Evidence-based complementary feeding recipe book for Kenyan caregivers: A novel approach.

The Kenyan Ministry of Health (MOH) and a consortium of nutritionists, researchers and communication, and design specialists developed a novel approach to create an evidence-based recipe book promoting complementary feeding (CF) in Kenya. The ADAPT approach includes five steps: applied research (A), dialogue with stakeholders (D), adapted behaviour change communication (BCC) theories (A), purpose-driven visual communication (P), and tailoring to priority audiences (T). Through this approach, the recipe book addresses key knowledge gaps using behaviour change theories and visual communication best practice to increase accessibility, acceptability, retention and motivation for behaviour change. The book addresses barriers to CF identified through formative applied research. Dialogue with stakeholders helped ensure cultural appropriateness and the book's alignment with MOH recommendations and key messages. The book uses behaviour change theories to approach the reader in a respectful way that motivates behaviour change. The use of consistent, purpose-driven visuals helps ensure key messages are easily understood and accessible to all caregivers regardless of literacy level. The book's tone and content are tailored to its audiences' attributes, needs and preferences. This five-step process inspired the development of ADAPT, a novel approach that integrates behaviour change and visual communication for greater impact. This paper outlines how the consortium used the ADAPT approach to develop an evidence-based book that thoughtfully and holistically addresses a wide range of barriers, provides practical solutions and increases self-efficacy around CF. It offers a blueprint for public health practitioners from any field who are interested in using visual behaviour change communication to promote healthy behaviour.

Perceptions and acceptability of an experimental Ebola vaccine among health care workers, frontline staff, and the general public during the 2014-2015 Ebola outbreak in Sierra Leone.

INTRODUCTION: Experimental Ebola vaccines were introduced during the 2014-2015 Ebola outbreak in West Africa. Planning for the Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE) was underway in late 2014. We examined hypothetical acceptability and perceptions of experimental Ebola vaccines among health care workers (HCWs), frontline workers, and the general public to guide ethical communication of risks and benefits of any experimental Ebola vaccine. METHODS: Between December 2014 and January 2015, we conducted in-depth interviews with public health leaders (N = 31), focus groups with HCWs and frontline workers (N = 20), and focus groups with members of the general public (N = 15) in Western Area Urban, Western Area Rural, Port Loko, Bombali, and Tonkolili districts. Themes were identified using qualitative content analysis. RESULTS: Across all participant groups, not knowing the immediate and long-term effects of an experimental Ebola vaccine was the most serious concern. Some respondents feared that experimental vaccines may cause Ebola, lead to death, or result in other adverse events. Among HCWs, not knowing the level of protection provided by experimental Ebola vaccines was another concern. HCWs and frontline workers were motivated to help find a vaccine for Ebola to help end the outbreak. General public participants cited positive experiences with routine childhood immunization in Sierra Leone. DISCUSSION: Our formative assessment prior to STRIVE's implementation in Sierra Leone helped identify concerns, motivations, and information gaps among potential participants of an experimental Ebola vaccine trial, at the time when an unprecedented outbreak was occurring in the country. The findings from this assessment were incorporated early in the process to guide ethical communication of risks and benefits when discussing informed consent for possible participation in the vaccine trial that was launched later in 2015.

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

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

Implementing a Multisite Clinical Trial in the Midst of an Ebola Outbreak: Lessons Learned From the Sierra Leone Trial to Introduce a Vaccine Against Ebola.

The Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE), a phase 2/3 trial of investigational rVSV∆G-ZEBOV-GP vaccine, was conducted during an unprecedented Ebola epidemic. More than 8600 eligible healthcare and frontline response workers were individually randomized to immediate (within 7 days) or deferred (within 18-24 weeks) vaccination and followed for 6 months after vaccination for serious adverse events and Ebola virus infection. Key challenges included limited infrastructure to support trial activities, unreliable electricity, and staff with limited clinical trial experience. Study staff made substantial infrastructure investments, including renovation of enrollment sites, laboratories, and government cold chain facilities, and imported equipment to store and transport vaccine at ≤-60oC. STRIVE built capacity by providing didactic and practical research training to >350 staff, which was reinforced with daily review and feedback meetings. The operational challenges of safety follow-up were addressed by issuing mobile telephones to participants, making home visits, and establishing a nurse triage hotline. Before the Ebola outbreak, Sierra Leone had limited infrastructure and staff to conduct clinical trials. Without interfering with the outbreak response, STRIVE responded to an urgent need and helped build this capacity. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220].

The Sierra Leone Trial to Introduce a Vaccine Against Ebola: An Evaluation of rVSV∆G-ZEBOV-GP Vaccine Tolerability and Safety During the West Africa Ebola Outbreak.

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

Implementing an Ebola Vaccine Study - Sierra Leone.

In October 2014, the College of Medicine and Allied Health Sciences of the University of Sierra Leone, the Sierra Leone Ministry of Health and Sanitation, and CDC joined the global effort to accelerate assessment and availability of candidate Ebola vaccines and began planning for the Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE). STRIVE was an individually randomized controlled phase II/III trial to evaluate efficacy, immunogenicity, and safety of the recombinant vesicular stomatitis virus Ebola vaccine (rVSV-ZEBOV). The study population was health care and frontline workers in select chiefdoms of the five most affected districts in Sierra Leone. Participants were randomized to receive a single intramuscular dose of rVSV-ZEBOV at enrollment or to receive a single intramuscular dose 18-24 weeks after enrollment. All participants were followed up monthly until 6 months after vaccination. Two substudies separately assessed detailed reactogenicity over 1 month and immunogenicity over 12 months. During the 5 months before the trial, STRIVE and partners built a research platform in Sierra Leone comprising participant follow-up sites, cold chain, reliable power supply, and vaccination clinics and hired and trained at least 350 national staff. Wide-ranging community outreach, informational sessions, and messaging were conducted before and during the trial to ensure full communication to the population of the study area regarding procedures and current knowledge about the trial vaccine. During April 9-August 15, 2015, STRIVE enrolled 8,673 participants, of whom 453 and 539 were also enrolled in the safety and immunogenicity substudies, respectively. As of April 28, 2016, no Ebola cases and no vaccine-related serious adverse events, which by regulatory definition include death, life-threatening illness, hospitalization or prolongation of hospitalization, or permanent disability, were reported in the study population. Although STRIVE will not produce an estimate of vaccine efficacy because of low case frequency as the epidemic was controlled, data on safety and immunogenicity will support decisions on licensure of rVSV-ZEBOV.The activities summarized in this report would not have been possible without collaboration with many U.S. and international partners (http://www.cdc.gov/vhf/ebola/outbreaks/2014-west-africa/partners.html).