temple University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
Responsible party
Sponsor
First posted
Aug 28, 2024
Start date
Jun 15, 2023
Primary completion
Mar 15, 2025
Completion
Mar 15, 2025
Results posted
Aug 20, 2026
Last update
Aug 20, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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