Project title: PrEP 4 Health Survey (Protocol #31506)
You are being asked to provide your consent to participate in research. The purpose of this research is help create education materials for people taking PrEP. Your participation is completely voluntary.
Principle Investigator
The study is being conducted by Dr. Christopher Wheldon from Temple University College of Public Health.
Sponsor
The research is funded by the National Institutes of Health & Temple University. This research is covered by a Certificate of Confidentiality from the National Institutes of Health. This means that the researchers cannot release or use information or documents that may identify you in any action or suit unless you say it is okay. They also cannot provide them as evidence unless you have agreed. This protection includes federal, state, or local civil, criminal, administrative, legislative, or other proceedings. An example would be a court subpoena. There are a few exceptions: (1) Government oversight: Certain government agencies might need your information for program checks or FDA regulations; (2) Your choice: You can always choose to share your information with others, like your doctor or insurance company; (3) Legal requirements: We might need to report things like child abuse, threats to harm yourself or others, or if this research finds that you have a reportable disease, as required by law; (4) If you say it’s okay, your information can be used for things like your medical treatment.
Why am I being invited to take part in this research?
You are being invited to take part in this research because you are current taking PrEP for the prevention of HIV.
Who is eligible to be in this research?
You are eligible for this research if you are 18 years or older and are currently taking PrEP for the prevention of HIV.
What happens to me if I agree to take part in this research?
If you agree to take part in this research, we will ask for your consent to participate.
- You will be asked to complete an online survey. There will be questions about your attitudes and beliefs regarding topics like cancer, HIV, and vaccination. Some questions will ask about your own sexual behaviors and healthcare experiences.
- Taking part in this research is voluntary. Whether you take part is up to you. If you decide not to take part in this study or if you change your mind later, there will be no penalties or loss of any benefits to which you are otherwise entitled.
- You can stop the study at any time or skip any questions you don’t want to answer.
- For taking part in this research, you will be offered a $50 gift card.
How long will I be in this research?
The one-time survey that will take about 15-20 minutes to complete.
Who can answer my questions about this research?
If you have questions, concerns, or complaints about this research you can talk to the research team. Dr. Christopher Wheldon is the principle investigator of this study. His contact information is: Temple University, 1301 Cecil B. Moore Ave., Philadelphia, PA 19122
(215) 204-5184 | chris.wheldon@temple.edu
This research is overseen by an Institutional Review Board (“IRB”). An IRB is a group of people who review research studies. You can talk to the Temple University IRB at (215) 707-3390 or email them at irb@temple.edu.
Could being in this research hurt me?
This research is considered minimal risk. There is a mild risk of breach of confidentiality. Your participation in this research will be held strictly confidential, however, confidentiality cannot be guaranteed. Your name, email address, or phone number will not be included in the survey data. Results will only be reported as aggregate statistics and will not be attributed to your individually.
Will being in this research benefit me?
There are no direct benefits to you from this research other than you may learn more about a health issues and decisions facing people your age.
Who other choices do I have besides taking part in this research?
This research is voluntary. You can choose not to take part in this study. You can stop the survey at any time or skip any questions you do not want to answer.
What happens to the information collected from me?
Your private information may be shared with individuals and organizations that conduct or watch over this research, including, the NIH, Temple University and Temple University’s Institutional Review Board (IRB). Your responses to the survey questions will be combined with the other participants of this study for statistical analyses. The findings will be used to create educational materials for people taking PrEP. Upon completion of the study, we will preserve and shared the data via a data repository. The rationale for sharing them is to promote the study of an under-researched area. Your name, email address, or phone number will not be included in the survey data or shared with anyone outside of the research team. All data will be stored on a protected server at Temple University. Your email and/or phone number will only be used to provide you with the survey link and send a gift card. Your contact information will be kept separate from your survey responses and could only be linked by a unique study ID number that will be assigned to you. This information will be kept in a separate file only accessible by Dr. Wheldon. After you complete the study (or choose to withdraw) and your gift card has been sent, Dr. Wheldon will delete the file. If you choose to provide contact information to participate in a future study, this information will be stored on a separate file on a protected Temple University server only accessible by Dr. Wheldon.
What happens if I agree to be in this research, but I change my mind?
You can stop taking part in this research at any time or skip any questions you do not want to answer.
Will I be paid for taking part in this research?
For taking part in this research, you will be offered a $50 gift card. You will be asked to provide an email address to deliver the electronic gift card. This information will be collected separately from your survey responses. Federal tax law requires you to report this payment as income to the Internal Revenue Service. You may be asked to tell us your social security number, full name, address, or other identifying information in order to compensate you for your participation. We may request this because we are required to report cumulative payments more than $599.00, to the Internal Revenue Service.