Covid19NCT04802187

Implementation of COVID-19 Testing Strategies in Community Health Centers

A study testing RADx CHCs testing intervention strategy in people with Covid19, run by Massachusetts General Hospital at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Covid19
What is being tested?: RADx CHCs testing intervention strategy
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 2 sitesUnited States
Study dates: 1 Dec 2020to 15 Jul 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

None

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Massachusetts League of Community Health Centers
Boston, Massachusetts, 02108
Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

Conditions: Covid19
Being tested: RADx CHCs testing intervention strategy, Usual care control
Keywords: implementation science, community health center
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RADx CHCs testing intervention strategyOther
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 controlOther
CHCs implement testing strategies in accordance with their usual supports.

Study groups in NCT04802187
Study group	Role	What they receive
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. Receives: Other: RADx CHCs testing intervention strategy
Usual care control	Other	Not described Receives: Other: Usual care control

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 85 weeks post-implementation compared to 35 weeks pre-implementation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 202015 Jul 2022

First posted17 Mar 2021
Study start1 Dec 2020
Primary completion15 Jul 2022
Study completion15 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Covid19Studies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04802187
Sponsor's protocol ID: 2020P003743
Other IDs: 3P50CA244433-02S1
Status last verified: Nov 2023
First submitted: 12 Mar 2021
Last updated: 8 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Covid19 trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Implementation of COVID-19 Testing Strategies in Community Health Centers
ClinicalTrials.gov ID: NCT04802187
Acronym / sponsor ID: 2020P003743
Conditions: Covid19
Keywords: implementation science, community health center
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: Dana-Farber Cancer Institute, Harvard School of Public Health (HSPH), Massachusetts League of Community Health Centers, National Cancer Institute (NCI)
Study start: 1 Dec 2020 (actual)
Primary completion: 15 Jul 2022 (actual)
Study completion: 15 Jul 2022 (actual)
First posted: 17 Mar 2021 (actual)
Results: Posted 8 Nov 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
RADx CHCs testing intervention strategy	Other	Other: RADx CHCs testing intervention strategySix Massachusetts community health center partnerships implementing both a common testing expansion implementation strategy plus tailored strategies designed for community partner needs.
Usual care control	Other	Other: Usual care control

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (1 listed)

None

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RADx CHCs testing intervention strategyThe 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.	Other	RADx CHCs testing intervention strategy
Usual care controlCHCs implement testing strategies in accordance with their usual supports.	Other	Usual care control

Primary outcome

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.

Results and safety

Results posted to the registry on 8 Nov 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
RADx CHCs Testing Intervention Strategy	–	–

Primary outcome: 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. Number (95% Confidence Interval). Unit: Percent change

Measure	RADx CHCs Testing Intervention Strategy n = NA	Usual Care Control n = NA
Value	0.0965 (.04 to .153)	0.0128 (-0.003 to 0.028)

Population analysed: No participants were enrolled in the study. The units analyzed represent the aggregate number of weekly COVID tests administered at the 6 community health centers.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
RADx CHCs Testing Intervention Strategy	0 of 0	0 of 0	0
Usual Care Control	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Elsie Taveras, MD, MPH principal investigator

Massachusetts General Hospital

Karen Emmons, PhD principal investigator

Harvard School of Public Health (HSPH)

Susan Dargon-Hart, LICSW principal investigator

Massachusetts League of Community Health Centers

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing RADx CHCs testing intervention strategy in people with Covid19, run by Massachusetts General Hospital at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04802187.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.