NCT00739752

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,747

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2008

Completed
9.2 years until next milestone

Results Posted

Study results publicly available

October 16, 2017

Completed
Last Updated

November 9, 2018

Status Verified

November 1, 2018

Enrollment Period

4 years

First QC Date

August 20, 2008

Results QC Date

April 6, 2017

Last Update Submit

November 7, 2018

Conditions

Keywords

Attitude to HealthCommunicationIntervention StudiesHealth PromotionPsychology, MedicalSexual BehaviorBehavioral ResearchVaccination

Outcome Measures

Primary Outcomes (1)

  • 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.

    Day of research visit with 8 month follow-up

Study Arms (6)

Non-Framed-Offered

EXPERIMENTAL

Non-Framed, Information Only Condition. Vaccine Offered.

Behavioral: Non-Framed-Offered

Non-Framed-Recommended

EXPERIMENTAL

Non-Framed, Information Only Condition. Vaccine Recommended.

Behavioral: Non-Framed-Recommended

Gain-Framed-Offered

EXPERIMENTAL

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

Behavioral: Gain-Framed-Offered

Gain-Framed-Recommended

EXPERIMENTAL

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

Behavioral: Gain-Framed-Recommended

Loss-Framed-Offered

EXPERIMENTAL

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

Behavioral: Loss-Framed-Offered

Loss-Framed-Recommended

EXPERIMENTAL

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

Behavioral: Loss-Framed-Recommended

Interventions

Subjects received information only and are offered the vaccine.

Non-Framed-Offered

Subjects receive information only and are recommended the vaccine.

Non-Framed-Recommended

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

Gain-Framed-Offered

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

Gain-Framed-Recommended

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

Loss-Framed-Offered

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

Loss-Framed-Recommended

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Under age 18
  • Received any prior HBV vaccination
  • Prior infection of Hepatitis B
  • Unable to read or comprehend the English language
  • HIV positive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chicago Department of Public Health

Chicago, Illinois, 60604, United States

Location

Bell Flower Clinic

Indianapolis, Indiana, 46202, United States

Location

Related Publications (2)

  • 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.

    RESULT
  • 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.

MeSH Terms

Conditions

Hepatitis BCommunicationSexual Behavior

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesBehavior

Results Point of Contact

Title
Dr. Gregory Zimet
Organization
Indiana University

Study Officials

  • Gregory D Zimet, PhD

    Indiana University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: 2 X 3 Factorial Design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics & Clinical Psychology

Study Record Dates

First Submitted

August 20, 2008

First Posted

August 22, 2008

Study Start

June 1, 2003

Primary Completion

June 1, 2007

Study Completion

October 1, 2007

Last Updated

November 9, 2018

Results First Posted

October 16, 2017

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations