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

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Indiana University

Status

Completed

Conditions

Hepatitis B Virus

Treatments

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

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00739752
R01AI049644 (U.S. NIH Grant/Contract)
0205-04

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,747 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Triple Blind

1,747 participants in 6 patient groups

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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