Cohort profile: the Viral load Cohort North-East Lesotho (VICONEL) from 2016 to 2022 – cohort description, test volumes, predictors of viraemia, and the road ahead

Purpose The prospective Viral load Cohort North-East Lesotho (VICONEL) aims to support clinical management and generate scientific evidence to inform HIV care. Specifically, VICONEL allows for monitoring of HIV treatment outcomes and health system performance, encompasses a biobank for further research with routinely collected blood plasma samples of consenting participants, and provides a valuable framework for nested observational and interventional studies. Participants VICONEL captures routine viral load test results alongside associated demographic and treatment information among people in care for HIV in Lesotho, southern Africa. As of December 2022, it encompasses all viral load testing from 23 healthcare facilities in two districts of Lesotho. Findings to date From January 2016 to December 2022, 114’838 viral load test results were available for 27,472 participants. At the time of the last viral load test, median age was 42 years (interquartile range [IQR]: 33-53); 17,324 (63%) were adult women, 9,273 (34%) adult men, and 870 (3%) children <15 years (age/sex missing for 5); and median time taking antiretroviral therapy (ART) was 6.0 years (IQR 3.0-9.2). Overall, the proportion of cohort participants with viral suppression to <1,000 copies/mL has continually exceeded 90% and has been above 95% since 2020; however, this proportion has consistently been lower among children. Sex, age category / ART regimen core agent (combined variable), time since ART initiation, and district were independently associated with viraemia. Future plans VICONEL offers potential for i) further digitalisation and automation of results sharing at the client, facility, and district/national level, ii) integration of additional clinical and diagnostic data, including HIV comorbidities, and iii) embedding randomised trials. Strengths and limitations ### Competing Interest Statement NDL reports having received travel grants to attend IAS, AIDS, and CROI conferences from Gilead Sciences Sarl and ViiV Healthcare. All other authors declare that they have no competing interests. ### Funding Statement This study was funded by the Swiss National Science Foundation (IZ07Z0\_160876/1, obtained by NDL; PCEFP3\_181355, obtained by NDL) and ESTHER Switzerland (acquired by NDL). JAB receives her salary through grants from Fondation Botnar (REG-19-008, obtained by NDL and JAB) and the University of Basel Research Fund Junior Researchers (3ZX1422, acquired quired by JAB). ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The National Health Research Ethics Committee in Lesotho has approved the cohort study (ID 134-2016) and waived consent for analyses using routine data. A biobank consent form for the further use of plasma left over after viral load testing is periodically offered at several sites. Several studies nested within VICONEL but involving non-routine procedures have required a separate study protocol and separate informed consent; data from such studies is not analysed here except insofar as it consists of additional viral load testing or overlaps with routinely collected data. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Aggregated or de-identified individual patient data can be shared upon reasonable request and signing of a data sharing agreement. Investigators must submit a concept sheet detailing the required data and planned analyses to the corresponding author for internal review and approval. Publications arising from VICONEL data are subject to written approval by the Sponsor/Chief Investigator and/or the Principal Investigator. VICONEL investigators or contributors shall be co-authors on publications using VICONEL data, provided they fulfil authorship criteria as defined by the International Committee of Medical Journal Editors.