Economic incentives for improving cure and treatment completion rates in patients with tuberculosis (TB) in South Africa: a study of feasibility and effectiveness

ISRCTN	ISRCTN50689131
DOI	https://doi.org/10.1186/ISRCTN50689131
Protocol serial number	083619
Sponsor	Medical Research Council of South Africa (South Africa)
Funders	South African National Department of Health (South Africa) - via the Research Directorate, The Royal Netherlands Tuberculosis Association (KNCV) (Netherlands) - via the TB CAP programme, The Wellcome Trust (UK) (grant ref: 083619)

Submission date: 17/04/2009
Registration date: 21/04/2009
Last edited: 30/06/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Elizabeth Lutge
Scientific

Health Systems Trust
P.O. Box 808
Durban
4000
South Africa

Phone	+27 (0)33 347 3967
Email	elizabeth@hst.org.za

Study information

Primary study design	Interventional
Study design	Multicentre pragmatic unblinded two-armed cluster randomided trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Economic incentives for improving clinical outcomes in patients with tuberculosis (TB) in South Africa: a pragmatic unblinded two-armed cluster randomised study of feasibility and effectiveness
Study objectives	Tuberculosis (TB) affects poor people disproportionately, and the costs of accessing treatment may be a profound financial stress for the household. Assisting TB patients financially may help them to adhere to treatment, and so improve clinical outcomes. As of 05/01/2010 this record has been updated to include a change to the protocol in order to accept child participants and amendments to the start and end dates of this trial. All details can be found under the relevant section with the update date of 05/01/2010. The intial trial dates were as follows at the time of registration: Initial anticipated start date: 01/06/2009 Initial anticipated end date: 30/04/2010
Ethics approval(s)	Committee for Human Research at the University of Stellenbosch, South Africa, approved on the 6th February 2008 (and has subsequently been granted a year's extension on 4th March 2009) (ref: N07/10/245). Amendments from 05/01/2010 were granted approval by the Committee for Human Research at the University of Stellenbosch.
Health condition(s) or problem(s) studied	Drug sensitive tuberculosis
Intervention	The intervention will be a voucher, valued at R120.00 (approximately US $15.00), given every month for the duration of TB treatment or a maximum of 6 months for drug sensitive cases, and 8 months for re-treatment or drug resistant cases. Vouchers will be administered by clinic nurses treating patients with TB. This voucher will be redeemable at a designated shop, for any goods (although the patient will be encouraged to purchase healthy foodstuffs). All TB patients within intervention clinics will receive the voucher. Patients at control clinics will receive routine TB treatment. Patients from intervention and control clinics will be followed up to the end of their TB treatment (6 months for drug sensitive cases, and 8 months for re-treatment).
Intervention type	Other
Primary outcome measure(s)	1. Cure: patient who is sputum smear-negative in the last month of treatment and on at least one previous occasion 2. Treatment completion: patient who has completed treatment but who does not meet the criteria to be classified as a cure or a failure. (World Health Organization. Global Tuberculosis Control: Surveillance, Planning, Financing. WHO Report 2004). These measures will be obtained from the clinic-maintained TB register, in which all patient outcomes are recorded. Outcomes are recorded at the end of patient treatment (6 months for drug sensitive cases, and 8 months for re-treatment).
Key secondary outcome measure(s)	1. Treatment failure: patient who is sputum smear-positive at 5 months or later during treatment 2. Default: patient whose treatment was interrupted for two consecutive months or more. (World Health Organization. Global Tuberculosis Control: Surveillance, Planning, Financing. WHO Report 2004). These measures will be obtained from the clinic-maintained TB register, in which all patient outcomes are recorded. Outcomes are recorded at the end of patient treatment (6 months for drug sensitive cases, and 8 months for re-treatment).
Completion date	31/07/2010

Eligibility

Participant type(s)	Patient
Age group	Other
Lower age limit	18 Years
Sex	All
Target sample size at registration	1000
Key inclusion criteria	Current inclusion criteria as of 05/01/2010: 1. With tuberculosis (TB), including re-treatment cases 2. Both men and women, all ages Initial inclusion criteria at time of registration: 1. Aged 18 years and older 2. With tuberculosis (TB), including re-treatment cases 3. Both men and women
Key exclusion criteria	Current exclusion criteria as of 05/01/2010: Patients with multi-drug resistant (MDR) or extremely drug-resistent (XDR) TB will be excluded from the analysis. However, they will receive the vouchers for a maximum of 8 months of the study. Initial exclusion criteria at time of registration: 1. Children less than 18 years 2. Patients with multi-drug resistant (MDR) or extremely drug-resistent (XDR) TB will be excluded from the analysis. However, they will receive the vouchers for a maximum of 8 months of the study.
Date of first enrolment	01/07/2009
Date of final enrolment	31/07/2010

Locations

Countries of recruitment

South Africa

Study participating centre

Health Systems Trust

Durban
4000
South Africa

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	28/05/2013		Yes	No
Results article	results	19/06/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes