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

This study has been completed.
Sponsor:
Collaborators:
World Health Organization
Universidade da Paz
Information provided by:
Menzies School of Health Research
ClinicalTrials.gov Identifier:
NCT00192556
First received: September 11, 2005
Last updated: February 8, 2007
Last verified: February 2007
  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
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00192556     History of Changes
Other Study ID Numbers: FITTCET_1, WHO-TDR ID A30746
Study First Received: September 11, 2005
Last Updated: February 8, 2007
Health Authority: Australia: National Health and Medical Research Council

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

ClinicalTrials.gov processed this record on September 16, 2014