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Covid19NCT04878328

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

A study testing Onsite Point-of-care in people with Covid19, run by Montefiore Medical Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid19
What is being tested?
Onsite Point-of-care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
2 sitesUnited States
Study dates
14 Apr 2022to 22 May 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Fortune Society

    Long Island City, New York, 11101

  • Montefiore Medical Center

    The Bronx, New York, 10467

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Covid19
Being tested
Onsite Point-of-care
Keywords
COVID19, justice-involved individuals, Point-of-care testing, community based organization
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Onsite Point-of-careBehavioural

    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.

Study groups in NCT04878328
Study groupRoleWhat they receive
onsite Point-of-care (o-POC)ExperimentalCHWs 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.
Receives: Behavioral: Onsite Point-of-care
Standard of Care (SOC)No interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Testing Uptake

    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.

    Measured: Up to 12 months

  2. Number of Participants Who Completed SARS-CoV-2 Tests

    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.

    Measured: Up to 12 months

Secondary outcomes (4)

  1. Masking Adherence

    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.

    Measured: 12 months post-enrollment

  2. Social Distancing Behavior

    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.

    Measured: 12 months post-enrollment

  3. Hand Washing Adherence

    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.

    Measured: 12 months post-enrollment

  4. Mitigation Measures

    The number/percentage of participants who reported mitigation behaviors in at least one biweekly smartphone survey is summarized by study arm.

    Measured: 12 months post-enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2021
  2. Study start14 Apr 2022
  3. Primary completion22 May 2025
  4. Study completion22 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04878328
Sponsor's protocol ID
2021-12976
Other IDs
5R01MD016744
Status last verified
May 2026
First submitted
30 Apr 2021
Last updated
25 Jun 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Akiyama MJ, Spaulding AC, Rich JD. Flattening the Curve for Incarcerated Populations - Covid-19 in Jails and Prisons. N Engl J Med. 2020 May 28;382(22):2075-2077. doi: 10.1056/NEJMp2005687. Epub 2020 Apr 2. No abstract available.

    PubMed 32240582

  • Kinner SA, Young JT, Snow K, Southalan L, Lopez-Acuna D, Ferreira-Borges C, O'Moore E. Prisons and custodial settings are part of a comprehensive response to COVID-19. Lancet Public Health. 2020 Apr;5(4):e188-e189. doi: 10.1016/S2468-2667(20)30058-X. Epub 2020 Mar 17. No abstract available.

    PubMed 32197116

  • Lim YW, Andersen R, Leake B, Cunningham W, Gelberg L. How accessible is medical care for homeless women? Med Care. 2002 Jun;40(6):510-20. doi: 10.1097/00005650-200206000-00008.

    PubMed 12021677

  • Reinhart E, Chen DL. Incarceration And Its Disseminations: COVID-19 Pandemic Lessons From Chicago's Cook County Jail. Health Aff (Millwood). 2020 Aug;39(8):1412-1418. doi: 10.1377/hlthaff.2020.00652. Epub 2020 Jun 4.

    PubMed 32496864

  • USICH. Connecting People Returning from Incarceration with Housing and Homelessness Assistance. United States Interagency Council on Homelessness;2016.

  • Levanon Seligson A, Parvez FM, Lim S, Singh T, Mavinkurve M, Harris TG, Kerker BD. Public Health and Vulnerable Populations: Morbidity and Mortality Among People Ever Incarcerated in New York City Jails, 2001 to 2005. J Correct Health Care. 2017 Oct;23(4):421-436. doi: 10.1177/1078345817727527. Epub 2017 Oct 5.

    PubMed 28982284

  • Lim S, Seligson AL, Parvez FM, Luther CW, Mavinkurve MP, Binswanger IA, Kerker BD. Risks of drug-related death, suicide, and homicide during the immediate post-release period among people released from New York City jails, 2001-2005. Am J Epidemiol. 2012 Mar 15;175(6):519-26. doi: 10.1093/aje/kwr327. Epub 2012 Feb 13.

    PubMed 22331462

  • Gu T, Mack JA, Salvatore M, Prabhu Sankar S, Valley TS, Singh K, Nallamothu BK, Kheterpal S, Lisabeth L, Fritsche LG, Mukherjee B. Characteristics Associated With Racial/Ethnic Disparities in COVID-19 Outcomes in an Academic Health Care System. JAMA Netw Open. 2020 Oct 1;3(10):e2025197. doi: 10.1001/jamanetworkopen.2020.25197.

    PubMed 33084902

  • Hawkins RB, Charles EJ, Mehaffey JH. Socio-economic status and COVID-19-related cases and fatalities. Public Health. 2020 Dec;189:129-134. doi: 10.1016/j.puhe.2020.09.016. Epub 2020 Oct 17.

    PubMed 33227595

  • Puglisi L, Calderon JP, Wang EA. What Does Health Justice Look Like for People Returning from Incarceration? AMA J Ethics. 2017 Sep 1;19(9):903-910. doi: 10.1001/journalofethics.2017.19.9.ecas4-1709.

    PubMed 28905731

  • Wang EA, White MC, Jamison R, Goldenson J, Estes M, Tulsky JP. Discharge planning and continuity of health care: findings from the San Francisco County Jail. Am J Public Health. 2008 Dec;98(12):2182-4. doi: 10.2105/AJPH.2007.119669. Epub 2008 Apr 1.

    PubMed 18381994

  • Walsh-Felz D, Westergaard R, Waclawik G, Pandhi N. "Service with open arms": enhancing community healthcare experiences for individuals with a history of incarceration. Health Justice. 2019 Dec 19;7(1):20. doi: 10.1186/s40352-019-0101-1.

    PubMed 31858291

  • Valera P, Boyas JF, Bernal C, Chiongbian VB, Chang Y, Shelton RC. A Validation of the Group-Based Medical Mistrust Scale in Formerly Incarcerated Black and Latino Men. Am J Mens Health. 2018 Jul;12(4):844-850. doi: 10.1177/1557988316645152. Epub 2016 May 4.

    PubMed 27192716

  • Kutnick AH, Leonard NR, Gwadz MV. "Like I Have No Choice": A Qualitative Exploration of HIV Diagnosis and Medical Care Experiences While Incarcerated and Their Effects. Behav Med. 2019 Apr-Jun;45(2):153-165. doi: 10.1080/08964289.2019.1591338.

    PubMed 31343965

  • Cutler DM, Summers LH. The COVID-19 Pandemic and the $16 Trillion Virus. JAMA. 2020 Oct 20;324(15):1495-1496. doi: 10.1001/jama.2020.19759. No abstract available.

    PubMed 33044484

Questions about this trial

What is this clinical trial studying?

A study testing Onsite Point-of-care in people with Covid19, run by Montefiore Medical Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Testing Uptake (time frame: Up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04878328, which also lists 53 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.

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