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DOT AFRICAN TRIAL
TUBERCULOSIS (INCO)
Framework programme: 5
Project number:
ICA4-CT-2001-10018
EC contribution: € 600 000
Duration: 48 months
Type: RS
Starting date: 1 November 2001
Graphic element A Multicentre Randomised Trial of Directly Observed Treatment for Tuberculosis Patients in Sub-Saharan Africa

Summary:

Adherence to TB remains poor even in well run TB Control Programmes. For chronic diseases, patient-centred approaches can improve adherence to treatment. Simple interventions for defaulter tracing seem effective. Although directly observed treatment has been widely introduced, scientific evidence regarding the efficacy of such a policy in terms of improving adherence and cure rates are still strongly needed. The proposal is a multicentre randomised trial with two combined studies and 1 412 TB patients will be randomly assigned to one of the two studies. The aim of the randomised trial is to compare the effect of directly observed treatment (DOT) and self supervised treatment (SST) on cure rates in pulmonary TB patients in the context of a flexible and patient-centred approach to care. In the intervention study, a DOT strategy will be carried out. A patient-centred approach will be implemented in both studies and evaluated in terms of processes. Focus group discussions and interviews with patients and caregivers will be conducted to explore perceptions of DOT and SST, and the barriers to treatment adherence.

Objectives:

The primary objective is to compare the effects of directly observed treatment (DOT) and self-supervised treatment (SST) on cure rates in smear positive pulmonary TB patients, in the context of a comprehensive, flexible and patient-centred approach to care. The secondary objectives are:

l) to assess opinions/perceptions of staff and patients regarding the care offered
2) to determine if a patient-centred care package can be successfully implemented in low income countries.

Description:

This is a multicentre randomised controlled trial with two combined studies covering the assessment of patients' and caregivers' opinions and perceptions, and the evaluation of a patient-centred care approach in terms of processes and caregivers' practices. Eighteen clinics from two African countries will participate. For the randomised controlled trial, 1 412 adults with smear positive pulmonary TB will be randomly allocated to either the intervention or the control study. The main outcome will be the cure rate and secondary outcomes will include treatment completion rate. In the intervention study, a DOT strategy will be carried out. Patients will be able to choose their supervisor from among clinic staff, community health workers or community volunteers. Patients will also be able to elect the place of supervision. The way care is provided to TB patients will be similar in the two studies except that in the control, treatment will not be supervised. Analysis will be in the intention to treat. A patient-centred approach to care and defaulter tracing actions will be carried out in both studies. Caregivers will provide in-depth information about treatment options to the patient, identify their needs and preferences and develop a follow-up treatment programme accordingly. Flexible arrangements for the patient will be emphasised. Counselling will be provided as well as special education/information material. At the start of the project, a multidisciplinary team will develop the patient-centred care package and the training of health staff. Process indicators will be elaborated to evaluate whether the approach can be successfully implemented in these settings. Focus group discussions and interviews with patients and caregivers will be conducted to explore perceptions of DOT and SST, the barriers to treatment adherence, with special attention to gender issues, and the quality of communication between patient and service provider.

Milestones:

1) The recruitment of patients begins in RCT at month 13.
2) Data collection achieved with the total sample size (n=1412) completed at month 36.
3) A publication about the effect of DOT vs SST on cure rates will be finalised by the end of the project.
4) Publication of the final results of the qualitative studies and of the management component of the project at month 48.

Coordinator:

Bruno Dujardin
Ecole de Santé Publique - Université Libre de Bruxelles
Department ‘Politiques et Systèmes de Santé’
Brussels
Belgium
Tel: +32 2 555 4081
Fax: +32 2 555 4049
E-mail: bruno.dujardin@ulb.ac.be

Partners:

  1. Medical Research Council - South African Cochrane Centre, Tygerberg, South Africa
  2. Ministère de la Santé, Programme National de Lutte contre la Tuberculose, Ouagadougou 01, Burkina Faso
  3. Liverpool School of Tropical Medicine - International Health Division, UK-Liverpool, United Kingdom

 
 
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