Recruiting

COVID-19 Interventions

Sponsor:

Yale University

Code:

NCT05796505

Conditions

COVID-19

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ADVANCE Steering Committee interventions

Study Details

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

Study ID

NCT05796505

Start date

Jul 23, 2024

Status verified date

Nov, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

37122 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

no intervention: Treatment as usual

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

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

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.

Primary outcome measure

  • COVID-19 vaccine acceptance rate [ Time Frame: up to 12 weeks post intervention ]

Central Contacts and Locations

Central contacts

Lisa B Puglisi, MD

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

Locations

Pennsylvannia Department of Corrections

Recruiting

Schwenksville, Pennsylvania, United States, 19473

More Information

Sponsor

Yale University

Last update posted

Nov 21, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Yale University on 2025-11-21.