THE PARTNERSHIP OF CLINICAL RESEARCH IN GUINEA (PREGUI)

By: Jackie Perodin

In 2015, the Ministry of Health (MOH) of the Republic of Guinea and the National Institute of Allergy and Infectious Diseases (NIAID) signed a Memorandum of Understanding (MOU) for Cooperation in Biomedical Research. Under the MOU, involved parties conducted collaborative clinical research on the Ebola virus and other infectious diseases, including the randomized clinical trials PREVAIL II and the Partnership for Research on Ebola Vaccination (PREVAC). Through these eﬀorts emerged the Partnership of Clinical Research in Guinea (PREGUI), created to support collaborative research between NIAID’s Division of Clinical Research (DCR) and the Guinean MOH, whose mission is to implement and conduct national and international high-quality research focused on public health priorities in Guinea and develop sustainable research capacity in-country. Conakry, Guinea’s capital, and Maferinyah, a rural town in the Forecariah prefecture, approximately 46 miles from Conakry, were chosen as the central location for PREGUI operations. Most logistical, administrative, and general operations occur in Conakry, while clinical operations and study-related activities occur in Maferinyah. To support research implementation and conduct, core infrastructure and capacities were built at the existing Maferin-yah National Training and Research Center in Rural Health, including a clinical research unit, pharmacy, participant ﬂow area, laboratory, training and conference rooms, and biorepository, as well as facilities (water, waste, electricity, storage) management, information management capabilities. In collaboration with PREGUI partners, CMRPD provides clinical research infrastructure and operational and facilities management support, from conceptualization through the implementation, conduct, and closeout of research activities.

CMRPD staff members play an important role in directly supporting PREGUI. A clinical project manager and a program manager are responsible for overseeing the entire program and ensuring that all project activities run smoothly. Their responsibilities include not only day-to-day oversight, but also the management of various subcontracts required for the successful implementation of research projects. In addition to these managerial roles, the team includes a dedicated research scientist who is responsible for providing scientific guidance and laboratory training to local personnel, ensuring that high-quality research standards are maintained throughout the project. A senior logistics analyst and a senior program coordinator will help to strengthen PREGUI’s operational capabilities. These two professionals specialize in procurement and logistics, ensuring that all necessary supplies, equipment, and materials are available when needed while also managing the logistics of their delivery and management. These five staff members form a cohesive team, ensuring the successful execution of PREGUI’s research activities.

Political unrest poses unforeseeable challenges to clinical research activities in country. A coup d’etat in September 2021, civil protests/demonstrations, distrust in public authorities, shortage of resources (e.g., the explosion of a fuel depot in December 2023), and electrical and connectivity issues aﬀect clinical operations of ongoing research. This requires the project team to readjust often and ﬁnd alternatives to mitigate situations for continuity of work, as feasible. The nature of the project requires CMRPD staﬀ to provide continuous guidance, hands-on and remote training, and support to ensure the availability of critical resources for smooth operations on the ground.

Despite numerous challenges, PREGUI has demonstrated remarkable resilience and has successfully participated in a wide range of important studies supported by NIAID and other international partners. These studies have spanned various infectious diseases of public health significance, such as an HIV study known as D2EFT, which focuses on treatment options for those who have failed first-line antiretroviral therapy. Additionally, PREGUI has been deeply involved in malaria research, contributing to critical studies like the Malaria Burden study, DeTACT, and the EDCTP-Malaria technology and data Transmission project. Most recently, PREGUI has played a key role in the ongoing NIAID DCR-supported InVITE COVID-19 and measles studies.

The 2017-2022 PREGUI strategic plan outlined the network’s many collaborating partners, stakeholders, goals, and approach to achieve their mission. Assessments and discussions are currently under-way with the network’s leadership to determine the best approaches to support PREGUI’s growth in its next phase.