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Behavioral Interventions for Control of Tuberculosis

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

11 Years - 19 Years (Child, Adult)All SexesDoes 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
    February 26, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00005742
    Brief Title
    Behavioral Interventions for Control of Tuberculosis
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    May 2005
    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
    To develop and test various educational strategies targeting primarily minority TB-infected adolescents at two health centers in Los Angeles in an experimental design to assess the relative effectiveness on medication adherence, appointment keeping, and completion of therapy.
    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: The educational content and modalities were based on an intervention-oriented model of behavioral action derived from the theory of reasoned action, the theory of planned behavior, and the transtheoretical model. An experimental four group design was used to assess the independent and combined effects of peer counseling, a participant/parent contingency contract intervention, and a combination of peer counseling and contingency contracting, compared with a usual care control group. Beginning July 15, 1996 a total of 794 participants were recruited and randomly assigned to one of the four groups. In addition to assessing the impact of the intervention, analyses compared the relative importance of the hypothesized influencing and mediating factors on behavior. Cost-effectiveness analyses were also conducted. During the later stages of the study, clinic staff from throughout Los Angeles County were trained and encouraged to integrate the strategies that appeared to be effective into their clinic setting. 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
    All
    Minimum Age & Unit of Time
    11 Years
    Maximum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Donald Morisky
    Organizational Affiliation
    University of California at Los Angeles

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    11137908
    Citation
    Ebin VJ, Sneed CD, Morisky DE, Rotheram-Borus MJ, Magnusson AM, Malotte CK. Acculturation and interrelationships between problem and health-promoting behaviors among Latino adolescents. J Adolesc Health. 2001 Jan;28(1):62-72. doi: 10.1016/s1054-139x(00)00162-2.
    Results Reference
    background
    PubMed Identifier
    11763291
    Citation
    Salabarria-Pena Y, Trout PT, Gill JK, Morisky DE, Muralles AA, Ebin VJ. Effects of acculturation and psychosocial factors in Latino adolescents' TB-related behaviors. Ethn Dis. 2001 Fall;11(4):661-75.
    Results Reference
    background
    PubMed Identifier
    11436933
    Citation
    Sneed CD, Morisky DE, Rotheram-Borus MJ, Ebin VJ, Malotte CK. Patterns of adolescent alcohol, cigarette, and marijuana use over a 6-month period. Addict Behav. 2001 May-Jun;26(3):415-23. doi: 10.1016/s0306-4603(00)00134-9.
    Results Reference
    background
    PubMed Identifier
    11397332
    Citation
    Sneed CD, Morisky DE, Rotheram-Borus MJ, Ebin V, Malotte CK, Lyde M, Gill JK. 'Don't know' and 'didn't think of it': condom use at first intercourse by Latino adolescents. AIDS Care. 2001 Jun;13(3):303-8. doi: 10.1080/09540120120043955.
    Results Reference
    background
    PubMed Identifier
    12196616
    Citation
    Morisky DE, Malotte CK, Ebin V, Davidson P, Cabrera D, Trout PT, Coly A. Behavioral interventions for the control of tuberculosis among adolescents. Public Health Rep. 2001 Nov-Dec;116(6):568-74. doi: 10.1093/phr/116.6.568.
    Results Reference
    background

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    Behavioral Interventions for Control of Tuberculosis

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