Offer of various nicotine replacement products (e-cigarettes, nicotine pouches, and nicotine patches) for smoking cessation in people living with HIV - The RETUNE study
Zusammenfassung der Studie
RETUNE is a study involving smokers in the Swiss HIV Cohort Study. Smokers are randomly assigned to one of two groups: the intervention group or the control group. Smokers in the control group continue to receive usual care in the cohort with regular visits. Smokers in the intervention group are offered various nicotine replacement products, from which they can choose one or decline the offer. During the routine cohort visits every 6 months, all participants are asked as usual whether they smoke tobacco or not. No additional samples are taken, and no additional consultations are required.
(BASEC)
Untersuchte Intervention
The RETUNE study investigates an intervention aimed at helping smokers quit smoking. The intervention consists of offering various nicotine replacement products such as nicotine patches, electronic cigarettes, and nicotine pouches in addition to the usual smoking cessation counseling, and is compared in the study to the usual smoking cessation counseling alone (control group).
(BASEC)
Untersuchte Krankheit(en)
People living with HIV in Switzerland are aging and increasingly suffering from lifestyle-related diseases such as cancer or cardiovascular diseases. For this reason, health promotion plays a key role in this population. Tobacco smoking, a significant risk factor for mortality and chronic diseases, significantly contributes to this health issue with a smoking rate of 34% among people with HIV in the Swiss HIV Cohort Study.
(BASEC)
Included are people with HIV who are being followed in the Swiss HIV Cohort Study, who have consented to random assignment to groups as part of a study, and who smoke one or more tobacco cigarettes per day. (BASEC)
Ausschlusskriterien
Excluded are participants in the Swiss HIV Cohort Study who are pregnant or who consume other nicotine products such as electronic cigarettes or nicotine pouches in addition to tobacco cigarettes. (BASEC)
Studienstandort
Basel, St Gallen, Zürich
(BASEC)
Sponsor
University Hospital Basel
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Christof Manuel Schönenberger
+41612653825
christofmanuel.schoenenberger@clutterusb.chDivision of Clinical Epidemiology, University Hospital Basel
(BASEC)
Allgemeine Auskünfte
University Hospital, Basel, Switzerland,University Hospital, Basel, Switzerland,University Hospital, Basel, Switzerland,
+ 4161 265 3815
christofmanuel.schoenenberger@clutterusb.ch(ICTRP)
Allgemeine Auskünfte
University Hospital, Basel, SwitzerlandUniversity Hospital, Basel, SwitzerlandUniversity Hospital, Basel, Switzerland
+ 4161 265 3815
christofmanuel.schoenenberger@clutterusb.ch(ICTRP)
Wissenschaftliche Auskünfte
University Hospital, Basel, Switzerland,University Hospital, Basel, Switzerland,University Hospital, Basel, Switzerland,
+ 4161 265 3815
christofmanuel.schoenenberger@clutterusb.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
08.01.2025
(BASEC)
ICTRP Studien-ID
NCT06789692 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Reduce tobacco use in people living with HIV in Switzerland: A pragmatic randomized trial within the Swiss HIV Cohort Study (RETUNE) (BASEC)
Wissenschaftlicher Titel
Reduce Tobacco Use in People Living With HIV in Switzerland: A Pragmatic Randomized Trial Within the Swiss HIV Cohort Study (ICTRP)
Öffentlicher Titel
Reduce Tobacco Use in People Living With HIV in Switzerland (ICTRP)
Untersuchte Krankheit(en)
HIVSmoking (ICTRP)
Untersuchte Intervention
Other: tobacco smoking substitution products (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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. (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Tobacco smoking status (yes/no) (ICTRP)
Tobacco smoking status (yes/no);Mean change in number of tobacco-based cigarettes smoked per day;Mean Change in Cholesterol (mmol/l);Mean change in blood pressure (mmHg);Mean change in body weight (kg);Mean change in SCORE2-risk prediction algorithm;Number of cardiovascular events;Serious Adverse events;Self reported use of any nicotine containing product other than tobacco cigarettes (yes/no);Self reported use of e-cigarettes (yes/no) or nicotine pouches (yes/no) or nicotine patches (yes/no);Self reported use of any nicotine containing product (yes/no) (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
Swiss National Science Foundation;Novartis Foundation for Medical-Biological Research (ICTRP)
Weitere Kontakte
Matthias Briel, Prof.;Alain Amstutz, Dr.;Christof Sch?nenberger, Dr.;Matthias Briel, Prof., Mathias.briel@usb.ch, + 4161 265 3815, University Hospital, Basel, Switzerland,University Hospital, Basel, Switzerland,University Hospital, Basel, Switzerland, (ICTRP)
Sekundäre IDs
2024-02417, ub25Briel (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT06789692 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar