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| ID | Type | Description | Link |
|---|---|---|---|
| 3UL1TR003017-02S2 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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This mixed methods study evaluates the effectiveness and cost of a healthcare worker focused outreach intervention strategy versus community organization led outreach to explore contextual factors (individual, family, and community) affecting COVID-19 testing implementation outcomes and scalability.
In Aim 2, the investigators conduct a mixed methods study to evaluate the effectiveness and cost of: (1) the healthcare worker focused outreach intervention strategy versus (2) community organization led outreach working with community based organizations. The investigators explore contextual factors (individual, family, and community) affecting COVID-19 testing implementation outcomes and scalability. The primary outcome is uptake of COVID-19 testing using the novel Rutgers Clinical Genomics Laboratory/RUCDR saliva test, the first FDA authorized diagnostic test using saliva to detect SARS-CoV-2 for non-invasive, home based self-testing. To compare participation rates in the two arms, our primary outcome, the investigators will use data on the number of tests performed per month up to a 12 month study period. For each intervention, the start time is the date of first attempted contact with potential participants and the end date is either the end of the study period, or the date at which the 1000th individual was tested (whichever comes first).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthcare Worker Focused Outreach Intervention Strategy | Active Comparator | Healthcare Worker Focused Outreach Intervention Strategy |
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| Community Organization Led Outreach | Active Comparator | Community Organization Led Outreach |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healthcare Worker Focused Outreach | Behavioral | This a focused outreach intervention strategy specifically designed for healthcare workers. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Complete COVID-19 Testing | Number of participants who return their saliva testing kit. | 1 year |
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Inclusion Criteria for Community Members and Healthcare Workers
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers University | New Brunswick | New Jersey | 08901 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34264327 | Background | Jimenez ME, Rivera-Nunez Z, Crabtree BF, Hill D, Pellerano MB, Devance D, Macenat M, Lima D, Martinez Alcaraz E, Ferrante JM, Barrett ES, Blaser MJ, Panettieri RA Jr, Hudson SV. Black and Latinx Community Perspectives on COVID-19 Mitigation Behaviors, Testing, and Vaccines. JAMA Netw Open. 2021 Jul 1;4(7):e2117074. doi: 10.1001/jamanetworkopen.2021.17074. | |
| 36265092 | Background | Barrett ES, Andrews TR, Roy J, Greenberg P, Ferrante JM, Horton DB, Gordon M, Rivera-Nunez Z, Pellerano MB, Tallia AF, Budolfson M, Georgopoulos P, Reed D, Lynn B, Rosati R, Castaneda M, Dixon F, Pernell C, Hill D, Jimenez ME, Blaser MJ, Panettieri R Jr, Hudson SV. Community- Versus Health Care Organization-Based Approaches to Expanding At-Home COVID-19 Testing in Black and Latino Communities, New Jersey, 2021. Am J Public Health. 2022 Nov;112(S9):S918-S922. doi: 10.2105/AJPH.2022.306989. Epub 2022 Oct 20. |
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Some participants (n=917) chose not to participate in the questionnaire data collection and as a result were not assigned to a study arm after consent.
From May through December 2021, 2017 eligible New Jersey residents registered for and consented to be part of an on-line study with a single questionnaire (including items on sociodemographic characteristics as well as COVID-19-related perceptions, behaviors, and challenges), after which they were able to order a free at-home saliva COVID-19 polymerase chain reaction test.
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthcare Worker Focused Outreach Intervention Strategy | Healthcare Worker Focused Outreach Intervention Strategy Healthcare Worker Focused Outreach: This a focused outreach intervention strategy specifically designed for healthcare workers. |
| FG001 | Community Organization Led Outreach |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 21, 2021 |
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| Community Organization Led Outreach | Behavioral | This is a standard community engaged outreach approach that has traditionally been used in previous research. Analogous to the standard of care for outreach. |
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| 35041702 | Background | Rivera-Nunez Z, Jimenez ME, Crabtree BF, Hill D, Pellerano MB, Devance D, Macenat M, Lima D, Gordon M, Sullivan B, Rosati RJ, Ferrante JM, Barrett ES, Blaser MJ, Panettieri RA Jr, Hudson SV. Experiences of Black and Latinx health care workers in support roles during the COVID-19 pandemic: A qualitative study. PLoS One. 2022 Jan 18;17(1):e0262606. doi: 10.1371/journal.pone.0262606. eCollection 2022. |
| 36108254 | Derived | Juarez R, Phankitnirundorn K, Ramirez A, Peres R, Maunakea AK, Okihiro M. Vaccine-Associated Shifts in SARS-CoV-2 Infectivity Among the Native Hawaiian and Other Pacific Islander Population in Hawaii. Am J Public Health. 2022 Nov;112(S9):S896-S899. doi: 10.2105/AJPH.2022.306973. Epub 2022 Sep 15. |
Community Organization Led Outreach Community Organization Led Outreach: This is a standard community engaged outreach approach that has traditionally been used in previous research. Analogous to the standard of care for outreach. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthcare Worker Focused Outreach Intervention Strategy | Healthcare Worker Focused Outreach Intervention Strategy Healthcare Worker Focused Outreach: This a focused outreach intervention strategy specifically designed for healthcare workers. |
| BG001 | Community Organization Led Outreach | Community Organization Led Outreach Community Organization Led Outreach: This is a standard community engaged outreach approach that has traditionally been used in previous research. Analogous to the standard of care for outreach. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Participants Who Complete COVID-19 Testing | Number of participants who return their saliva testing kit. | Posted | Count of Participants | Participants | 1 year |
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1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthcare Worker Focused Outreach Intervention Strategy | Healthcare Worker Focused Outreach Intervention Strategy Healthcare Worker Focused Outreach: This a focused outreach intervention strategy specifically designed for healthcare workers. | 0 | 23 | 0 | 23 | 0 | 23 |
| EG001 | Community Organization Led Outreach | Community Organization Led Outreach Community Organization Led Outreach: This is a standard community engaged outreach approach that has traditionally been used in previous research. Analogous to the standard of care for outreach. | 0 | 211 | 0 | 211 | 0 | 211 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shawna V. Hudson | Rutgers University | 848-932-0215 | hudsonsh@rutgers.edu |
| Feb 10, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D010342 | Patient Acceptance of Health Care |
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000074822 | Treatment Adherence and Compliance |
| D001519 | Behavior |
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| Male |
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| Latino, non-Black |
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| Black and Latino |
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