Addressing Vaccine Acceptance in Carceral Settings Through Community Engagement

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

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

Вторичные конечные точки (6)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• Pennsylvannia Department of Corrections — Schwenksville

Идентификаторы

NCT: NCT05796505 · 2000035026 · 1R01MD016853-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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