Clinical trial NCT01284374: Parent-son-provider Decision-making About HPV Vaccination
Official title: An Investigation of Parent-son-provider Decision-making About HPV Vaccination
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Papillomavirus Vaccination
Keywords: HPV Vaccines
Attitude to Health
Decision Making
Qualitative Research
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2011-01-27
Enrollment: 62
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parent-Adolescent pairs attending community-based adolescent health primary care clinics

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.

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 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

Primary outcomes:
measure: Decision Regarding Acceptance/Refusal of 1st Dose of HPV Vaccine
timeFrame: Up to 1 hour
measure: Health care providers decision-making regarding HPV vaccination of males
timeFrame: Up to 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: IU Medical Group Primary Care Clinic (IUMG-PC), including Wishard primary care clinics
state: Indiana
Study officials:
affiliation: Indiana University
name: Gregory D Zimet, PhD
role: PRINCIPAL_INVESTIGATOR
References: