Alain Amstutz is an MD PhD focusing on innovative 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, especially Lesotho.
He is currently a postdoc and project leader in Bristol, UK (Electronic Health Records Group, University of Bristol), Oslo, Norway (Oslo Centre for Biostatistics and Epidemiology, OCBE, Oslo University Hospital) and Basel, Switzerland (Division of Clinical Epidemiology). 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.
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 (mainly diabetes, hypertension and HIV) and how to decentralise services with the help of lay health workers and e-Health applications. As co-Principal Investigator of RETUNE, he investigates pragmatic smoking cessation interventions in collaboration with the Swiss HIV Cohort Study (SHCS) using the Trials-within-Cohorts (TwiCs) design.
He is part of the methods/stats team of EU-RESPONSE (pan-European platform trial for COVID-19 therapeutics) and MPX-RESPONSE (pan-European platform trial for Mpox therapeutics including an Mpox cohort study), and a member of the Young Researchers' Group of the SHCS and the global TwiCs network.
Moreover, he investigates if and how HIV and other sexual and reproductive health services can be offered at hair salons in Lesotho, is interested in individual participant data meta-analyses, currently conducting one on JAK inhibitors against COVID-19, and Patient and Public Involvement. Up to today, he has acquired substantial research funding as (Co-)Principal Investigator (>7 Million USD) and published >30 first- and last-author publications in peer-reviewed journals (Lancet Resp Med, Lancet HIV, PLOS Med, CID, JIAS, PLOS GPH, among others) and serves as Associate Editor at BMC Trials. He fluently speaks German, English, French and Italian and is constantly working on his Sesotho.
Selected Publications
Amstutz, A., Schandelmaier, S., Ewald, H., Speich, B., Schwenke, J. M., Schönenberger, C. M., Schobinger, S., Agoritsas, T., Tomashek, K. M., Nayak, S., Makowski, M., Morales-Ortega, A., Bernal-Bello, D., Pomponio, G., Ferrarini, A., Ghazaeian, M., Hall, F., Bond, S., García-Morales, M. T., et al. (2025). Effects of Janus kinase inhibitors in adults admitted to hospital due to COVID-19: a systematic review and individual participant data meta-analysis of randomised clinical trials [Journal-article]. The Lancet Respiratory Medicine. https://doi.org/10.1016/s2213-2600(25)00055-4
Pesonel, E., Laouénan, C., Guiraud, L., Bourner, J., Hoffmann, I., Molino, D., Tardivon, C., Bachelet, D., Mentré, F., Amstutz, A., Merson, L., Rojek, A., Cervantes Gonzalez, M., Antinori, A., Castagna, A., Nozza, S., Pourcher, V., Libois, A., Dunning, J., et al. (2025). Clinical characterisation and outcomes of human clade IIb mpox virus disease - a European multicentre observational cohort study (MOSAIC) [Journal-article]. Clinical Infectious Diseases. https://doi.org/10.1093/cid/ciae657
Hampanda, K., Bolt, M., Nayame, L., Hamoonga, T., Sehrt, M., Thorne, J., Harrison, M., Pintye, J., ., Abuogi, L., & Mweemba, O. (2024). HIV Risk and Intention to use PrEP among Sexually Active Female University Students in Zambia: A Cross-Sectional Survey to Understand Influential Factors [Posted-content]. Cold Spring Harbor Laboratory. https://doi.org/10.1101/2024.12.12.24318948
Firima, Emmanuel, Ntsoaki, Rameno, Lukau, Blaise, Tlahali, Mosa, Gonzalez Fernandez, Lucia, Manthabiseng, Molulela, Sematle, Mamoronts’ane P, Bane, Matumaole, Khomolishoele, Makhebe, Ikhetheleng, Leisa, Retselisitsoe, Lefokosane, Gupta, Ravi, McCrosky, Stephen, Lee, Tristan, Chammartin, Frederique, Weisser, Maja, Labhardt, Niklaus D, & . (2024). Prevalence of hepatitis B virus infection and treatment eligibility in Lesotho, Southern Africa: a population-based cross-sectional study with case-based follow-up [Journal-article]. BMJ Public Health, 2(2), e001195. https://doi.org/10.1136/bmjph-2024-001195
Jackson-Perry, David, Cart-Richter, Ellen, Haerry, David, Ahmeti, Lindrit, Bieri, Annatina, Calmy, Alexandra, Ballif, Marie, Pasin, Chloé, Notter, Julia, & . (2024). Patient and public involvement in HIV research: a mapping review and development of an online evidence map [Short Report]. Journal of the International AIDS Society, 27(11). https://doi.org/10.1002/jia2.26385
, Chammartin, Frédérique, Audigé, Annette, Eichenberger, Anna L., Braun, Dominique L., Amico, Patrizia, Stoeckle, Marcel P., Hasse, B., Papadimitriou-Olivgeris, Matthaios, Manuel, Oriol, Bongard, Cédric, Schuurmans, Macé, Hage, René, Damm, Dominik, Tamm, Michael, Mueller, Nicolas J., Rauch, A., Günthard, H.F., Koller, Michael T., et al. (2024). Antibody and T-Cell Response to Bivalent Booster SARS-CoV-2 Vaccines in People With Compromised Immune Function: COVERALL-3 Study. Journal of Infectious Diseases, 230(4), e847–e859. https://doi.org/10.1093/infdis/jiae291
, Schönenberger, Christof M., Speich, Benjamin, Griessbach, Alexandra, Schwenke, Johannes M., Glasstetter, Jan, James, Sophie, Verkooijen, Helena M., Nickolls, Beverley, Relton, Clare, Hemkens, Lars G., Chammartin, Frédérique, Gerber, Felix, Labhardt, Niklaus D., Schandelmaier, Stefan, & Briel, Matthias. (2024). Characteristics, consent patterns, and challenges of randomized trials using the Trials within Cohorts (TwiCs) design - A scoping review. Journal of Clinical Epidemiology, 174. https://doi.org/10.1016/j.jclinepi.2024.111469
Fernández, Lucia González, Firima, Emmanuel, Gupta, Ravi, Sematle, Mamoronts’ane Pauline, Khomolishoele, Makhebe, Molulela, Manthabiseng, Bane, Matumaole, Tlahali, Mosa, McCrosky, Stephen, Lee, Tristan, Chammartin, Frédérique, Seelig, Eleonora, Gerber, Felix, Lejone, Thabo Ishmael, Ayakaka, Irene, Labhardt, Niklaus Daniel, & . (2024). Awareness, treatment, and control among adults living with arterial hypertension or diabetes mellitus in two rural districts in Lesotho. PLOS Global Public Health, 4(9). https://doi.org/10.1371/journal.pgph.0003721
Manyara, Anthony Muchai, Davies, Philippa, Stewart, Derek, Weir, Christopher J, Young, Amber E, Blazeby, Jane, Butcher, Nancy J, Bujkiewicz, Sylwia, Chan, An-Wen, Dawoud, Dalia, Offringa, Martin, Ouwens, Mario, Hróbjartssson, Asbjørn, , Bertolaccini, Luca, Bruno, Vito Domenico, Devane, Declan, Faria, Christina D C M, Gilbert, Peter B, et al. (2024). Reporting of surrogate endpoints in randomised controlled trial protocols (SPIRIT-Surrogate): extension checklist with explanation and elaboration. Bmj, 386, 19. https://doi.org/10.1136/bmj-2023-078525
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, , , & 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(4), 857–869. https://doi.org/10.1007/s44197-023-00158-5
, 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
Kopo, M., Lejone, T. I., Tschumi, N., Glass, T. R., Kao, M., Brown, J. A., Seiler, O., Muhairwe, J., Moletsane, N., Labhardt, N. D., & (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
, 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
, 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
, 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
, 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
, 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
Labhardt, N. D., Ringera, I., Lejone, T. I., Klimkait, T., Muhairwe, J., , & 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
, 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
Kasenda, Benjamin, von Elm, Erik, You, John, Blümle, Anette, Tomonaga, Yuki, Saccilotto, Ramon, , 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
Selected Projects & Collaborations
EU-RESPONSE
Research Networks (Institutional Membership) | 3 Project Members
EU-RESPONSE is a 5-year project that includes two European Adaptive Platform Trials: DisCoVeRy and EU-SolidAct. The EU-RESPONSE consortium is composed of 22 partners, bringing together multidisciplinary partners from across the continent.
The group at the Division of Clinical Epidemiology is part of the methods and statistical group and co-leads specific meta-research projects such as several individual participant data meta-analyses (IPDMAs).
So war, we have conducted two large-scale IPDMAs to summarise all available randomised evidence on a) remdesivir and b) JAK inhibitors among hospitalised COVID-19 patients. Both IPDMAs contained more than >10'000 randomized patient data from more than 10 trial teams. The remdesivir IPDMA was published in The Lancet Respiratory Medicine, directly influenced the NICE guidelines in the UK, received high media attention, was cited in two editorials, and presented at the prestigious CROI conference 2023. The JAK inhibitor IPDMA (https://www.jakinhibitoripdma.org/) is currently under review at The Lancet Resp Med and in discussion at the WHO COVID-19 guidelines team for the upcoming update of their treatment guidelines.
