We began here in 1995 as part of Project Achieve's HIV prevention work. The project's community advisory board had advocated strongly for a women's component to the effort, although we had to push hard to get it funded. That led us here to the South Bronx, which is one of the highest HIV prevalence areas in New York [about 4%], and to a collaboration with the New York City Department of Health.

We started with two small cohorts. One was a 'first-generation' vaccine preparedness study (VPS) called "Achieve" that looked at issues of recruiting and retaining high-risk women but didn't include vaccine education. The other, called VPS I, was a cohort through HIVNET [the NIH-sponsored HIV vaccine trials network], and it had a vaccine education component.

The original plan was to recruit from the STD [sexually transmitted diseases] clinic in this building. But that didn't provide the steady stream of participants we expected, for several reasons. So we moved to a street outreach approach, which is what pulled most of the women in.

Our retention rate for those initial cohorts was pretty horrendous. We were very new to what it would take to involve women in these studies. In some ways, we were naive about their life circumstances—for instance, that it was a very transient population. If somebody's phone was disconnected or they moved, we lost them. We learned a lot. But still, we had the feeling we weren't getting the highest risk women. It's a trade-off: for the sake of retention you want more settled people, but they may not be the highest risk group. HIVNET then also became interested in a higher-risk cohort. That led to VPS II.

What was different the second time around? 

We narrowed the criteria for enrollment. To be eligible, women had to have a current male sex partner who was either HIV-positive or an injecting drug user, or within the past year they must have either exchanged sex for money or drugs, had five or more male sex partners or had an STD. At this site, we didn't include any women who were themselves injecting drugs, because we chose to focus on sexual transmission.

We also hired a former VPS I volunteer to do outreach for us. She was actively using crack when she first came here, but her involvement in the study and the relationship she developed with her counselor turned her life around. She is now doing very, very well.

People trusted her. Many of the women who enrolled in VPS II came through "friends" or "friends of friends." She was really able to tap into that network, because she was part of it. Our target for the cohort was 150, and we over-enrolled—we got 164 people in a very short space of time.

This time we had tremendous success with retention. We had learned that to hold onto people, we needed the names and addresses of at least two contacts at the start of the study. It also helps that our retention specialist has been on board from the beginning. Six months into VPS II we had retained 96% of the women and 92% after 12 months—this in a cohort of very poor women, where the majority report using crack.

HIV incidence in VPS II was 1.18%. So somehow we are still not tapping into the highest risk women.That might be partly a function of age. The women we see are in their early to mid-thirties. We're not reaching them in their early twenties or late teens, where the incidence is increasing most rapidly.

What would it take to bring in more younger women?

We will have to change the way we recruit. We would have to identify places in the area where young women hang out—bars, malls, shopping areas, movie houses—and go there at different times, including evenings. And we would need young women who are part of that network to do the recruiting.

How did you move from the preparedness study to a Phase III trial?

The VPS II created a group of women who were very ready to be involved in an actual vaccine trial. They had been exposed to information on what a vaccine trial involved and had become comfortable with the idea of taking part in the effort to find an HIV vaccine.

We also put some ads for volunteers in the newspaper and pulled in some women who had not been in VPS II. They ended up being quite different. Usually more educated. Some were health care professionals.

What are the lives of the women like?

There are two issues that stand out most. The first is their poverty. Almost 90% reported less than $12,000 income in the past year. Most are unemployed and on welfare, on Medicaid. Many have children who they support alone. Most have not completed high school. Some are homeless, or nearly so, or have kids in the foster care system.

The other issue is substance abuse. Two-thirds of the women in VPS II said they used crack within the past year.

In terms of numbers of sexual partners, over half reported having five or more partners in the last year. We see a lot of 'serial monogamy,' as well as a number of women with a main partner and several other partners who give them money or crack, in a casual way—it's not a formally negotiated transaction. Very few are actively engaged in sex work.

Violence is also an issue. In the VPS II cohort, 30% of the women said they were beaten by their partner within the last year, and two-thirds had seen someone else beaten up. When you're talking about the women trying to negotiate condom use, this is the context you need to look at.

What reasons do the volunteers give for joining the trial?

The woman we hired to do outreach for VPS II openly admits that she first came into our office because she heard in the street that she could make ten dollars, which is what we paid people for visits in VPS I. That's all she was interested in, because she was on crack. We've had other women, especially those in the vaccine preparedness studies, also tell us that they initially came because of the reimbursement.

Once they're here, a big part of what keeps them is the counselors. There were women who said to Debbie [Debbie Lucy, senior counselor in the trial], I'll join the vaccine trial because I want to keep coming back to see you.

But, given the intensive screening process for the trial, it's unlikely that people are motivated to enroll by the reimbursement. Many join an actual trial because the epidemic has touched them in a profound way, and volunteering is a way of giving back.

How do the counselors work with volunteers living under such difficult circumstances?

One of the things we recognized early on was the need for a case management component to the work. The women have so many needs in terms of getting their welfare cases reopened, or their Medicaid hooked up. Housing issues. Violence. Getting into drug treatment or mental health services. The counselors spend a lot of time on all of this. We deal with some of those needs by having a pretty good referral list, and following up during subsequent visits.

These women don't seem to really talk or get much support even from their women friends. They're all just trying to survive.

So it's very important for them to come here and have a counselor who gets to know them, who does risk-reduction counseling, and so on.

Even though our focus is HIV prevention, our counseling covers the gamut in terms of their needs. I think that's a big reason why women keep coming back. The women really connect with the counselors here.

And we have really made an effort to make this a woman-friendly space, and to give people a positive experience here. It's very hard to measure this piece of it, but we're thinking about possibilities—scientifically you want to be able to point and say, this is contributing this much.

What other issues do you face in the trial that are specific to women?

Because of these issues that come with poverty–especially transient housing and homelessness—we discovered that we need to be in touch with the women frequently. So, even though the vaccine trial only calls for visits once every six months, we make sure we contact them midway through that window, to make sure that they're still where we think they are.

The other issue that women bring, which we rarely think about in HIV vaccine trials, pregnancy. We're working with high-risk women, and most of them use condoms as their primary mode of contraception—sporadically. As is very common, they tend to use condoms with secondary partners, but not their primary partner. So we have had to deal with the issue of pregnancy during the trial. I think that's an issue which really needs to be taken into consideration.

What do you do?

Before people enroll, we say that if they're making a commitment to the study, they shouldn't intend to become pregnant during the study period. That's one of the reasons why women choose not to participate, because they think they might want to become pregnant. If they do become pregnant, we stop their immunizations but still follow them through the rest of the trial. But the fact that women will become pregnant obviously has implications for sample size and other aspects of protocol design.

What does your experience so far tell you about the prospects of getting larger numbers of high-risk women into Phase III trials in the future?

I'm a strong advocate of making sure that women are included in HIV vaccine trials, and not just considered an afterthought. I hope that concerns about recruitment and retention, which have been issues in the past, won't be used as reasons to exclude high-risk women from vaccine trials.

It's different, and more difficult, I suspect, than recruiting men who have sex with men. We know those differences well, because we have a men's site. In general the men have multiple modes of contact—home phone, work phone, e-mail, cell phone. It tends to be a more stable group. Here we work with volunteers who don't even have a phone.

But we've demonstrated here that you can recruit and retain women. So has Richard Novak's team at the University of Illinois in Chicago, which has a larger high-risk women's cohort. But it's much more labor-intensive to follow this type of semi-rooted or transient population. And it requires more resources. We need a full-time retention person just to hang onto the cohort. But the resources are not always forthcoming to do longitudinal studies, and do them well.

What else can be done to keep women involved?

It's hard when there are so few women. This trial has 300 women out of 5,400 volunteers in total. It's clear from the sample sizes that this is an MSM trial and that it's not geared to women.

To keep high-risk women involved, we need to recognize that they have different needs than men. They may need case management services, help with transportation for appointments—even if this means simply covering the cost of a bus ride to and from the clinic. They also need ongoing counseling, for example, around the issues of pregnancy and contraception. And there are other basic things, such as having a clinic space that is welcoming to children, who often accompany women on their visits.

In a larger sense, we've often had the feeling that the needs and concerns of women are not taken seriously in HIV prevention more generally. It's been a struggle. As we move into the future, I hope that women don't continue to be on the margins of this work but that we can take our rightful place as equal partners in this effort.

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©2001. The IAVI Report.

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