Condition category
Infections and Infestations
Date applied
17/04/2009
Date assigned
21/04/2009
Last edited
30/06/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Elizabeth Lutge

ORCID ID

Contact details

Health Systems Trust
P.O. Box 808
Durban
4000
South Africa
+27 (0)33 347 3967
elizabeth@hst.org.za

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

083619

Study information

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

Acronym

Study hypothesis

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

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.

Study design

Multicentre pragmatic unblinded two-armed cluster randomided trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/07/2009

Overall trial end date

31/07/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Other

Gender

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.

Participant 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.

Recruitment start date

01/07/2009

Recruitment end date

31/07/2010

Locations

Countries of recruitment

South Africa

Trial participating centre

Health Systems Trust
Durban
4000
South Africa

Sponsor information

Organisation

Medical Research Council of South Africa (South Africa)

Sponsor details

PO Box 19070
7505 Tygerberg
Cape Town
7505
South Africa
+27 (0)21 938 0911
info@mrc.ac.za

Sponsor type

Research council

Website

http://www.mrc.ac.za

Funders

Funder type

Government

Funder name

South African National Department of Health (South Africa) - via the Research Directorate

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Royal Netherlands Tuberculosis Association (KNCV) (Netherlands) - via the TB CAP programme

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Wellcome Trust (UK) (grant ref: 083619)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23714270
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24947537

Publication citations

  1. Results

    Lutge E, Lewin S, Volmink J, Friedman I, Lombard C, Economic support to improve tuberculosis treatment outcomes in South Africa: a pragmatic cluster-randomized controlled trial., Trials, 2013, 14, 154, doi: 10.1186/1745-6215-14-154.

  2. Results

    Lutge E, Lewin S, Volmink J, Economic support to improve tuberculosis treatment outcomes in South Africa: a qualitative process evaluation of a cluster randomized controlled trial., Trials, 2014, 15, 236, doi: 10.1186/1745-6215-15-236.

Additional files

Editorial Notes