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Reduce Tobacco Use in People Living With HIV in Switzerland

ConditionsHIVSmoking
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Basel, Switzerland

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Currently using e-cigarettes or nicotine pouches or nicotine patches.

Pregnant women.

Trial design

Design model

Parallel

Treatments tested in this trial

  • tobacco smoking substitution products

    Other intervention

    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.

Treatment groups

972 Participants
are divided into 2 treatment groups
Group A: Smoking substitution menuExperimental treatment 1 intervention
Group B: Standard of care groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Tobacco smoking status (yes/no)

Measured as self-reported abstinence in the last 7 day at 6-month visit

Time frame
at 6 month visit

Secondary outcomes

1

Tobacco smoking status (yes/no)

Measured as self-reported abstinence in the last 7 day at 12-month visit and at 24-month visit

Time frame
at 12 month visit, 24-month visit
2

Mean change in number of tobacco-based cigarettes smoked per day

Number will be self reported by participant

Time frame
at 6 month visit, at 12 month visit, at 24 month visit
3

Mean Change in Cholesterol (mmol/l)

High Density Lipoprotein (HDL) and Low Density Lipoprotein (LDL) Cholesterol in blood samples will be measured

Time frame
at 6 month visit, at 12 month visit, at 24 month visit
4

Mean change in blood pressure (mmHg)

systolic and diastolic blood pressure will be measured.

Time frame
at 6 month visit, at 12 month visit, at 24 month visit

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Basel, Switzerland

Lead sponsor

Swiss National Science Foundation

Collaborator

Novartis Foundation for Medical-Biological Research

Collaborator

Source ClinicalTrials.gov
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