NCT00412009

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:

  • 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 15, 2006

Completed
Last Updated

December 15, 2006

Status Verified

December 1, 2006

First QC Date

December 14, 2006

Last Update Submit

December 14, 2006

Conditions

Tuberculosis

Keywords

tuberculosiscontroltreatmentadherence

Outcome Measures

Primary Outcomes (2)

  • TB treatment success rate (cure + completed treatment)

  • Treatment defaulting rates

Secondary Outcomes (2)

  • treatment failure rate

  • death rate

Interventions

Comprehensive package of activitiesPROCEDURE

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Smear-negative tuberculosis cases
  • extra-pulmonary tuberculosis cases
  • TB re-treatment cases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Programme National de Lutte Anti-tuberculeuse

Dakar, Senegal

Location

Related Publications (2)

  • Lienhardt C, Ogden JA. Tuberculosis control in resource-poor countries: have we reached the limits of the universal paradigm? Trop Med Int Health. 2004 Jul;9(7):833-41. doi: 10.1111/j.1365-3156.2004.01273.x.

    PMID: 15228495BACKGROUND

  • Thiam S, LeFevre AM, Hane F, Ndiaye A, Ba F, Fielding KL, Ndir M, Lienhardt C. Effectiveness of a strategy to improve adherence to tuberculosis treatment in a resource-poor setting: a cluster randomized controlled trial. JAMA. 2007 Jan 24;297(4):380-6. doi: 10.1001/jama.297.4.380.

    PMID: 17244834DERIVED

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Moustapha Ndir, MD

    Programme de Lutte anti-tuberculeuse, Dakar, Senegal

    PRINCIPAL INVESTIGATOR

  • Christian Lienhardt, MD

    Institut de Recherche pour le Developpement, Paris, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 14, 2006

First Posted

December 15, 2006

Study Start

May 1, 2003

Study Completion

January 1, 2005

Last Updated

December 15, 2006

Record last verified: 2006-12

Locations

SE(1)