Parent-son-provider Decision-making About HPV Vaccination

An Investigation of Parent-son-provider Decision-making About HPV Vaccination

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.

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 62

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • IU Medical Group Primary Care Clinic (IUMG-PC), including Wishard primary care clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: January 24, 2011
• First Submitted That Met QC Criteria: January 25, 2011
• First Posted (Estimate): January 27, 2011

Study Record Updates

• Last Update Posted (Estimate): December 17, 2012
• Last Update Submitted That Met QC Criteria: December 13, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Decision Making; HPV Vaccines; Qualitative Research; Attitude to Health
• Other Study ID Numbers: Merck IISP 38094