- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05796505
Håndtering af vaccineaccept i karcerale omgivelser gennem samfundsengagement
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.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Lisa B Puglisi, MD
- Telefonnummer: 475-306-1023
- E-mail: Lisa.puglisi@yale.edu
Studiesteder
-
-
Pennsylvania
-
Schwenksville, Pennsylvania, Forenede Stater, 19473
- Rekruttering
- Pennsylvannia Department of Corrections
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Treatment as usual
Participants receive standard interventions currently in use (treatment as usual). |
|
|
Eksperimentel: 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
COVID-19 vaccine acceptance rate
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Respiratory infections rate
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Lisa B Puglisi, MD, Yale University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2000035026
- 1R01MD016853-01A1 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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