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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04878328
Enrollment
250
Registered
2021-05-07
Start date
2022-04-14
Completion date
2025-05-22
Last updated
2026-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Keywords

COVID19, justice-involved individuals, Point-of-care testing, community based organization

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.

Interventions

BEHAVIORALOnsite 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.

Sponsors

Montefiore Medical Center
Lead SponsorOTHER
The Fortune Society
CollaboratorUNKNOWN
University of Bristol
CollaboratorOTHER
National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH
Cepheid
CollaboratorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Testing UptakeUp to 12 monthsTesting 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.
Number of Participants Who Completed SARS-CoV-2 TestsUp to 12 monthsThe 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.

Secondary

MeasureTime frameDescription
Masking Adherence12 months post-enrollmentMasking 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.
Social Distancing Behavior12 months post-enrollmentSocial 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.
Hand Washing Adherence12 months post-enrollmentParticipants' 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.
Mitigation Measures12 months post-enrollmentThe number/percentage of participants who reported mitigation behaviors in at least one biweekly smartphone survey is summarized by study arm.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMatthew Akiyama, MD MSc

Albert Einstein College of Medicine Montefiore Medical Center

Participant flow

Pre-assignment details

572 participants were screened and 250 were randomized into the study. Of the 322 participants who were not enrolled into the study, 247 participants did not meet all of the eligibility criteria, 75 did not show up for the enrollment visit.

Baseline characteristics

Characteristic
Age, Continuous42.8 years
STANDARD_DEVIATION 12.2
Race/Ethnicity, Customized
Hispanic
43 Participants
Race/Ethnicity, Customized
Non-Hispanic Black
51 Participants
Race/Ethnicity, Customized
Non-Hispanic White
20 Participants
Race/Ethnicity, Customized
Other
11 Participants
Sex/Gender, Customized
Cisgender men
216 Participants
Sex/Gender, Customized
Cisgender women
13 Participants
Sex/Gender, Customized
Non-binary/None of these describe me
0 Participants
Sex/Gender, Customized
Transgender women
0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
1 / 1250 / 125
other
Total, other adverse events
16 / 12515 / 125
serious
Total, serious adverse events
0 / 1250 / 125

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 1, 2026