Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04878328 |
| Other study ID # |
2021-12976 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2021 |
| Est. completion date |
July 2026 |
Study information
| Verified date |
January 2024 |
| Source |
Montefiore Medical Center |
| Contact |
Matthew Akiyama, MD MSc |
| Phone |
718-920-7175 |
| Email |
makiyama[@]montefiore.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
The United States(U.S.) has experienced higher mortality than any other nation due to
COVID-19 with nearly 13.5 million cases and over 268,103 deaths. Due to the limited ability
to socially distance, poor ventilation, and limited hygiene supplies, U.S. prisons and jails
have observed explosive transmission of SARS-CoV-2 accounting for the 10 largest U.S.
outbreaks. Because 95% of criminal justice-involved individuals reenter societyCOVID-19
transmission extends beyond those who are currently incarcerated. As justice-involved
individuals reenter the community, they face high rates of homelessness, and many others live
in other congregate settings such as converted hotels and halfway houses. The increased risk
of SARS-CoV-2 while incarcerated coupled with the likelihood of living in congregate settings
after incarceration, create conditions ripe for rapid COVID-19 transmission that will be
critical to address in order to gain control of COVID-19 in the U.S. The goal of this study
is to test the impact and cost-effectiveness of an intervention to mitigate SARS-CoV-2
transmission among justice-involved individuals recently released from incarceration. The
investigators will conduct a randomized trial to compare the effectiveness of an onsite
Point-of-Care SARS-CoV-2 testing and education intervention with community health workers
(CHWs) as a central component compared to the standard of care at a community-based
organization (CBO) that provides services to justice-involved individuals in New York City.
The investigators will measure costs of testing, education, and navigation, and explore the
cost-effectiveness of the onsite Point-of-Care intervention compared to the standard of care.
The specific aims are to:1) Test the effectiveness of an onsite PoC SARS-CoV-2 intervention
in a corrections-focused CBO; 2) Model the cost-effectiveness of an onsite PoC SARS-CoV-2
intervention among CJIs compared to SoC. Because testing, education, and navigation will be
provided by CHWs in a culturally-sensitive environment and test results will be received in
minutes (rather than days), the investigators hypothesize that O-PoC will be associated with
improved testing uptake and receipt of test results, mitigation behaviors (mask wearing, hand
hygiene, social distancing), and those who attend more O-PoC sessions will have better
adherence to mitigation behaviors.
