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NCT Number: NCT05796505

Addressing Vaccine Acceptance in Carceral Settings Through Community Engagement

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennsylvannia Department of Corrections

Schwenksville, Pennsylvania, 19473, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

ADVANCE Steering Committee interventions

Behavioral

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 committee,12-week intervention period, and 2 months for analysis and rapid dissemination.

Primary outcomes

  1. COVID-19 vaccine acceptance rate

    Time frame: 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 outcomes

  1. COVID-19 infections

    Time frame: up to 12 weeks post intervention

    Number of participants with COVID-19 infections by EHR or self report.

  2. Hospitalization Rate

    Time frame: up to 12 weeks post intervention

    Total number of new admissions for COVID-19 infections by EHR or self report.

  3. Deaths

    Time frame: up to 12 weeks

    Number of deaths from COVID-19 infections by EHR

  4. Change in vaccination for other respiratory outbreaks

    Time frame: up to 12 weeks

    Change in vaccination rates for other respiratory outbreaks during winter season including influenza vaccine

  5. Vaccine refusal rate

    Time frame: up to 12 weeks post intervention

    Vaccine refusal rate assessed by number of vaccines refused/total number fully vaccinated at start of the intervention

  6. Vaccine acceptance rate

    Time frame: up to 12 weeks post intervention

    Vaccine acceptance rate assessed by number of vaccines administered/total number fully vaccinated at start of the intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa B Puglisi, MD

CONTACT

[email protected]

475-306-1023

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 3, 2023
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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