Experts meet on women and HIV clinic trials
07 December 2007
Specialists on AIDS and women’s health are meeting in Geneva from December 10-11 to review the latest developments in research into preventing and treating HIV among women and adolescent girls from HIV infection, and to make recommendations on priorities and strategies.
The conference, ‘Making HIV Trials Work for Women and Adolescent Girls’, is co-sponsored by UNAIDS, the Global Coalition on Women and AIDS, the International Centre for Research on Women (ICRW), and Tibotec. The Global Coalition is an alliance of civil society groups, networks of women living with HIV and U.N. agencies; ICRW presses for women’s needs to be integrated into the design and implementation of programmes and policies; and Tibotec is an international pharmaceuticals company.
In the last of three articles focusing on HIV clinical trials ahead of the conference, senior representatives of the sponsoring organisations were asked about the challenges of getting women involved in sufficient numbers in HIV trials, the current state of research into prevention and treatment strategies for women and what they hoped the two-day meeting could achieve.
Catherine Hankins, Chief Scientific Adviser to UNAIDS, was asked why the conference was being held now?
Hankins: Although great strides have been made in recent years to include women as participants in HIV treatment and prevention trials in adequate numbers to draw conclusions relevant for them, challenges remain in recruitment, retention, study design, pregnancy, and meaningful engagement of women in trial design, conduct, and monitoring. It is also clear that adolescent girls who are at very high risk of HIV exposure in some settings must participate in trials before the final results of efficacy in adults are known so that licensing of an effective product can proceed for both adolescents and adults at the same time. This conference focuses on the progress thus far, the challenges ahead, and solutions.
Question: Women make up an increasing percentage of people living with HIV, particularly in Africa. Do current international research programmes adequately reflect this?
Hankins: Yes, many of the Phase III efficacy trials underway for HIV prevention are taking place where incidence in women is highest – sub-Saharan Africa. These include microbicide trials, PrEP trials, trials of herpes simplex-2 suppression, and the vaccines trials.
Question: So what are the most promising lines of investigation? Is enough being done to find effective prevention tools and treatment for women?
Hankins: The first to report (already in 2008) will be the Carraguard microbicide trial and the herpes simplex-2 suppression trials. A number of other trials are underway but we are in this for the long haul. The amazingly consistent compelling results of the male circumcision trials may not be repeated for other HIV prevention products at quite the same efficacy level. Combination prevention is key. This means increasing the choices that women and girls have to use synergistically at different times of their lives and in different circumstances to protect themselves from HIV.
Question: What do you see coming out of this conference?
Hankins: Strong steps toward defining a research agenda, recommendations for policy and programmatic actions, and an advocacy strategy.
Kristan Schoultz, Director of the Global Coalition on Women and AIDS, was asked how the situation regarding women and AIDS had evolved since the coalition, which was launched by UNAIDS in 2004, and what she felt the coalition had achieved?
Schoultz: GCWA - together with women's groups and partners across the globe – has worked to put women's issues high on the agenda of top international AIDS forums. In 2006, U.N. Member states renewed and strengthened their commitments to scale up AIDS responses, and to address obstacles and barriers to access, particularly for women and girls. The ways in which gender inequalities and gender dynamics affect individual choices and behaviours are better understood and the issues facing women in a world of AIDS are more prominent in global and national advocacy.
However, the situation of women and girls in the AIDS response continues to be a major concern. We see rising rates of HIV infection among women in some regions and national AIDS responses have yet to sufficiently address the challenges and constraints women face in their everyday lives. We need to see more concerted work towards legal frameworks which secure women's rights, more funding for concrete programmes that benefit women, and greater participation of women's organizations in national decisions on AIDS programmes and budgets.
Schoultz: Within any trial, three issues must be addessed: scientific justification, safety, and benefits for the community. With respect to women, challenges all essentially relate to safety and benefit. While women comprise a growing share of HIV infections every year, they are still underrepresented in HIV clinical trials which test the safety and efficacy of drugs. Drugs tested only on men can be dangerous for women. To get the gender-specific data that are needed, vaccine trials will need to enrol enough women and men to detect gender differences. Drugs work differently with female chemistry, and furthermore, drugs to help those conditions that emerge only in women may never be tested. From a medical viewpoint, women do not reap as much from advances in medical technology. At present, more women are now being enrolled in clinical trials. But many of the factors that affect women’s access to health services -- decision-making on health care, their social responsibilities, stigma associated with high-risk behavior, the threat of violence -- are the same barriers to their involvement in clinical trials. Simple factors, such as physical access to the location of the study, availability of child or family care, inhibit their participation. Trials may need to investigate the socioeconomic position of women and offer support to potential trial participants.
A huge challenge for women and adolescent girls is exercising their autonomy in participating in trials. The process of enrollment, securing informed consent, and protecting them from the risks that can result from research participation is fraught with deeply embedded social norms which are largely biased towards males. Gender-sensitive approaches are key when designing consent and recruitment procedures and risk-reduction interventions in HIV clinical trials.
Question: What contribution can this conference make?
Schoultz: UNAIDS and the Global Coalition on Women and AIDS are keen to have guidance on the links and complications of sex and gender on HIV treatments. We hope this meeting will deepen our understanding of these intersections in various clinical research areas. We hope that this meeting will help get HIV clinical trials done right for women.
Julie McHugh, Company Group Chairman, Tibotec, was asked about what are currently the most promising avenues of research in HIV anywhere and for her company in particular.
McHugh: There has been a renewed push across the AIDS field recently with new treatments coming to patients with high genetic barriers to resistance, and superior efficacy and tolerability. This is an area that Tibotec is actively engaged in. Equally important are the development of new technologies and approaches that will simplify prevention and treatment approaches - in the fields of microbicides and Pre Exposure Prophylaxis particularly. But the key challenge for anyone concerned about reversing the global AIDS epidemic is making sure we have genuine partnerships between communities, international agencies, NGOs and the private sector to bring these new advances to women and girls. Highlighting this urgent need is the rationale for us holding this forum in Geneva.
Question: Do you feel that enough is being invested in HIV research worldwide?
McHugh: On the one hand, you could say that there is never enough being invested or conducted in HIV research. However, signficant increases in resources and commitments have been made in recent years across the public and private sectors. What we have to do is to ensure that these resources are most effectively used - and again, this calls for more enlightened and long term partnerships between sectors.
Question: What do you hope will come out of this conference?
McHugh: We want to raise awareness with policy makers and researchers of the importance of placing women and girls at the centre of HIV research. Twenty five years of this epidemic has taught us that women and girls are at the heart of any successful response to HIV.
Three-part web series
Part 1: Meeting ethical concerns over HIV trials
Part 2: The role of women in HIV trials
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)