- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04558307
Feasibility of Rapid COVID-19 Testing in Disadvantaged Populations
Enhancing Rapid Health Response in National Crises: Feasibility of Rapid COVID-19 Testing in Disadvantaged Populations Through Community-Academic Partnerships
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Accurate and early diagnosis of COVID-19 infections are critical for rapid initiation of quarantine interventions to reduce population spread and to provide appropriate medical care to reduce related morbidity and mortality during the current pandemic. The purpose of this study is to assess the feasibility of establishing a drive-through rapid COVID-19 testing site at a federally-qualified health center (FQHC) during a global health crisis to mitigate health consequences in socioeconomically disadvantaged populations. The investigators also seek to evaluate the effectiveness of community-driven communication in increasing access to rapid testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in this population. This will inform public health decisions about improving access to testing for SARS-CoV-2 in underserved populations, particularly those receiving care in FQHCs or community health centers.
The specific aims of the study are to:
Aim 1. To determine the feasibility of a community-engaged research partnership to support rapid SARS-CoV-2 testing for symptomatic patients of all ages in the underserved population during the COVID-19 crisis. A rapid testing strategy (drive-through testing site) at a FQHC using Mayo Clinic Laboratory (MCL) diagnostic processing will be piloted.
Aim 2. To compare the effectiveness of community-driven messaging in increasing uptake of rapid SARS-CoV-2 testing compared with usual sources of health information. A simple random sample will be drawn of FQHC patients (N=1000, age 18+) with 1:1 randomization of communication about COVID-19 and availability of rapid testing from the FQHC versus usual sources (control).
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Minnesota
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Rochester, Minnesota, États-Unis, 55905
- Mayo Clinic
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- This study will include all patients receiving clinically indicated testing for COVID-19 at a federally qualified health center (FQHC, Open Cities Health Center, St. Paul, MN).
- There will be no formal recruitment of patients in this research.
Exclusion Criteria:
-
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Observational Intervention
Rapid SARS-CoV-2 testing strategy
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Rapid testing strategy at an FQHC using Mayo Clinic Laboratory (MCL) diagnostic processing with a real-time polymerase chain reaction assay for SARS-CoV-2 and a Mayo Clinic drive-through collection protocol.
|
|
Behavioral Intervention
Community-driven messages to promote COVID-19 testing
|
A one-time communication about the availability of COVID-19 testing at the FQHC to patients randomized to the intervention group using any available means of communication (text and/or mailed letter).
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Intervention Feasibility Measures - FQHC Staff
Délai: 6-months after intervention start
|
FQHC staff will complete a comprehensive electronic survey adapted from the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) instrument to assess feasibility of community-engaged research partnership to support testing site (Weiner BJ, et al.
Implementation Science.
2017;12(1):108.).
|
6-months after intervention start
|
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2. Uptake of rapid SARS-CoV-2 testing strategy at the FQHC- Effectiveness of community-driven messaging to patients
Délai: 6-months after intervention start
|
Comparison of number of tests completed per group (intervention vs. control)
|
6-months after intervention start
|
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Uptake of rapid SARS-CoV-2 testing strategy at the FQHC
Délai: 9-months after intervention start
|
Comparison of number of tests completed per group (intervention vs. control)
|
9-months after intervention start
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Intervention Satisfaction Measures - Participant Satisfaction with COVID-19 testing
Délai: 6-months after intervention start
|
All randomized patients will complete a comprehensive survey with questions probing satisfaction with the drive-through testing site (ease of use, process, return of results, etc.).
|
6-months after intervention start
|
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5. Intervention Satisfaction Measures - Participant Satisfaction with community-driven messaging
Délai: 6-months after intervention start
|
Compare the satisfaction of community-driven messaging on availability of rapid SARS-CoV-2 testing at the FQHC (intervention vs. control)
|
6-months after intervention start
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: LaPrincess C Brewer, MD, MPH, Mayo Clinic
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 20-004046
Informations sur les médicaments et les dispositifs, documents d'étude
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