Onsite COVID-19 Testing for Criminal Justice-Involved Individuals

No longer recruiting at 2 trial locations

Overseen By Matthew Akiyama, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Montefiore Medical Center

Disqualifiers: Terminal illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve COVID-19 testing and prevention strategies for individuals recently released from jail or prison. It compares two approaches: one group receives onsite point-of-care testing (rapid antigen testing) and education, while the other follows usual care with offsite testing options. The researchers aim to determine if the onsite approach increases testing rates and encourages behaviors like mask-wearing and social distancing. Eligible participants are clients of the Fortune Society who have been released from incarceration in the last 90 days and live in NYC. As an unphased trial, this study allows participants to contribute to significant public health research that could enhance COVID-19 prevention strategies for vulnerable populations.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this onsite Point-of-Care SARS-CoV-2 testing is safe?

Research has shown that onsite point-of-care (o-POC) testing for COVID-19 is generally well-tolerated. Studies have found that these rapid antigen tests provide quick results and can be easily conducted at locations like community centers. The FDA has approved these tests for emergency use, indicating they meet safety standards for this type of testing.

The process typically involves a simple nasal or oral swab, which most people find easy and painless. No major reports of adverse reactions to the tests themselves have emerged, suggesting that o-POC testing is safe for community use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the onsite Point-of-care (o-POC) approach because it offers a comprehensive, accessible solution for COVID-19 testing and support, particularly for individuals involved in the criminal justice system. Unlike the standard of care, which typically involves referrals to offsite testing centers, o-POC brings testing directly to participants through community health workers. This method not only includes rapid COVID-19 testing but also provides essential education, access to masks and hygiene supplies, and guidance to vaccination sites and supportive housing. By integrating social support and immediate resources, o-POC aims to enhance the uptake of preventive behaviors, making it a potentially transformative approach in managing COVID-19 within this vulnerable population.

What evidence suggests that onsite Point-of-Care SARS-CoV-2 testing is effective for improving COVID-19 mitigation behaviors?

Research has shown that COVID-19 tests conducted at the point of care (POC) are accurate and reliable. In this trial, participants in the onsite Point-of-Care (o-POC) arm will receive rapid antigen tests, which studies have found effectively detect COVID-19 infections. These tests deliver quick results, making them practical for on-site testing. POC testing has played a crucial role in managing the COVID-19 pandemic by quickly identifying cases and helping to reduce the spread. Overall, these tests offer a simple and effective method for detecting COVID-19 in community settings. ^{1 3 6 7 8}

Who Is on the Research Team?

Matthew Akiyama, MD MSc

Principal Investigator

Albert Einstein College of Medicine Montefiore Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 who speak English or Spanish, live in NYC, and were released from jail or prison within the last 90 days. It's not for those with terminal illness, unable to attend study visits for a year, planning to move out of NYC soon, or can't consent.

Exclusion Criteria

You have a serious and advanced illness.

Inability to provide informed consent

Inability to complete study visits over 12 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Onsite Point-of-Care SARS-CoV-2 testing and education intervention with community health workers

12 months

Regular visits as scheduled by CHWs

Follow-up

Participants are monitored for adherence to mitigation behaviors and testing uptake

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Onsite Point-of-care

Trial Overview The study tests an onsite Point-of-Care SARS-CoV-2 testing and education strategy at a community organization focused on former inmates. It aims to see if this increases COVID-19 testing rates and encourages behaviors like mask-wearing and vaccination.

How Is the Trial Designed?

Group I: onsite Point-of-care (o-POC) Experimental Treatment 1 Intervention

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.

Group II: Standard of Care (SOC) Active Control 1 Intervention

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.

Onsite Point-of-care is already approved in United States, European Union for the following indications:

Approved in United States as Point-of-Care SARS-CoV-2 Testing for:

• COVID-19 diagnosis

Approved in European Union as Rapid Antigen Testing for:

• COVID-19 diagnosis

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Cepheid

Industry Sponsor

Trials

24

Recruited

10,500+

University of Bristol

Collaborator

Trials

114

Recruited

25,030,000+

The Fortune Society

Collaborator

Trials

1

Recruited

250+

Published Research Related to This Trial

In a study involving 50 COVID-19 index cases and 214 close contacts in Brazil, rapid antigen tests showed a sensitivity range of 33% to 76%, with better performance in symptomatic individuals and those with higher viral loads.

The rapid antigen tests provided results much faster than RT-PCR, achieving over 70% sensitivity within 24 hours and nearly 90% after 4 days, making them valuable for timely public health responses despite their lower analytical sensitivity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening for Severe Acute Respiratory Syndrome Coronavirus 2 in Close Contacts of Individuals With Confirmed Infection: Performance and Operational Considerations. Zobrist, S., Oliveira-Silva, M., Vieira, AM., et al.[2023]

The RT-PCR test is currently the most accurate method for diagnosing active COVID-19 infections, but it has limitations such as long turnaround times and the need for specialized equipment and trained personnel.

A new method has been developed to evaluate the performance of rapid antigen-based point-of-care tests (POCT), which could provide results in about 30 minutes, making them more accessible and cost-effective for national healthcare programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antigen-Based Point of Care Testing (POCT) for Diagnosing SARS-CoV-2: Assessing Performance. Keshav, V., Scott, L., David, A., et al.[2022]

Point-of-care (POC) RT-PCR testing for SARS-CoV-2 significantly reduces the time to results to 110 minutes, compared to 754 minutes for send-out PCR tests, making it a faster option for workplace safety.

The specificity of POC RT-PCR testing was very high at 98.7%, and while the initial sensitivity was reported as 100%, validation showed some limitations due to false positives, indicating the need for careful interpretation of results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring Workplace Testing with Real-Time Polymerase Chain Reaction SARS-CoV-2 Testing. Fuentes, L., Shah, N., Kelly, S., et al.[2022]

Implementing point-of-care testing (POCT) for SARS-CoV-2 in a large hospital's emergency department during the COVID-19 pandemic allowed for rapid and accurate diagnosis, which improved patient management and infection control.

The experience highlighted the importance of collaborative governance and quality assurance in POCT, especially since staff operating these tests often have limited laboratory training, emphasizing the need for better training and preparedness in future pandemics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preparing for the next pandemic: lessons learnt from the implementation of point-of-care SARS-CoV-2 testing in an emergency department. Donnelly, JA., Russell, M., O'Brien, G., et al.[2023]

Academic institutions are playing a crucial role in enhancing SARS-CoV-2 testing capabilities by quickly implementing COVID-19 diagnostic tests in large safety net hospitals.

This initiative provides a regulatory and logistical framework that can help expand testing capacity, particularly for at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SARS-Cov2 Clinical Diagnostics: Academic Scientists Take on the COVID-19 Pandemic. Urnov, F.[2023]

The Abbott Panbio rapid antigen test for SARS-CoV-2 demonstrated high specificity (>97.8%) but low overall sensitivity (54.2%), indicating it is reliable for confirming positive cases but may miss many infections, especially after the first week of symptoms.

In patients tested within the first week of symptoms, the sensitivity improved to 69.1%, and for those with a high viral load (Ct ≤25), sensitivity reached 82%, highlighting the importance of timing and viral load in test accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Panbio rapid antigen test for SARS-CoV-2 in symptomatic patients and their contacts: a multicenter study. Thirion-Romero, I., Guerrero-Zúñiga, DS., Arias-Mendoza, DA., et al.[2023]

In a study of 947 patients tested for COVID-19 in an otolaryngology clinic, the point-of-care nucleic acid amplification test showed a low true positive rate of only 0.95%, indicating that most positive cases were clinically suspected rather than detected through routine screening.

The study found that symptomatic patients and those seen by advanced practice practitioners had significantly higher true positivity rates, suggesting that targeted testing in these groups may be more effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of Point-of-Care COVID-19 Testing in an Outpatient Otolaryngology clinic. Ganesh, M., Brawley, CC., Khanwalkar, A., et al.[2022]

The DASH SARS-CoV-2 POC PCR test demonstrated high accuracy with a sensitivity of 96% and specificity of 98% in a study of 313 participants, making it comparable to traditional laboratory-based PCR tests.

With a rapid result time of just 16 minutes, DASH is a user-friendly testing option that can be effectively used in various healthcare settings, especially in areas lacking access to central laboratory testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of the Diagnostic Analyzer for Selective Hybridization (DASH): a point-of-care PCR test for rapid detection of SARS-CoV-2 infection. Achenbach, CJ., Caputo, M., Hawkins, C., et al.[2023]

The RAPTOR-C19 study aims to evaluate the diagnostic accuracy of various point-of-care tests (POCTs) for detecting current and past SARS-CoV-2 infections in community settings, involving both adults and children with suspected infections.

High-performing POCTs could significantly improve public health by providing real-time results that may reduce virus transmission and enhance surveillance, while poorly performing tests could lead to negative consequences, highlighting the need for thorough evaluations before widespread use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid community point-of-care testing for COVID-19 (RAPTOR-C19): protocol for a platform diagnostic study. Nicholson, BD., Hayward, G., Turner, PJ., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11527648/

Performance of self-performed SARS-CoV-2 rapid antigen ... Fully self-performed SARS-CoV-2 rapid antigen tests showed overall high accuracy compared to “gold standard,” and are reliable surrogates for the standard test ...

2. cdc.gov cdc.gov/covid/php/lab/point-of-care-testing.html

Guidance for SARS-CoV-2 Rapid Testing in Point-of-Care ... Rapid tests used in point-of-care settings can be NAAT or antigen tests. These tests can be used to diagnose SARS-CoV-2 infections in various point-of-care ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1386653221002080

“The effectiveness of rapid antigen test-based for SARS- ... A simple, affordable point of care test (POCT) is necessary for on-site detection of coronavirus disease 2019 (COVID-19). The lateral flow assay (LFA) has ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10252882/

Point-of-Care Testing for SARS-CoV-2 - PubMed Central - NIH The use of point-of-care tests (POCT) has been a central strategy in dealing with the COVID-19 pandemic. The aims of this study were to evaluate ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2795599

Accuracy of 2 Rapid Antigen Tests During 3 Phases ... This study found that 2 rapid antigen tests had consistent analytical and clinical accuracy across 3 phases of circulating SARS-CoV-2 variants.

6. coronavirus.health.ny.gov coronavirus.health.ny.gov/system/files/documents/2021/05/sars-cov-2-antigen-tests-faq-update-5-13-2021.pdf

SARS-CoV-2 Point of Care (POC) Antigen Tests - COVID-19 SARS-CoV-2 POC antigen tests are used for diagnostic testing when performed on symptomatic individuals or asymptomatic individuals exposed to a.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1386653221003292

Virucidal activity of SARS-CoV-2 rapid antigen extraction ... SARS-CoV-2 rapid antigen tests allow convenient mass testing in a cheaper and more flexible way, can be performed directly on site and deliver fast results [3].

8. cdph.ca.gov cdph.ca.gov/Programs/OSPHLD/LFS/Pages/COVIDTestingGuidance.aspx

Guidance for COVID-19 Testing - CDPH For antigen testing, this is usually done by nasal or oral swabbing. The FDA Emergency Use Authorization (EUA) and manufacturer's instructions ...