- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 4
Kontakte und Standorte
Studienorte
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Ohio
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Cincinnati, Ohio, Vereinigte Staaten, 45221-0068
- Manoj Sharma
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Fakultätszuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
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.
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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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Aktiver 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
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
Zeitfenster: 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)
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change From Baseline to Post Intervention to Follow-up (up to 3 Months) After the Interventions in Score of Perceived Susceptibility for HPV
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Manoj Sharma, Ph.D., University of Cincinnati
- Studienleiter: Rebecca Lee, Ph.D., University of Cincinnati
- Studienleiter: Purvi Mehta, MS, University of Cincinnati
Publikationen und hilfreiche Links
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 11083108
- 39991 (Andere Kennung: Merck Pharmaceuticals)
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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Klinische Studien zur HPV vaccine acceptability
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Maisonneuve-Rosemont HospitalRekrutierung
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Sun Yat-sen UniversityRekrutierungVorzeitige Ovarialinsuffizienz | MenstruationsstörungChina
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Zhejiang Provincial Center for Disease Control...Aktiv, nicht rekrutierendMasern | Röteln | Mumps | Infektion mit humanem Papillomavirus Typ 16 | Infektion mit humanem Papillomavirus Typ 18China
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H. Lee Moffitt Cancer Center and Research InstituteFlorida Department of Health; Health Choice NetworkRekrutierungImpfstoff gegen humanes Papillomavirus (HPV).Vereinigte Staaten
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Instituto Nacional de Cancerologia, ColumbiaAktiv, nicht rekrutierendGebärmutterhalskrebs | HPV-InfektionKolumbien
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OHSU Knight Cancer InstituteOregon Health and Science University; Robert Wood Johnson FoundationAbgeschlossenZervixkarzinom | Humane Papillomavirus-InfektionVereinigte Staaten
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University of AarhusMunicipality of Aarhus; Neighbourhood mothers, GellerupAktiv, nicht rekrutierend
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Deutsche Luft und RaumfahrtUnbekanntHIV-Infektionen | Papillomavirus-InfektionenDeutschland
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Xiamen UniversityXiamen Innovax Biotech Co., Ltd; Beijing Wantai Biological Pharmacy Enterprise...AbgeschlossenGebärmutterhalskrebs | Zervikale intraepitheliale NeoplasieChina
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Michigan State UniversityArizona State UniversityNoch keine RekrutierungHPV-Infektion | Durch Impfung vermeidbare KrankheitenVereinigte Staaten