Clinical trial NCT06789692: Reduce Tobacco Use in People Living With HIV in Switzerland
Official title: Reduce Tobacco Use in People Living With HIV in Switzerland: A Pragmatic Randomized Trial Within the Swiss HIV Cohort Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV
Smoking
Keywords: tobacco smoking
e-cigarettes
tobacco-free nicotine pouches
Trials within Cohorts (TwiCs)
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
name: Novartis Foundation for Medical-Biological Research
First posted: 2025-01-23
Enrollment: 972
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Clinical Trial using the Trials within Cohorts (TwiCs) design
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Tobacco smoking status (yes/no)
timeFrame: at 6 month visit
Secondary outcomes:
measure: Tobacco smoking status (yes/no)
timeFrame: at 12 month visit, 24-month visit
measure: Mean change in number of tobacco-based cigarettes smoked per day
timeFrame: at 6 month visit, at 12 month visit, at 24 month visit
measure: Mean Change in Cholesterol (mmol/l)
timeFrame: at 6 month visit, at 12 month visit, at 24 month visit
measure: Mean change in blood pressure (mmHg)
timeFrame: at 6 month visit, at 12 month visit, at 24 month visit
measure: Mean change in body weight (kg)
timeFrame: at 6 month visit, at 12 month visit, at 24 month visit
measure: Mean change in SCORE2-risk prediction algorithm
timeFrame: at 6 month visit, at 12 month visit, at 24 month visit
measure: Number of cardiovascular events
timeFrame: at 6 month visit, at 12 month visit, at 24 month visit
measure: Serious Adverse events
timeFrame: at 6 month visit, at 12 month visit, at 24 month visit
measure: Self reported use of any nicotine containing product other than tobacco cigarettes (yes/no)
timeFrame: at 6 month visit, at 12 month visit, at 24 month visit
measure: Self reported use of e-cigarettes (yes/no) or nicotine pouches (yes/no) or nicotine patches (yes/no)
timeFrame: at 6 month visit, at 12 month visit, at 24 month visit
measure: Self reported use of any nicotine containing product (yes/no)
timeFrame: at 6 month visit, at 12 month visit, at 24 month visit
Other outcomes:
Locations:
city: St. Gallen
country: Switzerland
facility: Cantonal Hospital St. Gallen
state: Saint Gallen
city: Lausanne
country: Switzerland
facility: University Hospital Lausanne
state: Waadt
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Geneva
country: Switzerland
facility: University Hospital Geneva
city: Zürich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Matthias Briel, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Basel, Switzerland
name: Alain Amstutz, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Basel, Switzerland
name: Christof Schönenberger, Dr.
role: PRINCIPAL_INVESTIGATOR
References: