Implementation of COVID-19 Testing Strategies in Community Health Centers

Covid19 Clinical Trial

Official title:

Implementation of COVID-19 Testing Strategies in Community Health Centers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04802187
• Other study ID #: 2020P003743
• Secondary ID: 3P50CA244433-02S
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: July 15, 2022

Study information

• Verified date: November 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: July 15, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

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.
• Usual care control
CHCs implement testing strategies in accordance with their usual supports.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Massachusetts League of Community Health Centers	Boston	Massachusetts

Sponsors (5)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Dana-Farber Cancer Institute, Harvard School of Public Health (HSPH), Massachusetts League of Community Health Centers, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage Change in Testing During the Study Compared to Tests Completed Prior to Study Start	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