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A Health Belief Model Based Intervention to Increase Human Papilloma Virus (HPV) Vaccination Among College Men

30. ledna 2013 aktualizováno: Sharma Manoj, University of Cincinnati

Designing and Evaluating a Health Belief Model Based Intervention to Increase Intent of HPV Vaccination Among College Men: Use of Qualitative and Quantitative Methodologies

The purposes of this study are to (1) identify predictors of Human papillomavirus (HPV) vaccine acceptability among college men based on the Health Belief Model through focus groups, (2) triangulate focus group results with a prior quantitative study in developing an intervention based on the Health Belief Model to enhance HPV vaccine acceptability, and (3) test the efficacy of the above intervention based on the Health Belief Model by comparing it to a knowledge-based intervention. Approximately five focus groups with ten participants in each group with college students in the ages 18-25 years will be conducted at a large Midwestern University for the qualitative piece. Data will be analyzed for categories and triangulated with previous study to develop a theory based intervention. For the quantitative piece a randomized controlled design with 45 participants in each arm (theory based intervention and knowledge based intervention) will be implemented.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

Up to this date, there was a lack of qualitative research on vaccine acceptability among men and theory-based interventions that promote HPV vaccination among men. A few studies have been conducted with parents and physicians regarding HPV vaccination with girls, and a few regarding women's awareness and acceptability. Results indicated increasing awareness of HPV, informing costs and benefits associated with the vaccine, and perceived susceptibility. Based on this information, it is crucial to obtain a further understanding of knowledge, awareness, and predictors related to HPV and its vaccination in men. Information obtained can be utilized in developing an intervention to increase intentions of taking the HPV vaccine. Refining results will lead to a standardization of an intervention that can be implemented across college campuses.

Typ studie

Intervenční

Zápis (Aktuální)

90

Fáze

  • Fáze 4

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • Ohio
      • Cincinnati, Ohio, Spojené státy, 45221-0068
        • Manoj Sharma

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 25 let (Dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Mužský

Popis

Inclusion Criteria:

  • Males
  • English speaking
  • 18-25 years
  • Undergraduate or graduate student at the University of Cincinnati

Exclusion Criteria:

  • Females
  • Under 18 years, or above 25 years
  • Non- English speaking individuals
  • Non-university attending students
  • If already received HPV vaccination

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Faktorové přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Health belief model based education
This experimental arm will provide an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
Behaviorální: HPV vaccine acceptability
One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention.
Aktivní komparátor: Knowledge-based education
This comparison arm will provide education based on knowledge regarding HPV vaccine acceptability.
Behaviorální: HPV vaccine acceptability
One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change From Baseline to Post Intervention to Follow-up (up to 3 Months) After the Interventions the Number of Participants Who Have Taken the HPV Vaccine
Časové okno: Post intervention and up to 3 months after the interventions
Before, after and one to three month following the health belief model based educational intervention and knowledge-based educational intervention the participants will be asked if they have taken the first dose of HPV vaccine and changes noted.
Post intervention and up to 3 months after the interventions
Change From Baseline to Post Intervention to Follow-up up to 3 Months After the Interventions the Number of Participants Who Intend to Take HPV Vaccine Using HPV Intent Scale (Possible Range 0-4 Likert Units)
Časové okno: Post intervention and up to 3 months after the intervention

Before the interventions, post test after the interventions and follow-up 1 to 3 months after the interventions (health belief model based and knowledge based) participants will be asked about their intent to take the HPV vaccine on a scale of 0-4 Likert units and changes noted.

Posttest was conducted immediately after the intervention. Minimum score = 0 indicating no intent to take vaccine; Maximum score = 4 indicating strong intent to take vaccine. Scale was a single item scale.
Post intervention and up to 3 months after the intervention

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change From Baseline to Post Intervention to Follow-up (up to 3 Months) After the Interventions in Score of Perceived Susceptibility for HPV
Časové okno: Post interventions and up to 3 months after the interventions

Before the interventions, after the interventions and up to 3 months following the interventions the health belief model construct of perceived susceptibility for HPV scores will be measured on a paper pencil self-report test and changes noted. Perceived susceptibility for HPV will be measured as a summative score on a three item Likert subscale with a range of 0 to 12 (0- not likely and 12-very likely). The subscale has acceptable validity and reliability.

Difference between posttest and pre-test was done. This value was then used to run the multiple regressions.
Post interventions and up to 3 months after the interventions
Change From Baseline to Post Test to Upto 3 Month Follow-up After the Interventions in Score for Perceived Severity for HPV
Časové okno: Post interventions and up to 3 months after the intervention

Before the interventions, after the interventions and up to 3 months following the interventions the health belief model construct of perceived severity for HPV scores will be measured on a paper pencil self-report test and changes noted. Perceived severity for HPV will be measured as a summative score on a three item Likert subscale with a range of 0 to 12 to 12 (0- not likely and 12-very likely). The subscale has acceptable validity and reliability.

Difference between posttest and pre-test was done. This value was then used to run the multiple regressions.
Post interventions and up to 3 months after the intervention
Change From Baseline to Post Test After the Interventions to up to 3 Month Follow-up in Score of Perceived Benefits of HPV Vaccine
Časové okno: post intervention and up to 3 months after the interventions

Before the interventions, after the interventions and one month following the interventions the health belief model construct of Perceived benefits of HPV vaccine scores will be measured on a paper pencil self-report test and changes noted. Perceived benefits of HPV vaccine will be measured as a summative score on a four item Likert subscale with a range of 0 to 16 (0-not very likely and 16- very likely). The subscale has acceptable validity and reliability.

Difference between posttest and pre-test was done. This value was then used to run the multiple regressions.
post intervention and up to 3 months after the interventions
Change From Baseline to Post Test After the Interventions to Follow-up (up to 3 Months) in the Score of Perceived Barriers to Receiving HPV Vaccine
Časové okno: post interventions and up to 3 months after the intervention

Before the interventions, post test after the interventions following the interventions the health belief model construct of perceived barriers to receiving HPV vaccine scores will be measured on a paper pencil self-report test and changes noted. Perceived barriers for receiving HPV vaccine will be measured as a summative score on a three item Likert subscale with a range of 0 to 12 (0- not likely to 12- very likely). The subscale has acceptable validity and reliability.

A difference between post-test and pre-test were taken to obtain the score. This score was then used in the regression.
post interventions and up to 3 months after the intervention
Change From Baseline to After the Interventions to Follow-up up to 3 Months After the Interventions in Score of Cues to Action to Receiving HPV Vaccine
Časové okno: Post interventions and up to three months after the intervention

Before the interventions, and after the interventions and up to 3 months after the interventions the health belief model construct of cues to action to receiving HPV vaccine scores will be measured on a paper pencil self-report test and changes noted. Cues to action to receiving HPV vaccine will be measured as a summative score on a four item Likert subscale with a range of 0 to 16 (0- not at all likely to 16-very likely). The subscale has acceptable validity and reliability.

Difference between post and pre-test were used to obtain a change score. This score was used for regressions.
Post interventions and up to three months after the intervention
Change From Baseline and After the Interventions to up to 3 Months Follow-up in Score of Self-efficacy for Receiving HPV Vaccine
Časové okno: Post interventions and up to 3 months follow-up

Before the interventions and after the interventions the health belief model construct of self-efficacy for receiving HPV vaccine scores will be measured on a paper pencil self-report test and changes noted. Self-efficacy for receiving HPV vaccine will be measured as a summative score on a three item Likert subscale with a range of 0 to 12 (0- not likely to 12- very likely). The subscale has acceptable validity and reliability.

The difference between post and pre-test was taken to determine a change score. This score was then used for regressions.
Post interventions and up to 3 months follow-up

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of Cincinnati

Vyšetřovatelé

  • Vrchní vyšetřovatel: Manoj Sharma, Ph.D., University of Cincinnati
  • Ředitel studie: Rebecca Lee, Ph.D., University of Cincinnati
  • Ředitel studie: Purvi Mehta, MS, University of Cincinnati

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. září 2011

Primární dokončení (Aktuální)

1. července 2012

Dokončení studie (Aktuální)

1. srpna 2012

Termíny zápisu do studia

První předloženo

3. září 2011

První předloženo, které splnilo kritéria kontroly kvality

8. září 2011

První zveřejněno (Odhad)

9. září 2011

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

4. února 2013

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

30. ledna 2013

Naposledy ověřeno

1. ledna 2013

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

  • 11083108
  • 39991 (Jiný identifikátor: Merck Pharmaceuticals)

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

produkt vyrobený a vyvážený z USA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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