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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
No Placebo-Only Group
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.
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.
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Testing uptake
Secondary study objectives
Mitigation measures
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
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Who is running the clinical trial?
Montefiore Medical CenterLead Sponsor
457 Previous Clinical Trials
588,371 Total Patients Enrolled
University of BristolOTHER
110 Previous Clinical Trials
25,026,252 Total Patients Enrolled
The Fortune SocietyUNKNOWN
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 18, speak English or Spanish, live in NYC, and was released from jail or prison within the last 90 days.You have a serious and advanced illness.
Research Study Groups:
This trial has the following groups:- Group 1: onsite Point-of-care (o-POC)
- Group 2: Standard of Care (SOC)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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