Dr. med., Dr sc. med. Alain Amstutz

Tobacco smoking represents a leading health burden in the aging population of people living with HIV in Switzerland. New tools for smoking cessation like electronic cigarettes or nicotine pouches are promising to reduce the harm caused by tobacco smoking. However, high quality evidence of their effectiveness among people living with HIV and outside of explanatory randomized trials is missing. 

RETUNE is a highly pragmatic randomized trial, fully embedded in the Swiss HIV Cohort Study (SHCS), using the “Trials within Cohorts” (TwiCs) design. 

In the TwiCs design, participants are recruited within a prospective cohort study and can consent not only to regular data collection at cohort visits, but also to be randomized in future low-risk pragmatic trials (“randomization consent”). Participants are informed that only participants randomized to the intervention arm are approached and may then accept or decline the offered intervention. Participants in the intervention who accept the intervention, are asked to sign an “intervention consent”, that only covers additional data collection in this group and the safety/side-effects of the intervention – similar to a routine clinical consent (e.g. consent for a lumbar puncture in clinical care). 

RETUNE aims to assess the effectiveness of the offer of a menu including different tobacco cigarettes substitutional products (e-cigarettes, nicotine pouches, nicotine patches) to quit smoking. People with HIV in the SHCS who smoke tobacco cigarettes and who signed the randomization consent will be randomized in a 1:1 ratio to the offer of the menu or to usual care. People are included regardless of their willingness to quit smoking. The primary endpoint is tobacco abstinence after 6 months. RETUNE is a multicenter trial which will include centers in Basel, Bern, Geneva, Lausanne, St. Gallen, and Zurich. 

RETUNE is funded by the Tobacco Prevention Fund, the Novartis foundation for medical-biological research, and the Swiss National Science Foundation.

Involved partner:

Community Based Chronic Care Lesotho (ComBaCaL) is a collaborative program between Lesotho and Switzerland dedicated to developing, testing, and sharing innovative solutions to enhance chronic disease care in remote settings in low- and middle-income countries.

At the core of ComBaCaL is the concept of Community Health Workers (CHWs) supported by a digital clinical decision support system, enabling them to provide treatment for selected conditions in remote areas with limited access to clinics.

In phase 1, we empowered CHWs to independently prescribe and manage treatment of uncomplicated hypertension and type 2 diabetes. This approach was effective in large cluster-randomised trials.

In the current phase 2, the focus has expanded to integrated care packages addressing a wider range of conditions, including HIV, sexual and reproductive health, and health services for children under five. The aim of this phase is to prepare ComBaCaL for scale.

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).