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Interventions to Increase HBV Vaccinations in Sexually Transmitted Disease (STD) Clinics

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00739752
First Posted: August 22, 2008
Last Update Posted: October 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Gregory Zimet, Indiana University
August 20, 2008
August 22, 2008
April 6, 2017
October 16, 2017
October 16, 2017
June 2003
June 2007   (Final data collection date for primary outcome measure)
Number of Participants Administered Hepatitis B Vaccine [ Time Frame: Day of research visit ]
Number of participants administered hepatitis B vaccine on the day of research visit.
Number of Hepatitis B Virus Vaccine Doses Received [ Time Frame: Baseline, 1-2 Months, 6-8 Months ]
Complete list of historical versions of study NCT00739752 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Interventions to Increase HBV Vaccinations in Sexually Transmitted Disease (STD) Clinics
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:
2 X 3 Factorial Design
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Hepatitis B Virus
  • Behavioral: Non-Framed-Offered
    Subjects received information only and are offered the vaccine.
  • Behavioral: Non-Framed-Recommended
    Subjects receive information only and are recommended the vaccine.
  • Behavioral: Gain-Framed-Offered
    Subjects receive gain-framed messages and are offered the vaccine.
  • Behavioral: Gain-Framed-Recommended
    Subjects receive gain-framed messages and are recommended the vaccine.
  • Behavioral: Loss-Framed-Offered
    Subjects receive loss-framed messages and are offered the vaccine.
  • Behavioral: Loss-Framed-Recommended
    Subjects receive loss-framed messages and are recommended the vaccine.
  • Experimental: Non-Framed-Offered
    Non-Framed, Information Only Condition. Vaccine Offered.
    Intervention: Behavioral: Non-Framed-Offered
  • Experimental: Non-Framed-Recommended
    Non-Framed, Information Only Condition. Vaccine Recommended.
    Intervention: Behavioral: Non-Framed-Recommended
  • Experimental: Gain-Framed-Offered
    Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Offered.
    Intervention: Behavioral: Gain-Framed-Offered
  • Experimental: Gain-Framed-Recommended
    Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Recommended.
    Intervention: Behavioral: Gain-Framed-Recommended
  • Experimental: Loss-Framed-Offered
    Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Offered.
    Intervention: Behavioral: Loss-Framed-Offered
  • Experimental: Loss-Framed-Recommended
    Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Recommended.
    Intervention: Behavioral: Loss-Framed-Recommended
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1747
October 2007
June 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00739752
0205-04
R01AI049644 ( U.S. NIH Grant/Contract )
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Gregory Zimet, Indiana University
Indiana University
  • National Institutes of Health (NIH)
  • National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Gregory D Zimet, PhD Indiana University
Indiana University
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP