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| Name | Class |
|---|---|
| Swiss National Science Foundation | OTHER |
| Novartis Foundation for Medical-Biological Research | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smoking substitution menu | Experimental | Offer of preference-based smoking substitution menu, consisting of e-cigarettes or nicotine pouches or nicotine patches in addition to standard of care. |
|
| Standard of care group | No Intervention | Standard smoking cessation counselling according to routine care in the SHCS. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tobacco smoking substitution products | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Tobacco smoking status (yes/no) | Measured as self-reported abstinence in the last 7 day at 6-month visit | at 6 month visit |
| Measure | Description | Time Frame |
|---|---|---|
| Tobacco smoking status (yes/no) | Measured as self-reported abstinence in the last 7 day at 12-month visit and at 24-month visit | at 12 month visit, 24-month visit |
| Mean change in number of tobacco-based cigarettes smoked per day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthias Briel, Prof. | Contact | + 4161 265 3815 | matthias.briel@usb.ch | |
| Christof Schönenberger, Dr. | Contact | ChristofManuel.Schoenenberger@usb.ch |
| Name | Affiliation | Role |
|---|---|---|
| Matthias Briel, Prof. | University Hospital, Basel, Switzerland | Principal Investigator |
| Alain Amstutz, Dr. | University Hospital, Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel | Completed | Basel | Basel | 4031 | Switzerland | |
| Inselspital Bern |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42205972 | Derived | Schonenberger CM, Ochoa SC, Speich B, Haerry DH, Cart-Richter E, Jackson-Perry D, Hutter A, Panettieri L, Aggeler S, Chaudron SE, Calmy A, Cavassini M, Abela IA, Kusejko K, Gunthard HF, Nemeth J, Rauch A, Wandeler G, Schmid P, Dorr T, Surial B, Berthet A, Auer R, Stoeckle MP, Labhardt N, Chammartin F, Briel M, Amstutz A. Acceptance and preferences for different nicotine substitute products to reduce tobacco smoking in people living with HIV: Results from an internal pilot study of a randomized trial. Tob Induc Dis. 2026 May 26;24. doi: 10.18332/tid/218987. eCollection 2026. | |
| 41952225 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 8, 2025 | Sep 26, 2025 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 27, 2026 | May 28, 2026 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D000073869 | Tobacco Smoking |
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D064424 | Tobacco Use |
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Randomized Clinical Trial using the Trials within Cohorts (TwiCs) design
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|
Number will be self reported by participant
| 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 | 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. | 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. | 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. | 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 | at 6 month visit, at 12 month visit, at 24 month visit |
| Serious Adverse events | This endpoint will be presented descriptively. | 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) | 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) | at 6 month visit, at 12 month visit, at 24 month visit |
| Self reported use of any nicotine containing product (yes/no) | at 6 month visit, at 12 month visit, at 24 month visit |
| Christof Schönenberger, Dr. |
| University Hospital, Basel, Switzerland |
| Principal Investigator |
| Recruiting |
| Bern |
| Canton of Bern |
| 3010 |
| Switzerland |
|
| Cantonal Hospital St. Gallen | Recruiting | Sankt Gallen | Canton of St. Gallen | 9007 | Switzerland |
|
| University Hospital Lausanne | Recruiting | Lausanne | Canton of Vaud | 1011 | Switzerland |
|
| University Hospital Zurich | Recruiting | Zurich | Canton of Zurich | 8006 | Switzerland |
|
| Cantonal Hospital Aarau | Recruiting | Aarau | 5001 | Switzerland |
|
| University Hospital Geneva | Recruiting | Geneva | Switzerland |
|
| Derived |
| Schonenberger CM, Speich B, Zehnder ER, Haerry DH, Cart-Richter E, Jackson-Perry D, Hutter A, Aggeler S, Steinmann J, Chaudron SE, Calmy A, Cavassini M, Braun D, Fux CA, Abela I, Kusejko K, Gunthard HF, Nemeth J, Rauch A, Wandeler G, Schmid P, Dorr T, Notter J, Weisser Rohacek M, Surial B, Berthet A, Auer R, Stoeckle MP, Labhardt N, Chammartin F, Briel M, Amstutz A; Swiss HIV Cohort Study. Offer of a menu of different nicotine substitute products to REduce Tobacco Use iN pEople living with HIV (RETUNE): a protocol for a pragmatic randomized trial within the Swiss HIV Cohort Study. Trials. 2026 Apr 8;27(1):372. doi: 10.1186/s13063-026-09622-6. |