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

This study has been completed.

First Received: September 11, 2005 Last Updated: February 8, 2007 History of Changes

Sponsors and Collaborators:	Menzies School of Health Research World Health Organization Universidade da Paz
Information provided by:	Menzies School of Health Research
ClinicalTrials.gov Identifier:	NCT00192556

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

MedlinePlus related topics: Tuberculosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Official Title:	Food Incentives for TB Treatment Compliance in East Timor

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:

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

Exclusion Criteria:

Children less than 18 years of age,
TB patients who have previously received treatment for TB for more than one month,
Not willing to continue treatment at the clinic for the full course.
TB Patient who are currently pregnant,
TB patients who are not willing to enrol in the study.

Contacts and Locations

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

Study ID Numbers:	FITTCET_1, WHO-TDR ID A30746
Study First Received:	September 11, 2005
Last Updated:	February 8, 2007
ClinicalTrials.gov Identifier:	NCT00192556 History of Changes
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

Study placed in the following topic categories:

Bacterial Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections
Tuberculosis

Additional relevant MeSH terms:

Bacterial Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections
Tuberculosis
Actinomycetales Infections

ClinicalTrials.gov processed this record on May 07, 2009