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

Primary Purpose

Hepatitis B Virus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Non-Framed-Offered
Non-Framed-Recommended
Gain-Framed-Offered
Gain-Framed-Recommended
Loss-Framed-Offered
Loss-Framed-Recommended
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis B Virus focused on measuring Attitude to Health, Communication, Intervention Studies, Health Promotion, Psychology, Medical, Sexual Behavior, Behavioral Research, Vaccination

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Chicago Department of Public Health
  • Bell Flower Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Non-Framed-Offered

Non-Framed-Recommended

Gain-Framed-Offered

Gain-Framed-Recommended

Loss-Framed-Offered

Loss-Framed-Recommended

Arm Description

Non-Framed, Information Only Condition. Vaccine Offered.

Non-Framed, Information Only Condition. Vaccine Recommended.

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

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

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

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

Outcomes

Primary Outcome Measures

Mean Number of Doses of HBV Vaccine Received
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

Full Information

First Posted
August 20, 2008
Last Updated
November 7, 2018
Sponsor
Indiana University
Collaborators
National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00739752
Brief Title
Interventions to Increase HBV Vaccinations in Sexually Transmitted Disease (STD) Clinics
Official Title
Interventions to Increase HBV Vaccinations in STD Clinics
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B Virus
Keywords
Attitude to Health, Communication, Intervention Studies, Health Promotion, Psychology, Medical, Sexual Behavior, Behavioral Research, Vaccination

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
2 X 3 Factorial Design
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1747 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-Framed-Offered
Arm Type
Experimental
Arm Description
Non-Framed, Information Only Condition. Vaccine Offered.
Arm Title
Non-Framed-Recommended
Arm Type
Experimental
Arm Description
Non-Framed, Information Only Condition. Vaccine Recommended.
Arm Title
Gain-Framed-Offered
Arm Type
Experimental
Arm Description
Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Offered.
Arm Title
Gain-Framed-Recommended
Arm Type
Experimental
Arm Description
Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Recommended.
Arm Title
Loss-Framed-Offered
Arm Type
Experimental
Arm Description
Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Offered.
Arm Title
Loss-Framed-Recommended
Arm Type
Experimental
Arm Description
Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Recommended.
Intervention Type
Behavioral
Intervention Name(s)
Non-Framed-Offered
Intervention Description
Subjects received information only and are offered the vaccine.
Intervention Type
Behavioral
Intervention Name(s)
Non-Framed-Recommended
Intervention Description
Subjects receive information only and are recommended the vaccine.
Intervention Type
Behavioral
Intervention Name(s)
Gain-Framed-Offered
Intervention Description
Subjects receive gain-framed messages and are offered the vaccine.
Intervention Type
Behavioral
Intervention Name(s)
Gain-Framed-Recommended
Intervention Description
Subjects receive gain-framed messages and are recommended the vaccine.
Intervention Type
Behavioral
Intervention Name(s)
Loss-Framed-Offered
Intervention Description
Subjects receive loss-framed messages and are offered the vaccine.
Intervention Type
Behavioral
Intervention Name(s)
Loss-Framed-Recommended
Intervention Description
Subjects receive loss-framed messages and are recommended the vaccine.
Primary Outcome Measure Information:
Title
Mean Number of Doses of HBV Vaccine Received
Description
Mean Number of HBV vaccine doses received over an 8-month period, including the clinic visit. Count values ranged from 0 to 3 doses.
Time Frame
Day of research visit with 8 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory D Zimet, PhD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chicago Department of Public Health
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60604
Country
United States
Facility Name
Bell Flower Clinic
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Cox AD, Cox D, Zimet G. Promoting prevention and early detection: The impact of message framing, product function and perceived product risk. J Marketing 2006;70:79-91.
Results Reference
result
PubMed Identifier
31404569
Citation
Kasting ML, Head KJ, Cox D, Cox AD, Zimet GD. The effects of message framing and healthcare provider recommendation on adult hepatitis B vaccination: A randomized controlled trial. Prev Med. 2019 Oct;127:105798. doi: 10.1016/j.ypmed.2019.105798. Epub 2019 Aug 9.
Results Reference
derived

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

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