Making HIV trials “work for women”
13 December 2007
Health experts from international agencies, non-governmental and research organisations and universities as well as industry agreed on a series of steps aimed at ensuring that HIV trials and interventions are designed and implemented to reflect more closely the needs of women, who are increasingly affected by AIDS.
At the end of a two-day meeting at the UNAIDS Secretariat headquarters in Geneva, the group identified areas in which more research is required, including into the effect of sex differences on HIV interventions, and committed themselves to strengthening advocacy surrounding women and HIV trials amongst the donor community, governments and industry.
Describing the outcome as “heart warming”, Kathleen Cravero, Director of Crisis Prevention and Recovery at the United Nations Development Programme, said the issue of women and HIV was finally getting the attention it deserved. “I remember that not so long ago it was very hard to get anyone’s attention to that subject,” she told delegates.
Half of those living with HIV around the world are women, but the figure rises to over 60% in sub-Saharan Africa where infection rates are increasing amongst adolescents girls.
However, women are still under-represented in clinical trials for treatments and prevention strategies. The reasons are varied, and in part historical, but in developing countries they include cultural, social and economic factors, such as lack of empowerment for women.
This in turn requires that solutions to the problem go beyond strictly biomedical considerations to include structural issues, including poverty, delegates agreed.
The meeting, sponsored by UNAIDS, the Global Coalition on Women and AIDS (GCWA), the International Center for Research on Women (ICRW) and the pharmaceutical company Tibotec, made recommendations in three core areas – policy and programmes, research and advocacy.
The key themes identified were the overall issue of women’s involvement in trials, sex differences – gaps in knowledge, such as the varying effects of viral loads in men and women -- capacity building, opportunities for research, improving the dissemination of what is already known, adolescents, and sexual and reproductive health issues, including abortion and pregnancy in women living with HIV.
On adolescent participation in trials, which is becoming a crucial issue given mounting infection rates in some parts of the world in this age-group, the group felt that more needed to be known about the benefits and drawbacks before clear recommendations could be made.
Targets for advocacy would include regulatory agencies, which would be encouraged to insist on the inclusion of more women in trials, research agencies and donors such as the Global Fund, medical journals and industry. The latter would be asked to set targets for the inclusion of women in testing.
Some future tasks were assigned amongst various organisations taking part in the meeting, attended by over 50 experts in various aspects of the AIDS response. The Global Coalition, for example, agreed to look into structural intervention issues, while UNAIDS will address the question of good participation practice (GPP).
It was suggested that the World Health Organisation, UNAIDS and the United Nations Population Fund (UNFPA) could call a special meeting to debate questions surrounding couples where one partner is HIV positive and the other not, often called sero-discordant couples, and issues such as fertility and pre-exposure prophylaxis.
The group, which will be issuing a full report on the outcome of the meeting, will also look into presenting a “report card” on HIV trials, assessing the degree to which they have included women.
Policy and guidance:
Good participatory practice guidelines for biomedical HIV prevention trials (pdf, 3.04Mb)
Global Coalition on Women and AIDS
International Center for Research on Women (ICRW)
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
Read more on the meeting - Women and HIV research