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DOT AFRICAN TRIAL


Tuberculosis (INCO)

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

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.

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