Parent-son-provider Decision-making About HPV Vaccination

Human Papillomavirus Vaccination Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01284374
• Other study ID #: Merck IISP 38094
• Status: Completed
• Phase: N/A
• First received: January 24, 2011
• Last updated: December 13, 2012
• Start date: February 2011
• Est. completion date: November 2012

Study information

• Verified date: December 2012
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 17 Years

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Human Papillomavirus Vaccination

Locations

Country	Name	City	State
United States	IU Medical Group Primary Care Clinic (IUMG-PC), including Wishard primary care clinics	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No