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Project ACHIEVE provides in depth counseling for all community members who wish to participate in an HIV vaccine trial. It is our desire to foster community education about HIV vaccines and some of the topics that we discuss with our participants are outlined in this model presentation.
What is HIV?
HIV (human immunodeficiency virus) is the name of the virus that causes AIDS. This virus is passed from one person to another through blood-to-blood and sexual contact. In addition, infected pregnant women can pass HIV to their babies during pregnancy, delivery, or breast-feeding. |
How is HIV contracted?
HIV is transmitted through the passage of body fluids from an infected person to an uninfected person.
Blood (such as sharing needles with an injection
drug user who is HIV infected)
Semen
Vaginal fluid
Breast milk
Other body fluids containing blood
How is HIV infection prevented?
Safer sex (male and female condoms)
Clean (sterile) needle use
Abstinence
Use of HIV medications during pregnancy
Avoidance of breast feeding by HIV infected mothers
Why we need new HIV prevention tools?
Despite the fact that we know how to prevent HIV, infections continue to occur. What are some reasons for continuing HIV infections despite known methods of prevention? Why don’t we always use condoms or clean (sterile) needles? (IF LEADING A DISCUSSION, ASK FOR RESPONSES FROM AUDIENCE.)
Desire for pregnancy
Desire for intimacy
Forced intimacy
Faith-based opposition to condoms
Lack of a clean (sterile) needle
Etc·
We need alternative HIV prevention methods that will address some of the gaps in safer sex and injection drug use behavior. One new method under research is HIV vaccines. A vaccine offers our best hope for ending the HIV pandemic.
What is a vaccine?
Vaccines introduce into the body an element (natural or engineered) of a pathogen or germ. The element causes the immune system, which is the body’s disease fighting mechanism, to develop antibodies and/or cytotoxic T-cells. The antibodies and/or cytotoxic T-cells stay in your body and maintain the ability to recognize virus elements so that if later on the virus tries to enter, the immune system will go to war against the invading virus cells.
Vaccines have been used for decades around the world, most commonly in children. They are very safe when manufactured and used properly and are very cost-effective compared to treatment. 16 vaccines are now used in the United States. Vaccines have eliminated smallpox worldwide, soon polio.
How do HIV vaccines work?
HIV vaccines are designed to stimulate the immune system to produce antibodies (proteins that kill virus found free-floating in the blood) and/or cytotoxic lymphocytes (CTLs or "killer T cells" that destroy HIV infected cells).
Vaccinated persons may test HIV positive on standard ELISA test due to the body’s response to HIV vaccines. Other HIV tests can done to see if a person is HIV positive due to the vaccines or to see if a person is truly infected with HIV.
HIV vaccines are being studied to see if they can prevent infection or diminish disease progression post infection.
HIV vaccines under study do no contain real HIV and therefore cannot cause HIV infection.
Are there risks in HIV vaccine studies?
There are risks to being in an HIV vaccine study. We don’t know all of the risks of HIV vaccines. If you would like to learn more about the risks of participating in an HIV vaccine study, you may schedule an appointment to meet with our research staff to discuss this and other information about being in a vaccine study.
How are HIV vaccines tested?
Potential vaccine products are first tested in the laboratory and in animal models. If these tests show that the vaccine appears to be safe and shows some ability to protect against HIV, the next step is to try the substances in humans.
Human subject trials proceed through 4 phases:
Phase 1 -- few participants, safety is main objective
Phase 2 -- more participants, safety and immune response are measured
Phase 3 -- hundreds to thousands of participants, safety and effectiveness in HIV prevention are assessed
Phase 4 -- thousands to tens of thousands of participants, post FDA approval, safety and effectiveness in widespread use.
Status of HIV vaccine research
Numerous phase 1 trials and a handful of phase 2 trials have been conducted with potential HIV vaccine products. Several efficacy trials have been conducted and an effective vaccine has not yet been identified.
Important Results from a Phase 2 study
In the fall of 2007, important results from a Phase 2 study (HVTN 502) were announced. You can read about these study findings at http://www.hvtn.org/media/pr/step1207.html
Would HIV vaccines eliminate the need for condoms?
No. It is unlikely that HIV vaccines will be 100% effective. Therefore, condoms are needed to provide protection against HIV and STDs.
Community issues
Vaccine trials need community members to enroll. These trial volunteers need initial and on-going education to understand vaccine research and the particulars about the trial they are joining.
A particularly sensitive issue for volunteers is the possibility of testing HIV antibody positive due to the immune system’s response to vaccination. Volunteers may experience social harms from immigration, incarceration, military, health/life insurance services and social stigmatization. Study staff are trained and are ethically bound to provide thorough education and supportive services to verify vaccine positive results versus positive results from true HIV infection.
Beyond study staff, trial volunteers need knowledgeable community advisors and representatives. Community leaders/representatives are needed to learn about vaccine research and to reach out within their community to educate others.
Finally, community activists are needed to continue to safeguard the interests of trial volunteers and to advocate for funding to conduct vaccine research.
Questions for audience
How best do we reach at-risk communities regarding HIV vaccine research?
How do we overcome distrust of the medical community and vaccines in adults?
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