STREAM Community Engagement Plan 2016-2021

The plan aims to establish a shared and trusted structure of communication between local stakeholders, including community members, health professionals, and researchers. This collaboration is essential for addressing the limited understanding of MDR-TB in many communities, particularly in areas with a high TB burden. The STREAM trial proposes a new 9-month treatment regimen for MDR-TB, which is expected to reduce the treatment duration and alleviate the burden on both patients and health systems. The trial will be conducted in multiple countries, with the first stage focusing on a randomized controlled clinical trial of the new treatment regimen. The second stage will test the efficacy of a new anti-TB medicine, bedaquiline, in two new regimens. The STREAM Community Engagement Plan is built upon the experience of the PROVE IT study, which assessed the costs associated with the roll-out of Line Probe Assays. The plan establishes a community advisory board (CAB) at each site to share study progress and help overcome challenges. The CABs will be successful due to the preexisting culture of community engagement, close contact with committees and policy forums, local expertise, knowledge of health system functions, and cooperation of stakeholders. The plan promotes culturally sensitive and comprehensive community engagement, utilizing local expertise to guide trial implementation. The optimal model for CE is organized around seven concepts: sensitize, map, engage, educate, follow up, interact, and interact. These activities will be conducted simultaneously or consecutively to achieve short, medium, and long-term goals. The first stage of the plan involves sensitizing local stakeholders to the objectives and strategy of the CE. This includes introducing trial members to program members, explaining CE objectives and strategy, and requesting support and authorization to develop CE. The second stage involves mapping local community organizations to better understand local culture and practices, community relationships with researchers and health authorities, TB and research literacy, and conditions and willingness to engage in research follow-up. The third stage involves engaging local stakeholders to promote their participation in the STREAM trial. This includes conducting a first local workshop and seminar to brainstorm and agree on ways to promote participation. The fourth stage involves educating community representatives on basic TB and research literacy through workshops, annual training of trainers, and education via CAB or regular meetings. The fifth stage involves following up with STREAM sites to support ongoing CE efforts and expansion of community activities. This includes conducting follow-up assessments to aid sites in overcoming challenges. The sixth stage involves interacting with local community coordinators to report and present outcomes, and encouraging representatives to present progress and outcomes in conferences such as the annual Union conference. The seventh stage involves documenting the CE experience in STREAM to highlight CE best practices in MDR-TB trials. The outcomes of the CE experience should be well-documented and published to promote community engagement and participation in research. The STREAM Community Engagement Plan has been piloted in Mongolia, with lessons from which will guide future CE efforts in other STREAM sites. The plan acknowledges the importance of upholding principles from the Good Participatory Guidelines for TB Trials 2012 and the World Health Organization's recommendations for CE against TB to strengthen commitments to improve access to prevention, diagnostics, and care. The STREAM trial aims to establish a sustainable culture of community participation in research, generate advocacy around trial results, and help legitimize the implementation of trial results in the health system. The trial will be conducted in multiple countries, with the first stage focusing on a randomized controlled clinical trial of the new treatment regimen. The second stage will test the efficacy of a new anti-TB medicine, bedaquiline, in two new regimens. The plan promotes culturally sensitive and comprehensive community engagement, utilizing local expertise to guide trial implementation. The optimal model for