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

November 7, 2018 updated by: Gregory Zimet, Indiana University

Interventions to Increase HBV Vaccinations in 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1747

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60604
        • Chicago Department of Public Health
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Bell Flower Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non-Framed-Offered
Non-Framed, Information Only Condition. Vaccine Offered.
Behavioral: Non-Framed-Offered
Subjects received information only and are offered the vaccine.
Experimental: Non-Framed-Recommended
Non-Framed, Information Only Condition. Vaccine Recommended.
Behavioral: Non-Framed-Recommended
Subjects receive information only and are recommended the vaccine.
Experimental: Gain-Framed-Offered
Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Offered.
Behavioral: Gain-Framed-Offered
Subjects receive gain-framed messages and are offered the vaccine.
Experimental: Gain-Framed-Recommended
Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Recommended.
Behavioral: Gain-Framed-Recommended
Subjects receive gain-framed messages and are recommended the vaccine.
Experimental: Loss-Framed-Offered
Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Offered.
Behavioral: Loss-Framed-Offered
Subjects receive loss-framed messages and are offered the vaccine.
Experimental: Loss-Framed-Recommended
Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Recommended.
Behavioral: Loss-Framed-Recommended
Subjects receive loss-framed messages and are recommended the vaccine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day of research visit with 8 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

August 20, 2008

First Submitted That Met QC Criteria

August 21, 2008

First Posted (Estimate)

August 22, 2008

Study Record Updates

Last Update Posted (Actual)

November 9, 2018

Last Update Submitted That Met QC Criteria

November 7, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

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

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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