Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT00005738 |
Other study ID # |
4947 |
Secondary ID |
R01HL055738 |
Status |
Completed |
Phase |
N/A
|
First received |
May 25, 2000 |
Last updated |
January 11, 2016 |
Start date |
September 1995 |
Est. completion date |
August 2001 |
Study information
Verified date |
May 2002 |
Source |
San Diego State University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
United States: Federal Government |
Study type |
Observational
|
Clinical Trial Summary
To test a public health model of screening, preventive isoniazid treatment, and adherence
counseling plus medical education of primary care clinicians to enhance their skills and
attention to TB control. Also, to test a behavioral adherence intervention for Latino
adolescents with latent disease and a medical education program designed to enhance primary
care (community clinic) practitioners' treatment of active and latent TB infection.
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:
To extend the proposed model to most community clinic settings, the investigators are
demonstrating outcome effectiveness as well as cost effectiveness in relation to the costs
of failing to control latent TB in this population. Public school adolescents are screened
and 300 PPD positive male and female Latino youth (13-18 years) are assigned at random to
either usual medical treatment, usual medical treatment plus non-directed (attention
control) counseling, or medical care plus behavioral adherence counseling. Concurrently
participating clinic personnel receive training in TB control.
The primary specific aims are to determine whether behavioral counseling increases clinic
attendance and adherence to prescribed isoniazid medication relative to controls, and to
determine if training increases professionals' knowledge and practice of TB screening and
control treatment. Pill count and reported estimates of adherence are verified by random
urine assays. Repeated measures analyses are used to assess the effects of professional
training. Exploratory analyses identify correlates of adherence, and cost effectiveness
analyses assess the relative costs of screening and treatment compared to the costs of not
controlling TB.