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The Research Unit is based at the Chris Hani Baragwanath Hospital in Soweto, Johannesburg, at the largest hospital in the world (according to the 1997 Guinness Book of Records) and offices in Durban, KwaZuluNatal, South Africa. The Chris Hani Baragwanath hospital has 3250 in-patient beds admits over 106 000 people per year. Over half a million out-patients Are seen at the hospital each year with close to one million visits. The RHRU works in Soweto, Johannesburg, Orange Farm and other areas to undertake research and service development in Reproductive Health Currently, RHRU employs a staff of approximately 100 professionals including doctors, nurses, research scientists and field workers who manage more than 40 research and training programmes, many with national and international links. In 1994, South Africa became a democratic nation, internationally the concept of Reproductive Health became a priority and it was in this year that the Reproductive Health Research Unit (RHRU) was established to support the development and implementation of new sexual and reproductive health policies of the government, to develop academic rigour in the field. To achieve this, RHRU:
To build an internationally renowned South African institution, respected for its global and national contribution to the improvement of sexual and reproductive health
The RHRU is a South African academic centre, dedicated to improving the sexual and reproductive health of all people particularly those marginalised in society. The RHRU identifies and responds to sexual and reproductive health priorities through research, training and capacity building, in partnership with governments, communities and other organisations. The RHRU works towards bridging the gap between sexual and reproductive health research, policy development and service delivery.
by Anne-christine d'Adesky
Much of the needed infrastructure is already in place. Besides its hospital setting that provides clinical services for many thousands of HIV-positive women and their babies, the Unit and its close collaborator at the Chris Hani, the Reproductive Health Research Unit (RHRU), have carried out 15 Phase I, II and III trials of agents to treat or prevent AIDS. Through these trials and other joint studies, the PHRU has worked with a wide range of multilateral and national agencies, major pharmaceutical companies and scientists around the world. Along the way it has built up a research staff of nearly 100 people, a variety of study cohorts and expertise in conducting large, scientifically rigorous trials. Meanwhile it has built community involvement, support and outreach programs, and become a passionate advocate on behalf of the community it serves. The PHRU was born through the efforts of its two directors, obstetrician James McIntyre and his colleague Glenda Gray, a pediatrician. The two have been working in the AIDS care field for over ten years, and alongside their clinical and research work, helped draft South Africa's National AIDS Plan - in particular the chapter on perinatal HIV. Before their scientific careers began, they were political activists involved in desegregation of the health sector and in helping the African National Congress formulate health policy. "We've always been part of the AIDS community," says McIntyre, who was also co-chair of the national AIDS consortium for many years. The result, adds Gray: "People trust us. You have to earn that trust." They started by setting up a perinatal HIV clinic in 1991, "as a response to bad treatment," says Gray, who adds that HIV testing of mothers in their hospital actually dates back to 1987 - making it one of the first facilities in South Africa set to offer HIV testing and counselling in a maternity setting. It was also among the first to emphasize STD management and to train midwives and counselors in outreach to the surrounding community - activities which grew out of early links with NGOs. In 1996, the clinic expanded to become a research unit of the University of the Witwatersrand and has produced a steady stream of scientific and policy work around HIV and reproductive health. The PHRU's international reputation was launched by its early clinical trials of treatments to prevent mother-to-child transmission (MTCT) of HIV. It was one of five PETRA trial sites in Africa that compared the effects of different AZT regimens on lowering maternal HIV transmission. More recently, it participated in the South African Intrapartum Nevirapine Trial (SAINT), which proved that nevirapine offers a cheaper, more effective alternative to AZT. In both cases, the community played an important role in shaping the trials. "We've never had a top-down approach that a lot of researchers have," states Gray. She cites placebo trials as a case in point. In September 1997, the New England Journal of Medicine published an editorial that strongly criticized the PETRA study for including a placebo arm, since a 14-week course of AZT given to HIV-positive pregnant women was already known to reduce MTCT - although the duration and price of this treatment put it out of reach for the developing world, including South Africa. "The moment there was a furor about it we called the community, the NGOs, the people in the trials and we discussed it," Gray says. "We allowed them to decide." The consensus: Go ahead. And the results: unambiguous validation of the shorter, cheaper regimen - and a community's empowerment. To Gray, these trials also reaffirmed the crucial importance of serving the community throughout the research process. "Our mother-to-infant trials were a success because we run good support groups," she says. Aside from quality medical care, the PHRU also offers mental health services, counseling for men by male counselors, and affordable milk at half the retail price, to name a few perks. Now the unit is embarking on another nevirapine trial, backed by a 4.5 million Rand (US$ 690K) grant from Bristol Myers Squibb's 'Secure The Future' project. And they are preparing to tackle another hot issue: extending nevirapine treatment to a small number of pregnant women outside the trial, with funding from France's International Solidary Fund. A recent South African government report found that MTCT treatment would save up to 50,000 lives a year and save the country 270 million Rand ($45 million). But a government decision on whether to fund treatment for HIV-infected pregnant women has been delayed in the wake of President Thabo Mbeki's controversial positions on HIV and AIDS therapies. But the Soweto group is forging ahead and has secured endorsements "at every single level within the health service nationally," says McIntyre. Again, the community provided the moral compass. "Now that we have gone to the communities," Gray cuts in, "their response is, "What took you so long?'" [Editor's Note: Since the IAVI Report went to press, the South African government has apparently decided to work towards making nevirapine treatment widely available.]
One partner is the hospital's Reproductive Health Research Unit (RHRU), directed by Helen Rees, which brings its own extensive experience in international trials and partnerships - for instance, as a reproductive health research site for the World Health Organization and a participant in the UNAIDS-sponsored Phase II multicenter study of nonoxyl-9 as a microbicide. The RHRU also works with HIV-negative cohorts in several different provinces of South Africa, thus adding a key component for vaccine trial capacity. Chief among them is the Palesa Study cohort, based in the Orange Farm squatter camp outside Soweto, a region with soaring HIV rates: seroprevalence is at 22% and seroincidence is 5%. The project, which will recruit and follow 2,000 HIV-negative women to examine whether injectable progestin contraceptives affect their risk of acquiring HIV, has strong community support, according to McIntyre. The RHRU also maintains several HIV-positive cohorts in which the screening process could be adapted to help build new negative cohorts or expand existing ones, such as the PHRU's serodiscordant couple cohort. The third potential collaborator is the AIDS Unit at the National Institute of Virology in Johannesburg, headed by Lynn Morris, whose newly-established southern African Regional Laboratory would carry out most of the immunological studies. Under the direction of Clive Gray, the Regional Laboratory is now involved in a study (HIVNET 028) with other NIH-sponsored southern African sites to identify strong neutralizing antibodies and dominant CTL epitopes in people newly infected with HIV subtype C, the main subtype in sub-Saharan Africa. From a research perspective, the proposed HIV vaccine plan emphasizes an important and under-researched question: Does infection with tuberculosis (TB) or an STD affect an individual's responses to an HIV vaccine? Every year in South Africa, 350 new TB infections are reported per 100,000 people - and up to 600 per 100,000 in Soweto, both underestimates of the true number. Several studies have found that people co-infected with HIV and TB show an enhanced state of immune activation, including altered levels of certain cytokines and increased CD8+ T-cell activation, which could affect HIV viral load. Researchers suspect that it could also impede immune responses to HIV vaccines. Given the importance of this question for developing world populations, many of which are experiencing explosive TB and STD epidemics, the partners hope to tackle this issue by testing vaccines in cohorts of people with TB or STDs. The group has already done some preliminary work to probe community attitudes, relying on Florence Ngobeni, the unit's seasoned community coordinator, to lead the effort. A poised, outspoken, HIV-positive woman, Ngobeni provides a role model, sounding board and advocate for many women who are afraid to reveal their HIV status. Incorporating vaccines into their community work will mean tackling a new set of issues, from educating people on HIV vaccines to probing the informed consent issues they raise to making decisions on treatment and care in the context of vaccine trials. And if there's one thing Ngobeni says she's learned as an outreach workers, it's never to assume she knows what communities will say or feel when it comes to HIV. This article was reprinted with permission from the International AIDS Vaccine Initiative (IAVI). It originally appeared in the December 2000 - January 2001 issue of IAVI Report (www.iavi.org).
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A Short drive from the modern metropolis of Johannesburg lies the sprawling, bustling, impoverished township of Soweto, best known to outsiders as the site of fervent anti-apartheid activism in the 1970s. Today Soweto is the largest residential area in South Africa, a place where the smoke from cooking fires at dusk leaves a haze over the new housing projects that stand beside the tin and cardboard shanties of squatter settlements. This is the legacy of apartheid: a high rate of unemployment and a lack of basic services, including health services, for many. Add to the list skyrocketing rates of HIV infection, which threaten to erode the hard-won progress of the recent past. Less well-known to outsiders is that Soweto is also home to a well-established HIV research and clinical trial facility: the Perinatal HIV Research Unit (PHRU) of the University of Witwatersrand's Chris Hani Baragwani Hospital, said to be the largest hospital in the world - and perhaps soon to be a new entrant into the HIV vaccine arena.
