Alain Amstutz is an MD PhD focusing on innovative trial designs, trial evidence synthesis methods, and target trial emulations. He is currently a senior research associate in Bristol UK (Electronic Health Records Group, University of Bristol), Oslo Norway (Oslo Centre for Biostatistics and Epidemiology, OCBE) and Basel Switzerland (Division of Clinical Epidemiology).
During his MD-PhD in Lesotho (2017–2021), he led four randomized trials addressing key HIV service delivery questions: The HOSENG trial demonstrated that secondary HIV self-test distribution, managed by trained lay community health workers (CHWs), substantially increased household testing coverage and was cost-effectiveness, directly influencing WHO guidelines and CDC’s best-evidence toolbox. The VIBRA trial showed that community-based ART refills by CHWs were comparable to clinic refills. The SESOTHO trial provided evidence for lowering the viral load threshold for treatment failure, informing both national and WHO guidelines. The PEBRA trial, co-created with youth living HIV, tested a peer educator mHealth model, achieving high engagement and catalyzing a South–South collaboration with Zambia.
As a postdoc, he continued and broadened his research into several streams:
(1) establishing a large population-based cohort study in Lesotho to investigate chronic diseases (esp. diabetes, hypertension) and studying CHW-based models of care – similar to HOSENG and VIBRA – in embedded trials (ComBaCaL, co-Principal Investigator);
(2) investigating a pragmatic smoking cessation intervention, embedded in the Swiss HIV Cohort Study (RETUNE trial, co-Principal Investigator);
(3) advancing the Trials-within-Cohorts (TwiCs) design and implementing it in Lesotho (ComBaCaL) and Switzerland (RETUNE);
(4) leading global Individual Participant Data Meta-Analyses (IPDMAs) on remdesivir and JAK inhibitors for COVID-19 (>20 trial teams), informing NICE guidelines;
(5) pioneering citizen science approaches while exploring hair salons as an alternative space to promote HIV and sexual health prevention in Lesotho;
(6) strengthening patient and public involvement in HIV research; and
(7) applying causal inference and the target trial emulation framework to large electronic health records through the OpenSAFELY platform, evaluating COVID-19 therapeutics.
He is part of the methods/stats team of EU-RESPONSE (European platform trial for COVID-19 therapeutics), PROACT (European adaptive platform trial for antivirals for respiratory tract infections), and MPX-RESPONSE (European Mpox MOSAIC cohort and platform trial for Mpox therapeutics), supporting the design and analysis of these adaptive platform trials, and lead methodological work around prospective meta-analyses and complementing the trials with target trial emulations.
He is a member of the Innovation Hub at the Swiss HIV Cohort Study and part of the global TwiCs network.
Up to today, he has acquired substantial research funding as (Co-)Principal Investigator (>7 million USD) and published >100 publications (>35 as first or last author) in peer-reviewed, high-impact journals (Lancet Resp Med, Lancet HIV, PLOS Med, CID, JIAS, PLOS GPH/Med, among others). He serves as Associate Editor at the BMC Trials. He fluently speaks German, English, French and Italian and is constantly working on his Sesotho. A recent portrait.
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, 13(6), 530–544. 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 Characterization and Outcomes of Human Clade IIb Mpox Virus Disease: A European Multicenter Mpox Observational Cohort Study (MOSAIC) [Journal-article]. Clinical Infectious Diseases, 80(5), 1060–1073. https://doi.org/10.1093/cid/ciae657
Jackson-Perry, David, & . (2025). Should we be paying more attention to HIV and adult ADHD? Lancet HIV. https://doi.org/10.1016/S2352-3018(25)00235-8
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
, 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 Medicine, 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, 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), 51–1045. 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.