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With 75% of patients now enrolled in the STREAM MDR-TB trial, investigators meet to discuss progress and next steps

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With three-quarters of the expected patients now enrolled in the STREAM clinical trial of a shortened MDR-TB regimen, investigators and partners working on the trial met in Johannesburg, South Africa  on 8-9 July to discuss progress and next steps.

STREAM – which stands for Standardised Treatment Regimen of Anti-Tuberculosis Drugs for Patients with MDR-TB – is testing a modified version of a nine-month regimen used successfully in Bangladesh against the locally used World Health Organization-approved regimen lasting up to 24 months.  As of this month, over 300 of the expected 400 patients are now enrolled at sites in Ethiopia, South Africa and Viet Nam. Mongolia is expected to begin recruitment to the trial this summer.

Because the investigators are implementing the trial in widely differing geographical sites with diverse epidemiological profiles, the face-to-face meeting represented an important opportunity to assess the study’s progress and identify priority actions for next phase of the trial.

The success of the trial to date has afforded the opportunity to consider additional study regimens that might be evaluated in an expansion of the STREAM trial. During the meeting in South Africa, the research team held preliminary discussions on the possibility of expanding the trial. According to TREAT TB Project Director Dr I.D. Rusen, “Given the effort and costs in setting up a trial like STREAM, the opportunity to answer additional questions about MDR-TB treatment regimens of public health importance is very welcome and extremely exciting for the trial team.”

Community engagement is one of the key pillars of the WHO’s global strategy to prevent, treat and control TB. The research team also selected community engagement as a priority topic in an effort to strengthen this component of the trial going forward, particularly in any trial expansion. The Community Advisory Board (CAB) developed in Johannesburg is an excellent model that the STREAM research would like to replicate in other trial sites.

As a result, the meeting agenda included guest speakers who talked about the role community engagement in public health programmes in South Africa and other countries.  Thandie Balfour, the MDR-TB CAB Chairperson for Johannesburg, gave an overview of the CAB’s activities there and approaches to community engagement in South Africa. Nomampondo Barnabas, Community Liaison Manager for the Perinatal HIV Research Unit, stressed the importance of involving the community by describing her own experience in implementing community engagement programmes in collaboration with other international trials.

Participants in the meeting included STREAM researchers based in South Africa; investigators from Ethiopia, Mongolia and Viet Nam; and trial staff from The Union, the Institute of Tropical Medicine and the Medical Research Council’s Clinical Trials Unit.  Other participants were Dr Mukadi Ya Diul, Senior Tuberculosis Advisor and Lessi Mnisi, South Africa Mission Representative from the US Agency for International Development (USAID), and Dr Norbert Ndjeka, Director of the Tuberculosis, Drug-Resistant Tuberculosis & HIV/AIDS Division of the South Africa Department of Health, as well as other Department of Health staff members.

The STREAM clinical trial is the major activity of the USAID-supported TREAT TB Initiative.