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

Not Applicable

Completed

Conditions: Hepatitis B Virus

Interventions: Behavioral: Non-Framed-Offered
Behavioral: Loss-Framed-Recommended
Behavioral: Non-Framed-Recommended
Behavioral: Loss-Framed-Offered
Behavioral: Gain-Framed-Offered
Behavioral: Gain-Framed-Recommended

Registration Number: NCT00739752

Lead Sponsor: Indiana University

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1747

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Non-Framed-Offered	Non-Framed-Offered	Non-Framed, Information Only Condition. Vaccine Offered.
Loss-Framed-Recommended	Loss-Framed-Recommended	Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Recommended.
Non-Framed-Recommended	Non-Framed-Recommended	Non-Framed, Information Only Condition. Vaccine Recommended.
Loss-Framed-Offered	Loss-Framed-Offered	Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Offered.
Gain-Framed-Offered	Gain-Framed-Offered	Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Offered.
Gain-Framed-Recommended	Gain-Framed-Recommended	Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Recommended.

Primary Outcome Measures

Name	Time	Method
Mean Number of Doses of HBV Vaccine Received	Day of research visit with 8 month follow-up	Mean Number of HBV vaccine doses received over an 8-month period, including the clinic visit. Count values ranged from 0 to 3 doses.

Secondary Outcome Measures