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Food Incentives for TB Treatment Compliance in East Timor (FITTCET)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00192556
First Posted: September 19, 2005
Last Update Posted: February 12, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
World Health Organization
Universidade da Paz
Information provided by:
Menzies School of Health Research
  Purpose
This study will examine whether food is a cost-effective method for improving treatment compliance for TB patients in Timor Leste. Our hypothesis is that the provision of locally available, locally acceptable, cheap and highly nutritious food at the clinic will encourage patients to come for daily directly observed treatment, and thus improve the chance of TB cure and decrease the chance of the development of TB drug resistance. Primary outcome will be successful completion of treatment and secondary outcomes will include treatment compliance and clinical and biological measures of nutritional improvement.

Condition Intervention
Tuberculosis Behavioral: food

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Food Incentives for TB Treatment Compliance in East Timor

Resource links provided by NLM:


Further study details as provided by Menzies School of Health Research:

Primary Outcome Measures:
  • proportion of patients who successfully complete TB treatment and achieve cure.

Secondary Outcome Measures:
  • proportion of clinic visits compared with expected
  • response to treatment measures: symptoms (cough, sputum, fever);
  • changes in weight;sputum clearance;
  • micronutrient measurements.

Estimated Enrollment: 270
Study Start Date: March 2005
Estimated Study Completion Date: August 2006
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adults 18 years of age or older;
  2. Have sputum smear positive or sputum smear negative pulmonary or extrapulmonary TB, using the standard NTP definitions for these diagnoses;
  3. Have never received more that one month of anti-tuberculosis treatment in the past (that is, only new cases of TB will be included).
  4. Agree to continue treatment at the clinic of diagnosis for the full eight month course of treatment.
  5. Not pregnant.
  6. Agree to enrol in the study.

Exclusion Criteria:

  1. Children less than 18 years of age,
  2. TB patients who have previously received treatment for TB for more than one month,
  3. Not willing to continue treatment at the clinic for the full course.
  4. TB Patient who are currently pregnant,
  5. TB patients who are not willing to enrol in the study.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00192556


Locations
Australia, Northern Territory
Menzies School of Health Research
Darwin, Northern Territory, Australia, 0811
Sponsors and Collaborators
Menzies School of Health Research
World Health Organization
Universidade da Paz
Investigators
Principal Investigator: Paul M Kelly, MBBS,PhD Menzies School of Health Research
Principal Investigator: Peter Morris, MBBS,PhD Menzies School of Health Research
Principal Investigator: Nelson Martins, MD, MAM(H) Menzies School of Health Research & Universidade da Paz
  More Information

ClinicalTrials.gov Identifier: NCT00192556     History of Changes
Other Study ID Numbers: FITTCET_1
WHO-TDR ID A30746
First Submitted: September 11, 2005
First Posted: September 19, 2005
Last Update Posted: February 12, 2007
Last Verified: February 2007

Keywords provided by Menzies School of Health Research:
tuberculosis
nutrition
directly observed therapy
Timor Leste
cost-effectiveness

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections