Where can I find information about trials?

If you are living with HIV and interested in clinical trials, talk to your doctors or local AIDS organization about possible alternative treatments and trials in your area.

The CIHR Canadian HIV Trials Network (CTN) and CATIE collaborate to produce a registry of enrolling HIV clinical trials in Canada. The registry is published on a poster and each trial is posted on the websites of both organizations.

The CIHR Canadian HIV Trials Network is a federally funded organization whose mandate is to develop treatments, vaccines, and a cure for HIV disease and AIDS through the conduct of scientifically sound and ethical clinical trials.
CATIE offers treatment information, helping people living with HIV and their caregivers make informed healthcare decisions.

There are several steps to take before you can participate in a clinical trial, but anyone can apply.

If you find a particular trial in which you are interested, contact your family doctor. He or she can refer you to the site investigator or you can call the site directly. A telephone screening interview with the trial nurse or another member of the trial staff will likely provide enough information for you to see whether you can participate, according to the entry criteria. Anyone who meets the initial criteria and is interested can make an appointment for a screening visit, the next step in the qualifying process.

 

How do I make a decision?

At the end of the screening interview, you may be asked if you want to enter the trial. At this point, you will receive a detailed information package, including an informed consent form.

Once you’ve reviewed the information and if you’re still interested in participating, it is often helpful to discuss with the trial nurse and/or doctor what the trial will mean to you, and how it will impact your health and lifestyle. They will also explain the known, and potential, benefits and risks.

Take all the time you need to make your decision about participating: discuss the trial with your doctor, partner, friends, family or your local AIDS organization. When making a decision, it is important for you to consider all factors, including the time commitment, the benefits and the possible risks.

The benefits and risks of participating in clinical trials include:

The benefits and risks of participating in clinical trials include:

Benefits

  • Being among the first to benefit if an experimental therapy is effective.
  • Having your health monitored more often, which may be beneficial.
  • Being part of a process that develops new treatments, vaccines, microbicides and New Prevention Technologies and helps other people living with HIV.

Risks

  • Having no guarantee of a personal benefit from the trial.
  • Experiencing side effects that could be dangerous or make your health worse, including being admitted to hospital.
  • Having to stop other medications that are working well.
  • Not being eligible for specific trials in the future.
  • Not knowing who is receiving the experimental drug.
  • Making changes in lifestyle, such as taking medication at regular intervals, or not eating certain foods.
  • Facing stigma and discrimination.

What is an informed consent?

Informed consent is a process in which the risks, benefits, and requirements of a trial are clearly explained to volunteers.
If you meet the preliminary study entry criteria and are strongly considering taking part in a trial, you will be asked to give your informed consent. The informed consent form should fully explain in plain language the trial as well as the possible risks or dangers. Informed consent forms usually require the participant’s signature, the signature of a witness and the signature of the principal investigator or designated study staff.

Giving your informed consent means that you understand the trial. In other words:

  • You understand that the trial is a scientific experiment, and there may be risks and dangers to your health.
  • You have been told the specific reasons for doing the trial, the drugs you might be given, the number of visits and the kinds of lab tests required.
  • You have the information you need to decide whether to take part in the trial.
  • You understand your rights and responsibilities.

If you are concerned about any of the trial requirements, talk to trial staff before giving informed consent. They may be able to make some exceptions, or you may decide not to take part in the trial after all.

You will receive a copy of the signed informed consent for your records. However, remember that signing the form is not the end of your consent. Informed consent is an ongoing process. Investigators have a responsibility to continue to inform you of any new information about the drug you are taking, or any information that would influence your decision to participate in the trial. In fact, the investigator needs your consent that you wish to continue to participate.

As a participant, you have the right to leave a clinical trial at any time.

Leaving a trial will not affect your regular health care or your ability to participate in other trials.

Once you sign the informed consent form, you are considered enrolled in the trial. However, before you can participate, you may first be asked to come to the study site for a screening visit to ensure you meet the more detailed study entry criteria.

What happens at the screening visit?

All trials examine a specific aspect of a treatment, which means that participants must meet strict entry requirements called inclusion and exclusion criteria. While broad criteria can be assessed during the preliminary screening interview, an in-person screening visit is necessary to assess detailed criteria, which may include a physical exam and testing.

Inclusion criteria ensure that relatively similar people take part in a trial. This allows researchers to make reliable comparisons about the way the experimental treatment works. Some examples of inclusion criteria might be that a participant “must be HIV+” (or “must be HIV-negative” for studies on prevention methods) and “must have a specific CD4 cell count.”

Exclusion criteria protect people who might be harmed by the study drug. For example, anyone who is being treated for an active illness, or who is pregnant will likely be excluded from a trial. Until recently, pregnant women have seldom been allowed to enter drug trials in case the drug harms their fetus. However, recent guidelines in the United States and Canada have made it increasingly acceptable to include pregnant women in particular circumstances.

At the screening visit, you will be asked a variety of questions about your health, your medical history as well as the drugs and treatments you use. You will also have an extensive physical exam, along with lab tests, such as blood tests or x-rays.
Once researchers are satisfied that you meet all the entry criteria, you are ready to move on to the clinical trial itself.

About Clinical Trials

Participating in a Clinical Trial

Once You’re Enrolled

Other Things to Consider

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