Insights gained from conducting a randomised controlled trial on Ivermectin-Albendazole against Trichuris trichiura in Côte d'Ivoire, Lao PDR and Pemba Island

• Published in: Advances in parasitology Vol. 111; pp. 253 - 276
• Main Authors: Keller, Ladina, Hürlimann, Eveline, Patel, Chandni, Welsche, Sophie, Sayasone, Somphou, Ali, Said M, Ame, Shaali M, Coulibaly, Jean Tenena, Keiser, Jennifer
• Format: Journal Article
• Language: English
• Published: England 2021
• Subjects: Pemba; Albendazole; Lao PDR; Trial implementation; Tanzania; Trichuris trichiura; Côte d'Ivoire; Soil-transmitted helminths; Randomized controlled trial; Ivermectin
• ISSN: 2163-6079
• DOI: 10.1016/bs.apar.2020.11.001

There is only limited scientific literature on trial methodology, trial procedures and mitigation strategies to overcome challenges faced during clinical research taking place in resource constrained healthcare environments. Organisational, cultural, infrastructural and ethical challenges may vary between settings although conduct of clinical trials for the same disease (in our case soil-transmitted helminth (STH) infections) share similar risks for implementation. We use the example of a phase III randomised controlled trial, conducted between 2018 and 2020 in Côte d'Ivoire, Lao PDR and Pemba Island (Tanzania), to share challenges faced and mitigation strategies to guide future planning of studies in similar settings. We describe the planning, screening, enrolment and implementation phases in each of the three settings. Our findings indicate that involvement of local staff and close collaboration are essential factors for successful trial preparation and implementation. A strategic plan adapted to each setting with a distinct focus on community engagement and workforce is crucial to proceed efficiently. Mutual trust between the trial population and the trial team is of utmost importance and allows for early reaction and adaption to emerging issues.