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

The Ebola outbreak was ongoing in Sierra Leone when the Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE) launched in April 2015, creating a constantly changing environment as the country dealt with a public health emergency. It was against this backdrop that STRIVE developed and implemented a flexible communication strategy to recruit participants, support human subjects' protection, build trust in the community, and mitigate potential rumours and misinformation. This article focuses on the 5 major activities conducted by STRIVE communications team - materials development, sensitisation activities, informational/educational activities, staff communication capacity development, and community engagement - and how those activities were structured and implemented to support human-subjects-protection principles. The article also outlines lessons learned from STRIVE and recommendations for similar clinical trial communication efforts during outbreaks.

To begin, the article provides an overview of STRIVE. In brief, in late 2014, the Centers for Disease Control and Prevention (CDC), Sierra Leone's Ministry of Health and Sanitation, and the College of Medicine and Allied Health Sciences, University of Sierra Leone, began planning an unblinded, individually randomised clinical trial to study the efficacy and safety of rVSV∆G-ZEBOV-GP vaccine. The CDC reported in December 2014 that healthcare workers (HCWs) were at 100-fold increased risk of Ebola, compared with the general adult population. Because of this risk, STRIVE defined the trial population as healthcare workers and frontline workers (e.g., ambulance drivers and burial teams) who provided care to people with confirmed or suspected Ebola. All participants were eligible to receive the vaccine by the end of the trial; there was no placebo.

There were 4 major considerations for the STRIVE communication team:

1. Working in a clinical-trial-naive population: It was important that potential participants understood clinical trial processes, principles of human subjects protection, and their rights as part of the trial. STRIVE staff also had to be able to effectively communicate in order to facilitate participants' voluntary, informed decision-making.
2. Implementing Sierra Leone’s first vaccine clinical trial: STRIVE needed to help potential participants understand what an experimental vaccine meant and provide information about the risk/benefits and unknowns about the vaccine, as well as manage the expectations of the vaccine licensure process.
3. Conducting research in the midst of a national emergency: Communication efforts had to be integrated with overall response communication activities, and STRIVE activities had to be sure not to impact the Ebola response efforts.
4. Adapting to the rapidly changing nature of emergency response: Information about the virus was evolving, locations of case clusters changed over time, and individuals' perception of their risk of contracting Ebola changed as the context changed.

Strategies and activities were based on STRIVE's communication framework, which used a tailored social ecology model to identify and reach specific spheres that influence a potential participant's decision-making (see Table 1 in the article). The STRIVE communication team adapted the model to address cultural norms around participatory decision-making, acknowledging interpersonal influences, community perceptions, and societal support. The framework used 3 approaches: ongoing formative activities, to identify and address emerging issues; anthropological understandings, so that communication was culturally appropriate and understandable; and participatory communication, so that potential and enrolled participants, as well as stakeholders and trusted leaders, could provide insights, and participants would feel empowered to make informed decisions. All communication efforts used risk communications principles, including ensuring transparency, conveying risk and benefits, and acknowledging unknowns.

A description of formative activities is included in the article. In brief, communication efforts began months prior to trial launch, building awareness and support through sensitisation sessions with stakeholders (paramount and district chiefs, and religious, cultural, and community leaders). Community engagement activities continued throughout the trial to maintain relationships with leaders and stakeholders and disseminate accurate information, fostering trust in the trial. Key insights that emerged from these formative activities, which informed STRIVE's communication activities, included: concerns regarding safety (including unfounded concerns the vaccine could cause Ebola) and the unknown level of protection from an experimental vaccine, the limited understanding of differences between approved and experimental vaccines, the need for a high level of trust that the trial was providing complete and accurate information, the need for clear and transparent information about the trial protocol and vaccine licensure process, the importance of culturally relevant communications and materials, and the need for staff training on communications designed to inform about STRIVE without promoting or influencing participation.

In addition to several hundred people deployed from the CDC, STRIVE staff included more than 350 Sierra Leoneans, most of whom had little knowledge of best practices for public health communication. Therefore, the STRIVE communication team provided formal and informal training and mentorship, primarily focusing on interpersonal communication and interaction that supported human subjects protections. Training continued throughout the trial to reinforce skills and address emerging issues.

During April-June 2016, the communication team led recruitment - with hundreds of information sessions for potential participants, facilitating the informed consent process. The sessions were conducted by local STRIVE staff in the audience's language. Outreach was designed to be participatory to foster empowerment; STRIVE communications staff used information gained during question-and-answer exchanges to identify recurring themes and tailor informal communications to address them. These tailored messages were provided at subsequent information sessions, through a telephone hotline for participants, and in the form of regularly updated key messages distributed to STRIVE staff to assist them in delivering clear, consistent, and understandable information.

As part of the enrollment packet, STRIVE developed a suite of more than a dozen materials, ranging from flip books and presentations to posters and fact sheets. Though the materials were in English, messages used the Krio word marklate for "vaccine". Materials relied heavily on visual communications to address varied literacy among potential participants. Illustrations were gender- and job-inclusive. Some materials were designed to help facilitate conversations with family members or others involved in the decision-making process. Key messages about voluntary participation, confidentiality, and safety were reiterated across materials - particularly as part of the materials given to enrolled participants (vs. potential ones).

Communication efforts continued post-enrollment, supporting ongoing voluntary participation in the trial. Also, informal formative activities during the trial yielded insights on participants' perceptions and information needs. While CDC institutional review board (IRB)-approved activities and materials did not change, this flexible strategy allowed for responsive interactions with participants. The authors of the article explain that the trial's success and its community acceptance illustrated STRIVE's successful communications efforts, owing in large part to this flexibility and commitment to community engagement.

A chart of STRIVE-specific issues and solutions can be found in Table 2 in the article; in addition, 6 overarching lessons learned are detailed:

1. Define phases of effort (i.e., development, initial implementation, and close-down of the study) and key milestones ahead of such activities to negate risk of rumours.
2. Design a flexible strategy: It was important to use risk communications principles particularly foreshadowing change and to communicate transparently so STRIVE's reputation remained strong even when its messages shifted. By identifying recurring questions at information sessions, staff were able to address these questions up front in a manner that showed respect and transparency.
3. Integrate communications efforts with response communication efforts.
4. Invest in communication training, particularly in interpersonal communication skills, for all staff.
5. Build and maintain strong community partnerships to help create and maintain trust in the trial and its staff, provide valuable insights to help navigate the changing environment, and build trusted intermediaries in the community at the district and chiefdom levels.
6. Use cultural norms to support the scientific integrity of research. For example, STRIVE used a balloting process for trial arm assignment that addressed an expressed need for transparency while supporting the need for randomisation.

In conclusion: "The STRIVE communication experience helps fill a gap in the communication literature on a systematic approach to communication to support Human Subjects Protection in a clinical trial in a resource-limited setting during a public health emergency."