New Studies Look at PrEP for Trans People

The California HIV/AIDS Research Program has announced that it has funded three new demonstration projects - including two in the Bay Area - to learn more about PrEP for transgender women and men.

"These studies will provide critical information on the implementation of PrEP among transgender people in California, and will help guide state and national efforts to address the epidemic in this often neglected population at high risk for HIV," said CHRP director Dr. George Lemp.

The announcement was made last week.

Transgender women have among the highest rates of HIV infection. One recent meta-analysis found that 22 percent of trans women in the U.S. are HIV-positive. Little is known about HIV rates among trans men, with estimates ranging from 0 to 8 percent.

Transgender populations - and especially trans women of color - face a number of HIV prevention challenges and may have additional barriers to PrEP adherence, including sociocultural, economic, and health-related factors.

"We have some science-based hunches" about lower PrEP adherence among trans women, Dr. Madeline Deutsch of UCSF's Center for Excellence in Transgender Health told the Bay Area Reporter . "We think transgender women do not respond to social marketing designed for men, are more disenfranchised and disconnected from health care in general, and prioritize hormone therapy and are concerned about interactions with PrEP."

Gilead Sciences' Truvada (tenofovir/emtricitabine) was approved for HIV prevention in July 2012, but so far its uptake has been greatest among gay and bisexual men.

The international iPrEx study, which enrolled about 2,500 men and transgender women who have sex with men, found that once-daily Truvada reduced the risk of HIV infection by 44 percent overall, rising to 92 percent for those with measurable blood drug levels. In an open-label extension of iPrEx, no one who took Truvada at least four times a week became infected.

A more detailed analysis of the 339 trans women in iPrEx showed that they were less likely than gay men to take Truvada regularly, but those who did appeared to be protected.

"While this analysis did not include a large enough sample group to draw firm conclusions, we did find strong evidence pointing to efficacy," senior investigator Dr. Robert Grant from the UCSF Gladstone Institutes told the B.A.R. when that analysis was published last December. "Additional research designed specifically for transgender women is needed to confirm this finding."

Three teams funded

The new demonstration projects are intended to do just that.

One team, which will receive $2.9 million over four years, is a collaboration between UCSF, the Gladstone Institutes, the Gender Health Center in Sacramento, and La Clinica de la Raza in Oakland.

This team will develop a demonstration project for trans women of color dubbed TRIUMPH (Trans Research-Informed Communities United in Mobilization for the Prevention of HIV). The program involves community-led efforts to increase knowledge and acceptability of PrEP, using advocates from within trans communities and trans-specific educational materials. To improve drug adherence, the project will feature peer-led health workshops and one-on-one counseling sessions.

The other Bay Area team - with a four-year budget of $2.6 million - includes the San Francisco Department of Public Health, Tom Waddell Urban Health Center, Castro Mission Health Center, and Asian Pacific Islander Wellness Center, along with the Tri-City Health Center in Fremont.

This team will use a patient-centered "medical home" approach to develop a comprehensive PrEP education, access, and support package for trans women and men.
Project investigator Dr. Albert Liu Photo: Liz Highleyman

"To date, PrEP has largely been framed as an HIV prevention tool for gay men," lead project investigator Dr. Albert Liu from the DPH told the B.A.R. "Our project will partner with four Bay Area clinics highly experienced in delivering transgender care and integrate PrEP provision into transgender services. Through the San Francisco DPH's Transgender Advisory Group, we will work closely with the transgender community in developing and implementing all phases of this project."

The team will develop a trans-specific social marketing campaign and online education to increase knowledge about PrEP, as well as a sexual risk assessment tool, peer navigators, and adherence reminders delivered via text messaging.

"The transgender community's HIV risk is 49 times greater than the general population, but so often transgender people are an afterthought in HIV prevention," co-investigator Dr. Tri Do of the API Wellness Center told the B.A.R. "We hope to show that PrEP delivery is most successful when medical care and HIV prevention are provided in the context of safe, trusted community spaces like API Wellness Center and its Trans: Thrive program."

Finally, the third team - with a $3.75 million budget - is a collaboration between the UC San Diego School of Medicine, the Los Angeles LGBT Center, Family Health Centers of San Diego, the University of Southern California, and Harbor-UCLA Medical Center.

These researchers will evaluate whether a trans-focused case management approach to contextualize PrEP within the needs of the whole person can improve engagement with and adherence to PrEP.

All three teams will look at potential drug interactions between PrEP and gender-affirming hormone therapy. The UCSF project will include a pharmacokinetic drug interaction study, while the UCSD team will evaluate whether protective PrEP drug levels are reached in trans women on hormonal therapy and if PrEP is associated with any changes in hormone levels.

"Our overarching goal is to really determine the best practices for engaging trans women with PrEP and getting trans people to say 'PrEP is for me if I'm at risk for HIV,'" said Deutsch, who is a co-principal investigator for the UCSF project. "We not only need to get 165 trans people to take PrEP at sites in Oakland and Sacramento, but also get them to tell two friends - the way the gay community has promoted PrEP."