Investigation of a Novel Approach to Improve Treatment Success Rates for Tuberculosis Patients in Senegal
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|ClinicalTrials.gov Identifier: NCT00412009|
Recruitment Status : Completed
First Posted : December 15, 2006
Last Update Posted : December 15, 2006
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.
The overall objective of the project is to improve tuberculosis treatment success rates in Sénégal. The specific objectives are:
- to assess the current situation of tuberculosis (TB) in Sénégal
- to identify the determinants of cure,
- to develop measures to improve patient’s compliance with the treatment that are adapted to the local situation, acceptable, affordable and sustainable
- to evaluate the impact of these measures on TB control.
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).
Methods to improve patients’ adherence to treatment that are affordable, acceptable and sustainable will be developed and tested according to qualitative and quantitative criteria.
|Condition or disease||Intervention/treatment||Phase|
|Tuberculosis||Procedure: Comprehensive package of activities||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||1500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Investigation of a Novel Approach to Improve Adherence to Treatment and Treatment Success Rates for Tuberculosis Patients in Senegal|
|Study Start Date :||May 2003|
|Study Completion Date :||January 2005|
- TB treatment success rate (cure + completed treatment)
- Treatment defaulting rates
- treatment failure rate
- death rate
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00412009
|Programme National de Lutte Anti-tuberculeuse|
|Principal Investigator:||Moustapha Ndir, MD||Programme de Lutte anti-tuberculeuse, Dakar, Senegal|
|Principal Investigator:||Christian Lienhardt, MD||Institut de Recherche pour le Developpement, Paris, France|