The Union, supported by United States Agency for International Development (USAID) through the TREAT TB Cooperative Agreement, and in partnership with The Brazilian Network of Tuberculosis Research (REDE-TB), has released a Community Engagement Plan, designed to support global communities undertaking clinical trials and research in tuberculosis (TB). The plan, launched at the STREAM Joint Community Advisory Board Meeting for community engagement on 15 July, is available from the TREAT TB website
A core area of The Union’s work in the field is the development of randomised clinical trials to support the scientific implementation of treatment regimens for multidrug-resistant tuberculosis (MDR-TB). This includes the STREAM Trial - a multi-centre international randomised controlled trial sponsored by The Union to evaluate standardised shortened treatment regimens of anti-tuberculosis drugs for patients with MDR-TB.
But the work is much more than clinical research; there is a vital hearts and minds element in the form of effective community engagement that is needed to create understanding within those communities that are hosting the trial.
The Community Engagement Plan is aimed at clinical researchers, local stakeholders (from health professionals to TB and HIV activists) and programme managers. It outlines the necessary steps to ensure communities most at risk are engaged and supported in understanding the research and the opportunities the clinical trial offer to improve quality of care to their members.
Those steps include: early assessment of the community’s knowledge, needs, and capacity for MDR-TB research involvement; increasing treatment and research literacy; improving communication between community representatives, researchers and programme managers; and generating advocacy around the implementation of trial results in local health systems.
“When clinical research takes place in a community, the need to incorporate existing community structures is paramount.” says Dr I.D. Rusen, Senior Vice President, Research and Development, The Union. “All clinical research must fulfil health related needs within the community and members of that community must understand the research and the ethics and regulatory requirements involved. Trusted communication between all parties is essential to ensuring MDR-TB and other diseases are understood – so that we can better find the correct treatment and move towards eradicating this disease for good.”
“The Community Engagement Plan by STREAM aims to strengthen partnerships and improve health policies in tuberculosis,” says Ezio Tavora, Health Policies Researcher, STREAM-CE and Social Mobilization Coordinator at REDE-TB. “Community Advisory Boards are critical in enhancing the impact of clinical trials on communities, ensuring they are aware of all aspects related to research and the opportunities they bring, particularly in areas that have never hosted a clinical trial before. This downloadable guide creates a pathway through community engagement, ensuring the easy to follow steps can be factored into any community-led programme.”
In 2014, just over 6.3 million people were newly diagnosed with TB, and there were an estimated 480,000 new cases of MDR-TB, a particularly complicated form of TB characterised by resistance to at least two of the standard four-drug, anti-TB treatment regimen. MDR-TB is estimated to have killed 190,000 people worldwide in 2014 but one economic analysis projects that it could claim a further 2.6 million lives per year by 2050 if left unchecked.
About Community Advisory Boards
Community Advisory Boards (CAB) created during the PROVE-IT study in Brazil between 2011 and 2013 for community engagement was effective in bringing legitimacy, ownership, transparency, and efficacy to the study, which helped research development. PROVE-IT was a study that compared rapid diagnostic methods for MDR-TB in the context of the Brazilian Unified Health System (SUS). Since then, The Union is expanding the implementation of community engagement efforts around its studies.