Parent-son-provider Decision-making About HPV Vaccination

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01284374
Recruitment Status : Completed
First Posted : January 27, 2011
Last Update Posted : December 17, 2012
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Gregory Zimet, Indiana University

Brief Summary:

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 or disease
Human Papillomavirus Vaccination

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.

Study Type : Observational
Actual Enrollment : 62 participants
Official Title: An Investigation of Parent-son-provider Decision-making About HPV Vaccination
Study Start Date : February 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

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

Primary Outcome Measures :
  1. Decision Regarding Acceptance/Refusal of 1st Dose of HPV Vaccine [ Time Frame: Up to 1 hour ]
    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.

  2. Health care providers decision-making regarding HPV vaccination of males [ Time Frame: Up to 1 hour ]
    Semi-structured interviews will be conducted with 20 health care providers regarding their decision-making around vaccinating adolescent male patients against HPV

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Parent-Adolescent pairs attending community-based adolescent health primary care clinics

Inclusion Criteria:


  • English-speaking adolescent boys
  • 13-17 years of age
  • No prior receipt of HPV vaccine
  • Accompanied by parent


  • English-speaking or Spanish-speaking parent

Health Care Provider:

  • Physician
  • Provides care to adolescent boys 13-17 years of age

Exclusion Criteria:


  • Non-English-speaking
  • Younger than 13 or older than 17
  • Previous receipt of 1 or more doses of HPV vaccine


  • Non-English-speaking and Non-Spanish-speaking

Health Care Provider:

  • Not a physician
  • Does not provide care to males 13-17 years of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01284374

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.
Principal Investigator: Gregory D Zimet, PhD Indiana University

Responsible Party: Gregory Zimet, Professor, Indiana University Identifier: NCT01284374     History of Changes
Other Study ID Numbers: Merck IISP 38094
First Posted: January 27, 2011    Key Record Dates
Last Update Posted: December 17, 2012
Last Verified: December 2012

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

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs