Addressing Vaccine Acceptance in Carceral Settings Through Community Engagement
The objective of this study is to identify a set of interventions that are effective in improving preventive healthcare engagement, including vaccination and chronic disease prevention, among incarcerated individuals and correctional staff in the Pennsylvania prison system.
Study Overview
Status
Intervention / Treatment
Detailed Description
Aim 1: Identify promising strategies and implementation approaches for respiratory preventive health engagement, including vaccination, among correctional staff and formerly incarcerated individuals from high-performing correctional systems.
Aim 2: Select community-endorsed prevention strategies for a statewide correctional system.
Aim 3: Test the effectiveness of strategies to improve respiratory preventive health engagement using rapid-cycle, cluster randomized trials and related evaluative activities, as applicable.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lisa B Puglisi, MD
- Phone Number: 475-306-1023
- Email: Lisa.puglisi@yale.edu
Study Locations
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Pennsylvania
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Schwenksville, Pennsylvania, United States, 19473
- Recruiting
- Pennsylvannia Department of Corrections
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Treatment as usual
Participants receive standard interventions currently in use (treatment as usual). |
|
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Experimental: ADVANCE Steering Committee chosen 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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
COVID-19 vaccine acceptance rate
Time Frame: up to 12 weeks post intervention
|
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 inclusive of boosters. |
up to 12 weeks post intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Respiratory infections rate
Time Frame: up to 12 weeks post intervention
|
Number of participants with respiratory infections by EHR or self report. |
up to 12 weeks post intervention
|
|
Hospitalization Rate
Time Frame: up to 12 weeks post intervention
|
Total number of new admissions for COVID-19 infections by EHR or self report. |
up to 12 weeks post intervention
|
|
Deaths
Time Frame: up to 12 weeks post intervention
|
Number of deaths from COVID-19 infections by EHR |
up to 12 weeks post intervention
|
|
Influenza 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 |
up to 12 weeks post intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lisa B Puglisi, MD, Yale University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2000035026
- 1R01MD016853-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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