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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03824093
Other study ID # ChildrensMHC
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2018
Est. completion date May 6, 2020

Study information

Verified date January 2021
Source Children's Mercy Hospital Kansas City
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Human Papillomavirus (HPV) is a significant public health issue affecting nearly 14 million people in the United States. HPV can lead to cervical, oropharyngeal, anal, and penile cancers as well as genital warts.The purpose of this study is to test the comparative effectiveness of two interventions, AFIX only vs. AFIX + communication training, to increase Human Papillomavirus (HPV) vaccination rates among adolescent patients in outpatient clinic settings. Providers and staff at four pediatric practices will be randomized to receive an in-person AFIX consultation or an AFIX consultation combined with communication training and commitment poster displays. Provider and parent data will be collected via a tablet computer RedCap survey. Additional practice and provider level HPV vaccination rates will be collected via patient de-identified claims data. The results of this study could contribute to the existing body of literature that suggests provider recommendations and routine vaccination assessments are key to increasing HPV vaccination uptake. This project has the potential to lead to the implementation and dissemination of low resource interventions to increase HPV vaccination rates among children and adolescents.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
AFIX Only
The intervention will include an in-person AFIX assessment of the practice's adolescent vaccination rates.
AFIX+ Provider Communication Training
The intervention will include an in-person AFIX assessment of the practice's adolescent vaccination rates along with communication training for providers and poster and brochure displays.

Locations

Country Name City State
United States Children's Mercy Hospital Kansas City Kansas City Missouri

Sponsors (3)

Lead Sponsor Collaborator
Children's Mercy Hospital Kansas City Midwest Cancer Alliance, University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary HPV vaccination rates Practice and provider level HPV vaccination rates will be collected from patient de-identified claims data. 18 months
Secondary Parent Satisfaction Parent satisfaction with visit will be collected using validated measures on tablet computers 18 months
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