CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 250 enrolled / 250 target
Drug / intervention
Onsite Point-of-carebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04878328
NCT04878328N/ACompletedHigh Momentum (4.9/mo)Completion was 13mo ago

Leveraging Community Health Workers to Improve COVID-19 Testing and Mitigation Among Criminal Justice-involved Individuals Accessing a Corrections-focused Community-based Organization

Montefiore Medical Center·interventional·Posted May 7, 2021·Updated Jun 25, 2026

In Brief

A clinical study evaluating Onsite Point-of-care for Covid19. Completed, enrolled 250 participants across 2 sites.

Signals

Enrolling ahead of pace

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCovid19
CountriesUnited States

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMay 7, 2021
Enrollment StartApr 14, 2022
Primary CompletionMay 22, 2025
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 5.2 years ago

Arms & Interventions

onsite Point-of-care (o-POC)experimental

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.

Behavioral: Onsite Point-of-care
Standard of Care (SOC)no_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.

Interventions

Onsite Point-of-carebehavioral

Guided by Social Cognitive Theory, O-PoC 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.