Tuberculosis Clinical Trial
Official title:
Food Incentives for TB Treatment Compliance in East Timor
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.
Status | Completed |
Enrollment | 270 |
Est. completion date | August 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 15 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Menzies School of Health Research | Darwin | Northern Territory |
Lead Sponsor | Collaborator |
---|---|
Menzies School of Health Research | Universidade da Paz, World Health Organization |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | proportion of patients who successfully complete TB treatment and achieve cure. | |||
Secondary | proportion of clinic visits compared with expected | |||
Secondary | response to treatment measures: symptoms (cough, sputum, fever); | |||
Secondary | changes in weight;sputum clearance; | |||
Secondary | micronutrient measurements. |
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