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Expanding Clinical Trial Access for Women Living With HIV

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For over 30 years, Merck has been committed to improving the lives of people living with HIV. In those three decades, there have been remarkable advances in therapies to treat and monitor the disease. Today, however, the people who are infected with HIV is changing; there is a silent epidemic of women living with HIV, requiring new ways of understanding the needs of people living with HIV and developing more effective options for treatment and care.

Globally, there are 18.8 million women and girls living with HIV and approximately 870,000 new cases annually. That means every 80 seconds, a young woman becomes infected. Designing clinical trials for these women presents challenges given their unique barriers. From a cultural, social, and economic perspective, many women with HIV are not aware of or willing to participate in clinical trials. We want to change that.


Connecting through the community

Merck is working with community outreach groups and women living with HIV to understand the burden of the disease and what solutions might help. Partnering with female patient advocates (patients who publicly support or make recommendations for a disease) has helped us to listen and learn about known barriers to clinical trial engagement and to develop a female-focused recruitment strategy for our clinical trials. A community advisory board also helps generate solutions that address patients’ questions and helps them overcome challenges to participating in a clinical trial such as transportation or even child care. 

Kathleen Squires, M.D., Merck Scientific Affairs, reiterates the importance of evolving our approach to better meet the needs of women with HIV. “Less than 20 percent of HIV clinical trial participants are women. Women may be at higher risk for complications, and we need to understand these risks and address their concerns and needs if we want to design effective trials and medicines.” Bringing meaningful input from women living with HIV into the design of clinical trials helps us partner with patients to make trials more women-friendly.

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