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

30 de janeiro de 2013 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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 de estudo

Intervencional

Inscrição (Real)

90

Estágio

  • Fase 4

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Estados Unidos
    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45221-0068
        • Manoj Sharma

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 25 anos (Adulto)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Macho

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição fatorial
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Comportamental: HPV vaccine acceptability
One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention.
Comparador Ativo: Knowledge-based education
This comparison arm will provide education based on knowledge regarding HPV vaccine acceptability.
Comportamental: HPV vaccine acceptability
One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
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
Prazo: 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)
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change From Baseline to Post Intervention to Follow-up (up to 3 Months) After the Interventions in Score of Perceived Susceptibility for HPV
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of Cincinnati

Investigadores

  • Investigador principal: Manoj Sharma, Ph.D., University of Cincinnati
  • Diretor de estudo: Rebecca Lee, Ph.D., University of Cincinnati
  • Diretor de estudo: Purvi Mehta, MS, University of Cincinnati

Publicações e links úteis

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Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de setembro de 2011

Conclusão Primária (Real)

1 de julho de 2012

Conclusão do estudo (Real)

1 de agosto de 2012

Datas de inscrição no estudo

Enviado pela primeira vez

3 de setembro de 2011

Enviado pela primeira vez que atendeu aos critérios de CQ

8 de setembro de 2011

Primeira postagem (Estimativa)

9 de setembro de 2011

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

4 de fevereiro de 2013

Última atualização enviada que atendeu aos critérios de controle de qualidade

30 de janeiro de 2013

Última verificação

1 de janeiro de 2013

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • 11083108
  • 39991 (Outro identificador: Merck Pharmaceuticals)

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

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