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Article History

Received: 12 October 2022

Accepted: 2 September 2023

First Online: 14 November 2023

Declarations

:

: The PROUD study provided drug free of charge by Gilead Sciences plc. which also distributed it to participating clinics and provided funds for additional diagnostic tests for HCV and drug levels. SMc reports grants from the European Union H2020 scheme, EDCTP 2, the National Institute of Health Research, and Gilead Sciences; other support from Gilead Sciences, and the Population Council Microbicide Advisory Board; and is Chair of the Project Advisory Committee for USAID grant awarded to CONRAD to develop tenofovir-based products for use by women (non-financial). AS’s organisation has received Gilead fellowships in the past. The remaining authors have no competing interests to declare.

: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The PROUD study protocol was approved by London Bridge Research Ethics Committee, the Medicines and Healthcare Products Regulatory Agency and each of the 12 participating Hospital Trusts. The trial is registered with ISRCTN (Number ISRCTN94465371) and ClinicalTrials.gov (NCT02065986).

: Written informed consent was obtained from all individual participants included in the study at enrolment into the trial and prior to in-depth interview. The study protocol, including participant information sheet (PIS) and informed consent form (ICF), and the in-depth interview PIS, ICF and interview guide, are available on the study website (ExternalRef removed).