Table 3:

Select Quotes – Meaningful Women’s Involvement in HIV Cure-Related Research (United States, 2022)

Themes	Sub-Themes	Participant Number	Participant Type	Quotations
Inclusion of Women in HIV (Including Cure) Clinical Research
Perceptions on Inclusion of Women in HIV Clinical Research
Need to ensure broad representation by sex and gender		27	Biomedical Researcher	Honestly, we've known for a long time that physiologically, men and women and people of different genders have different immune system, different physiologic biology of HIV in terms of their virus host interactions, they also have different socio-economic realities… So it's extremely important for us to involve many different types of people, including people of different sexes and genders.
Need clear definition around sex or gender		12	Community Member	Most of the research today is still done with binary gender in mind, male or female, and really doesn’t capture some of the gender identity and expressions on the spectrum. I think that it's really important, if we are looking at these demographic informations, that we reflect accurate gender identity or gender expressions of participants. So in addition to transgender women, there are transgender men. Also, there are some who identify as non-binary, and they don't consider themselves on the spectrum
Common Challenges to Including Women in HIV Cure Clinical Research
Engagement and outreach-level challenges	Paternalism	19	Biostatistician	There's a paternalism… And so women are never approached and not asked… the theme I have heard over the years when having the wonderful opportunity to hear members of the community… is, "I was never asked, I was never approached, I was never aware."
Meaningful Participation of Women in HIV (Including Cure) Research
Successful and Less Successful Clinical Trial Examples
Successful examples	GRACE study	03	Community Member	The GRACE study, done almost 15 years ago now, really demonstrated that it was possible to recruit women in the US in a treatment study. GRACE stood for Gender, Race, and Clinical Experience, which really resonated and meant something to women – to us. One of the amazing things about the GRACE study is that it enrolled nearly 70% women and 87% people of color. It was pretty astonishing in the US at the time and it really dispelled the myth that enrolling women domestically wasn’t possible.
Less successful examples	DESCOVY pre-exposure prophylaxis trial	18	Community Member	Let's just be real and talk about what a tragic mistake and bad decision not including cisgender women in the DESCOVY trial was, right? … Now there's a whole new trial rolling out that is inclusive, actually has a separate track specifically for cis women, and had to have the inclusion of these women from the beginning, from before the protocol was finalized, before the protocol was written, submitted, and approved for study. All of that had to be done creating a whole different way of engaging the community so that there was accountability on top of the advisory work that's supposed to be done. And having more of a partner approach to how this study is going to roll out is what has happened as a result of not including women in the first place.
Steps to Facilitate More Equitable Participation of Women
Protocol-level solutions	Socio-behavioral and mental health component	18	Community Member	It has to have a very robust social, behavioral and mental health approach to the overall enterprise for cure research. That it cannot just be about cells and drugs in bodies, that it really has to be understanding what cure means, how it might play out.
Institution-level solutions	Representation at clinic level	01	Biomedical Researcher	Representation matters. If we have a clinic where 90% of the doctor are white men, women will not be motivated to even show up and enroll. Having representation at every stage from the nurse to the doctor will be important.
Disaggregating Scientific Data by Sex and Gender
Frequent mis-categorizations and misclassification by gender		16	Community Member	People report a category of trans or non-binary, which, it's not disaggregating transgender men versus women. It's not disaggregating transgender or non-binary people. It's just kind of lumping them together into a category, which is not ideal, or that doesn't seem ideal to me. It would be far better to actually identify transgender men and women and non-binary people separately… One uses the term transgender spectrum. Just sort of lack of standardization of terminology.
Testing Interventions in Women
Sex is an important variable		22	Biomedical Researcher	The data broadly indicates that sex is one host factor that will have to be considered, and it has top level implications for a bunch of interventions, including histone modification and latency reversal agents, which are impacted by estrogen in vitro potently, including anti-exhaustion therapies like anti-PD1 [programmed-death-1], which in the cancer literature have been shown to have sex differential efficacy, so one would predict that they might have the same difference in efficacy here. Then vaccines, which in that case, maybe females will do better, because female responses to vaccination are generally somewhat more robust. For block and lock, we really don't have much data… if it's silencing and it's histone modification or chromatin modification, there are lots of differences in how those are managed on the cellular level between male cells and female cells.
Willingness to Undergo Invasive Procedures (e.g., Biopsies)
Women willing to undergo invasive procedures	Adequate compensation needed	02	Community Member	So one thing that I've learned about the HIV community is that the HIV community is willing to be involved in research to help the next person, right? If it's going to help the next person down the line, then I'm willing to do it. But presentation matters, compensation matters. I'm definitely not going to let you do a biopsy for a gift card. You can forget that. But if it's something that's going to make a difference for my family that I'm trying to take care of, then yes, I would consider it. So it depends on the woman. It depends on how the information is presented and it depends on the compensation and that's just as real as I know how to be about it.
Deterrents	Prior physical abuse	14	Community Member	She cannot have someone touching her body when she's asleep. Most of this is not even to do with the fear of that, but a lot of women have had abuses. They've had rape, they've been sexually violated and for some of them, these are triggers. These are issues that you need to talk about.
People of Child-Bearing Potential
Double barrier of contraception acting as a deterrent		09	Community Member	One thing that always bothers me is when they request two forms of birth control. I think that's a little overboard for a lot of people. That's just not something that's going to happen when you're married and on birth control… I'm not going to go through the extra step and ask my partner to also put on a condom, because in addition to everything that we're already doing, I have to have two forms of birth control for this study… I don't have an issue with one form of birth control because I understand that you don't want anything occurring to the baby, but when they go to the two forms of birth control, that always irritates me a bit.
Women and HIV Treatment Interruptions
Women’s Willingness to Interrupt HIV Treatment
Willing to undergo HIV treatment interruption	Skipping pills occasionally	02	Community Member	I actually was looking into a treatment interruption study… It doesn't have as much to do with the cure research as it does with me personally, which is that I've been skipping pills anyway… I've been skipping just because of life. Life is doing what life is doing right now. And so for me, my thought was, "If I'm already missing medication, maybe I can get involved in this treatment interruption study." It benefits me because then I don't feel guilty about skipping my meds, but then it also benefits science because I'm participating in this research. So that again is how is it being presented, right? Or how are you asking me if I'm interested in this and are you listening to my reasons for why I want to be involved? … So that way, if I know that you're going to be checking my viral load and you're going to be watching out for what's going on.
Not willing to undergo HIV treatment interruption	Ritualistic relationship with ART pills	10	Community Member	I have to say, my relationship to my pills may be unusual in that I love my pills. I've had blessing ceremonies for my pills. When I take my pills, I see my friends in a circle, praying for me and my pills. So it's like I have a very consciously chosen choreographed relationship to my pills. And that's very unusual. Most people's relationship to their pills is… “This is a daily reminder that I'm stigmatized. This is a daily reminder that there's something wrong with me.”
Enrollment of Women in ATI-Inclusive Trials
Need to understand partnership dynamics		02	Community Member	I definitely feel like if you're going to involve a woman in treatment interruption, then you need to make sure what's her current partnership status. Does she have a partner? Is that partner HIV positive or negative? Is that partner on PrEP? What are their thoughts around U=U [Undetectable = Untransmittable] and the potential interruption of that? So there definitely needs to be a sexual health context and conversation, especially if the woman is in a sero-discordant relationship. So at that point, it's not just a woman conversation, it's a whole relationship conversation. What's her support system look like? If she has other family members that are heavily invested and involved in keeping her healthy, like say for example, in the Black community, we tend to be multi-generational as far as living arrangements, parents, grandparents, grandchildren. If my mother is living with me, is it going to freak her out to know that I'm not taking my medication? How do I have that conversation with her? So those are things that need to be considered. The overall lifestyle of a woman needs to be considered.
Transgender and Gender-Diverse Individuals
Role of hormones		07	Biomedical Researcher	Inclusion obviously is the biggest issue, and being able to really answer questions around treatment interruption and cure research in this population, particularly, if they're taking hormone therapy, because it does seem like hormones are playing a role here in terms of the immunology and virology
Needs for trauma-informed research		18	Community Member	There's a certain level of built-in trauma, a desire to be seen, known, and felt as fully human, that people of trans experience have been denied mostly all their lives. Most people of trans experience at some point in their lives, if not most of the lives, have been denied that full recognition of their humanity… And come at me with that kind of compassion and empathy and humility and understanding and respect and see me and hear me in my full humanity. And then we can talk about the rest.