Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 3P50CA244433-02S1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Dana-Farber Cancer Institute | OTHER |
| Harvard School of Public Health (HSPH) | OTHER |
| Massachusetts League of Community Health Centers | OTHER |
| National Cancer Institute (NCI) |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Usual care control | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts League of Community Health Centers | Boston | Massachusetts | 02108 | United States | ||
| Massachusetts General Hospital |
No participants were enrolled. 6 community health centers (CHC) contributed to control and intervention groups. These 6 CHCs were on the same time sequence in the interrupted time series and are listed as one group. To include an intervention and a control group separately would inaccurately sum the total participants to 12 CHCs. 6 CHCs contributed to both analytic groups (intervention and control). The study is therefore most accurately represented by including all CHCs in the same group.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | RADx CHCs Testing Intervention Strategy | Six Massachusetts community health center partnerships implementing both a common testing expansion implementation strategy plus tailored strategies designed for community partner needs. 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. All six community health centers had the same interruption point in the interrupted time series contributing 35 pre implementation usual care weeks, 85 post implementation intervention weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants were not enrolled into the study.
| ID | Title | Description |
|---|---|---|
| BG000 | RADx CHCs Testing Intervention Strategy | Six Massachusetts community health center partnerships implementing both a common testing expansion implementation strategy plus tailored strategies designed for community partner needs. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | 95% Confidence Interval | Percent change | 85 weeks post-implementation compared to 35 weeks pre-implementation | COVID tests | COVID tests |
|
Not provided
Patients were not recruited for the intervention. Enrolled study participants were community health centers. Therefore adverse event reporting did not apply.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RADx CHCs Testing Intervention Strategy | Six Massachusetts community health center partnerships implementing both a common testing expansion implementation strategy plus tailored strategies designed for community partner needs. 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Madeline Davies | Massachusetts General Hospital | 617-726-6653 | medavies@mgh.harvard.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 14, 2023 | Jul 14, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 29, 2023 | Sep 29, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Usual care control | Other | CHCs implement testing strategies in accordance with their usual supports. |
|
| Boston |
| Massachusetts |
| 02114 |
| United States |
| BG001 | Usual Care Control | Usual care control: CHCs implement testing strategies in accordance with their usual supports. |
| BG002 | Total | Total of all reporting groups |
| Number of tests |
|
| years |
| Number of tests |
|
| Sex/Gender, Customized | Count of Units | Number of tests | Number of tests |
|
| Ethnicity (NIH/OMB) | Count of Units | Number of tests | Number of tests |
|
| Race (NIH/OMB) | Count of Units | Number of tests | Number of tests |
|
| OG001 | Usual Care Control | Usual care control: CHCs implement testing strategies in accordance with their usual supports for 35 pre implementation weeks. |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Usual Care Control | Usual care control: CHCs implement testing strategies in accordance with their usual supports. | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |