A review of strategies used to retain participants in clinical research during an infectious disease outbreak: The PREVAIL I Ebola vaccine trial experience

Abstract

IntroductionThis article describes a retrospective review of participant follow-up and retention strategies in the Partnership for Research on the Ebola Virus in Liberia (PREVAIL) I Vaccine Trial. It illustrates and analyzes strategies used to retain participants in an emergency clinical research response vaccine trial conducted during the 2014 Ebola outbreak in Liberia.MethodsAn anecdotal review of participant retention strategies developed and employed during the PREVAIL I vaccine trial.ResultsThough other factors likely contributed to the high retention rate of trial participants, the unique PREVAIL I follow-up process described resulted in an exceptionally high participant retention rate (97.8%) through 12 months of follow-up, increased the ability to obtain meaningful trial results, and provided a platform through which to respond to social issues in an emergency clinical research response setting.ConclusionSuccessful strategies were developed and employed in the PREVAIL I vaccine trial that resulted in extraordinarily high participant retention and follow-up rates during an infectious disease outbreak. This review illustrates that employing host country social mobilization concepts within a modified clinical research management framework is highly correlated to elevated rates of retention and minimal loss to follow-up. These strategies also contributed to increased data quality and enhanced adherence to protocol requirements. The increased ability to respond to social issues such as stigma, job retention and relationship conflicts was an additional and significant benefit of this follow-up methodology.

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

“…Reflecting the variation in CE approaches with that of trial design, all teams recognised the importance of a wide range of communication activities, from outreach to bidirectional and interpersonal. For example, the PREVAIL team described using multiple communication strategies in different ways to achieve “an exceptionally high participant retention rate (97%)”, despite numerous logistical and operational challenges ([ 8 ], p. 50). Throughout the following sections, we provide examples of different communication activities and the authors’ reflections on these in terms of ‘effectiveness’ or satisfying aims.…”

“…It involved approximately 80 radio, television, and print journalists from Sierra Leone trained by experts to develop one critical idea every week through culturally sensitive messaging [ 6 ]. For PREVAIL, the strategic plan for ‘social mobilisation’ included outreach elements of branding, print and broadcast media communication through distributing flyers, television, radio and mobile phone messaging [ 8 ]. The aim of these mechanisms was getting ‘facts’ to a wide audience in order to clarify, support and inform through a largely one-way process, but also to be part of a wider approach to targeting myths, rumour and suspicions.…”

“…The feedback about these ‘participant trackers’ was that crucial information was collected in determining the names of participants (in the communities some residents were only known by nicknames), their locations (using descriptions if there were no street names and relying on family and friends to have knowledge of their whereabouts), and the ability to contact them (e.g. a phone number of a community store) [ 8 ]. While Browne et al do not comment on the potential for these kinds of strategies to be intrusive or coercive, they do see ‘effectiveness’ in the high participant retention, and the success of strategies such as home visits in avoiding any overt opposition and dissatisfaction.…”

“…While Browne et al do not comment on the potential for these kinds of strategies to be intrusive or coercive, they do see ‘effectiveness’ in the high participant retention, and the success of strategies such as home visits in avoiding any overt opposition and dissatisfaction. Another interpersonal communication strategy reported was supporting members of the clinical team (nurses and clinical monitors) to take on communication roles for the trial as part of their everyday interactions with participants and others, by reinforcing messages and tackling stigma, myths and rumours ([ 8 ], p. 52).…”

“…Knowing and understanding whose feedback is getting incorporated and why is an important step in mapping out the effectiveness of CE strategy. Browne, et al [ 8 ] note how PREVAIL nurses responded to participants’ experiences of stigma by reiterating messages relayed by the Social Mobilisation Experts (SMEs) as part of their broader strategy. Community health workers (CHWs) are also highlighted by Miller et al [ 40 ] as playing an important role during the EVD outbreak and remained active in their communities after.…”