Last updated 5/18/2021
The University of North Carolina at Chapel Hill (“UNC“), University of Cape Town (“UCT”), and Duke University are committed to providing notice about the Personal Information (defined below) collected via the MASI research study mobile application (“App“). The formal name of the research study is: “Developing a Smartphone App to Improve Treatment Adherence among South African Adolescents Living with HIV,” (the “Study“) and it is sponsored by Duke, UCT, and UNC-Chapel Hill with external funding from funding from U.S. National Institute of Mental Health. To participate in the Study, you were required to sign a consent form (“Informed Consent“).
The App is available to you for free. You will not need to provide any payment information for the use of the App.
We are not asking you to make any health decisions based on the use of the App. You should discuss health decisions directly with your healthcare provider.
The Study is designed for young South African adolescents, ages 14-21 years old. We do not knowingly collect or solicit Personal Information from anyone under the age of 14 and we do not wish to receive it. In the event that we gain actual knowledge that we have collected Personal Information from someone under age 14 years, we will delete that information. If you are a parent or guardian and believe that we might have collected such information, please contact us using the contact information below. An adult must consent for the participation of minors under 18 years of age in this study. The following adults can give consent for the participation of minors: (1) the parent (including adoptive parents); (2) if no parent, the guardian (either court-appointed OR as indicated by the parent in a Will); (3) if no guardian, a foster parent; (4) if no foster parent, a caregiver (any person other than a parent or guardian, who cares for a child); (5) and if the child is from a child-headed household with no supervisory adult, a trusted adult chosen by the minor.
What information does the App collect?
The purpose of this Study is to evaluate the MASI intervention, a smartphone application (app) built using the HealthMpowerment (HMP) platform, designed to provide health and wellness information and resources relevant to adolescents in South Africa. The purpose of MASI is to support adherence to HIV antiretroviral medication, help build community, reduce stigma, and provide information and resources about relationships, wellness, sexual health, and HIV. Your use of the app and the feedback you provide will help us to improve the app and make it more inclusive to the diverse needs of the entire community.
As part of your registration process in the Study, you will be asked to provide your name, contact phone number, and email address (if you have one). This Personal Information will be securely stored following HIPAA standards (see detailed description in Informed Consent form) and will only be available to Study staff who need to contact you for Study-related activities. This information will not be visible to other Study participants or staff who are using the app.
While you are in the Study, you will have access to interactive features within the app. Any content that you choose to share will only appear with your username in the app. To protect your privacy, we encourage you to choose a unique username that is different from your real name, email address, and your social media accounts. Other participants will not see any of your identifying information or your personal health information. If you choose to share information in the app, that content will only be visible to other participants and staff in the Study. We strongly discourage participants from sharing personal information in the app that could reveal their identity. If you choose to share identifiable information about yourself in the app, it may result in the breach of your confidentiality to other participants. We reserve the right to remove it from the app if it violates our app guidelines.
What else does the App collect?
The App includes tools that automatically collect certain information beyond that which you affirmatively provide. One tool collects information about crashes (Crashlytics) and one about use of the App (iTunes Connect). These tools work on an anonymous basis, without collecting personally identifiable information. Through these tools, the App may automatically receive anonymous technical information relating to your operating system, device, features used, content viewed and downloaded, whether crashes occurred, and the dates and times of your interactions with the App. We may internally use this information to understand, customize and generally improve user experience with the App and the Study.
Once you provide Informed Consent and enroll in the Study, you will receive push notifications regarding the Study. “Push Notifications” are messages that are sent to your smart device within the App. Push Notifications may be sent to remind you about Study activities after your initial enrollment. You may also receive Push Notifications when we update the App or features.
The App may also send you Push Notifications throughout your participation in the Study, as necessary. You can choose to receive or not receive notifications about the Study and you have the option to control notification settings on your smartphone (for example, to turn off audible notification tone). Lastly, the App may send you a Push Notification to let you know about new content on the app or to invite you to participate in other optional activities related to the Study (e.g., additional optional surveys).
What about security for Personal Information? How long will UNC, UCT, and Duke University keep it?
All information that is collected through the App will be encrypted through encryption methods currently used at UNC and will sent to a protected data server behind UNC’s firewall. Data will be encrypted at rest and in transit, and will be securely transferred to Duke University.
UNC and Duke will replace the direct identifiers you provide – like your name and address – with a code to help protect your identity. UNC and Duke will encrypt the direct identifiers and store them separately. Because the remaining information is coded, researchers using this information should not be readily able to identify which information pertains to you.
Every effort will be taken to protect your identity as a participant in this study. You will not be identified by name in any report or publication of this study or its results. Instead, you will be known only through a study ID number. Any data linking your first name to your study ID number will be kept on a secure server. Any data that are collected from you will be stored on a secure, confidential, and HIPAA-compliant server housed at UNC or Duke University. Data from the study will be kept indefinitely for secondary analyses. Additionally, all data will be secured using an SSL 256-bit encryption. SSL encryption is the standard for all web-based transactions.
Any study-related messages that are sent to you will not disclose the fact that you are in a research study. All messages will be free of any identifying information and will not have any of your personal health information. All messages generated by the study are sent and stored on a HIPAA-compliant server. Messages can only be directly linked to your study ID and first name. You too can help with security. For example, access to the App on your smart device may be protected by a biometric authentication mechanism (such as Touch ID) or a passcode. You should take these or other steps to prevent unauthorized access to your smart device by protecting and limiting access to your smart device. We strongly recommend that you always use the most updated version of the operating system for your smart device. You should review the privacy and security settings often and restrict any unnecessary access.
No matter our efforts, we cannot guarantee complete security. Unauthorized entry or use, hardware or software failure, and other factors, may compromise the security of your Personal Information.
Will UNC, UCT or Duke University share any of the information it receives?
The information collected by the App will only be used for research purposes. Your name will never be used in publications or presentations when the results of the Study become available.
As described above, your Personal Information will be coded. The code will be stored separately and in a protected way. The only people who will have permission to access this code will be the UNC, UCT, and Duke University research team. We intend that the only time your identifiable information will be shared outside of UNC, UCT, and Duke University is when required by law. For example, we might believe disclosure is necessary to comply with a regulatory requirement, judicial proceeding, court order, or legal process served on us, or to protect the safety, rights, or property of UNC, UCT, Duke University or the public.
What Personal Information can I access?
Through the App, you may access the following information you’ve provided to us: name, contact phone number, and email address (if you have one).
When you update information, however, we may maintain a copy of the unrevised information in our records to track the data entry into the Study. The information you can view and update may change as the App undergoes further development. Please note that any information that is automatically uploaded from the App (e.g., dates App used) cannot later be changed or updated. If you have any questions about viewing or updating information you have provided to us, please contact us using the contact information below.
What choices do I have?
You may choose not to install the App. If you choose not to install the App, you cannot participate in the Study.
If you join the Study, you can choose when and how you engage with the app. When you use the app, you can choose what content to engage with in the app. You can also withdraw from the Study at any time by emailing the researchers at MASI@duke.edu. When you withdraw from the Study, we will remove your Personal Information from the Study databases, though we may not be able to remove your de-identified information from research or publications that may have already happened (e.g. de-identified interim Study results).
Once the Study is over, we may only use your Personal Information to contact you in the future if you consented to your interest in being contacted for future research studies.
What limitations are there on my use of the App?
By downloading and using the App, you agree that you will not do anything to interfere with or disrupt the operation of the App, will provide only accurate and current information through the App, and will not impersonate anyone else in your use of the App.
You further agree not to transmit content that you do not have the right to transmit or that infringes the rights of any party, and you agree to use the App in compliance with all applicable laws. You understand that the App or portions of it may be subject to patent, copyright, trademark, and other intellectual property protection and that the ownership of software and other intellectual property related to the App, as well the goodwill associated therewith, remains with UNC, UCT, Duke University, or its licensors. You agree that any improvements or other changes to the App or the Study itself are the sole property of UNC.
Questions or concerns?
Duke University School of Nursing
307 Trent Drive, Durham NC 27710
United States of America
Attention: Dr. Marta Mulawa