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Clinical Trials/NCT04802187
NCT04802187CompletedNot Applicable

Implementation of COVID-19 Testing Strategies in Community Health Centers

Massachusetts General Hospital4 sites in 1 country6 target enrollmentStarted: December 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
6
Locations
4
Primary Endpoint
Percentage Change in Testing During the Study Compared to Tests Completed Prior to Study Start

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Sex
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

  • Not provided

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Elsie Taveras, MD

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

Massachusetts General Hospital

Study Sites (4)

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