Transcending Barriers for Safer Pleasure: A Publication for Transgender Women

This booklet was authored by Brandyn Gallagher in collaboration with Project Inform to provide the most up-to-date, science-based information available for transfeminine people at the time of publication in March 2016.

To learn more about PrEP, advancements in HIV prevention, and options for protecting your health and wellness, please ask your physician or visit https://www.facebook.com/groups/PrEPFacts/ for direction toward more current information.

Is Taking PrEP the Right Choice for You?

Brandyn Gallagher edited this booklet in collaboration with David Evans of Project Inform, updating an older version written for MSM so the writing is trans-inclusive as of January 2016. The scientific evidence upon which this writing is based was the most up-to-date available at the time of publication.

To learn more about PrEP, advancements in HIV prevention, and options for protecting your health and wellness, please ask your physician or visit https://www.facebook.com/groups/PrEPFacts/ for direction toward more current information.

Will the AMP Study Set the Standard for Transgender Inclusion in HIV Prevention Research?

This November, the AMP Study (also known as HVTN 703/HPTN 081) will bring a fresh approach to HIV prevention research. The Phase 2B study is inspired by vaccine research, which seeks to arm the immune system to resist HIV infection — but it skips a step by directly giving HIV-negative people antibodies rather than using a vaccine to trigger the desired antibody response. However, the AMP study is notable for more than this new approach to HIV prevention. It’s also engaging transgender people and people of color at every step of the process, and is the first HIV prevention clinical efficacy trial to explicitly name transgender men as an eligible population to be included in the study.

As explained by HIV Vaccine Trials Network (HVTN)’s lead behavioral scientist, Michele Andrasik, Ph.D., the AMP Study is taking “a true community-based participatory approach.” Trans people and people of color have been involved in writing the protocol, crafting language on enrollment forms and reviewing informed consent and educational materials. Trans people have been employed to fill clinic staff openings, and professional consultants with lived trans experience have been hired to train cisgender (non-transgender) clinicians and staff.

Even as clinic staff have been learning about the concept of AMP in preparation for trial launch, they’ve also been adjusting to the idea of working with transgender people — a minority population that has been widely excluded from HIV research despite a 1993 federal law prohibiting such exclusions.

As a transgender advocate, I’ve been working with the staff of the AMP Study as a member of their community advisory board. A month before the trial’s launch, I sat down with Andrasik and the AMP Study’s community engagement project manager, Gail Broder to hear more about their experiences in this process.

“It’s been interesting, because we usually hear that studies move too slow, but we’re not hearing that,” Andrasik noted. “There’s a balance between moving forward … and ensuring that all the appropriate community stakeholders have a say.”

“Some staff want more time to learn because AMP is a new concept, and because working with trans people also seems new to them,” Broder said. “Once we start explaining, it’s really pretty simple for people to understand.”

“Are they really so ‘hard to reach’? Or have we just not figured out how to reach them?” Andrasik asked rhetorically about minority populations, while emphasizing the importance of positively engaging those populations financially whenever possible. She notes that community participation means more than merely soliciting feedback from members of minority communities — who may or may not get paid — to inform work being controlled by white cisgender people receiving a salary. Moreover, she stresses that including minorities in research is imperative for good data, and if researchers want minority participation in their research, they must begin by hiring staff and leadership from those minority groups.

That can be an intimidating shift for professionals who aspire to work as allies to transgender people, especially once they’re confronted by the rest of society and its attachment to unexamined attitudes and practices on gender and whiteness. But no one said being an ally was easy.

“We booked reservations for community stakeholders to meet at a hotel, but the reservation system required us to enter ‘Mr.’, ‘Mrs.’, or ‘Ms.’ for each attendee. We were baffled,” said Broder, sharing her growing appreciation for the difficulties trans people face while trying to do basic things she takes for granted every day. “We said: ‘We don’t know if this person is a ‘Mr.’ or a ‘Ms.’. They’re just a human being trying to attend this meeting. Just leave it blank and enter their name.’ But the hotel staff couldn’t do that. It’s a hotel room! Why does it matter whether they’re a ‘Mr.’ or a ‘Ms.’ or neither? We’re paying the same for everyone, but no one can opt out of being non-consensually gendered.”

“Ultimately we called the hotel specifically to discuss the problem with their reservation system and to explain why they need to not call people ‘Mr.’ when they show up to check in,” Broder said. “We’re trying to be as proactively educational as we can be and help all the cisgender people we work with along the way to understand that we [cisgender people] aren’t the only people who exist, and good customer service means respecting everyone.”

Broder added that “stock photo sites did not have appropriate images,” and that the HVTN chose to deliberately recruit — and monetarily compensate — trans people and people of color for photo shoots to appropriately reach the minority populations most impacted by HIV.

Despite often-heard fears expressed by the research community about the “hard to reach” transgender population, early findings reveal that HVTN’s choice to genuinely engage minorities is paying off, with the communities it needs to reach taking notice after decades of being turned away as research participants.

“Transgender people can be a part of our research studies, and they’re great participants, and we need to be including them in all of our trials because they’re part of the population relying on these data, too,” Andrasik expressed emphatically. “We’ve found, in our limited sample size in phase I studies, that transgender participants appear to have no greater chance of HIV outcome than their cisgender counterparts, and they have the same rate of showing up to clinic appointments.”

Sites have begun actively recruiting trans people not just for the AMP study, but also for many clinical trials across all levels of risk. The impact on enrollment, though anecdotal and unpublished for now, has been positive across the board.

“Did visibly including trans people in our recruitment efforts improve overall recruitment and ability to reach enrollment goals? It appears that the answer may be ‘yes’,” Andrasik stated.

“People keep saying ‘we don’t have the epidemiology data to include trans people in this study’, but then they don’t do the research needed to correct the exclusion,” Broder stated. “You just have to start including minorities. Start where you can. Don’t wait for someone else to do it. Just start.”

Where do I fit in? PrEP and Transgender Men

View original publication on BetaBlog.org

When I read results from clinical trials about PrEP—or other HIV prevention tools or strategies for that matter—I’m often left wondering: Where do I fit in?

There aren’t guidelines about Truvada-based PrEP use for transgender men who have sex with men because there haven’t been any studies specifically looking at how the drug works in our bodies. In fact, major PrEP clinical efficacy trials have not included transgender men in any of their study populations to date. Robert Grant, MD, MPH, the principal investigator of the first successful randomized controlled PrEP trial with human subjects, iPrEx, confirmed this, saying, “to my knowledge, no trans men have been included in PrEP research.”

Grant says that it’s challenging to get study protocols that include transgender men approved. “The study sponsors will often ask that trans women and men be excluded if there will not be sufficient recruitment for a separate analysis. We had to argue to include trans women in iPrEx. We wanted to include trans men too, but we did not have estimates of HIV incidence among trans men that were required for inclusion in an efficacy trial.”

Because the majority of transgender men have reported condomless anal or vaginal sex with cisgender (non-transgender) men, it makes sense from a public health standpoint to include us in studies in order to capture the role we play in HIV prevention and transmission as a part of the MSM population.

Studies that present their findings as applicable to all MSM but do not include transgender MSM in their data fall short of having representative samples. This gap in our research agenda, evidence-based recommendations, and knowledge of PrEP has important clinical, ethical, and practical implications. Not knowing how PrEP can, and will, work for transgender bodies means that we’re left to wonder—are we truly protected?

“The lack of information about PrEP in trans men is a real problem,” said Grant.

The PrEP CDC guidelines tell us that it may take different amounts of time for people to achieve full protection based on whether they’re exposed to HIV rectally or vaginally. Many PrEP providers tell male patients that they will be adequately protected against HIV after seven consecutive days of adherence, with the assumption that their patients will be exposed to HIV only during anal sex.

Providers may fail to note, however, that Truvada takes longer to accumulate in vaginal tissue—and that transgender men often do not engage exclusively in anal intercourse. The best available information suggests that transgender men who have receptive vaginal intercourse will be protected after 20 consecutive days of dosing, when Truvada reaches its maximum concentration in the body.

Everything known about how PrEP works during vaginal sexual exposure is based on studies of cisgender women—but transgender men have different biological and physiological considerations than cisgender women. Transgender men oftentimes experience vaginal atrophy as a result of testosterone use. Might this condition significantly change the effectiveness of Truvada as PrEP?

Many men are unable or unwilling to use condoms for receptive vaginal intercourse because of the tearing and bleeding that often occurs during sex with vaginal atrophy. Does PrEP provide better HIV protection in combination with condoms despite the damage caused, or counterintuitively, does PrEP provide better protection without condoms since they may exacerbate tissue damage?

PrEP providers may reassure male patients that it’s not a big deal to miss a single dose once in a rare while1, based on the iPrEx OLE study which found no seroconversions among MSM who took Truvada at least 4 times per week. Because no transgender men were included in the iPrEx study, however, we can’t say for sure if this also holds true for transgender men. Cisgender women need to have nearly perfect adherence in order for PrEP to provide full protection against HIV. Is this the case for transgender men who engage in receptive vaginal intercourse, too?

It will be some time before PrEP research is able to fill in the missing data for trans men and answer these questions, but it is critical that efforts begin immediately. Transgender men are currently experiencing a watershed moment of visibility in the larger gay community. Casual bath house sex, cruising, and hooking up using phone apps are increasingly commonplace.

“The field desperately needs HIV and STD prevalence and incidence data, as well as information on demographics, comorbidities, and risk behaviors. In concert with epidemiologic characterization, at-risk trans men should be included in HIV prevention studies based on the type of exposure being investigated—that is, trans men who engage in receptive rectal intercourse should be included with other populations who have receptive rectal intercourse, and trans men who engage in receptive vaginal intercourse should be included in studies of others who have the same sexual practices,” said Raphael J. Landovitz, Associate Professor of Medicine in the Division of Infectious Diseases at UCLA.

Despite the gaps in clinical knowledge of how PrEP works for transgender men, all evidence supports the idea that Truvada provides a high degree of protection in people who take the pill consistently as prescribed—with no reason to believe that it is ineffective for transgender people. Even if there is a slight reduction in effectiveness, which has not yet been tested and is thus unknown, PrEP isrecommended for anyone HIV-negative at substantial risk for HIV infection.

PrEP may well be a life saver for transgender people who are disproportionately affected by HIV risk factors like poverty, unstable housing, discrimination, survival sex work, and disconnection from health care. We can’t give up on including transgender people in medical research. The urgency with which this minority population needs evidence-based guidance on sexual health care recommendations is an opportunity to improve the humanity of science moving forward.

OP-ED: WHY I IDENTIFY AS A FAGGOT

View original publication on HIV Equal

In my younger years, I was called a faggot. I did not consent to this. A kid in gym class swung a three-foot metal pole at my head, and the teacher didn’t care when I reported being bullied. I grew older and connected with mentors who’ve since passed on their own lessons to me about moving through the world being irremediably and obviously gay. Being a faggot is not synonymous with being a gay man, however. Many gay men do not identify as faggots – and some faggots do not identify as men. We’re a diverse bunch like that. But regardless of our internal identities, it’s a word we’ve all heard.

“I was called faggot growing up. I hated it because I knew those jocks were right. I hated they could see the thing I was trying so hard to hide,” a friend shared with me early in my transition. “Calling someone faggot, for me, is basically saying, ‘I can see what you really are. The thing you’re trying to hide.’”

Isn’t that why we hate the word? Because people see us, and sometimes they hate what they see, so we try harder than anything not to be seen at all? Because being called “faggot” means we’re failing to convince our oppressors that we’re their equal? Because invisibility feels safer, and we’re exhausted from living in constant fear?

There are certain images the word “faggot” evokes – images of brutality, of discrimination, of vitriol; images of disease, of stigma, of suffering; images of loneliness, of brokenness, of heartbreak.

In those same images though, I see something more.

Survival. Perseverance. Strength. Determination. Triumph. Authenticity. People who call themselves faggots exhibit courage beyond measure. We have stared Death in the eyes and refused to blink. We are more than deviant sex behind closed doors. We are a tribe in which membership has nothing to do with our genital configurations or our blood, and everything to do with the capacity of our ever-expansive hearts to love one another in the face of great and divisive adversity.

In embracing my faggotry, I embrace my resilience. Owning this aspect of my identity is an expression of gratitude – both toward my former self for making my way through Hell alive, and toward those strong-willed fighters who came before me for the contributions they’ve made to the world I live in today.

Being a faggot means living in a way that feels right to me as a priority over what’s expected. It means being seen for the rawness of my humanity rather than the mask I so often wear. It means taking struggles and obstacles by the horns and hacking my way through them without reservation. It means surviving a part of my identity I once believed could only result in my death. It means being a whole human being whose sexuality, whose existence, requires no apology.

This word holds the same meaning regardless of who is saying it. It is the intent that changes. The intent is what we respond to. The intent is where its power comes from.

Jocks in high school: “I see what you really are. I hate you. I don’t want you to live, faggot.”

My partners: “I see what you really are. I want you. Don’t hide from your authenticity, faggot.”

Me: “I see what you really are. I love you. There is nothing shameful about being a faggot.”

TRANS MEN: THE INVISIBLE BATTLE WITH HIV

View at HIV Equal

So there I was, sitting in a room full of the world’s top HIV researchers, uncomfortably under-dressed in my Mr. Friendly t-shirt but not letting that stop me from asking the question I need answered.

“Dr. Molina, in your study on intermittent PrEP dosing among men who have sex with men (MSM), did you see or anticipate any differences in efficacy between the transgender gay men in your study versus the cisgender men? What have we learned about the 2+1+1 dosing for men who engage in receptive vaginal intercourse?”

I desperately need this information, you see, because every day I log into Facebook and respond to yet another question about HIV prevention from yet another trans guy who wants to protect himself from HIV and whose doctors won’t help him. I am a moderator of the PrEP Facts: Rethinking HIV Prevention and Sex discussion group where people from all over the world – research scientists, doctors, community organizers, and lay people alike – come to learn and digest the latest information about HIV prevention and safer sex strategies. There are a lot of trans folks and a myriad of gender identities present there. Many of us use this Facebook group as our primary source for medical information concerning HIV prevention because we cannot get adequate care from our doctors.

But then I ask the doctors why they’re failing us, and they say to me that they don’t have any data. They don’t know the answer. They can’t answer these questions without studies to back them up.

So I asked Dr. Jean-Michel Molina about the trans men in his study, with the naïve and unwarranted optimism that he would tell me something useful, something I could relay to the droves of trans men seeking me out as their last glimmer of hope for sexual health. He responded by telling me about the one trans woman in the study, with no mention of trans men at all. Another researcher in the room explained to me afterward that trans men were not included in this study. Dr. Sheena McCormack would later apologize to me that her PROUD study in the UK, about which I’d been on the edge of my seat for months to see results, also failed to include trans men.

I have been a participant in a PrEP research study at the University of Washington, as have many of my trans brothers in Seattle, so I know we’re showing up to do our part for medical science. Yet, even though we’re presenting ourselves, able and willing to offer our researchers abundant data about our bodies, at best these studies have not been designed to track the information we’re providing. Or, at worst, as was the case in both the IPERGAY and PROUD studies, the criteria for entry into the studies are designed in such a way that explicitly makes trans men ineligible altogether.

I want to let you in on a little secret: Transgender gay men are not heterosexual women. We do not have sex like women do. Our behavioral risk factors are the same as the behavioral risk factors of gay men, because – big surprise – we are gay men. Sometimes we have anal sex. Sometimes we have vaginal sex. We have sex in bathhouses, perhaps with 20 or more guys in one evening. Not all of us, but some. We cruise for hookups in the twilight hours at Volunteer Park. We meet guys on Scruff, Grindr, and Craigslist for casual one-offs. Some of us use poppers, crystal, and other drugs associated with the gay party-and-play scene. We are at high risk of HIV just like cisgender MSMs are, and we’re being ignored.

This cannot continue. We already have a 41 percent or greater rate of suicide attempts. For trans folks who survive society at large, we are then faced with incompetent medical professionals who use the wrong pronouns, who refuse to listen to us and who cannot or will not give us answers about how our bodies work. We have to fight for basic healthcare, fight for HIV prevention, and then ultimately fight for HIV treatment after we’ve been cast aside until it’s too late to prevent infection. Still, no matter how hard we fight, we cannot bypass our doctors to independently investigate research about the HIV prevention strategies that are optimal for us ourselves – because no such research exists. We are an invisible, dying group of gay men being left to face the threat of HIV with no one hearing our cries, no researchers taking notice and no public health officials acknowledging our plight.

The HIV epidemic of the 80s and 90s does not have to repeat itself. We have the tools and the knowledge to prevent HIV. We just need medical professionals, researchers and advocates to step up and make it happen now. Please, help us.