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Lung DiseasesNCT00005742

Behavioral Interventions for Control of Tuberculosis

An observational study of Lung Diseases and Tuberculosis, run by National Heart, Lung, and Blood Institute (NHLBI).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 11 to 19 years
Conditions the study is for
Lung Diseases, Tuberculosis
How many people
Not given
Where
No sites listed yet
Study dates
Sep 1995to Aug 2001
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 19 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

No eligibility criteria

About this study

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.

Read the 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.

Medical subject headings
Lung Diseases, Tuberculosis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2000 (estimated)
  2. Study startSep 1995
  3. Study completionAug 2001

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005742
Sponsor's protocol ID
4951
Other IDs
R01HL055770
Status last verified
May 2005
First submitted
25 May 2000
Last updated
29 Feb 2016
Results posted
No

Publications

  • 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.

    PubMed 11137908
  • 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.

    PubMed 11763291
  • 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.

    PubMed 11436933
  • 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.

    PubMed 11397332
  • 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.

    PubMed 12196616

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Diseases and Tuberculosis, run by National Heart, Lung, and Blood Institute (NHLBI).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00005742, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2016.

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