Clinical trial NCT04878328: Leveraging CHWs to Improve COVID-19 Testing and Mitigation Among CJIs Accessing a Corrections-focused CBO
Official title: Leveraging Community Health Workers to Improve COVID-19 Testing and Mitigation Among Criminal Justice-involved Individuals Accessing a Corrections-focused Community-based Organization
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Covid19
Keywords: COVID19
justice-involved individuals
Point-of-care testing
community based organization
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: The Fortune Society
name: University of Bristol
name: National Institute on Minority Health and Health Disparities (NIMHD)
name: Cepheid
First posted: 2021-05-07
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators will conduct a randomized trial to assess the effectiveness of an onsite Point-of-Care testing and education intervention (O-PoC) compared to standard of care (SoC) at The Fortune Society (Fortune). The current SoC includes a referral to offsite community testing. Guided by Social Cognitive Theory, in O-PoC we will employ CHWs with lived experience of incarceration to provide: 1) COVID-19 education; 2) SARS-CoV-2 testing with Cepheid XpertXpress PCR tests at Fortune facilities; 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.
Primary purpose: SCREENING

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* 1) Fortune clients
* \>18 years old
* fluent in English or Spanish
* residents of NYC
* released from jail or prison within 90 days

Exclusion Criteria:

* Inability to provide informed consent
* inability to complete study visits over 12 months
* Does not plan to reside in the NYC area for the next year.
* terminal illness

Primary outcomes:
measure: Testing uptake
timeFrame: 12 months
Secondary outcomes:
measure: Mitigation measures
timeFrame: 12 months
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Long Island City
country: United States
facility: Fortune Society
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine Montefiore Medical Center
name: Matthew Akiyama, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: