Addressing Vaccine Acceptance in Carceral Settings Through Community Engagement

Not Applicable

Recruiting

• Conditions: COVID-19

• Registration Number: NCT05796505
• Lead Sponsor: Yale University

Brief Summary

The goal of this study is to reduce morbidity and mortality from COVID-19 amongst people who are detained in and work in correctional facilities. The overall objective is to identify feasible and effective interventions to improve vaccine uptake in correctional facilities and study the effectiveness of these interventions through rapid cycle, cluster randomized trials in the Pennsylvania prison system.

Detailed Description

Aim 1: To identify correctional system strategies to address COVID-19 and influenza vaccine acceptance amongst incarcerated people and correctional staff.

Aim 2: To select feasible strategies for a statewide correctional system at the patient-, provider-, practice- and prison-level to address COVID-19 and influenza vaccine uptake through a community engaged research approach.

Aim 3: To compare the effectiveness of interventions to address COVID-19 and influenza vaccine acceptance using a rapid cycle cluster randomized trial design in prison.

This study is highly innovative in its application of rapid cycle, cluster randomized trials in correctional systems to test the effectiveness of strategies identified using a community based participatory research approach. The results will serve as an evidence base for improving vaccine uptake that can be scaled nationally and adapted for other populations affected by the criminal legal system.

Study Timeline

• Study First Submitted: 2023-03-21
• Study First Submitted QC: 2023-03-21
• Study First Posted: 2023-04-03
• Study Start: 2024-07-23
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-14
• Last Update Posted: 2024-08-16
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 37122

Inclusion Criteria

• All incarcerated people in the Pennsylvania DOC are included in the study population for these low risk interventions. In this each individual intervention, inclusion criteria will be based on where incarcerated people are housed and therefore what intervention they will be exposed to.

Exclusion Criteria

• Exclusion criteria will likely include severe physical or mental illness as these individuals are often incarcerated in special units which will not be included in the study (i.e. medical units).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
COVID-19 vaccine acceptance rate	up to 12 weeks post intervention	COVID-19 vaccine acceptance rate amongst incarcerated people and correctional staff assessed as the number of participants that receive a COVID-19 vaccine dose or complete the COVID-19 vaccine series by electronic health record (EHR) or self report. This will apply to anyone not fully up-to-date with the full immunization series, which is defined as inclusive of boosters.

Secondary Outcome Measures

Name	Time	Method
COVID-19 infections	up to 12 weeks post intervention	Number of participants with COVID-19 infections by EHR or self report.
Vaccine refusal rate	up to 12 weeks post intervention	Vaccine refusal rate assessed by number of vaccines refused/total number fully vaccinated at start of the intervention
Change in vaccination for other respiratory outbreaks	up to 12 weeks	Change in vaccination rates for other respiratory outbreaks during winter season including influenza vaccine
Hospitalization Rate	up to 12 weeks post intervention	Total number of new admissions for COVID-19 infections by EHR or self report.
Deaths	up to 12 weeks	Number of deaths from COVID-19 infections by EHR
Vaccine acceptance rate	up to 12 weeks post intervention	Vaccine acceptance rate assessed by number of vaccines administered/total number fully vaccinated at start of the intervention

Trial Locations

Locations (1)

Pennsylvannia Department of Corrections; 🇺🇸 Schwenksville, Pennsylvania, United States