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

Hepatitis B Virus Clinical Trial

Official title:

Interventions to Increase HBV Vaccinations in STD Clinics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00739752
• Other study ID #: 0205-04
• Secondary ID: R01AI049644
• Status: Completed
• Phase: N/A
• Start date: June 2003
• Est. completion date: October 2007

Study information

• Verified date: November 2018
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1747
• Est. completion date: October 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis B
• Hepatitis B Virus
• Sexually Transmitted Diseases

Intervention

Behavioral:
• Non-Framed-Offered
Subjects received information only and are offered the vaccine.
• Non-Framed-Recommended
Subjects receive information only and are recommended the vaccine.
• Gain-Framed-Offered
Subjects receive gain-framed messages and are offered the vaccine.
• Gain-Framed-Recommended
Subjects receive gain-framed messages and are recommended the vaccine.
• Loss-Framed-Offered
Subjects receive loss-framed messages and are offered the vaccine.
• Loss-Framed-Recommended
Subjects receive loss-framed messages and are recommended the vaccine.

Locations

Country	Name	City	State
United States	Chicago Department of Public Health	Chicago	Illinois
United States	Bell Flower Clinic	Indianapolis	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Indiana University	National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Number of Doses of HBV Vaccine Received	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