Onsite COVID-19 Testing for Criminal Justice-Involved Individuals

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Matthew Akiyama, MD MSc

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Montefiore Medical Center

No Placebo Group

Approved in 2 Jurisdictions

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.

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 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 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}

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.

Inclusion Criteria

I am over 18, speak English or Spanish, live in NYC, and was released from jail or prison within the last 90 days.

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

Treatment Details

Interventions

• Onsite Point-of-care (Behavioral Intervention)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Fortune Society Long Island City, NY

Montefiore Medical Center Bronx, NY

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Patients Recruited

599,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Patients Recruited

1,374,000+

Cepheid

Industry Sponsor

Trials

24

Patients Recruited

10,500+

University of Bristol

Collaborator

Trials

114

Patients Recruited

25,030,000+

The Fortune Society

Collaborator

Trials

1

Patients Recruited

250+

Findings from Research

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]

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]

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

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]

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]