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Women make up more than half of all people living with HIV – why are they under-represented in studies of new medicines?

Today, out of all the key populations affected by the HIV epidemic, women make up more than half (52%) of all people living with HIV worldwide and HIV/AIDS is now the leading cause of death globally for women aged 15-44.1

In low-and middle-income countries, the statistics around the incidence of HIV in women are even starker. Gender inequalities and harmful practices that promote unsafe sex and limit access to health services mean young women in sub-Saharan Africa are often prevented from gaining access to HIV treatment and do not have the final say in their own healthcare decisions. As a consequence, the prevalence of HIV among girls and young women is more than double that of similarly aged males.2

Romina Quercia, Global Medical Director, ViiV Healthcare, specializes in the study of HIV in women:

Romina Quercia, Director of Clinical Development, explains why we can’t forget to include women and transgender people when it comes to HIV research.

Although HIV in women is a serious and significant issue, women remain largely underrepresented in HIV clinical trials. A large proportion of HIV clinical trials and cure-related research take place in developed countries, where the HIV epidemic is predominantly driven by men who have sex with men.3

The under-representation of women in HIV clinical trials leads to gaps in scientific knowledge about how HIV in women may behave differently in men. These variations can affect the safety and efficacy of treatment, including how medicines may interact differently with the female body.4

Current guidelines for treatment using antiretrovirals (ARVs) lack specific guidelines for women because they are based on research conducted predominantly in a male population.

"Every minute, more than two women are newly infected with HIV. One of those will be below 18-years old"

How can we understand more about HIV in women?

The lack of enrollment of women in HIV clinical trials prevents study findings from being truly relevant to women. If gender-specific biological markers are not set up and relevant questions are not asked (or are unable to be answered due to a small percentage of women taking part in studies), how can we confidently treat women living with HIV?

Competing priorities for women, which can include childcare, home responsibilities and shift-driven jobs, often make traditional recruitment practices for HIV clinical trials less successful and lead to a gender imbalance in studies.3

In addition, too often, budgetary and time constraints limit the ability of study sites to develop women-friendly recruitment strategies, and therefore limit their ability to engage with women.5

Closing the research gap for HIV in women

Targeted enrollment of women in clinical trials and careful, separate analysis of data for men and women are crucial to gaining further insights into gender-based differences in HIV infection, to designing sex-specific approaches to HIV treatment and in the future, to potential elimination of the virus through cure or remission.

Increasing female recruitment into HIV studies is not a simple task and the scientific community is the main driver to take action in order to address the shortfall. Ending the HIV epidemic requires basic science, clinical and social research plans, and increased efforts to work in a coordinated manner to obtain scientific data that can inform ways to curb the progression that today targets young women.

Annemiek De Ruiter, Head of Global Medical Science, ViiV Healthcare, says there’s no simple solution to correcting these issues related to HIV in women:

Annemiek de Ruiter, Head of Global Medical Sciences, explains the barriers to including women in clinical trials.

Closing the research gap for HIV in women

Recognizing the impact of the HIV epidemic on girls and women, ViiV Healthcare is putting specific emphasis on this population as part of our HIV clinical trials strategy and community partnerships programs.

We contribute knowledge to fill gaps and reach unmet medical needs through our research programs to understand more about HIV in women. We have and continue to undertake and support numerous HIV clinical trials specifically among women, with more than 2,100 women taking part in our treatment studies and 300 women in prevention clinical trials.6

While women represent 19% of participants in HIV ARV studies on average, several clinical trials sponsored by ViiV Healthcare have surpassed this mark, including some with 100% participation by women.3

Further, through our international Positive Perspectives survey of people living with HIV and their partners, we are exploring the unique challenges faced by women living with HIV. This research aims to expand community-wide knowledge on gender discrepancies regarding attitudes towards health, sexual intimacy and relationships with healthcare providers.


  1. UNAIDS. Core Epidemiology Slides. Available at: https://www.unaids.org/sites/default/files/media_asset/UNAIDS_2017_core-epidemiology-slides_en.pdf. Last accessed February 2020.
  2. UNAIDS and African AIDS Union. Empower young women and adolescent girls: Fast-track the end of the AIDS Epidemic in Africa. Available at: http://www.unaids.org/sites/default/files/media_asset/JC2746_en.pdf. Last accessed February 2020.
  3. Curno, J. Rossi S, Hodges-Mameletzis I, et al. A Systematic Review of the Inclusion (or Exclusion) of Women in HIV Research: From Clinical Studies of Antiretrovirals and Vaccines to Cure Strategies. J Acquir Immune Defic Syndr. 2016 Feb 1;71(2): 181-8.
  4. British HIV Association. British HIV Association guidelines for the treatment of HIV-1-positive adults with antiretroviral therapy 2015 (2016 interim update). Available at https://www.bhiva.org/file/RVYKzFwyxpgiI/treatment-guidelines-2016-interim-update.pdf. Last accessed February 2020. 
  5. Gianella S, Tsibris A, Barr L, Godfrey C. Barriers to a cure for HIV in women. J Int AIDS Soc. 2016 Feb 18;19(1):20706.
  6. Data on file. ViiV Healthcare. February 2020.


Since the advent of highly active antiretroviral therapy HIV has become a long-term health condition, as many people living with HIV with access to treatment are now living longer, healthier lives than before. However, Positive Perspectives study results indicate that many people living with HIV still aspire to treatments that have even less impact on quality of life.

Collaboration is the key to finding solutions to HIV challenges – and it’s at the heart of what we do at our HIV research facility in Branford, Connecticut.  

Through collaboration, we are advancing our efforts to discover a cure for the millions of people living with HIV.