Covid19, Health Behavior, Health Care Seeking Behavior
Conditions
Brief summary
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.
Detailed description
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).
Interventions
BEHAVIORALHealthcare Worker Focused Outreach
This a focused outreach intervention strategy specifically designed for healthcare workers.
BEHAVIORALCommunity 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.
Sponsors
National Center for Advancing Translational Sciences (NCATS)
Rutgers, The State University of New Jersey
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
for Community Members and Healthcare Workers * Self-identification as Black or Hispanic/Latino. * Resident of Union, Passaic, Middlesex, or Essex County, NJ. * Parent/legal guardian able to provide permission to participate for those under 18
Exclusion criteria
* Under 4 years of age. * Unable to speak, understand, and/or read English or Spanish. * Unable to provide informed consent/assent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Complete COVID-19 Testing | 1 year | Number of participants who return their saliva testing kit. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 23 |
| 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. | 211 |
| Total | 234 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 40 | 826 |
Baseline characteristics
| Characteristic | Healthcare Worker Focused Outreach Intervention Strategy | Community Organization Led Outreach | Total |
|---|---|---|---|
| Age, Continuous | 37 years | 44 years | 40.5 years |
| Race/Ethnicity, Customized Black and Latino | 3 Participants | 13 Participants | 16 Participants |
| Race/Ethnicity, Customized Black, non-Latino | 9 Participants | 133 Participants | 142 Participants |
| Race/Ethnicity, Customized Latino, non-Black | 11 Participants | 65 Participants | 76 Participants |
| Sex: Female, Male Female | 16 Participants | 157 Participants | 173 Participants |
| Sex: Female, Male Male | 7 Participants | 54 Participants | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 211 |
| other Total, other adverse events | 0 / 23 | 0 / 211 |
| serious Total, serious adverse events | 0 / 23 | 0 / 211 |
Outcome results
Primary
Number of Participants Who Complete COVID-19 Testing
Number of participants who return their saliva testing kit.
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Healthcare Worker Focused Outreach Intervention Strategy | Number of Participants Who Complete COVID-19 Testing | 23 Participants |
| Community Organization Led Outreach | Number of Participants Who Complete COVID-19 Testing | 211 Participants |
p-value: <0.0595% CI: [0.17, 1.23]Regression, Logistic