Reduce Tobacco Use in People Living With HIV in Switzerland

Due to highly effective antiretroviral therapy, people living with HIV (PLWH) in Switzerland have a close-to-normal life expectancy. Among PLWH, there has been a shift of focus from HIV-related health issues to non communicable diseases, especially cardiovascular diseases (CVDs) and cancer. Smoking, a prominent risk factor for both diseases, takes a key role in view of the high number of smokers among PLWH.

New approaches to smoking cessation focus on harm reduction by substituting tobacco cigarettes by less harmful alternatives. Conventional nicotine replacement therapy like nicotine patches is well established and effective against withdrawal symptoms after quitting. However, these products are exceptionally expensive and the missing "nicotine hit" often limits therapy adherence. The long-term abstinence rate remains low. Electronic cigarettes (e-cigarettes) and nicotine pouches as alternative nicotine replacement therapies have the potential to overcome these problems and are accessible.

E-cigarettes play a growing role in smoking cessation therapy. Evidence from randomized trials shows superiority over conventional nicotine replacement therapies, which is probably based on the better imitation of the smoking experience. Although e-cigarettes are not without concerns, there is consensus that they are significantly less harmful than tobacco cigarettes.

Tobacco-free nicotine pouches, delivering nicotine through oral mucosa, are a relatively novel option for nicotine substitution. Similar to e-cigarettes, nicotine pouches are relatively affordable and can address the limitation of poor imitation of the "nicotine hit" seen with traditional nicotine replacement therapy. To the best of our knowledge, no trials have investigated the potential of nicotine pouches for smoking cessation so far.

With this trial, the investigators also want to address frequent shortcomings of smoking cessation trials, such as restrictive inclusion criteria and highly controlled interventions, by RETUNE Version 1.1, January 06, 2025 10/45 offering a menu of different tobacco smoking substitutional products (e-cigarettes or nicotine pouches or nicotine patches) and by using a novel pragmatic trial design, the Trials within Cohorts (TwiCs) design. The investigators plan to recruit tobacco smokers in the Swiss HIV Cohort Study (SHCS), regardless of their willingness to quit. This so called "opt-out-approach" has been suggested as a new promising approach for smoking cessation trials to increase generalizability of the results. The TwiCs design optimally allows to implement and evaluate the "opt-out" approach embedded in the SHCS.

• Tobacco smoking status (yes/no) [Time frame: at 12 month visit, 24-month visit]
• Mean change in number of tobacco-based cigarettes smoked per day [Time frame: at 6 month visit, at 12 month visit, at 24 month visit]
• Mean Change in Cholesterol (mmol/l) [Time frame: at 6 month visit, at 12 month visit, at 24 month visit]
• Mean change in blood pressure (mmHg) [Time frame: at 6 month visit, at 12 month visit, at 24 month visit]
• Mean change in body weight (kg) [Time frame: at 6 month visit, at 12 month visit, at 24 month visit]
• Mean change in SCORE2-risk prediction algorithm [Time frame: at 6 month visit, at 12 month visit, at 24 month visit]
• Number of cardiovascular events [Time frame: at 6 month visit, at 12 month visit, at 24 month visit]
• Serious Adverse events [Time frame: at 6 month visit, at 12 month visit, at 24 month visit]
• Self reported use of any nicotine containing product other than tobacco cigarettes (yes/no) [Time frame: at 6 month visit, at 12 month visit, at 24 month visit]
• Self reported use of e-cigarettes (yes/no) or nicotine pouches (yes/no) or nicotine patches (yes/no) [Time frame: at 6 month visit, at 12 month visit, at 24 month visit]
• Self reported use of any nicotine containing product (yes/no) [Time frame: at 6 month visit, at 12 month visit, at 24 month visit]