Tuberculosis Clinical Trial
To conduct a three-arm, randomized controlled trial of methods to improve adherence to biweekly directly observed prophylaxis (DOPT) for tuberculosis in homeless adults in San Francisco.
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 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.
DESIGN NARRATIVE:
Three approaches were compared for improving adherence to biweekly directly observed
prophylaxis for tuberculosis in the homeless: $5 biweekly money incentive (MI) for adherence
to DOPT, $5 value biweekly non-money incentive (NMI) for adherence to DOPT, and $5 biweekly
money incentive supplemented by a peer community outreach worker (MI + PCOW). The outreach
worker assisted subjects with completion of adherence to DOPT. Predictors of adherence to
DOPT were examined, including sociodemographic, psychological and behavioral, and
environmental factors.
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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