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Parent-son-provider Decision-making About HPV Vaccination

13 december 2012 bijgewerkt door: Gregory Zimet, Indiana University

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.

Studie Overzicht

Toestand

Voltooid

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

62

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

13 jaar tot 17 jaar (Kind)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Cohorten en interventies

Groep / 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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Decision Regarding Acceptance/Refusal of 1st Dose of HPV Vaccine
Tijdsspanne: 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.
Up to 1 hour
Health care providers decision-making regarding HPV vaccination of males
Tijdsspanne: 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
Up to 1 hour

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 februari 2011

Primaire voltooiing (Werkelijk)

1 november 2012

Studie voltooiing (Werkelijk)

1 november 2012

Studieregistratiedata

Eerst ingediend

24 januari 2011

Eerst ingediend dat voldeed aan de QC-criteria

25 januari 2011

Eerst geplaatst (Schatting)

27 januari 2011

Updates van studierecords

Laatste update geplaatst (Schatting)

17 december 2012

Laatste update ingediend die voldeed aan QC-criteria

13 december 2012

Laatst geverifieerd

1 december 2012

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • Merck IISP 38094

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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