Condition category
Infections and Infestations
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
HIV and tuberculosis (TB) infections are the leading causes of death for young adults in South Africa. TB bacteria that have developed resistance to first-line TB drugs (multidrug-resistant TB or MDR-TB) are now causing significant numbers of deaths. Diagnosis of MDR-TB is a laborious process which can take two to three months, by which time up to half of those with MDR-TB will have died. The Xpert MTB/RIF system is a new diagnostic test which can identify TB and can also recognise whether or not there is drug resistance within two hours. Hlabisa sub-district in KwaZulu-Natal is one place where MDR-TB has become very common in association with high levels of HIV infection. This study aims to investigate the impact of the Xpert MTB/RIF system, specifically whether outcomes are different when the system is positioned at different levels of the health system.

Who can participate?
Patients aged 18 or older with suspected TB, who have a confirmed HIV infection and/or are at high risk for MDR-TB

What does the study involve?
Participants are randomly allocated to one of two strategies: Xpert MTB/RIF testing at a district hospital laboratory or Xpert MTB/RIF testing at a primary health care clinic (point-of-care). The number of TB patients starting appropriate treatment within 30 days, the time taken to start TB treatment, and the number of deaths and hospital admissions in first 60 days are all measured.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Africa Centre for Health and Population Studies (South Africa)

When is the study starting and how long is it expected to run for?
July 2011 to December 2012

Who is funding the study?
Wellcome Trust (UK)

Who is the main contact?
Dr Richard Lessells

Trial website

Contact information



Primary contact

Dr Richard Lessells


Contact details

Africa Centre for Health and Population Studies
PO Box 198
South Africa
+27 (0)35 550 7500

Additional identifiers

EudraCT number number

Protocol/serial number

Wellcome Trust grant number 090999/Z/09/Z, South African National Clinical Trials Registry DOH-27-0711-3568

Study information

Scientific title

Impact of a novel molecular tuberculosis (TB) diagnostic system in patients at high risk of TB mortality in rural South Africa: a pragmatic cluster randomised controlled trial


Study hypothesis

Timely initiation of appropriate tuberculosis (TB) treatment will be improved when the diagnostic system is positioned at the primary health care clinic (point-of-care) compared to when it is positioned centrally at the district hospital laboratory

Ethics approval

1. University of KwaZulu-Natal Biomedical Research Ethics Committee (BF033/11)
2. London School of Hygiene and Tropical Medicine Ethics Committee (5926)
Approval pending as of 15/06/2011

Study design

Single-centre cluster randomised controlled trial

Primary study design


Secondary study design

Cluster randomised trial

Trial setting


Trial type


Patient information sheet

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


Pulmonary tuberculosis


Comparison between two delivery strategies for the GeneXpert system and Xpert MTB/RIF test: Positioning at district hospital vs positioning at primary health care clinic

Intervention type



Not Applicable

Drug names

Primary outcome measures

Proportion of TB cases initiated on appropriate TB treatment within 30 days of enrolment

Secondary outcome measures

1. Time to initiation of appropriate TB treatment
2. Time to initiation of appropriate MDR-TB treatment
3. All-cause mortality at 60 days
4. Hospital admissions in first 60 days
5. Time to initiation of antiretroviral therapy (for eligible HIV-infected participants)

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. TB suspect (defined as cough of any duration)
2. Age 18 years or older
3. Confirmed human immunodeficiency virus (HIV) infection and/or high risk for multi-drug-resistant tuberculosis (MDR-TB)

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Severely unwell requiring admission to hospital
2. Previous MDR/extensively drug-resistant tuberculosis (XDR-TB) diagnosis or treatment
3. Diagnosis or suspicion of extra-pulmonary TB only
4. Unable to give informed consent

Recruitment start date


Recruitment end date



Countries of recruitment

South Africa

Trial participating centre

Africa Centre for Health and Population Studies
South Africa

Sponsor information


London School of Hygiene and Tropical Medicine (UK)

Sponsor details

Research Grants & Contracts Office
Keppel Street
United Kingdom
+44 (0)20 7927 2626

Sponsor type




Funder type


Funder name

Wellcome Trust (UK) (090999/Z/09/Z)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype



United Kingdom

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 protocol in:

Publication citations

  1. Protocol

    Lessells RJ, Cooke GS, McGrath N, Nicol MP, Newell ML, Godfrey-Faussett P, Impact of a novel molecular TB diagnostic system in patients at high risk of TB mortality in rural South Africa (Uchwepheshe): study protocol for a cluster randomised trial., Trials, 2013, 14, 170, doi: 10.1186/1745-6215-14-170.

Additional files

Editorial Notes

12/09/2016: Plain English summary added.