Addressing Vaccine Acceptance in Carceral Settings Through Community Engagement

Overview

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.

Interventions

• Behavioral ADVANCE Steering Committee interventions
  Interventions will be selected by the ADVANCE Steering Committee and will be rapidly deployed without additional effort on the part of front-line staff at four distinct levels: patient, provider, practice and prison level. Interventions will be tested one at a time in an iterative process. A participatory, assets-based framework will be used to identify acceptable and feasible strategies to improve vaccine acceptance. Each round of testing will include 1 month of preparation by the steering comm

Primary outcome measures

• COVID-19 vaccine acceptance rate [Time frame: up to 12 weeks post intervention]

Secondary outcome measures (6)

• COVID-19 infections [Time frame: up to 12 weeks post intervention]
• Hospitalization Rate [Time frame: up to 12 weeks post intervention]
• Deaths [Time frame: up to 12 weeks]
• Change in vaccination for other respiratory outbreaks [Time frame: up to 12 weeks]
• Vaccine refusal rate [Time frame: up to 12 weeks post intervention]
• Vaccine acceptance rate [Time frame: up to 12 weeks post intervention]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

United States · 1 center

• Pennsylvannia Department of Corrections — Schwenksville

Identifiers

NCT: NCT05796505 · 2000035026 · 1R01MD016853-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗