- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01431079
A Health Belief Model Based Intervention to Increase Human Papilloma Virus (HPV) Vaccination Among College Men
Designing and Evaluating a Health Belief Model Based Intervention to Increase Intent of HPV Vaccination Among College Men: Use of Qualitative and Quantitative Methodologies
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45221-0068
- Manoj Sharma
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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.
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One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention.
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Aktiv komparator: Knowledge-based education
This comparison arm will provide education based on knowledge regarding HPV vaccine acceptability.
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One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
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
Tidsramme: Post intervention and up to 3 months after the interventions
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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.
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Post intervention and up to 3 months after the interventions
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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)
Tidsramme: Post intervention and up to 3 months after the intervention
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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
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change From Baseline to Post Intervention to Follow-up (up to 3 Months) After the Interventions in Score of Perceived Susceptibility for HPV
Tidsramme: Post interventions and up to 3 months after the interventions
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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
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Change From Baseline to Post Test to Upto 3 Month Follow-up After the Interventions in Score for Perceived Severity for HPV
Tidsramme: Post interventions and up to 3 months after the intervention
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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
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Change From Baseline to Post Test After the Interventions to up to 3 Month Follow-up in Score of Perceived Benefits of HPV Vaccine
Tidsramme: post intervention and up to 3 months after the interventions
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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
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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
Tidsramme: post interventions and up to 3 months after the intervention
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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
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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
Tidsramme: Post interventions and up to three months after the intervention
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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
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Change From Baseline and After the Interventions to up to 3 Months Follow-up in Score of Self-efficacy for Receiving HPV Vaccine
Tidsramme: Post interventions and up to 3 months follow-up
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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
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Manoj Sharma, Ph.D., University of Cincinnati
- Studieleder: Rebecca Lee, Ph.D., University of Cincinnati
- Studieleder: Purvi Mehta, MS, University of Cincinnati
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 11083108
- 39991 (Anden identifikator: Merck Pharmaceuticals)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Kliniske forsøg med Acceptabilitet af HPV-vacciner
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H. Lee Moffitt Cancer Center and Research InstituteNational Cancer Institute (NCI)AfsluttetHPV-vaccine | HPVForenede Stater, Puerto Rico
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Indiana UniversityMerck Sharp & Dohme LLCAfsluttetHPV-vaccine holdninger | HPV-vaccine hensigtForenede Stater
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Global Alliance to Immunize Against AIDS Vaccine...Merck Sharp & Dohme LLCAfsluttetHPV-relateret livmoderhalskræft | HPV
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Emory UniversityRekruttering
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East Carolina UniversityRekruttering
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University of FloridaNational Cancer Institute (NCI)Aktiv, ikke rekrutterende
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University of MinnesotaAfsluttet
-
Brigham and Women's HospitalNational Institutes of Health (NIH)Ikke rekrutterer endnu
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Fudan UniversityThe University of Hong KongIkke rekrutterer endnu
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Memorial Sloan Kettering Cancer CenterHackensack Meridian Health; The City College of New YorkAktiv, ikke rekrutterendeForsøg med en social marketingkampagne for at øge HPV-vaccination blandt mexicanske amerikanske børnHPV-vaccinationForenede Stater
Kliniske forsøg med HPV vaccine acceptability
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Central Hospital, Nancy, FranceUkendt
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Maisonneuve-Rosemont HospitalRekruttering
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Sun Yat-sen UniversityRekrutteringFor tidlig ovariesvigt | MenstruationsforstyrrelseKina
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Zhejiang Provincial Center for Disease Control...Aktiv, ikke rekrutterendeMæslinger | Røde hunde | Fåresyge | Human Papilloma Virus Infektion Type 16 | Human Papilloma Virus Infektion Type 18Kina
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H. Lee Moffitt Cancer Center and Research InstituteFlorida Department of Health; Health Choice NetworkRekrutteringHuman Papilloma Virus (HPV) VaccineForenede Stater
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Instituto Nacional de Cancerologia, ColumbiaAktiv, ikke rekrutterendeLivmoderhalskræft | HPV-infektionColombia
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Xiamen UniversityXiamen Innovax Biotech Co., Ltd; Beijing Wantai Biological Pharmacy Enterprise...AfsluttetLivmoderhalskræft | Cervikal intraepitelial neoplasiKina
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OHSU Knight Cancer InstituteOregon Health and Science University; Robert Wood Johnson FoundationAfsluttetCervikal karcinom | Human papillomavirus infektionForenede Stater
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University of AarhusMunicipality of Aarhus; Neighbourhood mothers, GellerupAktiv, ikke rekrutterende
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Deutsche Luft und RaumfahrtUkendtHIV-infektioner | Papillomavirus infektionerTyskland