The Food Incentives for Tuberculosis Treatment Compliance study in Dili, East Timor (FITTCET)
Completed
- Conditions
- TuberculosisInfections and Infestations
- Registration Number
- ISRCTN11134588
- Lead Sponsor
- ICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 270
Inclusion Criteria
Adult Tuberculosis (TB) patients diagnosed at one of the participating clinics during the study period will be eligible for enrolment if they are:
1. 18 years of age or older
2. Diagnosed to have tuberculosis (sputum smear positive or smear negative or extrapulmonary TB) using the standard National Tuberculosis Programme (NTP) definition for this diagnosis
3. Have never received more than one month of anti-tuberculosis treatment in the past
4. Not pregnant
5. Voluntarily accept to be involved in this study
Exclusion Criteria
Does not comply with inclusion criteria.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of patients who successfully complete the eight month course of TB treatment and achieve cure in each group (treatment success) and the proportion of patients who do not complete treatment or have persistent disease (treatment failure).
- Secondary Outcome Measures
Name Time Method 1. The proportion of clinic visits compared with expected, measured weekly for first 2 months then monthly for next 6 months<br>2. Response to treatment measures: <br>2.1. Symptoms (cough, sputum, fever), measured at 4, 8, 24 and 32 weeks <br>2.2. Changes in weight and Body Mass Index (BMI), measured at 4, 8, 24 and 32 weeks <br>2.3. Sputum clearance, measured at at 8 weeks<br>2.4. Nutritional markers, measured at 4, 8, 24 and 32 weeks