Food Incentives for TB Treatment Compliance in East Timor (FITTCET)

NCT00192556 | Completed

• 2 other identifiers: FITTCET_1WHO-TDR ID A30746
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculosis

Keywords

tuberculosis; nutrition; directly observed therapy; Timor Leste; cost-effectiveness

Outcome Measures

Primary Outcomes (1)

• proportion of patients who successfully complete TB treatment and achieve cure.

Secondary Outcomes (4)

• proportion of clinic visits compared with expected

• response to treatment measures: symptoms (cough, sputum, fever);

• changes in weight;sputum clearance;

• micronutrient measurements.

Interventions

food BEHAVIORAL

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 18 years of age or older;
• Have sputum smear positive or sputum smear negative pulmonary or extrapulmonary TB, using the standard NTP definitions for these diagnoses;
• Have never received more that one month of anti-tuberculosis treatment in the past (that is, only new cases of TB will be included).
• Agree to continue treatment at the clinic of diagnosis for the full eight month course of treatment.
• Not pregnant.
• Agree to enrol in the study.

You may not qualify if:

• Children less than 18 years of age,
• TB patients who have previously received treatment for TB for more than one month,
• Not willing to continue treatment at the clinic for the full course.
• TB Patient who are currently pregnant,
• TB patients who are not willing to enrol in the study.

Sponsors & Collaborators

• Menzies School of Health Research: lead
• World Health Organization: collaborator
• Universidade da Paz: collaborator

Study Sites (1)

Menzies School of Health Research

Darwin, Northern Territory, 0811, Australia

Location

Related Publications (1)

• 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.

  PMID: 19858174 DERIVED

MeSH Terms

Conditions

Tuberculosis; Directly Observed Therapy

Interventions

Food

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Paul M Kelly, MBBS,PhD

  Menzies School of Health Research

  PRINCIPAL INVESTIGATOR

• Peter Morris, MBBS,PhD

  Menzies School of Health Research

  PRINCIPAL INVESTIGATOR

• Nelson Martins, MD, MAM(H)

  Menzies School of Health Research & Universidade da Paz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 11, 2005
• First Posted: September 19, 2005
• Study Start: March 1, 2005
• Study Completion: August 1, 2006
• Last Updated: February 12, 2007

Record last verified: 2007-02

Locations

AU (1)