TuberculosisNCT00149448
Effectiveness of the TB Contact Priority Model
An observational study of Tuberculosis, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
The broad purpose of this project, proposed by investigators at the University of Alabama at Birmingham and the State of Alabama Department of Public Health, is to use a behaviorally focused education that has been proven effective to enhance the accuracy and efficiency of the contact investigation process. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Tuberculosis
- What is being tested?
- TB Contact Priority Model
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- May 2004to Mar 2009
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
B field workers for the Alabama Department of Public Health.
About this study
The broad purpose of this project, proposed by investigators at the University of Alabama at Birmingham and the State of Alabama Department of Public Health, is to use a behaviorally focused education that has been proven effective to enhance the accuracy and efficiency of the contact investigation process. The behaviorally focused intervention will focus on enabling public health workers to understand and implement a recently published model of TB transmission.
Read the detailed description
BACKGROUND:
Investigation of contacts of patients with active pulmonary tuberculosis (TB) is an important epidemiological tool in TB control. Unfortunately, due to budgetary and resource constraints, many health departments struggle to fulfill their responsibility of TB control through contact investigation.
DESIGN NARRATIVE:
Primary outcome The primary outcome of this project is to examine the clinical effectiveness of the TB transmission model. This will be done by examining the sensitivity and specificity of the model when used in a field application.
Key secondary outcomes Evaluation of the efficiency of contact investigation (two outcomes: 1) weekly average time to tuberculin skin test placement for high risk contacts, 2) weekly average time to the close of the contact investigation.) Qualitative assessment of individuals who are incorrectly predicted by the model to have a negative tuberculin skin test
- Conditions
- Tuberculosis
- Being tested
- TB Contact Priority Model
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TB Contact Priority ModelBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startMay 2004
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00149448
- Sponsor's protocol ID
- 1304
- Status last verified
- Apr 2009
- First submitted
- 6 Sep 2005
- Last updated
- 14 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the TB Contact Priority Model
- ClinicalTrials.gov ID
- NCT00149448
- Acronym / sponsor ID
- 1304
- Conditions
- Tuberculosis
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- May 2004
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 8 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The broad purpose of this project, proposed by investigators at the University of Alabama at Birmingham and the State of Alabama Department of Public Health, is to use a behaviorally focused education that has been proven effective to enhance the accuracy and efficiency of the contact investigation process. The behaviorally focused intervention will focus on enabling public health workers to understand and implement a recently published model of TB transmission.
Detailed description
BACKGROUND:
Investigation of contacts of patients with active pulmonary tuberculosis (TB) is an important epidemiological tool in TB control. Unfortunately, due to budgetary and resource constraints, many health departments struggle to fulfill their responsibility of TB control through contact investigation.
DESIGN NARRATIVE:
Primary outcome The primary outcome of this project is to examine the clinical effectiveness of the TB transmission model. This will be done by examining the sensitivity and specificity of the model when used in a field application.
Key secondary outcomes Evaluation of the efficiency of contact investigation (two outcomes: 1) weekly average time to tuberculin skin test placement for high risk contacts, 2) weekly average time to the close of the contact investigation.) Qualitative assessment of individuals who are incorrectly predicted by the model to have a negative tuberculin skin test
Study design
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TB Contact Priority Model | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of 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.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2009. 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?
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 14 Apr 2009.