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临床试验/NCT00739752
NCT00739752已完成不适用

Interventions to Increase HBV Vaccinations in STD Clinics

Indiana University2 个研究点 分布在 1 个国家目标入组 1,747 人开始时间: 2003年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,747
试验地点
2
主要终点
Mean Number of Doses of HBV Vaccine Received

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

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

研究组 & 干预措施

Non-Framed-Offered

Experimental

Non-Framed, Information Only Condition. Vaccine Offered.

干预措施: Non-Framed-Offered (Behavioral)

Non-Framed-Recommended

Experimental

Non-Framed, Information Only Condition. Vaccine Recommended.

干预措施: Non-Framed-Recommended (Behavioral)

Gain-Framed-Offered

Experimental

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

干预措施: Gain-Framed-Offered (Behavioral)

Gain-Framed-Recommended

Experimental

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

干预措施: Gain-Framed-Recommended (Behavioral)

Loss-Framed-Offered

Experimental

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

干预措施: Loss-Framed-Offered (Behavioral)

Loss-Framed-Recommended

Experimental

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

干预措施: Loss-Framed-Recommended (Behavioral)

结局指标

主要结局

Mean Number of Doses of HBV Vaccine Received

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gregory Zimet

Professor of Pediatrics & Clinical Psychology

Indiana University

研究点 (2)

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