Tuberculosis Clinical Trial
To develop a behavioral intervention aimed at public health workers who perform tuberculosis contact investigation and designed to enhance the contact investigation process.
BACKGROUND:
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 tubercuosis 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.
DESIGN NARRATIVE:
The project, based on social learning theory, was conducted in several phases. First, a
process evaluation of the current contact investigation process was conducted. Results
guided the development of a revised contact investigation protocol, a software program for
notebook computers designed to enhance protocol implementation, and a behavioral
intervention to educate contact investigators in the use of the protocol and software. A
formative evaluation of the intervention, protocol, and software was used to refine the
procedures, which were then implemented throughout the State of Alabama. An impact
evaluation was then conducted to assess the effectiveness of the procedures. If the impact
evaluation results weresatisfactory, the behavioral intervention and contact investigation
procedures would be developed in a format that could be exported to other areas and
settings.
The study completion date listed in this record was obtained from the "End Date" entered in
the Protocol Registration and Results System (PRS) record.
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N/A
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