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Trial Outcomes & Findings for COVID-19 Self-testing IMPROVE (NCT NCT06576167)

NCT ID: NCT06576167

Last Updated: 2026-08-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1277 participants

Primary outcome timeframe

baseline, 1-month follow up, and 3-month follow up

Results posted on

2026-08-20

Participant Flow

Unit of analysis: Community Based Organizations

Participant milestones

Participant milestones
Measure
Wedge 1
The earliest group to implement the IMPROVE intervention ( in 4-9 study months). Clusters assigned to this sequence remained in the Control/Baseline phase for 3 months, received the IMPROVE intervention for 6 months, and completed post-intervention follow-up assessments for 3 months. 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.
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/Baseline phase for 6 months, received the IMPROVE intervention for 6 months, and completed post-intervention follow-up assessments for 3 months. 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.
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. 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.
Control and Baseline Phase
STARTED
389 12
527 11
361 6
Control and Baseline Phase
COMPLETED
389 12
527 11
361 6
Control and Baseline Phase
NOT COMPLETED
0 0
0 0
0 0
IMPROVE Phase
STARTED
389 12
527 11
361 6
IMPROVE Phase
COMPLETED
389 12
527 11
361 6
IMPROVE Phase
NOT COMPLETED
0 0
0 0
0 0
Follow-Up Phase
STARTED
389 12
527 11
361 6
Follow-Up Phase
COMPLETED
309 12
453 11
298 6
Follow-Up Phase
NOT COMPLETED
80 0
74 0
63 0

Reasons for withdrawal

Reasons for withdrawal
Measure
Wedge 1
The earliest group to implement the IMPROVE intervention ( in 4-9 study months). Clusters assigned to this sequence remained in the Control/Baseline phase for 3 months, received the IMPROVE intervention for 6 months, and completed post-intervention follow-up assessments for 3 months. 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.
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/Baseline phase for 6 months, received the IMPROVE intervention for 6 months, and completed post-intervention follow-up assessments for 3 months. 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.
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. 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.
Follow-Up Phase
Lost to Follow-up
80
74
63

Baseline Characteristics

There is some missing data in age across wedges. Thanks.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Wedge 1
n=389 Participants
The earliest group to implement the IMPROVE intervention ( in 4-9 study months). Clusters assigned to this sequence remained in the Control/Baseline phase for 3 months, received the IMPROVE intervention for 6 months, and completed post-intervention follow-up assessments for 3 months. 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.
Wedge 2
n=527 Participants
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/Baseline phase for 6 months, received the IMPROVE intervention for 6 months, and completed post-intervention follow-up assessments for 3 months. 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.
Wedge 3
n=361 Participants
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. 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.
Total
n=1277 Participants
Total of all reporting groups
Age, Continuous
62.51 years
n=381 Participants • There is some missing data in age across wedges. Thanks.
59.63 years
n=518 Participants • There is some missing data in age across wedges. Thanks.
61.85 years
n=358 Participants • There is some missing data in age across wedges. Thanks.
61.13 years
n=1257 Participants • There is some missing data in age across wedges. Thanks.
Sex: Female, Male
Female
290 Participants
n=368 Participants • There's some info missing in the data for this variable.
363 Participants
n=516 Participants • There's some info missing in the data for this variable.
210 Participants
n=343 Participants • There's some info missing in the data for this variable.
863 Participants
n=1227 Participants • There's some info missing in the data for this variable.
Sex: Female, Male
Male
78 Participants
n=368 Participants • There's some info missing in the data for this variable.
153 Participants
n=516 Participants • There's some info missing in the data for this variable.
133 Participants
n=343 Participants • There's some info missing in the data for this variable.
364 Participants
n=1227 Participants • There's some info missing in the data for this variable.
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=389 Participants
0 Participants
n=527 Participants
0 Participants
n=361 Participants
0 Participants
n=1277 Participants
Race (NIH/OMB)
Asian
389 Participants
n=389 Participants
527 Participants
n=527 Participants
361 Participants
n=361 Participants
1277 Participants
n=1277 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=389 Participants
0 Participants
n=527 Participants
0 Participants
n=361 Participants
0 Participants
n=1277 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=389 Participants
0 Participants
n=527 Participants
0 Participants
n=361 Participants
0 Participants
n=1277 Participants
Race (NIH/OMB)
White
0 Participants
n=389 Participants
0 Participants
n=527 Participants
0 Participants
n=361 Participants
0 Participants
n=1277 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=389 Participants
0 Participants
n=527 Participants
0 Participants
n=361 Participants
0 Participants
n=1277 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=389 Participants
0 Participants
n=527 Participants
0 Participants
n=361 Participants
0 Participants
n=1277 Participants

PRIMARY outcome

Timeframe: baseline, 1-month follow up, and 3-month follow up

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Control
n=1277 Participants
Participants assessed during their cluster's waitlist control period, pooled across Wedges 1, 2, and 3.
IMPROVE
n=1193 Participants
Participants received IMPROVE intervention, pooled across Wedges 1, 2, and 3.
Lifetime Rate of COVID-19 Home Self-Testing Kit Use
Baseline (Control Period)
430 Participants
0 Participants
Lifetime Rate of COVID-19 Home Self-Testing Kit Use
1-month follow up
0 Participants
583 Participants
Lifetime Rate of COVID-19 Home Self-Testing Kit Use
3-month follow up
0 Participants
732 Participants

Adverse Events

Follow Up

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

IMPROVE

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Grace X. Ma

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

Phone: 215-707-6493

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place