HEALTH SYSTEM ANALYSIS OF THE BARRIERS TO ACCESS, AVAILABILITY, UTILISATION AND READINESS OF SEXUAL AND REPRODUCTIVE HEALTH SERVICES IN COVID-19 AFFECTED AREAS: DEVELOPMENT AND VALIDATION OF A DATA COLLECTION SYSTEM TO BE APPLIED FOR FUTURE HEALTH PANDEMICS

Background: The Coronavirus Disease 19 (COVID-19) pandemic has severely impacted sexual health service provision with consequences at both individual and public health level. The collection of real-time high-quality data is of utmost importance to monitor the impact on service delivery and disruption in case of future health emergencies. Aims: This is a 3-year study, implemented in the framework of a broader collaboration between World Health Organization (WHO) Department of Sexual and Reproductive Health Research and University of Brighton (UOB) with the University Hospital Verona (UHVR). The overarching study aim was to develop and pilot a secure, standardised, web-based electronic case report form (eCRF), via Research Electronic Data Capture (REDCap) system, for sexually transmitted infection (STIs) and HIV clinical data management. The eCRF constituted the basis for a research infrastructure aimed at conducting multi-centric implementation studies able to answer selected research questions and guide decision making processes. Methods: The eCRF construction required a multidisciplinary approach (9 study experts from UHVR and UOB with different backgrounds) and consisted of a series of distinct steps: i) identification of a minimum set of standardised HIV-STIs core variables required to increase study consistency; ii) design of the eCRF framework according to literature key-principles with particular focus on a structure based on modularity, longitudinal mode, flexibility, intuitive workflow, and compliance with the General Data Protection Regulation; iii) set up of a series of quality checks at different levels to minimise errors and ensure data integrity at time of data entry; iv) eCRF piloting by 12 healthcare providers external to the study, who were asked to assess and provide feedback on key eCRF aspects; v) testing of entry procedure and quality checks efficiency using clinical routine data on HIV-Pre-Exposure Prophylaxis (PrEP) users accessing UHVR Centro MISTRA from January 2108 to September 2022. Mixed manual and automatic entry processes (with import of a pre-existing Excel sheet) were performed for checking feasibility of both tasks. The tool usability was evaluated via an implementation study which tested data entry system (data reconciliation) and data processing through exploratory statistical analyses, which focused on the assessment of COVID-19 impact on PrEP users in pre-pandemic, pandemic, and post-pandemic periods. Results: Four instruments were developed (Demographics, Past Medical History, Standard Visits, Antimicrobial Prescription) hosting 7 modules. The modular approach was used to test the current set of instruments and, in the future, to add further functionalities allowing an interchangeable, dynamic, and independent modules development without impacting the overall eCRF frame. The repeatable Standard Visit instrument (including sexual behaviour, PrEP intake, signs & symptoms, and laboratory assessment modules) is the eCRF core. Given the longitudinal mode, baseline instrument is populated only at enrolment and then can be further filled in at various time points (patient follow-up visits), if needed. The core eCRF feature is the possibility of completing visits based on patients’ needs with little burden for physician or data collector. The reconciliation process uploading already collected data into the eCRF was straightforward with 95% of successful import without need of further review. Exploratory analyses were conducted on 256 PrEP users and 1595 visits. Main findings showed significant decrease in visits number and increase in PrEP discontinuation during pandemic period. Conclusion: The study led to the implementation of an easy-to-use eCRF able to host standardised, real-time, high-quality data. The eCRF suggests a wide range of applicability in both research and clinical areas to be adopted in case of future health emergencies, potentially useful to guide clinical decision-making and support healthcare practice with telehealth implementation.