Interventions to Increase HBV Vaccinations in Sexually Transmitted Disease (STD) Clinics
2018年11月7日 更新者:Gregory Zimet、Indiana University
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.
研究概览
地位
完全的
条件
详细说明
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.
研究类型
介入性
注册 (实际的)
1747
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Illinois
-
Chicago、Illinois、美国、60604
- Chicago Department of Public Health
-
-
Indiana
-
Indianapolis、Indiana、美国、46202
- Bell Flower Clinic
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:阶乘赋值
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Non-Framed-Offered
Non-Framed, Information Only Condition.
Vaccine Offered.
|
Subjects received information only and are offered the vaccine.
|
|
实验性的:Non-Framed-Recommended
Non-Framed, Information Only Condition.
Vaccine Recommended.
|
Subjects receive information only and are recommended the vaccine.
|
|
实验性的:Gain-Framed-Offered
Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine.
Vaccine Offered.
|
Subjects receive gain-framed messages and are offered the vaccine.
|
|
实验性的:Gain-Framed-Recommended
Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine.
Vaccine Recommended.
|
Subjects receive gain-framed messages and are recommended the vaccine.
|
|
实验性的:Loss-Framed-Offered
Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine.
Vaccine Offered.
|
Subjects receive loss-framed messages and are offered the vaccine.
|
|
实验性的:Loss-Framed-Recommended
Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine.
Vaccine Recommended.
|
Subjects receive loss-framed messages and are recommended the vaccine.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mean Number of Doses of HBV Vaccine Received
大体时间: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.
|
Day of research visit with 8 month follow-up
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2003年6月1日
初级完成 (实际的)
2007年6月1日
研究完成 (实际的)
2007年10月1日
研究注册日期
首次提交
2008年8月20日
首先提交符合 QC 标准的
2008年8月21日
首次发布 (估计)
2008年8月22日
研究记录更新
最后更新发布 (实际的)
2018年11月9日
上次提交的符合 QC 标准的更新
2018年11月7日
最后验证
2018年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.