We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
  Purpose
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.

Condition Intervention
Hepatitis B Virus Behavioral: Non-Framed-Offered Behavioral: Non-Framed-Recommended Behavioral: Gain-Framed-Offered Behavioral: Gain-Framed-Recommended Behavioral: Loss-Framed-Offered Behavioral: Loss-Framed-Recommended

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:
2 X 3 Factorial Design
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Interventions to Increase HBV Vaccinations in STD Clinics

Resource links provided by NLM:


Further study details as provided by Gregory Zimet, Indiana University:

Primary Outcome Measures:
  • 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.


Enrollment: 1747
Study Start Date: June 2003
Study Completion Date: October 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Non-Framed-Offered
Non-Framed, Information Only Condition. Vaccine Offered.
Behavioral: Non-Framed-Offered
Subjects received information only and are offered the vaccine.
Experimental: Non-Framed-Recommended
Non-Framed, Information Only Condition. Vaccine Recommended.
Behavioral: Non-Framed-Recommended
Subjects receive information only and are recommended the vaccine.
Experimental: Gain-Framed-Offered
Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Offered.
Behavioral: Gain-Framed-Offered
Subjects receive gain-framed messages and are offered the vaccine.
Experimental: Gain-Framed-Recommended
Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Recommended.
Behavioral: Gain-Framed-Recommended
Subjects receive gain-framed messages and are recommended the vaccine.
Experimental: Loss-Framed-Offered
Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Offered.
Behavioral: Loss-Framed-Offered
Subjects receive loss-framed messages and are offered the vaccine.
Experimental: Loss-Framed-Recommended
Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Recommended.
Behavioral: Loss-Framed-Recommended
Subjects receive loss-framed messages and are recommended the vaccine.

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00739752


Locations
United States, Illinois
Chicago Department of Public Health
Chicago, Illinois, United States, 60604
United States, Indiana
Bell Flower Clinic
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Gregory D Zimet, PhD Indiana University
  More Information

Publications:
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.

Responsible Party: Gregory Zimet, Professor of Pediatrics & Clinical Psychology, Indiana University
ClinicalTrials.gov Identifier: NCT00739752     History of Changes
Other Study ID Numbers: 0205-04
R01AI049644 ( U.S. NIH Grant/Contract )
First Submitted: August 20, 2008
First Posted: August 22, 2008
Results First Submitted: April 6, 2017
Results First Posted: October 16, 2017
Last Update Posted: October 16, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gregory Zimet, Indiana University:
Attitude to Health
Communication
Intervention Studies
Health Promotion
Psychology, Medical
Sexual Behavior
Behavioral Research
Vaccination

Additional relevant MeSH terms:
Hepatitis B
Sexually Transmitted Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis
Liver Diseases
Digestive System Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female
Vaccines
Immunologic Factors
Physiological Effects of Drugs