Clinical trial: NCT05530603
Section: Confidentiality
Subsections: How Will We Protect Your Information?

The records of this study will be kept confidential to the extent permitted by law. The survey does not ask for any information that would identify who the responses belong to (e.g., it does not ask for your name). Your name or other identifying information will not be stored with the data, which will be saved on the University of South Dakota, School of Health Science, Department of Social Work server. The server is password protected and only Dr. Soonhee Roh will have access to the data. The code key linking your name to name or other identifying information about you will be kept in a separate, secure location. Information contained in your records will not be given to anyone unaffiliated with the research team. Your name or other identifying information will not be used in any publication or teaching without your specific permission. Since other people will be present at the focus group, we cannot guarantee what you say will be kept confidential. We encourage you to not reveal any identifying information about yourself or others, or to repeat anything that is said during the focus group afterwards. The focus group will be audio recorded, but the recordings will be transcribed without identifying information and then deleted. You are free request to view and edit the transcriptions. The audio tapes, research data, and personal information of participants in this study will be kept in locked filing cabinets which will be secured by the researcher. Only the researcher will have access to this information. If the results of the research are published or discussed at conferences, no information will be included that would reveal your identity. The transcriptions, and de-identified research data will be kept for 3 years for subsequent research and then will be destroyed. It is possible that other people may need to see the information we collect about you. These people work for the University of South Dakota and other agencies as required by law or allowed by federal regulations.  
How will we compensate you for being part of the study?  
You will be given $50 for participating in the focus group. Also, travel expenses will be reimbursed with a VISA gift card: $50 for 2 hours round trip, $100 for 4 hours round trip. If you complete the surveys, you will receive $20 in cash.  
Will you have any costs for participating in this study?  
You may have travel expenses for driving to and from the interviews and focus groups. For those who drive over 50 miles, they will be reimbursed the amounts stated in the previous section.  
Who is funding this research?  
The National Institutes of Health (a federal agency) and the University of South Dakota is funding this research.  
Contact Information for the Study Team and Questions about the Research The researcher conducting this study is Soonhee Roh, PhD. You may ask any questions you have now. If you later have questions, concerns, or complaints about the research please contact Dr. Soonhee Roh at 605-357-1593 during the day.  
If you have questions regarding your rights as a research subject, you may contact The University of South Dakota- Office of Human Subjects Protection at (605) 658-3767. You may also call this number with problems, complaints, or concerns about the research. Please call this number if you cannot reach research staff, or you wish to talk with someone who is an informed individual who is independent of the research team.  
Your Consent Before agreeing to be part of the research, please be sure that you understand what the study is about. We will give you a copy of this document for your records. I understand that by signing below, I volunteer to participate in this research. I understand that I am not waiving any legal rights. I have been provided with a copy of this consent form.  
I give consent for my quotes to be used in the research; however I will not be identified.  
USD IRB  
Please initial: ____ Yes *____ No*  
| USD IRB                                                                                                                                                          |          |         |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|---------|
| Please initial:                                                                                                                                                  | ____ Yes | ____ No |
| Subject's Name: ______________________________________________________ ______________________________________ ________________________ Signature of Subject Date |          |         |
Clinical trial: NCT05530603
Section: Procedures
Subsections: What Will Happen If You Take Part In This Study?

This study has two parts. In the first part, you will be asked to answer questions in a face-to-face focus group interview.  
The group will consist of AI community leaders/members and local health professionals with backgrounds in cancer and health management. It will last up to two hours. Questions will cover the following topics: 1) knowledge, beliefs, perceptions and attitudes about breast cancer and screening; 2) individual, structural, and cultural barriers to screening; 3) perceptions about Mobile Web App intervention approaches; 4) current mobile phone usage habits, including text and picture messaging, SMS and MMS subscriptions; and 5) suggestions regarding the most effective content, type, and frequency of messages to appeal to AI women. In the second part, you will use the phone app (wMammogram) for seven days. After intervention, there will be 3 interviews: one at the beginning, one-week post-intervention, and six-month follow-up, and post-intervention focus group. We will ask if you have scheduled a doctor appointment to get screened for breast cancer, which is called a mammography. We will ask you that after the 7 day period and again 6 months later. We will also ask you questions about breast cancer knowledge, health beliefs, cultural attitudes, and intent to undergo screening. We will also ask your health-related questions. These interview questions will take about 30 minutes to answer in person. Focus group participation will take about 2 hours.  
If you do not have a cell phone, the researcher will lend you one to use. It must be returned when the study is over. The phone will have one month worth of service/available data and may only be used for this research study. It may not be used for personal use. If you stop participating, the phone must be returned. If something happens to this phone, we may end your participation in this study.  
Your Participation in this Study is Voluntary It is totally up to you to decide to be in this research study. Participating in this study is voluntary. Even if you decide to be part of the study now, you may change your mind and stop at any time. You do not have to answer any questions you do not want to answer. You may refuse to participate or choose to discontinue participation at any time without losing any benefits to which you are otherwise entitled.  
What risks might result from being in this study?  
There are no risks in participating in this research beyond those experienced in everyday life.  
How could you benefit from this study?  
Although you will not directly benefit from being in this study, we hope to have a positive impact on clinical and public health practice through the development of an innovative health intervention that builds upon low cost technology and enhances accessibility and sustainability of preventive care to help reduce health disparities experienced in Indian Country.