You may choose to participate in a clinical trial, but the researchers must determine whether you are eligible. Each clinical trial includes people who have the same or very similar health profiles based on specific inclusion and exclusion criteria. When selecting participants, researchers may consider these or other factors: CD4 or T-cell count, HIV viral load, past medical history, medication history, current medical status, and your willingness and ability to follow all of the trial's instructions and schedules.
Before you agree to join a clinical trial, researchers must be sure that you understand everything about the study - risks, benefits, obligations, etc. The staff will explain the study in detail. Then they will ask you to read and sign an informed consent document and will give you a copy of the consent form.
There are some risks to participants in clinical trials, but the federal government has imposed mandatory safeguards to protect them. Each clinical trial is reviewed by an Institutional Review Board (IRB), a diverse group of people that must approve the trial. The IRB periodically reviews the clinical trial operations to ensure that the risks are as low as possible, and worth the potential benefits. Some trials also have community advisory boards. In addition, all study participants must read and sign informed consent documents. These documents ensure that participants understand the risks and potential benefits as well as their rights and responsibilities should they decide to participate in the study.
Study participants may be among the first people to try a new experimental medication. Other benefits include receiving HIV/AIDS health care related to the research study by HIV-experienced physicians and study nurses and helping others by adding to the medical information about HIV/AIDS. The medications, clinic visits, evaluations, and laboratory tests required by the research study will usually be free of charge. Medical information obtained during the clinical trial can be shared with your own health care provider.
A study medication may not be helpful; in fact it may be harmful to you, or have side effects. The expected side effects are listed in the consent form and will be reviewed with you by the study staff. While in the study, you can use only treatments approved by the researchers - some you are taking now may not be allowed. After your part of the trial ends, you may not be able to continue receiving the tested drug - even if it worked for you.
Check out the following videos for participant perspectives in their own words: