Hepatitis B Virus
Conditions
Keywords
Attitude to Health, Communication, Intervention Studies, Health Promotion, Psychology, Medical, Sexual Behavior, Behavioral Research, Vaccination
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.
Interventions
Subjects received information only and are offered the vaccine.
Subjects receive information only and are recommended the vaccine.
Subjects receive gain-framed messages and are offered the vaccine.
Subjects receive gain-framed messages and are recommended the vaccine.
Subjects receive loss-framed messages and are offered the vaccine.
Subjects receive loss-framed messages and are recommended the vaccine.
Sponsors
Study design
Intervention model description
2 X 3 Factorial Design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Number of Doses of HBV Vaccine Received | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Non-Framed-Offered Non-Framed, Information Only Condition. Vaccine Offered.
Non-Framed-Offered: Subjects received information only and are offered the vaccine. | 299 |
| Non-Framed-Recommended Non-Framed, Information Only Condition. Vaccine Recommended.
Non-Framed-Recommended: Subjects receive information only and are recommended the vaccine. | 284 |
| Gain-Framed-Offered Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Offered.
Gain-Framed-Offered: Subjects receive gain-framed messages and are offered the vaccine. | 292 |
| Gain-Framed-Recommended Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Recommended.
Gain-Framed-Recommended: Subjects receive gain-framed messages and are recommended the vaccine. | 288 |
| Loss-Framed-Offered Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Offered.
Loss-Framed-Offered: Subjects receive loss-framed messages and are offered the vaccine. | 291 |
| Loss-Framed-Recommended Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Recommended.
Loss-Framed-Recommended: Subjects receive loss-framed messages and are recommended the vaccine. | 293 |
| Total | 1,747 |
Baseline characteristics
| Characteristic | Non-Framed-Offered | Total | Loss-Framed-Recommended | Loss-Framed-Offered | Gain-Framed-Recommended | Gain-Framed-Offered | Non-Framed-Recommended |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 31.2 Years STANDARD_DEVIATION 9.7 | 31.7 Years STANDARD_DEVIATION 9.9 | 32.3 Years STANDARD_DEVIATION 10.6 | 32.1 Years STANDARD_DEVIATION 10.1 | 31.7 Years STANDARD_DEVIATION 9.4 | 31.2 Years STANDARD_DEVIATION 9.8 | 31.8 Years STANDARD_DEVIATION 9.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 48 Participants | 9 Participants | 6 Participants | 8 Participants | 9 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 284 Participants | 1669 Participants | 278 Participants | 282 Participants | 275 Participants | 278 Participants | 272 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants | 30 Participants | 6 Participants | 3 Participants | 5 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 6 Participants | 2 Participants | 1 Participants | 0 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 252 Participants | 1426 Participants | 233 Participants | 236 Participants | 233 Participants | 239 Participants | 233 Participants |
| Race (NIH/OMB) More than one race | 8 Participants | 43 Participants | 9 Participants | 7 Participants | 6 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 46 Participants | 4 Participants | 12 Participants | 10 Participants | 9 Participants | 5 Participants |
| Race (NIH/OMB) White | 32 Participants | 224 Participants | 45 Participants | 35 Participants | 38 Participants | 37 Participants | 37 Participants |
| Region of Enrollment United States | 299 Participants | 1747 Participants | 293 Participants | 291 Participants | 288 Participants | 292 Participants | 284 Participants |
| Sex: Female, Male Female | 178 Participants | 1054 Participants | 177 Participants | 179 Participants | 166 Participants | 175 Participants | 179 Participants |
| Sex: Female, Male Male | 121 Participants | 693 Participants | 116 Participants | 112 Participants | 122 Participants | 117 Participants | 105 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 299 | 0 / 284 | 0 / 292 | 0 / 288 | 0 / 291 | 0 / 293 |
| other Total, other adverse events | 0 / 299 | 0 / 284 | 0 / 292 | 0 / 288 | 0 / 291 | 0 / 293 |
| serious Total, serious adverse events | 0 / 299 | 0 / 284 | 0 / 292 | 0 / 288 | 0 / 291 | 0 / 293 |
Outcome results
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.
Time frame: Day of research visit with 8 month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-Framed-Offered | Mean Number of Doses of HBV Vaccine Received | .78 Doses of HBV Vaccine | Standard Deviation 1 |
| Non-Framed-Recommended | Mean Number of Doses of HBV Vaccine Received | .85 Doses of HBV Vaccine | Standard Deviation 1.02 |
| Gain-Framed-Offered | Mean Number of Doses of HBV Vaccine Received | .94 Doses of HBV Vaccine | Standard Deviation 1.11 |
| Gain-Framed-Recommended | Mean Number of Doses of HBV Vaccine Received | .98 Doses of HBV Vaccine | Standard Deviation 1.06 |
| Loss-Framed-Offered | Mean Number of Doses of HBV Vaccine Received | .81 Doses of HBV Vaccine | Standard Deviation 1.04 |
| Loss-Framed-Recommended | Mean Number of Doses of HBV Vaccine Received | 1.10 Doses of HBV Vaccine | Standard Deviation 1.14 |