Implementation of COVID-19 Testing Strategies in Community Health Centers

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04802187
Collaborator
Dana-Farber Cancer Institute (Other), Harvard School of Public Health (HSPH) (Other), Massachusetts League of Community Health Centers (Other)
76,300
2
2
21
38150
1820

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: RADx CHCs testing intervention strategy
  • Other: Usual care control
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
76300 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Implementation of COVID-19 Testing Strategies in Community Health Centers
Actual Study Start Date :
Dec 1, 2020
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Aug 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Percentage change in testing during the study compared to tests completed prior to study start [Months 1-9 post-implementation compared to 9 months pre-implementation]

    Using a controlled interrupted time series design, comparing number of tests across the participating CHCs with matched control CHCs in MA

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Massachusetts League of Community Health Centers Boston Massachusetts United States 02108
2 Massachusetts General Hospital Boston Massachusetts United States 02114

Sponsors and Collaborators

  • Massachusetts General Hospital
  • Dana-Farber Cancer Institute
  • Harvard School of Public Health (HSPH)
  • Massachusetts League of Community Health Centers

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Elsie Taveras, MD, Executive Director, Kraft Center for Community Health and Division Chief, General Academic Pediatrics, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT04802187
Other Study ID Numbers:
  • 2020P003743
First Posted:
Mar 17, 2021
Last Update Posted:
Sep 17, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Elsie Taveras, MD, Executive Director, Kraft Center for Community Health and Division Chief, General Academic Pediatrics, Massachusetts General Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 17, 2021