Enrollment Process

What should I do if I want to participate in a clinical trial?

  1. Review the list of Categories of Clinical Trials to see which studies are currently open for enrollment.
  2. Refer to the list of Participating Sites for each study and contact your nearest Clinical Research site. 
  3. The contact person at the site will answer your questions about general study requirements and will help determine if there is a specific study for which you may be eligible. Your conversation will be completely confidential. You do not need to give your name or phone number.
  4. If you are interested in finding out more about the studies that are available and if you are eligible for any of them, you should make an appointment for a screening visit at the clinic.
  5. Obtain a copy of your medical records from your primary care provider that includes your HIV-related and other significant medical history, anti-HIV medication history, and recent laboratory results.

What happens during the screening visit?

  1. During the screening visit, the study will be reviewed in detail and you will have an opportunity to ask any questions. If you decide to participate, the study nurse will review a consent form with you and ask you to sign the form to give us permission to proceed with the screening evaluations.
  2. The evaluations done during the screening visit are to determine whether you would meet the eligibility criteria. In most cases blood samples will be drawn for laboratory tests, including a complete blood count, chemistries, HIV viral load, and CD4 count, and a physical examination will be done by the study doctor. The screening visit will take about 1 hour. You may need to return to the clinic for a second (pre-entry) visit before entering the study.

What happens during the clinic trial?

If screening tests show that you qualify to enter the study, the study nurse will schedule an entry visit. You will receive your study medication at the entry visit. There will also be additional lab tests done to get baseline values before starting your study treatment. During this visit the study medication dosing will be reviewed with you and you will receive information about possible side effects and phone numbers to call with questions or problems.

The frequency of your visits to the clinic will depend on the study. Studies vary in length from a few weeks to several years with follow-up visits every 4 to 8 weeks. Most follow-up visits consist of a brief physical exam, a review of your study medications, asking about symptoms and doing lab tests.

Will my primary care physician receive information about the clinical trial?

The CRS staff will be in close communication with your primary care or referring physician. Your physician will receive copies of the lab results obtained through the study. The study staff will also contact them if you have any trouble with the study medication to discuss management and any changes needed in your study medication.