Implementation of COVID-19 Testing Strategies in Community Health Centers

NCT04802187 | Completed Results

• 2 other identifiers: 2020P0037433P50CA244433-02S1
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

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.

Conditions

Covid19

Keywords

implementation science; community health center

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

RADx CHCs testing intervention strategy

OTHER

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

Usual care control

OTHER

Other: Usual care control

Interventions

RADx CHCs testing intervention strategy OTHER

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.

RADx CHCs testing intervention strategy

Usual care control OTHER

CHCs implement testing strategies in accordance with their usual supports.

Usual care control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

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

Study Sites (2)

Massachusetts League of Community Health Centers

Boston, Massachusetts, 02108, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Madeline Davies
• Organization: Massachusetts General Hospital

medavies@mgh.harvard.edu

617-726-6653

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director, Kraft Center for Community Health and Division Chief, General Academic Pediatrics

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 17, 2021
• Study Start: December 1, 2020
• Primary Completion: July 15, 2022
• Study Completion: July 15, 2022
• Last Updated: November 8, 2023
• Results First Posted: November 8, 2023

Record last verified: 2023-11

Locations

US (2)