Developing knowledge, building trust: Addis Ababa’s Community Advisory Board takes part in community engagement capacity building training as part of the STREAM trial

Earlier this month, 15 members of the STREAM community advisory board (CAB) from Addis Ababa took part in a refresher training session run by Dr Mohammed Abseno, trial sub-investigator and coordinator for the St. Peter’s Tuberculosis Specialized Hospital, one of the two STREAM sites in Ethiopia. Along with the site’s principal investigator, Dr Daniel Meressa, he worked with the various members of the CAB- which includes religious leaders, managers, technicians, and members of the police force - to improve their understanding of tuberculosis (TB), multidrug-resistant tuberculosis (MDR-TB) and the STREAM trial itself.

'These refresher trainings are an important part of the STREAM trial, as they provide much needed capacity building and best practice sharing for members of the CAB. By the end of the training session, the members of the CAB feel empowered and ready for action!’, said Meressa. It is hoped that, as a result of these training sessions, the CAB members will feel confident and able to deliver accurate messages to the community where the STREAM trial is taking place, resulting in more people seeking medical advice where needed and an increased rate of suspected case referrals.

As part of TREAT TB’s STREAM trial, CABs play an important role in raising awareness and making complex information about TB and the trial accessible to members of the community. STREAM CABs help ensure community members are aware of the symptoms of TB and encourage them to seek medical care. They also improve retention and compliance by providing psychosocial support to trial participants and family members. Finally, they provide a critical feedback link between communities and trial staff, sharing community views on key issues to improve early diagnosis and enrolment in the trial. 

Comprised of volunteers from affected communities, CAB members have a unique relationship of trust with the communities participating in the trial. CABs work hand in hand with members of the community to inform them about the trial and keep them updated with the latest results so that they are aware of the purpose of the research, understand why it is so important, and know that it is carried out in accordance with the highest ethical standards.

To read more about STREAM in Ethiopia, click here

STREAM responds to South African MDR-TB treatment policy update

The STREAM trial Sponsor and Chief Investigators acknowledge the decision of the South African Government to offer all South African patients with multi-drug resistant tuberculosis (MDR-TB) an injectable-free regimen. While we believe STREAM’s ongoing evaluation of an all-oral regimen, as well as the safety of Bedaquiline in a late phase clinical trial, remain very relevant for the field, we fully respect the autonomy of national programs to implement the treatment guidelines they believe are most appropriate in their setting. The trial will stop enrolling patients in South African sites when this policy is implemented at any given site, but will continue treatment and careful follow-up for all consenting patients already enrolled in the trial in accordance with the protocol.

In STREAM sites outside of South Africa, the trial will continue to randomize patients (consistent with local treatment practices), to allow a timely completion of recruitment and generation of crucial evidence to guide future national and global MDR-TB treatment policy.

Read more about the STREAM trial in South Africa.

Capacity building for clinical trial research boosts efforts to control TB in South Africa

Thanks to the efforts of hospital staff and the training and resources provided as part of the STREAM Stage 2 trial, South Africa’s Empilweni TB Hospital in the Eastern Cape recently enrolled its first patient with multidrug-resistant tuberculosis (MDR-TB).

Empilweni Hospital is the fourth and most recent site to join the trial in South Africa, where there were an estimated 19,000[1] incident cases of MDR-TB in 2016. This decentralized facility accepts referrals for drug-resistant TB and is able to provide in-patient treatment of MDR-TB. STREAM Stage 2 is the first time Empilweni Hospital has participated in a clinical trial, which represents an important milestone for both the hospital and the community.

As part of the STREAM trial, the Empilweni Hospital will contribute to the evaluation of shorter, more tolerable drug regimens, while also benefitting from essential capacity building for clinical trial research. To date, capacity building has focused on study procedures and referral pathways, as well as the process for obtaining informed consent. The STREAM Stage 2 trial is a welcome response to the urgent need for improved TB management in this region, where MDR-TB is common.

Read more about the STREAM Stage 2 trial at www.treattb.org/overview.

[1] Estimated incidence of MDR/RR in 2016 was 19,000 as per the Global TB Report Page 45. 

 Empilweni hospital and STREAM trial staff participate in capacity building training

Empilweni hospital and STREAM trial staff participate in capacity building training

Maximizing TB clinical trial results to influence policy

Originally posted here on the Vital Strategies site.

Roughly 600,000 people contract multidrug-resistant tuberculosis (MDR-TB) each year, of whom approximately 40% die. As such MDR-TB remains a significant global health threat, especially for people living in low and middle-income countries. Until recently, the WHO-recommended treatment for MDR-TB lasted 20-24 months, resulting in significant burden and cost to both patients and health systems. MDR-TB treatments are expensive and can have serious side effects, including permanent hearing loss. As a result, only about half of all people who start treatment for MDR-TB successfully complete it.

In response to the difficult and limited treatment options available for treating MDR-TB, The Union, Vital Strategies and their partners are undertaking the STREAM clinical trial to evaluate shorter, more tolerable regimens for MDR-TB. STREAM is the first large-scale, multi-country clinical trial to examine shortened regimens for MDR-TB and is the first phase III trial to test the effectiveness and safety of bedaquiline within a shortened regimen. STREAM aims to generate evidence for shorter, more tolerable MDR-TB regimens, while improving local capacity to conduct clinical trials.

The evidence generated by STREAM is important for guiding policy-making at the international and national levels. To achieve maximum impact, trials must ensure that results are shared widely and effectively with all key stakeholders. However, dissemination of important research results is often limited to publication in peer reviewed journals, with far less effort made to inform key stakeholders, such as Ministries of Health, community stakeholders, and trial participants, about the results. Failure to involve key stakeholders in results dissemination can diminish the impact of important research findings by excluding key advocates of change.

 STREAM trial staff at B.J. Medical College in Ahmedabad, India participate in a webinar session about the STREAM Stage 1 trial results.

STREAM trial staff at B.J. Medical College in Ahmedabad, India participate in a webinar session about the STREAM Stage 1 trial results.

The STREAM trial is comprised of 2 stages. Stage 1 of the STREAM trial began in 2012 in Ethiopia, Mongolia, South Africa, and Vietnam and sought to determine whether the nine-month treatment regimen is no worse than the 20-month treatment regimen.  Preliminary results for Stage 1 were released at the 48th Union World Conference on Lung Health in Guadalajara, Mexico in October 2017. According to those preliminary results, the efficacy of the shortened, 9-month regimen is expected to be very close to the 20-24 month regimen. The nine-month regimen also reduces the number of pills a patient needs to take by approximately two-thirds, requires fewer visits to health facilities for treatment, and is cheaper for both the health system and patients.

Disseminating clinical trial results like the Stage 1 results is an ethical obligation for researchers and can greatly facilitate policy and program change. But, in practice, dissemination often fails to reach key stakeholders, and the logistics and technical challenges of disseminating complex findings can make the process challenging. In response, Vital Strategies’ Research Division designed a comprehensive results-dissemination strategy to ensure the Stage 1 findings reached all key stakeholder using appropriate communication channels and materials developed specifically for each key audience. The strategy encompassed five key steps to address the main stakeholder groups:

  • Sponsor dissemination to international health organizations, including the WHO
  • Sponsor dissemination to trial staff
  • Principal investigator dissemination to Ministries of Health and other national policy makers
  • Principal investigator dissemination to community advisory boards (CABs)
  • Principal investigators/CAB dissemination to participants and other community stakeholders

The STREAM dissemination process was impressive for both its impact and its reach.  At the international level, after release of the results and subsequent one-on-one discussions with Vital Strategies and MRC, the World Health Organization confirmed their earlier recommendation for use of the standard shortened regimen evaluated in STREAM, acknowledging the importance of STREAM’s contribution:

“We appreciate the significant work done by the [STREAM] study investigators to generate randomised controlled clinical trial evidence for the shorter regimen,” said Dr. Tereza Kasaeva, Director of WHO’s Global TB Programme. “Having evidence-based policies is key to improving care for patients affected by the global public health crisis of MDR-TB.”

At the national level, key stakeholders from all walks of life participated in STREAM events.  In Moldova, 176 participants from the Ministry of Health, Labor and Social Protection, the national TB Control Program, the State University of Medicine and Pharmacy “Nicolae Testemitanu”, the Municipal Clinical Hospital of Phthisiopneumology and others gathered at the STREAM trial site in Chisinau (the Institute of Phthisiopneumology “Chiril Draganiuc”) to hear Dr. Elena Tudor present the results.  In Mongolia, Bazra Tsogt, Trial Coordinator, presented the results to 96 participants from the national TB program and district MDR-TB treatment facilities at the National Centre for Communicable Diseases of Mongolia.

 Mongolia STREAM Trial team shares results with the National TB Program and district MDR-TB staff.

Mongolia STREAM Trial team shares results with the National TB Program and district MDR-TB staff.

Perhaps most importantly, STREAM dissemination reached those most affected by the illness – STREAM trial participants, their families and local community members.  In all, more than 473 trial participants and community stakeholders gathered at large community celebrations where their participation in the trial was acknowledged and where they learned about the results from STREAM principal investigators and community advisory board members.

 Principal Investigator at St. Peter’s Hospital, Addis Ababa presents results to participants and community stakeholders

Principal Investigator at St. Peter’s Hospital, Addis Ababa presents results to participants and community stakeholders

Results dissemination should be inclusive and involve all affected stakeholders. It creates opportunities for building long-term relationships between researchers and local communities, and for better understanding of the needs and capacity for MDR-TB research in those communities. Ultimately, dissemination is the first step to generating policy and program change, and will help legitimize changes made in response to trial results.

The STREAM Clinical Trial was initiated by The International Union Against Tuberculosis and Lung Disease (The Union).  The trial represents a unique collaboration between USAID, Janssen Pharmaceuticals, The Union and The Union’s affiliate, Vital Strategies, and aims to generate evidence regarding the effectiveness of shorter, more tolerable treatment regimens for MDR-TB.

Joint CAB Meeting in South Africa for STREAM

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There are now four STREAM Stage 2 sites in South Africa across three provinces. Each serves a very different community, but what unites them all is their commitment to finding better ways to treat MDR-TB through clinical research. Leading the community engagement efforts for STREAM, community advisory boards (CABs) at the STREAM Stage 2 sites are encouraged to share experiences and join efforts with each other and their study teams.

On 24 February 2018, the Community Liaisons Officers (CLOs) from all four Stage 2 sites met in Durban, Kwa Zulu Natal along with the members of the King Dinuzulu and Doris Goodwin Community Advisory Boards. On the hot Saturday morning, the turnout was impressive, with over 60 people in attendance. The Good Participatory Practice Guidelines for TB Drug Trials were presented by the Johannesburg CLO and participants discussed how to measure the impact of community engagement.

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The Principal Investigator from King DinuZulu Hospital in Durban presented preliminary results from Stage 1 of the STREAM trial, and participants then turned to how they can best work with local Departments of Health to ensure the results are translated to improved programs and policies. Participants were also encouraged to attend local AIDS Council meetings to share the Stage 1 results.

A similar joint CAB meeting will be planned for next year to share ideas, reinforce commitment to community engagement and build sustainability of the South African CABs.