Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR2010010001275437 Date of Approval: 06/01/2010
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The feasibility and effectiveness of economic incentives for patients with TB
Official scientific title Economic incentives for improving clinical outcomes in patients with TB in South Africa: a study of feasibility and effectiveness.
Brief summary describing the background and objectives of the trial Poverty undermines the ability to adhere to TB treatment. Financial incentives have shown to be effective in improving adherence in the US. However, no such studies have been done in developing countries. This trial will assess the feasibility and effectiveness of economic incentives for patients with TB in a developing country context.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Tuberculosis
Purpose of the trial Supportive care
Anticipated trial start date 01/07/2009
Actual trial start date
Anticipated date of last follow up 02/07/2010
Actual Last follow-up date
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
Ethical approval from Committee for Human Research at the University of Stellenbosch: N07/10/245
ISRCTN50689131 ISRCTN
Ethical approval from Committee for Human Research at the University of Stellenbosch: N07/10/245
ISRCTN50689131 ISRCTN
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised simple randomisation using a random table created by a computer software program Allocating the participant to the intervention arms - units of anaylsis are the clinics, allocation of clinics to itnervention or control groups was done by the MRC statistician off site - allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised simple randomisation using a random table created by a computer software program Allocating the participant to the intervention arms - units of anaylsis are the clinics, allocation of clinics to itnervention or control groups was done by the MRC statistician off site - allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Voucher R120.00 every month 6 months for new TB cases, 8 months for retreatment cases Voucher that can be redeemed at an allocated shop for any goods to the value of R120.00 1000
Control Group Routine TB treatment As per Department of Health protocol 6 months for new patients, 8 months for re-treatment cases Routine TB treatment 1000 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
For patients: any patients receiving TB treatment at selected public sector clinics in eThekwini or Uthungulu districts For clinics: Any clinics in the above districts with cure rates between 40% and 70%, and case load of TB patients between 20 and 150 per quarter. Patients with MDR TB or XDR TB will not receive the voucher. Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/06/2008 Committee for Human Research, University of Stellenbosch
Ethics Committee Address
Street address City Postal code Country
Francie van Zijl Drive Tygerberg, Cape Town 7505 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Cure 6 months of treatment for new cases, 8 months of treatment for re-treatment cases
Secondary Outcome Treatment failure 6 months of treatment for new cases, 8 months of treatment for re-treatment cases
Secondary Outcome Treatment completion 6 months of treatment for new cases, 8 months of treatment for re-treatment cases
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Amatikwe clinic Inanda Durban 4001 South Africa
Goodwins clinic KwaMashu Durban 4001 South Africa
Msunduze clinic Cato Ridge Durban 4001 South Africa
Kwandengezi clinic Kwandengezi Durban 4001 South Africa
Dondotha clinic Dondotha Uthungulu South Africa
Khandisa clinic Vulindlela Uthungulu South Africa
Ntuze clinic Uthungulu South Africa
Dondotha clinic Dondotha Uthungulu South Africa
Gingindlovu Clinic Main Road Gingindlovu 3800 South Africa
Mlazi N clinic N section, Mlazi Durban 4001 South Africa
Mlazi L clinic L section, Mlazi Durban 4001 South Africa
Mbumbulu clinic Mbumbulu Mbumbulu, Durban 4001 South Africa
Folweni clinic Folweni Durban 4001 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Department of Health Pretoria South Africa
Department of Health Pretoria South Africa
KNCV Tuberculosis Foundation P. O. Box 146 The Hague 2501 Netherlands
KNCV Tuberculosis Foundation P. O. Box 146 The Hague 2501 Netherlands
Wellcome Trust 215 Euston Road London NW1 2BE United Kingdom
Wellcome Trust 215 Euston Road London NW1 2BE United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Medical Research Council Francie van Zijl Drive Tygerberg 7505 South Africa Charities/Societies/Foundation
Secondary Sponsor Medical Research Council Francie van Zijl Drive Tygerberg 7505 South Africa Charities/Societies/Foundation
Primary Sponsor Health Systems Trust Salmon Grove Durban 4001 South Africa Charities/Societies/Foundation
Primary Sponsor Health Systems Trust Salmon Grove Durban 4001 South Africa Charities/Societies/Foundation
Secondary Sponsor University of Stellenbosch Francie van Zijl Drive Tygerberg 7505 South Africa University
Secondary Sponsor University of Stellenbosch Francie van Zijl Drive Tygerberg 7505 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Elizabeth Lutge Salmon Grove Durban 4001 South Africa
Elizabeth Lutge Salmon Grove Durban 4001 South Africa
Simon Lewin MRC, Francie van Zijl Drive Tygerberg 7505 South Africa
Simon Lewin MRC, Francie van Zijl Drive Tygerberg 7505 South Africa
Jimmy Volmink University of Stellenbosch, Francie van Zijl Drive Tygerberg 7505 South Africa
Jimmy Volmink University of Stellenbosch, Francie van Zijl Drive Tygerberg 7505 South Africa
Irwin Friedman Health Systems Trust, Salmon Grove Durban 4001 South Africa
Irwin Friedman Health Systems Trust, Salmon Grove Durban 4001 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Elizabeth Lutge elizabeth@hst.org.za 033 - 3473967 Health Systems Trust, 14 Cascades Crescent
City Postal code Country Position/Affiliation
Pietermarizburg 3200 South Africa Senior Researcher
Role Name Email Phone Street address
Public Enquiries Elizabeth Lutge elizabeth@hst.org.za 033 - 3473967 Health Systems Trust, 14 Cascades Crescent
City Postal code Country Position/Affiliation
Pietermarizburg 3200 South Africa Senior Researcher
Role Name Email Phone Street address
Scientific Enquiries Elizabeth Lutge elizabeth@hst.org.za 033 - 3473967 Health Systems Trust, 14 Cascades Crescent
City Postal code Country Position/Affiliation
Pietermarizburg 3200 South Africa Senior Researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information