Back to resultsImplementation of COVID-19 Testing Strategies in Community Health Centers
Primary Purpose
Covid19
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RADx CHCs testing intervention strategy
Usual care control
Sponsored by
About this trial
This is an interventional health services research trial for Covid19 focused on measuring implementation science, community health center
Eligibility Criteria
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
Sites / Locations
- Massachusetts League of Community Health Centers
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
RADx CHCs testing intervention strategy
Usual care control
Arm Description
Six Massachusetts community health center partnerships implementing both a common testing expansion implementation strategy plus tailored strategies designed for community partner needs.
Outcomes
Primary Outcome Measures
Percentage change in testing during the study compared to tests completed prior to study start
Using a controlled interrupted time series design, comparing number of tests across the participating CHCs with matched control CHCs in MA
Secondary Outcome Measures
Full Information
NCT ID
NCT04802187
First Posted
March 12, 2021
Last Updated
March 13, 2023
Sponsor
Massachusetts General Hospital
Collaborators
Dana-Farber Cancer Institute, Harvard School of Public Health (HSPH), Massachusetts League of Community Health Centers
1. Study Identification
Unique Protocol Identification Number
NCT04802187
Brief Title
Implementation of COVID-19 Testing Strategies in Community Health Centers
Official Title
Implementation of COVID-19 Testing Strategies in Community Health Centers
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
July 15, 2022 (Actual)
Study Completion Date
July 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Dana-Farber Cancer Institute, Harvard School of Public Health (HSPH), Massachusetts League of Community Health Centers
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
implementation science, community health center
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
436148 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RADx CHCs testing intervention strategy
Arm Type
Other
Arm Description
Six Massachusetts community health center partnerships implementing both a common testing expansion implementation strategy plus tailored strategies designed for community partner needs.
Arm Title
Usual care control
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
RADx CHCs testing intervention strategy
Intervention Description
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
Intervention Name(s)
Usual care control
Intervention Description
CHCs implement testing strategies in accordance with their usual supports.
Primary Outcome Measure Information:
Title
Percentage change in testing during the study compared to tests completed prior to study start
Description
Using a controlled interrupted time series design, comparing number of tests across the participating CHCs with matched control CHCs in MA
Time Frame
Months 1-9 post-implementation compared to 9 months pre-implementation
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elsie Taveras, MD, MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karen Emmons, PhD
Organizational Affiliation
Harvard School of Public Health (HSPH)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Susan Dargon-Hart, LICSW
Organizational Affiliation
Massachusetts League of Community Health Centers
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts League of Community Health Centers
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02108
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Implementation of COVID-19 Testing Strategies in Community Health Centers
We'll reach out to this number within 24 hrs