A secure analytics platform to study the prognosis of people with HIV in the USA, Canada and Europe and comparative effectiveness of treatment regimens: the Antiretroviral Therapy Cohort Collaboration

PROJECT SUMMARY/ABSTACT The HIV epidemic has changed dramatically since the introduction of effective antiretroviral therapy (ART), which substantially increased the life expectancy of people with HIV (PWH). As ART regimens and health care for PWH continue to improve, the population of PWH in North America and Europe is aging. As the treatment

landscape changes, it is important to provide up-to-date data on prognosis for PWH in the modern ART era and compare effectiveness of modern ART regimens. Large datasets are required to study important subgroups of PWH. The Antiretroviral Therapy Cohort Collaboration (ART-CC) is the largest collaboration of

HIV cohorts across North America and Europe, with 20 HIV cohorts and data on around 250,000 PWH on ART. ART-CC pioneered standardized coding of causes of death in treated PWH and has classified causes of death for 16,832 PWH. ART-CC has fostered a collaborative approach to research and enabled researchers

across the globe to utilize its data and methodological expertise. Approaches to analyzing data from HIV cohort collaborations have evolved with increasing awareness of the need to protect participants’ privacy, international data protection laws, and wide use of data use agreements to govern data transfers. We will develop a new secure data platform that enables international ART-CC

collaborators and external researchers to conduct secure, privacy-protecting analyses of pseudonymized ART- CC data using reproducible, shared code. data will be accessed in a controlled environment, with export of analysis results requiring approval from trained output checkers. This platform will facilitate a distributed

collaborative model in which researchers from any contributing cohort, as well as verified external researchers, can conduct analyses, whilst participating cohorts retain ownership of their data. Research within the secure platform will incorporate 3 aims. 1) Enhance the understanding of cause-specific

mortality and cause-specific hospitalizations among PWH, building on ART-CC’s world-leading data on causes of death among PWH and extending these methods to causes of hospitalization. 2) Enhance understanding of prognosis for all-cause mortality in under-studied groups of PWH, such as transgender PWH and PWH starting

ART aged ≥60. 3) Estimate the comparative effectiveness of novel ART regimens versus older, more commonly used regimens and of GLP-1 agonists, which are increasingly used to address ART-associated weight gain in PWH. ART-CC’s large size and geographical heterogeneity will allow analyses to be sex-

stratified and for comparisons between US and non-US cohorts. In summary, this proposal will develop a data platform to simplify data sharing for HIV cohorts in North America and Europe, enabling efficient analyses based on open science principles that address high priority research questions for PWH in the modern ART era.