The first step is to map out national and broader stakeholders. With the expertise of these stakeholders and based on research, the community for the trial program would be identify. Regular advocacy visits would be conducted to the community involving the community stakeholders, other stakeholders and the team. It is at this stage that potential trial participants are selected and informed of their voluntary participation; potential trial participants, their families and community stakeholders would participate in drafting the guidelines for participant safety and program monitoring, and to also constitute a Community Advisory Board (CAB) that would play supervisory roles during the trial program.