Human Papillomavirus VaccinationNCT01284374
Parent-son-provider Decision-making About HPV Vaccination
An observational study of Human Papillomavirus Vaccination, run by Indiana University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Human Papillomavirus Vaccination
- Type of treatment
- Vaccines
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Nov 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Parent-Adolescent pairs attending community-based adolescent health primary care clinics
Who may be able to join
- Adolescent:
- English-speaking adolescent boys
- 13-17 years of age
- No prior receipt of HPV vaccine
- Accompanied by parent
- Parent:
Show all 10Show fewer
- English-speaking or Spanish-speaking parent
- Health Care Provider:
- Physician
- Provides care to adolescent boys 13-17 years of age
Who cannot join
- 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
Show all 9Show fewer
- Health Care Provider:
- Not a physician
- Does not provide care to males 13-17 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
IU Medical Group Primary Care Clinic (IUMG-PC), including Wishard primary care clinics
Indianapolis, Indiana, 46202
About this study
Official title: An Investigation of Parent-son-provider Decision-making About HPV Vaccination
The objectives of this study are:
- 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.
- To evaluate health care providers (HCPs) attitudes, implementation intentions, and planned communication strategies with respect to HPV vaccination of adolescent boys.
Read more
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.
Read the 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.
- Conditions
- Human Papillomavirus Vaccination
- Keywords
- HPV Vaccines, Attitude to Health, Decision Making, Qualitative Research
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus VaccinationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Gregory Zimet, Indiana University
- Investigators
- Gregory D Zimet, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01284374
- Sponsor's protocol ID
- Merck IISP 38094
- Status last verified
- Dec 2012
- First submitted
- 24 Jan 2011
- Last updated
- 17 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of Parent-son-provider Decision-making About HPV Vaccination
- ClinicalTrials.gov ID
- NCT01284374
- Acronym / sponsor ID
- Merck IISP 38094
- Conditions
- Human Papillomavirus Vaccination
- Keywords
- HPV Vaccines, Attitude to Health, Decision Making, Qualitative Research
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Feb 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 27 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are:
- 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.
- 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.
Study design
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Parent-Adolescent pairs attending community-based adolescent health primary care clinics
Key inclusion criteria (10 listed)
- English-speaking adolescent boys
- 13-17 years of age
- No prior receipt of HPV vaccine
- Accompanied by parent
- English-speaking or Spanish-speaking parent
Key exclusion criteria (9 listed)
- 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
- Not a physician
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory D Zimet, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Papillomavirus Vaccination, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decision Regarding Acceptance/Refusal of 1st Dose of HPV Vaccine (time frame: Up to 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2012.