The Clinical Trials Process

Be The Generation To End The AIDS Epidemic

The Clinical Trials Process

Why do people participate in clinical trials for HIV prevention?

People join trials for many reasons. Some are altruistic and want to give back to their community. Others have been personally impacted by HIV/AIDS and want to honor a friend or loved one by getting involved in research. Whatever their reasons, scientific progress could not be made if it weren’t for wonderful study volunteers! Study volunteers make an informed decision to join a trial to help find out if a product is safe, acceptable, and effective. Anyone interested in being in a trial goes through an informed consent process to make sure they understand everything about the trial, including the risks and benefits of participating, what they will need to do, and to ensure that any questions they have are answered.

What are the different phases of clinical trials for HIV prevention?

Clinical trials are conducted in a stepwise manner and under strict government and community oversight to protect study participants. Clinical trials for HIV prevention are carried out in phases:

Phase 1: basic safety and acceptability; conducted in a small group of people for a short period of time.

Phase 2: expanded safety and acceptability; conducted in a larger group of people (perhaps several hundred) for a longer period of time; may provide very early signs that the product could be effective.  Sometimes Phase 2 trials are differentiated between Phase 2A and Phase 2B trials; Phase 2A trials answer questions about product safety while Phase 2B trials may provide early signs about a product’s effectiveness in addition to answering questions about safety.

Phase 3: long-term safety and to see if the product can prevent HIV; conducted in a group of thousands of people for a few years; to see if a product works to prevention HIV.

What are the risks of being in a clinical trial for HIV prevention?

Some of the procedures may cause discomfort or be time-consuming. It is also possible that the product being tested could cause side-effects. Every person makes their own decision about enrolling in a trial, and can choose to withdraw from the study at any time for any reason. If the clinic staff feels it is not in a participant’s best interests to continue in the trial, they will let the participant know. It is also important to understand that ethics committees and other groups work to ensure that the rights of trial participants are protected and that they are kept safe through a safety oversight process that takes place throughout the entire trial.The safety of study participants is the top concern of the research team.

Are clinical trial participants exposed to HIV from being in the trials?

No. Clinical trials sponsored by the National Institute of Allergy and Infectious Diseases do not increase your chances of being exposed to HIV. In fact, to reduce the risk of HIV for people participating in trials, everyone receives frequent HIV testing and risk reduction counseling, including information about the correct and consistent use of condoms, safer behaviors, PrEP, and routine testing and access to treatment.

Are people paid to participate in clinical trials?

Clinical trials compensate volunteers for their time and participation. The amount of compensation varies between trials and is usually related to how long the clinic visits are and how burdensome the clinical procedures may be. Some research sites are also able to provide assistance with parking or transportation costs.

How do studies protect the health and rights of participants?

Protecting the health and respecting the rights of participants are top priorities for everyone in the HIV Prevention Trials Network (HPTN), HIV Vaccine Trials Network (HVTN), and Microbicide Trials Network (MTN). Without volunteers, we would never be able to find new methods for preventing HIV infection.

A first step in protecting the rights of study participants is to give them information about the study before they join. This process is called informed consent. Clinic staff give people information about the study products and the study procedures, the possible risks and benefits to participants, and the rights that they have. These include the right to receive any new information about the study that could affect whether they want to stay in it, and the right to leave the study at any time.

During the study, the clinic staff monitors participants to make sure the study products are not causing any health problems. The clinic staff also asks participants about any social problems they may experience from being in the study.  If a participant has a health or social problem related to being in the study, clinic staff helps them.

There are also several groups involved in protecting participants’ rights and well-being:

  • A study safety review team and an independent safety monitoring board regularly look at the health information from the study to decide whether it appears safe to continue giving the study product or the placebo.
  • An Institutional Review Board (IRB) or Ethics Committee (EC) reviews and monitors the study plan for each clinic doing the study, including the information that is given to people about the study, study progress, and health problems in participants. The IRB/EC also looks to make sure that participants’ rights are being respected.
  • The US Food & Drug Administration (FDA) also reviews the study. The FDA enforces US laws about research in humans and the use of experimental products in research. Regulatory agencies from other participating countries also review the study.  These groups enforce the local laws about research in humans and the use of experimental products in research.  
  • Each study clinic has a Community Advisory Board (CAB). Its members are local people who advise the researchers and bring the concerns and interests of the community and study participants to the researchers. CAB members are also part of the team that develops each study.  They also help develop or review the information that is given to participants. 

How long does it take to find out if a particular HIV prevention product works?

All drugs go through a lengthy development process. Before HIV prevention products are tested in people, they must go through a range of tests in the laboratory. Then, products go through a pre-clinical research phase to answer basic questions about their safety before they are tested in humans. Finally,  there are a series of different studies with humans called “clinical trials” to see if the product is safe and effective. The whole product development process usually takes at least 10 years (until a new product is fully tested and available on the market).

Why do we need to conduct clinical trials on new products for HIV prevention when we already have Truvada as pre-exposure prophylaxis (PrEP) and condoms?

No single HIV prevention product will be right for everyone. Having additional options could help protect against HIV in people who are unable or reluctant to use condoms every time they have sex, or who do not want to take a daily pill (PrEP) to reduce their risk of HIV.  Just as there are multiple choices in contraception to prevent pregnancy, having choices in HIV prevention makes it more likely that people will find a particular product that meets their needs.