NCT04802187

Implementation of COVID-19 Testing Strategies in Community Health Centers

Completed NA Results posted Last updated 8 November 2023

What this trial tests

NA trial testing RADx CHCs testing intervention strategy in Covid19 in 6 participants. Completed in 15 July 2022.

Timeline

1 December 2020

Primary endpoint
15 July 2022

15 July 2022

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	6
Start date	1 December 2020
Primary completion	15 July 2022
Estimated completion	15 July 2022
Sites	2 locations across United States

Drugs / interventions tested

• RADx CHCs testing intervention strategy
• Usual care control

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

Massachusetts General Hospital

Who can join

Eligibility, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage Change in Testing During the Study Compared to Tests Completed Prior to Study Start Primary · 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.

Group	Value	95% CI
RADx CHCs Testing Intervention Strategy	0.0965	.04 – .153
Usual Care Control	0.0128	-0.003 – 0.028

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Implementing expanded COVID-19 testing in Massachusetts community health centers through community partnerships: Protocol for an interrupted time series and stepped wedge study design.
   Kruse GR, Pelton-Cairns L, Taveras EM, Dargon-Hart S, et al · · 2022 · cited 9× · PMID 35533978 · DOI 10.1016/j.cct.2022.106783