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

30 janvier 2013 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

90

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Ohio
      • Cincinnati, Ohio, États-Unis, 45221-0068
        • Manoj Sharma

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 25 ans (Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Homme

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation factorielle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comportemental: HPV vaccine acceptability
One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention.
Comparateur actif: Knowledge-based education
This comparison arm will provide education based on knowledge regarding HPV vaccine acceptability.
Comportemental: HPV vaccine acceptability
One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
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
Délai: 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)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change From Baseline to Post Intervention to Follow-up (up to 3 Months) After the Interventions in Score of Perceived Susceptibility for HPV
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Cincinnati

Les enquêteurs

  • Chercheur principal: Manoj Sharma, Ph.D., University of Cincinnati
  • Directeur d'études: Rebecca Lee, Ph.D., University of Cincinnati
  • Directeur d'études: Purvi Mehta, MS, University of Cincinnati

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 septembre 2011

Achèvement primaire (Réel)

1 juillet 2012

Achèvement de l'étude (Réel)

1 août 2012

Dates d'inscription aux études

Première soumission

3 septembre 2011

Première soumission répondant aux critères de contrôle qualité

8 septembre 2011

Première publication (Estimation)

9 septembre 2011

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

4 février 2013

Dernière mise à jour soumise répondant aux critères de contrôle qualité

30 janvier 2013

Dernière vérification

1 janvier 2013

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • 11083108
  • 39991 (Autre identifiant: Merck Pharmaceuticals)

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

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