- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT06098690
Kulturelt skræddersyet HPV-psykoeducerende multimedieintervention
Implementering af innovative og strategiske tilgange til at forebygge og afbøde de skadelige virkninger af HPV i hele levetiden for latinamerikanere af mexicansk oprindelse: Fællesskabsintervention
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Texas
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El Paso, Texas, Forenede Stater, 79968
- The University of Texas at El Paso, Border Biomedical Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- Voksne mellem 18 og 45 år
- Voksne, der ikke har gennemført HPV-vaccineserien (uvaccinerede eller undervaccinerede)
- Voksne, der i øjeblikket bor eller arbejder i El Paso County, Texas
Ekskluderingskriterier:
- Voksne, der deltog i fase I eller II af det større forskningsprojekt [tværsnitsfaser]
- Voksne under 18 år
- Voksne ældre end 45 år
- Voksne, der ikke bor, planlægger at bo eller arbejde i El Paso County, Texas, inden for de næste 12 måneder efter starten af interventionen
- Voksne, der ikke er i stand til at deltage i den fulde undersøgelsesintervention og opfølgningstidspunkter
- Voksne, der ikke kan gennemføre studiedeltagelse og aktiviteter på hverken engelsk eller spansk.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Behandling
En skræddersyet HPV psykoedukativ multimedieintervention
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Den kulturelt skræddersyede psykoedukative multimedieintervention vil involvere lyd- og visuelt indhold og vil blive leveret på en tosproget måde (engelsk og spansk) blandt voksne 18-45 år.
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Aktiv komparator: Aktiv kontrol
Generelt/standard multimediemateriale om HPV og HPV-vaccine
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Den generelle/offentligt tilgængelige multimedieintervention vil involvere lyd- og visuelt indhold og vil blive leveret på en tosproget måde (engelsk og spansk) blandt voksne 18-45 år.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants With Human Papillomavirus (HPV) Vaccine Uptake After the Survey
Tidsramme: 1-month post-intervention
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Human Papillomavirus (HPV) vaccine uptake was assessed using the self-reported question, "Since completing the initial survey, I have been vaccinated against HPV," which measured whether participants received the HPV vaccine after survey completion.
The outcome was treated as a binary variable (Yes/No), with higher proportions indicating greater HPV vaccine uptake following the intervention.
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1-month post-intervention
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Changes in Human Papillomavirus (HPV) Vaccination Intention Score
Tidsramme: baseline to 0 month post intervention (right after the survey)
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Human Papillomavirus (HPV) vaccination intention was assessed using a self-reported Likert-scale item measuring participants' intention to receive the HPV vaccine.
Responses were recorded on a 5-point scale ranging from 1 ("Strongly disagree") to 5 ("Strongly agree"), with higher scores indicating greater intention to receive HPV vaccination.
Changes in HPV vaccination intention scores from baseline to follow-up were compared between intervention and control groups.
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baseline to 0 month post intervention (right after the survey)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Human Papillomavirus (HPV) Vaccine Attitude Score
Tidsramme: Baseline
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Human Papillomavirus (HPV) vaccine attitudes (perceived safety, perceived harm, perceived effectiveness) measured using an 11-item scale, scored on a Likert scale from Strongly disagree (1) to Strongly agree (5). A composite score was calculated by averaging responses across all assessed items, ranging from 1 to 5, with higher scores indicating more positive attitudes toward HPV vaccination. |
Baseline
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Human Papillomavirus (HPV) Vaccine Attitude Score
Tidsramme: 0 month post intervention
|
Human Papillomavirus (HPV) vaccine attitudes (perceived safety, perceived harm, perceived effectiveness) measured using an 11-item scale, scored on a Likert scale from Strongly disagree (1) to Strongly agree (5). A composite score was calculated by averaging responses across all assessed items, ranging from 1 to 5, with higher scores indicating more positive attitudes toward HPV vaccination. |
0 month post intervention
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Human Papillomavirus (HPV) Vaccine Attitude Score
Tidsramme: 1 month post intervention
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Human Papillomavirus (HPV) vaccine attitudes (perceived safety, perceived harm, perceived effectiveness) measured using an 11-item scale, scored on a Likert scale from Strongly disagree (1) to Strongly agree (5). A composite score was calculated by averaging responses across all assessed items, ranging from 1 to 5, with higher scores indicating more positive attitudes toward HPV vaccination. |
1 month post intervention
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Human Papillomavirus (HPV) Knowledge Score
Tidsramme: Baseline (pre-assessment)
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The Human Papillomavirus (HPV) knowledge score was measured using a 14-item scale, with responses coded as True = 1 and False = 0. Item scores were averaged to create a composite score and multiplied by 100 to yield a percentage score. A composite score was calculated by averaging responses across all assessed items and multiplying the result by 100 to obtain a percentage score, ranging from 0 to 100, with higher scores indicating greater HPV-related knowledge. |
Baseline (pre-assessment)
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Human Papillomavirus (HPV) Knowledge Score
Tidsramme: 0 month post intervention
|
The Human Papillomavirus (HPV) knowledge score was measured using a 14-item scale, with responses coded as True = 1 and False = 0. Item scores were averaged to create a composite score and multiplied by 100 to yield a percentage score. A composite score was calculated by averaging responses across all assessed items and multiplying the result by 100 to obtain a percentage score, ranging from 0 to 100, with higher scores indicating greater HPV-related knowledge. |
0 month post intervention
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Human Papillomavirus (HPV) Knowledge Score
Tidsramme: 1 month post intervention
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The Human Papillomavirus (HPV) knowledge score was measured using a 14-item scale, with responses coded as True = 1 and False = 0. Item scores were averaged to create a composite score and multiplied by 100 to yield a percentage score. A composite score was calculated by averaging responses across all assessed items and multiplying the result by 100 to obtain a percentage score, ranging from 0 to 100, with higher scores indicating greater HPV-related knowledge. |
1 month post intervention
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Eva M Moya, PhD, LMSW, The University of Texas at El Paso, Border Biomedical Research Center
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
- Voksen
- Kvinde
- Han
- Sundhedsforskelle
- Sociale determinanter for sundhed
- Seksuel og reproduktiv sundhed
- Ung voksen
- Adfærdsforskning
- Human Papillomavirus Vaccination
- Human Papillomavirus kræftscreening
- Forebyggelse af HPV-kræft
- Bekæmpelse af HPV-kræft
- Grænsesundhed mellem USA og Mexico
- Samfundsengageret forskning
- Sundhedsuligheder
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 8321-2
- 2U54MD007592-26 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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