IAVI Report - July / September 2001

Michelle Rotchford Galloway

In the remote rural regions of South Africa, young women constitute the highest risk group for HIV infection, as they do throughout much of the continent. Over the past several years, one such location—a tribal ward called Hlabisa (pronounced "shla-bisa")—has launched intensive vaccine preparedness efforts, under the auspices of South Africa's Medical Research Council (MRC) and NIAID's HIV Vaccine Trials Network (HVTN). Here we describe some aspects of the work relevant to women's risk and their possible willingness to participate in Phase III trials, based on interviews with Quarraisha Abdool Karim and Janet Fröhlich, and data supplied by Salim Abdool Karim. 

Quarraisha Abdool Karim, an epidemiologist and molecular biologist, was the original director of the site and was involved early on in mobilizing the community. She has recently moved to the University of Natal. Fröhlich comes from a background of grassroots HIV/AIDS work among community organizations and is MRC research site manager at Hlabisa (and presently Project Director of the Vaccine Preparedness Study).

Starting out from the coastal city of Durban, it takes three hours of strenuous driving—the last part on steep, winding, dirt roads—to reach the tribal ward of Hlabisa. The village has no formal addresses, so visitors are guided to their destination with instructions such as, "turn left where the old tree used to be." Its people survive on subsistence farming and income sent home by men working hundreds of miles away as migrant laborers in South Africa's mines and large urban industries.

That's where the explosive AIDS epidemic in this region begins. It continues when the men bring HIV home to their wives or girlfriends, and is catalyzed by the extremely high number of relationships between girls in their teens and men in their 30's or older.

The result is that young women between the ages of 15-19 years old are up to three times more likely than males the same age to become infected with HIV according to S. Abdool Karim—a gender disparity that has existed since the early days of the region's AIDS epidemic. Sero-prevalence in women attending prenatal clinics, determined by anonymous HIV testing, has shown a rise from 4.2% in 1992 to 34% in 1999, with incidence rates rising from 2.3% per annum in 1993 to 15% per annum in 1999 (as measured by detuned ELISA tests). In the 25-29 year age group, a staggering 45% of the women were HIV-positive, and their death rate is more than double that of men the same age.

From Vulnerability to Participation
Hlabisa's involvement in vaccine testing is an outgrowth of the prevention and epidemiological studies started there in the early 1990's by David Wilkinson, then superintendent of the district hospital, and Salim Abdool-Karim, then with the MRC and now at the University of Natal in Durban. In 1997, largely as a result of that groundwork, the Hlabisa and Durban groups received NIH funding to begin developing the infrastructure and cohorts needed for Phase III trials of HIV vaccines, as one site within a network of trial sites then called HIVNET. (The network was revamped in 2000 and is now the HVTN).

With this solid funding, the researchers were able to begin real vaccine preparedness activities. One was an intensified surveillance effort, which among other things provided more precise data on the disproportionately high risk to young women. Another is a vaccine preparedness study, now in full swing, in which community educators will visit 2500 households by the end of this year, collecting data from all consenting household members (ages 15-54 for women and 15-70 for men) on a broad range of HIV-related questions. Starting with standard demographic and health information, the survey then asks about the labor migration patterns of household breadwinners, sexual behaviors relevant to HIV, willingness to participate in vaccine trials and factors influencing that decision. After pre-HIV test counseling, blood is drawn and arrangements made for participants to receive the results, along with further counseling, at the study clinic.

As the researchers begin to analyze early results, the outlines of some gender-related differences are beginning to emerge. "Our preliminary data suggest that about two-thirds of the women interviewed indicated willingness to participate in HIV vaccine trials, compared to a third of the men," says Quarraisha Abdool Karim.

Overall, both men and women cite altruistic reasons for their willingness to participate, and their belief that a vaccine brings hope to their community. But women were much more likely than men to cite the need to protect themselves against HIV as another reason to participate—a motivation that will need to be addressed in the pre-enrollment knowledge-building, but which suggests that "women have a keener perception of their risk of acquiring HIV," says Abdool Karim.

But she adds that it is too early to tell whether this general willingness will translate into a concrete decision to volunteer when a Phase III trial actually gets underway. While this will partly depend on the requirements of the specific trial, the broader issue is that of women's lower status and degree of autonomy in making decisions—an issue that emerged even in the 18-person Phase I HIV vaccine trial now ongoing in Nairobi (see interview with Dorothy Mbori-Ngacha).

"Constitutionally, women have a right to give individual consent, but in reality it may not always work," says Fröhlich. "This is part of the knowledge-building that will have to occur prior to recruitment. Rural women will need guidance as to what their rights are and will need to understand that they have their own voice in decision-making."

Fröhlich says there are also differences in the types of logistical support it will take to involve women versus men into trials. With women closely tied to home through their responsibility for household, farming work and childcare, finding time to attend a study clinic located as far as 25 kilometers away along poor roads would be extremely difficult for some, and therefore mobile clinics may be necessary to secure their participation. In contrast, unemployed men tend to congregate in the middle of the village, making them easier to access, while men with jobs are often working far away from Hlabisa in the urban centers.

These men's long absences raise the somewhat unusual issue of the difficulties that could arise in including an equal proportion of men in vaccine efficacy trials. Follow-up visits to the clinic would require either that the men make more frequent trips home, or that trials are somehow set up to accommodate their absences. One possibility, suggests Fröhlich , is "a collaborative multi-site model in which participating migrant laborers could be monitored at different trial sites." While that would clearly require a new level of logistics and organization, she is hopeful that a solution can be found. "Migrant workers shouldn't be discriminated against in [trial] inclusion criteria because migrant labor is a reality of the South African situation," she says.

At this point, says Abdool Karim, discussions are still on very general terms. But once a definite product is ready to move into Phase III—probably in 5-7 years time—decisions will become more concrete.

In the meantime, as the crisis of the sick and dying continues to worsen, the focus in Hlabisa is on finding feasible ways to provide more care. About 80% of the patients at the Hlabisa District Hospital are AIDS patients, most of them young women. But the 95-bed hospital is completely overwhelmed in terms of staff, space and lack of medicines (and too far away for many Hlabisa Ward residents to access), which has led to growing use of mobile clinics that visit the remote areas in each ward about once in six weeks. Home-based care is also on the rise through efforts of the partnership between the research project's Community Advisory Board (CAB) and the hospital HIV/AIDS and TB program. The CAB is also working on palliative care initiatives and support for orphans and disrupted families. For the short-term, MRC researchers are launching two small trials of natural medicines—Aloe ferox for treating AIDS-related diarrhea and Sutherlandia microphulla for cachyxia—for which there are "good anecdotal findings" of some effectiveness, along with widespread community acceptance, says Fröhlich . On the prevention front, a key goal is bringing about wider HIV testing and counseling, now limited both by the hospital's understaffing and "a reluctance in the community to go for testing because of a lack of privacy—in the hospital, everybody knows everybody," she says.

So for now, the community of Hlabisa struggles on amid the devastation of the epidemic, especially on its young women—and the prospect of a future vaccine that has so strongly engaged the ward which now calls itself the "Village of Hope."

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