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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00192556




Registration number
NCT00192556
Ethics application status
Date submitted
11/09/2005
Date registered
19/09/2005
Date last updated
12/02/2007

Titles & IDs
Public title
Food Incentives for TB Treatment Compliance in East Timor (FITTCET)
Scientific title
Food Incentives for TB Treatment Compliance in East Timor
Secondary ID [1] 0 0
WHO-TDR ID A30746
Secondary ID [2] 0 0
FITTCET_1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tuberculosis 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
proportion of patients who successfully complete TB treatment and achieve cure.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
proportion of clinic visits compared with expected
Timepoint [1] 0 0
Secondary outcome [2] 0 0
response to treatment measures: symptoms (cough, sputum, fever);
Timepoint [2] 0 0
Secondary outcome [3] 0 0
changes in weight;sputum clearance;
Timepoint [3] 0 0
Secondary outcome [4] 0 0
micronutrient measurements.
Timepoint [4] 0 0

Eligibility
Key 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.
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NT
Recruitment hospital [1] 0 0
Menzies School of Health Research - Darwin
Recruitment postcode(s) [1] 0 0
0811 - Darwin

Funding & Sponsors
Primary sponsor type
Other
Name
Menzies School of Health Research
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
World Health Organization
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Universidade da Paz
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00192556
Trial related presentations / publications
Martins N, Morris P, Kelly PM. Food incentives to improve completion of tuberculosis treatment: randomised controlled trial in Dili, Timor-Leste. BMJ. 2009 Oct 26;339:b4248. doi: 10.1136/bmj.b4248. Erratum In: BMJ. 2016 May 27;353:i3039. doi: 10.1136/bmj.i3039.
Public notes

Contacts
Principal investigator
Name 0 0
Paul M Kelly, MBBS,PhD
Address 0 0
Menzies School of Health Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00192556