The purpose of this trial is to test the effectiveness of offering a menu of different tobacco smoking substitutional products (e-cigarettes, nicotine pouches, nicotine patches in addition to usual of care) for smokers in the SHCS (Swiss HIV Cohort Study) in achieving self-reported 7-day tobacco cigarette abstinence at 6 months.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
972
Offer of preference-based smoking substitution menu, consisting of e-cigarettes or nicotine pouches or nicotine patches in addition to standard of care. This menu will be offered by the treating physician during the routine cohort visit and the participant can choose one product to test as an alternative to tobacco smoking. The products will be handed out directly after the consultation and are provided free of charge for 6 months.
Cantonal Hospital St. Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland
RECRUITINGUniversity Hospital Lausanne
Lausanne, Canton of Vaud, Switzerland
RECRUITINGCantonal Hospital Aarau
Aarau, Switzerland
Tobacco smoking status (yes/no)
Measured as self-reported abstinence in the last 7 day at 6-month visit
Time frame: at 6 month visit
Tobacco smoking status (yes/no)
Measured as self-reported abstinence in the last 7 day at 12-month visit and at 24-month visit
Time frame: at 12 month visit, 24-month visit
Mean change in number of tobacco-based cigarettes smoked per day
Number will be self reported by participant
Time frame: at 6 month visit, at 12 month visit, at 24 month visit
Mean Change in Cholesterol (mmol/l)
High Density Lipoprotein (HDL) and Low Density Lipoprotein (LDL) Cholesterol in blood samples will be measured
Time frame: at 6 month visit, at 12 month visit, at 24 month visit
Mean change in blood pressure (mmHg)
systolic and diastolic blood pressure will be measured.
Time frame: at 6 month visit, at 12 month visit, at 24 month visit
Mean change in body weight (kg)
Mean change in body weight from baseline to 6,12 and 24 months.
Time frame: at 6 month visit, at 12 month visit, at 24 month visit
Mean change in SCORE2-risk prediction algorithm
SCORE2: Algorithm to Predict Cardiovascular Disease Risk in Europe Linear regression model adjusted for the variables used in the minimization (region \[French vs. German speaking part of Switzerland\], men having sex with men \[yes/no\], current drug user \[yes/no\], number of cigarettes per day) and will be reported as an adjusted odds ratio with 95% confidence interval.
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University Hospital Basel
Basel, Switzerland
RECRUITINGInselspital Bern
Bern, Switzerland
RECRUITINGUniversity Hospital Geneva
Geneva, Switzerland
RECRUITINGUniversity Hospital Zurich
Zurich, Switzerland
RECRUITINGTime frame: at 6 month visit, at 12 month visit, at 24 month visit
Number of cardiovascular events
Occurrence of cardiovascular events (myocardial infarction, coronary angioplasty/stenting, coronary artery by-pass grafting, carotid endarterectomy, stroke, deep vein thrombosis, pulmonary embolism, heart transplantation) and all-cause death
Time frame: at 6 month visit, at 12 month visit, at 24 month visit
Serious Adverse events
This endpoint will be presented descriptively.
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