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, especially 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 for COVID-19 therapeutics) and MPX-RESPONSE (pan-European platform trial for Mpox therapeutics including an Mpox cohort study), 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 Patient and Public Involvement. Up to today, he has acquired substantial research funding as (Co-)Principal Investigator (>7 Million USD) and published >25 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

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

URLs

Hampanda, K., Bolt, M., Nayame, L., Hamoonga, T., Sehrt, M., Thorne, J., Harrison, M., Pintye, J., Amstutz, A., 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

URLs

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, & Amstutz, Alain. (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

URLs

Amstutz, Alain, 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, Andri, Günthard, H.F., Koller, Michael, 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-article]. Journal of Infectious Diseases, 230, e847–e859. https://doi.org/10.1093/infdis/jiae291

URLs

Amstutz, Alain, 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

URLs

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, & Amstutz, Alain. (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

URLs

Jackson-Perry, David, Cart-Richter, Ellen, Haerry, David, Ahmeti, Lindrit, Bieri, Annatina, Calmy, Alexandra, Ballif, Marie, Pasin, Chloé, Notter, Julia, & Amstutz, Alain. (2024). Patient and public involvement in HIV research: a mapping review and development of an online evidence map. Journal of the International AIDS Society, 27. https://doi.org/10.1002/jia2.26385

URLs

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, Amstutz, Alain, 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

URLs

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

URLs

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

URLs

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

URLs

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

URLs

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

URLs

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

URLs

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

URLs

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

URLs

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

URLs

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

URLs

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

URLs

MD PhD Alain Amstutz

Selected Publications