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临床试验/NCT05796505
NCT05796505招募中不适用

Addressing Vaccine Acceptance in Carceral Settings Through Community Engagement

Yale University2 个研究点 分布在 1 个国家目标入组 37,122 人开始时间: 2024年7月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
37,122
试验地点
2
主要终点
COVID-19 vaccine acceptance rate

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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).

结局指标

主要结局

COVID-19 vaccine acceptance rate

时间窗: 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.

次要结局

  • COVID-19 infections(up to 12 weeks post intervention)
  • Vaccine refusal rate(up to 12 weeks post intervention)
  • Deaths(up to 12 weeks)
  • Change in vaccination for other respiratory outbreaks(up to 12 weeks)
  • Vaccine acceptance rate(up to 12 weeks post intervention)
  • Hospitalization Rate(up to 12 weeks post intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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