Behavioural approaches to HIV prevention have been particularly difficult for young women because it is most often the behaviour of their partners that makes them vulnerable to infection. Gender-specific approaches are needed to provide young women with the knowledge and skills to protect themselves, and to engage men and boys in understanding and reducing their own vulnerabilities and those of their partners. Interventions to shift gender-related social norms that perpetuate young women's vulnerabilities are also needed. While these approaches hold promise if serious investments are made, it is critical that we expand the range of prevention options available to young women and girls, especially female-initiated and female-controlled methods. An example of a ‘female-controlled' or ‘female-initiated' method that is currently available is the female condom, however, unfortunately this is not yet widely known and used, and may be impractical for many young women who lack knowledge about their bodies and risks. While a woman can initiate use of the female condom, it may still require some level of partner negotiation, particularly where there is a serious imbalance of power such as in transactional or intergenerational sex.

If we look for parallels in the use of family planning methods, we have seen that women of all ages often prefer methods that can be used without the knowledge of their partner. Another lesson from family planning is that having a broader array of options to meet different needs of individuals increases overall use. There is a clear recognition today that the comprehensive prevention, treatment, care and support continuum must include the technologies and approaches currently in use, expanded access to treatment, and the urgent development of microbicides and vaccines. Both technologies are still in the research and development stage, but will one day offer increased choices to women and men.

Women and girls in AIDS vaccine trials

In order to ensure that AIDS vaccines work for both women and men, that they meet women's needs, and that women, especially young women, eventually have access to them, gender issues must be considered in the planning and implementation of clinical trials and preparations for access and use. Compelling biological, scientific, social and ethical arguments call for inclusion of significant numbers of women and men in trials. Biological differences in the risk of infection and viral load may lead to differences in effect of the vaccine on women and men. A single trial may not be able to determine whether the vaccine works differently for men than for women, but it can detect trends. Past clinical trials have not always included enough female participants and have been unable to distinguish such trends.

Considerable effort and planning is required to bring women, particularly in developing countries, to participate in trials. Trial experience from many countries around the world has made us aware of the cultural and logistical barriers to women's participation. The challenge lies in investing the time and effort needed to explain the process and trial requirements to women, communities and families. Trial staff must be aware of gender-related factors that might hinder women's participation: a) many women lack the autonomy to make independent decisions about HIV testing or trial enrolment; b) women often shoulder additional responsibilities of childcare, care of the elderly, and housework, and may not be as readily available as men to attend information sessions or frequent clinic visits; and c) in cultures where a woman's perceived worth is often tied to her fertility, trial requirements that she avoid pregnancy during the course of the trial may place constraints on her participation.

Developing a gender-sensitive vaccine strategy

IAVI is a global not-for-profit organization working to speed the search for a vaccine to prevent HIV. Founded in 1996 and operational in 22 countries, IAVI and its network of scientific partners research and develop vaccine candidates.

In order to ensure that clinical trials are conducted in ethical and gender-sensitive ways, IAVI is engaged in developing a framework to identify and address gender issues. This framework not only focuses on enrolling and keeping women in trials, but also on a range of gender issues central to the appropriate conduct of trials. These issues include, for example, ensuring that informed consent processes take into account the gender norms that make women vulnerable to coercion; sensitivity of trial staff to ways in which gender bias can affect confidentiality, stigma and discrimination; and the impact of gender on the potential social harms and benefits that could result from trial participation.

Beginning in India, in 2002, IAVI began to develop this framework by bringing together experts representing diverse experiences ranging from HIV/AIDS, health, gender, counselling, research and activism to help map out the key issues. A series of consultative meetings were held with NGOs, the media, government partners, trial administrators, and people infected and affected with HIV/AIDS. These experts raised pertinent questions: What barriers will we encounter in recruiting women? How can we prepare the trial sites to be non-threatening and non-intimidating to women and men? How can we make the trial staff sensitive to the differential needs of women and men? How can we support women in trials by way of good counselling and protect them from stigma, discrimination and violence?

One recommendation that emerged from these consultations was that IAVI should set up a Gender Advisory Board in India to steer the process of making its upcoming trials more gender-sensitive (the first Phase I trials in India are anticipated to start towards the end of 2005). Members of the Board have been part of a review committee to discuss the informed consent form and the protocol for enrolment and screening to ensure that gender concerns are taken into account. They have assisted IAVI in developing gender training modules to train the trial teams in gender sensitivity. They have offered to be spokespersons with the national and institutional ethics review committees to ensure gender is integrated in protocol development and programme design. They are providing advice and oversight in developing gender-sensitive indicators and monitoring accountability procedures.

IAVI has begun to extend this work in East Africa by holding its first gender consultation in Kenya in 2004. An additional consultation will be held in Uganda in 2005, and it is expected that trial site staff in both countries will be trained, using an adaptation of the Indian curriculum, in 2005.

Promoting investment in new approaches

Many challenges lie ahead, and the results of the efforts in India can only be assessed once the trials take place at the end of 2005. It is to be seen whether this trial – conducted by a team that has been trained to adopt gender-sensitive approaches – will be successful in recruiting sufficient numbers of women. However, success should be measured not just with numbers but with the process. The proactive steps taken to incorporate gender concerns in AIDS vaccine trials in India is in itself a unique experiment that might hold important lessons for other AIDS vaccine trials. A report that documents the consultative process in India, as well as a paper outlining the range of gender concerns related to AIDS vaccine trials more generally are available, and documentation of lessons learned by the trial team is planned.¹

In the end, technology is useful only if it is safe, accessible and available to all who need it. Vaccines – even when fully effective – will not eliminate the need for treatment and other prevention strategies. Nor can vaccines change the harmful gender dynamics in and of themselves. It will be one more prevention tool that women of all ages can use to protect themselves against HIV. Women's health advocates must include AIDS vaccine research and development in their efforts to promote investment in approaches that address young women's vulnerability. We need to align the agendas of different prevention approaches and find common grounds for advocacy, education and access.