NCT06789692

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
972

participants targeted

Target at P75+ for not_applicable hiv

Timeline
18mo left

Started Feb 2025

Typical duration for not_applicable hiv

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Feb 2025Dec 2027

First Submitted

Initial submission to the registry

January 17, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 23, 2025

Completed
28 days until next milestone

Study Start

First participant enrolled

February 20, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

June 2, 2026

Status Verified

May 1, 2026

Enrollment Period

2.8 years

First QC Date

January 17, 2025

Last Update Submit

May 28, 2026

Conditions

Keywords

tobacco smokinge-cigarettestobacco-free nicotine pouchesTrials within Cohorts (TwiCs)

Outcome Measures

Primary Outcomes (1)

  • Tobacco smoking status (yes/no)

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

    at 6 month visit

Secondary Outcomes (11)

  • Tobacco smoking status (yes/no)

    at 12 month visit, 24-month visit

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

    at 6 month visit, at 12 month visit, at 24 month visit

  • Mean Change in Cholesterol (mmol/l)

    at 6 month visit, at 12 month visit, at 24 month visit

  • Mean change in blood pressure (mmHg)

    at 6 month visit, at 12 month visit, at 24 month visit

  • Mean change in body weight (kg)

    at 6 month visit, at 12 month visit, at 24 month visit

  • +6 more secondary outcomes

Study Arms (2)

Smoking substitution menu

EXPERIMENTAL

Offer of preference-based smoking substitution menu, consisting of e-cigarettes or nicotine pouches or nicotine patches in addition to standard of care.

Other: tobacco smoking substitution products

Standard of care group

NO INTERVENTION

Standard smoking cessation counselling according to routine care in the SHCS.

Interventions

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.

Smoking substitution menu

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Currently using e-cigarettes or nicotine pouches or nicotine patches.
  • Pregnant women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University Hospital Basel

Basel, Basel, 4031, Switzerland

COMPLETED

Inselspital Bern

Bern, Canton of Bern, 3010, Switzerland

RECRUITING

Cantonal Hospital St. Gallen

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

RECRUITING

University Hospital Lausanne

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

University Hospital Zurich

Zurich, Canton of Zurich, 8006, Switzerland

RECRUITING

Cantonal Hospital Aarau

Aarau, 5001, Switzerland

RECRUITING

University Hospital Geneva

Geneva, Switzerland

RECRUITING

Related Publications (2)

  • Schonenberger CM, Ochoa SC, Speich B, Haerry DH, Cart-Richter E, Jackson-Perry D, Hutter A, Panettieri L, Aggeler S, Chaudron SE, Calmy A, Cavassini M, Abela IA, Kusejko K, Gunthard HF, Nemeth J, Rauch A, Wandeler G, Schmid P, Dorr T, Surial B, Berthet A, Auer R, Stoeckle MP, Labhardt N, Chammartin F, Briel M, Amstutz A. Acceptance and preferences for different nicotine substitute products to reduce tobacco smoking in people living with HIV: Results from an internal pilot study of a randomized trial. Tob Induc Dis. 2026 May 26;24. doi: 10.18332/tid/218987. eCollection 2026.

  • Schonenberger CM, Speich B, Zehnder ER, Haerry DH, Cart-Richter E, Jackson-Perry D, Hutter A, Aggeler S, Steinmann J, Chaudron SE, Calmy A, Cavassini M, Braun D, Fux CA, Abela I, Kusejko K, Gunthard HF, Nemeth J, Rauch A, Wandeler G, Schmid P, Dorr T, Notter J, Weisser Rohacek M, Surial B, Berthet A, Auer R, Stoeckle MP, Labhardt N, Chammartin F, Briel M, Amstutz A; Swiss HIV Cohort Study. Offer of a menu of different nicotine substitute products to REduce Tobacco Use iN pEople living with HIV (RETUNE): a protocol for a pragmatic randomized trial within the Swiss HIV Cohort Study. Trials. 2026 Apr 8. doi: 10.1186/s13063-026-09622-6. Online ahead of print.

MeSH Terms

Conditions

SmokingTobacco SmokingVaping

Condition Hierarchy (Ancestors)

BehaviorTobacco Use

Study Officials

  • Matthias Briel, Prof.

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR
  • Alain Amstutz, Dr.

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR
  • Christof Schönenberger, Dr.

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthias Briel, Prof.

CONTACT

Christof Schönenberger, Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized Clinical Trial using the Trials within Cohorts (TwiCs) design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2025

First Posted

January 23, 2025

Study Start

February 20, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

June 2, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP

Locations