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Indigenous Outreach Among Injection Drug Users to Treat and Control TB

Primary Purpose

Lung Diseases, Tuberculosis

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Lung Diseases

Eligibility Criteria

undefined - 100 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2000
    Last Updated
    May 12, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00005741
    Brief Title
    Indigenous Outreach Among Injection Drug Users to Treat and Control TB
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    May 2002
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1995 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    August 2001 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    Brief 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.
    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: 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Diseases, Tuberculosis

    7. Study Design

    10. Eligibility

    Sex
    Male
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria

    12. IPD Sharing Statement

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    Indigenous Outreach Among Injection Drug Users to Treat and Control TB

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