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 |
| Secondary identifying numbers | 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
Scientific
Health Systems Trust
P.O. Box 808
Durban
4000
South Africa
| Phone | +27 (0)33 347 3967 |
|---|---|
| elizabeth@hst.org.za |
Study information
| Study design | Multicentre pragmatic unblinded two-armed cluster randomided trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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). |
| Secondary outcome measures | 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). |
| Overall study start date | 01/07/2009 |
| Completion date | 31/07/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | A total of 20 clinics (clusters) will be included (10 intervention and 10 controls). This amounts to approximately 1000 participants across both arms and in both districts. |
| 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
4000
South Africa
Sponsor information
Medical Research Council of South Africa (South Africa)
Research council
Research council
PO Box 19070
7505 Tygerberg
Cape Town
7505
South Africa
| Phone | +27 (0)21 938 0911 |
|---|---|
| info@mrc.ac.za | |
| Website | http://www.mrc.ac.za |
"ROR" |
https://ror.org/05q60vz69 |
Funders
Funder type
Government
South African National Department of Health (South Africa) - via the Research Directorate
No information available
The Royal Netherlands Tuberculosis Association (KNCV) (Netherlands) - via the TB CAP programme
No information available
The Wellcome Trust (UK) (grant ref: 083619)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
