Addressing Vaccine Acceptance in Carceral Settings Through Community Engagement

NCT05796505 | Recruiting DMC

• 2 other identifiers: 20000350261R01MD016853-01A1
• Study Type: interventional
• Target: 37,122
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• COVID-19 vaccine acceptance rate

  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.

  up to 12 weeks post intervention

Secondary Outcomes (6)

• COVID-19 infections

  up to 12 weeks post intervention

• Hospitalization Rate

  up to 12 weeks post intervention

• Deaths

  up to 12 weeks

• Change in vaccination for other respiratory outbreaks

  up to 12 weeks

• Vaccine refusal rate

  up to 12 weeks post intervention

Study Arms (2)

Treatment as usual

NO INTERVENTION

Participants receive standard interventions currently in use (treatment as usual).

ADVANCE Steering Committee chosen interventions

EXPERIMENTAL

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.

Behavioral: ADVANCE Steering Committee interventions

Interventions

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.

ADVANCE Steering Committee chosen interventions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Yale University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Pennsylvannia Department of Corrections

Schwenksville, Pennsylvania, 19473, United States

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Lisa B Puglisi, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa B Puglisi, MD

CONTACT

475-306-1023; Lisa.puglisi@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 3, 2023
• Study Start: July 23, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)