TY - JOUR
T1 - CASCADE protocol
T2 - 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
AU - Ruiz-Burga, Elisa
AU - Tariq, Shema
AU - Touloumi, Giota
AU - Gill, John
AU - Nicholls, Emily Jay
AU - Sabin, Caroline
AU - Mussini, Cristina
AU - Meyer, Laurence
AU - Volny Anne, Alain
AU - Carlander, Christina
AU - Grabar, Sophie
AU - Jarrin, Inma
AU - van der Valk, Marc
AU - Wittkop, Linda
AU - For CASCADE Collaboration
AU - Spire, Bruno
AU - Pantazis, Nikos
AU - Burns, Fiona M.
AU - Porter, Kholoud
N1 - Funding Information: This research is funded by ViiV Healthcare UK (award/grant number N/A), Janssen Pharmaceutica NV (award/grant number N/A) and Merck Sharp & Dohme (award/grant number N/A). Funding Information: The funders did not participate in the study design and will not intervene in its process, analysis or publication of the findings. ST has received speaker honoraria and consultancy fees from Gilead Sciences. CC has received speaker/moderator honoraria and advisory board fees from Gilead Sciences, GSK/ViiV and MSD as well as an unrestricted Gilead Sciences Nordic Fellowship Research Grant. CS has received funding from Gilead Sciences, ViiV Healthcare and Janssen-Cilag for participation in Advisory Boards, speaker panels and for preparation of educational materials. MVdV has received consultancies fees for participation in advisory boards and research grants from Gilead, MSD and ViiV all paid to his institution. FMB has received funding from Gilead Sciences Ltd for preparation and delivery of educational materials. IJ has received teaching fees from ViiV Healthcare and advisory fees from Gilead Sciences. GT has received research grants and advisory board fees from Gilead, all paid to her institution, and MJG has received honoraria for ad hoc participation in national Advisory boards of Gilead Merck and ViiV. Publisher Copyright: © The Author(s)
PY - 2023/5/11
Y1 - 2023/5/11
N2 - 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.
AB - 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.
KW - EPIDEMIOLOGIC STUDIES
KW - HIV & AIDS
KW - INFECTIOUS DISEASES
KW - Primary Prevention
UR - http://www.scopus.com/inward/record.url?scp=85159741229&partnerID=8YFLogxK
U2 - https://doi.org/10.1136/bmjopen-2022-070837
DO - https://doi.org/10.1136/bmjopen-2022-070837
M3 - Article
C2 - 37169505
SN - 2044-6055
VL - 13
SP - e070837
JO - BMJ Open
JF - BMJ Open
IS - 5
M1 - e070837
ER -