Addressing Vaccine Acceptance in Carceral Settings Through Community Engagement

COVID-19 Clinical Trial

Official title:

Addressing Vaccine Acceptance in Carceral Settings Through Community Engagement

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05796505
• Other study ID #: 2000035026
• Secondary ID: 1R01MD016853-01A
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 24, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: April 2024
• Source: Yale University
• Contact: Lisa B Puglisi, MD
• Phone: 475-306-1023
• Email: Lisa.puglisi[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 37122
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Locations

Country	Name	City	State
United States	Pennsylvannia Department of Corrections	Schwenksville	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	COVID-19 infections	Number of participants with COVID-19 infections by EHR or self report.	up to 12 weeks post intervention
Secondary	Hospitalization Rate	Total number of new admissions for COVID-19 infections by EHR or self report.	up to 12 weeks post intervention
Secondary	Deaths	Number of deaths from COVID-19 infections by EHR	up to 12 weeks
Secondary	Change in vaccination for other respiratory outbreaks	Change in vaccination rates for other respiratory outbreaks during winter season including influenza vaccine	up to 12 weeks
Secondary	Vaccine refusal rate	Vaccine refusal rate assessed by number of vaccines refused/total number fully vaccinated at start of the intervention	up to 12 weeks post intervention
Secondary	Vaccine acceptance rate	Vaccine acceptance rate assessed by number of vaccines administered/total number fully vaccinated at start of the intervention	up to 12 weeks post intervention