Table 1.

Strategies to improve involvement of women in HIV clinical trials

Target group	Suggested strategy for increasing involvement of women
Clinical researchers	Ensure equal representation of men and women in earlier clinical studies (e.g. in Phase II) Women-only trials conducted at Phase III Protocols should be statistically powered to provide meaningful data on gender differences Protocols should be designed to remove unfair barriers to the involvement of women
Physicians	Work with clinical trial investigators to develop ways to improve appropriate recruitment of women into trials Put strategies into place to address barriers by catering to the specific needs of women (e.g. through providing childcare options)
Clinical trial sponsors	Collaborate with women investigators and centres responsible for the treatment of a high proportion of WLWH Provide specific tools to enable recruitment of more women
Regulatory authorities and ethical committees	Recommend that pharmaceutical companies, trial sponsors, and clinical trial investigators recognize and address the gender imbalance in HIV trials Recommend pharmaceutical companies and trial sponsors use female investigators
Journal editors	Encourage the reporting and publication of results for female participants in HIV clinical studies Incorporate a recommendation in the CONSORT guidelines* to include women in clinical trials of HIV treatment and to report female sub-analyses Ensure that publications represent and discuss women where possible and that the use of women-specific endpoints is investigated Encourage inclusion of a discussion of any evident differences between men and women that emerge from studies Include a women's health specialist on journal editorial boards Highlight where further research is required
Medical societies and congress organizers	Encourage the submission of study data on women in the congress call for abstracts Give priority to data on women when allocating scientific sessions and symposia Ensure scientific sessions and symposia address gender-specific issues related to treatment Ensure female investigators are part of congress organizing committees Give priority for oral presentation to high quality abstracts that address gender issues Monitor the numbers of female investigators and presenters attending congresses Monitor the proportion of women in studies that are reported at congresses
Advocacy groups	Raise awareness and highlight gaps in the reporting of data on women during scientific symposia Include articles in patient advocacy publications on the importance of the adequate representation of women in trials Provide peer education and support

^*Available at: http://www.consort-statement.org/

Adapted from d'Arminio Monforte et al. [3] with permission.