Reduce Tobacco Use in People Living With HIV in Switzerland
RETUNE
1 other identifier
interventional
972
1 country
7
Brief 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 at 6 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv
Started Feb 2025
Typical duration for not_applicable hiv
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2025
CompletedFirst Posted
Study publicly available on registry
January 23, 2025
CompletedStudy Start
First participant enrolled
February 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
June 2, 2026
May 1, 2026
2.8 years
January 17, 2025
May 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tobacco smoking status (yes/no)
Measured as self-reported abstinence in the last 7 day at 6-month visit
at 6 month visit
Secondary Outcomes (11)
Tobacco smoking status (yes/no)
at 12 month visit, 24-month visit
Mean change in number of tobacco-based cigarettes smoked per day
at 6 month visit, at 12 month visit, at 24 month visit
Mean Change in Cholesterol (mmol/l)
at 6 month visit, at 12 month visit, at 24 month visit
Mean change in blood pressure (mmHg)
at 6 month visit, at 12 month visit, at 24 month visit
Mean change in body weight (kg)
at 6 month visit, at 12 month visit, at 24 month visit
- +6 more secondary outcomes
Study Arms (2)
Smoking substitution menu
EXPERIMENTALOffer 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 INTERVENTIONStandard smoking cessation counselling according to routine care in the SHCS.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Currently using e-cigarettes or nicotine pouches or nicotine patches.
- Pregnant women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
University Hospital Basel
Basel, Basel, 4031, Switzerland
Inselspital Bern
Bern, Canton of Bern, 3010, Switzerland
Cantonal Hospital St. Gallen
Sankt Gallen, Canton of St. Gallen, 9007, Switzerland
University Hospital Lausanne
Lausanne, Canton of Vaud, 1011, Switzerland
University Hospital Zurich
Zurich, Canton of Zurich, 8006, Switzerland
Cantonal Hospital Aarau
Aarau, 5001, Switzerland
University Hospital Geneva
Geneva, Switzerland
Related Publications (2)
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.
PMID: 42205972DERIVEDSchonenberger 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. doi: 10.1186/s13063-026-09622-6. Online ahead of print.
PMID: 41952225DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2025
First Posted
January 23, 2025
Study Start
February 20, 2025
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
June 2, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP