Offer of various nicotine replacement products (e-cigarettes, nicotine pouches, and nicotine patches) for smoking cessation in people living with HIV - The RETUNE study
Résumé de l'étude
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)
Intervention étudiée
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)
Maladie en cours d'investigation
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)
Critères d'exclusion
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)
Lieu de l’étude
Bâle, Berne, St-Gall, Zurich
(BASEC)
Sponsor
University Hospital Basel
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Christof Manuel Schönenberger
+41612653825
christofmanuel.schoenenberger@clutterusb.chDivision of Clinical Epidemiology, University Hospital Basel
(BASEC)
Informations générales
University Hospital, Basel, Switzerland,University Hospital, Basel, Switzerland,University Hospital, Basel, Switzerland,
+ 4161 265 3815
christofmanuel.schoenenberger@clutterusb.ch(ICTRP)
Informations générales
University Hospital, Basel, SwitzerlandUniversity Hospital, Basel, SwitzerlandUniversity Hospital, Basel, Switzerland
+ 4161 265 3815
christofmanuel.schoenenberger@clutterusb.ch(ICTRP)
Informations scientifiques
University Hospital, Basel, Switzerland,University Hospital, Basel, Switzerland,University Hospital, Basel, Switzerland,
+ 4161 265 3815
christofmanuel.schoenenberger@clutterusb.ch(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Date d'approbation du comité d'éthique
08.01.2025
(BASEC)
Identifiant de l'essai ICTRP
NCT06789692 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
Reduce tobacco use in people living with HIV in Switzerland: A pragmatic randomized trial within the Swiss HIV Cohort Study (RETUNE) (BASEC)
Titre académique
Reduce Tobacco Use in People Living With HIV in Switzerland: A Pragmatic Randomized Trial Within the Swiss HIV Cohort Study (ICTRP)
Titre public
Reduce Tobacco Use in People Living With HIV in Switzerland (ICTRP)
Maladie en cours d'investigation
HIVSmoking (ICTRP)
Intervention étudiée
Other: tobacco smoking substitution products (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
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 disponible
Critères d'évaluation principaux et secondaires
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)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
Swiss National Science Foundation;Novartis Foundation for Medical-Biological Research (ICTRP)
Contacts supplémentaires
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 secondaires
2024-02417, ub25Briel (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT06789692 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible