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Completed

NCT Number: NCT00739752

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chicago Department of Public Health, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Framed-Offered

Behavioral

Subjects received information only and are offered the vaccine.

Non-Framed-Recommended

Behavioral

Subjects receive information only and are recommended the vaccine.

Gain-Framed-Offered

Behavioral

Subjects receive gain-framed messages and are offered the vaccine.

Gain-Framed-Recommended

Behavioral

Subjects receive gain-framed messages and are recommended the vaccine.

Loss-Framed-Offered

Behavioral

Subjects receive loss-framed messages and are offered the vaccine.

Loss-Framed-Recommended

Behavioral

Subjects receive loss-framed messages and are recommended the vaccine.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)
  • National Institutes of Health (NIH)

Registry information

Official study title

Interventions to Increase HBV Vaccinations in STD Clinics

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Aug 22, 2008
Registry last updated
Nov 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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