Onsite COVID-19 Testing for Criminal Justice-Involved Individuals
Palo Alto (17 mi)Overseen byMatthew Akiyama, MD MSc
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
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.
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.23568
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.23579
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.13457
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.Treatment Details
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: onsite Point-of-care (o-POC)Experimental Treatment1 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 Control1 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 nearbySelect from list below to view details:
Fortune SocietyLong Island City, NY
Montefiore Medical CenterBronx, NY
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Who is running the clinical trial?
Montefiore Medical CenterLead Sponsor
University of BristolCollaborator
The Fortune SocietyCollaborator
References
SARS-Cov2 Clinical Diagnostics: Academic Scientists Take on the COVID-19 Pandemic. [2023]In this issue of Med, Vanuytsel and colleagues1 demonstrate how academic institutions are stepping up to the forefront of SARS-CoV-2 testing by rapidly implementing a COVID-19 diagnostic test at a large safety net hospital serving an at-risk population, providing a regulatory and logistical roadmap to broaden testing capacity.
Rapid community point-of-care testing for COVID-19 (RAPTOR-C19): protocol for a platform diagnostic study. [2023]The aim of RApid community Point-of-care Testing fOR COVID-19 (RAPTOR-C19) is to assess the diagnostic accuracy of multiple current and emerging point-of-care tests (POCTs) for active and past SARS-CoV2 infection in the community setting. RAPTOR-C19 will provide the community testbed to the COVID-19 National DiagnOstic Research and Evaluation Platform (CONDOR).
Utility of Point-of-Care COVID-19 Testing in an Outpatient Otolaryngology clinic. [2022]To evaluate the utility of point-of-care COVID-19 testing for identifying infected patients in an otolaryngology practice.
Evaluation of Panbio rapid antigen test for SARS-CoV-2 in symptomatic patients and their contacts: a multicenter study. [2023]Point-of-care rapid tests to identify SARS-CoV-2 can have clinical benefits.
Exploring Workplace Testing with Real-Time Polymerase Chain Reaction SARS-CoV-2 Testing. [2022]Molecular tests (ie, real-time polymerase chain reaction [RT-PCR]) and antigen tests are used to detect SARS-CoV-2. RT-PCR tests are generally considered to be the standard for clinical diagnosis of SARS-CoV-2 due to accuracy and reliability but can take longer to return results than antigen tests. Our aim was to examine if point-of-care (POC) testing for SARS-CoV-2 infection would provide a flexible resource to help achieve workplace safety. We compared test results and time-to-test results between a POC RT-PCR test and a send-out PCR test in a program implemented in summer 2020.
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]Rapid and accurate testing for SARS-CoV-2 is an essential tool in the medical and public health response to the COVID-19 pandemic. An ideal test for COVID-19 would combine the sensitivity of laboratory-based PCR combined with the speed and ease of use of point-of-care (POC) or home-based rapid antigen testing.
Antigen-Based Point of Care Testing (POCT) for Diagnosing SARS-CoV-2: Assessing Performance. [2022]Currently, the most accurate way to diagnose an active SARS-CoV-2 (COVID-19) infection is through detection of viral RNA using reverse transcription polymerase chain reaction (RT-PCR) test. While RT-PCR tests are the most sensitive for identifying infection, there are significant limitations, such as global access to sufficient test kits, turnaround times (TAT) from specimen collection to test result is often greater than 24 h and the need for skilled operators in accredited laboratories requiring specialized equipment. A rapid test performed at the point of care (POC) could provide a result within an approximate time of 30 min post specimen collection, be performed by a health care worker and comprise a simple workflow, improving both turnaround time and potentially decreasing costs (e.g., transport, cold-chain, skilled laboratory staff, complex equipment). Determining the performance of SARS-CoV-2 RT-PCR tests is, however, easier to assess than antigen-based POCT, as residual clinical specimens (swabs in universal transport media [UTM]) are readily available in laboratory environments, and do not require patient informed consent. Evaluating the performance of POCT requires informed-consent driven studies, with patients required to provide a standard of care specimen as well as study evaluation specimens, which is often not acceptable as nasopharyngeal swabbing can be invasive, clinical field trials are costly and time consuming. Many institutions and regulatory bodies also require preliminary data prior to use in field settings. Therefore, we have developed a method to determine the performance of antigen based POCT that can be used by implementers in national healthcare programs, regulators and rapid test developers. The method investigates both quantitative and qualitative parameters, with the latter providing insights into the capability for implementation and national program uptake.
Screening for Severe Acute Respiratory Syndrome Coronavirus 2 in Close Contacts of Individuals With Confirmed Infection: Performance and Operational Considerations. [2023]Point-of-care and decentralized testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is critical to inform public health responses. Performance evaluations in priority use cases such as contact tracing can highlight trade-offs in test selection and testing strategies.
Preparing for the next pandemic: lessons learnt from the implementation of point-of-care SARS-CoV-2 testing in an emergency department. [2023]Point-of-care testing (POCT) provides rapid, accurate results that facilitate diagnosis and patient management. POCT for infectious agents allows timely infection prevention and control interventions and informs decisions around safe patient placement. However, POCT implementation requires careful governance as they are primarily operated by staff with limited prior education on laboratory quality control and assurance processes. Here, we describe our experience implementing SARS-CoV-2 POCT in the emergency department of a large tertiary referral hospital during the COVID-19 pandemic. We describe collaborative governance between pathology and clinical specialities, quality assurance, testing (volume and positivity rates), impact on patient flow and focus on lessons learnt during implementation that should be incorporated into revised pandemic preparedness planning.