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

Interventions to Increase HBV Vaccinations in STD Clinics

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00739752
Enrollment
1747
Registered
2008-08-22
Start date
2003-06-30
Completion date
2007-10-31
Last updated
2018-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B Virus

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

BEHAVIORALNon-Framed-Offered

Subjects received information only and are offered the vaccine.

BEHAVIORALNon-Framed-Recommended

Subjects receive information only and are recommended the vaccine.

BEHAVIORALGain-Framed-Offered

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

BEHAVIORALGain-Framed-Recommended

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

BEHAVIORALLoss-Framed-Offered

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

BEHAVIORALLoss-Framed-Recommended

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

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
National Institute of Allergy and Infectious Diseases (NIAID)
CollaboratorNIH
Indiana University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

2 X 3 Factorial Design

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

MeasureTime frameDescription
Mean Number of Doses of HBV Vaccine ReceivedDay of research visit with 8 month follow-upMean 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

ArmCount
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
Total1,747

Baseline characteristics

CharacteristicNon-Framed-OfferedTotalLoss-Framed-RecommendedLoss-Framed-OfferedGain-Framed-RecommendedGain-Framed-OfferedNon-Framed-Recommended
Age, Continuous31.2 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 Participants48 Participants9 Participants6 Participants8 Participants9 Participants9 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
284 Participants1669 Participants278 Participants282 Participants275 Participants278 Participants272 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
8 Participants30 Participants6 Participants3 Participants5 Participants5 Participants3 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants6 Participants2 Participants1 Participants0 Participants2 Participants1 Participants
Race (NIH/OMB)
Black or African American
252 Participants1426 Participants233 Participants236 Participants233 Participants239 Participants233 Participants
Race (NIH/OMB)
More than one race
8 Participants43 Participants9 Participants7 Participants6 Participants5 Participants8 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants0 Participants0 Participants1 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
6 Participants46 Participants4 Participants12 Participants10 Participants9 Participants5 Participants
Race (NIH/OMB)
White
32 Participants224 Participants45 Participants35 Participants38 Participants37 Participants37 Participants
Region of Enrollment
United States
299 Participants1747 Participants293 Participants291 Participants288 Participants292 Participants284 Participants
Sex: Female, Male
Female
178 Participants1054 Participants177 Participants179 Participants166 Participants175 Participants179 Participants
Sex: Female, Male
Male
121 Participants693 Participants116 Participants112 Participants122 Participants117 Participants105 Participants

Adverse events

Event typeEG000
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 / 2990 / 2840 / 2920 / 2880 / 2910 / 293
other
Total, other adverse events
0 / 2990 / 2840 / 2920 / 2880 / 2910 / 293
serious
Total, serious adverse events
0 / 2990 / 2840 / 2920 / 2880 / 2910 / 293

Outcome results

Primary

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

ArmMeasureValue (MEAN)Dispersion
Non-Framed-OfferedMean Number of Doses of HBV Vaccine Received.78 Doses of HBV VaccineStandard Deviation 1
Non-Framed-RecommendedMean Number of Doses of HBV Vaccine Received.85 Doses of HBV VaccineStandard Deviation 1.02
Gain-Framed-OfferedMean Number of Doses of HBV Vaccine Received.94 Doses of HBV VaccineStandard Deviation 1.11
Gain-Framed-RecommendedMean Number of Doses of HBV Vaccine Received.98 Doses of HBV VaccineStandard Deviation 1.06
Loss-Framed-OfferedMean Number of Doses of HBV Vaccine Received.81 Doses of HBV VaccineStandard Deviation 1.04
Loss-Framed-RecommendedMean Number of Doses of HBV Vaccine Received1.10 Doses of HBV VaccineStandard Deviation 1.14
Comparison: The two gain-framed groups were compared to the two loss-framed groups using poisson regression.p-value: =0.88595% CI: [0.88, 1.12]Regression, Poisson
Comparison: Groups receiving any framed interventions (gain-framed or loss-framed) were compared to those in the two non-framed control groups.p-value: <0.0195% CI: [1.06, 1.31]Regression, Poisson
Comparison: The 3 vaccine-recommended groups were compared with the 3 vaccine-offered groups using poisson regression.p-value: <0.0195% CI: [1.05, 1.28]Regression, Poisson

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026