Community and stakeholder engagement in the clinical trial process aims to enhance collaboration, partnership and dialogue between trial sponsors, trial researchers (international and national), and individuals at various levels who have a stake in, or are directly affected by the disease or condition being studied and/or in the implementation and outcomes of the clinical or biomedical research. Community and stakeholder engagement requires representatives of the research team to become part of the community and community members to become part of the research team, creating a unique working and learning environment before, during, and after the research.
This manual and database presents background and a set of tools to set in motion a culture of monitoring the CSE programs affiliated to HIV and TB related clinical trials. This represents the first CSE M&E toolkit of its kind.
The toolkit, which includes a manual and the database outlines a set of tools which can assist CSE teams to adopt a culture of systematically monitoring their CSE programs running alongside HIV and TB related clinical trials. This is the first CSE M&E toolkit of its kind.
The development of this toolkit was led by TB Alliance and AVAC and their consultants Monique Oliff and Kenneth Babigumira, with invaluable contribution from a multi-¬ agency Working Group. This cross-organization effort to develop metrics for CSE aims to contribute to compliment the standards of Good Participatory Research Practices across all forms of biomedical research in low-¬resource settings. The intention is to enrich the understanding of CSEs potential impact on the outcomes of clinical research.

Executive Summary



The development of the M&E toolkit, manual and corresponding database was led by AVAC and Global Alliance for TB Drug Development (TB Alliance). AVAC and TB Alliance acknowledge the invaluable review and contributions of a multi-agency Working Group (WG) focused on monitoring and evaluation for community and stakeholder engagement (CSE). Members of this workgroup included: International AIDS Vaccine Initiative (IAVI); International HIV/AIDS Alliance; Wellcome Trust; and the National Institute of Allergy and Infectious Diseases (NIAID), Division of AIDS (DAIDS).