Clinical trial: NCT02157610
Section: Confidentiality
Subsections: Certificate Of Confidentiality

To help us protect your privacy, we have obtained a Certificate of Confidentiality from the National Institutes of Health. With this Certificate, the study investigators may not disclose research information that may identify you in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings, unless you have consented for this use. Research information protected by this Certificate cannot be disclosed to anyone else who is not connected with the research unless:
1) There is a law that requires disclosure (such as to report child abuse or communicable diseases but not for legal proceedings);
2) You have consented to the disclosure, including for your medical treatment; or 3) The research information is used for other scientific research, as allowed by federal regulations protecting research participants.  
Disclosure is required, however, for audit or program evaluation requested by the agency that is funding this project or for information that is required by the Food and Drug Administration (FDA). You should understand that a Confidentiality Certificate does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. If you want your research information released to an insurer, medical care provider, or any other person not connected with the research, you must provide consent to allow the researchers to release it. This means that you and your family must also actively protect your own privacy.  
Finally, you should understand that the study investigator is not prevented from taking steps, including reporting to authorities, to prevent serious harm to yourself or others.
Clinical trial: NCT02157610
Section: Participant's Rights
Subsections: Whom To Contact About This Study|Statement Of Consent And Authorization|Statement Of Person Obtaining Informed Consent / Research

During the study, if you have questions, concerns or complaints about the study, please contact the study investigator at the telephone number listed on the first page of this consent document. An institutional review board (IRB) is an independent committee established to help protect the rights of research participants. If you have any questions about your rights as a research participant, and/or concerns or complaints regarding this research study, contact:
Version 2 version date: 09/05/2019 Advarra IRB Approved Version 5 Sep 2019 Page 8 of 10
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I have read this form and its contents were explained to me. I agree to be in this research study for the purposes listed above. I authorize the use and disclosure of my personal health information for the use of this study. All of my questions were answered to my satisfaction. I will receive a signed and dated copy of this form for my records. Printed Name of Participant  
Signature of Participant Date Time

AUTHORIZATION
I attest that the participant named above had enough time to consider this information, had an opportunity to ask questions, and voluntarily agreed to be in this study. Printed Name of Person Explaining Consent Signature of Person Explaining Consent Date Time
Clinical trial: NCT02157610
Section: Procedures
Subsections: What Is Involved In The Study?|Study Questionnaires:|Saliva Testing:|Telephone Counseling (For Group 2 Only):

No matter which group you are in, you will receive a 12-week supply of nicotine replacement therapy (the patch and lozenges). The strength of the nicotine patches and lozenges you receive will depend on how much you smoke each day. You should use the nicotine patch as directed by the package instructions.  
The most common and most serious risks that may be related to taking part in this research include: - Side effects from the nicotine patch or lozenges, such as increased heart and blood pressure
- Skin redness - Symptoms of nicotine overdose like nausea, dizziness, weakness - Vivid dreams or difficulty sleeping
- Allergic reactions such as difficulty breathing or rash
- Mouth, teeth, and jaw problems
- Indigestion
- Sore throat
Unused and used patches have enough nicotine to poison children and pets. Be sure to fold the sticky ends together when you are done using the patch. In case of accidental overdose, call your regular doctor or a poison control center right away.  
Even if you do not wish to use the nicotine patch, you will be allowed to take part in the study.

You will be asked to complete questionnaires over the phone, in person, or via a web-based link. You will be asked to complete these questionnaires 5 times. These will occur at the beginning of study and at months 3, 6, 12 and 18. You will be asked about your feelings, moods, cervical cancer or dysplasia diagnosis, and smoking status. These questionnaires should take about 45 minutes each time to complete.

At months 3, 6, 12 and 18, you may also be asked to provide a saliva sample to test for cotinine. Cotinine is a chemical released in your body when it breaks down nicotine. This test is to confirm your smoking status. You will receive a kit in the mail with supplies for testing. The study staff will call you to make sure you received the kit and to discuss the instructions with you. If you have any questions about how to use the kit, you may contact the study staff during the study. To collect the saliva, you will put a small piece of cotton in your mouth for a few minutes. You will be asked to mail the saliva sample back to the study staff using a prepaid return envelope.  
During the study, you may be contacted by mail, telephone, and/or email to be reminded to send back the kit.

If you are in Group 2, you will have 6 telephone counseling sessions. These sessions may last up to 30 minutes each. These calls will occur over a 12-month period at times that are convenient for you. During the calls, you will be asked about how motivated you are to quit smoking, what barriers to quitting you may have, and factors that may be related to your smoking such as stress and family issues. The telephone counseling sessions will be digitally recorded. Only the study investigators and study staff will be allowed to view or listen to the recordings. Your identity will be kept strictly confidential. Your study identification number will be stated by the counselor at the beginning of the taped session. The recordings are stored digitally, encrypted, and password protected. The telephone counseling recordings will be destroyed 10 years after results from the study are published.