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RETUNE

Research Project | 7 Project Members

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:
Swiss HIV Cohort Study

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Trials within Cohorts (TwiCs)

Research Project | 5 Project Members

Innovative Trial Design: Overcoming some of the problems common to traditional Randomized Clinical Trials

Trials within Cohorts (TwiCs) are a randomized trial design in which a trial is set up and conducted within an existing or newly started cohort. In a cohort that uses the TwiCs approach a group of participants with a particular condition of interest may agree to regular data collection and observation – and to random assignment into a future intervention. Once an intervention is trialed, only the cohort participants who have been assigned to the intervention group will be informed of their role as the trial group and an additional consent will be obtained. The control group receives the standard treatment according to the cohort procedures. Because of the multi-staged consent process, which differs from classic randomized controlled trials, TwiCs may better mimic clinical practice and improve recruitment of study participants. However, TwiCs-specific ethical, statistical and methodological challenges need to be addressed.

Since Juli 2024 we are implementing the TwiCs in the main centers of the Swiss HIV Cohort Study (SHCS). The SHCS, established in 1988 is a multicenter, prospective, nationwide, observational cohort study with around 10’000 active participants.

In parallel, we have implemented the TwiCs design in the ComBaCaL cohort, a large-scale general population-based cohort in two districts of Lesotho, in Southern Africa. Using the design, we evaluate several community-led decentralised models of care for hypertension, diabetes and HIV.