eCRF for the ESTER Study
Starting treatment during primary HIV-1 infection (PHI) offers significant benefits over starting during chronic infection, such as reducing viral replication and preserving immune function. However, the best treatment strategy for PHI is still debated. Intensified regimens with multiple drugs have not shown clear benefits in viral suppression or immune recovery, and can impact adherence and tolerability.
The ESTER study, conducted at INMI L. Spallanzani from March 2017 to December 2018, aimed to evaluate the efficacy of switching early to a single-pill regimen of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir alafenamide (E/C/F/TAF) from a 5-pill treatment regimen in patients with primary HIV-1 infection.
The study was carried out in collaboration with several institutions, including the Division of Infectious Diseases of the San Gerardo Hospital, University of Milan-Bicocca, the IRCCS San Raffaele Scientific Institute in Milan, the Infectious Diseases Clinic of the San Paolo Hospital in Milan and the Infectious Diseases Unit of the University of Turin.
Given the limited size of the study, the researchers needed an eCRF developed affordably and rapidly.
The eCRF application was developed in March 2017, in just three days, by a single data scientist, leveraging the ability of Livebase to cut down time and the resources typically required for software development in clinical trials.
Despite the quick development time, the application was tailored to meet the specific needs of the ESTER study, ensuring that all necessary features and functionalities were included from the start.
The data was collected on several parameters at baseline, week 24, and week 48. These parameters included CD4 T-cell counts, HIV-1 DNA levels, HIV antibody levels, lymphocyte activation markers, inflammation markers, urinary tubular damage markers, and BMD by DXA scan. The study also monitors self-reported adherence levels, patient-reported quality of life, and neurocognitive performance.
With 35 patients tracked and 246 visits, efficient data management was crucial. Livebase facilitated the collection, storage, and analysis of large amounts of data through its robust database capabilities, while keeping participants' sensitive data confidential. The platform's built-in data validation and verification processes also helped maintain high data quality, reducing the risk of errors and inconsistencies that could compromise the study's outcomes.
The ESTER study's application showcased numerous advantages of leveraging Livebase's architecture to generate eCRF applications.
Livebase's reliance on a relational DBMS ensures robust data management through structured schemas, enforcing data integrity and consistency. Furthermore, it enables efficient querying and manipulation of data, supporting fast retrieval and analysis operations.
These qualities empower researchers to manage data effectively, collaborate seamlessly, and harness advanced analytical capabilities to drive impactful discoveries in their respective fields of study, integrating seamlessly with analytical tools and systems.