Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00412009
Status:
COMPLETED
Last Update Posted:
2006-12-15
First Post:
2006-12-14
Brief Title:
Investigation of a Novel Approach to Improve Treatment Success Rates for Tuberculosis Patients in Senegal
Sponsor:
Institut de Recherche pour le Developpement
Organization:
Institut de Recherche pour le Developpement
Study Overview
Official Title:
Investigation of a Novel Approach to Improve Adherence to Treatment and Treatment Success Rates for Tuberculosis Patients in Senegal
Status:
COMPLETED
Status Verified Date:
2006-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 patients 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
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 patients 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
Detailed Description:
General Project Methods
The proposed research seeks to develop and test innovative methods to improve treatment success rates in TB patients in Senegal 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 that will be run concurrently and complement each other
Phase 1 baseline assessment of the TB situation It is first proposed to assess the magnitude of the TB problem and of the means to control it through a standard baseline assessment 6 months
Phase 2 anthropological study investigating various domains contributing to patients cure the patients the community the general health services the policy makers and the TB control staff using a range of qualitative research methods 12 months At the end of this investigation it is expected that determinants of care will be clearly identified with a comprehensive understanding of their relationinterface On this basis suitable methods for improving patients adherence to treatment will be 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 24 months
Methods of the Intervention Trial
The intervention is intended to improve access to care and increase adherence to treatment targeting simultaneously DHC staff TB patients and communities and includes four components
1 improving communication between health personnel and patients through appropriate training
2 decentralising treatment to remote health posts and involving community health workers CHW
3 strengthening the DOT strategy by giving patients the opportunity to choose their treatment supporter and
4 reinforcing supervision of health posts by the DHC team
The intervention is applied at the District Health Centre DHC level which is the unit of randomisation
Sample Size
Based on the detection of an average of 100 new TB cases per DHC per year an estimated coefficient of variability k012 an estimated success rate in the control arm of 65 using conventional TB control programmes procedures with 80 power and a type I error of 5 the required sample size aiming to detect a difference of at least 15 in the treatment success rate between the intervention and control arms is eight DHCs per arm In order to take into account the variation in recruitment of TB patients between the DHCs the randomisation is stratified on baseline detection rate of sputum smear positive cases in 2001 that were classified as less than 60100 000 and more than or equal to 60100 000
Patients and follow-up DHCs with a functional TB diagnosis and treatment unit where no other research projects were being undertaken were eligible for inclusion The study population consisted of all individuals presenting to the DHC between June 2003 and May 2004 with 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 DHC Written informed consent was obtained at recruitment and patients were followed-up during the course of their eight month treatment regimen with the last patients seen in January 2005
Smear-negative and extra-pulmonary tuberculosis cases as well as re-treatment cases were not eligible for the study Patients were recruited into the study between June 2003 and May 2004 and followed up till January 2005
Endpoints
Primary endpoints are both the proportion of recruited patients experiencing treatment success those cured those completing treatment and the proportion of patients defaulting from treatment before completion A cured patient is defined by a negative sputum-smear at eight months and on at least one previous occasion Patients completing treatment are those missing smear results but who had finished their treatment regimen A defaulter is defined as a patient who definitely stopped treatment before completion
The proposed research seeks to develop and test innovative methods to improve treatment success rates in TB patients in Senegal 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 that will be run concurrently and complement each other
Phase 1 baseline assessment of the TB situation It is first proposed to assess the magnitude of the TB problem and of the means to control it through a standard baseline assessment 6 months
Phase 2 anthropological study investigating various domains contributing to patients cure the patients the community the general health services the policy makers and the TB control staff using a range of qualitative research methods 12 months At the end of this investigation it is expected that determinants of care will be clearly identified with a comprehensive understanding of their relationinterface On this basis suitable methods for improving patients adherence to treatment will be 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 24 months
Methods of the Intervention Trial
The intervention is intended to improve access to care and increase adherence to treatment targeting simultaneously DHC staff TB patients and communities and includes four components
1 improving communication between health personnel and patients through appropriate training
2 decentralising treatment to remote health posts and involving community health workers CHW
3 strengthening the DOT strategy by giving patients the opportunity to choose their treatment supporter and
4 reinforcing supervision of health posts by the DHC team
The intervention is applied at the District Health Centre DHC level which is the unit of randomisation
Sample Size
Based on the detection of an average of 100 new TB cases per DHC per year an estimated coefficient of variability k012 an estimated success rate in the control arm of 65 using conventional TB control programmes procedures with 80 power and a type I error of 5 the required sample size aiming to detect a difference of at least 15 in the treatment success rate between the intervention and control arms is eight DHCs per arm In order to take into account the variation in recruitment of TB patients between the DHCs the randomisation is stratified on baseline detection rate of sputum smear positive cases in 2001 that were classified as less than 60100 000 and more than or equal to 60100 000
Patients and follow-up DHCs with a functional TB diagnosis and treatment unit where no other research projects were being undertaken were eligible for inclusion The study population consisted of all individuals presenting to the DHC between June 2003 and May 2004 with 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 DHC Written informed consent was obtained at recruitment and patients were followed-up during the course of their eight month treatment regimen with the last patients seen in January 2005
Smear-negative and extra-pulmonary tuberculosis cases as well as re-treatment cases were not eligible for the study Patients were recruited into the study between June 2003 and May 2004 and followed up till January 2005
Endpoints
Primary endpoints are both the proportion of recruited patients experiencing treatment success those cured those completing treatment and the proportion of patients defaulting from treatment before completion A cured patient is defined by a negative sputum-smear at eight months and on at least one previous occasion Patients completing treatment are those missing smear results but who had finished their treatment regimen A defaulter is defined as a patient who definitely stopped treatment before completion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None