Improving Recruitment and Retention of Transgender Women in HIV Prevention Trials: Strategies to Make Trial Participation More Congruent with the Needs of Transgender Women

Abstract

Transgender women are disproportionately burdened by HIV. Though there is a substantial body of research exploring barriers and facilitators of HIV prevention among transgender women, many barriers remain unaddressed. This study identifies strategies to make HIV prevention trials more congruent with transgender women’s preferences and needs to boost trial participation and ultimately enhance initiation and uptake of pre-exposure prophylaxis (PrEP). We conducted in-depth interviews with 15 sexually active, HIV-negative transgender women in New York City to understand: (1) preferences concerning long-acting injectable cabotegravir for PrEP and (2) ideas on how to make HIV prevention trial environments more comfortable. We identified five themes related to increasing transgender women’s appeal to trials: (1) creating a more inclusive/welcoming environment, (2) providing compensation that is responsive to transgender women and community needs, (3) centering transgender women in recruitment and informational materials, (4) training study staff on gender-affirming practices, and (5) hiring transgender people as study staff. Participants wanted to see more gender diversity, representation, correct pronouns, gender-affirming practices, and compensation or reimbursements. Together, these practices may improve recruitment and retention of transgender women in HIV prevention trials.

Introduction

It is estimated that a fifth of transgender women are living with HIV in the United States, with transgender women being about 50 times as likely than others to have HIV.¹ They are in urgent need of prevention and treatment services, but recruiting transgender women to HIV prevention trials remains a persistent challenge in the field. The primary reasons for reluctance in joining HIV trials, particularly in the U.S. context, include high levels of stigma and discrimination when receiving care, lack of provider knowledge regarding HIV care for transgender women, cisnormativity, lack of trans-specific resources, and structural violence.² In HIV research efforts, transgender women’s data are typically looped in with those of men who have sex with men (MSM), hindering the evaluation of the impact of HIV, making transwomen neglected in studies. In addition, transgender women have begun to challenge the scientific rigor and ethical principles with which trans-focused HIV studies are established. Research designs have not accommodated the concerns of transgender women and have severely underrepresented transgender women. Transgender women and other nonbinary communities are essentially excluded from research representation, making it difficult to obtain efficacy data specific to this group or incorporate their preferences in product design.² This results in limited HIV pre-exposure prophylaxis (PrEP) uptake and adherence in real-world settings by transgender women.

Transgender women-specific barriers include concern about cross-interactions between PrEP and gender-affirming hormones; perceiving PrEP as a masculinized product;^3,4 lack of transgender women representation in informational materials or advertisements;⁵ and challenges with transgender women patient/provider communication about PrEP,⁶ among others. Other work has shown that transgender women experience discrimination in health care settings,^7,8 and report health system mistrust,⁹ which likely further limits trial participation. In fact, research indicates that transgender women who find themselves educating their health care providers about transgender issues are four times more likely to delay seeking medical care.⁷

Despite these barriers, transgender women are aware that HIV prevention trial participation is important if we are to develop PrEP products that are efficacious and effective for them. It is essential that gender-affirming care and clinics are created to diminish stigmatizing encounters and create trans-inclusive marketing strategies to transgender women’s unique barriers.⁵ Although the iPrEX trial was unable to demonstrate effectiveness of tenofovir/emtricitabine for PrEP in their transgender sub-arm owing to poor adherence, they were still able to recruit >300 transgender women participants.¹⁰ This suggests that transgender women are willing to participate in HIV prevention trials research. This study will present the results of in-depth interviews (IDIs) with transgender women on this topic and allow researchers to make study enrollment and PrEP product adherence more congruent with transgender women’s lives and experiences.

Methods

Participants and recruitment

Fifteen participants were recruited from May to August 2019 via a convenience sample of transgender women participating in Project AFFIRM,¹¹ a longitudinal cohort study on transgender identity development and community resilience. AFFIRM used a purposive, venue-based approach in three major metropolitan areas in the United States (New York City, Atlanta, San Francisco) across offline (e.g., bars and clubs/outdoors, clinics, LGBT-focused (i.e., Pride) and online sources (e.g., LGBT-oriented chat rooms and Facebook). Racial and ethnic diversity were maximized by capping enrollment of White participants and seeking out locations with high percentages of racial and ethnic minorities. Further demographic information was not collected. AFFIRM was used to support recruitment for this study, whereas HPTN 083 was used to inform any protocol surrounding the long-acting injectable; however, this study focuses on the IDIs discussing user preferences between distinct delivery strategies.

Individuals who identified as transgender women were HIV-negative via a rapid HIV test (OraQuick Advance^®) at the study visit, spoke Spanish or English, were at least 18 years old, and lived in the NY metropolitan area were eligible for the study. In addition, participants had to be sexually active (e.g., reported oral, anal, or vaginal sex with another person in the past 3 months). Participants with silicone injections or implants in their buttock/thigh area were excluded, given that such implants could cause physical obstruction for the intramuscular injection, as indicated by the HPTN 083 study protocols.¹²

We posted advertisements about our study on social media (Facebook, Instagram, Twitter, Craig’s List) as well as on an internal university-based study recruitment system to supplement recruitment efforts. Participants were given $50 to compensate for their time and travel expenses.

Approach

Participants’ eligibility and interest were determined using a screening questionnaire via their preferred method of communication (e.g., email, telephone, text). Participants recruited from the previously mentioned online/offline sources were directed to a link posted in an online study advertisement, which took them to a brief web-based screen tool. Transgender women who met our eligibility criteria were invited to the research site to participate in a two-part IDI.; To create an IDI guide, members of the research team went through an iterative process in which individual questions were developed, circulated, and refined. Ultimately, the team went through each question together and made final revisions to ensure consensus. Each interview ranged from 40 min to 1.5 h in length.

The IDIs were conducted by two cisgender individuals, CT.R. (PhD) and J.L.R. (PhD), who have a combined 30 years of experience working with the LGBTQ+ community and 25 years working specifically with transgender women. The data discussed in this paper were exclusively collected during Part 1 of the IDI, and we will thus limit the description of the interview process to this section. In Part 1, participants observed two brief (e.g., 5 min, each) PowerPoint presentations describing both “self-injection” and injection at “drop-in” clinics as different methods of delivering the example product. The presentation also included what each method would entail for participants (side effects, appointment time, instructions on where to inject, how to contact a nurse for help, etc.). A description of the tailored injection delivery methods studied in this research is available elsewhere.¹³

In this study, participants self-injected a saline placebo injection designed to mimic a long-acting cabotegravir injection (CAB-LA) in every way (i.e., volume of injection, dosing schedule, syringe gauge used, and location of injection). Saline, in place of cabotegravir, was used to isolate the delivery method from the drug and thus prevent the side effects from confounding the user experience of this delivery method. After the injection, participants completed an audio-recorded IDI discussing their perspectives on the overall delivery experience, including their experiences with the study staff, marketing PrEP to transgender women, compensation, and creating an inclusive environment.

Ethics approval

The New York State Psychiatric Institute Institutional Review Board approved the study. Depending on the preferred language of the participant, consent forms were presented in either English or Spanish. All participants provided written informed consent before participation.

Analysis

IDI audio recordings were transcribed by a professional third-party service, which were then confirmed for accuracy by the research team. Data were analyzed using Dedoose. First, the research team developed a priori codes based on topics addressed in the interview guide. Then, coders analyzed the text to find in vivo codes (e.g., language participants used to describe their thoughts/experience with the topics covered). Subsequently, coders developed a list of recurring themes that included a priori and in vivo codes.

Coders discussed their respective a priori and in vivo codes after an initial pass to ensure consensus. Codes were also analyzed alongside the text they were intended to represent to encourage reasonable and realistic representation. A priori codes that were absent from or poorly represented by the text were eliminated. Finally, coders reanalyzed the text for an all-inclusive assessment of possible themes and reconvened to confirm that examples of text represented the themes they were intended to illustrate and ensure consensus.

Some research suggests it is possible to reach data saturation with as few as six interviews depending on the topic and population,¹⁴ whereas some scholars recommend between 12 and 24 participants to “guarantee” saturation. As such, data saturation is believed to have been achieved upon interviewing the 15 participants discussed in the paper. This study was exploratory in nature and is intended to serve as a basis to help develop future studies and is not intended to be a conclusive generalization. Although a singular theory did not guide the methodological analysis, the process aligned most closely with content analysis.

Results

It is important to address participation because data regarding transgender populations’ preferences and needs about products is gathered through participation in these HIV trials. Knowing their unique concerns allows us to address them in development and delivery stages of the product and facilitate optimal rollout. In addition, we provide a holistic picture of what was said about each theme under each subheading; if participants did not mention anything under the same subheading, it did not necessarily mean they disagreed, but rather they just did not state anything related to that topic.

Five main themes were identified among the participants (N = 15): (1) creating a more inclusive and welcoming environment (e.g., displaying a transgender pride flag, having pictures of transgender women, hosting study activities in a known transgender-friendly space), (2) providing compensation that is responsive to transgender women community needs; (e.g., transportation reimbursement, monetary incentives, food), (3) targeting PrEP to transgender women (e.g., featuring only transgender women in recruitment materials, addressing cross-interactions with gender-affirming hormones, validating the product as a normal and feminine thing), (4) training study staff on gender-affirming practices (e.g., using correct pronouns, addressing trans folk without judgment), and (5) hiring transgender people to the study staff.

Creating a more inclusive and welcoming environment

Creating a more inclusive and welcoming environment involved acknowledging and celebrating transgender identity in the study space. Participants viewed this as an important part of making trials more welcoming to them.

Displaying a transgender pride flag

Four participants explained that having a transgender or pride flag would signal allyship and promote a sense of inclusion at the study sites. For example, Participant 101 explained,

“So I would say like maybe put a trans flag, you know, to make it more inclusive. I would even say put a trans flag around here.” She continued to explain that

“…if you guys want to make a certain community feel welcome, then it’s like put something around … like a trans flag, or like ‘You are welcome here’ or, you know, like that.”

Another participant described that displaying a transgender pride flag communicates the study environment is safe for transgender women, and that they will be treated with respect.

“Even something so simple as, like, having a little pride flag on there, on the window, and saying, like, “Queers – Queer-friendly space.” Or, like, “pronouns respected here.” You know, things like this. You know, just, like, really simple stuff that just makes feeling safe here a little bit easier.” (Participant 103)

Another participant agreed that a flag would be a comforting addition to the room. “Well, I mean, I think it would be nice to have, like, a trans flag in here, would be nice.” (Participant 106) Participant 107 followed by exclaiming “Put up a big, gay flag out there, damn it!”

Using pictures/brochures that resonate with transgender women

Six participants stated that displaying pictures of transgender women around the room and in brochures could make transgender women participants feel represented. One participant specified that using study materials that resonate with transgender women (e.g., show celebratory images, prioritize respecting transgender women’s names/pronouns, promote trans visibility, and acceptability) conveys the message that transgender women are accepted and respected by everyone who is occupying the shared space.

“Yeah, a lot more advertisements of like, trans, so that they don’t feel like they’re still the taboo part of society. Yeah, I would just love to see more acceptability. That’s the first, after comfortability. The right paperwork, the right visuals, the right training. All of that will help with bringing us to the forefront, so that we can help people help us.” (Participant 109)

Participant 106 explained further that such images help them feel part of a large and proud community.

“I think that, when they’re in the space, I think seeing images that they could resonate with. You know, that represent the community that they are part of, and that could look very vast.”

Two participants in particular emphasized the importance of presenting a variety of transgender women with respect to their physical characteristics. One person mentioned “… I mean, you could put different posters with different models, like real transgender, real cis-gender, real lesbians, right?…” (Participant 120). Another participant explained that seeing those images helps participants relate to the individuals in the images.

“So yeah, it would go back to all sizes, literally, because you know there are different sizes of trans women. So I think yeah, just honestly as long as there’s some – I think honestly the key point is to see somebody that relates to you. That’s what makes it more easier. You can see yourself doing it. When you have someone that just does not look like you or relate, it’s hard to put yourself in that shoes. That’s what I have realized a lot.” (Participant 112)

Hosting study activities in a known transgender-friendly space

Having trials take place in community spaces where trans folk feel safe was a request among three participants in particular.

“Like, if it feels good to have it in a more, like, community-oriented setting, and just, kind of, like a space overall where they may feel more welcome. Or there’s at, like, a wellness center, or, you know, something like that, or, like, a community center. You know, that can kind of take the edge off, like, a little bit.” (Participant 106)

Two participants explained that some transgender women may not feel comfortable going to a clinic with cisgender people present. One individual suggested having drop-in places as safe spaces for LGBT folk.

“…let’s also use them in safe spaces, in LGBT community spaces, safe spaces where we can link them in and also to know there’s options. And if they decide, we can also do it at the safe spaces. If they don’t feel comfortable going to the doctor, there’s also drop-in spaces that they give out needle exchange programs. They can do that as well. That’d be perfect.” (Participant 114)

Another individual extended this idea, suggesting drop-in hours dedicated to only trans folk.

“You know, it’s difficult sometimes to like—that’s why a lot of trans folks don’t go to health providers, because, you know, the uncomfortability that they experience when they’re sitting – and before, when I started transition, I know this is a funny way of saying it, but I called it the Ugly Duckling stage. The Ugly Duckling stage is like when you’re beginning your process of hormones, so you still look masculine but you’re dressing feminine, you still have that strong structure. I call it the Ugly Duckling stage…because it’s the transition stage. Yeah, so but, you know, a lot of girls might not feel comfortable sitting in a clinic where there’s a whole group of people. Maybe making the clinic…maybe picking a specific hour where just trans folks will be here, right?…” (Participant 101)

Providing compensation that is responsive to transgender women’s needs

Nine participants discussed the importance of providing reimbursements and incentives for transgender women to offer support in their daily lives and help them travel to the study sites. These incentives included Metro cards, food/grocery vouchers, cash, and refreshments, in addition to the main incentives offered.

Metro card

Accessing reliable transportation was a concern among three participants, and offering travel compensation could help support them in attending study trials. One participant said, “…folks might…have transportation issues…where we offer them a Metrocard…” (Participant 106). Another participant said, “If you guys offer carfare, I feel like it’s a there and back situation every couple of months.” (Participant 115)

Monetary Incentives

In addition to transportation reimbursement, three participants stated that they would be highly incentivized to participate if the trials offered compensation in the form of cash or Amazon/Visa gift cards.

One participant in particular acknowledged that cash would allow them to address other imminent needs.

“I mean, I personally prefer the cash, but I mean, like, some girls might not have – like, you might give her $50 – you might give me $50 today and I might go use that to eat because I haven’t ate in weeks, you know what I’m saying, so maybe giving a Metrocard as well, for those that decide to go to the drop-in center.” (Participant 101)

Another participant mentioned that gift cards would also help: “…better incentives…besides the cash, a nice little gift to go food shopping or something …like an Amazon gift card or something…” (Participant 101).

One of the participants detailed how many transgender women are struggling to survive, and offering gift cards and money for trial participation would be helpful in both study recruitment and supporting participants in their daily lives.

“You know, the majority of them is in the streets and they in a survival mode. So, you got to think like them, as if you was homeless. I came here to help you guys and you’re going to bless me. That coin is going to bless me to put food in my house. You don’t know what situation I’m going through.” She also says “A coin help. (laughs) I’m going to be so real. I’m going to – my sisters – One, in the job-work ethic, they’re not trying to hire no trans-woman. Even in our own community, they’re not trying to see it. I’m still looking for work. It’s going to be two years I’ve been unemployed and looking. And no one sees it. I don’t give trans, but no one sees it, in the community and outside. So, a coin. If you want to promote this PrEP idea to events, to approach it at a different way, approach it with a cute coin, you’re going to get what you need to get.” (Participant 114)

Refreshments

Five participants described nonmonetary compensation items that could encourage trial participation.

Three women stated they would like refreshments to be present. One said, “I don’t really have a problem with the space. Some I know, when they go to a space for a study, they want refreshments.” (Participant 119). Another participant shared,

“I guess honestly I know a lot of T girls like to eat, so if you could have, I mean, some snacks somehow, I know that definitely would bring in people – like definitely T girls, once again, because some of them obviously have to work a lot harder.” (Participant 112)

Centering transgender women in recruitment and informational materials

In total, five participants expressed their opinions on the lack of representation and targeting of transgender women in advertisements for PrEP.

Featuring transgender women in commercials/advertisements

These five participants noted the importance of marketing HIV prevention tools toward transgender women specifically, as most of the current marketing is geared toward gay and bisexual men. Two participants explained that they feel that PrEP is not meant for them or not necessary for them to take. Participant 112 said,

“What would make people more want to take it? And so when they show us the videos, they use a lot of gay men and then trans women, and so it’s like when people see that, you’re just automatically going to think, “Oh, this is just for gay people, and it’s not just for everybody.”

Another participant explained,

“Marketing for PrEP, just historically, has been really tailored toward, like, cis gay men….some of the questions that, you know, some transwomen might have is, like, ‘Well, I don’t engage in, you know, this sort of sexual activity.’ …so kind of assuring them that, you know, PrEP is, like worth their while…” (Participant 106)

One of the participants suggested changing the narrative about PrEP and advertising it as something useful for all people.

“… change the conversation around PrEP…this is a disease prevention drug that needs to be catered to everyone…don’t make it seem like this is a drug we that we don’t have to worry about, because it’s not being targeted to us.” (Participant 109)

Three of the participants suggested that PrEP needs to be normalized as a product for women. One of them suggested that we “…create a commercial for just trans, or create a commercial for just a hetero couple…” (Participant 109)

One participant described the lack of diversity in advertisements, and suggested broadening the scope of the target population.

“Or even you can put a poster for a straight man and a straight woman, one man and one woman, doing like the poster. But why does it always have to be two gays, and it’s always Black people there? You can put Spanish. You can put white people. Why is it always Black people, and always it’s gays? No other gender. (laughter) I mean, you could put different posters with different models, like real transgender, real cis-gender, real lesbians, right? It’s always two gays. I don’t understand that. So, only the gays need to have all this medication. I mean, other genders don’t? I think it’s for everybody, so they should have different posters having different kinds of gender people doing – or just a few of them standing there. But no, only gays, and only it’s Black. Only Black always. It’s kind of discrimination about Black people that they have higher risk, right?…Maybe they will be – I feel that way why is it always Black people? Why there’s no white people? Why there’s no Spanish, why there’s no other colors, right?”

She follows with,

“When this thing came – when this PrEP came in or whatever, like safe sex condom, it’s always about the gays…Since on the pictures it’s always gays. You don’t see other – you don’t see lesbians. I mean, lesbians, they can get virus, too….Transgender can get virus, too. Cis-gender, they can get virus, too. But why is it always two men? I mean, it’s just that – I mean, you should have different people on the posters, like transgender, or cis-gender, or two lesbians, or whatever. This is for everybody, right? Everybody can take this, right?” (Participant 120).

A separate participant also said to market PrEP as a normal feminine product rather than something exclusively for gay men.

“Well, we all know that marketing’s everything, right? Just making it more appealing, making it – so, like, instead of having – because how PrEP is marketed at the moment is very much toward the gay men sort of side of things, which makes sense, because they’re the more at-risk category of people who get HIV. But if you’re going to target this particular product towards trans women to make it more – to advertise it more geared towards trans women and have it be more of a validating of their using this product as a normal feminine thing to do, rather than as a masculine sort of “gay man” sort of thing to do.” (Participant 103)

Training study staff on gender-affirming practices

The most common request among participants was to have a trained study staff, all of whom should know how to correctly address trans folk, promote a gender inclusive environment, and be mindful of stereotyping. Eight participants detailed the extent of training which they would like to see among the study staff.

Respectfully addressing trans folk

Seven participants explicitly stated that the staff should make an effort to know participants’ pronouns, or know what to do in case they do not know trans folks’ correct pronouns. One of the participants explained that training staff on gender inclusivity makes for a more comfortable environment for transgender study participants.

“Well I would say the first step would be making sure that there’s all around, generalized training on, you know, like preferred gender pronouns, and preferred names. Just so that that’s one less thing to make a person feel like they’re not welcome. Because I see all too often, you go into a clinic’s office, and they have the very basic sex, male or female, government name, or given birth name, and it’s like, that off the bat would make someone want to get up and walk out. Number two, you know, the training to be conscious of trans insecurities…Some trans still aren’t comfortable with the body they’re in. So, they’re that much less comfortable with someone seeing or touching that body. So if there was some sort of training about how to verbally make someone comfortable before you actually physically, you know, poke and prod.” (Participant 109)

Addressing participants by their correct pronouns is a way of showing respect.

“I’m very much a binary woman. It’s – you know, that’s neither here nor there for me. But I know it’s – in the community – it’s a very big deal. And in the community, it’s just a show of respect to ask what their pronouns are, specifically for the non-passing trans people, or maybe the non-binary people who aren’t, you know, just, like, fully trans one way or the other…] I mean, for me, that doesn’t matter so much, because respect is respect, no matter who it comes from. That’s my personal opinion. I don’t know, generally, the greater community’s perspective on that. I think mostly what the community as a whole is looking for is just respect. You know?” (Participant 103)

If unsure about pronouns, the staff member should simply ask, as suggested by one participant, or give out badges/stickers for participants to indicate their pronouns.

“Like what’s your preferred pronoun? She, her, Miss, Mister, him, he. Like, preferred pronouns. “Or would you just want me to call you by your name?”

Study sites could also give out stickers or badges to each participant on which they can

“Write down their name and/or preferred pronouns, so others will know without having to ask. (Participant 107)

Participant 106 said, “You know, maybe, like, the interviewer, like, wearing, you know, like, a pronoun sticker, a pronoun button, you know?”

Another participant said,

“… talking about ideal circumstances…there are queer people on the staff. Everyone, cis or otherwise, has little ‘my pronouns are’ badges….And you have – there’s a thing of stickers or something that you could write your pronouns on and stick them to you somewhere so that you don’t even need to be asked. People can just look at the sticker and know. But you don’t have to identify yourself that way. You don’t have to do that if you don’t choose to.” (Participant 122)

This participant also emphasized the importance of not referring to trans folk by their deadname (the name assigned to some transgender individuals at birth, which they have opted to no longer use).

“The ideal comfortable environment is one where you don’t have to deadname yourself. Where you aren’t referred to by your deadname if you don’t want to be. Where your pronouns are used correctly. Where people are up-to-date on gender theory. And where, other than the very specific cases where they ask you for your preferred name instead of your legal name or they ask you what your pronouns are. Neither of those are things that happen for cis people. But beyond that, just treating us the same as you would treat us if we were cis.” (Participant 122)

She went on to explain that although IDs or driver’s licenses may be good sources of learning the correct pronouns, sometimes they are not updated, and study staff should still respectfully inquire and confirm with the participant to ensure they are addressing them correctly.

“I would train the staff to, when you get someone’s driver’s license, for example, my driver’s license, my name has been legally changed but my gender marker hasn’t. So if you’re just going by my driver’s license, you would say that my name is – and my pronouns are he, him, if you’re just going by my driver’s license. Obviously that’s not accurate. My pronouns are she, her. So I would train the staff to, okay, you’re given driver’s license and you ask them, okay, and is this the name you go by. Are these –is this the gender you identify as. To just know that the staff has to be aware that just because something is, just because there’s legal documentation indicating something doesn’t necessarily mean that that’s how you should refer to that someone dealing with them socially. And then just the way that bars have to card everybody regardless of how old you look, you have to ask everybody regardless of how well they pass. You have to ask cis people, regardless of how well they pass for cis.” (Participant 122)

Participants also agreed that they would prefer being called by their last names in case clinic staff is unsure how to address them.

“That is something that I have found to be very comforting, myself, where there have been instances of people in a clinic just calling out people’s names and just using their last names. And I remember liking that. And, yeah, that’s a great strategy.”

Participant 101 also agreed, saying “I think the last name thing will be much, much better, if you see that someone’s ID doesn’t match their appearance.” (Participant 122)

Creating a nonjudgmental and comfortable space

Seven participants discussed the importance of being sensitive toward participants. One participant explicitly said there should be dedicated training toward sensitive behavior. “Sensitivity. Make sure they all have a sensitivity training.” (Participant 107). Four participants encouraged mindfulness of microaggressions (indirect, subtle, or unintentional discrimination against members of a marginalized group).

“For me, it’s – for me it’s just so hard because there’s so many different types of T girls out there, and they all have their own – they all have their own thing in their head. For me, I just like to be treated like a regular girl. Like, that is all. So – but it’s so hard because it’s like sometimes, people don’t realize that they’re giving a micro – what’s it called? Mini aggression? A micro aggression? And so it’s just like – it’s kind of hard. It’s just hard because some people you can tell, they don’t have a problem with you, but they just feel uncomfortable.” (Participant 112)

Similarly, another individual said, “…just being mindful that that might be a trigger for some people or might not.” (Participant 106)

Three participants explained that study staff should:

“keep a good focus on providing a supportive environment where people feel comfortable openly communicating when they do need help or when they do have questions or when they do feel uncomfortable.” (Participant 122)

More specifically, it is the people rather than the space that needs to be free of judgment.

“There’s nothing never wrong with the spaces. It’s the people that make the spaces welcome. Always remember that…It’s never the spaces. We are the ones that can – for example, I said I wanted chips last week. What did you do? you got me chips baby (laughing). It’s the people who make the spaces welcome, never the spaces….You care, because you went and got me chips, baby. You heard me last week. So, it’s all about the – everybody is not a people-person, and I get that. But for those like me and you, a people-person, we go beyond to make sure our consumers are well-taken care of and they know that you’re not a rabbit or a hamster. You’re like us. We just need your help, and we’re going to help you. And that’s what brings them in and makes them comfortable. Make you safe. These girls out here, they go through a lot of judgment. They go through a lot of discrimination. They go through a lot of attack and not being accepted, and especially in their own community. I’ll be there to let any of my sisters, continue to come to different spaces, and still be treated. At least one or two spaces can understand where we’re coming from. And not just saying you understand because you’re trying to make a coin or this is your job, no. Go beyond your fucking title and care about that person.” (Participant 114)

This participant also mentioned that people should not be disingenuous in an effort to make transgender women feel comfortable through compliments and similar behaviors.

“Me personally, I would train people in the art of being complimented without it being flattery, or disturbing, or uncomfortable. You know, just knowing how to say something that 9 times out of 10 is uplifting and hard to be misconstrued, that’s one way…Like, you know, telling someone they look beautiful today, but there’s, you know, a chance where, depending on how you say it, it could be misconstrued as creepy…or it can be like, are you trying to flatter me? Or are you being fake about it just to create a sort of fake atmosphere of comfortability. Like it just, I feel like people being genuine is the most comfortable way to be. Like a sense of genuinity (sic) it just works for me.”

Hiring trans-identified study staff

A sense of community and a safe space was a common theme among transgender women, and having a trans person as a member of the study staff greatly increases participants’ sense of security. Nine participants mentioned they would feel safer, more respected, and more comfortable upon seeing a trans person working in the study.

One individual explained that transgender women would feel more comfortable with a trans person on study staff because they are members of the same community.

“I mean a trans person that’s one of the people working in the study working with the trans women would make them even more comfortable…Because it’s one of their own people. It’s how they spend so much outside problems without the side of the community of how we’ve been treated over the years. And unfortunately, a lot of those issues aren’t healed from Stonewall yet – because I was at Stonewall at 13 with mom and Aunt Marsha and started that whole movement. But, as one of the very few people still alive from Stonewall, and seeing that rift of trusting a lot of people from outside of the community, isn’t healed, it would have to be a trans person working as part of the study to make them more comfortable.”

She also mentioned that known leaders of the trans community should be the ones answering transgender women’s questions regarding PrEP.

“So trans individuals, leaders that know about prep are the ones that should be sitting there in the clinic to answer any questions…And we have trans medical people that should be the ones giving the shots… to make it more comfortable.” (Participant 119)

Another participant named the waiting room as a nice place to have a transwoman staff member present because it builds rapport and offers participants a sense of understanding.

“And I’ve always wanted like, the platform to say this, but I think the first way to start is to get more trans in the health care industry. And that’s where it kind of dwindles down, because all too often, trans feel like their only acceptable workplace is sex work, or the street. So if we got trans into feeling comfortable enough to join the medical field, just having a trans face to walk in to in a facility that is catering to trans research would be that much more of a, you know, just make it more identifiable. Trans nurses, or trans counselors. Just somebody who would relate, as opposed to someone who’s listening and trying to understand, because in reality, until you get in my shoes, you will never know what it’s like to live in my shoes. So, that’s one step to making that much better.” (Participant 109)

Discussion

Our research shows that the participants wanted to see more representation of transgender women in scientific studies and had specific suggestions about how research teams could create a welcoming and comfortable environment for them. Their suggestions included creating an inclusive research setting, providing compensation (in addition to reimbursement for time and travel expenses) that is responsive to needs pervasive in the transgender community, targeting study materials and products to transgender women, training study staff on gender-affirming practices, and hiring transgender individuals to study staff and leadership.

Creating an inclusive research setting

Nearly all participants suggested that displaying items showing support for transgender pride in the research environment [i.e., transgender pride flags, posters with phrases such as “You are welcome here” or “Pronouns respected here” and/or clothing accessories (e.g., buttons, pins)] signals that the study team is welcoming and supportive of all gender identities and builds a sense of community. Other studies have also found that including transgender identity-affirming visuals and study information tailored to the unique needs of transgender women (e.g., study information cards or pamphlets) in waiting rooms is received positively by transgender participants.⁵

Similarly, participants explained that they would like to see research materials (e.g., informational materials, brochures) that feature a visually diverse array of transgender women (e.g., body size inclusivity, racial and ethnic diversity, diversity in gender transition/gender expression, diversity in sexual orientation). Existing literature explains that subjecting transgender women of color to racialized standards of beauty is harmful because it may create demand for risky body modification procedures such as using off-label hormones, taking higher than advised hormone dosages, and using injection silicone, e.g., an illegal practice that can lead to serious health consequences¹⁵ such as deformities, scarring, infections, and granulomas.¹⁶ As supported by literature, including images of transgender people of various races and ethnicities on research materials could help dismantle stigma-related stressors and help participants feel accepted and welcome.¹⁷

Another concern brought up among participants was the underrepresentation of transgender women in clinical product development (e.g., PrEP is marketed to gay men, so it is a “gay men thing” and not a “woman” or even “transwoman thing”). It is critical that advertisements are careful to represent transgender women as a distinct and important group rather than as an “afterthought.”⁴ This may be particularly prevalent in clinics equipped to serve MSM.⁵ For example, health organizations which provide HIV services for gay men often apply the same services to transgender women. Failing to acknowledge the distinct needs of transgender women leads to failure of providing adequate care.¹⁸ Feminine gender identity is also an important part of transgender women’s self-understanding and using HIV prevention products they perceive are meant for men is an affront to this identity and thus a significant barrier.⁴ If efforts are taken to study the effect of PrEP medications on transgender bodies, and market these medications to transgender women specifically, this could increase this population’s comfort with taking such products and remaining engaged in their care. To do this well, we must include transgender women in the design and development of HIV prevention products and programs. This will help to ensure the messaging, environment, and questions asked of these women are relevant and appropriate to their specific needs, priorities, and life contexts,⁵ creating a gender-affirming study environment.

In addition, hosting study activities in spaces known to be transgender-friendly promotes a feeling of safety and trust for potential participants. Existing literature shows that a priority for both cisgender and transgender women is to have a safe space, distinct from male-identified individuals, in which they can address their unique HIV-related challenges.¹⁹ A participant explained that during the transition period, many trans folk do not like going to health providers, as they do not feel comfortable with others around. This concurs with the literature, as some studies show that despite having a transgender-friendly provider, experiences of transphobia and “clocking” (e.g., being identified by others as presenting an incongruent gender package) in the waiting room or by clinic staff may cause transgender women to avoid medical settings.³ Furthermore, compounded experiences of trauma related to gender identity or expression, layered atop of fear of and actual experiences of rejection, can also prevent engagement and retention in care.¹⁹; Thus, dedicating space with a reputation as “for” transgender women could promote feelings of comfortability and increase study enrollment and retention. Conversely, some transgender women felt that designating space for gender nonconforming folks challenges their feminine identity rather than affirming it.

Providing compensation (in addition to reimbursement for time and travel expenses) that is responsive to needs pervasive in the transgender community

Many participants indicated they would be more interested in participating in HIV prevention trials if these studies provided food (e.g., snacks, lunches, drinks) in addition to monetary incentives and transportation reimbursement. Participants in other studies also explained the prevalence of food insecurity in the transgender community,²⁰ and how offering grocery vouchers or food can help to offset this in the short term for some participants.

Sensitivity training and pronoun usage

The most common suggestion given by participants was to train study staff in using correct pronouns and remaining vigilant to intentional and unintentional discriminatory or judgmental behavior. Many transgender women report common forms of transphobic and insensitive treatment including (but not limited to) misgendering by clinic staff, and staff use of the patient’s “dead name” (e.g., a transgender individual’s birth name that they no longer use).³ Transgender stigma and anticipated discrimination often turn trans folk away from seeking health care.²¹ Gender-affirming care can be shown using language that aligns with participants’ gender identity and could potentially enhance study participation.²² This includes respecting individuals’ pronouns, preferred names, diversity, and appropriate trans-related terminology.⁵ Addressing patients in a way that creates a welcoming environment is promoted by the Center for Disease Control as well. They list strategies including using their preferred names and pronouns, avoiding using gender terms or pronouns with new patients until this information is known, asking patients how they want to be addressed, and apologizing for mistakes. They also explain steps health care staff could take (and avoid) in case patient records do not match with a given patient’s registration forms or identity documents and practicing these tactics with colleagues.¹⁷

In addition to ensuring that correct pronouns and preferred names are used, study staff should be trained to recognize potential microaggressions that may cause transgender women to feel judged. A study about transgender women’s barriers to participating in HIV vaccine trials recommends transgender cultural competency and trans-friendly environments as methods of improving engagement of transwomen.²³ The CDC also details the benefits of training managers, so they understand policies and procedures related to patient-centered care for transgender people and encourages annual training for all staff.¹⁷ Bauer’s study suggests that health care workers’ lack of training in respectful, compassionate treatment of trans patients places the impetus on the patients themselves to fix inequities in the system.²⁴ This burden, in addition to stigmatization and alienation in health care, drives transwomen away from both care and study participation. Some health clinics that serve sexual and gender minorities in New York City, such as Callen Lorde Community Health Center and Apicha Community Health Center, have multilingual, respectful, and friendly staff greet patients at the door, offer community health education on gender affirming practices, provide maps of transgender health resources, list gender-confirming surgeons and safety practices, and coordinate care for transgender individuals. Training health care providers in gender-affirming care would facilitate increasing acceptability to PrEP and trial participation.^5,22

Hiring transgender individuals to study staff and leadership

A strong way to build a sense of belonging and safety in HIV prevention trials comes from having trans folk as members of the study staff. Findings from one study indicate that involving transgender and gender nonconforming people in all levels of the project and the study and the staff can improve participation in trials.⁵ Community engagement in the form of partnering with LGBTQ community groups could boost inclusivity and thus increase trust while delivering health care to trans folk.¹⁷ Furthermore, engaging with existing transgender social networks offers a chance to reach them and deliver interventions in a way that is grounded in their realities.²²

Most of the literature available on strategies to improve patient-centered transgender care or barriers transgender people experience are consistent with our findings. While this study focuses on improving recruitment and retention of transgender women in HIV trials specifically, many of the discussions given by participants detailed their experiences of health care settings overall. However, there is not much literature addressing the overlap or collocation of research sites with clinical spaces. Future work could consider whether this is something that should be done and how this would alter implications for things like sensitivity training and patient experiences.

Limitations

Although this research focuses on the experiences of transgender women in New York City (NYC), it is important to note that these perspectives may differ from transgender women living in other parts of the United States, or in less urban environments. There are many transgender-focused health advocacy groups and health care organizations dedicated to supporting this population in NYC. Transgender women living in less resourced environments may have different concerns and preferences, limiting the generalizability of our findings. In addition, we acknowledge the limitation set by the lack of demographic information about our participants. Despite these limitations, we believe that the research in this article makes a valuable contribution and acts as an initial step to improve and/or tailor research settings to the needs of transgender women.

Conclusion

The findings in this article provide a set of initial suggestions to make HIV prevention trials more welcoming and supportive of transgender women participants.; Incorporating these suggestions increases the likelihood that trials can recruit and retain transgender participants and improves data quality focused on this population. Together, this could have the subsequent effect of improving uptake and adherence of HIV prevention medications once they receive regulatory approval.

Footnotes

Acknowledgments

The primary author and research team thanks all participants who contributed their time, expertise, and ideas to this project.

Authors’ Contributions

T.R.: PI of the study. D.D., T.R, L.R., and S.A.M: Drafted this article and performed primary data analysis duties. L.R. and E.A.: Collected data. C.D.: Managed data. J.M.L.: Responsible for participant outreach. J.L.-R. and T.R.: Provided mentorship support to D.D. M.P.V. and J.P.: Provided writing support. All authors listed in this citation contributed to the critical revision of this work.

Author Disclosure Statement

The authors have no conflicts to declare.

Funding Information

This work was supported by a K01 Award (K01 MH115785; Principal Investigator: C.T.R., Ph.D.) from the National Institute of Mental Health at the University of Colorado College of Nursing. M.P.V. was supported by a T32 Award (MH019139 (Principal Investigator, Theodorus Sandfort, Ph.D.) from the National Institute of Mental Health at the New York State Psychiatric Institute (NYSPI)/Columbia University (P30 MH43520; Center Principal Investigator: Robert Remien, Ph.D.). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Mental Health or the National Institutes of Health.

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