Frequently Asked Questions
Below is a list of the most Frequently asked Questions about the ACTU.
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Q: Do I have to be part of the research program just because I am a patient at the Infectious Diseases Clinic?
A: No, being part of research is a personal choice. If you decide not to, it will NOT affect how you are treated as a patient in any way.
Q: If I am in a study will I receive a placebo ('sugar pill')?
A: Rarely. When we test new therapies, we compare them to conventional therapy (what your doctor would prescribe) to see if they work better or not as well. Not all research studies include a placebo. Sometimes, a new drug will be developed which is intended as an add-on to your existing therapy. In that case, you might receive the placebo instead of the new add-on drug; however, you will still take all your regular HIV medicines. This information will be explained in the informed consent document which you will read and discuss with the research nurse before the study begins. You will be asked to sign this consent form when you enroll. If you don't feel comfortable participating in the study, you can always change your mind or say no.
Q: Will I be a guinea pig if I am in a research study?
A: No. The drugs used in our treatment studies have been tested by HIV infected and/or uninfected volunteers and have been found to be safe. Often times, the medicines are already approved by the FDA for other uses, and we are just trying them with a new combination of drugs.
Q: Will I receive money for being in a study?
A: Generally, no - participation in research is on a voluntary basis. However, some studies offer compensation for your time and travel.
Q: If my HIV doctor is not part of the IDC, can I still be part of the research program?
A: Yes! We will ask you to sign a release of information so that we can receive your medical information from your physician and so that we can share your study information with your doctor, which will make it easier for him or her to monitor your progress while you are participating in studies. This will also allow us to review your medical history and labwork that you had done with that doctor.
Q: If I sign up for a study that provides HIV medications and laboratory tests, will I still need to see my doctor?
A: Yes. Since you will see a nurse during most of your study visits, you will need to continue seeing your doctor so he or she can monitor your health and help you handle any other ongoing medical issues you may have.
Q: Where is the AIDS Clinical Trials Unit (ACTU)?
A: We are located on the first floor of Holmes Hospital, at the corner of Eden Avenue and Albert Sabin Way in Clifton.
Q: What happens if the medicine doesn't work?
A: If your therapy doesn't work, we will try different therapies so that you receive the best possible outcome. This may mean that you have to leave a study, but that's okay! Your health always comes first.
Q: Who reviews a research study to make sure that the patients are safe?
A: The Institutional Review Board (IRB) at the University of Cincinnati reviews all research studies involving human volunteers to ensure they are ethical and safe. We are closely monitored by the IRB, as well as state and federal regulatory agencies, to ensure that our research practices are legal and ethical.
Q: What days and time are you open?
A: We usually see patients Monday through Thursday, 8am to 4:30pm. We also offer a Saturday morning clinic once a month for those who cannot see us during the week. When necessary, you can be seen before 8am and after 4:30pm when arrangements are made with your research nurse.
Q: What if I change my mind and decide that I no longer want to be in a study?
A: You may withdraw from a study at any time, for any reason. If you decide to withdraw early, this does not affect your care with your physician.
Q: Is there a way to talk to other patients who have been on a study before I sign up?
A: Of course! Just ask the Screening Coordinator or one of the research nurses; we'll be happy to have someone give you a call.
Q: If my Research Nurse & Primary Care Physician are unavailable, who else will I be able to contact?
A: We have three clinical research assistants in our office who will be happy to direct your call to another nurse or physician.
Q: Can I see my research records or get a copy of them?
A: Yes! You always have the right to inspect your medical records or get a copy.
Q: How often do I have to come in for visits? How long will they last?
A: This will depend on what study you are on - some require more frequent visits than others. This information is in the consent form that will be reviewed with you prior to going on study. An initial study visit will usually last about 1-2 hours; follow-up visits typically last ½ - 1 hour.
Q: Who/ what decides what study I can be in?
A: There are many reasons you might qualify for a study - age, gender, other infections (like hepatitis), or even what medicines you are taking now or have taken in the past. The study nurses will review your records to determine if you are eligible to take part in a trial. Your eligibility for a study is confirmed by the Principal Investigator (physician-in-charge).
Q: What happens when the study is over? How will I get medications? Can I find out the results?
A: When a study ends, your nurse will help you transition to a medication regimen that works for you. This may involve continuing on the medicines you started taking during the trial, or returning to a previous regimen. Your study nurse will work together with you and your physician to make sure you have all the treatment you need, and most importantly, that there is not an interruption in your therapy. If you have been receiving medication for free on a treatment study and cannot afford your medication once the study ends, help is available through the Ohio Drug Assistance Program (OHDAP) and possibly other sources. We will refer you to a social worker locally who can help you apply for the assistance you need. Upon completion of the analysis of all the data collected from the clinical trial study you will receive information on the results of the study. If during a study preliminary results becomes available which may affect your willingness to remain in a study, we will notify you of that information.
Q: What if I do not have a means of transportation?
A: When on a study, if needed, you will be assisted with transportation. This is discussed when you first meet with your nurse. If your needs change during the course of the study, your nurse will work with you to address this.