High and Low Resource Interventions to Promote HPV Vaccines

NCT03824093 | Completed DMC

• 1 other identifier: ChildrensMHC
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Human Papilloma Virus; Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination; Meningitis, Meningococcal; Communication; Satisfaction

Keywords

Adolescent Vaccines

Outcome Measures

Primary Outcomes (1)

• HPV vaccination rates

  Practice and provider level HPV vaccination rates will be collected from patient de-identified claims data.

  18 months

Secondary Outcomes (1)

• Parent Satisfaction

  18 months

Study Arms (2)

AFIX Only

ACTIVE COMPARATOR

Practices enrolled in the AFIX only arm will receive an in-person AFIX consultation that includes assessment of current HPV vaccination rates and feedback on strategies to increase vaccination rates.

Behavioral: AFIX Only

AFIX+ Provider Communication Training

ACTIVE COMPARATOR

Practices enrolled in the AFIX+ Provider Training arm will receive an in-person AFIX consultation along with a brief communication training for providers and poster and brochure displays in clinic waiting and exam rooms.

Behavioral: AFIX+ Provider Communication Training

Interventions

AFIX Only BEHAVIORAL

The intervention will include an in-person AFIX assessment of the practice's adolescent vaccination rates.

AFIX Only

AFIX+ Provider Communication Training BEHAVIORAL

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.

AFIX+ Provider Communication Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parent or legal guardian of a child 11-18 years of age or a pediatric health care provider
• Parent or legal guardian of a child being seen for a well-child visit
• Ability to provide informed consent

You may not qualify if:

• Prior participation in the study
• Unable to read or understand English

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead
• University of Kansas Medical Center: collaborator
• Midwest Cancer Alliance: collaborator

Study Sites (1)

Children's Mercy Hospital Kansas City

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Diphtheria; Meningitis, Meningococcal; Communication; Personal Satisfaction

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Meningococcal Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Practices will be randomly assigned to the AFIX only or AFIX+ communication training study arms. Both groups will receive identical AFIX consultations, but only practices assigned to the AFIX+ communication training arm will receive brief, provider communication training and commitment poster displays. Once practices have been randomized, parents of adolescent patients will be exposed to one of the interventions based on their practice location. Participants will not be informed of their practice's study arm.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: January 31, 2019
• Study Start: July 1, 2018
• Primary Completion: May 6, 2020
• Study Completion: May 6, 2020
• Last Updated: January 20, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be made available 9 months after the conclusion of the study upon request and completion of a data sharing agreement.

Locations

US (1)