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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Interventions to Increase HBV Vaccinations in STD Clinics

Conditions
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Hepatitis B Virus

Intervention / Treatment
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* Behavioral: Non-Framed-Offered
* Behavioral: Non-Framed-Recommended
* Behavioral: Gain-Framed-Offered
* Behavioral: Gain-Framed-Recommended
* Behavioral: Loss-Framed-Offered
* Behavioral: Loss-Framed-Recommended


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: 2 X 3 Factorial Design
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Attitude to Health, Communication, Intervention Studies, Health Promotion, Psychology, Medical, Sexual Behavior, Behavioral Research, Vaccination