Investigation of a Novel Approach to Improve Treatment Success Rates for Tuberculosis Patients in Senegal
|ClinicalTrials.gov Identifier: NCT00412009|
Recruitment Status : Completed
First Posted : December 15, 2006
Last Update Posted : December 15, 2006
|First Submitted Date ICMJE||December 14, 2006|
|First Posted Date ICMJE||December 15, 2006|
|Last Update Posted Date||December 15, 2006|
|Start Date ICMJE||May 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Investigation of a Novel Approach to Improve Treatment Success Rates for Tuberculosis Patients in Senegal|
|Official Title ICMJE||Investigation of a Novel Approach to Improve Adherence to Treatment and Treatment Success Rates for Tuberculosis Patients in Senegal|
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:
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:
Methods to improve patients’ adherence to treatment that are affordable, acceptable and sustainable will be developed and tested according to qualitative and quantitative criteria.
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:
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:
The intervention is applied at the District Health Centre (DHC) level, which is the unit of randomisation.
Based on the detection of an average of 100 new TB cases per DHC per year, an estimated coefficient of variability k=0.12, 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 60/100 000 and more than or equal to 60/100 000.
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.
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 Type ICMJE||Interventional|
|Study Phase||Phase 4|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Intervention ICMJE||Procedure: Comprehensive package of activities|
|Study Arms||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Completion Date||January 2005|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||15 Years to 65 Years (Child, Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Senegal|
|Removed Location Countries|
|NCT Number ICMJE||NCT00412009|
|Other Study ID Numbers ICMJE||PAL+ 2671|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Institut de Recherche pour le Developpement|
|Collaborators ICMJE||Not Provided|
|PRS Account||Institut de Recherche pour le Developpement|
|Verification Date||December 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP