AIDS Research Alliance Step Study Frequently Asked Questions What is the Step Study?
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| A weakened, non-disease causing form of a cold virus, called adenovirus type 5 | |
| the HIV genes gag, pol, and nef | |
| saline solution (salt water) |
Who is eligible to participate in this trial?
Participants must be HIV-negative (not HIV infected) adults between 18 and 45 years old and considered to be at high risk of HIV infection. All volunteers must meet certain medical and non-medical criteria for eligibility and volunteers are carefully screened to make sure they meet the eligibility requirements.
How can people find out if they are qualified to join this trial?
Please contact AIDS Research Alliance by telephone at (310) 358-2429 or send an email to info@aidsresearch.org.
Women who want to join the trial will be given a pregnancy test. A woman who is pregnant or breastfeeding is not allowed to participate in the trial and all female participants must agree to avoid pregnancy by using contraception during the vaccine trial.
All volunteers are tested to make sure they are HIV-negative. A volunteer who is HIV-positive at screening cannot enroll in the trial. However, there are several studies at the AIDS Research Alliance for HIV-positive individuals.
What is the design of this trial?
The trial will enroll about 3000 people internationally. Over the course of six months, half of these people will be given three shots of the investigational vaccine and the other half will be given three shots of a placebo (an injection without any active vaccine) made of a saline solution (salt water).
Participants will be tested for HIV infection every six months. All trial participants will be given state-of-the-art counseling to reduce risk behavior. Because the trial enrolls people whose behavior puts them at high risk for HIV infection, it is expected that some people will become infected, even though they are being counseled about ways to stay safe. Some of these people will have received placebo, but others may have received the investigational vaccine. These people will get more blood tests to see if the investigational vaccine lowers the level of HIV in their blood.
The Step Study is a multicenter, randomized, placebo-controlled, double-blind trial. 'Multicenter' means that people in more than one place volunteer for the study. 'Randomized' means that participants are randomly assigned to get the study vaccine or placebo. 'Placebo-controlled' means that some people are given placebo, so the researchers can tell if the investigational vaccine makes a difference. 'Double-blind' means that neither the participants nor the scientists know who is getting the investigational vaccine and who is getting the placebo.
How will the safety and rights of participants be protected?
Trial participants play a very important role in the search for an HIV vaccine and the safety and rights of participants are given the highest priority. This trial meets international standards for ethical research that were created by the Helsinki Declaration of the World Medical Association and Council for International Organizations of Medical Sciences (CIOMS) guidelines.
During the study, all of the data is reviewed by a Safety Monitoring Board. This group of experts can stop the study at any time if they feel that the risks for participants are too great. Additionally, every study location works with an Institutional Review Board (IRB) that reviews all of the details of the trial. IRBs also make certain that the rights of participants are protected. ARA has its own, independent IRB comprised of community volunteers. Follow this link for information about ARA's IRB.
Before they join the trial, volunteers are provided with information about HIV and AIDS, the reasons for the trial, possible risks and benefits, and trial procedures. Clinic staff allow plenty of time to talk with volunteers and answer their questions. All of the information is provided in writing. It is important for participants to know that any new study vaccine may have both medical and non-medical risks and there may be additional risks that we do not know about yet.
For more information on participants' rights and responsibilities, visit www.hvtn.org/community/rights.html.
For a screening appointment, please call AIDS Research Alliance at (310) 358-2429. At the screening appointment and after the trial has been fully explained, volunteers are asked to sign an informed consent form before enrolling. This form outlines exactly what will happen over the course of the vaccine trial. Also, the risks of participating are clearly stated. Volunteers will be given plenty of time to consider whether or not they want to join the trial. If they do enroll, they may still leave the trial at any time without losing the benefits of their standard medical care or any other services provided at that location.
During the trial, clinic staff will monitor the volunteers to make sure the investigational vaccine is not causing problems. Throughout the trial, any new information researchers learn about the safety of the study vaccine will be given to participants. Volunteers will be able to decide whether or not to stay in the study based on any new information.
Participants are frequently reminded that being part of a vaccine trial does not mean they are protected from HIV infection. They are counseled at each clinic visit on ways to avoid HIV infection (for example, correct and consistent condom use).
Are there non-medical (social) risks?
Participants are asked to carefully consider all risks before joining a trial. Some risks are medical, but there are also social risks. Trial participation takes time and commitment. It can also lead to complications with others who do not agree with the participant's choice to join the trial. For example, some people have reported that being in a trial has upset their spouse, partners, friends or family members.
Participating in a trial may also restrict the volunteer's behavior. For instance, participants are asked not to donate blood and women should not get pregnant during the trial.
Some people have experienced discrimination when they told people they were participating in clinical research for an HIV vaccine. In the case of discrimination, study staff can (at a participant's request and with their permission) talk to insurance companies, employers, and others to explain a participant's involvement in a trial.
The investigational vaccine could cause a false positive result on a standard HIV test (see below), and such a result may lead to being treated unfairly by others. This will be explained to potential participants in more detail during the informed consent process.
To help avoid problems that could come from participating in a trial, participants will be offered an identification card that shows that they have joined an HIV vaccine study. A telephone number will be listed on the card that may be called for information or for help in resolving problems.
Could the investigational vaccine cause a "false positive" result on an HIV antibody test?
Some investigational vaccines may cause a trial participant to have an HIV test that appears HIV positive. Standard HIV tests look for antibodies (a part of the immune system) that recognize HIV. This investigational vaccine could cause the body to produce these antibodies. Receiving a positive result on an antibody test does not necessarily mean the study participant is infected with HIV. A false positive means that some tests make a person appear infected. Participants are counseled to get HIV testing done only at their trial site. The site has access to the specific tests that can differentiate false positives from true HIV infection.
No medical side effects or health problems are associated with a false positive HIV test result. But such a result may lead to being treated unfairly by others. People with a positive HIV test, even a false positive, are not allowed to donate blood. They may also have difficulties with getting insurance, medical/dental care, traveling to other countries, employment, service in the military or Peace Corps, or relationships with friends and family. Clinic staff members are available to help with any difficulty.
What will happen to participants if they become HIV-infected from their behavior during this trial?
While the investigational vaccine cannot cause HIV infection there is no guarantee that the investigational vaccine will prevent HIV infection. All participants must be HIV negative when they enroll in the trial.
It's important to note that participants can still get infected with HIV through sexual contact, sharing of injection drug equipment, or any other exchange of blood or bodily fluids, even if they are receiving the study vaccine.
Participants are counseled to avoid behavior that would put them at risk of HIV infection. Those who become infected during the trial will stop receiving injections, but clinic staff will ask to continue monitoring their health for the rest of their scheduled time in the trial and the researchers will test their blood to see how the body fights the HIV infection.
There are many drugs that can be used to treat HIV infection, but none of these drugs can cure HIV infection. These drugs are not provided as part of this trial. Participants who become infected during the trial will be referred to an appropriate doctor or medical agency for medical care, including antiretroviral therapy and counseling. ARA will run baseline viral load and T-Cell counts as well as make appropriate referrals.
About the HIV Vaccine Trials Network: www.hvtn.org
About the AIDS Research Alliance: www.aidsresearch.org
About the Step Study: www.stepstudies.org
To schedule a screening appointment, please call AIDS Research Alliance at (310) 358-2429.