BMJ Open (May 2023)

CASCADE protocol: exploring current viral and host characteristics, measuring clinical and patient-reported outcomes, and understanding the lived experiences and needs of individuals with recently acquired HIV infection through a multicentre mixed-methods observational study in Europe and Canada

  • ,
  • Cristina Mussini,
  • Fiona Burns,
  • Shema Tariq,
  • Fiona M Burns,
  • Caroline Sabin,
  • Udi Davidovich,
  • Bruno Spire,
  • John Gill,
  • Marc van der Valk,
  • Linda Wittkop,
  • Laurence Meyer,
  • Kholoud Porter,
  • Inés Suárez-García,
  • Giota Touloumi,
  • Lars Eriksson,
  • Sophie Grabar,
  • Santiago Moreno,
  • Emily Jay Nicholls,
  • Christina Carlander,
  • Elisa Ruiz-Burga,
  • Alain Volny Anne,
  • Inma Jarrin,
  • Nikos Pantazis,
  • Rafael Eduardo Campo,
  • Harmony Garges,
  • Barbara Pinto,
  • Vani Vannappagari,
  • Alain Volny Anne,
  • Lital Young,
  • Marc van der Valk,
  • Agnes Aisam,
  • Diana Barger,
  • Marie Dos Santos,
  • Eli Fitzgerald,
  • Argyro Karakosta,
  • Hartmut Krentz,
  • Nicoletta Policek,
  • Chris Sandford

DOI
https://doi.org/10.1136/bmjopen-2022-070837
Journal volume & issue
Vol. 13, no. 5

Abstract

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Introduction Despite the availability of pre-exposure prophylaxis (PrEP) and antiretroviral therapy (ART), 21 793 people were newly diagnosed with HIV in Europe in 2019. The Concerted action on seroconversion to AIDS and death in Europe study aims to understand current drivers of the HIV epidemic; factors associated with access to, and uptake of prevention methods and ART initiation; and the experiences, needs and outcomes of people with recently acquired HIV.Methods and analysis This longitudinal observational study is recruiting participants aged ≥16 years with documented laboratory evidence of HIV seroconversion from clinics in Canada and six European countries. We will analyse data from medical records, self-administered questionnaires, semistructured interviews and participatory photography. We will assess temporal trends in transmitted drug resistance and viral subtype and examine outcomes following early ART initiation. We will investigate patient-reported outcomes, well-being, and experiences of, knowledge of, and attitudes to HIV preventions, including PrEP. We will analyse qualitative data thematically and triangulate quantitative and qualitative findings. As patient public involvement is central to this work, we have convened a community advisory board (CAB) comprising people living with HIV.Ethics and dissemination All respective research ethics committees have approval for data to contribute to international collaborations. Written informed consent is required to take part. A dissemination strategy will be developed in collaboration with CAB and the scientific committee. It will include peer-reviewed publications, conference presentations and accessible summaries of findings on the study’s website, social media and via community organisations.