Reduce Tobacco Use in People Living With HIV in Switzerland (RETUNE)

November 17, 2025 updated by: University Hospital, Basel, Switzerland

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

972

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
      • Aarau, Switzerland, 5001
        • Recruiting
        • Cantonal Hospital Aarau
        • Contact:
        • Principal Investigator:
          • Christoph Fux, MD
      • Basel, Switzerland, 4031
        • Recruiting
        • University Hospital Basel
        • Contact:
        • Principal Investigator:
          • Marcel Stoeckle, Dr.
      • Bern, Switzerland, 3010
        • Recruiting
        • Inselspital Bern
        • Contact:
        • Principal Investigator:
          • Gilles Wandeler, Prof.
      • Geneva, Switzerland
        • Recruiting
        • University Hospital Geneva
        • Principal Investigator:
          • Alexandra Calmy, Prof.
        • Contact:
          • Alexandra Calmy, Prof.
      • Zurich, Switzerland, 8006
        • Recruiting
        • University Hospital Zurich
        • Contact:
        • Principal Investigator:
          • Johannes Nemeth, Dr.
    • Canton of St. Gallen
      • Sankt Gallen, Canton of St. Gallen, Switzerland, 9007
        • Recruiting
        • Cantonal Hospital St. Gallen
        • Contact:
          • Patrick Schmid, Dr.
        • Contact:
        • Principal Investigator:
          • Patrick Schmid, Dr.
    • Canton of Vaud
      • Lausanne, Canton of Vaud, Switzerland, 1011
        • Recruiting
        • University Hospital Lausanne
        • Principal Investigator:
          • Matthias Cavassini, Prof.
        • Contact:
          • Matthias Cavassini, Prof.
          • Phone Number: +41 21 314 1022

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Currently using e-cigarettes or nicotine pouches or nicotine patches.
  • Pregnant women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Smoking substitution menu
Offer of preference-based smoking substitution menu, consisting of e-cigarettes or nicotine pouches or nicotine patches in addition to standard of care.
Other: tobacco smoking substitution products
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.
No Intervention: Standard of care group
Standard smoking cessation counselling according to routine care in the SHCS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at 6 month visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tobacco smoking status (yes/no)
Time Frame: at 12 month visit, 24-month visit
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
Time Frame: at 6 month visit, at 12 month visit, at 24 month visit
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)
Time Frame: at 6 month visit, at 12 month visit, at 24 month visit
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)
Time Frame: at 6 month visit, at 12 month visit, at 24 month visit
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)
Time Frame: at 6 month visit, at 12 month visit, at 24 month visit
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
Time Frame: at 6 month visit, at 12 month visit, at 24 month visit
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
Time Frame: at 6 month visit, at 12 month visit, at 24 month visit
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
Time Frame: at 6 month visit, at 12 month visit, at 24 month visit
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)
Time Frame: at 6 month visit, at 12 month visit, at 24 month visit
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
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
at 6 month visit, at 12 month visit, at 24 month visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Collaborators

Swiss National Science Foundation
Novartis Foundation for Medical-Biological Research

Investigators

  • Principal Investigator: Matthias Briel, Prof., University Hospital, Basel, Switzerland
  • Principal Investigator: Alain Amstutz, Dr., University Hospital, Basel, Switzerland
  • Principal Investigator: Christof Schönenberger, Dr., University Hospital, Basel, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

January 17, 2025

First Submitted That Met QC Criteria

January 17, 2025

First Posted (Actual)

January 23, 2025

Study Record Updates

Last Update Posted (Actual)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-02417; ub25Briel

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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