Cross-Sectional Survey on the Use of Tobacco Products - Italy

Study Overview
=================
Brief Summary
-----------------
The main purpose of the research study is to estimate the prevalence of tobacco product use and describe the tobacco use patterns in adults in Italy.

Detailed Description
-----------------
The aim of the survey is to describe the current and past patterns of use of tobacco products in the general adult population of Italy and in adult IQOS users registered in the IQOS user database of Philip Morris Italia S.r.l. (Italy IQOS User Database), and explore their association with key independent variables. More specifically, the objectives are: Estimate the prevalence of current tobacco use status in the study population. Describe the past tobacco use status (cigarette, IQOS and other innovative products, including e-cigarettes) in the study population (i.e. never-use, initiation, product use transition, cessation, re-initiation, and relapse). Explore the association between self-reported health status and use of tobacco products in the study population. Explore the association between patterns of use (including misuse) with motivation to use, perceived quality attributes of IQOS (e.g. risk and self-reported changes since switching to the product, in a number of relevant domains where IQOS may have potential benefits), and consumer's satisfaction in the population of IQOS users in Italy registered in the Italy IQOS User Database.

Official Title
-----------------
Cross Sectional Survey on the Use of Tobacco Products in the General Population and in Users of IQOS in Italy (2018-2020)

Conditions
-----------------
Tobacco Use

Intervention / Treatment
-----------------
* Other: Survey on Use of Tobacco Products in the General Population
* Other: Survey on Use of Tobacco Products in IQOS Users


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (all participants, including IQOS users): Legally permitted to buy tobacco products in Italy (≥18 years of age). Currently residing in Italy. Able to read, write and understand Italian. Consent to participate in the survey Inclusion Criteria (IQOS users only): Has used more than 100 HEETS tobacco sticks in his or her lifetime. Is currently using IQOS. Has access to the internet. Is not currently employed by Philip Morris International or any of its affiliates Exclusion Criteria: Not meeting the inclusion criteria.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| General Population<br>Survey on use of tobacco products in the general population of adults living in Italy. | Other: Survey on Use of Tobacco Products in the General Population<br>* Face-to-face survey to estimate the prevalence of current tobacco use status in the general population of Italy.<br>|
| IQOS Users<br>Survey on use of tobacco products in adult current IQOS Users (at the time of survey) living in Italy who are registered in the Italy IQOS User Database and agreed to be contacted for research purposes at the time of registration. | Other: Survey on Use of Tobacco Products in IQOS Users<br>* Online survey to describe patterns of use in IQOS users residing in Italy.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of current tobacco use | Prevalence of current tobacco use status in the study population. | Study duration (3 years). | 
| Past tobacco use status | Past tobacco use status (cigarette, IQOS and other innovative products) in the study population. | Study duration (3 years). | 
| Self-reported health status | Association between self-reported health status and use of tobacco products in the study population. | Study duration (3 years). | 
| Perceived risk | Association between patterns of use with perceived risk. | Study duration (3 years). | 
| IQOS use experience | Describe the IQOS user experience, including motivation to use, mis-use, satisfaction, and self-reported changes since switching to the product (in a number of relevant domains where IQOS may have potential benefits). | Study duration (3 years). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tobacco Use, IQOS