Lessons Learned in Clinical Trial Communication During an Ebola Outbreak: The Implementation of STRIVE

Abstract

ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220].

How can community engagement in health research be strengthened for infectious disease outbreaks in Sub-Saharan Africa? A scoping review of the literature

“…The need for accurate and culturally sensitive communication with relevant community stakeholders about a trial is widely recognised as a critical preliminary step in the research process [ 11 , 51 ]. As is well described in the literature, communication can serve a range of purposes, from more ‘one-way’ or outreach forms of communication to more ‘bi-directional’ or participatory forms-supporting learning and consultation, for example.…”

“…The team at STRIVE (a Phase III vaccine trial involving front line health workers in Sierra Leone) also highlight communication as important in building community trust and mitigating rumours and misinformation [ 11 ]. The main rationale described for their engagement was to encourage recruitment, protect participants, and get buy-in at higher levels of national leadership [ 12 ].…”

“…The main rationale described for their engagement was to encourage recruitment, protect participants, and get buy-in at higher levels of national leadership [ 12 ]. The communication team, with the help of social mobilisation experts (SMEs) [ 20 ], were responsible for ensuring voluntary, informed participation [ 11 ]. The approach to participation was based on a tailored social ecology model “to identify and reach specific spheres that influence a potential participant’s decision-making” (ibid.…”

“…Learning lessons over time: Incorporating findings, creating feedback loops and building a sustaining legacy Abramowitz et al 2018 [ 2 ] Alirol et al 2017 [ 3 ] Caleo et al 2018 [ 10 ] Coltart et al 2017 [ 15 ] Dean et al 2016 [ 17 ] Emanuel et al 2004 Folayan et al 2015 [ 30 ] Keusch et al, 2017 [ 34 ] Marsh et al, 2008 [ 38 ] Marchant & Lees, 2019 [ 37 ] Mehand et al 2018 [ 39 ] Mills et al 2005 [ 41 ] Olu et al 2016 [ 45 ] Pedi et al 2017 [ 46 ] Slevin et al 2008 [ 50 ] Tindana, 2007 [ 52 ] UNAIDS, AVAC. 2011 [ 53 ] Wellcome Trust and CIDRAP, 2015 [ 14 ] WHO, 2017 [ 59 ] WHO, 2016 [ 57 ] Wilkinson et al 2017 [ 58 ] Bedrosian et al 2016 [ 6 ] Browne et al 2018 [ 8 ] Callis et al 2018 [ 11 ] Carter et al 2018 [ 12 ] Ebola ça suffit consortium 2015 [ 20 ] Emanuel et al 2005 [ 21 ] Enria et al 2016 [ 24 ] Enria et al 2016a [ 25 ] Enria et al 2016b [ 26 ] Fairhead 2016 [ 28 ] Perez et al 2017 [ 47 ] Fayia Tengbeh et al 2018 Fayia [ 29 ] Kennedy et al 2016 [ 33 ] Mooney et al 2018 [ 44 ] Reynolds & Sariola 2018 [ 48 ] Spengler et al 2016 [ …”

Nurses' experiences of their decision‐making process when participating in clinical trials during the 2014–2016 West African Ebola crisis

“…In order to facilitate the consent and decision-making process, participants in this study voiced a need for more information and educational sessions. To address this lack of information (Huo et al, 2016;Ughasoro et al, 2015), project STRIVE (the Sierra Leone Trial to Introduce a Vaccine Against Ebola) has implemented a communication strategy that is based on a combination of various formative activities, enabled by mobile technologies, to ensure that high-risk HCWs have access to accurate, timely and consistent information (Callis et al, 2018). Examples of activities are information materials, sensitization activities, informational and educational outreach, and community engagement.…”