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Investigation of a Novel Approach to Improve Treatment Success Rates for Tuberculosis Patients in Senegal

NCT00412009 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1500

Last updated 2006-12-15

No results posted yet for this study

Summary

Tuberculosis (TB) patients who receive inadequate treatment or do not complete therapy are more likely to remain infectious, thus contributing to the continuous spread of TB infection in communities. Despite the widespread use of Directly Observed Therapy, defaulters remain an important problem in TB control programmes. In Sénégal, defaulters rate reach 30%, which is hampering dramatically the effectiveness of control. New strategies to deliver treatment to TB patients and ensure proper adherence that are adapted to the local situations are urgently needed.

Objectives

The overall objective of the project is to improve tuberculosis treatment success rates in Sénégal. The specific objectives are:

1. to assess the current situation of tuberculosis (TB) in Sénégal
2. to identify the determinants of cure,
3. to develop measures to improve patient's compliance with the treatment that are adapted to the local situation, acceptable, affordable and sustainable
4. to evaluate the impact of these measures on TB control.

Methods

The proposed research seeks to develop and test innovative methods to improve cure rates in TB patients. It will explore the factors of success of TB treatment using inter-disciplinary approach, integrating social sciences and economic analyses into TB research. The project is composed of 3 comprehensive phases:

* Phase 1: baseline assessment of the TB situation.
* Phase 2: anthropological study, investigating various domains contributing to patients cure using a range of qualitative research methods. At the end of this investigation, it is expected that determinants of care will be clearly identified. On this basis, suitable methods for improving patients' adherence to treatment will be tailored and developed.
* Phase 3: these methods will be tested and compared using a cluster randomised controlled trial design, in populations served by defined health centres. Their efficacy will be measured in terms of improvement of the classical TB control programme indicators (cure rate, defaulter rate, failure rate, death rates). The methods will also be evaluated on their acceptability by the TB patients and the communities and on their feasibility (duration : 24 months).

Expected results:

Methods to improve patients' adherence to treatment that are affordable, acceptable and sustainable will be developed and tested according to qualitative and quantitative criteria.

Conditions

Interventions

PROCEDURE

Comprehensive package of activities

Sponsors & Collaborators

  • Institut de Recherche pour le Developpement

    lead OTHER_GOV

Principal Investigators

  • Moustapha Ndir, MD · Programme de Lutte anti-tuberculeuse, Dakar, Senegal

  • Christian Lienhardt, MD · Institut de Recherche pour le Developpement, Paris, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-05-31
Completion
2005-01-31

Countries

  • Senegal

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00412009 on ClinicalTrials.gov