COVID-19NCT05796505
Addressing Vaccine Acceptance in Carceral Settings Through Community Engagement
A study testing ADVANCE Steering Committee interventions in people with COVID-19, run by Yale University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- ADVANCE Steering Committee interventions
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37,122 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Pennsylvannia Department of Corrections
Schwenksville, Pennsylvania, 19473
About this study
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.
Read the detailed 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.
- Conditions
- COVID-19
- Being tested
- ADVANCE Steering Committee interventions
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADVANCE Steering Committee interventionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: ADVANCE Steering Committee interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 12 weeks post intervention
Secondary outcomes (6)
COVID-19 infections
Number of participants with COVID-19 infections by EHR or self report.
Measured: up to 12 weeks post intervention
Hospitalization Rate
Total number of new admissions for COVID-19 infections by EHR or self report.
Measured: up to 12 weeks post intervention
Deaths
Number of deaths from COVID-19 infections by EHR
Measured: up to 12 weeks
Change in vaccination for other respiratory outbreaks
Change in vaccination rates for other respiratory outbreaks during winter season including influenza vaccine
Measured: up to 12 weeks
Vaccine refusal rate
Vaccine refusal rate assessed by number of vaccines refused/total number fully vaccinated at start of the intervention
Measured: up to 12 weeks post intervention
Vaccine acceptance rate
Vaccine acceptance rate assessed by number of vaccines administered/total number fully vaccinated at start of the intervention
Measured: up to 12 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start23 Jul 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 37,122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Lisa B Puglisi, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05796505
- Sponsor's protocol ID
- 2000035026
- Other IDs
- 1R01MD016853-01A1
- Status last verified
- Nov 2025
- First submitted
- 21 Mar 2023
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Vaccine Acceptance in Carceral Settings Through Community Engagement
- ClinicalTrials.gov ID
- NCT05796505
- Acronym / sponsor ID
- 2000035026
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 37,122 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 23 Jul 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | No intervention | –Participants receive standard interventions currently in use (treatment as usual). |
| ADVANCE Steering Committee chosen interventions | Experimental | Behavioral: ADVANCE Steering Committee interventionsInterventions 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADVANCE Steering Committee interventionsInterventions 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. | Behavioural | ADVANCE Steering Committee chosen interventions |
Primary outcome
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.
6 secondary outcomes
COVID-19 infections
Time frame: up to 12 weeks post intervention
Hospitalization Rate
Time frame: up to 12 weeks post intervention
Deaths
Time frame: up to 12 weeks
Change in vaccination for other respiratory outbreaks
Time frame: up to 12 weeks
Vaccine refusal rate
Time frame: up to 12 weeks post intervention
Vaccine acceptance rate
Time frame: up to 12 weeks post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisa B Puglisi, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADVANCE Steering Committee interventions in people with COVID-19, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa B Puglisi, MD (475-306-1023, Lisa.puglisi@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 vaccine acceptance rate (time frame: up to 12 weeks post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.