Offer of various nicotine replacement products (e-cigarettes, nicotine pouches, and nicotine patches) for smoking cessation in people living with HIV - The RETUNE study
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
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)
Criteri di esclusione
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)
Luogo dello studio
Basilea, Berna, San Gallo, Zurigo
(BASEC)
Sponsor
University Hospital Basel
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Christof Manuel Schönenberger
+41612653825
christofmanuel.schoenenberger@clutterusb.chDivision of Clinical Epidemiology, University Hospital Basel
(BASEC)
Informazioni generali
University Hospital, Basel, Switzerland,University Hospital, Basel, Switzerland,University Hospital, Basel, Switzerland,
+ 4161 265 3815
christofmanuel.schoenenberger@clutterusb.ch(ICTRP)
Informazioni generali
University Hospital, Basel, SwitzerlandUniversity Hospital, Basel, SwitzerlandUniversity Hospital, Basel, Switzerland
+ 4161 265 3815
christofmanuel.schoenenberger@clutterusb.ch(ICTRP)
Informazioni scientifiche
University Hospital, Basel, Switzerland,University Hospital, Basel, Switzerland,University Hospital, Basel, Switzerland,
+ 4161 265 3815
christofmanuel.schoenenberger@clutterusb.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
08.01.2025
(BASEC)
ID di studio ICTRP
NCT06789692 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Reduce tobacco use in people living with HIV in Switzerland: A pragmatic randomized trial within the Swiss HIV Cohort Study (RETUNE) (BASEC)
Titolo accademico
Reduce Tobacco Use in People Living With HIV in Switzerland: A Pragmatic Randomized Trial Within the Swiss HIV Cohort Study (ICTRP)
Titolo pubblico
Reduce Tobacco Use in People Living With HIV in Switzerland (ICTRP)
Malattie studiate
HIVSmoking (ICTRP)
Intervento studiato
Other: tobacco smoking substitution products (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
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)
non disponibile
Endpoint primari e secondari
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)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
Swiss National Science Foundation;Novartis Foundation for Medical-Biological Research (ICTRP)
Contatti aggiuntivi
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)
ID secondari
2024-02417, ub25Briel (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT06789692 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile