Leveraging CHWs to Improve COVID-19 Testing and Mitigation Among CJIs Accessing a Corrections-focused CBO

Brief Summary
Given the likelihood of COVID-19 remaining an endemic disease among high-risk populations, establishing effective mitigation interventions will be critical to stemming community transmission. Criminal justice-involved individuals are extremely important to reducing community-based SARS-CoV-2 transmission due to their increased risk of contracting SARS-CoV-2 while incarcerated and their likelihood of living in congregate settings after incarceration. The investigators will evaluate an onsite Point-of-Care SARS-CoV-2 testing and education strategy in a corrections-focused community-based organization and its impact on improving testing uptake, mitigation behaviors(e.g. mask wearing, hand hygiene, social distancing, vaccine uptake when available), and cost-effectiveness.
Brief Title
Leveraging CHWs to Improve COVID-19 Testing and Mitigation Among CJIs Accessing a Corrections-focused CBO
Detailed Description
The United States(U.S.) has experienced higher mortality than any other nation due to COVID-19 with nearly 13.5 million cases and over 268,103 deaths. Due to the limited ability to socially distance, poor ventilation, and limited hygiene supplies, U.S. prisons and jails have observed explosive transmission of SARS-CoV-2 accounting for the 10 largest U.S. outbreaks. Because 95% of criminal justice-involved individuals reenter societyCOVID-19 transmission extends beyond those who are currently incarcerated. As justice-involved individuals reenter the community, they face high rates of homelessness, and many others live in other congregate settings such as converted hotels and halfway houses. The increased risk of SARS-CoV-2 while incarcerated coupled with the likelihood of living in congregate settings after incarceration, create conditions ripe for rapid COVID-19 transmission that will be critical to address in order to gain control of COVID-19 in the U.S. The goal of this study is to test the impact and cost-effectiveness of an intervention to mitigate SARS-CoV-2 transmission among justice-involved individuals recently released from incarceration. The investigators will conduct a randomized trial to compare the effectiveness of an onsite Point-of-Care SARS-CoV-2 testing and education intervention with community health workers (CHWs) as a central component compared to the standard of care at a community-based organization (CBO) that provides services to justice-involved individuals in New York City. The investigators will measure costs of testing, education, and navigation, and explore the cost-effectiveness of the onsite Point-of-Care intervention compared to the standard of care. The specific aims are to:1) Test the effectiveness of an onsite PoC SARS-CoV-2 intervention in a corrections-focused CBO; 2) Model the cost-effectiveness of an onsite PoC SARS-CoV-2 intervention among CJIs compared to SoC. Because testing, education, and navigation will be provided by CHWs in a culturally-sensitive environment and test results will be received in minutes (rather than days), the investigators hypothesize that O-PoC will be associated with improved testing uptake and receipt of test results, mitigation behaviors (mask wearing, hand hygiene, social distancing), and those who attend more O-PoC sessions will have better adherence to mitigation behaviors.
Completion Date
Completion Date Type
Actual
Conditions
COVID19
Eligibility Criteria
Inclusion Criteria:

* Fortune Society clients
* Greater than or equal to 18 years old
* Fluent in English or Spanish
* Resident of NYC
* Released from a jail or a prison system within 90 days

Exclusion Criteria:

* Inability to provide informed consent
* Inability to complete study visits over 12 months
* Does not plan to reside in the NYC area for the next year
* Terminal illness
Inclusion Criteria
Inclusion Criteria:

* Fortune Society clients
* Greater than or equal to 18 years old
* Fluent in English or Spanish
* Resident of NYC
* Released from a jail or a prison system within 90 days

Gender
All
Gender Based
false
Keywords
COVID19
justice-involved individuals
Point-of-care testing
community based organization
Healthy Volunteers
No
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04878328
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2021-12976
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Leveraging Community Health Workers to Improve COVID-19 Testing and Mitigation Among Criminal Justice-involved Individuals Accessing a Corrections-focused Community-based Organization
Primary Outcomes
Outcome Description
Testing uptake will be defined as the number and percentage of participants who had tests performed and will be determined using program logs and healthcare record extraction. To measure testing uptake, a dichotomous outcome of having at least one complete SARS-CoV-2 test over the 12-month study period, defined as having a test performed with results received by participants within two weeks of the test being conducted, was used.
Outcome Measure
Testing Uptake
Outcome Time Frame
Up to 12 months
Outcome Description
The number/percentage of participants who completed at least one SARS-CoV-2 test for the whole 12-month study period (up to 5 tests available) is summarized by study arm.
Outcome Measure
Number of Participants Who Completed SARS-CoV-2 Tests
Outcome Time Frame
Up to 12 months
Secondary Ids
Secondary Id
5R01MD016744
Secondary Outcomes
Outcome Description
Masking adherence behavior was measured using a composite weighted variable estimating how frequently participants engaged in activities with potential COVID-19 exposure and how often they wore a mask during those activities in the previous two weeks. Initial response options were 1=Always, 2=Most of the time, 3=Sometimes, 4=Rarely or 5=Never. Responses were combined and standardized to a scale of 1 to 100 with higher scores indicating greater masking adherence. Results are summarized by study arm using descriptive statistics.
Outcome Time Frame
12 months post-enrollment
Outcome Measure
Masking Adherence
Outcome Description
Social distancing measured the participants' social distancing behavior by their responses to the following question: "Overall, on a scale of 1-100, how often did you stay greater than 6 feet away from others when you were not masked in the past 2 weeks? Higher scores were indicative of more frequent social distancing. Results are summarized by study arm using descriptive statistics.
Outcome Time Frame
12 months post-enrollment
Outcome Measure
Social Distancing Behavior
Outcome Description
Participants' hand washing behavior was measured by the following question: Overall, on a scale of 1-100, how often did you wash hands after shaking hands with or touching surfaces that were touched by someone else in the past two weeks? Higher scores were indicative of more frequent hand washing behavior. Results are summarized by study arm using descriptive statistics.
Outcome Time Frame
12 months post-enrollment
Outcome Measure
Hand Washing Adherence
Outcome Description
The number/percentage of participants who reported mitigation behaviors in at least one biweekly smartphone survey is summarized by study arm.
Outcome Time Frame
12 months post-enrollment
Outcome Measure
Mitigation Measures
Start Date
Start Date Type
Actual
Status Verified Date
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Matthew Akiyama
Investigator Email
makiyama@montefiore.org
Investigator Department
Medicine
Investigator Division
General Internal Medicine
Investigator Sponsor Organization
Einstein
Study Department
Medicine
Categories Mesh Debug
COVID-19 --- COVID-19
COVID-19 --- PNEUMONIA, VIRAL
COVID-19 --- PNEUMONIA
Lung --- PNEUMONIA
COVID-19 --- RESPIRATORY TRACT INFECTIONS
Lung --- RESPIRATORY TRACT INFECTIONS
COVID-19 --- INFECTIONS
Infectious Disease --- INFECTIONS
COVID-19 --- VIRUS DISEASES
Hepatitis --- VIRUS DISEASES
Infectious Disease --- VIRUS DISEASES
COVID-19 --- CORONAVIRUS INFECTIONS
COVID-19 --- CORONAVIRIDAE INFECTIONS
COVID-19 --- NIDOVIRALES INFECTIONS
COVID-19 --- RNA VIRUS INFECTIONS
Infectious Disease --- RNA VIRUS INFECTIONS
COVID-19 --- LUNG DISEASES
Lung --- LUNG DISEASES
Asthma and Other Respiratory Diseases --- RESPIRATORY TRACT DISEASES
COVID-19 --- RESPIRATORY TRACT DISEASES
Lung --- RESPIRATORY TRACT DISEASES
MeSH Terms
COVID-19
PNEUMONIA, VIRAL
PNEUMONIA
RESPIRATORY TRACT INFECTIONS
INFECTIONS
VIRUS DISEASES
CORONAVIRUS INFECTIONS
CORONAVIRIDAE INFECTIONS
NIDOVIRALES INFECTIONS
RNA VIRUS INFECTIONS
LUNG DISEASES
RESPIRATORY TRACT DISEASES