Women and HIV research
11 December 2007
Women and adolescent girls are on the frontline in the AIDS epidemic but getting them the special treatments, HIV prevention strategies and protection they need will require a varied, multi-disciplined response -- medical, social and economic, health specialists agreed.
Meeting at UNAIDS in Geneva, health experts from international agencies, non-governmental organisations (NGOs), research institutions and the private sector, said that cultural and social barriers can still stop women taking part in HIV trials in sufficient numbers, while too little is known about the effects of biological differences between the sexes in such areas as the impact of HIV drugs.
Winding up the first of two days of discussions on Monday 10 December, Kristan Schoultz, Director of the Global Coalition on Women and AIDS, said delegates had made a thorough review of the challenges and difficulties and the moment had come to start putting forward proposals for solutions.
“I think we have determined some of the challenges we face, (now) we need to tease out of this a way forward,” she said.
The route lay beyond a strict interpretation of the conference’s theme – “Making HIV Trials Work for Women and Girl Adolescents” -- and should include economic and social changes to address background factors such as poverty and empowerment.
“We need to highlight the difference between sex and gender differences. Gender also brings in social, cultural and economic issues as opposed to the straight biological issues,” said Geeta Rao Gupta, President, the International Center for Research on Women (ICRW).
Although women account for some 50% of people infected with HIV worldwide, in sub-Saharan Africa the figure is around 60% and amongst some ethnic minorities in developed countries women also account for a disproportionate percentage. In parts of southern Africa, girl adolescents are some four times more likely to become infected with HIV than males of the same age.
For years after AIDS was first recognized in the early 1980s, medical research continued to be largely male orientated. Clinical trials involving women of child-bearing age had been banned in the United States in the late 1970s, in part because of the thalidomide scandals, and the restriction was not lifted until the early 1990s. In addition, the epidemic was initially thought largely a disease affecting men who had sex with men.
“The current research emphasis being put on microbicides for women is an illustration of the way in which priorities have changed,” said Roberta Jean Black, tropical microbicides team leader of the U.S. National Institutes of Health.
“Some of these inequalities simply represented misunderstandings of the disease and its evolution…We have responded successfully but the work is not done,” she added.
“The existing strategy was not designed with the percentage (of women) in mind. This is an iniquitous state of affairs,” declared Julie McHugh, company group chairman, virology, Tibotec.
More needs to be known about the progress of HIV in women.
“We are looking for answers for women. We now have women in menopause with HIV and we do not know anything about it,” said Heidi Nass, Director, Education and Policy Advocacy, Health HIV Care Program, University of Wisconsin. “We have seen the list (of things to do) a million times, it would be really nice to come out with action,” she added.
Gaps in understanding
There are many gaps in our understanding of HIV and how it evolves in women and the difference that gender can make, participants agreed. For example, CD4 tends to be higher in women, yet there appears to be no significant impact on the progress of the disease.
But the difference can lead to delays in the timing of treatment for women. When it comes to mother-to-child-transmission (MTCT), this can have the unfortunate result that women who are not deemed sick, and are therefore not treated, are far more likely to infect their children than those who were inside the treatment threshold.
Most trials are not designed to detect sex differences. “We are relying on safety trials from the (rich, developed) north, and carried out on men,” said Catherine Hankins, Chief Scientific Adviser to UNAIDS.
There are also indications that some treatments have significant toxicity for women. Nevirapine, for example, can produce rashes and hepatic complaints. Toxicity can be one reason why women tend to abandon trials more often than men and is another area in which more research is needed.
Even if there are no side effects, it is possible that existing treatments may not be the best possible way of tackling HIV in women. Women are biologically different, so they need specific research.
Women in poorer countries can face a host of barriers to taking part in clinical trials. They may fear it will suggest that they are ill and lead to them being stigmatised, they could need permission from their partners or family – most people at risk are in long-term partnerships -- and they may not want to use contraception or they may fear for their future fertility.
Male circumcision provides no protection for women, although there could be secondary benefits for women, but more needs to be learned.
The whole question of trials for adolescents was thick with difficulties. Even a standard definition of what constitutes an adolescent is difficult to establish.
“Communities are very sensitive about involving young girls in trials for fear that they are promoting sexual activity,” said Gita Ramjee, Director, HIV/AIDS Lead Programme and HIV Prevention Research Unit, South African Medical Research Council.
Summing up the changes needed to help women and adolescent girls, Isabelle de Zoysa, senior adviser on HIV/AIDS at the World Health Organisation said: “We are looking how we move through gender unbiased, through gender sensitive to gender transforming.”
The conference, ‘Making HIV Trials Work for Women and Adolescent Girls’, takes place in Geneva on 10 – 11 December 2007. The meeting is co-sponsored by UNAIDS, the Global Coalition on Women and AIDS, the International Centre for Research on Women (ICRW), and Tibotec.
Read part 1 - Meeting ethical concerns over HIV trials
Read part 2 - The role of women in HIV trials
Read part 3 - Experts meet on women and HIV clinic trials
More on biomedical research
HIV Prevention Research: A Comprehensive Timeline
Global Coalition on Women and AIDS
International Center for Research on Women (ICRW)
Ethical considerations in biomedical HIV prevention trials (pdf, 750kb)
Good participatory practice guidelines for biomedical HIV prevention trials (pdf, 3.04Mb)