HIVRETUNENCT06789692
Reduce Tobacco Use in People Living With HIV in Switzerland
A study testing tobacco smoking substitution products in people with HIV and Smoking, run by University Hospital, Basel, Switzerland at 7 sites in Switzerland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- tobacco smoking substitution products
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 972 participants
- Where
- 7 sitesSwitzerland
- Study dates
- 20 Feb 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent for the data collection and participation in the SHCS (Cohort consent).
- Signed informed consent to be randomized to future interventions (Randomization consent).
- Age 18 years or older.
- Smoked one or more tobacco cigarettes per day (smoking status = yes) at the time of enrolment.
Who cannot join
- Currently using e-cigarettes or nicotine pouches or nicotine patches.
- Pregnant women.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Christof Schönenberger, Dr. contact
7 sites in 1 country
Switzerland7 sites, 6 recruiting
- Recruiting
Cantonal Hospital Aarau
Aarau, 5001
Christoph Fux, MD, +41 62 838 68 56, christoph.fux@ksa.ch
Christoph Fux, MD
- Completed
University Hospital Basel
Basel, Basel, 4031
- Recruiting
Inselspital Bern
Bern, Canton of Bern, 3010
Gilles Wandeler, Prof., gilles.wandeler@insel.ch
Gilles Wandeler, Prof.
- Recruiting
University Hospital Geneva
Geneva
Alexandra Calmy, Prof.
Alexandra Calmy, Prof.
- Recruiting
University Hospital Lausanne
Lausanne, Canton of Vaud, 1011
Matthias Cavassini, Prof., +41 21 314 1022
Matthias Cavassini, Prof.
- Recruiting
Cantonal Hospital St. Gallen
Sankt Gallen, Canton of St. Gallen, 9007
Patrick Schmid, Dr.
Tamara Dörr, Dr., tamara.doerr@kssg.ch
- Recruiting
University Hospital Zurich
Zurich, Canton of Zurich, 8006
Johannes Nemeth, Dr., +41 44 255 33 22, johannes.nemeth@usz.ch
Johannes Nemeth, Dr.
About this study
Official title: Reduce Tobacco Use in People Living With HIV in Switzerland: A Pragmatic Randomized Trial Within the Swiss HIV Cohort Study
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.
Read the detailed description
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.
- Being tested
- tobacco smoking substitution products
- Keywords
- tobacco smoking, e-cigarettes, tobacco-free nicotine pouches, Trials within Cohorts (TwiCs)
- Medical subject headings
- Smoking, Tobacco Smoking, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tobacco smoking substitution productsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: tobacco smoking substitution products |
| Standard of care group | No intervention | Standard smoking cessation counselling according to routine care in the SHCS. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tobacco smoking status (yes/no)
Measured as self-reported abstinence in the last 7 day at 6-month visit
Measured: at 6 month visit
Secondary outcomes (11)
Tobacco smoking status (yes/no)
Measured as self-reported abstinence in the last 7 day at 12-month visit and at 24-month visit
Measured: 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
Measured: 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
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.
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.
Measured: 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.
Measured: 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
Measured: at 6 month visit, at 12 month visit, at 24 month visit
Serious Adverse events
This endpoint will be presented descriptively.
Measured: 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)
Measured: 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)
Measured: at 6 month visit, at 12 month visit, at 24 month visit
Self reported use of any nicotine containing product (yes/no)
Measured: at 6 month visit, at 12 month visit, at 24 month visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start20 Feb 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Clinical Trial using the Trials within Cohorts (TwiCs) design
- Masking
- None (open label)
- Enrolment
- 972 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation, Novartis Foundation for Medical-Biological Research
- Responsible party
- Sponsor
- Investigators
- Matthias Briel, Prof., Principal investigator, University Hospital, Basel, SwitzerlandAlain Amstutz, Dr., Principal investigator, University Hospital, Basel, SwitzerlandChristof Schönenberger, Dr., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789692
- Sponsor's protocol ID
- 2024-02417; ub25Briel
- Acronym
- RETUNE
- Status last verified
- May 2026
- First submitted
- 17 Jan 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 42205972Schonenberger 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.
PubMed 41952225
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduce Tobacco Use in People Living With HIV in Switzerland: A Pragmatic Randomized Trial Within the Swiss HIV Cohort Study
- ClinicalTrials.gov ID
- NCT06789692
- Acronym / sponsor ID
- RETUNE / 2024-02417; ub25Briel
- Keywords
- tobacco smoking, e-cigarettes, tobacco-free nicotine pouches, Trials within Cohorts (TwiCs)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 972 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation, Novartis Foundation for Medical-Biological Research
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial using the Trials within Cohorts (TwiCs) design
| Arm | Type | Receives |
|---|---|---|
| Smoking substitution menu | Experimental | Other: tobacco smoking substitution productsOffer 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent for the data collection and participation in the SHCS (Cohort consent).
- Signed informed consent to be randomized to future interventions (Randomization consent).
- Age 18 years or older.
- Smoked one or more tobacco cigarettes per day (smoking status = yes) at the time of enrolment.
Key exclusion criteria (2 listed)
- Currently using e-cigarettes or nicotine pouches or nicotine patches.
- Pregnant women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tobacco smoking substitution productsOffer 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. | Other | Smoking substitution menu |
Primary outcome
Tobacco smoking status (yes/no)
Time frame: at 6 month visit
Measured as self-reported abstinence in the last 7 day at 6-month visit
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Derived from this study: PubMed 42205972Schonenberger 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.
- Derived from this study: PubMed 41952225Schonenberger 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christof Schönenberger, Dr. contact
Matthias Briel, Prof. principal investigator
University Hospital, Basel, Switzerland
Alain Amstutz, Dr. principal investigator
University Hospital, Basel, Switzerland
Christof Schönenberger, Dr. principal investigator
University Hospital, Basel, Switzerland
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tobacco smoking substitution products in people with HIV and Smoking, run by University Hospital, Basel, Switzerland at 7 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthias Briel, Prof. (+ 4161 265 3815, matthias.briel@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tobacco smoking status (yes/no) (time frame: at 6 month visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06789692, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.