It's natural to have many questions about clinical trials, and it's important to get them answered. Below are answers to the most frequently asked questions about clinical trials, and information on how to contact the AIDS Clinical Trial Unit staff. Scroll to the end of this page to contact our staff. They are happy to help you.
What is a clinical trial?
A clinical trial is a careful research study that examines the benefits and risks of news drugs or new drug combinations for persons with HIV/AIDS. There are several types of clinical trials:
Phase 1: Study medication given to a small group of people to measure a drug's safety.
Phase 2: Study medication given to larger groups of people to measure a drug's safety and effectiveness.
Phase 3: Study medication given to very large groups of people to verify a drug's safety and effectiveness.
What drugs are tested?
ACTU staff test different kinds of drugs, including the following:
Are the trials safe?
Yes, the trials are safe. The FDA approves all research studies before patients voluntarily enroll in a clinical trial. The OSU Institutional Review Board also reviews each study to safeguard the rights of volunteers. All studies provide at least the current recommended care. Volunteers are constantly monitored and are told of all known risks. They must consent before participating in a research study. In addition, the Community Advisory Board (CAB) provides input to ACTU staff. The CAB works to create a partnership between HIV-affected communities and ACTU researchers to advance knowledge of HIV.
Do I need my own doctor?
Yes. With your permission, your doctor will receive lab results and other health updates while you are in a research study. If you need a doctor, expert HIV specialty and primary care is available by appointment. Click here if you need a doctor.
Why should I volunteer to enroll in a clinical trial?
There are many good reasons to enroll in a clinical trial. Volunteers are the first to have access to new drugs not yet available to the public. Participants are closely monitored by expert physicians and nurses while on experimental drugs and study drugs are provided free of charge. Volunteers also have an opportunity to help others by contributing to medical research aimed at finding better treatments for HIV infection.
You owe it to yourself to learn about clinical trials. Talk first with your doctor and loved ones. You can also call the AIDS Clinical Trials Unit. The ACTU staff is trained and happy to respond to your needs and concerns. To talk with someone about a clinical trial, please contact our peer support program at (614) 293-8112.
How will I know what studies (protocols) are available?
All studies are based on a set of rules called a protocol. Because most studies test new treatments on groups of volunteers who are alike, each protocol has very specific health requirements that volunteers must meet. After enrolling in the ACTU program, volunteers are kept informed of all new studies. Click here to see descriptions of different types of studies.
How will I know if I qualify for a research protocol?
Visit One: During your first visit to the ACTU you will have an interview with our screening counselor and a nurse will draw blood samples. The blood and interview are used to determine the extent of your HIV infection.
During this first visit you will also be given information about our Peer Support Program. This program enables new participants to meet with a trained volunteer who is HIV positive. Optional participation in this one-on-one peer helping program allows new volunteers to meet a trained HIV positive person who has been a study volunteer. This volunteer is available at your second visit to help answer your questions about participating in studies and general questions about living with HIV infection. Plan to spend about one and a half hours completing your first visit with the screening counselor.
Visit Two: The following week you will return for a second visit with our screening nurse. The screening nurse will check your skin tests and will explain your CD4 counts and other lab test results (for some studies, HIV-viral load testing is also done). Please be prepared to provide the nurse with the dates of your first positive HIV test and any HIV related infections or hospitalizations. If you are taking any medications we ask that you bring your medicines with you. The nurse will give you information about your HIV infections and how you can maintain your health.
Our screening nurse will also tell you about current protocols. You will be given detailed information about the protocols for which you may be eligible, and you will have an opportunity to ask questions. During this visit you will have the opportunity to meet with a peer support volunteer. This second visit with the nurse will last about 45 minutes. If you are eligible for a protocol you will be referred to a protocol nurse who will explain the study and any necessary testing.
If you do not qualify for a study, you will be asked to return in the future to update your medical information. We want to maintain contact with you because you may be eligible for a future protocol. With your consent, we will mail you periodic newsletters which describe upcoming studies and new information about HIV.
What are the risks of being in a clinical trial?
Investigational drugs may be less beneficial than expected or may be harmful. Study drugs may have unanticipated side effects. Protocols require a commitment of time for trips to the research unit.
What questions should I ask as I consider enrolling in a protocol?
Before beginning participation in a research protocol, all volunteers are given a detailed explanation of the study. If you are considering a protocol you may want to ask these questions:
What is the purpose of the study?
What are the drug(s) side effects?
Will placebos (sugar pills that look like the study drug but do not contain the medication) be used on the protocol?
What other treatment options do I have?
Are there any drugs I must not take while in the protocol?
How long will the study last?
How often will I need to visit the clinic?
Who will pay the costs of the study?
Am I committed enough to stay in the trial until it's completed?
Will my participation in the study limit my participation in future protocols?
Will I have a chance to continue receiving the study medication after the trial ends?
How soon after completing the trial will I learn which treatment I was receiving?
When will I get the study results?
Who provides my care at the ACTU?
Protocol care is provided by a staff of registered nurses and physician specialists trained in Infectious Diseases. The ACTU physicians are members of the OSU Hospitals staff and are either faculty or fellows in the OSU College of Medicine. In addition, all research volunteers must have a primary care doctor for their routine medical care. If you already have a primary care physician, we want to provide this doctor with information about your research program participation. For this reason we ask that you bring the name, address, and phone number of your doctor to your first appointment.
If you do not have a physician, we can help you locate one. Expert medical care is available on site at OSU Hospitals Clinics, and referrals for dental, psychological, nutritional, and legal services can also be made. Our social worker and nurses can also provide you with information about support groups and other community services.
Are my ACTU records confidential?
We recognize the sensitive nature of HIV infection and our staff appreciates the importance of confidentiality. During the screening process, all lab tests and records are identified by a patient number only. Persons who eventually participate in a protocol of investigational medications do have research records that identify them by name. These research records are kept separately from routine medical records. No records are ever released without your written permission. A special release form must be signed by you before any records are released. We ask for your permission to keep your doctor informed of your health and your progress in the research program.
Are there any charges for services at the ACTU?
Most ACTU studies are funded by a federal research grant. Additional studies are sponsored by pharmaceutical companies. Screening visits (to determine if you are eligible for a protocol) are always free and there are no charges for the experimental medicines on the research studies. On some studies, the physician visits and/or laboratory tests are also free. Before you enroll in any study you will be told if there are any charges associated with the study. Please let the screening counselor know if you anticipate any financial difficulties. No one is ever denied access to studies because of an inability to pay related expenses. Because our funds do not cover routine medical care, usual medical care expenses are the patient's responsibility. If additional physician visits, lab tests or medical procedures are required to manage a health problem that develops while you are on a protocol (i.e. a side effect of the study medication or a new illness) you will be responsible for the costs of this care.
Can I use my health insurance if there are bills on my protocol?
If there are any expenses on your protocol, with your permission, we will bill your insurance company. Because many insurance plans restrict which hospitals and doctors that must be used, please verify your coverage. Also, please note that all insurance companies require medical information when claims are submitted. Your authorization to file a claim automatically authorizes the insurer to have access to your medical record. If you prefer not to use your insurance, bills can be sent directly to you. Please tell our receptionist to mark your account as "self-pay"
Where is the ACTU located?
The ACTU is located in the Infectious Diseases Clinic on the fourth floor of McCampbell Hall. Parking is provided free of charge for all research program visits. Please park in the Safe Auto Parking garage; the entrance is on Westpark which is between Medical Center Drive and West 10th. Avenue or the South Cannon Drive garage at the corner of Cannon Drive and 10th Avenue. McCampbell Hall is located on the corner of Cannon Drive and 10th. Avenue. When you arrive in McCampbell Hall thake the elevator to the 4th floor and stop at the desk and let the receptionist know you are here for a research appointment. During your visit you will be given a voucher for free parking. For general directions to our location, click here.
How do I join a clinical trial?
Call us at (614) 293-8112 and ask for our screening nurse. All information is strictly confidential.
The Ohio State University Wexner Medical Center
Infectious Diseases Clinic
McCampbell Hall, 4th Floor
1581 Dodd Drive
Columbus, Ohio 43210
(614) 293- 8112