The Women's Interagency
HIV Study (WIHS)
A new four-year project called the Women's Interagency HIV Study (WIHS) will begin early next year. This is the first wide scale "natural history" (also called epidemiology) study for women. This probe into the natural history of AIDS in women will have a gynecological focus, allowing clinicians a better grasp on the virus' impact on vaginal candidiasis, pelvic inflammatory disease, herpes, genital warts and cervical cancer, etc. The study will include women at high risk for infection along with women who have HIV/AIDS.
Approximately 2,100 women will be followed for 4 years. Every 6 months, participants will be given complete physical and pelvic exams, and interviews. Laboratory tests will be performed to obtain information on immune status and gynecological conditions.
What is epidemiology? It's a way to look at what causes a disease by reviewing every single aspect of life that a group of people with that disease has in common. We are going to look at what might cause HIV manifestations and progression to AIDS in women by identifying, reviewing, and studying every aspect of life that a group of women with AIDS/HIV might have in common.
Perhaps one way to understand what epidemiology is, would be to think about what causes lung cancer. Twenty years ago, epidemiologists identified 100 people of a certain age, of a certain sex, a certain racial group, ethnic group, a certain economic status and so forth. Scientists studied those 100 people all of whom had lung cancer. Then they studied 100 "controls." The controls were all the same age, sex, ethnic group, etc., matched perfectly with the other group, but without lung cancer. They carefully administered, a long questionnaire to both groups of people, using the same exact words. They were as objective as anyone could be. They asked those 200 people the exact same questions: "Do you drink alcohol?" "How much?" "Do you smoke cigarettes?" "How much?" "Do you ever eat vegetables?" "What pills do you take?" "What vitamins have you ever been on?" "What areas of the world have you traveled to?" They asked questions about all the life factors that may or may not have been related to that
lung cancer. What came up in those studies, and what always comes up in those studies, is cigarette smoking. And that's an epidemiological link between cigarette smoking and the subsequent development of lung cancer. The next step is to go back biologically and prove that when you give an experimental animal cigarette smoke, eventually the same thing happens in the experimental model. Then you have scientific proof.
The WIHS study will need to determine exactly what kinds of factors contribute to the development of opportunistic infections
in women with HIV/AIDS. Researchers will attempt to answer several questions: "What are the factors that determine who gets sick?" "What are the factors that are associated with women who stay healthier longer with HIV?" We will begin to examine the links between HIV and various illnesses in women. The study will also have a control group that will consist of women who have been at risk for HIV but do not test positive for the anti-bodies. Researchers will learn from the differences and the similarities among these women.
Scientists are beginning to understand that there are a whole series of gynecological illnesses that occur in women who are infected with HIV. The most serious, of course, is cervical cancer. Cervical cancer is caused by a virus, the human papaloma virus. There are certain kinds of HPV that cause warts, which is no big deal. But, other types of HPV are associated with cervical or anal cancer. It stands to reason, that if a woman has a weakened immune system and then is infected with HPV, that her immune system isn't there to keep the HPV in check. Therefore, she is more likely to have complications with a more aggressive cervical cancer, much more quickly, which is much more difficult to treat, or cure.
As we begin to make some progress in some areas of the epidemic, we can get better treatment for HIV, better prophylaxis (prevention) for infections, and new treatments for opportunistic infections. As we improve in prolonging survival in men, we have to look at what happens in women with AIDS. And what happens is cervical cancer. One big issue here, is that cervical cancer might be a disease that could be preventable. If we know which HPV types are associated with cervical cancer, we can suppress the HPV virus, and possibly prevent the cancers.
We have the technology to type HPV, once it has been detected. However, it's not a routine clinical test. The process is only financed in research settings. It's hard to do, you need a specialist, and it is very costly. But, it definitely can be done. That's one of the things that we will definitely be doing for these women in the WIHS study. We will be typing the HPV. We will identify which types really are associated with early carcinoma, or later on in cervical cancer. We can sort all of that out with the help of this study, and we will. So, in a big way, this study could potentially prolong women's lives. The ultimate goal is to have an impact on the Natural History of AIDS in women.
This example of cervical cancer, is just one example of many different aspects of disease that we have to learn about, that are still unknown in women. It's one example of what we can learn about in women that will immediately have a direct impact as far as patient care is concerned. With this knowledge we can help women with AIDS/HIV do better for longer. Close Monitoring It's always to ones' benefit to join a study in an academic or university setting because your care ends up being better. It's advantageous to a patient to have 20 different doctors, nurses, and clinicians looking at every test, worrying about it, genuinely concerned, questioning, arguing over it. One of the problems with private practice is that you're dealing with one care provider. And no one person can know everything. It's better to have somebody else to look at what's going on in your body, particularly with HIV/AIDS. If something is not right, it's better to have several people asking questions as to why this is happening, how
to fix it, or how to prevent it from happening again. Every piece of information is going to be thought about and examined a lot and that can only help the women who participate in the study. It will also eventually help to improve patient care for all women living with AIDS/HIV.
We will learn to treat women better, prolong survival and improve quality of life.
Participants will undergo a whole series of different tests that will be examined by scientists who will be looking for early signs of a variety of different illnesses. It would be an advantage to have any doctor or nurse or PA, looking so carefully, routinely every six months, no matter what. The women will be seen by very experienced clinicians.
I have many patients who are women. They're from all different walks of life. I have patients at the County who have no resources or support around them. I have other patients who are wealthy or famous women. They all say the same thing, that they are completely alone. There is nobody that they can talk with about this whole illness. Nobody understands what they are going through. That's a very different situation than the gay men have. The gay men have a whole support team around them. Their whole community has organized to be there for them and to understand, to be a buddy, to do all those nice things that make it easier to cope. Women don't have any of that. Part of the study incorporates all kinds of support services for women. There will be everything from transportation to and from the clinic to child care, to support groups. All kinds of social services will be available. One of the things that we hope will happen is the same kind of networking among the women, that has happened already
among the men. There's a definite relationship between mind and body. This relationship is of major importance, and it is the most powerful tool that a PWA has. If you can allow a woman to feel better about the whole situation and she has somebody to share this with, somebody who's been there, and she can get that support, then she will do better! All kinds of studies have shown that people who get support actually do live longer. As scientists we believe that there is a physical reason, a biological response, that causes the person with support to do better. We don't have scientific proof, because we haven't identified the chemistry or the mechanism that causes this phenomenon.
One example, for a scientific explanation, could be the way that the gay men take care of each other, which is very impressive. At one time, in the beginning of AZT, it was fashionable for everybody with AIDS to have these little pill boxes that beep every four hours. It was almost as if you were in the "IN" group if you had one of those pill boxes. They reminded each other to take their medicine. So, it isn't just the support. It's also the real objective, practical things that can result from getting support. Many people have a hard time taking their medicine. It's hard, and I assume it's very hard for the women to take pills. They're no different in that regard, maybe even a little bit worse, because they have so many other things and people to take care of. Women may be least likely to care about their own health. When you have support around you to take those pills on time, you're going to take the pills and your survival will be longer and your quality of life could also improve. These kinds of issues that
will also help the women.
This is not a treatment study, per se, where somebody is getting drug "X" or "Y". No one will be given experimental therapies or treatments. But, we'll be networking with the clinical trial's system to access the latest available treatments. There are all kinds of protocols on-going at USC and the other sites. If a woman wanted to try drug "X" or "Y" she would have easier access to be enrolled in drug studies. We are creating a situation where it's easier for the woman to come in for the study. We can also inform women when a drug looks really exciting. If she's interested in trying it, we'll make it easier for her to do so.
Contribution to Life
Perhaps the most significant benefit of participating in this research project is the massive contribution to life that a woman could make. It's not a direct benefit at all, but any woman who participates in this study will, by definition, know for the rest of her life that she did something in a huge way to help everybody else around her. That's a huge thing. It's one thing to donate five dollars. It's another thing to donate you; yourself, your time, your blood samples. It is a massive giving that no one else can do. And no matter what else happens in life, from that point on, she knows that she did something in a really big way to try to solve the problem and to try to help somebody else.
Another aspect of this research is that if one of these clinicians sees something unusual, we're all going to know it. I can't even give you the number of examples, where major scientific discoveries from USC and many other places have come about because someone has "stumbled", so to speak, upon them. People will be asking why for every single thing. Isn't this weird? Why did this happen? We'll be in a setting where there are major investigators, scientists, from all over the country, who are going to be looking at these questions. That means that we are going to learn new things. As scientists, we're going to answer questions that we don't even know about. We're going to pick up things earlier, we will know about things sooner, so women can be treated sooner.
Quality of Life
We hope to learn as quickly as we can, publish the information as quickly as we can so that others can also learn from it. We will ultimately learn how to treat women better, prolong survival, and improve quality of life. One of the most exciting things about doing this study is that it's not just pure research for its own sake. I mean, that's nice too, but the only real meaning of any of this is directly translated to the patient. We will improve quality and quantity of survival. I would hope that from day one we're going to use the information to try to prevent illness, as an example, cervical cancer. From day one, we will try to treat illness better.
The sites where the WIHS study will be taking place are:
- Bronx-Lebanon Hospital Center, NY
- University of California, San Francisco
- University of Southern California, LA
- Georgetown University, Wash DC
To participate in the LA effort Contact Yvonne Barranday (213) 343-8288.