1) How can engagement efforts impact a participant’s experience in a trial? Do you have a concrete example from your own work?
Engagement effort can help participant more understanding study. In accrual period, out reach staff have meeting with stakeholder in several groups and receive information/opinion about study that useful for study. Staff can use this opportunity to create and share plan such as recruitment and retention plan, safety plan, plan for management in case stigma etc. Staff will have awareness about anything that community and stakeholder concerns. From my experiences for PrEP study in MSM/TG, prior start recruitment staff have forum with activist, CAB and key persons. These meeting we receive more information about any concerns of group such as concern about side effect of study product, fear rectal exam, concern brand of condom that provide to participant and confuse about process in protocol. We have plan for every process of study as community concern such as what are concern in recruitment process, what is message that use for participants, how to manage risk management.
2) How did CAPRISA’s comprehensive approach contribute to their success and network of relationships?
CAPRISA’ team have excellent process to engage community. They have deep interesting and more power for manage plan. I think they have great preparing participant to deep understand protocol. Because this is important thing for success of protocol. Participant can comply with protocol and no problem of retention or adherence. Staff analyze in each steps and have community consultation. The important is staff maintain relationship in whole study with community. Because they can build relationship and known any concern during the trial.
3) What are some examples of how you have sustained relationships with communities after and between trials?
Between trial, we have CAB meeting in quarterly. We have meeting regularly with stakeholder and join activities that they have. After study close out, we still have meeting with CAB. We will report them about close out plan, progression of study result, participant found social harm or not. Additional, we have website that use for report result of study. If community have forum or activity, staff will participate for updating and evaluate about impact of study after close.
