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Clinical Trials/NCT00739752
NCT00739752CompletedNot Applicable

Interventions to Increase HBV Vaccinations in STD Clinics

Indiana University2 sites in 1 country1,747 target enrollmentStarted: June 1, 2003Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
1,747
Locations
2
Primary Endpoint
Mean Number of Doses of HBV Vaccine Received

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Prevention
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Non-Framed-Offered

Experimental

Non-Framed, Information Only Condition. Vaccine Offered.

Intervention: Non-Framed-Offered (Behavioral)

Non-Framed-Recommended

Experimental

Non-Framed, Information Only Condition. Vaccine Recommended.

Intervention: Non-Framed-Recommended (Behavioral)

Gain-Framed-Offered

Experimental

Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Offered.

Intervention: Gain-Framed-Offered (Behavioral)

Gain-Framed-Recommended

Experimental

Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Recommended.

Intervention: Gain-Framed-Recommended (Behavioral)

Loss-Framed-Offered

Experimental

Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Offered.

Intervention: Loss-Framed-Offered (Behavioral)

Loss-Framed-Recommended

Experimental

Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Recommended.

Intervention: Loss-Framed-Recommended (Behavioral)

Outcomes

Primary Outcomes

Mean Number of Doses of HBV Vaccine Received

Time Frame: 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 Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gregory Zimet

Professor of Pediatrics & Clinical Psychology

Indiana University

Study Sites (2)

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