Investigation of a Novel Approach to Improve Treatment Success Rates for Tuberculosis Patients in Senegal
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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:
- 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.
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Tuberculosis |
Procedure: Comprehensive package of activities |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Investigation of a Novel Approach to Improve Adherence to Treatment and Treatment Success Rates for Tuberculosis Patients in Senegal |
- TB treatment success rate (cure + completed treatment)
- Treatment defaulting rates
- treatment failure rate
- death rate
| Estimated Enrollment: | 1500 |
| Study Start Date: | May 2003 |
| Estimated Study Completion Date: | January 2005 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 15 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- newly diagnosed sputum-smear positive pulmonary TB (at least two positive specimens), aged 15 years or more, and living in the district served by the District Health Centre.
Exclusion Criteria:
- Smear-negative tuberculosis cases
- extra-pulmonary tuberculosis cases
- TB re-treatment cases
Contacts and Locations| Senegal | |
| Programme National de Lutte Anti-tuberculeuse | |
| Dakar, Senegal | |
| 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 |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00412009 History of Changes |
| Other Study ID Numbers: | PAL+ 2671 |
| Study First Received: | December 14, 2006 |
| Last Updated: | December 14, 2006 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Institut de Recherche pour le Developpement:
|
tuberculosis control treatment adherence |
Additional relevant MeSH terms:
|
Tuberculosis Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on May 16, 2013