- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00739752
Interventions to Increase HBV Vaccinations in Sexually Transmitted Disease (STD) Clinics
7. november 2018 opdateret af: Gregory Zimet, Indiana University
Interventions to Increase HBV Vaccinations in STD Clinics
The goal of this study is to evaluate two sets of interventions to increase acceptance of hepatitis B virus (HBV) vaccination in patients attending sexually transmitted disease (STD) clinics.
The 1st set of interventions, with 3 levels, is based on message framing.
The 3 levels are: 1. information only; 2. gain-framed message; and 3. loss-framed message.
The 2nd set of interventions, with 2 levels, involves how the vaccine is recommended by the health care provider.
The 2 levels are: 1. HBV vaccine offered; and 2. HBV vaccine recommended.
The outcome of interest is1st dose acceptance.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
The goal of this study is to evaluate two sets of interventions to increase acceptance of hepatitis B virus (HBV) vaccination in patients attending sexually transmitted disease (STD) clinics.
The 1st specific aim is to assess the effect of message-framing on vaccine acceptance.
Framing theory suggests that positively framed messages (i.e., benefits of getting vaccine) are more effective than negatively framed messages (i.e., dangers of not getting vaccine) in stimulating preventive health behaviors.
Research on Framing Theory and engagement in health behaviors suggests also that the effects may be moderated by other attitudinal factors, including perceived risk of the behavior and degree of involvement in the message.
The 2nd aim is to evaluate the effect of provider-based interventions.
Prior research suggests that recommendations by health providers are very important in patients' decisions regarding acceptance of health care procedures.
Patients (18 years and older) will be recruited and followed from Chicago and Indianapolis STD clinics during routine medical visits.
An audio computer-assisted self-interview (A-CASI) will cover demographics, risk behaviors, and perceived risk associated with vaccination.
Subjects then will be randomized to receive a gain-framed, loss-framed, or information only message regarding HBV immunization (also delivered by A-CASI).
Upon completion of the message-framing intervention, subjects will complete additional attitude questions via A-CASI.
Upon completion of the A-CASI subjects will be randomly assigned to one of two provider intervention conditions: 1. vaccine offered or 2. vaccine recommended.
For both conditions free HBV immunization will be provided by a nurse practitioner.
Subsequently, postcard reminders will be sent and phone call reminders made for follow-up appointments for those receiving the first and second doses of vaccine.
The primary outcome measure is HBV vaccination.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
1747
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Illinois
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Chicago, Illinois, Forenede Stater, 60604
- Chicago Department of Public Health
-
-
Indiana
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Indianapolis, Indiana, Forenede Stater, 46202
- Bell Flower Clinic
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Age 18 and older males and females
- No prior self-reported history of HBV immunization or infection
- Fluent in English
- Not known to be HIV positive.
Exclusion Criteria:
- Under age 18
- Received any prior HBV vaccination
- Prior infection of Hepatitis B
- Unable to read or comprehend the English language
- HIV positive
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Non-Framed-Offered
Non-Framed, Information Only Condition.
Vaccine Offered.
|
Subjects received information only and are offered the vaccine.
|
|
Eksperimentel: Non-Framed-Recommended
Non-Framed, Information Only Condition.
Vaccine Recommended.
|
Subjects receive information only and are recommended the vaccine.
|
|
Eksperimentel: Gain-Framed-Offered
Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine.
Vaccine Offered.
|
Subjects receive gain-framed messages and are offered the vaccine.
|
|
Eksperimentel: Gain-Framed-Recommended
Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine.
Vaccine Recommended.
|
Subjects receive gain-framed messages and are recommended the vaccine.
|
|
Eksperimentel: Loss-Framed-Offered
Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine.
Vaccine Offered.
|
Subjects receive loss-framed messages and are offered the vaccine.
|
|
Eksperimentel: Loss-Framed-Recommended
Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine.
Vaccine Recommended.
|
Subjects receive loss-framed messages and are recommended the vaccine.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean Number of Doses of HBV Vaccine Received
Tidsramme: Day of research visit with 8 month follow-up
|
Mean Number of HBV vaccine doses received over an 8-month period, including the clinic visit.
Count values ranged from 0 to 3 doses.
|
Day of research visit with 8 month follow-up
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Cox AD, Cox D, Zimet G. Promoting prevention and early detection: The impact of message framing, product function and perceived product risk. J Marketing 2006;70:79-91.
- Kasting ML, Head KJ, Cox D, Cox AD, Zimet GD. The effects of message framing and healthcare provider recommendation on adult hepatitis B vaccination: A randomized controlled trial. Prev Med. 2019 Oct;127:105798. doi: 10.1016/j.ypmed.2019.105798. Epub 2019 Aug 9.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2003
Primær færdiggørelse (Faktiske)
1. juni 2007
Studieafslutning (Faktiske)
1. oktober 2007
Datoer for studieregistrering
Først indsendt
20. august 2008
Først indsendt, der opfyldte QC-kriterier
21. august 2008
Først opslået (Skøn)
22. august 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. november 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. november 2018
Sidst verificeret
1. november 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 0205-04
- R01AI049644 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ingen
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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Kliniske forsøg med Hepatitis B virus
-
Bristol-Myers SquibbAfsluttet
-
Tasly Tianjin Biopharmaceutical Co., Ltd.Ukendt
-
Bristol-Myers SquibbAfsluttetKronisk hepatitis B-virus, pædiatriskForenede Stater, Korea, Republikken, Taiwan, Det Forenede Kongerige, Belgien, Canada, Den Russiske Føderation, Argentina, Tyskland, Grækenland, Indien, Israel, Polen, Rumænien
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Jiyan LiuWest China HospitalRekrutteringKronisk hepatitis B-virus (Hbv)Kina
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The First Affiliated Hospital of Guangzhou Medical...UkendtKOL | Hyperkapnisk respirationssvigtKina
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-
Fundació Institut de Recerca de l'Hospital de la...Aktiv, ikke rekrutterendeDyb hjernestimulation | Behandlingsresistent skizofreniSpanien