The Ghana Health Service (GHS) Research and Development Division, along with the Neglected Tropical Diseases Programme, Mundo Sano, and the Margan Clinical Research Organization, successfully conducted a Site Initiation Visit (SIV) from June 3rd to 6th in Axim and Takoradi (Ghana). This visit is a necessary step before the launch of the clinical trial titled “A Pragmatic Phase III Multi-Center Clinical Trial to Evaluate the Safety and Effectiveness of a Single Dose of an Albendazole-Ivermectin Co-formulation vs. Albendazole for Preventive Chemotherapy of Soil-Transmitted Helminth Infections in School-Aged Children”, also known as the REALISE study, due to start soon.

This study is an important part of the STOP2030 project, funded by Global Health EDCTP3 and the Swiss Government.

The meeting was facilitated by the clinical research organization Margan CRO, Liconsa (the sponsor of the study) and the investigators. Over 50 participants attended the meeting, including representatives from the Ghana Health Service Neglected Tropical Diseases, Research and Development Division, the Public Health Reference Lab, Takoradi, District Hospital, Axim, District Health Directorate, Nzema East, and the Ghana Education Service in Axim. Participants included study investigators, program officers, data managers, research officers, biomedical scientists, disease control officers, medical officers, pharmacists, school health coordinators, district directors of health services, and the medical superintendent.

The discussions covered various topics, including an overview of the protocol and its requirements, the introduction to the clinical trial, components of the study, the legal and regulatory framework, assessment of comprehension, documentation of the informed consent process, and considerations for vulnerable populations. Key points reviewed included the history of informed consent forms (ICFs), ethical conduct, protocol adherence, investigator qualifications, compliance and data integrity, monitoring activities, site readiness, essential study files, study documents, investigational products (IP), sample handling, quality assurance, standard operating procedures (SOPs), and training and certifications.

Additional discussions focused on case report forms (CRFs), guidelines for completing CRFs, a demonstration of the RedCap system, principles of good data practice (GDP), data management, recording and handling data, document storage and archiving, document review and quality control, maintenance of data integrity, study procedures and timelines, follow-up activities and timelines, randomization and IP administration, and accountability for IP storage and temperature monitoring.

In the coming days, training will be conducted for field workers to prepare for the initiation of community and school screenings.