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Promoting Adherence to TB Regimens in Latino Adolescents

This study has been completed.

Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00005738
  Purpose

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.


Condition
Lung Diseases
Tuberculosis

MedlinePlus related topics:   Tuberculosis   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Natural History

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date:   September 1995
Estimated Study Completion Date:   August 2001

Detailed 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.

  Eligibility
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Criteria

No eligibility criteria

  Contacts and Locations

No Contacts or Locations Provided
  More Information


Study ID Numbers:   4947
First Received:   May 25, 2000
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00005738
Health Authority:   United States: Federal Government

Study placed in the following topic categories:
Bacterial Infections
Gram-Positive Bacterial Infections
Respiratory Tract Diseases
Lung Diseases
Mycobacterium Infections
Tuberculosis

Additional relevant MeSH terms:
Actinomycetales Infections

ClinicalTrials.gov processed this record on December 03, 2008




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