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

May 29, 2026 updated by: Montefiore Medical Center

Leveraging Community Health Workers to Improve COVID-19 Testing and Mitigation Among Criminal Justice-involved Individuals Accessing a Corrections-focused Community-based Organization

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Long Island City, New York, United States, 11101
        • Fortune Society
      • The Bronx, New York, United States, 10467
        • Montefiore Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: onsite Point-of-care (o-POC)
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.
Behavioral: Onsite Point-of-care
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.
No Intervention: Standard of Care (SOC)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Testing Uptake
Time Frame: Up to 12 months
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.
Up to 12 months
Number of Participants Who Completed SARS-CoV-2 Tests
Time Frame: Up to 12 months
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.
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Masking Adherence
Time Frame: 12 months post-enrollment
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.
12 months post-enrollment
Social Distancing Behavior
Time Frame: 12 months post-enrollment
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.
12 months post-enrollment
Hand Washing Adherence
Time Frame: 12 months post-enrollment
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.
12 months post-enrollment
Mitigation Measures
Time Frame: 12 months post-enrollment
The number/percentage of participants who reported mitigation behaviors in at least one biweekly smartphone survey is summarized by study arm.
12 months post-enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)
University of Bristol
Cepheid
The Fortune Society

Investigators

  • Principal Investigator: Matthew Akiyama, MD MSc, Albert Einstein College of Medicine Montefiore Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2022

Primary Completion (Actual)

May 22, 2025

Study Completion (Actual)

May 22, 2025

Study Registration Dates

First Submitted

April 30, 2021

First Submitted That Met QC Criteria

May 4, 2021

First Posted (Actual)

May 7, 2021

Study Record Updates

Last Update Posted (Actual)

June 25, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-12976
  • 5R01MD016744 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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