Behavioral Interventions for Control of TB
Behavioral Interventions for Control of Tuberculosis
To compare alternative methods to ensure completion of treatment and preventive therapy for tuberculosis (TB) in inner cities, and to identify the most cost-effective methods to accomplish that. The basis for comparison included adherence rates and cost savings as primary outcomes, and other parameters such as patient satisfaction, development of social networks, and participation in support programs as secondary outcomes.
Two clinical trials were conducted with patients from Harlem. Among those with active disease, a clinic-based surrogate family model was compared to traditional community-based directly observed therapy (DOT). Among those eligible for preventive therapy, a community-based intervention conducted by trained graduates of a TB DOT program (peer workers) was compared to traditional self-administered preventive treatment.
研究概览
地位
详细说明
Tuberculosis was on the decline from the mid 1950s until the mid 1980s; however, the United States is now experiencing a resurgence of tuberculosis. In 1992, approximately 27,000 new cases were reported, an increase of about 20 percent from 1985 to 1992. Not only are tuberculosis cases on the increase, but a serious aspect of the problem is the recent occurence of outbreaks of multidrug resistant (MDR) tuberculosis, which poses an urgent public health problem and requires rapid intervention.
Control programs involve two major components. First, and of highest priority, is to detect persons with active tuberculosis and treat them with effective antituberculosis drugs, which prevents death from tuberculosis and stops the transmission of infection to other persons. Treatment of active tuberculosis involves taking multiple antituberculosis drugs daily or several times weekly for at least six months. Failure to take the medications for the full treatment period may mean that the disease is not cured and may recur. If sufficient medications are not prescribed early and taken regularly, the tuberculosis organism can become resistant to the drugs, and the drug resistant tuberculosis then may be transmitted to other persons. Drug resistant disease is difficult and expensive to treat, and in some cases, cannot be treated with available medications.
The second major goal of control efforts is the detection and treatment of persons who do not have active tuberculosis, but who have latent tuberculosis infection. These people may be at high risk of developing active tuberculosis. The only approved treatment modality for preventive therapy requires treatment daily or twice weekly for a minimum of six months, and many patients do not complete the full course of therapy. Public and patient programs are needed to increase the awareness of the problems associated with tuberculosis control.
The study is part of the NHLBI initiative "Behavioral Interventions for Control of Tuberculosis" . The concept for the initiative originated from the National Institutes of Health Working Group on Health and Behavior. The Request for Applications was released in October, 1994.
研究类型
注册 (实际的)
联系人和位置
学习地点
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New York
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New York、New York、美国、10023
- Columbia University
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
-Patients with suspected and confirmed TB
Exclusion Criteria:
-Patients that are not a part of the therapy program established at Harlem Hospital, New York City
学习计划
研究是如何设计的?
设计细节
- 观测模型:病例对照
- 时间观点:预期
队列和干预
团体/队列 |
干预/治疗 |
---|---|
Community-based therapy (case)
Community-based directly observed therapy (DOT) - A community-based intervention conducted by trained graduates of a TB directly observed therapy (DOT) program (peer workers)
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A community-based intervention conducted by trained graduates of a TB directly observed therapy (DOT) program (peer workers)
其他名称:
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Self-administered treatment (control)
Clinic directly observed therapy (DOT) - Traditional self-administered preventive treatment
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A traditional self-administered preventive treatment
其他名称:
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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 |
---|---|---|
Visit adherence rate
大体时间:At the end of study
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Prevalence of suspected and confirmed tuberculosis patients that continued treatment
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At the end of study
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Treatment completion rate
大体时间:At end of study
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Prevalence of suspected and confirmed tuberculosis patients that completed treatment
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At end of study
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合作者和调查者
调查人员
- 首席研究员:Wafaa El-Sadr, MD、University Professor; Director, ICAP, Department of Epidemiology
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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