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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT00739752
First received: August 20, 2008
Last updated: August 21, 2008
Last verified: August 2008
  Purpose

The goal of this study is to evaluate interventions to increase acceptance of, and follow through with, 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. The 3rd aim is to examine the effect of the interventions on follow-through with the 2nd & 3rd dose. 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. In addition, a randomly selected 50% of subjects will be asked questions regarding their intention to accept free HBV vaccination, enabling us to examine the effects on behavior of asking intention. 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 number of HBV vaccine doses received.


Condition Intervention
Hepatitis B Virus
Behavioral: Message Framing
Behavioral: Intention
Behavioral: Recommendation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, 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 Indiana University:

Primary Outcome Measures:
  • Number of Hepatitis B Virus Vaccine Doses Received [ Time Frame: Baseline, 1-2 Months, 6-8 Months ] [ Designated as safety issue: No ]

Enrollment: 1749
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
No Intervention: Non-Framed
Non-Framed, Information Only Condition
Behavioral: Message Framing
Subjects receive 1 of 3 possible Framing Messages about HBV Vaccination: 1. Non-Framed (information only); 2. Loss-Framed (emphasizing risks on non-vaccination); and 3. Gain-Framed (emphasizing benefits of vaccination)
Experimental: Loss-Framed
Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine
Behavioral: Message Framing
Subjects receive 1 of 3 possible Framing Messages about HBV Vaccination: 1. Non-Framed (information only); 2. Loss-Framed (emphasizing risks on non-vaccination); and 3. Gain-Framed (emphasizing benefits of vaccination)
Experimental: Gain-Framed
Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine
Behavioral: Message Framing
Subjects receive 1 of 3 possible Framing Messages about HBV Vaccination: 1. Non-Framed (information only); 2. Loss-Framed (emphasizing risks on non-vaccination); and 3. Gain-Framed (emphasizing benefits of vaccination)
No Intervention: No Intention
No Intention Question Asked regarding acceptance of HBV vaccination
Behavioral: Intention
Subjects randomized to 1 of 2 intention conditions: 1. Not Asked Intention Question and 2. Asked Intention Question. The intention question asks subjects if they intend to accept free HBV vaccine, if offered.
Experimental: Intention
Intention Question Asked regarding acceptance of HBV vaccination
Behavioral: Intention
Subjects randomized to 1 of 2 intention conditions: 1. Not Asked Intention Question and 2. Asked Intention Question. The intention question asks subjects if they intend to accept free HBV vaccine, if offered.
No Intervention: Offered
Health care provider offers HBV vaccine
Behavioral: Recommendation
Subjects randomized to 1 of 2 Recommendation Conditions: 1. Health care provider offers free HBV vaccine and 2. Health care provider recommends HBV vaccine
Experimental: Recommended
Health care provider recommends HBV vaccine
Behavioral: Recommendation
Subjects randomized to 1 of 2 Recommendation Conditions: 1. Health care provider offers free HBV vaccine and 2. Health care provider recommends HBV vaccine

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  • 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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 D. Zimet, PhD / Professor of Pediatrics, Indiana University
ClinicalTrials.gov Identifier: NCT00739752     History of Changes
Other Study ID Numbers: 0205-04, R01 A1049644-01A2
Study First Received: August 20, 2008
Last Updated: August 21, 2008
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Sexually Transmitted Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Infection
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 14, 2014