Onsite COVID-19 Testing for Criminal Justice-Involved Individuals

Recruiting at 1 trial location

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

250 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the idea that Onsite COVID-19 Testing for Criminal Justice-Involved Individuals is an effective treatment?

The available research shows that onsite COVID-19 testing, specifically rapid antigen tests, can provide quick results, often within 30 minutes, which is much faster than the standard RT-PCR tests that can take over 24 hours. This quick turnaround can help in making timely decisions to prevent the spread of the virus, especially in settings like workplaces or clinics. Although RT-PCR tests are more accurate, the speed and ease of use of rapid antigen tests make them a practical choice for immediate testing needs. This is particularly beneficial in environments where quick isolation of infected individuals is crucial, such as in criminal justice settings. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Onsite Point-of-care, Point-of-Care SARS-CoV-2 Testing, Rapid Antigen Testing for COVID-19?

Research shows that rapid antigen tests for COVID-19 can provide quick results, often within 30 minutes, which helps in timely decision-making and potentially reduces costs. Although not as sensitive as RT-PCR tests, these rapid tests are beneficial in settings where quick results are crucial, such as workplaces or clinics. ^{1 2 3 4 5}

What safety data exists for onsite COVID-19 testing?

The research does not directly address safety data for onsite COVID-19 testing, but it discusses the implementation and performance of point-of-care testing (POCT) for SARS-CoV-2. The studies highlight the benefits of rapid results and improved patient management, but also note the need for careful governance and quality assurance due to the limited laboratory training of staff conducting the tests. The performance of antigen-based POCT is assessed through informed-consent driven studies, which are necessary for regulatory approval and implementation in healthcare programs. ^{1 2 4 6 7}

Is onsite COVID-19 testing safe for humans?

The research articles do not provide specific safety data for onsite COVID-19 testing, but they discuss the implementation and performance of point-of-care tests, which are generally used safely in various healthcare settings. ^{1 2 4 6 7}

Is Onsite Point-of-care testing a promising treatment for COVID-19?

Yes, Onsite Point-of-care testing is promising because it provides quick results, helping to identify COVID-19 cases rapidly. This can be especially useful in places like criminal justice settings where timely decisions are important for safety and health. ^{1 2 7 8 9}

How is onsite point-of-care COVID-19 testing different from other COVID-19 treatments?

Onsite point-of-care COVID-19 testing is unique because it provides rapid results directly at the location where the test is conducted, unlike standard PCR tests that require samples to be sent to a lab, which can take longer to process. This makes it particularly useful for quickly identifying infections in specific settings, such as among individuals involved in the criminal justice system. ^{1 2 7 8 9}

Research Team

Matthew Akiyama, MD MSc

Principal Investigator

Albert Einstein College of Medicine Montefiore Medical Center

Eligibility Criteria

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 complete study visits over 12 months

Does not plan to reside in the NYC area for the next year

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Utility of Point-of-Care COVID-19 Testing in an Outpatient Otolaryngology clinic. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Exploring Workplace Testing with Real-Time Polymerase Chain Reaction SARS-CoV-2 Testing. [2022]

3. Canada pubmed.ncbi.nlm.nih.gov

Evaluation of Panbio rapid antigen test for SARS-CoV-2 in symptomatic patients and their contacts: a multicenter study. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Antigen-Based Point of Care Testing (POCT) for Diagnosing SARS-CoV-2: Assessing Performance. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. England 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. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Rapid community point-of-care testing for COVID-19 (RAPTOR-C19): protocol for a platform diagnostic study. [2023]

8. United States 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. [2023]

9. United States 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. [2023]