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Table 2 Trial name, intervention, targeted recruitment population, reported CE strategy, activities, and outcomes

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

Trial Name Intervention Targeted recruitment population Reported CE strategy Reported CE activities and outcomes
  EBOLA VACCINE TRIALS [20, 34]
STRIVE (completed) Vaccine trial phase III;
individually randomised, open-label trial;
immediate vs deferred vaccination;
8673 participants enrolled.
Non-pregnant, frontline EVD health workers or related care workers across 5 districts in Sierra Leone. Dedicated significant time and resources for CE. This meant communication
beginning before trial launch (and presentation to the full government/ media). Communication continued post-enrolment to support ongoing recruitment and participation.
Communication activities included a 24-hour hotline for questions.
Educational activities involved more than 175 sensitisation and information sessions for potential participants, hospitals, community health centres and ETUs.
Ebola ça Suffit (completed) Ring vaccination; novel cluster RCT;
immediate vs deferred vaccination;
7284 participants enrolled.
Index cases and their contacts within an epidemiologically informed ring. Social mobilisation began prior to any vaccination related activities taking place. Consent was gained from the main ring site where the vaccination took place, around the index patient’s residence. ‘Social mobilisation experts’ to find cases and contacts who they sought to mobilise and gain consent for participation. Community leaders and representatives assisted in contacting patients where applicable. The experts explained the trial’s objectives and implications of potential participation.
Ebovac Salone (ongoing) Vaccine trial Phase III (staged). Healthy volunteers, Sierra Leone. Iterative CE approach strongly informed by prior and ongoing qualitative research. ‘Research-driven community engagement’ seen as contributing to smooth recruitment and reducing disruption due to rumours and misinformation. Dedicated social science team and community liaison teams aimed to understand intra-community power dynamics. Conclusion that local understandings of fairness can inform the recruitment strategy design and rumours can be addressed through ‘active dialogue’ rather than on correcting misinformation. This emerging understanding was used to support and adapt CE over the course of the trial.
PREVAIL (completed) Vaccine trial phase II/III;
randomised, double-blind, placebo-controlled trial;
1500 participants enrolled.
Liberian residents aged > 18 years.
High risk communities proximal and distal to an identified referral hospital in Monrovia.
Social mobilisation strategy with four pillars: advocacy, communications, community engagement and monitoring and evaluation. Activities included: Reaching out to community decision-makers, opinion leaders and political leaders for support and approval, targeted messaging, answering FAQs, print and broadcast media communication, distributing flyers, jingles and songs on television and radio, text message communications with telecommunication companies’ subscribers etc.
  EBOLA TREATMENT TRIALS [47]
JIKI (completed) Treatment trial Phase II;
non-comparative, single-arm, open-label clinical trial.
Any patient aged > 1 year with lab confirmed EVD;
four rural Ebola treatment centers (ETCs) in Guinea.
The trial organisers recognised the context of fear and mistrust of international actors. The main recruitment efforts were inside the four ETCs involved in the study. A CAB was set up and involved in discussions on trial protocol, CE approach and informed consent processes. A pretrial initiative was used to inform and involve community leaders, and develop ‘thoughtful, culturally appropriate messages’ and a consensual community strategy.
The trial was conducted in partnership with public health response NGOs.
Ebola Tx. (completed) Treatment trial, phase II/III.
Open-label, nonrandomised clinical trial.
Donor mobilisation of EVD survivors.
Lab-confirmed EVD patients
Strong focus on donor mobilisation and role of Survivors Association-motivation to donate linked to feelings of social responsibility as survivors. Issues identified were the stigma and perceptions of health impacts of donating blood – a decrease in vital strength and antibodies, fears of loss of acquired protection against EVD.