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PALO ALTO UNIVERSITY CONSENT TO PARTICIPATE IN A RESEARCH STUDY

The aim of this study is to examine the use of a web app smoking cessation tool. The web app is a newly developed tool that is intended to meet the needs and preferences of patients and health providers of the San Francisco Health Network (SFHN). The principal investigator of this study is Dr. Ricardo F. Muñoz, a professor at Palo Alto University and emeritus professor at the University of California, San Francisco/San Francisco General Hospital. You are being asked to take part in this study because you are either a patient of the SFHN, or you have found out about our study online or via media announcements, you currently smoke tobacco, and you have indicated a desire to quit smoking.

Research studies are completely voluntary and only should include people who choose to take part. If you have any questions about the study, you can reach the research team by phone at 650-433-3868 or by email at stopsmoking@paloaltou.edu.

Why is this study being done?

This study is being done to help researchers learn the best methods to notify and invite tobacco smokers to use a newly designed web app smoking cessation tool, Aim2Quit SF. This study is also being done to examine how users engage with the web app tool and which features are the most successful at helping individuals quit smoking.

Who pays for this study?

The Tobacco-Related Disease Research Program is funding this study.

How many people will take part in this study?

We anticipate enrolling 75 English- and 75 Spanish-speaking adults.

What will happen if I take part in this research study?

If you agree to be a part of this study, the following will happen:

1. You will answer questionnaires over a web app about characteristics that describe you (e.g. age), your smoking behaviors and history, and your quit confidence.
2. After completing the initial questionnaires and downloading the web app, you will be invited to use the web app.
3. You will receive a text message inquiring about your quit success at 1, 2, and 3 months after you enroll in the study.

Study location: Given that this study is through the use of your smartphone or computer, you can choose where you will complete your participation in this study.

How long will I be in the study?

Participation in this study will end 3 months after you enroll in the study.

Can I stop being in the study?

Taking part in this study is your choice. You are free to choose not to be part of this study. If you decide to take part in this study, you may leave the study at any time. No matter what decision you make, there will be no penalty to you in any way. The research team may also stop you from taking part in this study at any time if they believe it is in your best interest, if you do not follow the study rules, or if the study is stopped.

What are the possible side effects or risks if I participate in the study?

There is a small, but possible, chance that some of the questions or the information presented to you may influence how you are feeling. You can choose not to answer any questions you do not wish to answer or to stop the observation session at any time.

Are there benefits to taking part in the study?

As a participant in this study, we hope the web app will help you quit smoking. It is possible that you will not benefit directly from being in the study. Even if you do not benefit personally, your participation may help researchers better understand how to design digital tools for smoking cessation.

What other choices do I have if I do not take part in this study?

You are free to choose not to participate in the study. If you decide not to enroll in this study, there will be no penalty to you.

Will information about me be kept private?

Yes. We will do our best to make sure that the personal information (your name, contact information, and responses to questionnaires and interviews) gathered for this study is kept private. However, we cannot guarantee total privacy. Your personal information may be given out if required by law. If information from this study is published or presented at scientific meetings, we will never use your name and other personal information.

What are the costs of taking part in this study?

There are no costs as a result of participating in this study.

Will I be paid for taking part in this study?

No. You will not be paid for participation in this study.

What are my rights if I take part in this study?

Taking part in this study is your choice. If you decide to take part in this study, you may leave the study at any time. No matter what decision you make, there will be no penalty to you in any way.

Who can answer my questions about the study?

You can talk to the researchers about any questions or concerns you have about this study. If you have any questions, comments, or concerns about taking part in this study, first e-mail or call the research staff at stopsmoking@paloaltou.edu or (650) 433-3868. Questions about your rights as a participant in this study may be presented to the IRB Chair by mail at Palo Alto University, IRB, 1791 Arastradero Road, Palo Alto, CA 94304 or by phone at 650-433-3870.

PARTICIPATION IN RESEARCH IS VOLUNTARY. You have the right to decline to be in this study, or to withdraw from it at any point without penalty or loss of benefits to which you are otherwise entitled.

For further information, you may contact Professor Ricardo F. Muñoz at stopsmoking@paloaltou.edu.