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

Primary Purpose

Covid19

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Onsite Point-of-care
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Covid19 focused on measuring COVID19, justice-involved individuals, Point-of-care testing, community based organization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1) Fortune clients
  • >18 years old
  • fluent in English or Spanish
  • residents of NYC
  • released from jail or prison 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

Sites / Locations

  • Montefiore Medical CenterRecruiting
  • Fortune SocietyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

onsite Point-of-care (o-POC)

Standard of Care (SOC)

Arm Description

CHWs will reach out to participants to schedule O-PoC visits. At O-PoC visits, CHWs will provide: 1. COVID-19 education; 2. PoC Cepheid XpertXpressSARS-CoV-2PCR tests; 3. Needs assessments and facilitated access to masks and hygiene supplies; 4. Navigation to vaccination sites (when available) and single-room housing at Fortune's supportive housing sites and partnering shelters or alternative strategies that will maximize the ability to socially distance for those who test PCR positive; 5. Supportive counseling. Due to SCT's emphasis on social influence, external and internal social reinforcement, we propose our O-PoC intervention delivered by CHWs onsite at Fortune locations over a 12-month period will lead to increased uptake of mitigation behaviors.

The current standard of care (SoC) for SARS-CoV-2 testing for Fortune clients is referral to offsite community testing sites and informal, unstructured education. In the SoC arm, Fortune staff will provide clients with a list of offsite SARS-CoV-2 testing locations, which are published online and available to all NYC residents. Those without insurance are not subject to a copay. Participants in SoC will continue to receive Fortune's suite of services as they are delivered (remote and/or in-person) at the time of study participation.

Outcomes

Primary Outcome Measures

Testing uptake
Testing uptake will be defined as the number and proportion of tests performed and will be determined using Program logs and healthcare record extraction. For all participants, the proportion of tests will be calculated from the total possible denominator of 5 tests (at times 0, 3, 6, 9, and 12 months). Receipt of test results will be defined as the number and proportion of test received and will be determined by self-report

Secondary Outcome Measures

Mitigation measures
For mitigation measures, participants will be asked: Which of the following have you done in the last 14 days to keep yourself safe from coronavirus? Worn a mask or other face covering; Washed your hands with soap or used hand sanitizer; Avoided contact with people who could be high-risk; Avoided public spaces, gatherings, or crowds.For answers to which the answer is yes: The investigators will ask questions about mitigation measures on a sliding Likert scale regarding the last 14 days that will be programmed into Ethica software. Likert scales will include a legend with both numbers (1 day-14 days). The investigators will assign a score with higher adherence to mitigation measures as higher scores (from 1 to 14) and create a composite score averaging 2-week questionnaire conducted over the course of the 3 months following PoC intervention visits for each mitigation measure.

Full Information

First Posted
April 30, 2021
Last Updated
January 7, 2023
Sponsor
Montefiore Medical Center
Collaborators
The Fortune Society, University of Bristol
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1. Study Identification

Unique Protocol Identification Number
NCT04878328
Brief Title
Leveraging CHWs to Improve COVID-19 Testing and Mitigation Among CJIs Accessing a Corrections-focused CBO
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
July 1, 2026 (Anticipated)
Study Completion Date
July 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center
Collaborators
The Fortune Society, University of Bristol

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
COVID19, justice-involved individuals, Point-of-care testing, community based organization

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The investigators will conduct a randomized trial to assess the effectiveness of an onsite Point-of-Care testing and education intervention (O-PoC) compared to standard of care (SoC) at The Fortune Society (Fortune). The current SoC includes a referral to offsite community testing. Guided by Social Cognitive Theory, in O-PoC we will employ CHWs with lived experience of incarceration to provide: 1) COVID-19 education; 2) SARS-CoV-2 testing with Cepheid XpertXpress PCR tests at Fortune facilities; 3) Needs assessments and facilitated access to masks and hygiene supplies; 4) Navigation to vaccination sites (when available) and single-room housing at Fortune's supportive housing sites and partnering shelters, or alternative strategies that will maximize the ability to socially distance for those who test PCR positive; 5) Supportive counseling.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
onsite Point-of-care (o-POC)
Arm Type
Experimental
Arm Description
CHWs will reach out to participants to schedule O-PoC visits. At O-PoC visits, CHWs will provide: 1. COVID-19 education; 2. PoC Cepheid XpertXpressSARS-CoV-2PCR tests; 3. Needs assessments and facilitated access to masks and hygiene supplies; 4. Navigation to vaccination sites (when available) and single-room housing at Fortune's supportive housing sites and partnering shelters or alternative strategies that will maximize the ability to socially distance for those who test PCR positive; 5. Supportive counseling. Due to SCT's emphasis on social influence, external and internal social reinforcement, we propose our O-PoC intervention delivered by CHWs onsite at Fortune locations over a 12-month period will lead to increased uptake of mitigation behaviors.
Arm Title
Standard of Care (SOC)
Arm Type
No Intervention
Arm Description
The current standard of care (SoC) for SARS-CoV-2 testing for Fortune clients is referral to offsite community testing sites and informal, unstructured education. In the SoC arm, Fortune staff will provide clients with a list of offsite SARS-CoV-2 testing locations, which are published online and available to all NYC residents. Those without insurance are not subject to a copay. Participants in SoC will continue to receive Fortune's suite of services as they are delivered (remote and/or in-person) at the time of study participation.
Intervention Type
Behavioral
Intervention Name(s)
Onsite Point-of-care
Intervention Description
Guided by Social Cognitive Theory, O-PoC will employ CHWs with lived experience of incarceration to provide: 1) COVID-19 education; 2) SARS-CoV-2 testing with Cepheid XpertXpress PCR tests at Fortune facilities; 3) Needs assessments and facilitated access to masks and hygiene supplies; 4) Navigation to vaccination sites (when available) and single-room housing at Fortune's supportive housing sites and partnering shelters, or alternative strategies that will maximize the ability to socially distance for those who test PCR positive; 5) Supportive counseling.
Primary Outcome Measure Information:
Title
Testing uptake
Description
Testing uptake will be defined as the number and proportion of tests performed and will be determined using Program logs and healthcare record extraction. For all participants, the proportion of tests will be calculated from the total possible denominator of 5 tests (at times 0, 3, 6, 9, and 12 months). Receipt of test results will be defined as the number and proportion of test received and will be determined by self-report
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Mitigation measures
Description
For mitigation measures, participants will be asked: Which of the following have you done in the last 14 days to keep yourself safe from coronavirus? Worn a mask or other face covering; Washed your hands with soap or used hand sanitizer; Avoided contact with people who could be high-risk; Avoided public spaces, gatherings, or crowds.For answers to which the answer is yes: The investigators will ask questions about mitigation measures on a sliding Likert scale regarding the last 14 days that will be programmed into Ethica software. Likert scales will include a legend with both numbers (1 day-14 days). The investigators will assign a score with higher adherence to mitigation measures as higher scores (from 1 to 14) and create a composite score averaging 2-week questionnaire conducted over the course of the 3 months following PoC intervention visits for each mitigation measure.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1) Fortune clients >18 years old fluent in English or Spanish residents of NYC released from jail or prison 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Akiyama, MD MSc
Phone
718-920-7175
Email
makiyama@montefiore.org
First Name & Middle Initial & Last Name or Official Title & Degree
Lindsey Riback, MPH
Phone
201-372-4089
Email
lindsey.riback@einsteinmed.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Akiyama, MD MSc
Organizational Affiliation
Albert Einstein College of Medicine Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Akiyama, MD
Phone
718-920-7175
Email
makiyama@montefiore.org
First Name & Middle Initial & Last Name & Degree
Lindsey R Riback, MPH
Phone
201-372-4089
Email
lindsey.riback@einsteinmed.org
First Name & Middle Initial & Last Name & Degree
Matthew Akiyama, MD
Facility Name
Fortune Society
City
Long Island City
State/Province
New York
ZIP/Postal Code
11101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronald Day
Phone
347-510-3675
Email
rday@fortunesociety.org
First Name & Middle Initial & Last Name & Degree
Matthew Akiyama, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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