Parent-son-provider Decision-making About HPV Vaccination

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Gregory Zimet, Indiana University
ClinicalTrials.gov Identifier:
NCT01284374
First received: January 24, 2011
Last updated: December 13, 2012
Last verified: December 2012
  Purpose

The objectives of this study are:

  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. To evaluate health care providers (HCPs) attitudes, implementation intentions, and planned communication strategies with respect to HPV vaccination of adolescent boys.

Hypothesis 1: Sons will have a significant role in the process of parent-son decision-making about HPV vaccination. The relative importance of this role will increase with the son's age.

Hypothesis 2: Pediatric HCPs will be unsure about vaccinating males and will lack knowledge about issues related to male HPV infection and vaccination.


Condition
Human Papillomavirus Vaccination

Study Type: Observational
Official Title: An Investigation of Parent-son-provider Decision-making About HPV Vaccination

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Decision Regarding Acceptance/Refusal of 1st Dose of HPV Vaccine [ Time Frame: Up to 1 hour ] [ Designated as safety issue: No ]
    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.

  • Health care providers decision-making regarding HPV vaccination of males [ Time Frame: Up to 1 hour ] [ Designated as safety issue: No ]
    Semi-structured interviews will be conducted with 20 health care providers regarding their decision-making around vaccinating adolescent male patients against HPV


Enrollment: 62
Study Start Date: February 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed Description:

This protocol will involve individual semi-structured qualitative interviews with 30 parent-son dyads and 20 pediatric health care providers. Parent-son pairs will be recruited from IUMG primary care adolescent health clinics. Recruitment will occur and consent/assent for participation obtained during the visit with the health care provider, with the physician out of the room. Interviews with parents and sons will take place after the health care appointment and after HPV vaccine acceptance/refusal. Parents and sons will be administered a brief questionnaire that will cover socio-demographic and other background information. The parent-son interviews will be separate, simultaneous one-on-one ethnographic interviews (30-60 min) that focus on the decision making process regarding HPV vaccination (yes/no). Each interview will consist of 8-10 open-ended questions, serving as an elicitation device. Sample questions include: (1) Tell me what you understand about the HPV vaccine? (2) Tell me what happened when you were in the examination room and your doctor asked you and your parent/son about getting the vaccine? (3) Was the decision made quickly, or did you have a conversation about it first? (4) Who had the most influence on the decision, you or your parent/son? (5) Why did you decide to get (or not to get) the vaccine? The interviewer will ask participants to elaborate on the meaning and contexts of their responses, and look for organization in what the participant is saying, developing and testing hypotheses during the interview. Each interview will be conducted by a trained, gender-matched research assistant.

Health care providers will be interviewed at a different time, and the interviews (25-30 min) will focus on HPV vaccine related attitudes, supply, costs, communication and perceived benefits associated with vaccinating adolescent males, rather than care to specific patients. Sample questions include: (1) How do you inform patients about the HPV vaccine? (2) What is the specific wording that you use when you offer HPV vaccine? Be very specific. Don't leave out any detail.

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

Adolescent:

  • English-speaking adolescent boys
  • 13-17 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

Exclusion Criteria:

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01284374

Locations
United States, Indiana
IU Medical Group Primary Care Clinic (IUMG-PC), including Wishard primary care clinics
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Gregory D Zimet, PhD Indiana University
  More Information

No publications provided

Responsible Party: Gregory Zimet, Professor, Indiana University
ClinicalTrials.gov Identifier: NCT01284374     History of Changes
Other Study ID Numbers: Merck IISP 38094
Study First Received: January 24, 2011
Last Updated: December 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
HPV Vaccines
Attitude to Health
Decision Making
Qualitative Research

ClinicalTrials.gov processed this record on April 17, 2014