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Onsite COVID-19 Testing for Criminal Justice-Involved Individuals

N/A

Recruiting

Led By Matthew Akiyama, MD MSc

Research Sponsored by Montefiore Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial will help to establish if an onsite Point-of-Care SARS-CoV-2 testing and education strategy can help reduce community transmission by improving testing uptake, mitigation behaviors, and vaccine uptake among criminal justice-involved individuals.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since the intervention involves COVID-19 testing and educational strategies rather than medication, traditional side effects are not applicable. However, discomfort from swab collection during testing may occur.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Testing uptake

Secondary outcome measures

Mitigation measures

Trial Design

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Montefiore Medical CenterLead Sponsor

441 Previous Clinical Trials

581,946 Total Patients Enrolled

University of BristolOTHER

107 Previous Clinical Trials

25,022,047 Total Patients Enrolled

The Fortune SocietyUNKNOWN

Media Library

Onsite Point-of-care Clinical Trial Eligibility Overview. Trial Name: NCT04878328 — N/A

Coronavirus Research Study Groups: onsite Point-of-care (o-POC), Standard of Care (SOC)

Coronavirus Clinical Trial 2023: Onsite Point-of-care Highlights & Side Effects. Trial Name: NCT04878328 — N/A

Onsite Point-of-care 2023 Treatment Timeline for Medical Study. Trial Name: NCT04878328 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are enrollees currently being welcomed for this experiment?

"Yes, the details provided on the clinicaltrials.gov website verify that this study is currently recruiting participants. It was initially posted on July 1st 2021 and its most recent update occurred on April 14th 2022. The trial seeks to include 250 people from 2 centers."

Answered by AI

How many participants are being enrolled in this clinical trial?

"Affirmative. Clinicaltrials.gov contains the evidence that this clinical trial, which was initially published on July 1st 2021, is actively searching for volunteers. The study requires 250 participants from 2 different treatment sites in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "Leveraging CHWs to Improve COVID-19 Testing and Mitigation Among CJIs Accessing a Corrections-focused CBO". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04878328.

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