HPV Vaccination: Evaluation of Reminder Prompts for Doses 2 & 3

NCT02558803 | Completed

• 1 other identifier: Merck 21
• Study Type: interventional
• Target: 1,305
• Locations: 1 country
• Sites: 5

Brief Summary

Randomized, 2-arm observational study. The 2 arms (randomized at the level of health care provider) will be: 1. usual practice; 2. automated reminders to recommend 2nd and 3rd doses of HPV vaccine for eligible male and female adolescents who have initiated vaccination.

Conditions

Human Papilloma Virus Infection Type 11; Human Papilloma Virus Infection Type 16; Human Papilloma Virus Infection Type 18; Human Papilloma Virus Infection Type 6; Cervical Cancer; Genital Warts; Oropharyngeal Cancer

Keywords

HPV Vaccinations; Quadrivalent Vaccine

Outcome Measures

Primary Outcomes (1)

• Rate of physician-targeted automated HPV vaccination reminders on 2nd and 3rd dose HPV vaccination rates among 11-17 year old male and female patients

  To evaluate the rate of physician-targeted automated HPV vaccination reminders on 2nd and 3rd dose HPV vaccination rates among 11-17 year old male and female patients who have received 1 or 2 doses of vaccine.

  Six Months

Secondary Outcomes (1)

• Assessment of Physician Acceptance of the Prompts

  Six Months

Study Arms (2)

Usual Care

NO INTERVENTION

The clinical team will be left to identify the need for a follow-up HPV vaccine through existing mechanisms

Simple Reminder

EXPERIMENTAL

A simple reminder prompt in which CHICA will provide an immunization reminder to the physician that the child is eligible for the 2nd or 3rd dose of vaccine.

Behavioral: Simple Reminder

Interventions

Simple Reminder BEHAVIORAL

A simple reminder prompt in which CHICA will provide an immunization reminder to the physician that the child is eligible for the 2nd or 3rd dose of vaccine.

Simple Reminder

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Provider Criteria
• All pediatricians and nurse practitioners who provide health care at the 5 CHICA clinics will be included in this study
• Subject Criteria
• Patients will be 11-17 year old
• Males and females
• A visit to at least one of the five CHICA clinics
• Eligible for the 2nd or 3rd dose of HPV vaccine

You may not qualify if:

• Patients in the eligible age range who have not started or have completed the HPV vaccine series will be excluded

Sponsors & Collaborators

• Regenstrief Institute, Inc.: lead
• Merck Sharp & Dohme LLC: collaborator
• Indiana University: collaborator

Study Sites (5)

Eskenazi Health Outpatient Care Center

Indianapolis, Indiana, 46202, United States

Location

Eskenazi Health Center Blackburn

Indianapolis, Indiana, 46208, United States

Location

Eskenazi Health Center Forest Manor

Indianapolis, Indiana, 46226, United States

Location

Eskenazi Health West 38th Street

Indianapolis, Indiana, 46254, United States

Location

Eskenazi Health Center Pecar

Indianapolis, Indiana, 46268, United States

Location

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MeSH Terms

Conditions

Uterine Cervical Neoplasms; Condylomata Acuminata; Oropharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Papillomavirus Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Warts; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Gregory D Zimet, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2015
• First Posted: September 24, 2015
• Study Start: February 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 25, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)