Parent-son-provider Decision-making About HPV Vaccination

NCT01284374 | Completed

• 1 other identifier: Merck IISP 38094
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this study are:

1. 1.To better understand factors associated with acceptance and refusal of HPV vaccine among parent-son pairs and the process of parent-son decision-making with respect to vaccination.
2. 2.To evaluate health care providers (HCPs) attitudes, implementation intentions, and planned communication strategies with respect to HPV vaccination of adolescent boys.

Conditions

Human Papillomavirus Vaccination

Keywords

HPV Vaccines; Attitude to Health; Decision Making; Qualitative Research

Outcome Measures

Primary Outcomes (2)

• Decision Regarding Acceptance/Refusal of 1st Dose of HPV Vaccine

  The semi-structured interviews with parents \& sons will focus on how the decision was made to accept or refuse HPV vaccine. The interviews will take place immediately after the clinic visit during which the vaccination decision was made.

  Up to 1 hour

• Health care providers decision-making regarding HPV vaccination of males

  Semi-structured interviews will be conducted with 20 health care providers regarding their decision-making around vaccinating adolescent male patients against HPV

  Up to 1 hour

Study Arms (3)

Male Adolescents

Male adolescents, 13-17 years old, who are seen at community adolescent health clinics and are offered HPV vaccine

Parents of Male Adolescents

Parents of Male Adolescents, whose adolescents are being seen at community adolescent health clinics and are offered HPV vaccine

Health Care Providers for Males 13-17 yo

Health care providers who provide medical care to male adolescents in pediatric and adolescent clinics

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Parent-Adolescent pairs attending community-based adolescent health primary care clinics

You may qualify if:

• Adolescent:
• English-speaking adolescent boys
• years of age
• No prior receipt of HPV vaccine
• Accompanied by parent
• Parent:
• English-speaking or Spanish-speaking parent
• Health Care Provider:
• Physician
• Provides care to adolescent boys 13-17 years of age

You may not qualify if:

• Adolescent:
• Non-English-speaking
• Younger than 13 or older than 17
• Previous receipt of 1 or more doses of HPV vaccine
• Parent:
• Non-English-speaking and Non-Spanish-speaking
• Health Care Provider:
• Not a physician
• Does not provide care to males 13-17 years of age

Sponsors & Collaborators

• Indiana University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

IU Medical Group Primary Care Clinic (IUMG-PC), including Wishard primary care clinics

Indianapolis, Indiana, 46202, United States

Location

Study Officials

• Gregory D Zimet, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 24, 2011
• First Posted: January 27, 2011
• Study Start: February 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: December 17, 2012

Record last verified: 2012-12

Locations

US (1)