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MD PhD Alain Amstutz

Department of Clinical Research
Profiles & Affiliations

Alain Amstutz is an MD PhD focusing on innovative randomized trial designs, cluster randomized trials, trial evidence synthesis methods, and target trial emulations. He is passionate about advancing clinical research with applied clinical projects across Europe and Southern Africa (esp. Lesotho). 

He is currently a postdoc and project leader at the Division of Clinical Epidemiology (Basel, Switzerland), as well as a visiting postdoc at the Oslo Centre for Biostatistics and Epidemiology (OCBE, Oslo University Hospital) and the Bristol Medical School (University of Bristol, UK). He has conducted several cluster- and individual-randomized trials in Lesotho assessing HIV self-testing, treatment for HIV low-level viremia, adolescent care and service delivery for people living with other chronic diseases - as part of a large North-South research consortium.

He is part of the methods/stats team of EU-RESPONSE (pan-European platform trial on COVID-19) and MOSAIC (pan-European Mpox cohort), project leader for the COVERALL trial (Swiss COVID-19 vaccine trial platform of SHCS and STCS), part of the Young Researchers' Group of the SHCS (Swiss HIV Cohort Study) and the global TwiCs network. As co-Principal Investigator of ComBaCaL, he currently builds a large-scale general population-based cohort study in two districts in Lesotho to investigate chronic diseases and how to decentralise services with the help of lay health workers and e-Health applications. Moreover, he investigates if and how sexual and reproductive health services can be offered at hair salons in Lesotho, is interested in individual patient data meta-analyses, currently conducting one on JAK inhibitors against COVID-19, and passionate about Patient and Public Involvement. Up to today, he has acquired substantial research funding as (Co-)Principal Investigator (>7 Million USD) and published >20 first- and last-author publications in peer-reviewed journals (Lancet Resp Med, Lancet HIV, PLOS Med, CID, JIAS, among others) and serves as Associate Editor at BMC Trials and BMC Pilot & Feasibility Studies. He fluently speaks German, English, French and Italian – and is constantly working on his Sesotho.

Selected Publications

Troseid M., Arribas J.R., Assoumou L., Holten A.R., Poissy J., Terzic V., Mazzaferri F., Bano J.R., Eustace J., Hites M., Joannidis M., Paiva J.-A., Reuter J., Puntmann I., Patrick-Brown T.D.J.H., Westerheim E., Nezvalova-Henriksen K., Beniguel L., Dahl T.B., et al. (2023). Efficacy and safety of baricitinib in hospitalized adults with severe or critical COVID-19 (Bari-SolidAct): a randomised, double-blind, placebo-controlled phase 3 trial. Critical Care, 27(1). https://doi.org/10.1186/s13054-022-04205-8

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Amstutz, Alain, Speich, Benjamin, Mentré, France, Rueegg, Corina Silvia, Belhadi, Drifa, Assoumou, Lambert, Burdet, Charles, Murthy, Srinivas, Dodd, Lori Elizabeth, Wang, Yeming, Tikkinen, Kari A O, Ader, Florence, Hites, Maya, Bouscambert, Maude, Trabaud, Mary Anne, Fralick, Mike, Lee, Todd C, Pinto, Ruxandra, Barratt-Due, Andreas, et al. (2023). Effects of remdesivir in patients hospitalised with COVID-19: a systematic review and individual patient data meta-analysis of randomised controlled trials. The Lancet Respiratory Medicine, 11(5), 453–464. https://doi.org/10.1016/s2213-2600(22)00528-8

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Ciani, O., Manyara, A. M., Davies, P., Stewart, D., Weir, C. J., Young, A. E., Blazeby, J., Butcher, N. J., Bujkiewicz, S., Chan, A.-W., Dawoud, D., Offringa, M., Ouwens, M., Hróbjartssson, A., Amstutz, A., Bertolaccini, L., Bruno, V. D., Devane, D., Faria, C. D. C. M., et al. (2023). A framework for the definition and interpretation of the use of surrogate endpoints in interventional trials. eClinicalMedicine, 65. https://doi.org/10.1016/j.eclinm.2023.102283

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Firima, Emmanuel, Gonzalez, Lucia, Khan, Moazziz Ali, Manthabiseng, Molulela, Sematle, Mamoronts’sane P., Bane, Matumaole, Khomolishoele, Makhebe, Leisa, Ikhetheleng, Retselisitsoe, Lefokotsane, Burkard, Thilo, Seelig, Eleonara, Lee, Tristan, Chammartin, Frédérique, Gupta, Ravi, Leigh, Bailah, Weisser, Maja, Amstutz, Alain, Amstutz, Alain, & Labhardt, Niklaus Daniel. (2023). High Rates of Undiagnosed Target Organ Damage Among Adults with Elevated Blood Pressure or Diabetes Mellitus in a Community-Based Survey in Lesotho. Journal of Epidemiology and Global Health, 13, 857–869. https://doi.org/10.1007/s44197-023-00158-5

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Gerber, Felix, Gupta, Ravi, Lejone, Thabo Ishmael, Tahirsylaj, Thesar, Lee, Tristan, Kohler, Maurus, Haldemann, Maria Ines, Räber, Fabian, Chitja, Mamakhala, Manthabiseng, Molulela, Khomolishoele, Makhebe, Mota, Mota, Bane, Matumaole, Sematle, Pauline Mamorontsane, Makabateng, Retselisitsoe, Mphunyane, Madavida, Phaaroe, Sejojo, Basler, Dave, Kindler, Kevin, et al. (2023). Community-based type 2 diabetes care by lay village health workers in rural Lesotho: protocol for a cluster-randomized trial within the ComBaCaL cohort study (ComBaCaL T2D TwiC). Trials, 24. https://doi.org/10.1186/s13063-023-07729-8

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Kopo, M., Lejone, T. I., Tschumi, N., Glass, T. R., Kao, M., Brown, J. A., Seiler, O., Muhairwe, J., Moletsane, N., Labhardt, N. D., & Amstutz, A. (2023). Effectiveness of a peer educator-coordinated preference-based differentiated service delivery model on viral suppression among young people living with HIV in Lesotho: the PEBRA cluster-randomized trial. PLoS Med, 20(1), e1004150. https://doi.org/10.1371/journal.pmed.1004150

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Ndongala NJ, Maepa C, Nyondo E, Amstutz A, & du Reau de la Gaignonnière B. (2022). Etiology, characteristics and occurrence of heart diseases in rural Lesotho (ECHO-Lesotho): A retrospective echocardiography cohort study. PloS One, 17(12), e0278406. https://doi.org/10.1371/journal.pone.0278406

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Amstutz, A., Lejone, T. I., Khesa, L., Kopo, M., Kao, M., Muhairwe, J., Bresser, M., Räber, F., Klimkait, T., Battegay, M., Glass, T. R., & Labhardt, N. D. (2021). Offering ART refill through community health workers versus clinic-based follow-up after home-based same-day ART initiation in rural Lesotho: the VIBRA cluster-randomized clinical trial. PLoS Medicine, 18(10), e1003839. https://doi.org/10.1371/journal.pmed.1003839

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Amstutz, A., Matsela, L., Lejone, T. I., Kopo, M., Glass, T. R., & Labhardt, N. D. (2021). Reaching absent and refusing individuals during home-based HIV testing through self-testing-at what cost? Front Med, 8, 653677. https://doi.org/10.3389/fmed.2021.653677

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Brown, J. A., Amstutz, A., Nsakala, B. L., Seeburg, U., Vanobberghen, F., Muhairwe, J., Klimkait, T., Daniel Labhardt, N., & Daniel Labhardt, N. (2021). Extensive drug resistance during low-level HIV viraemia while taking NNRTI-based ART supports lowering the viral load threshold for regimen switch in resource-limited settings: a pre-planned analysis from the SESOTHO trial. The Journal of Antimicrobial Chemotherapy, 76(5), 1294–1298. https://doi.org/10.1093/jac/dkab025

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Amstutz, Alain, Kopo, Mathebe, Lejone, Thabo I., Khesa, Lefu, Kao, Mpho, Muhairwe, Josephine, Glass, Tracy R., & Labhardt, Niklaus D. (2020). “If it is left, it becomes easy for me to get tested”: use of oral self-tests and community health workers to maximize the potential of home-based HIV testing among adolescents in Lesoth. Journal of the International AIDS Society, 23(Suppl 5), e25563. https://doi.org/10.1002/jia2.25563

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Amstutz, Alain, Lejone, Thabo Ishmael, Khesa, Lefu, Muhairwe, Josephine, Bresser, Moniek, Vanobberghen, Fiona, Kopo, Mathebe, Kao, Mpho, Nsakala, Bienvenu Lengo, Tlali, Katleho, Klimkait, Thomas, Battegay, Manuel, Labhardt, Niklaus Daniel, & Glass, Tracy Renée. (2020). Home-based oral self-testing for absent and declining individuals during a door-to-door HIV testing campaign in rural Lesotho (HOSENG): a cluster-randomised trial. The Lancet. HIV, 7(11), e752–e761. https://doi.org/10.1016/s2352-3018(20)30233-2

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Amstutz, Alain, Nsakala, Bienvenu Lengo, Vanobberghen, Fiona, Muhairwe, Josephine, Glass, Tracy Renée, Namane, Tilo, Mpholo, Tlali, Battegay, Manuel, Klimkait, Thomas, & Labhardt, Niklaus Daniel. (2020). Switch to second-line versus continued first-line antiretroviral therapy for patients with low-level HIV-1 viremia: an open-label randomized controlled trial in Lesotho. PLoS medicine, 17(9), e1003325. https://doi.org/10.1371/journal.pmed.1003325

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Amstutz, Alain, Brown, Jennifer Anne, Ringera, Isaac, Muhairwe, Josephine, Lejone, Thabo Ishmael, Klimkait, Thomas, Glass, Tracy Renée, & Labhardt, Niklaus Daniel. (2019). Engagement in care, viral suppression, drug resistance and reasons for non-engagement after home-based same-day ART initiation in Lesotho: a two-year follow-up of the CASCADE trial. Clinical Infectious Diseases : An Official Publication of the Infectious Diseases Society of America, 71(10), 2608–2614. https://doi.org/10.1093/cid/ciz1126

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Labhardt, N. D., Ringera, I., Lejone, T. I., Klimkait, T., Muhairwe, J., Amstutz, A., & Glass, T. R. (2018). Effect of offering same-day ART vs usual health facility referral during home-based HIV testing on linkage to care and viral suppression among adults with HIV in Lesotho : the CASCADE randomized clinical trial. JAMA : The Journal of the American Medical Association, 319(11), 1103–1112. https://doi.org/10.1001/jama.2018.1818

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Amstutz A, Schandelmaier S, Frei R, Surina J, Agarwal A, Olu KK, Alturki R, Von Niederhäusern B, Von Elm E, & Briel M. (2017). Discontinuation and non-publication of randomised clinical trials supported by the main public funding body in Switzerland: a retrospective cohort study. BMJ open, 7(7), e016216. https://doi.org/10.1136/bmjopen-2017-016216

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Kasenda, Benjamin, von Elm, Erik, You, John, Blümle, Anette, Tomonaga, Yuki, Saccilotto, Ramon, Amstutz, Alain, Bengough, Theresa, Meerpohl, Joerg J., Stegert, Mihaela, Tikkinen, Kari A. O., Neumann, Ignacio, Carrasco-Labra, Alonso, Faulhaber, Markus, Mulla, Sohail M., Mertz, Dominik, Akl, Elie A., Bassler, Dirk, Busse, Jason W., et al. (2014). Prevalence, characteristics, and publication of discontinued randomized trials. Journal of the American Medical Association, 311(10), 1045–1051. https://doi.org/10.1001/jama.2014.1361

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