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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

August 20, 2008
August 21, 2008
June 2003
June 2007   (final data collection date for primary outcome measure)
Number of Hepatitis B Virus Vaccine Doses Received [ Time Frame: Baseline, 1-2 Months, 6-8 Months ] [ Designated as safety issue: No ]
Same as current
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 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Hepatitis B Virus
  • 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)
  • 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.
  • 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
  • No Intervention: Non-Framed
    Non-Framed, Information Only Condition
    Intervention: Behavioral: Message Framing
  • Experimental: Loss-Framed
    Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine
    Intervention: Behavioral: Message Framing
  • Experimental: Gain-Framed
    Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine
    Intervention: Behavioral: Message Framing
  • No Intervention: No Intention
    No Intention Question Asked regarding acceptance of HBV vaccination
    Intervention: Behavioral: Intention
  • Experimental: Intention
    Intention Question Asked regarding acceptance of HBV vaccination
    Intervention: Behavioral: Intention
  • No Intervention: Offered
    Health care provider offers HBV vaccine
    Intervention: Behavioral: Recommendation
  • Experimental: Recommended
    Health care provider recommends HBV vaccine
    Intervention: Behavioral: Recommendation
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
1749
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:

  • 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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00739752
0205-04, R01 A1049644-01A2
Yes
Gregory D. Zimet, PhD / Professor of Pediatrics, Indiana University
Indiana University
National Institutes of Health (NIH)
Principal Investigator: Gregory D Zimet, PhD Indiana University
Indiana University
August 2008

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