Implementation of COVID-19 Testing Strategies in Community Health Centers

November 6, 2023 updated by: Elsie Taveras, MD, Massachusetts General Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02108
        • Massachusetts League of Community Health Centers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Other: 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.
Other: Usual care control
Other: Usual care control
CHCs implement testing strategies in accordance with their usual supports.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage Change in Testing During the Study Compared to Tests Completed Prior to Study Start
Time Frame: 85 weeks post-implementation compared to 35 weeks pre-implementation
Acceleration of covid testing volume during covid surges, estimated as the percent change in weekly covid testing volume trend for each 10% increase in covid cases. A slope value was estimated from a segmented regression model for the entire study period, which was then used to calculate a difference between the post- and pre-implementation periods.
85 weeks post-implementation compared to 35 weeks pre-implementation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

National Cancer Institute (NCI)
Dana-Farber Cancer Institute
Harvard School of Public Health (HSPH)
Massachusetts League of Community Health Centers

Investigators

  • Principal Investigator: Karen Emmons, PhD, Harvard School of Public Health (HSPH)
  • Principal Investigator: Susan Dargon-Hart, LICSW, Massachusetts League of Community Health Centers
  • Principal Investigator: Elsie Taveras, MD, MPH, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

July 15, 2022

Study Completion (Actual)

July 15, 2022

Study Registration Dates

First Submitted

March 12, 2021

First Submitted That Met QC Criteria

March 12, 2021

First Posted (Actual)

March 17, 2021

Study Record Updates

Last Update Posted (Estimated)

November 8, 2023

Last Update Submitted That Met QC Criteria

November 6, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020P003743
  • 3P50CA244433-02S1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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