Hepatitis B VirusNCT00739752
Interventions to Increase HBV Vaccinations in Sexually Transmitted Disease (STD) Clinics
A study testing Non-Framed-Offered, Non-Framed-Recommended and Gain-Framed-Offered in people with Hepatitis B Virus, run by Indiana University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B Virus
- What is being tested?
- Non-Framed-Offered, Non-Framed-Recommended and Gain-Framed-Offered
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,747 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2003to Oct 2007
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Under age 18
- Received any prior HBV vaccination
- Prior infection of Hepatitis B
- Unable to read or comprehend the English language
- HIV positive
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Chicago Department of Public Health
Chicago, Illinois, 60604
Bell Flower Clinic
Indianapolis, Indiana, 46202
About this study
Official title: 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.
Read the 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.
- Conditions
- Hepatitis B Virus
- Being tested
- Non-Framed-Offered, Non-Framed-Recommended, Gain-Framed-Offered, Gain-Framed-Recommended, Loss-Framed-Offered
- Keywords
- Attitude to Health, Communication, Intervention Studies, Health Promotion, Psychology, Medical, Sexual Behavior, Behavioral Research, Vaccination
- Medical subject headings
- Hepatitis B, Communication, Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Framed-OfferedBehavioural
Subjects received information only and are offered the vaccine.
Non-Framed-RecommendedBehavioural
Subjects receive information only and are recommended the vaccine.
Gain-Framed-OfferedBehavioural
Subjects receive gain-framed messages and are offered the vaccine.
Gain-Framed-RecommendedBehavioural
Subjects receive gain-framed messages and are recommended the vaccine.
Loss-Framed-OfferedBehavioural
Subjects receive loss-framed messages and are offered the vaccine.
Loss-Framed-RecommendedBehavioural
Subjects receive loss-framed messages and are recommended the vaccine.
| Study group | Role | What they receive |
|---|---|---|
| Non-Framed-Offered | Experimental | Non-Framed, Information Only Condition. Vaccine Offered. Receives: Behavioral: Non-Framed-Offered |
| Non-Framed-Recommended | Experimental | Non-Framed, Information Only Condition. Vaccine Recommended. Receives: Behavioral: Non-Framed-Recommended |
| Gain-Framed-Offered | Experimental | Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Offered. Receives: Behavioral: Gain-Framed-Offered |
| Gain-Framed-Recommended | Experimental | Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Recommended. Receives: Behavioral: Gain-Framed-Recommended |
| Loss-Framed-Offered | Experimental | Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Offered. Receives: Behavioral: Loss-Framed-Offered |
| Loss-Framed-Recommended | Experimental | Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Recommended. Receives: Behavioral: Loss-Framed-Recommended |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day of research visit with 8 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2008 (estimated)
- Study startJun 2003
- Primary completionJun 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis B VirusStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2 X 3 Factorial Design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,747 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Principal investigator, Gregory Zimet, Indiana University
- Investigators
- Gregory D Zimet, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00739752
- Sponsor's protocol ID
- 0205-04
- Other IDs
- R01AI049644
- Status last verified
- Nov 2018
- First submitted
- 20 Aug 2008
- Last updated
- 9 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
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.
PubMed 31404569
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventions to Increase HBV Vaccinations in STD Clinics
- ClinicalTrials.gov ID
- NCT00739752
- Acronym / sponsor ID
- 0205-04
- Conditions
- Hepatitis B Virus
- Keywords
- Attitude to Health, Communication, Intervention Studies, Health Promotion, Psychology, Medical, Sexual Behavior, Behavioral Research, Vaccination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,747 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Jun 2003
- Primary completion
- Jun 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 22 Aug 2008 (estimated)
- Results
- Posted 16 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- 2 X 3 Factorial Design
| Arm | Type | Receives |
|---|---|---|
| Non-Framed-Offered | Experimental | Behavioral: Non-Framed-OfferedNon-Framed, Information Only Condition. Vaccine Offered. |
| Non-Framed-Recommended | Experimental | Behavioral: Non-Framed-RecommendedNon-Framed, Information Only Condition. Vaccine Recommended. |
| Gain-Framed-Offered | Experimental | Behavioral: Gain-Framed-OfferedGain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Offered. |
| Gain-Framed-Recommended | Experimental | Behavioral: Gain-Framed-RecommendedGain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Recommended. |
| Loss-Framed-Offered | Experimental | Behavioral: Loss-Framed-OfferedLoss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Offered. |
| Loss-Framed-Recommended | Experimental | Behavioral: Loss-Framed-RecommendedLoss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Recommended. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- Under age 18
- Received any prior HBV vaccination
- Prior infection of Hepatitis B
- Unable to read or comprehend the English language
- HIV positive
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Framed-OfferedSubjects received information only and are offered the vaccine. | Behavioural | Non-Framed-Offered |
| Non-Framed-RecommendedSubjects receive information only and are recommended the vaccine. | Behavioural | Non-Framed-Recommended |
| Gain-Framed-OfferedSubjects receive gain-framed messages and are offered the vaccine. | Behavioural | Gain-Framed-Offered |
| Gain-Framed-RecommendedSubjects receive gain-framed messages and are recommended the vaccine. | Behavioural | Gain-Framed-Recommended |
| Loss-Framed-OfferedSubjects receive loss-framed messages and are offered the vaccine. | Behavioural | Loss-Framed-Offered |
| Loss-Framed-RecommendedSubjects receive loss-framed messages and are recommended the vaccine. | Behavioural | Loss-Framed-Recommended |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationCox 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.
- Derived from this study: PubMed 31404569Kasting 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.
- Individual participant dataSharing planned: No
Related trials for Hepatitis B Virus
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory D Zimet, PhD principal investigator
Indiana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Framed-Offered, Non-Framed-Recommended and Gain-Framed-Offered in people with Hepatitis B Virus, run by Indiana University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Number of Doses of HBV Vaccine Received (time frame: Day of research visit with 8 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00739752, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2018.