Clinical trial NCT05796505: Addressing Vaccine Acceptance in Carceral Settings Through Community Engagement
Official title: Addressing Vaccine Acceptance in Carceral Settings Through Community Engagement
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COVID-19
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-04-03
Enrollment: 37122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Rapid cycle cluster randomized controlled trial (RCT). Randomization will occur at different levels, depending on the intervention that is being tested. Interviews: 14 key informant interviews will be conducted within each state correctional system that is identified as high performing (high vaccination rates for staff and incarcerated individuals). For rapid RCT: Pennsylvania Department Of Corrections operates 23 prisons which incarcerate approximately 35000 men and 1800 women. Every incarcerated individual in a PA prison is a potential candidate for the rapid RCT.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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).

Primary outcomes:
measure: COVID-19 vaccine acceptance rate
timeFrame: up to 12 weeks post intervention
Secondary outcomes:
measure: COVID-19 infections
timeFrame: up to 12 weeks post intervention
measure: Hospitalization Rate
timeFrame: up to 12 weeks post intervention
measure: Deaths
timeFrame: up to 12 weeks
measure: Change in vaccination for other respiratory outbreaks
timeFrame: up to 12 weeks
measure: Vaccine refusal rate
timeFrame: up to 12 weeks post intervention
measure: Vaccine acceptance rate
timeFrame: up to 12 weeks post intervention
Other outcomes:
Locations:
city: Schwenksville
country: United States
facility: Pennsylvannia Department of Corrections
state: Pennsylvania
Study officials:
affiliation: Yale University
name: Lisa B Puglisi, MD
role: PRINCIPAL_INVESTIGATOR
References: