Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT00005741 |
Other study ID # |
4950 |
Secondary ID |
R01HL055760 |
Status |
Completed |
Phase |
N/A
|
First received |
May 25, 2000 |
Last updated |
May 12, 2016 |
Start date |
September 1995 |
Est. completion date |
August 2001 |
Study information
Verified date |
May 2002 |
Source |
National Heart, Lung, and Blood Institute (NHLBI) |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
United States: Federal Government |
Study type |
Observational
|
Clinical Trial Summary
The Community Outreach Intervention Project (COIP) implemented and evaluated a TB
intervention with injection drug users (IDUs) in two Chicago Neighborhoods, guided by the
indigenous outreach leadership model that had been used for AIDS prevention among drug
users.
Description:
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:
Three hypotheses were tested. The first was that rates of treatment adherence would be
greater among actively infected injection drug users assisted through indigenous outreach
than through conventional TB control methods practiced by the Chicago Department of Health.
The second hypothesis was that rates of compliance with contact tracing, screening and
treatment wouldl be greater through the COIP intervention than through the practices of the
Health Department. The third was that community level rates of TB would decrease over the
years of the study as a result of the intervention.
Enrollment of the cases and contacts for Phase II began in July 1996. The intervention was
implemented by a specially trained indigenous outreach staff guided by an experienced
ethnographer. Quantitative and qualitative methods were used to assess the effects of the
intervention on treatment completion, attendance, compliance with contact and screening
efforts, knowledge of TB transmission, reduction of health risk behavior and rates of TB
infection.
The study completion date listed in this record was obtained from the "End Date" entered in
the Protocol Registration and Results System (PRS) record.