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

30 gennaio 2013 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

90

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Ohio
      • Cincinnati, Ohio, Stati Uniti, 45221-0068
        • Manoj Sharma

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 25 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Maschio

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione fattoriale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: HPV vaccine acceptability
One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention.
Comparatore attivo: Knowledge-based education
This comparison arm will provide education based on knowledge regarding HPV vaccine acceptability.
Comportamentale: HPV vaccine acceptability
One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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
Lasso di tempo: 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)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline to Post Intervention to Follow-up (up to 3 Months) After the Interventions in Score of Perceived Susceptibility for HPV
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Cincinnati

Investigatori

  • Investigatore principale: Manoj Sharma, Ph.D., University of Cincinnati
  • Direttore dello studio: Rebecca Lee, Ph.D., University of Cincinnati
  • Direttore dello studio: Purvi Mehta, MS, University of Cincinnati

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 settembre 2011

Completamento primario (Effettivo)

1 luglio 2012

Completamento dello studio (Effettivo)

1 agosto 2012

Date di iscrizione allo studio

Primo inviato

3 settembre 2011

Primo inviato che soddisfa i criteri di controllo qualità

8 settembre 2011

Primo Inserito (Stima)

9 settembre 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

4 febbraio 2013

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 gennaio 2013

Ultimo verificato

1 gennaio 2013

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • 11083108
  • 39991 (Altro identificatore: Merck Pharmaceuticals)

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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