The Importance of Including Women in HIV Cure-Related Research

Segment Description: Brian Minalga, MSW, project manager in the Office of HIV/AIDS Network Coordination at Fred Hutchinson Cancer Research Center, discusses research on the historical exclusion of women in HIV cure-related research.

Contagion®: Can you describe the current state of cisgender and trans women’s involvement in HIV cure-related research?

Minalga: In much HIV research cisgender and transgender women have a underrepresented status, in HIV cure related research. Historically we've seen primarily cisgender men being included in HIV clinical research. And the same holds true for cisgender and transgender women's participation in HIV cure related research.

Contagion®: Why have women been historically excluded (or not actively included) from HIV cure-related research?

Minalga: Systemically, we have a problem, we live in an unequal society and researchers don't necessarily mean to perpetuate injustices and inequities in our society, but those injustices do get perpetuated through practices and research.

I think ultimately, taking the big picture systemic perspective, the reason that cisgender and transgender women are excluded from clinical research or otherwise not supported to participate in research has to do with systemic discrimination, misogyny, transgender antagonism, negativity, and all the things that play out in our society and show up in unexpected ways in clinical research.

Contagion®: What can be done to better include women in these trials?

Minalga: A few different things could be done. One of them starts at the policy level. In 1993, congress authorized for the first time the NIH Revitalization Act. And what the NIH Revitalization Act requires is that all NIH funded clinical research includes women and racial and ethnic minorities. This is the language of 1993, how it's written into the act.

However, this guidance and this requirement only applies to late phase clinical research. There's a problem in the beginning of research starting all the way with animal research where we're only looking at assigned male at birth or in the animal version, male animals, and how potential products work in the male biology. And so we see that happen in early phase clinical research as well involving humans, where people assigned female at birth tend to be left out. And that's kind of in our binary world as well. But of course, we know that there are more than two genders. There's more than men and women. And so we have transgender people, we have nonbinary people as well. And those research questions are very early in development. We already have an issue with cisgender women being excluded from HIV related research. And we also have a major problem with transgender and nonbinary folks being excluded from research.

Well, we had a really clear example last month on the importance of including women and minorities and transgender people and research as well. And that was the FDA approval of Descovy for PrEP. It was approved for some people and not for others. And basically what happens when research fails to include women and minorities and transgender people, is it creates a hierarchy where products are approved for some people and not approved for others. When we're talking about HIV cure related research, we know epidemiologically that women are heavily impacted by HIV. Globally, more than half of the world's population of people living with HIV are women. And in the United States, about 20% of new diagnoses are among cisgender women. We know that transgender women, especially transgender women of color, are heavily impacted by HIV as well. So when it comes to HIV cure related research, if a cure is to work, it must work for women. And the only way we know it's going to work for women is if women are included in HIV cure related research.

I mentioned the NHI revitalization act of 93. One thing we could do is broaden the vision of the NIH revitalization act to include women and minorities at all phases of clinical research, not just late phase. And we could also do a better job of holding researchers accountable.

It's one thing to have the policy in place that says researchers need to include women, transgender people, people of color, in research. But it's another thing to actually hold the researchers accountable for doing that. We see in some research that I presented today that researchers are not including women, there was a landscape analysis of 128 different HIV care related studies. Only one of those studies included all women, and few of them even included a combination of men and women.

And once again, this is problematic because we're talking still in a binary of people assigned either male or female at birth without looking at how gender differences, how hormonal differences, play a role not only for cisgender women but for transgender women and other transgender people as well. So we can make a policy change to do a better job of including women and minorities in HIV care research, we can also do a better job programmatically of holding researchers accountable. And for the research teams themselves, they can really do a better job of considering sex-based differences when writing research protocols for new strategies and looking at HIV cure. And the research teams can do a better job of employing folks from the communities so women, transgender people, people of color as well, in terms of recruitment and retention of these underrepresented populations in HIV care related research.