Food Incentives for TB Treatment Compliance in East Timor (FITTCET)
Food Incentives for TB Treatment Compliance in East Timor (FITTCET)
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.
We propose to conduct a randomised controlled trial of a food intervention to improve
 compliance in East Timor. Patients will be diagnosed in the usual way and given the
 opportunity to enrol in the study. Consenting individuals will be randomised to receive the
 intervention (meal at the clinic daily during the first two months of treatment and a food
 parcel fortnightly during the other six months of treatment) or standard care (nutritional
 advice only). The primary outcome will be TB cure rates and the secondary outcomes will
 include response to treatment (weight gain, decreased symptoms, sputum clearance) and
 percentage of days attended at the clinic. In conjunction with this study of TB treatment
 compliance we will collect blood samples to measure micro-nutrient changes in response to the
 food intervention. A cost-effectiveness analysis of the intervention will also be performed.

 We plan to do a pilot study in three urban clinics in Dili to establish feasibility and
 provide pilot data for other funding applications so that, if the intervention does improve
 compliance, and funding applications are successful, we can expand the project to include
 rural districts in conjunction with the National TB Control Program. Ultimately, the health
 outcome addressed by this project is improved control of tuberculosis in a high burden, low
 income setting. Better compliance with tuberculosis treatment at the community level will
 contribute to this process.

 TRIAL OBJECTIVES AND PURPOSES

 The specific objectives of the project are:

 1. Design a locally appropriate food intervention to improve adherence to TB treatment and
 TB treatment outcomes in East Timor; and

 2. Conduct a study of the intervention in three clinics in Dili. If this pilot study is
 successful, we will use our experience and pilot data to obtain funds to generalise the
 intervention to rural clinics as well.

 3. Food incentives are an achievable, effective method of encouraging full adherence to
 DOTS and thus improved cure rates in East Timor;

 4. Locally available, whole food supplements are a cost-effective intervention to improve
 cure rates in East Timor; and

 5. Lessons learned in East Timor are adaptable to other settings in other parts of the
 world.

 TRIAL DESIGN

 Expected Outcomes and its measurements :

 1. To show statistically significant differences in treatment success (cure rate) between
 the intervention and the control arm. We will assess the sputum clearance, treatment
 compliance and treatment completion rates and compare the two groups.

 2. To show the effectiveness of food supplementation in improving compliance with
 treatment. In the intensive phase of treatment (usually the first two months), we will
 compare the observed versus expected daily visits to the clinic, compliance with daily
 medications and the default rate between the intervention and control arms. In the
 continuation phase of treatment (usually 6 months), we will compare the observed versus
 expected fortnightly visits to the clinic, daily medication diaries and default rates
 between the two groups.

 3. To show a statistically significant difference in nutritional status between the
 intervention arm and the control arm. We will measure clinical improvement, sputum
 clearance (in sputum smear positive patients), gain in BMI, changes in bio-impedence and
 improvement in levels of micronutrients in both groups.

 4. To demonstrate the cost-effectiveness of the intervention to improve TB control in East
 Timor.

 Randomisation Patients will be randomly assigned to receive one of two interventions: food
 supplements or nutritional advice (standard care). The random assignment to intervention
 group will be provided by the statistician at the Menzies School of Health Research. The
 random allocation sequence will be computer-generated (Stata Version 8.0) and concealed from
 all investigators throughout the study. Allocation will be stratified by community health
 clinic and by the TB diagnosis (sputum smear positive and other). Block randomisation will be
 used to maintain similar numbers of participants in both intervention groups and to minimise
 the potential influence of time of enrolment. The random allocation will be in sealed
 envelopes in two boxes (smear positive and other) in each clinic. Prior to opening the
 envelope, the research assistant will complete the randomisation form to check if the patient
 is eligible for enrolment, obtain informed consent and complete the enrolment questionnaire.
 The research assistant will then inform the local investigator of the name of the patient,
 the time of randomisation and the randomisation number.

 Outcome Assessment

 1. The primary outcome measure will be 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 (defaulters) or
 have persistent disease (treatment failure). The primary analysis will be by intention
 to treat. All participants in the study will contribute an outcome for analysis.

 2. Secondary analyses will be conducted to evaluate the proportion of clinic visits
 compared with expected and response to treatment measures: symptoms (cough, sputum,
 fever); changes in weight, BMI and bio-impedence; sputum clearance; and micronutrient
 measurements.

 3. The primary outcome (treatment success) will be determined by an independent observer
 (based in Darwin) who will be blinded to the intervention received by the patients.
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.