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IRB Approval Date: February 3, 2021 IRB Consent Version No.: 1
JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH
ADULT INFORMED CONSENT FOR OPEN CONTEST
Principal Investigator: Cui Yang
Study Title: Development and evaluation of a crowdsourced U=U campaign to reduce HIV stigma and promote HIV prevention and care utilization
IRB No.: 14979
Sponsor/Supporter/Funded By: NIH
PI Version Date: V2/January 18, 2021
Key Information about the Study
We are asking you to volunteer for a research study to develop a public health campaign to raise the awareness of the Undetectable=Untransmittable (U=U) message. U=U messaging represents the scientific evidence that people living with HIV who take their HIV medications as prescribed and have an undetectable viral load have no risk of transmitting HIV to an HIV‐negative sex partner.
If you join, we will ask you to complete an online survey and to submit an entry on how to raise the awareness of U=U. If you join the study, it is possible that we will work with you to develop a health campaign to raise the awareness of U=U in communities where it is less known, to reduce stigma associated with HIV, and to motivate people to seek HIV prevention or care services.
You do not have to join the study; it is your choice and there is no penalty for not joining. This consent form explains the research study and your part in the study. Please read it carefully and take as much time as you need. Ask as many questions as you need to help you make your decision. Please call or text us at 443-618-3942 if you have any questions while reviewing this document. Please review the details outlined in the rest of this consent document before deciding. During the study, we will tell you if we learn any new information that might affect whether you wish to continue to be in the study.
Details about the Study
This is a crowdsourcing contest to encourage community members to share their creative ideas on how to promote the awareness of “U=U.” Again, U=U messaging represents the scientific evidence that people living with HIV who take their HIV medications as prescribed and have an undetectable viral load have no risk of transmitting HIV to an HIV‐negative sex partner. A lot of people don’t know about U=U, and we are asking you to join in solution to raise the awareness of U=U.
Who can join this study?
Anyone who is 18 years or older is eligible to participate in the contest.
What will happen if you join this study?
If you agree to be in this study, we will ask you to do the following things:
1) You will be asked to complete a brief online survey. This will take less than 5 minutes. The survey contains questions about your background, such as your age, race/ethnicity, sex at birth, gender identity and HIV status. The survey will not collect any personally identifiable information. If there are
questions you do not want to answer, you do not have to answer them. Please take the survey only once.
2) You will be asked to submit your ideas online on how to promote awareness of U=U. The submissions can be written descriptions (150 words or less), images, drawings, posters, videos, or taglines describing how to raise the awareness of U=U. You will be asked to provide your name and email address. The open contest submission will open for 3 months. You can submit multiple entries.
3) All contest entries will be evaluated by a panel of judges and community voting. If your entry has been chosen as one of the top three finalists, you will win a prize and we will work with you to develop a full public health campaign using your idea.
4) We will host a public announcement of the top three finalists. If you were chosen as one of top three finalists, other people will know you are taking part in the contest. It is up to you to decide what information you want to share or not share in this contest. Feel free to use any user name when submitting your idea(s). Please choose one of the following options:
- If I am chosen as one of the top three finalists, I agree to share my name or username that I provide in the contest with the public
- If I am chosen as one of the top three finalists, I do not agree to share my name or username that I provide in the contest with the public
What happens to data that are collected in the study?
The information you provide in the brief online survey are research data (“data”). The data we collect from you in the survey will help advance science and public health. As a participant, you will not own your research data, and you will not benefit financially from any new product or idea that might arise from our work. Sharing of research data is often done to increase what scientists can learn. The data you provide us might be shared
- directly with other researchers, funders, government agencies, publishers of papers
- through government or other databases/repositories
People at Johns Hopkins who work on the study or who need to make sure the study is being done correctly may see your data. After the study is complete, we may share your data with other researchers. If we share your data with other researchers, they will need to sign a confidentiality form. If we share your data, it will be de‐identified, meaning your name, contact information, or any other information that could be used to determine who you are will not be included.
We will do our best to protect the data you provide, and sharing of data would normally only be done anonymously (that is, the data would not be linked to your name or contact information). If data are shared with identifiers, further review and approval by an ethical review board might be required. If you are not comfortable with the use of your data in future research, you may not want to participate in this study.
What are the risks or discomforts of the study?
Participation in this study is completely voluntary. You can refuse or stop participating in the study at any time, and for any reason. Some questions in the survey may make you feel embarrassed or uncomfortable. You do not have to answer any question you do not want to answer.
If you agree to join the study, other people will know you are taking part in the contest. It is up to you to decide what information you want to share or not share in this contest. Feel free to use any user name. We will make every effort to protect your identity. All of your information will be kept confidential. Also we will keep all data in a highly secured server.
Please be aware, however, that as with anything involving the internet it is not possible to completely guarantee the confidentiality of your information while it is in the process of being sent electronically. Findings from this study may be shared through journal articles, online and print, and presentations. Your name or any other individual information by which you could be identified will not be shared. If you have questions or want a copy or summary of this study’s results, you can contact the researcher at the email address below.
How will the confidentiality of your data be protected?
Your research data are protected by a Certificate of Confidentiality. This Certificate allows us, in some cases, to refuse to give out your information even if requested using legal means.
It does not protect information that we have to report by law, such as child abuse or some infectious diseases. The Certificate does not prevent us from disclosing your information if we learn of possible harm to yourself or others, or if you need medical help.
Disclosures that you consent to in this document are not protected. This includes putting research data in the medical record or sharing research data for this study or future research. Disclosures that you make yourself are also not protected.
What are the potential benefits to being in the study?
Our main focus is to provide new knowledge. There is no benefit directly to you for completing the survey. The information that you provide will be used to help us understand who has participated in this contest, and findings can potentially help us to improve future contests to better engage the community.
You won’t benefit personally or be paid from participating in the contest but you will have a hand in helping your local community and society! You don’t have to pay anything to participate!
There is no payment for participating in this research study. You may win a prize if one of your ideas is chosen as one of the top finalists. You have the chance to win a prize by simply submitting your ideas or voting for your favorite entries.
What are your options if you do not want to be in the study?
You do not have to join this study. If you do not join, your care at Johns Hopkins Hospital or any affiliated clinics will not be affected.
Can you leave the study early?
- You can agree to be in the study now and change your mind later.
- If you wish to stop, please tell us right away.
- Leaving this study early will not stop you from getting regular medical care.
If you leave the study early, Johns Hopkins may use or share your health information that it has already collected if the information is needed for this study or any follow‐up activities.
Why might we take you out of the study early?
You may be taken out of the study if:
- Staying in the study would be harmful.
- You fail to follow instructions.
- The study is cancelled.
There may be other reasons to take you out of the study that we do not know at this time.
What other things should you know about this research study?
What is the Institutional Review Board (IRB) and how does it protect you?
This study has been reviewed by an Institutional Review Board (IRB), a group of people including scientists and community members, that reviews human research studies. The IRB can help you if you have questions about your rights as a research participant or if you have other questions, concerns or complaints about this research study. You may contact the IRB at 410‐955‐3193 or email@example.com.
What should you do if you have questions about the study, or are injured or ill as a result of being in this study?
Call the principal investigator, Dr. Cui Yang at 410‐502‐5368. If you wish, you may contact the principal investigator by letter. The address is on page one of this consent form. If you cannot reach the principal investigator or wish to talk to someone else, call the IRB office at 410‐955‐3193.
You may end your consent at any time. Information obtained and used before you end your consent will continue to be used for research. If you wish to end your consent, you can navigate away from or close the survey webpage.
Clicking the button below indicates your agreement to participate in this study.
I am 18 years of age or older, and I agree to take the survey and participate in the contest