- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT05796505
Ta itu med vaccinacceptans i cancermiljöer genom samhällsengagemang
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Lisa B Puglisi, MD
- Telefonnummer: 475-306-1023
- E-post: Lisa.puglisi@yale.edu
Studieorter
-
-
Pennsylvania
-
Schwenksville, Pennsylvania, Förenta staterna, 19473
- Rekrytering
- Pennsylvannia Department of Corrections
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: Treatment as usual
Participants receive standard interventions currently in use (treatment as usual). |
|
|
Experimentell: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
COVID-19 vaccine acceptance rate
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Respiratory infections rate
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Lisa B Puglisi, MD, Yale University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2000035026
- 1R01MD016853-01A1 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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