Study Participants are the Heart and Soul of the HVTN

Participants volunteer their time and so much more! The following pages will help you understand more about participating in one of our studies and give you the facts about some common misconceptions. 

Francisco Rentas explains HIV testing

Getting the Right Test for HIV

Getting the right test will prevent an incorrect diagnosis of HIV.  Your study site or VISP Testing Service can provide the right test.  Visit our frequently asked questions for more information.

Nurse explains consent form to patient

Participant’s Rights

This document provides a short list of the rights and responsibilities you have while you participate in an HVTN clinical trial. The purpose of this Bill of Rights and Responsibilities is to help research participants act on their own behalf and in partnership with study staff.

It Takes a Village

The HIV Vaccine Trials Network is an international partnership of research scientists, clinical trial sites, laboratories, regulators and ethicists, participants, volunteers and community representatives working with industry, academia, and governments in the global search for a preventive HIV vaccine.

Volunteer FAQs

AIDS, the disease caused by the human immunodeficiency virus (HIV), shows no signs of diminishing. More than 35 million people worldwide are now infected with HIV. Finding a safe and effective HIV vaccine that will protect people is a formidable task. We cannot do it without the help of volunteers.

We are recruiting healthy, HIV-negative people ages 18 and up, who are committed to making a difference in the fight against HIV. Volunteers need to live within the area of the study clinic location for the duration of the trial (usually at least 12 to 24 months). Please check with the clinic in your area for more details about studies they have available.

No. There is no way to get HIV or AIDS from the vaccine. Because the vaccines are man-made, there is no HIV in the vaccine, either living or dead. They cannot cause HIV or AIDS.

In general, the vaccines are created from genetically engineered pieces of proteins copied from HIV that are designed to stimulate a response in your immune system. However, each study tests a different vaccine. If you come in for a screening appointment, the clinic staff will go over the details of the study vaccine with you.

An HIV vaccine trial is a study to find out how the body’s immune system reacts to the vaccine when it is administered to people. It is a carefully controlled test in which people receive an experimental vaccine to find out if it is safe and causes an immune response. The experimental vaccines have already been tested in animals and shown to be safe to move forward for testing in people. 

You will first be asked some basic eligibility questions to see if you qualify for a trial. If you meet these initial criteria, you will then go on to have a screening visit where a clinician will explain the plan for the trial (known as the protocol) in full detail. A physical exam, some blood tests, and an HIV test will be done. Each study is different, but a typical trial lasts between 12 and 24 months and requires 10 or more visits to the clinic. During the screening you will find out exactly what is involved with the specific trial. At clinic visits you will be asked questions about your health, any side effects you may have experienced, and medications you are taking. Some studies also require additional medical procedures, and these will be explained to you.

The trials are being coordinated by the HIV Vaccine Trials Network, funded through the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH).

No. Pregnant people will not be accepted as volunteers, and people who plan pregnancy should postpone it until after the trial. Pregnancy tests are done as part of the screening process and before each immunization. People of childbearing potential must agree to use an adequate method of birth control prior to their first immunization and during the study. This is because the vaccines are experimental, and we do not yet know whether they are safe to use during pregnancy, or if they are safe for the baby.

The total amount of blood drawn over the course of the trial will be less than you would give as a frequent donor through a blood bank.

Not always. To have a controlled comparison, many studies give some of the participants a placebo, an inactive substance or substitute, instead of the vaccine. You can't choose which you are given. Neither you nor your clinician will know whether you receive a vaccine or a placebo. This is called a "double blind" study design and guarantees that all participants are studied and followed in exactly the same way. After the trial is over, you and your clinician will find out which product you received.

We don’t know. It is not known whether any of the experimental vaccines will protect you against HIV, and not all studies are designed to answer this question. It is important for you to protect yourself from acquiring HIV. The clinic staff will provide you with information and counseling on how to minimize your risks.

Yes, your confidentiality will be protected within the limits of the law. No medical information will be released to outside individuals without your written permission. No names are given when reports on trials are made to the scientific community, the US Food and Drug Administration (FDA) or other regulatory agencies, or the companies involved in making the vaccines.

Possible side effects of the experimental vaccines could include fever, chills, rash, aches and pains, nausea, headache, dizziness, and fatigue. Injections can cause pain, soreness, redness, and swelling on the part of the body where you receive the vaccine shot. The side effects usually do not last long and participants usually do not need any form of treatment. However, if necessary, staff will advise you on treatment.

Safeguards have been built in so that you are told everything that is known about the vaccine, any other study products, and the procedures, including all the possible risks. No one can take part in a study without giving informed consent—learning about the study and signing a form to show that you understand the information. The FDA and other agencies in each country must approve all research before volunteers can be enrolled. The Institutional Review Board or Ethics Committee at each study site where vaccines are being tested monitor the participation and safety of volunteers. The safety and results of the trials are overseen by a Data and Safety Monitoring Board made up of independent experts, and they can stop a trial if any safety concerns are identified.

To volunteer for one of our studies, contact the clinical trial site near you.