Engaging Transgender Women and Transgender Men in Digital Spaces Trans Participants in the AMP Study Fostering Transgender Inclusion in HIV Research
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
VOLUME 19, ISSUE 1: JUNE 2019 Engaging Transgender Women and Transgender Men in Digital Spaces Trans Participants in the AMP Study Fostering Transgender Inclusion in HIV Research
LETT
Welcome to the newest edition
of the HIV Vaccine Trials Network
(HVTN) Community Compass.
In this issue, we dive deeper
into some of the considerations,
Please help us ensure that this
publication is representative of our
entire global HVTN community!
HVTN members (who have access
to the HVTN member’s website)
can use our submission page that
perspectives, and best practices for offers the ability to submit content
the engagement of transgender and articles for inclusion in future
populations in our research. It is my issues. More information about
hope that this issue enhances your this follows on page 04 under the
understanding of the dynamic lives “Meet the Community Compass
of transgender people, and gives Team” section.
you a glimpse into the topics and
concerns that should be considered Thank you for your continued
when engaging transgender support of the HVTN wherever you
persons in HIV prevention research. are in the world, for the work that
In this issue, we offer perspectives you do in whatever role you have
from members of the population, in the HVTN community, and for
overviews of research done with the impact we have been able to
transgender populations, and make in our collective history and
other information that I hope communities, together. Though we
you find useful. have come very far in response to
the HIV epidemic, we have so much
None of this is a substitute for further to go to achieve an effective
effective community engagement global HIV vaccine. The HVTN
in your own local communities, Community Compass team wants
and as always, the best way to to be everywhere you are, so please
ensure that the voices of any share with us what’s happening
community or population are heard at your research sites, institutions,
is to meaningfully engage and and in your communities, so that
include them. When you engage we can share it with the world.
transgender persons and ask for
their input and perspective,
do so from a place of sincere
humility, and be prepared Be well,
to be responsive to the Stephaun E. Wallace, Ph.D.
feedback you receive. Editor-in-Chief, HVTN Community Compass
1 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 19, ISSUE 1: JUNE 2019
TER
The Transgender Pride Flag was
created by American trans woman
Monica Helms in 1999,[1][2] and was
first shown at a pride parade in
Phoenix, Arizona, United States
in 2000.[3]
Stephaun E. Wallace, Editor-in-Chief
sewallac@fredhutch.org
The flag represents the transgender
community and consists of five
horizontal stripes: two light blue,
two pink, and one white in
the center.
Helms describes the meaning of the
transgender pride flag as follows:
“The stripes at the top and bottom
are light blue, the traditional color
for baby boys. The stripes next
to them are pink, the traditional
color for baby girls. The stripe
in the middle is white, for those
who are transitioning or consider
themselves having a neutral
or undefined gender.”[3][4]
Brian van de Mark (10 May 2007). “Gay
[1]
and Lesbian Times”. Archived from the
original on 6 September 2012. Retrieved
3 November 2016.
Fairyington, Stephanie (12 November
[2]
2014). “The Smithsonian’s Queer
Collection”. The Advocate. Retrieved
5 June 2015.
“Transgender Flag Flies In San
[3]
Francisco’s Castro District After Outrage
From Activists” by Aaron Sankin,
HuffingtonPost, 20 November 2012.
“The History of the Transgender Flag”.
[4]
point5cc.com. 23 April 2015. Archived
from the original on 9 July 2015.
Retrieved 9 July 2015.
HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 19, ISSUE 1: JUNE 2019 2
CONTENTS
Meet The Community Compass Team 4
Engaging Transgender Women and
Transgender Men in Digital Spaces 5
Case Western CAB Outreach in Local Communities 7
From Noun to Verb: Three Parallel Lives of Beauty,
Competitiveness, and Empowerment 8
Trans Participants in the AMP Study: Voices From Via Libre 11
Exploring the Potential for Interactions Between Oral PrEP and
Gender-Affirming Therapy Among Transgender Women 13
Upcoming Events/Conferences/Meetings 15
Seen Around the HVTN 17
HVTN 505 Recap 21
Fostering Transgender Inclusion in HIV Research 23
HVTN 705/HPX2008 – The Imbokodo Study 27
A Community Launch Event for the Imbokodo Study 29
South Africans Do Not Have the Luxury to Claim That
They Are HIV/AIDS Fatigued 31
Interview With a Study Volunteer 33
Never Give Up 35
OUT Role Model: Shawn Reilly 36
Getting the Right Test for HIV 37
Healthcare Experiences and Being Transgender 39
Spotlight on the People of the HVTN 41
3 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 19, ISSUE 1: JUNE 2019
COMMUNITY COMPASS
Stephaun E. Wallace, Ph.D. Editor-in-Chief Cody Shipman, Layout & Design
Our vision is an informed HVTN community that is aware of current events and activities relating to the HVTN
network and its sites, advances in the field of HIV prevention and vaccination, as well as community priorities.
We work to accomplish this by providing relevant information and updates to promote awareness, understanding,
and support for HIV prevention and HIV vaccines, reaching global communities invested in the response to the
HIV epidemic.
We welcome submissions of articles on any topic for publication that is relevant to the HVTN community.
Submissions must be exclusive to us, and not appear in any other publication. Submissions must be 500 words
or less to comply with our layout and design requirements.Due to space limitations, we may need to hold
publishing your article for a future issue.
To submit articles for Community Compass, please go to the HVTN Members Site homepage, click on “About”,
then click “Community Compass”, then click on “Submit to Community Compass”.
Nina Ennis, Production & Distribution Gail Broder, Contributing Editor
HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 19, ISSUE 1: JUNE 2019 4
Featured Article
Engaging Transgender Women and
Transgender Men in Digital Spaces
By: Rafael Gonzalez & Bianca S. Hill, Bridge HIV CRS, San Francisco, CA, USA
There are approximately 1 million Participants identified the need
adults in the US who identify as to be inclusive and have visible
transgender. And while we don’t transgender representation in an
know the true prevalence and ad. The representation can take
incidence of HIV transmission place in a variety of ways: visible
within the community, we do Trans flag colors, or including
know that about 2,300 folks who specific text that explicitly states
identify as trans were diagnosed the study is recruiting transgender
with HIV between 2009 and 2014 women and men. If using models
in the United States. It’s estimated in a campaign, the consensus
that HIV is 5 times the national was to use people from within the
average among transgender women community rather than opting for
and men. Yet transgender people stock photos that use non-familiar
account for a small proportion in or celebrity-style images.
HIV prevention research studies,
including vaccine research studies. A variety of messages were
With the growing prevalence of discussed that ranged from
HIV among transgender men “Doing Good” by helping end
and women, it is essential to HIV, to messages that were not
identify barriers and facilitators for directly about HIV but spoke to the
transgender people to participate community such as “Big and Bold.
in HIV vaccine clinical trials. Beyond the Binary.” Participants
unanimously agreed that messages
Studies that are exploring the such as “Do Good” imply judgment
reasons for underrepresentation (that if you are not interested in
of trans people in HIV vaccine participating or being involved
trials have pointed out that there in HIV prevention, you are doing
is a need to develop recruitment bad). A transman under age 30 in
strategies geared specifically toward the focus group stated, “People are
the transgender community. Some Word based ads from Bridge HIV. imperfect, also, their goodness is
of the barriers to address in such not determined by their STI status.”
strategies include stigma, being To explore the acceptability On the other hand, some of the
unaware of or misinformed about of recruitment campaigns on younger transwomen in the group
HIV, mistrust of the scientific social media sites/apps among
community, and concerns about transgender women and
possible vaccine side effects. But transgender men, Bridge HIV
before any of these can even be invited members of the community
addressed, how are we reaching to a paid focus group. We sought
trans-identified women and men? to evaluate and compare the
effectiveness of multiple styles
Our ever-evolving culture is of advertisements on social media
guiding us into digital spaces sites/apps (such as Instagram)
where visual advertisements grab as a recruitment tool for HIV
the attention of people. It has been prevention studies. Specifically,
estimated that 72% of US adults visit we focused on obtaining feedback
social media websites and 12% of about the imagery, text/language,
internet users access social media style, and overall message of
to research health-related issues. the campaigns. Ads featuring Trans people from the Bay Area.
5 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 19, ISSUE 1: JUNE 2019
and HPTN 083, phase 1 and 2b References:
(respectively) injectable PrEP
• https://www.cdc.gov/hiv/group/gender/
studies that required participants transgender/index.html
to receive an injection in one of
• Karuna, Shelly & Grove, Doug & Broder,
their butt cheeks. This campaign Gail & Anude, Chuka & Hammer, Scott &
depicts a variety of cartoon butt Sobieszczyk, Magda & Andrasik, Michele.
cheeks in different shapes and (2014). Transgender Participants in the
sizes with text stating, “Show us yer HIV Vaccine Trial Network’s HVTN 505
Trial: A Descriptive and Comparative
cheeks!” Participants thought that
Analysis. AIDS research and human
cartoon-based images were a great retroviruses. 30 Suppl 1. A189. 10.1089/
way to be inclusive: “I like the butts, aid.2014.5405.abstract.
because I think they’re universal,
• Burrell, E.R., Pines, H.A., Robbie, E. et
and I think that isn’t – it’s not very al. Use of the Location-Based Social
gendered, and I like that.” Networking Application GRINDR as a
Recruitment Tool in Rectal Microbicide
Our take-away at Bridge HIV is to Development Research. AIDS Behav
(2012) 16: 1816. https://doi.org/10.1007/
create a customized campaign for
s10461-012-0277-z
the trans community, as opposed
• Lee JL, DeCamp M, Dredze M, Chisolm
to creating one general campaign.
MS, Berger ZD. What Are Health-Related
While cartoon-based and text-based Users Tweeting? A Qualitative Content
Cartoon based ads from Bridge HIV. advertisements are acceptable, we Analysis of Health-Related Users and
think creating a campaign with Their Messages on Twitter. Eysenbach G,
felt that a tagline like “Big and Bold. members from the transgender ed. Journal of Medical Internet Research.
Beyond the Binary” targeted them community as models would be a 2014;16(10):e237. doi:10.2196/jmir.3765.
in a good way. They felt that the great way to show the community • Sun CJ, Stowers J, Miller C, Bachmann
message is “really clever alliteration” that we are listening to their LH, Rhodes SD. Acceptability and
feasibility of using established geosocial
and that “this is meant for me. feedback, that we care, and that we
and sexual networking mobile
This is meant for me to be reading want to cultivate our relationship applications to promote HIV and STD
right now.” with the community. It would also testing among men who have sex with
create a paid opportunity for the men. AIDS Behav 2015; 19:543–52.
Animated or cartoon-based models, which is also a facilitator
campaigns were appreciated in establishing trust.
among the group. Specifically,
the conversation focused on a Rafael Gonzalez is the Community Program
campaign created for HPTN 077 Manager and Bianca Hill is a RAMP Scholar
at the Bridge HIV CRS.
Altruistic ads from Bridge HIV.
HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 19, ISSUE 1: JUNE 2019 6
Featured Article
Case Western CAB Outreach
in Local Communities
By: Bob Bucklew, Case Western Reserve University, Cleveland, Ohio
On October 5, 2018, the Community
Advisory Board (CAB) of the
Case Western Reserve University/
University Hospitals AIDS Clinical
Research Site sponsored a showing
of the film “Kings, Queens, &
In-Betweens” for the Greater
Cleveland community. The
film, a documentary filmed
in Columbus, Ohio, explores
gender, race, sexuality and
changing self-identity against
the backdrop of a then-thriving
local drag performance scene.
The event was open to the
community free of charge.
“Kings, Queens, & In-Betweens” Promotional Advertisement
Approximately 50 people attended
the event which started out with a reception, and included popcorn
(of course!). Following the screening, an audience discussion was led
by CAB Chair Julie Patterson. One of the stars of the movie, Sile Singleton
who performs as Luster dela Virgion and Anita Kwan, owner of Reel
Hoot Productions and editor of the film. The discussion was lively and
inspirational. Topics covered included the differences between drag
performance and gender identity, and the particular ways race and
racism impact transgender people and communities.
The CAB brainstormed new ways to continue the critical conversation
around gender, justice, and HIV. Several members had previously seen the
film at the Cleveland International Film Festival. In addition to being an
intelligent and entertaining film, the CAB members thought that having
the film set in Ohio would allow a greater connection with our community
than if it had been filmed in a larger coastal city, and they were correct.
Julie Patterson summed up the event, “Community members enjoyed the
film and found it was a springboard for discussion about gender fluidity,
generational differences in identity, and the transformative power of drag.
Ohio is full of amazing people - you just have to know where to find them!”
Audience discussion leaders (l to r): Luster
Bob Bucklew is the outreach coordinator with Case Western Reserve University. dela Virgion, Julie Patterson (CAB Chair),
and Anita Kwan
7 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 19, ISSUE 1: JUNE 2019
Featured Article
From Noun to Verb: Three Parallel Lives of
Beauty, Competitiveness, and Empowerment
By: Carolina Arredondo Villar, Lucía Ruíz Escalante, Carlos Vela Vela, Association Civil Selma Amazonica CRS, Iquitos, Peru
The value of stories lies in learning It was difficult for Chris to accept Chris thinks about modeling in
from brave people who share their herself, and the process began with Lima, plans she’ll carry out in the
so-called life lessons and how they a hormone treatment at the age of future. Chris is convinced that
have overcome life’s challenges. 17. The following year she began her physical beauty is accompanied
These three survival stories lead transformation to become a trans by intellectual beauty, your
us to understand the urgency of woman. Were there any jokes? Yes education, which she defines
leaving speech behind and taking there were, and they were indeed as as the glamor of women.
action, that is, transforming nouns numerous as the love of her family
into verbs. was huge, which was Chris’ source Like many others, Chris Martínez
of power to face life. Likewise, Chris considers that Angela Ponce’s
“Some people mistake has Francesca, her transgender participation in the Miss Universe
sister who always supports and 2018 pageant (representing
nudity for sensuality and accompanies her. Spain) has opened a wide door
vulgarity. Stay a mystery!” for transgender women. She also
thinks that this fact will help to
- Carolina Herrera unite the Iquitos trans community,
minimizing the fears of coming out
BEAUTY + INTELLIGENCE and making themselves visible to
= POWER society. For that purpose, Chris will
continue to help empower others
Since 2015, Chris Martínez dreamt through beauty, knowledge, and
about becoming a queen after acceptance of themselves, because
watching Lady Jeri crowned as Miss it is not only about a face or a body,
Dragon fantasy costume show but also about education, and there
Amazonas, but there was a huge
obstacle Chris had to overcome: her The Beauty Academy (a component is much to learn!
shyness. She had never participated of the Miss Amazonas pageant) was
in any play in high school, nor being very difficult for Chris because it
a contestant for any beauty pageant. demanded her time and sacrifice,
She had actually refused to run for which in exchange gave her
Miss Belén Trans. Then, her mother information and empowerment.
and sister encouraged her. At that It was great. Now Chris wants to
moment, Miss Amazonas 2018 follow this method to strengthen
Queen was born, bringing the herself and help other transgender
crown back to Belén after 11 women by giving motivational
years of absence. speeches on the advantages
and disadvantages of hormone
treatment. “There is very little
known about this topic, but by
2019 I’ll start this path at the
Asociación Civil Selva Amazónica,”
she said. Chris will also carry
out sensitization work about the
importance of participating as
volunteers in the research for
solutions to prevent HIV.
Chris Martínez, Miss Amazonas 2018
Chris Martínez presentation MA2018
Continued on Next Page...
HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 19, ISSUE 1: JUNE 2019 8
within her family, and responds or clubs and then drug and rob
“We cannot allow others’
with defiance on a daily basis, them], or sex workers, however
limited perceptions to because it has been neither easy there are many trans women who
nor impossible at all. don’t do any of that.”
define us.”
- Virginia Satir Cris works at a store in Iquitos “Those who don’t
where she was required to have
a short hairstyle, and when she
move do not notice
KNOWLEDGE CREATES asked her boss if the company their chains.”
COMPETITIVENESS would hire a trans girl as allowed
by law, she was told “absolutely
- Rosa Luxemburgo
Cristina Vela, previously runner- not” and that they would take her
up for “Miss Amazonas 2016,” is application but wouldn’t hire her. BUILDING IDENTITY
currently hostess of the Asociación This affected Cris’ self-esteem, since TO EMPOWER
Civil Selva Amazónica. She has she had to play a role that was not
worked in many places where she true to herself. To be a contestant Fiorella Jiménez is a spokesperson
had played a role as a male, but in “Miss Amazonas 2016,” Cris for Kallpa, and jointly works with
knew herself to be a transgender joined the Beauty Academy, CHERL and the Office of the
woman. For Cristina, education is empowered herself, acquired Public Defender in Loreto-Perú
the engine for change in the world. knowledge, and changed. on the defense of the community.
She doesn’t consider herself as
a role model, but she does desire
to become a reference for
her community.
Fiorella’s at Ayacucho, in Mesa de
Kallpa, to share experiences using
a methodology guide to implement
a comprehensive sexual education
program with CHERL and the Office
of the Public Defender. She has
been working on this since she
was 15 years old and in high school.
Her life has not been easy, especially
regarding her family; she got
away for a while, but now they
Cristina Vela, hostess at ACSA
live together once again.
The first challenge of her life was Cris has been working for two
to accept herself. It was difficult years at the Asociación Civil Selva
because she didn’t know who Amazónica as hostess and it’s
she was, she didn’t know what a great opportunity to empower
a “trans girl” was, and she was herself and widen her knowledge.
not comfortable with her gender. She works in a comfortable
Nowadays, she knows she environment, because her
is a transgender woman and co-workers treat her as a
why she is living day after transgender woman.
day. Knowledge was the key
to her liberation. Cris says, “The trans community
is in the process of strengthening
Cristina states that competitiveness itself and gaining acceptance from
has meant improving herself society. If they have no rights, they
to overcome the difficult cannot move forward or evolve.
circumstances she has faced Transgender women are often
along her way. Therefore, she faces labeled as thieves, “peperas” [women
obstacles and challenges, including hired to attract men at parties, bars Fiorella Jiménez, transgender woman leader
9 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 19, ISSUE 1: JUNE 2019Empowering contestants for “Miss Amazonas 2018”
“Up until now, the topic Fiorella has a great concern about Participating in “Miss Amazonas
(empowerment) has been difficult. I the absence of regional ordinances 2015” contributed to her
am focusing on working with trans that directly endorse transgender empowerment. Through the Beauty
women, and it is twice as difficult women. There are ordinances Academy she had the opportunity
because there are only a few trans about discrimination based on to receive support, and since then
women participating in this topic. sexual orientation and gender she has had the opportunity to
Why? It’s a matter of stigma and identity that are more focused empower other contestants. In 2019,
discrimination. The trans women on the gay community, and the she plans to develop a personal
exclude themselves because of their trans communities don’t consider project with transgender women.
work, and they are more concerned themselves included. In the health
about doing well. If they were sector, for example, many women
properly directed, we would stop coming to medical facilities Carolina Arredondo Villar, Communication
do greater things,” she said. because they are badly treated. expert on Community Education, Asociación
Civil Selva Amazónica
“Using the bathroom is a small
However, discrimination is not only thing but causes great damage,” Lucía Ruíz Escalante, Chief of the
she stated. Community Education Area, Asociación
experienced externally, but also
Civil Selva Amazónica.
internally because there are those
who say they are transgender Fiorella shared that an example of a Carlos Vela, Recruitment and
Retention Coordinator, Asociación
but do not transition and live positive response from an authority
Civil Selva Amazónica.
openly as transgender people. It is is that her social name is respected,
a challenge to build a self-identity and she is acknowledged in her
that includes the concept of “trans” study center. On the other hand, she
and to live with the suffering of received a negative answer when
not knowing who you are. For she tried to talk to the dean of a
Fiorella, transgender women may local university and the members
be directed and empowered to know of the university assembly but they
and enforce their rights from this refused to receive her because
moment on, and then they of being transgender.
can dialogue with the authorities
to propose changes.
HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 19, ISSUE 1: JUNE 2019 10Featured Article
Trans Participants in the AMP Study:
Voices From VIA LIBRE
By: Julio Ortiz and Diego Torres, VIA LIBRE CRS, Lima, Peru
Among the participants enrolled Another woman, Zoe, found that the
in the AMP Study at the VIA LIBRE discovery of, initially, a gay identity,
research site, about 9% identify as a gave way to her transgender
transwoman (about 24 out of a total identity: “In the garden I played
of 254 enrolled). Five of the women with the girls, with the dolls. I felt
happily gave us their feedback like I was gay. When I was 12, I felt
and testimony regarding a few different. The change started at 15,
questions we asked them during 16. I let my hair grow and I started
one of their scheduled study visits. taking hormones.”
Jeampi said: “I started to realize that
I was gay when I was 5 years old,
when I was in the nest. I realized
that I liked a child in the classroom.
At 8 I had my first kiss with a boy
who was from my neighborhood. Jeampi
I think that my taste for being because in a job application they
a woman came at 12 years. At look for male or female sex. You
5 [as a boy] he was mannered, go where it says female, but your
he had a taste for makeup, but documentation comes out
I still did not see my future like as a man.”
that [as a woman].”
There is also a difference in the
Likewise, the family plays an treatment of homosexuals and
important support role in this heterosexuals, especially with trans
process, or can reject them. Carola girls who demand equality. Zoe said,
shared: “My dad looked at me, gave “They need to recognize us as they
me a bean on the forehead and recognize the heterosexuals, and
said “I cannot do anything.” But getting that recognition is in the
Shirley my mom did not talk to me for works. They need to call me by
almost a year.” my name if I think about changing
How was the process it, but that will come later.”
of acceptance of your Problems with
gender identity? trans identity? On the other hand, there are those
who have a more optimistic outlook
One of the women, Michel, For this question, we heard answers and the conviction that they can
found that the conception of ranging from feeling pessimistic create changes. Jeampi said, “My
their identity was a trauma that about being trans, linked to the dream is to be a journalist and work
could be overcome, and sought difficulty of being recognized in on a newscast. I want to escape the
the assistance of a psychologist their authentic gender identity cliché of gossip journalism and do
for about 8 years: “I received to being able to obtain an more serious journalism. A trans girl
psychological therapy since I was identification in which their “social” can also be a professional.” Jeampi
4 years old, because at school they name is used and appreciated. also noted that it is important to
realized [my true identity]. It was a Michel said, “Study something else, recognize the difficulties and lack
pleasure, because it was something not because the society we live of sexual education that trans
that could not be hidden.” in does not accept a transgender women still suffer, which hinders
person.... It is not easy to get a job personality development and the
affirmation of their identities.
11 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 19, ISSUE 1: JUNE 2019Carola along with Jose-Luis Castro (Lead Community Educator, VIA LIBRE CRS) (right) and Enrique
Avila (Retention staff, VIA LIBRE CRS) (left)
According to a recent statistic, 70% say they received when they were
of the trans population is engaged invited to learn about the trial, and
in sex work. This affects those who during their time in the clinic. Zoe
suffer stigma for being trans. Shirley said, “I was informed first and I
told us, “Most people discriminate liked how I was treated more than
against you, treat you badly, anything. I like the whole site; if
sometimes insult you. I try to lead I hadn’t felt comfortable I would
my life quietly. We are dedicated not have come.” Carola felt it was
to our homes, I am a stylist; not important that people could access
all trans women are dedicated information about prevention and
to sex work.” high-risk exposures. “That protected
me, as I run risks almost every day.”
On the other hand, Jeampi hopes
the study will obtain beneficial
results. “More than any benefit, it is
knowing how to inform people. And
to know if it works, if it really works
and if it can protect many people.”
Four of the women granted us
permission to publish their photos.
Jeampi’s photo is particularly
significant for her, since she
published it on social networks for
the viral #10YearChallenge, which
was shared and generated many
comments. Jeampi decided to
communicate, with great courage
Michel
and pride, the change in how she
looks now, different from the earlier
How did you decide child that appears in the first part
to participate in the of the photo.
AMP Study?
Julio Ortiz is the Recruitment and Retention
The participation of these trans Coordinator and Diego Torres is a Recruiter at
girls goes hand in hand with the the VIA LIBRE CRS in Lima, Peru.
information they had access to
and the good treatment that they
HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 19, ISSUE 1: JUNE 2019 12Featured Article
Exploring the Potential for Interactions
Between Oral PrEP and Gender-Affirming
Therapy Among Transgender Women
Craig W. Hendrix, MD., The Johns Hopkins University School of Medicine, Baltimore, MD
HIV is very common among were used and in which tissues. transgender women and cisgender
transgender women, indicating Naturally high concentrations men, and changes in estrogen
a special population that would of estrogen in pregnant women concentrations before and after
greatly benefit from pre-exposure are associated with reduced PrEP in transgender women. To
prophylaxis (PrEP) with oral concentrations of many drugs assess the impact of GAHT on
tenofovir and emtricitabine (sold that are processed by the kidneys, PrEP, we calculated the total drug
by the brand name Truvada®). including PrEP drugs. There is no concentration in blood over 24
However, transgender women laboratory or clinical evidence to hours, also known as the area under
are not well represented in most suggest that PrEP drugs have any the concentration versus time
large PrEP clinical trials and there effect on estrogen concentrations, curve for 24 hours (AUC24), and we
are very few pharmacokinetic but this has not been previously measured the drug concentration
studies (where drug concentrations studied directly in clinical trials. 24 hours after the last PrEP dose
are measured over time) in Given the concern among was taken, also known as the trough
transgender women. In addition, transgender women that PrEP concentration. After one week of
many transgender women also might adversely affect GAHT, and daily PrEP dosing, tenofovir and
benefit from taking estrogens conflicting laboratory data that emtricitabine AUC24 and trough in
with or without anti-androgens estrogen might affect PrEP drug the blood plasma of TGW were lower
as gender-affirming hormone concentrations, we and others set by 20% to 27% when compared to
therapy (GAHT). However, several out to study drug-drug interactions cisgender men. The other research
surveys of transgender women between PrEP and GAHT team at the Thai Red Cross/HIVNAT
taking GAHT indicate a high degree in transgender women. also showed a slightly lower 12-
of unwillingness to take PrEP due 18% reduction in tenofovir blood
to concerns that PrEP may impact We performed a small, open concentrations when an estrogen/
their hormone regimens. Given the label study of daily oral PrEP cyproterone regimen was added
established benefits from both PrEP drug concentrations in blood to PrEP alone (presented at the
and GAHT, their likely use together, and rectal tissue in eight HIV- Paris IAS 2019 meeting). Seeking
and the reluctance of many negative transgender women a biologic explanation for these
transgender women to take PrEP, (TGW) consistently taking GAHT results, we found that kidney
it is essential to understand the and eight cisgender men. Research function (creatinine clearance
potential for interactions between participants took daily oral PrEP for and glomerular filtration rate)
these drugs. Better understanding one week under direct observation was substantially higher in the
could provide reassurance to in the research clinic to assure 100% transgender women. These
transgender women and clinicians adherence. After the last dose, blood measures were also strongly and
that PrEP and GAHT could be and rectal tissue were collected to inversely correlated with plasma
prescribed together without risk measure PrEP drug concentrations. AUC and trough concentrations
of reducing the effectiveness We also measured estrogen and for both drugs—meaning that the
or increasing side effects of testosterone in the blood. We higher the clearance, the lower the
either regimen. reported study results at the HIVR4P PrEP drug concentrations.
(HIV Research for Prevention)
Previously, laboratory and animal meeting in Madrid in October 2018. To work, both of the medicines
studies suggested that estrogens included in Truvada® must be
might either increase or decrease The two primary outcome activated by enzymes in the body’s
the concentrations of PrEP drugs, measures were differences in PrEP cells by the addition of phosphates
depending on which specific tests drug concentrations between to become tenofovir diphosphate
13 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 19, ISSUE 1: JUNE 2019and emtricitabine triphosphate. study participants were on the of oral PrEP using Truvada® in
Because we believe the location of same GAHT regimen, which transgender women, as in cisgender
drug action for these medicines introduced a lot of variability, women, until other studies are
used as PrEP in transgender women making it harder to pick up small completed. More importantly, there
is primarily in the rectal tissue cells, differences. Better evidence to is reassurance across these two
we measured these activated forms prove there is no effect of PrEP on studies that PrEP drugs do not affect
of the medicines in rectal tissue GAHT comes from the Thai Red GAHT drug concentrations. Larger
as well as blood. The differences Cross/HIVNAT study (mentioned and more carefully controlled
in concentration of both active earlier) in which all transgender PrEP-GAHT interaction studies
drugs inside certain white blood women were on the same GAHT are needed to establish whether
cells, known as peripheral blood regimen of estrogen/cyproterone, the differences in PBMC and rectal
mononuclear cells (PBMC), showed in which PrEP drugs had no impact tissue are real, so that we could
similar lower concentrations like on estrogen concentrations. Their better understand the role of the
that seen in the blood plasma. rigorous study design allowed different anti-androgen drugs
Unlike the plasma, however, these the investigators to confidently such as spironolactone or Lupron
were not statistically significant detect smaller differences in drug in the GAHT regimens, and to
and could have occurred by concentrations than we could. provide more definitive guidance
chance alone. In rectal tissue Taken together, these studies to clinicians who prescribe GAHT
cells, the differences in active provide good evidence that GAHT to transgender women who wish
drug concentration were 62% to is not affected by oral PrEP. Because to take Truvada® as PrEP and
68% lower in TGW compared to cyproterone is not available in GAHT together.
cisgender men, however, as in the the US and its specific role in
PBMC, these were not statistically the changes seen in PrEP drug Dr. Craig Hendrix is the Wellcome Professor
significant. Measuring drugs concentrations was not directly and Director in the Division of Clinical
in tissue cells is highly variable assessed, we believe additional Pharmacology in the Departments of
and the small differences seen in studies are needed. Medicine and Pharmacology and Molecular
Sciences at Johns Hopkins University
plasma are hard to detect. Thus,
School of Medicine.
we cannot say with confidence The magnitude of the decreases
that the differences in activated in the 2 PrEP medicines in
drug in PBMC and rectal tissue transgender women on GAHT are
cells are real. However, PBMC similar to the effects of regularly
concentrations are highly related to missing 1-2 doses each week. This
blood plasma concentrations based decrease probably still provides high
on other studies, and we saw no concentrations of protection with a
evidence of changes in the body to daily dosing regimen – even if the
explain a loss of this relationship. rectal tissue cell concentrations are
These facts provide a good reason real and consistent with every other
to do larger studies to determine day dosing. However, PrEP drug
with confidence whether or not concentrations in combination
these changes in active PrEP drug with GAHT and an on demand oral
concentration truly occur when PrEP regimen, such as the regimen
PrEP is taken together with GAHT. used in the Ipergay trial (the so-
called 2-1-1 regimen), may fall
We saw no effect of Truvada® on below protective concentrations.
estrogen or testosterone in our Therefore, it would be wise to
study. However, not all transgender only recommend daily dosing
Craig W. Hendrix, MD.
HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 19, ISSUE 1: JUNE 2019 14UPCOMING
EVENTS/CONFERENCES/MEETINGS
11-14 JUNE 2019
2019 IMPAACT Annual Meeting
Washington, DC, USA
https://impaactnetwork.org/
16-20 JUNE 2019
2019 ACTG Annual Meeting
Washington, DC, USA
https://actgnetwork.org/
14-17 JULY 2019
2019 STI and HIV World Congress
Vancouver, BC, Canada
https://stihiv2019vancouver.com/
21-24 JULY 2019
10th IAS Conference on HIV Science
Mexico City, Mexico
http://www.ias2019.org/
5-8 SEPTEMBER 2019
2019 US Conference on AIDS
Washington, DC, USA
http://2019usca.org/
2-6 NOVEMBER 2019
2019 American Public Health Association Meeting
Philadelphia, PA, USA
https://www.apha.org/events-and-meetings/annual
3-4 DECEMBER 2019
NMAC Biomedical HIV Prevention Summit
Houston, TX, USA
https://www.biomedicalhivsummit.org/
15 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 19, ISSUE 1: JUNE 2019HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 19, ISSUE 1: JUNE 2019 16
Seen Around the
HVTN
Dr. Larry Corey (HVTN PI) being interviewed by the South Zoe Moodie (SCHARP) being interviewed by Malawi News
African Broadcasting Corporation (SABC) during HIVR4P during HIVR4P Conference in Madrid, Spain, October 2018
Conference in Madrid, Spain, October 2018
HVTN RAMP Scholar Shay Behrens (Duke University School of Medicine) presenting her poster on bnAb lineage at the HIVR4P Conference
in Madrid, Spain, October 2018
17 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 19, ISSUE 1: JUNE 2019UNIDEC Recruitment and Retention Team: Daniel Alva,
Hugo Sanchez, Yolanda Vidal, and David Velasquez at
UNIDEC Participant Appreciation Dinner, November 2018
UNIDEC Counselor Miguel Morales and hostess Ariel in
vintage clothes at UNIDEC Participant Appreciation Dinner,
Hosts in vintage costume welcoming the attendees at November 2018
UNIDEC Participant Appreciation Dinner, November 2018
“Doctor Owl and his team”: (l to r) UNIDEC community educator Ruller Soto, Drag Langosta,
Hugo Sánchez, Dr. Buho, Juan Carlos Gomez, and Lenin Silva at UNIDEC Participant
Appreciation Dinner, November 2018
HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 19, ISSUE 1: JUNE 2019 18Seen Around the
HVTN
UNIDEC Patient advocate Jhonatan Zamor (r), event
coordinator Cristal del Castillo (center), and UNIDEC
volunteer Augusto Vallejos at UNIDEC Participant
Appreciation Dinner, November 2018
UNIDEC Retention Coordinator Daniel Alva and
even host Benjamin Marín at UNIDEC Participant
Appreciation Dinner, November 2018
UNIDEC Principal investigator Dr. Jorge Sanchez (left)
and performer Monique Pardo at UNIDEC Participant
Appreciation Dinner, November 2018
19 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 19, ISSUE 1: JUNE 2019Ceremonial masters and UNIDEC CER leads Daniel Alva and
Hugo Sanchez at UNIDEC Participant Appreciation Dinner,
November 2018
Drag Performer Georgia Hart at UNIDEC Participant
Appreciation Dinner, November 2018
Drag Performer Georgia Hart at UNIDEC Participant
Appreciation Dinner, November 2018
HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 19, ISSUE 1: JUNE 2019 20Special Feature
HVTN 505 Recap
By: Dr. Shelly Karuna- HVTN, Seattle, WA, USA, with contributions from the HVTN 505 Protocol Team
The phase 2b HVTN 505 study
(n=2,504) opened in May 2008 and
the final participant enrolled in
March 2013. The trial assessed the
safety and efficacy of a preventive
DNA/rAd5 HIV vaccine regimen
in MSM and transgender women
(TGW) who have sex with men
who were at risk for acquiring
HIV. It was HVTN’s first trial to
specifically include TGW, distinct
from MSM. Though by eligibility
criteria participants were required
to have been assigned male sex at
Table 1 | Baseline Demographics in HVTN 505 *SD = standard deviation.
birth, no required gender identity
was specified, and 44 participants 11% “other,” and 2% each as Asian retention factors such as stopping
did not identify as having a male or multi-racial. [Editor’s note: a vaccinations or dropping out of the
gender identity at study entry. statistic is defined as “significant” study. Trans and cis participants
These 44 identified their gender when the p value isTransgender participants said that
“a friend joined” as a reason to
enroll more often than cisgender
participants, which may prove
informative for future transgender
engagement & recruitment. Both
trans and cis individuals reported
participating primarily for
altruistic reasons.
Figure 1 | HIV Prevalence in Transgender People. Overall sample refers to the general US adult
There were no differences in population. Survey total and remaining circles refer to transgender respondents to the National
numbers of social harms or benefits. Transgender Discrimination Survey, 2015.
87% of participants reported
experiencing social benefits to trial In March 2011 the Institute of TG are, thus, among those most
participation. The most common Medicine (IOM) published a in need of an HIV vaccine. Yet,
benefit was feeling good about report of lesbian, gay, bisexual, TG experience increased rates
helping others, reported by 75% and transgender health in which of stigma, discrimination, and
of TG and 70% of CG participants. it was noted that transgender prejudice and these factors—
Other benefits included: receiving individuals (TG) in the US have alongside lower educational
risk reduction counseling (50% TG, increased risks of adverse health attainment and income,
42% CG); receiving medical care outcomes, generally. With respect employment discrimination risks,
(46% TG, 29% CG); and positive to HIV infection, specifically, and reduced social support—create
impacts on personal relationships prevalence and incidence rates significant barriers to HIV vaccine
(36% TG, 31% CG). are much higher among TG than trial participation.
among cisgender (CG) individuals,
New HIV infections were higher with prevalence among black TG Dr. Shelly Karuna is the Director of Clinical
approaching 25%. This is largely Development for the HVTN and the Protocol
among TG ppts. However, the
Team Leader for HVTN 505.
difference was not statistically attributed to complex relationships
significant, although there was between known predictors of HIV
limited power to detect a difference incidence such as sero-discordant
because of the small number of primary partners, unprotected anal
transgender participants who intercourse, sex work and drug use,
were enrolled (3 TG ppts or 4.3/100 as well as the interaction
person-yrs vs. 84 CG ppts or 2.1/100 of interpersonal, social, and
p-y; p=0.37). structural variables with
these predictors.
In conclusion, transgender and
cisgender participants at risk of
HIV can be successfully recruited
and retained, and contribute
meaningfully to HIV vaccine
clinical trials.
HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 19, ISSUE 1: JUNE 2019 22Special Feature
Fostering Transgender Inclusion in HIV Research
By: DAIDS Cross-Network Transgender Working Group
Transgender people face stigma sex they were assigned at birth. also provides multiple choices for
and discrimination in all aspects of Simply asking if someone is male responding, including options such
society--family, schools, workplace, or female fails to capture that as genderqueer, transgender man,
health care settings, housing, person’s identity as a transgender transgender woman, man, woman,
the criminal justice system, and or cisgender person. Furthermore, and gender non-conforming. We
more. The cumulative effects it completely excludes those who also recommend providing space
of these traumatic experiences don’t fit into one of the binary boxes for someone to write-in how they
often create fear and distrust of man or woman. Transgender identify, since there are many terms
among transgender people, and people represent an entirely distinct for gender identity, and they are
this may directly impact their population and experience unique always evolving. As an example, the
involvement in HIV research. epidemiological circumstances. 2015 U.S. Transgender Surveyi of
In order to successfully recruit, We now know that transgender nearly 28,000 individuals included
enroll, and retain transgender people—particularly transgender a list of gender identity terms;
individuals into our clinical women of color—are among the respondents could check all the
trials, it is important for research populations most vulnerable to terms that they used to describe
staff to develop some degree of HIV worldwide, and the factors themselves. In addition to the 26
understanding, knowledge and driving this are different from gender identity terms listed, the
humility. This is necessary across those affecting cisgender women respondents wrote in more than
all the NIH-funded HIV/AIDS and men of all sexual orientations. 500 unique terms with which
clinical trials networks and can To miscategorize transgender they identified. No one identifies
help ensure that the mistreatment people is not only disrespectful as “other,” nor should we ask
and discrimination that are already and discriminatory, it’s just bad them to.
part of the transgender experience science. Without accurate scientific
are not perpetuated in the clinical information about transgender
research setting. To address these people, it’s difficult to fully
issues, the Division of AIDS (DAIDS) assess HIV treatment and
established the Cross-Network prevention interventions for
Transgender Working Group transgender communities.
(CNTWG) in 2015. The group’s
goals are to foster coordination, After reviewing data collection
collaboration and an exchange of forms across the networks and
information related to transgender looking at best practices from
issues across the networks. The organizations such as the Center
Working Group has members of Excellence for Transgender
representing each of the networks Health, the CNTWG recommended
and DAIDS and meets quarterly. the standard use of the two-step
method, which as the name implies,
Data collection was the first issue asks people to describe themselves
This is an example of the two-step method
the CNTWG addressed, recognizing in two ways: their gender identity with the gender options listed alphabetically
that the research networks were not and the sex they were assigned to avoid the perception that they’re listed in
regularly collecting information at birth. By separating gender any form of hierarchy. Intersex was also added
to the question about sex assigned at birth.
about study participants’ gender identity from sex assigned at birth, While people are not necessarily assigned
identity in a unified, systematic, study participants can accurately intersex at birth, and some intersex conditions
and affirming manner. By failing describe who they are, and aren’t identified until later in life, an additional
category is available in some states in the U.S.
to collect information about researchers can correctly categorize
so that people can change their birth certificate
gender identity, we do two things: transgender participants who might to reflect their intersex or non-binary status.
we compromise the validity of otherwise be missed (for example,
the research, and we perpetuate a participant who indicates she is
discrimination against people a woman but was assigned male
whose gender does not match the at birth). The two-step method
23 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 19, ISSUE 1: JUNE 2019The HIV Vaccine Trials Network
(HVTN) was at the forefront
regarding data collection, having
revised its Demographic Case
Report Forms in 2009 to adopt
the two-step method. Using the
HVTN form as a model, the DAIDS
CNTWG developed a template to
share with the other networks and
recommended its use for all studies.
Given the unique needs of each
network, not all the case report
forms are identical but overall, the
two-step method is now a regular
part of the data collection process.
However, DAIDS and the networks “An Introduction to Transgender Communities” and “HIV in Transgender Communities” are both
acknowledge that there may be available on the DAIDS Learning Portal.
specific reasons not to ask about areas to help build the capacity HIV Research Environment; 4)
gender identity. For instance, in of all site and network staff. Input Clinical Considerations and HIV
some regions of the world, gender and guidance from subject matter Risk Assessments for Transgender
identity disclosure could result experts, including transgender Research Participants; and 5)
in harm to the participant due to and gender non-conforming Trauma-Informed Care for
significant discrimination, stigma, people, advocates, researchers, Transgender Research Participants.
or criminalization. Therefore, and site staff, were solicited to
exceptions can and should be further identify, design, develop, To date, each module has been
made for not asking about gender and review the training content. presented at one or more of the
identity, but there should be a clear Their experiences and perspectives annual network meetings. Each
rationale as to why this is being were essential to the process and one was very well received and
done. The two-step method helps ensured that a variety of key issues generated thoughtful discussion.
acknowledge participants for who were appropriately addressed. The We found that having at least
they are and helps ensure that the specific content of each module was one transgender presenter was
information collected is accurate. then pilot tested during training extremely valuable, as their personal
In the context of HIV research, sessions at the annual network stories and experiences helped
this allows us to better understand meetings of each of the five DAIDS bring the material to life. Attendees
the impact of HIV vaccines, other clinical trials networks. The idea of the training represented a
prevention strategies, and treatment was to test the content to make sure cross-section of our networks
on transgender communities. that it was relevant and clear before and sites, including community
pursuing the costlier development advisory board members, clinicians,
The CNTWG also recognized that of web-based training tools, community educators/recruiters,
in order to foster a welcoming which were needed to reach staff data managers, study coordinators,
and affirming environment for throughout the research enterprise. laboratory and regulatory staff, as
transgender participants, staff well as staff from DAIDS – all of
needed more educational tools. The five modules that were whom are the intended users of
While some materials exist, the developed as part of the overall the final training tools. While the
Working Group felt that they weren’t Transgender Training Curriculum training modules were developed
always applicable to the research for HIV Research include: 1) An with a strong U.S. focus, training
setting. The group decided to create Introduction to Transgender attendees from outside of the U.S.
a comprehensive transgender Communities; 2) HIV in felt that the content was relevant,
training curriculum and identified Transgender Communities; 3) valuable, and globally applicable.
five of the most important content Creating a Gender-Affirming Continued on Next Page...
HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 19, ISSUE 1: JUNE 2019 24The process used to develop the
content, which involved ongoing
review and input by a transgender-
inclusive and diverse group of
subject matter experts, was essential
to the success of the final training
curriculum. Having the input
and experience of the subject
matter experts helped ensure the
accuracy, sensitivity, and cultural
responsiveness described in the
curriculum itself. The first two
modules are already available as
web-based training tools, and the To access the transgender training modules and related material go to the DAIDS Learning Portal at
https://daidslearningportal.niaid.nih.gov/
remaining modules should be
available in the coming months. It Training Support Team”). Simply Cisgender describes someone
is hoped that they will help reduce note that you are interested in the whose gender identity matches the
the misinformation and lack of transgender training modules. sex they were assigned at birth. This
understanding that perpetuate In addition to the web-based term comes from chemistry, where
the misgendering, stigma, training tool, you will also have “cis” means “same.”
mistreatment, and trauma too often access to the in-person training
experienced by transgender people. materials, including a PowerPoint Transgender or trans describes
Cultivating awareness, knowledge presentation, facilitator’s guide, and a person whose gender identity
and understanding of transgender any hand-outs such as exercises, differs from their sex assigned
communities is a vital step in answer keys, and a listing of at birth, and it is defined by the
providing transgender-affirming resources and publications. person’s present identity. As an
care and services, and in supporting example, a transgender woman is
transgender inclusion in HIV Sidebar: Selected someone who currently identifies
vaccine, prevention, and Definitions as a woman but was assigned male
treatment research. at birth. In the US, transgender
Sex is typically considered to be can also be used as an “umbrella”
Sidebar: Transgender our anatomy as female or male. term to encompass the other
Training Curriculum for It includes our internal and gender identities.
HIV Research: external sex organs, chromosomes,
and hormones. Gender Non-Conforming refers to
Two of the five training modules a person whose gender expression
– An Introduction to Transgender Sex Assigned at Birth is determined is not consistent with the societal
Communities and HIV in when a health care provider or cultural norms expected of that
Transgender Communities are inspects a baby’s genitalia; the gender. People who are gender non-
currently available to the public infant’s sex is assigned, without conforming do not follow other
on the DAIDS Learning Portal at the expectation of ambiguity. peoples’ ideas or stereotypes about
https://daidslearningportal.niaid. how they should look or act based
nih.gov/ Gender is the social construct on the female or male sex they were
of being a man, woman, neither, assigned at birth.
Anyone affiliated with a or both, and can vary by culture.
site, including community Genderqueer is used to describe
representatives, can get an account Gender Identity is a person’s people who don’t identify as a man
by clicking on “request an account” internal sense of their gender. It’s or a woman; they do not subscribe
and providing your site number how we identify themselves. We to conventional gender distinctions.
(available from your site) and may identify as a man, woman, as It may also be considered a catch-
other relevant information. For neither, or as non-binary – which all term for gender identities other
people who are not affiliated with describes any identity that doesn’t than man and woman, thus outside
a site or network, you can request fit neatly into the categories of the gender binary. It can also be
an account using the link at the a term that separates someone from
of man or woman.
bottom of the page (“Contact DAIDS the heteronormative majority.
25 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 19, ISSUE 1: JUNE 2019You can also read
