In fits and starts, the HIV research community is finally awakening to the existence of transgender and gender-diverse people. Like a small oasis appearing in a desert, the past few years have featured a greater trickle of focus on needs and concerns affecting gender-diverse populations, as well as data-collection methods that begin to provide a more accurate picture of how HIV affects transgender people and gender-diverse individuals.*
But these fits and starts are just that: an inconsistent beginning. In hopes of providing a clear pathway for progress, an international group of prominent advocates recently published a manifesto, “No Data No More,” that offers a comprehensive set of recommendations regarding where the HIV prevention research field can focus its priorities and resources in order to improve trans and gender-diverse representation—and, ultimately, health outcomes. They released the manifesto to coincide with the 11th International AIDS Society Conference on HIV Science (IAS 2021) in July.
To learn more, our correspondent Terri Wilder spoke with four of the manifesto’s architects:
JD Davids, an HIV-focused activist and strategist with JD Strategies who authors The Cranky Queer Guide to Chronic Illness.
Cindra Feuer, a senior program manager at AVAC: Global Advocacy for HIV Prevention.
Max Appenroth, the project coordinator for trans men and HIV with Global Action for Trans Equality (GATE).
Immaculate (Imma) Nyawira Mugo, a consultant based in Cape Town, South Africa, who focuses on the intersectional issues affecting reproductive rights and health.
*A transcript of that interview follows; it has been edited for length and clarity.
What Prompted the “No Data No More” Manifesto
Terri Wilder: This 20-plus-page document was released the same week of the 11th International AIDS Conference on HIV Science. My understanding is that it was written by and for trans and gender-diverse global activists, with support and solidarity from AVAC.
I’d love to hear about why this manifesto is important. How is it relevant right now, in this time of science and research?
JD Davids: Thanks, Terri. This report has always been needed—throughout the HIV pandemic. Across most, if not all, medical research, there’s been either a total ignoring of, or misunderstanding of, trans realities that has led to either excluding or misrepresenting trans people in medical research and literature.
At this point in the global pandemic, in some areas we’ve seen great progress against HIV transmission or acquisition, and finding treatments that allow people, if they can access treatments, to live a healthy, long time. But in the case of trans people, in many parts of the world there’s not even basic estimates of how many trans people are living with HIV, let alone inclusion in research trials in smart and accurate ways [that will help us] understand how interventions may be useful or not useful for the myriad of different folks who are trans or gender diverse.
Terri Wilder: Cindra, I know that AVAC was part of this effort. How did this project come about? What was the thinking from AVAC to gather people together to work on this?
Cindra Feuer: Thanks, Terri. Well, first of all, I wanted to just say that this is a manifesto, not a report. A manifesto, historically, is a vision by the community about what they want to see in the world.
At AVAC, our focus is ethical research. And there was just a deafening void of trans representation in every area that we work in. It was on the burner for years and years, and it just had to happen. Because AVAC has the technical expertise, we thought we were in a really nice position to gather and support the trans community to actually envision this manifesto.
A Focus on Transmasculine People
Terri Wilder: As mentioned in the manifesto, HIV in trans men is understudied. And the absence of data leads to false assumptions that trans men bear little to no burden of HIV. Max, I’ve heard the call from trans men—for many, many years—to be recognized in the HIV pandemic as people who deserve HIV prevention services, as well as HIV care. I’m wondering if you can talk to me about this historical exclusion of trans masculine people from research and the conversations around what this manifesto is about.
Max Appenroth: This is something that is very personal for me. If I go to the doctor and I ask them about HIV prevention, they ask me why. Like, “Why do you care about it?”
Because many people really don’t see that we as transmasculine people, we are exposed to HIV risk from very different perspectives. We have sex with other men, we have sex with trans women, some of us are drug users, some of us are sex workers. People just never see that we’re part of these, what they call “high-risk networks.” And this is something that needs to get out there, that we are at risk, and that people need to understand that we have very specific needs.
Regarding what is out there in terms of HIV prevention: For example, PrEP has never been properly researched in transmasculine people. My doctor told me, “I think it’s safe for you to use it, but there is no proof.” This is what I have to live with.
This needs to change. I want to take the agency of taking care of my health and my safety. And I can’t do that if I can’t trust the medical system.
This is something that has been ongoing for many, many years. In 2018 at the [International] AIDS Conference in Amsterdam, there was a big panel where experts were talking about marginalized communities in the HIV response. And they were talking about transgender people. A friend of mine stood up and said, “So, what do you know about trans men?” And the answer was, “Trans who?”
The experts are not—or many of them are not—even aware that we exist. This is something that is unacceptable.
This is also why we formed a group, called the International Transmasculine HIV Working Group, with GATE (Global Action for Trans Equality); it’s a global network of transmasculine people coming together to jointly raise our voices and to make ourselves and our needs heard. And I think this is what’s happening right now. And I’m very happy that we got this manifesto out, as well—this is a big step in the right direction.
Terri Wilder: There’s increasing data available around the pharmacokinetics showing that hormones are stable with PrEP use among trans women, but there’s limited data for trans men and trans adolescents. One of the things that was written about in the manifesto is that trans people assigned female sex at birth who are taking testosterone may experience vaginal atrophy, posing a potential high risk of degenerative genital tissue. I think that’s really important for clinicians, scientists, etc., to know about, in terms of PrEP services.
Max Appenroth: Yeah. It’s not only the atrophy; it’s also that vaginal tissue changes, it gets thinner. And the combination of a thinning tissue plus atrophy—if you have penetrative vaginal sex (not all transmasculine people do, but many do), that is a big, big problem. If there are small fissures, small wounds, that happen through penetration, this is a perfect entry port for viruses and bacteria, and that increases our risk for infection.
That is something that people really need to learn. In medical school, students need to learn about the diversity of bodies—not only in trans people, but also in cis people, you know? Right now it’s about us, but in general, everyone would [benefit] if people would be a bit more individual in looking at people’s bodies.
The Current State of Gender-Diverse HIV Prevention Research
Terri Wilder: Cindra, in the manifesto there’s a sentence that says, “To date, no HIV primary endpoint trials have focused specifically on transgender individuals.” Could you talk about some of the biggest gaps and recent progress in the HIV prevention landscape, in terms of transgender and the gender-diverse community?
Cindra Feuer: Well, there’s broad, sweeping gaps. First of all, the HIV surveillance or the [epidemiological data] is sorely missing [information] about: What is the incidence, and where are the trans people? Specifically in sub-Saharan Africa, Eastern Europe, and Central Asia, there’s very, very little data. If you have little epidemiological data, then you can’t do the research.
But in places where there is research ongoing—or big, randomized clinical trials happening—there is a trend, an upward tick these days, of including trans, mostly trans women. But thus far, as a subgroup, the trials that have included trans women have not included enough trans women in these subgroups to make statistically significant declarations.
So, we either need to move forward—where we have more inclusion in these large, randomized clinical trials, where we can actually make some real clinical analyses about whether or not an intervention works in trans populations—or trans populations need their own studies with HIV endpoints. And to date, that hasn’t happened.
Although there is an ongoing [study]: HPTN 091, which is this great vanguard study that’s looking at the uptake of PrEP with the provision of case management and gender-affirming hormones. The secondary endpoint is HIV incidence, but the primary endpoint is whether or not they are taking up PrEP and hormones when they’re both offered together.
What else? Implementation studies: Once an intervention is proven to work, the next step is how to get it to the people who need it most. There’s been very, very minimal implementation studies specifically with trans populations.
And so that’s something that needs to be remedied, as well.
Lastly, I’ll say that the pharmacokinetic studies—so, any compound, whether it’s cabotegravir, islatravir, lenacapavir, Truvada, Descovy—we really need to see pharmacokinetic studies with hormones, and what the drug-drug interactions are. Do the hormones lessen the [levels of] PrEP drugs, or vice versa?
Thus far we’ve seen a lot in Truvada. And what we’re seeing is that things are looking really good, that though there might be lower levels of either hormone or PrEP, they’re not clinically significant. But going forward, we need to see those pharmacokinetic studies with all compounds that are studied for HIV prevention.
Oh! And of course—I mean, it was said beautifully by Max already, and JD, but—on transmasculinizing hormones, we’ve seen very, very little representation. And this is a very sad and egregious area of neglect that needs to be rectified.
How to Improve Trans Representation in Medical Research
Terri Wilder: Imma, I’m wondering if you could maybe shed some light on some of the good participatory practices that scientists should be thinking about for the inclusion of trans and gender-diverse people in research.
Immaculate Nyawira Mugo: One thing that the manifesto wants to bring forward for researchers to remember is that they need to explicitly list trans men in their eligibility criteria. [For instance], in all the PrEP trials and all the other HIV prevention clinical trials—unless, of course, they have a valid reason as to why they can’t be able to include trans men, which would be either a medical or a physiological reason.
The second thing is to ensure that trans and gender-diverse people are included within the development of the research in itself. And when I’m talking about inclusion, I’m talking about meaningful inclusion and engagement with trans and gender-diverse people—in terms of them being part of the protocol team, advisory committee—to ensure that the research that comes out after that is representative of the community.
For me, the main thing that would come out [of this manifesto] is to ensure that the slogan that we always keep saying—nothing for us without us—is meaningfully included in terms of the research, by having researchers actually embody that ethos, in terms of ensuring that trans people are included all the way through the research process.
[Another goal] is to report on how trans and gender-diverse people were included in the study in itself: how they were included in the clinical trials, as well as how they defined concepts such as gender.
In this case, it would be good to ensure that a trans and gender-diverse person be the person who is then doing the data collection. Then they can be able to explain the information better to a study participant who would then be taking part in the process.
And then the last one is around funding of trans and gender-diverse organizations: Having the organizations themselves receive the funding to be able to carry out the research, either in collaboration with the researchers, or to carry out the research individually and then be able to feed that into a wider clinical trial—or research protocol, or project—that would then come through.
Terri Wilder: HPTN 083 [which studied long-acting cabotegravir for PrEP as compared to emtricitabine/tenofovir disoproxil fumarate], as stated in the manifesto, missed an opportunity to include transmasculine and other gender-diverse people who have been assigned female at birth but identify as men who have sex with men, and are in the same sexual networks and share similar heightened risk factors. What are some of the problems or issues that this creates when this community is not included? I know we’ve kind of talked about this, but I’m wondering if we can unpack it a little bit more.
Max Appenroth: If you don’t include trans people in your research, you don’t know how to ask the right questions. You’re not taking into account what our needs are, what our bodies are, how we use our bodies—with all the stereotypical assumptions of how trans people engage in sexual activities and stuff. And if you don’t ask the right questions, then why should I answer them? People who do research about MSM [men who have sex with men], for example, they need to start asking the questions that also concern us.
JD Davids: I would also specifically add in that, you know, people may not even identify as men, or men who have sex with men. We need to know, for example: Someone with my anatomy, physiology, and hormonal mix—what does and doesn’t work for someone like me with PrEP? And what does or doesn’t work in terms of being able to access effective interventions and use them in people’s complex lives?
I think this is most imperative when looking particularly at trans and gender-diverse people who are in criminalized and marginalized categories, who already face a lot of barriers to care and can be at a distance from information that they can use in order to reach their own life goals and maintain what’s healthy for them. There’s no need for researchers who don’t have lived experience to puzzle through and do their best guess at what language or what questions will be the most useful for people who aren’t like them. People need to have jobs, working in research, who are trans and gender-diverse, just like we know the importance of having primary investigators, for example, who are Black or Brown researchers in the United States, in terms of what gets studied and who will participate in studies.
Trans people need to be the ones making key decisions in this research, and need to be compensated for that work, in order to be able to have the best possible research that’s going to be the most relevant to them and their peers. Period.
Words Matter—as Do the Right Classifications
Terri Wilder: One of the things that was covered in this manifesto was a study of HIV testing events by the U.S. Centers for Disease Control in which they identified six subgroups of transgender or gender-diverse populations. They talked about how, for example, a person who’s assigned male at birth and who identified as a trans woman had much higher HIV prevalence than a person who identified as a [non-trans] woman. Their subgrouping revealed distinct differences among the categories that could have been missed had they lumped gender-diverse populations together.
I’m wondering if we can talk about the significance of that. You all gave a shout out to the NIAID HIV language guide and its guidance on the use of gender-inclusive HIV research practices.
JD Davids: I’d love to talk a bit about the lack of response to that data from the CDC. To my knowledge, as a former editor at TheBody and now participant in this conversation, I’ve been sort of one of the few pointing this out. It was a key presentation at that conference; it was emphasized by the press apparatus there. And yet, I haven’t seen it really utilized or reported on hardly anywhere outside TheBody, to be honest.
It also reemphasizes the effectiveness of a two-step question model: When research uses this validated model of asking people what gender was assigned at birth and their gender today, it can reveal differences that you would never get at with a one-step question.
This seems pretty important, yet it hasn’t been integrated or followed up on in significant ways that I have seen. And it needs to be. And that level of specificity—even a greater level of specificity, frankly, when it comes to people’s lived use of language? It’s vital.
We’ve had a little more work out there in the last bunch of years about how clinical care settings can be more appropriate and successful in their use of language, and in their understanding of language used by trans and gender-diverse people in a clinical setting. It’s not enough, and it hasn’t gone far enough. But I fear that it’s gone even less far when it comes to planning and tracking research.
Again, one of the best ways to do this is to hire trans and gender-diverse people on your staff, and to not follow the same failed model of saving community input when it comes to doing publicity for a trial for which all the major decisions have been made.
Max Appenroth: This is exactly what I said earlier: You need to know how to ask the right questions, and the way to do it is including trans people. Even if we’re not trained public health researchers, our community expertise—our lived experience—is an expertise. We do not have to have a degree in being trans.
But if you go up to community organizations or trans individuals to be like, “Can you please tell me how to do this right?” then please also pay us for our expertise. It happens so many times that people are like, “Oh, can you have a quick look on this?” We don’t have the time to do these things, because we still need to fight for survival—economically, but also, oftentimes, physically. And it’s really important to honor our knowledge and what we bring to the table.
The Importance of Gender-Affirming Hormone Therapy
Terri Wilder: I live in the United States. In particular states in our country there’s elected officials who are trying to make it harder and harder for transgender people, particularly adolescents, to access gender-affirming hormone therapy and other services. Why is this therapy important to be included in something like HIV prevention service provision?
Cindra Feuer: It’s so important that UNAIDS just recently came out with a declaration saying that they support the implementation of gender-affirming hormone therapy, with all service delivery, for trans populations. That’s something that HIV service providers should strive for throughout the globe. So there’s definitely a recognition that this is something that’s needed but not yet realized.
JD Davids: I would add that there’s previous research, for example, in the United States, with which I’m most familiar, that shows that the number-one health care concern of trans women living with HIV is gender-affirming care. Being able to attend that is not just a matter of preference or desire; it’s a matter of survival. In terms of not just people’s mental health, but also physical safety; in terms of how gender-affirming care may be that which allows people to present in a way that they choose and that can confer safety in a transphobic and gender binary world that’s filled with violence.
And related to that: For trans women of color, daily life is challenging, replete with bias and outright violence. And to be honest, people may not have a lot of time to play around with a whole lot of appointments, and [they] need to be able to access care that is the right care, that is delivered with caring and compassion and confidence, and that is accessible to them at the times and places that they can get to it.
That’s one of the reasons that it’s so important to have a baseline of basic health care, which includes gender-affirming care—which, for many people, hormones are a part of that—in order for people to be able to access this research.
Immaculate Mugo: I think I can add on to what Cindra and JD have said, in looking specifically at South Africa. There is a clinic that we have here—that’s based in four provinces in the country—that offers gender-affirming hormone therapy, as well as HIV treatment and prevention services. Just in the first three years of its implementation, they have found that there is an uptake in a retention of people who come in who are HIV positive, who are then retained on treatment, if they’re able to get gender-affirming hormone treatment at the same facility.
But then, again, there is not much research that has been done, because it’s the first clinic of its kind. And it’s, I think, going to roll into its second implementation phase.
Cindra Feuer: This is exactly what HPTN 091 is looking at: If you offer gender-affirming hormone therapy with HIV services, will uptake be greater, and will HIV incidence go down? And their hypothesis is: Yes, of course it will.
Terri Wilder: In the manifesto, it also mentions that it has the potential to enhance an individual’s self-worth and self-esteem. I think that’s important, as well.
Cindra Feuer: Exactly.
Key Takeaways and Next Steps for Trans and Gender-Diverse Inclusion in Medical Research
Terri Wilder: Part of this manifesto was that you all put together key recommendations that you want researchers, funders, and program implementers to implement. I’m wondering if, in one sentence, you can each name a key recommendation that you want these folks to implement, as it relates to HIV prevention research among trans and gender-diverse communities.
Immaculate Mugo: Mine would be leadership and inclusion of trans and gender-diverse persons all through the research process—from protocol design to advisory committees, all the way through to data collection and the reporting of it.
Cindra Feuer: One of the key things—one of the urgent scientific questions that hasn’t been answered yet for trans people—is whether intermittent PrEP, or on-demand PrEP, works. We know it works with people who do not have receptive vaginal sex. But we don’t know in trans communities. And this is an urgent gap that needs to be rectified, because we’re seeing through other studies that, when offered daily PrEP versus intermittent PrEP, often people want to take intermittent PrEP. So we need to make this available to trans communities. And in order for it to be available we need to see what the science says. Does it work?
Going forward, my closing would be: We need to have studies designed by trans people that have enough trans inclusion that we have statistically significant results once the study is completed. And then once there’s results, we need to have specific implementation studies with trans people.
And we need to have research that’s inclusive of trans men and people who are assigned female at birth. And all the range and diversity of gender.
I also think that going forward, the field needs to start with an apology for failing trans populations for 40 years. And I think that we should commit to rectifying this neglect and fulfill the visions of the manifesto.
Max Appenroth: The famous slogan, “Nothing about us without us,” is really something that holds true in this case. We’ve been excluded and kind of segregated for so many years. People are not aware, they just don’t know what our needs and concerns are. Getting us back—well, not back, but starting to get us—at the table. And accepting us, firstly, for who we are, but also acknowledging our different expertises that we bring to the table.
We bring a lot of superpowers, because we’ve learned to think outside of the box and to reinvent ourselves all the time, and to stand up again and again and again. See us as a resource for any type of project.
JD Davids: I want to uplift an immediate, practical measure that could be put in place by editors and hosts of HIV-related conferences, which is: Any time there is any research on any topic that specifies that it included women and/or men, there should be a footnote or a clarification of what that definition entails and what has been asked and not asked.
When studies are published in academic journals or given in scientific conferences, there’s always a section on study limitations. Where the two-step method of looking at gender has not been used, that should always be put in as a study limitation. When there has not been an effort or assessment to deaggregate [sic] data to look at trans and gender-diverse people, that should be put as a limitation. And where questions haven’t been asked, it needs to be revealed that questions haven’t been asked.
We need to actually normalize an understanding of the neglect, oversight, and misunderstanding of trans and gender-diverse bodies and lives. And that could include telling the truth in scientific reports, in written and oral forms, in scientific publications and gatherings.