Supporting Community Engagement to Promote Tuberculosis Research Ethics and Science (SCEPTRES). Grant Ref: TMA2019CDF-2788

This study is premised on the evidence that community engagement is often undervalued in clinical trials despite being intrinsic to the ethical implementation and outcomes of the clinical trials. Currently, there are few examples of genuine community engagement in TB trials that seek to empower communities and participants, minimize exploitation of research participants and increase the benefits that participants derive from trials.

Supporting Community Engagement to Promote Tuberculosis Research Ethics and Science (SCEPTRES) is a community engagement qualitative three-year (2021-2023) career fellowship study awarded to Dr Musonda Simwinga. This qualitative study seeks to demonstrate the critical role of community engagement in promoting understanding of and participation in Tuberculosis (TB) clinical trials using a pragmatic and ethical approach, leveraging two EDCTP TB trials implemented by Zambart. These are Tuberculosis Reduction through Expanded Anti-Retroviral Treatment and Screening (TREATS), and the Scalable Active Case Finding Intervention for TB (XACT-3) trial.

The aim of the study is to develop the potential of community engagement in ethics and knowledge generation and sharing in TB clinical trials, drawing on experience from two the EDCTP trials in Zambia. The specific objectives of the study are to:

1. Use retrospective and on-going experience of community engagement in two EDCTP TB trials (TREATS and XACT-3) to examine community understanding and experience of the trial process, participation in the trial process and enduring influence on the management of TB beyond the trials. This study will examine participants’ understanding of the TREATS/ XACT-3 trial processes, the key concepts and terms used in the trials, the science behind the two trials and how understanding of these influenced people’s decisions to participate in the trials.

2. Develop tools for engendering the role of community engagement in enduring ethics and TB science at community level. This objective will use findings from the first objective to develop tools that are currently missing in community engagement processes for understanding and documenting the trial process and concepts. There is a lack of necessary tools to document, and properly characterize insights generated by the community. This objective will therefore include adapting or developing the following tools: exploring and examining the ethics of community engagement in TB trials through a review of GPP and developing ethics case-studies for TB trials; TB lexicon tool for new technologies and approaches; a tool on tips for disseminating TB research results. These tools will be piloted in one XACT-3 community.

The study will use innovative co-production approaches to data collection and analysis. Ten Community members will be trained as Community Based Participatory Ethnographic Researchers (CBPERs). The CBPERs will be trained in research methods using principles of community based participatory research (CBPR) and participatory research more generally, to participate in data collection, data analysis, report and manuscript writing and dissemination of the research findings. The study will be carried out in two communities in Lusaka both of which are former TREATS communities, and one is an XACT-3 community.