STREAM Moldova: Strengthening health systems for effective TB control through regional advocacy

Earlier this year, the Alliance for Public Health, Ukraine, organized the TB Regional Eastern Europe and Central Asia Project (TB REP) for Health System Transformation and Financing Reform to Scale up Drug-Resistant TB Control meeting in Istanbul on behalf of the TB Europe Coalition. This two-day meeting gathered over 30 TB-REP project partners from 11 Eastern European and Central Asian countries and provided the ideal space to share best practices, strengthen partnerships and identify next steps for regional TB advocacy.

 Oxana Rucsineanu & Svetlana Doltu, STREAM Moldova

Oxana Rucsineanu & Svetlana Doltu, STREAM Moldova

During the group sessions, discussions focused on the impact of the STREAM trial in the region and how the advent of (SSTR) for MDR-TB could influence tuberculosis care and adherence to treatment. STREAM community advisory board (CAB) coordinator in Moldova, Oxana Rucsineanu (SMIT NGO), and STREAM community engagement officer Svetlana Doltu, discussed the importance of short treatment regimens for TB patients. “The STREAM clinical trial is designed to compare treatment regimens for people affected by drug resistant strains of tuberculosis and find the most efficient regimen of the treatment. We all know that the period of treatment takes its toll on people’s adherence to the regimen and so it is important to identify an effective, shorter treatment regimen.”

Participants also discussed the upcoming High-Level Meeting (HLM) on TB which will take place on 26th September in New York, and identified next steps for regional advocacy, agreeing to work towards better involving affected communities in research and innovation in the field of TB treatment and control. The importance of community engagement was highlighted as an integral issue to be raised at the upcoming HLM. The 11 participating countries collectively drafted a letter to the leaders attending the HLM in which the major key asks of the global TB community were reiterated. It is hoped that civil society partners will use this letter in pre HLM meetings and briefings and that it will provide a foundation for future in-country advocacy and TB control efforts.

The STREAM Clinical Trial is part of the TREAT TB project, a multi-year project funded by USAID, which seeks to contribute to new knowledge regarding shorter, more tolerable treatment regimens for multi-drug resistant tuberculosis (MDR-TB) through clinical trials of priority research questions, targeted operational research benefitting global, regional, and country TB control efforts.

STREAM: Promoting TB prevention, screening and treatment among South Africa’s taxi drivers

Last month, the STREAM Stage 2 community advisory board (CAB) in Durban, South Africa carried out an awareness raising and screening session for tuberculosis (TB) at Emtshebheni Taxi Rank in Inanda, Durban. This forms part of the STREAM Clinical Trial researchers’ and the affected communities’ commitment to working together to improve awareness regarding TB.

The Community Outreach Officer responsible for this area, Nomsa Ngwane, explained the initiative to take TB screening to taxi ranks as part of the CAB’s community outreach activities to access vulnerable groups. “We wanted to give the taxi drivers an opportunity to be screened. They work very long hours, starting early in the morning and finishing late at night and so they do not have time to visit the health clinics for TB and HIV screening.”

Throughout the course of the day, the community was educated on transmission and symptoms of TB. They were also informed about research processes and the benefits of participating in a clinical trial, such as STREAM. The community outreach team distributed information on TB/MDR-TB and drivers were given stickers for their taxi windows to encourage drivers to keep at least one window open to reduce the risk of TB transmission in their taxi.

Neighbouring health facilities came to the taxi rank with their mobile clinics and provided TB, HIV/AIDS, blood pressure and diabetes screening, in addition to  HIV/AIDS counselling. Rapid turnaround of the results was provided so that people attending the screening knew their TB status within a matter of hours. Those who tested positive for TB were referred to a nearby health facility for further tests and treatment.

STREAM CABs will continue to work with affected communities to raise awareness and ensure that complex information about TB and the trial is accessible to all.

The STREAM Trial is part of the TREAT TB project, a multi-year project funded by USAID, which seeks to contribute to new knowledge regarding shorter, more tolerable treatment regimens for multi-drug resistant tuberculosis (MDR-TB) through clinical trials of priority research questions, targeted operational research benefitting global, regional, and country TB control efforts.

Challenges with MDR-TB clinical trial implementation – Site and sponsor perspectives

Earlier this year, TREAT TB launched a webinar series to strengthen capacity to conduct high-quality clinical trials for multi drug-resistant tuberculosis (MDR-TB). The first webinar brought together eight experts to discuss the challenges faced when implementing MDR-TB clinical trials. The presentations provided an overview of ongoing and future trials and covered various aspects of MDR-TB clinical trial implementation, such as patient recruitment, enrolment and retention, challenges encountered by sponsors and regulatory requirements such as import and export permits.

Over 65 participants from around the world joined the discussion, including clinicians, donors, researchers, representatives from the pharmaceutical industry, and advocates. Following the presentations, speakers and participants addressed common challenges in the implementation of MDR-TB clinical trials and agreed that collaboration with key stakeholders and efficient project management were key components to ensuring the success of a trial.

Common challenges in implementing an MDR-TB clinical trial

MDR-TB trials are challenging for many reasons including methodological limitations that lead to lengthy trials, a lack of consensus on terminology and endpoints for use in trials, and limited coordination between researchers.[1]

Furthermore, for a clinical trial to be successfully implemented, chosen sites require established infrastructure such as laboratory capacity, areas to provide patient care which allow for infection control practices, sufficient drug storage, properly trained staff and principal investigators. Identifying sites with the required facilities can be difficult, as the burden of MDR-TB is often felt in areas where resources are limited. Once suitable sites are identified, the lengthy process of preparing the site for the trial can begin, including obtaining local ethics and regulatory approvals, development of budgets and contracts, procurement of required trial supplies and insurances, and completion of site refurbishments. Trial staff, such as principal investigators, sub-investigators, pharmacists, nurses, and trial coordinators need to be identified and trained before the trial can be initiated. These obligatory activities are time consuming and processes vary from country to country, adding further complication and a significant challenge to timely trial implementation. Finally, it is essential to establish collaborative relationships with key stakeholders including the national TB program, regulatory authorities, and advocacy groups.

TREAT TB’s MDR-TB clinical trial capacity building webinar series will continue over the coming months, with webinars scheduled for September, November, January, March, and May. Future topics to be addressed include regulatory requirements, institutional review boards and ethics approval, pharmacy and supply chain management, laboratory strengthening  and community engagement among others.

 Watch the first webinar of the series here

You can find the presentations made during the webinar here

To read more about the TREAT TB project, click here.

¹ Horsburgh CR, Rusen ID, Mitnick CD. Optimizing MDR-TB clinical trials: insights from the first global MDR-TB Clinical Trials Landscape Meeting. Int J Tuberc Lung Dis. 2016; 20(12):1–3. doi: 10.5588/ijtld.16.0568