NCT06576167

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,271

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started Jun 2023

Typical duration for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 27, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 28, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2024

Completed
Last Updated

June 10, 2025

Status Verified

June 1, 2025

Enrollment Period

1.5 years

First QC Date

August 27, 2024

Last Update Submit

June 5, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • the change in the rate of COVID-19 self-testing

    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).

Behavioral: IMPROVE

Wedge 2

EXPERIMENTAL

Following the wedge 1 group, the wedge 2 group started the intervention in the study months 7-12.

Behavioral: IMPROVE

Wedge 3

EXPERIMENTAL

The wedge 3 group started the intervention in the study months 10-15.

Behavioral: IMPROVE

Interventions

IMPROVEBEHAVIORAL

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 1Wedge 2Wedge 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SEQUENTIAL
Model Details: stepped wedge clustered-randomized trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2024

First Posted

August 28, 2024

Study Start

June 15, 2023

Primary Completion

December 2, 2024

Study Completion

December 2, 2024

Last Updated

June 10, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations