Implementation of COVID-19 Testing Strategies in Community Health Centers

NCT ID: NCT04802187

Last Updated: 2023-11-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2022-07-15

Brief Summary

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This project is part of a competitive revision to accelerate COVID-19 testing in underserved populations. The overall aim is to implement strategies to expand COVID testing in hotspot communities in MA, through 6 community health center (CHC)-community partnerships. A base strategy will be implemented at all sites. A tailored strategy unique to local populations will be added and tested in a stepped wedge design.

Detailed Description

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Conditions

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Covid19

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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RADx CHCs testing intervention strategy

Six Massachusetts community health center partnerships implementing both a common testing expansion implementation strategy plus tailored strategies designed for community partner needs.

Group Type OTHER

RADx CHCs testing intervention strategy

Intervention Type OTHER

The study team will support partner CHCs to implement workflows with some combination of dedicated testing staff, off-site testing, outreach/communications to priority populations, and linkage with local contact tracing systems. Implementation support will take the form of practice facilitation, rapid cycle testing (by supporting CHCs to review their internal data to assess the impact of workflow changes), and expert consultation from the research team on testing technology and testing location design.

Usual care control

Group Type OTHER

Usual care control

Intervention Type OTHER

CHCs implement testing strategies in accordance with their usual supports.

Interventions

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RADx CHCs testing intervention strategy

The study team will support partner CHCs to implement workflows with some combination of dedicated testing staff, off-site testing, outreach/communications to priority populations, and linkage with local contact tracing systems. Implementation support will take the form of practice facilitation, rapid cycle testing (by supporting CHCs to review their internal data to assess the impact of workflow changes), and expert consultation from the research team on testing technology and testing location design.

Intervention Type OTHER

Usual care control

CHCs implement testing strategies in accordance with their usual supports.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Participants are patients at the intervention or control CHCs or members of the local community. The participating sites constitute one group; a set of matched control CHCs that will conduct testing as usual constitute the second group.

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dana-Farber Cancer Institute

OTHER

Sponsor Role collaborator

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role collaborator

Massachusetts League of Community Health Centers

OTHER

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Elsie Taveras, MD

Executive Director, Kraft Center for Community Health and Division Chief, General Academic Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elsie Taveras, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Karen Emmons, PhD

Role: PRINCIPAL_INVESTIGATOR

Harvard School of Public Health (HSPH)

Susan Dargon-Hart, LICSW

Role: PRINCIPAL_INVESTIGATOR

Massachusetts League of Community Health Centers

Locations

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Massachusetts League of Community Health Centers

Boston, Massachusetts, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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3P50CA244433-02S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2020P003743

Identifier Type: -

Identifier Source: org_study_id

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