COVID-19 Self-testing IMPROVE

A study testing IMPROVE in people with COVID-19, run by Temple University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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 Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: COVID-19
What is being tested?: IMPROVE
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,277 participants
Where: 1 siteUnited States
Study dates: 15 Jun 2023to 15 Mar 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

(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,

Who cannot join

Trial locations and contacts

1 site in 1 country.

United States1 site

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

Other trials in United States

About this study

Official title: 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

Conditions: COVID-19
Being tested: IMPROVE
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IMPROVEBehavioural
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.

Study groups in NCT06576167
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Behavioral: IMPROVE

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: baseline, 1-month follow up, and 3-month follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jun 202315 Mar 2025

First posted28 Aug 2024
Study start15 Jun 2023
Primary completion15 Mar 2025
Study completion15 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for COVID-19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Randomised
Intervention model: Sequential
Model description: stepped wedge clustered-randomized trial
Masking: None (open label)
Enrolment: 1,277 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06576167
Sponsor's protocol ID: RADxUP
Status last verified: May 2026
First submitted: 27 Aug 2024
Last updated: 20 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingPhase 4
A Study to Investigate the Immunogenicity and Safety of mRNA COVID-19 Variant-containing Formulations
SARS-CoV-2
Not yet recruitingPhase 2
Study of VYD2311 for the Treatment of Adults With Long-COVID or Post-Vaccination Syndrome
Long COVID, COVID-19 (SARS-CoV-2 Infection)
Active, not recruiting
Motivational Interviewing Intervention for Families With Overweight and Obesity
Obesity & Overweight

All COVID-19 trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Project IMPROVE: Implementing Community-Engaged Intervention Research to Increase Rapid SARS-CoV-2 Self-Testing Among Diverse Underserved and Vulnerable Asian Americans
ClinicalTrials.gov ID: NCT06576167
Acronym / sponsor ID: RADxUP
Conditions: COVID-19
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,277 participants (actual)
Lead sponsor: Temple UniversityUniversity, hospital or other
Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
Study start: 15 Jun 2023 (actual)
Primary completion: 15 Mar 2025 (actual)
Study completion: 15 Mar 2025 (actual)
First posted: 28 Aug 2024 (actual)
Results: Posted 20 Aug 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Screening
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 3
Model description: stepped wedge clustered-randomized trial

Arm	Type	Receives
Wedge 1	Experimental	Behavioral: IMPROVEThe 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.
Wedge 2	Experimental	Behavioral: IMPROVEFollowing 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.
Wedge 3	Experimental	Behavioral: IMPROVEThe 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

(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,

Key exclusion criteria (1 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IMPROVEIMPROVE 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.	Behavioural	Wedge 1, Wedge 2, Wedge 3

Primary outcome

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.

Results and safety

Results posted to the registry on 20 Aug 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Wedge 1	389	389
Wedge 2	527	527
Wedge 3	361	361

Primary outcome: Lifetime Rate of COVID-19 Home Self-Testing Kit Use

Time frame: baseline, 1-month follow up, and 3-month follow up. Count of participants. Unit: Participants

Measure	Control n = 1277	IMPROVE n = 1193
Baseline (Control Period)	430	0
1-month follow up	0	583
3-month follow up	0	732

Population analysed: Control Period N=1,277 (Wedge 1: 389, Wedge 2: 527, Wedge 3: 361); assessed at cluster baseline; IMPROVE Period: 1-month N=1,193 (Wedge 1: 352, Wedge 2: 502, Wedge 3: 339); 3-month N=1,125 (Wedge 1: 332, Wedge 2: 466, Wedge 3: 327). Results was gained using non-missing cases.

Adverse events

Time frame: Adverse events were monitored from enrollment through completion of post-intervention follow-up assessments, up to 15 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	0 of 1,277 (0%)	0 of 1,277 (0%)	0 of 1,277
IMPROVE	0 of 1,277 (0%)	0 of 1,277 (0%)	0 of 1,277
Follow Up	0 of 1,060 (0%)	0 of 1,060 (0%)	0 of 1,060

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for COVID-19

RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingPhase 4
A Study to Investigate the Immunogenicity and Safety of mRNA COVID-19 Variant-containing Formulations
SARS-CoV-2
Not yet recruitingPhase 2
Study of VYD2311 for the Treatment of Adults With Long-COVID or Post-Vaccination Syndrome
Long COVID, COVID-19 (SARS-CoV-2 Infection)
Active, not recruiting
Motivational Interviewing Intervention for Families With Overweight and Obesity
Obesity & Overweight

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing IMPROVE in people with COVID-19, run by Temple University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lifetime Rate of COVID-19 Home Self-Testing Kit Use (time frame: baseline, 1-month follow up, and 3-month follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06576167.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.