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Multicomponent Clinic-based Intervention for COVID-19 Vaccination Uptake (CONFIDENCE Trial)

N/A
Recruiting
Led By Stephenie C Lemon, PhD
Research Sponsored by University of Massachusetts, Worcester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Parent/guardian (referred to as parents in this proposal) of child between ages 5 and 17
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of study; approximately 15 months
Awards & highlights

CONFIDENCE Trial Summary

This trial will test an intervention to increase COVID-19 vaccine intention in parents of under-vaccinated children. Clinics will receive webinar training, materials, and posters to help communicate with vaccine-hesitant parents.

Who is the study for?
This trial is for parents of children aged 5-17 who are not up-to-date with COVID-19 vaccines, according to CDC guidelines. The families should be patients at certain clinics serving a diverse community with at least 30% minority groups and must understand English, Spanish, Portuguese or Vietnamese.Check my eligibility
What is being tested?
The CONFIDENCE intervention is being tested to see if it increases the intention and uptake of COVID-19 vaccines among youth. It includes webinar training for clinic staff on vaccine hesitancy communication, educational materials for parents, and personalized poster campaigns.See study design
What are the potential side effects?
Since this study focuses on an educational intervention rather than a medical treatment, there are no direct side effects from medications or procedures involved in the trial.

CONFIDENCE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am the parent or guardian of a child aged 5 to 17.

CONFIDENCE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of study; approximately 15 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study; approximately 15 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
COVID-19 vaccine intention
Secondary outcome measures
Acceptability: Parents
Acceptability: Providers and clinic staff
Feasibility: Data Completeness
+6 more

CONFIDENCE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention ConditionExperimental Treatment1 Intervention
Group II: Waitlist ConditionActive Control1 Intervention
Clinics in this condition will receive the intervention approximately 12 months after the intervention condition.

Find a Location

Who is running the clinical trial?

University of Massachusetts, WorcesterLead Sponsor
343 Previous Clinical Trials
986,210 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,060,271 Total Patients Enrolled
Baystate HealthOTHER
6 Previous Clinical Trials
52,725 Total Patients Enrolled

Media Library

CONFIDENCE Clinical Trial Eligibility Overview. Trial Name: NCT05722652 — N/A
COVID-19 Vaccination Research Study Groups: Intervention Condition, Waitlist Condition
COVID-19 Vaccination Clinical Trial 2023: CONFIDENCE Highlights & Side Effects. Trial Name: NCT05722652 — N/A
CONFIDENCE 2023 Treatment Timeline for Medical Study. Trial Name: NCT05722652 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open enrolment slots for this research project?

"Indeed, the clinicaltrials.gov website shows that this medical trial is still recruiting patients since it was first published on March 27th 2023 and last revised on May 5th of the same year. 400 individuals need to be recruited from one particular site for this study."

Answered by AI

What is the current participant count for this clinical experiment?

"Affirmative. According to clinicaltrials.gov, this research project is still recruiting participants who applied after the initial posting on March 27th 2023 and before the last update on May 5th 2023. 400 people are required across 1 centre for successful completion of this study."

Answered by AI

Who else is applying?

What site did they apply to?
UMass Chan Medical School
What portion of applicants met pre-screening criteria?
Did not meet criteria
~75 spots leftby Aug 2024