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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
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