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Parent-son-provider Decision-making About HPV Vaccination

13. desember 2012 oppdatert av: 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.

Studieoversikt

Status

Fullført

Detaljert beskrivelse

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

Observasjonsmessig

Registrering (Faktiske)

62

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

13 år til 17 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Kohorter og intervensjoner

Gruppe / Kohort
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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Decision Regarding Acceptance/Refusal of 1st Dose of HPV Vaccine
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Samarbeidspartnere

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. februar 2011

Primær fullføring (Faktiske)

1. november 2012

Studiet fullført (Faktiske)

1. november 2012

Datoer for studieregistrering

Først innsendt

24. januar 2011

Først innsendt som oppfylte QC-kriteriene

25. januar 2011

Først lagt ut (Anslag)

27. januar 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

17. desember 2012

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. desember 2012

Sist bekreftet

1. desember 2012

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • Merck IISP 38094

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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