NCT00739752

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

Interventions to Increase HBV Vaccinations in STD Clinics

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,747 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Hepatitis B Virus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2003-06-01
• Primary completion: 2007-06-01
• Completion: 2007-10-01
• First posted: 2008-08-22
• Last updated: 2018-11-09
• Results posted: 2017-10-16

Locations

2 sites across 1 country: United States