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].

How can we recruit more men of African or African-Caribbean ancestry into our research? Co-creating a video to raise awareness of prostate cancer risk and the PROFILE study.

BACKGROUND: Men of African ancestry are at increased risk of developing prostate cancer (PrCa) compared to men from other backgrounds. The PROFILE study aims to understand whether genetic information can better target who needs PrCa screening. PROFILE has so far had difficulty reaching men of African or African -Caribbean ancestry to take part. In this involvement project we worked in partnership with a group of such men to co-create a video to raise awareness of PrCa risk amongst this community and promote participation in the study. METHODS: We recruited seven men of African or African-Caribbean ancestry who completed an initial survey on the Cancer Patients' Voice platform. We then held an online discussion panel and maintained contact to encourage dialogue and planning of the video. Utilising a participatory approach, the ideas for the video were decided in collaboration with the panel who held expert knowledge of various communities and understood the messages that would best resonate and engage with other men of the same origins. Once the video had been edited and finalised, two members of the group expressed interest in writing up the project and are listed as co-authors. RESULTS: The video in its entirety was driven by the panel's ideas. The choice of a barber shop setting; leading with a positive case study and highlighting the importance of men's family members rather than a focus on scientific language, statistics or researchers were all features that were discussed and agreed upon by the panel. The men shared the video within their networks. It was placed on websites and promoted as part of a social media campaign during Black History Month. CONCLUSIONS: Groups with the greater healthcare needs and the most to gain from advances in care and treatment can often be the most excluded from research participation. This is pertinent in PrCa research where men of African or African-Caribbean ancestry are at greater risk. The project gave equal power and decision making to the men and provides an example of successful inclusive involvement. The result was a unique approach to making a study video.

METHODS: We engaged seven men of African or African-Caribbean ancestry: three PROFILE study participants and four from the Race, Ethnicity and Cultural Heritage (REACH) staff forums across the Royal Marsden Hospital and the Institute of Cancer Research. They completed a survey, joined an online discussion panel and we continued working together. The group decided on the structure and content of the video; to include a PrCa survivor who had been successfully screened and treated early for his disease, and a daughter of one of the panellists. The men were also involved in the dissemination plans of the finished video, and two agreed to be co-authors of this paper. FINDINGS: Features of the video led by the men included the choice of a barber shop setting; leading with a positive shared story and highlighting the importance of family rather than science, statistics or researchers. DISSEMINATION: The group shared the video within their networks. It was placed on websites and promoted as part of a social media campaign during Black History Month.

This project involved working in partnership with men of African or African-Caribbean ancestry to co-create a video intended to raise awareness of prostate cancer (PrCa) risk and promote participation in a genetic screening study called PROFILE. Men of African or African-Caribbean ancestry are at increased risk of developing PrCa compared to other men. The PROFILE study aims to understand whether genetic information can better target who needs PrCa screening. The study has had problems recruiting men from these communities.