Integrating HIV Treatment with Gender-Affirming Care
In our pursuit of health equity, it's critical to focus on the specific needs of transgender people living with HIV, particularly regarding the safe and effective use of antiretroviral therapy (ART) alongside gender-affirming hormone therapy (GAHT). A groundbreaking study conducted by Thomas Jefferson University and the National Institutes of Health (NIH) has significantly advanced our understanding of ART with GAHT for transgender people, specifically women, living with HIV. This research, a direct response to the previously identified gaps in knowledge, offers concrete evidence on the safety of such co-administration, marking a shift in how healthcare providers can approach treatment plans for their transgender patients.
Until now, the apprehension to combine ART and GAHT has led a significant portion of the community to modify their treatment regimens due to fears of adverse interactions. A 2017 study in LGBT Health reveals the depth of this issue, noting that among study participants 40% reported not taking ART (12%), GAHT (12%), or both (16%) as directed due to drug-drug interaction (DDI) concerns. The recent study, published in Clinical and Translational Science, directly addresses these concerns by analyzing the pharmacokinetic interactions of doravirine, tenofovir (key components of ART), and estradiol (a common estrogen used in GAHT). The findings reveal that these medications, when used together, do not significantly impact each other's effectiveness, providing a much-needed evidence base to support the concurrent use of ART and GAHT.
For transgender women living with HIV, the integration of ART and GAHT is essential not only for managing their HIV status but also for affirming their gender identity. This aspect of their healthcare journey underscores the need for clear, evidence-based guidelines that address the co-administration of these treatments without compromising their efficacy or safety. The recent study's findings mark a significant advancement in our understanding, challenging previous assumptions about potential DDIs.
Safety of Co-administration
The study, "Bidirectional pharmacokinetics of doravirine, tenofovir, and feminizing hormones in transgender women (IDentify): A randomized crossover trial," examines the pharmacokinetic parameters—essentially, how the body absorbs, distributes, metabolizes, and excretes a drug—of doravirine and tenofovir (two key antiretroviral medications) when administered alongside estradiol, a common estrogen used in GAHT.
The findings are significant: the co-administration of these ART medications with estradiol does not significantly alter the effectiveness of each drug. Specifically, the study observed that the levels of doravirine, tenofovir, and estradiol remained stable when used together, indicating that these medications can be safely combined without diminishing their ability to treat HIV or support gender transition.
This research addresses a critical gap in healthcare for transgender women living with HIV, who have historically faced uncertainty about combining ART with GAHT. By demonstrating that these medications do not interfere with one another to a clinically significant degree, the study reassures patients and healthcare providers alike that pursuing both HIV treatment and gender affirmation simultaneously is both safe and viable.
Furthermore, this study lays the groundwork for more informed healthcare practices. It underscores the importance of considering the unique needs of transgender people in HIV treatment plans and encourages ongoing research to explore the interactions between various ART and GAHT regimens. Ultimately, this evidence supports the development of comprehensive care models that fully address the health and well-being of transgender women living with HIV, ensuring they receive effective, affirming care without compromise.
Advancing Guidelines and Communication for Integrated Care
For providers, this new data addresses the concerns expressed in a prior literature review in the Journal of the International AIDS Society, which noted the "insufficient data to address DDIs between ART and feminizing hormone regimens." Now, with fresh insights available, the emphasis can shift to using this updated information to craft and apply comprehensive guidelines and to kickstart education campaigns for providers and the community that align with these new findings.
The urgency now is to convert this research into practical, accessible guidelines that assist healthcare providers and transgender women in navigating the safe use of ART alongside GAHT. It's critical to update healthcare providers with the latest evidence, ensuring they are well-equipped to guide their patients through informed treatment choices. This means integrating new research findings into professional development programs and encouraging open, knowledgeable conversations between healthcare professionals and their patients about the combined use of these treatments.
Expanding the Scope: Inclusive Research for Transgender Men and Non-Binary People
While significant strides have been made in understanding the co-administration of antiretroviral therapy (ART) and gender-affirming hormone therapy (GAHT) for transgender women, our knowledge remains limited when it comes to transgender men and non-binary people living with HIV and seeking gender affirming care. With the completion of this major study by Thomas Jefferson University and the NIH, the next step is to expand our research efforts to encompass the full spectrum of transgender experiences, ensuring that future studies are as inclusive and comprehensive as possible.
Transgender men and non-binary people face unique healthcare challenges that are often overlooked in medical research. This oversight not only perpetuates health disparities but also leaves significant gaps in our understanding of how ART interacts with testosterone and other aspects of gender-affirming care utilized by transgender men and non-binary people. To ensure that all members of the transgender community receive comprehensive and affirming care, it is imperative that future studies specifically investigate these interactions.
The call for research extends beyond the pharmacokinetic interactions to encompass the physiological, psychological, and social outcomes of combining HIV treatment with gender-affirming care across all gender identities. Such studies should aim to provide a holistic understanding of treatment efficacy, safety, and the overall well-being of gender diverse patients, regardless of their specific gender identity or the nature of their gender-affirming treatments.
By advocating for and conducting research that includes transgender men and non-binary people, we can move towards a healthcare model that truly embraces diversity and inclusivity. This approach not only enriches our collective knowledge but also ensures that healthcare practices and guidelines are reflective of the needs of the entire transgender community. It is through this comprehensive understanding that we can improve care, enhance treatment adherence, and ultimately support the health and well-being of all transgender people living with HIV.
Mobilizing for Inclusive Healthcare Reform
The recent advancements in understanding the co-administration of antiretroviral therapy (ART) and gender-affirming hormone therapy (GAHT) represent a significant step forward. However, the journey towards fully supporting the health and well-being of all transgender people living with HIV continues. We must intensify our efforts in advocacy, education, and policy reform to ensure equitable treatment for everyone. Here's how different stakeholders can contribute:
For Healthcare Providers:
Educate Yourself: Actively seek out and participate in continuing medical education (CME) opportunities focused on the latest research in ART and GAHT co-administration. Utilize resources from reputable organizations such as the World Professional Association for Transgender Health (WPATH) and the Centers for Disease Control and Prevention (CDC).
Practice Inclusive Care: Implement guidelines and practices in your clinical setting that respect and address the unique needs of transgender patients. Ensure that your staff is trained in cultural competency regarding transgender health issues.
For Researchers:
Fill the Research Gaps: Prioritize studies that explore the long-term health implications of ART and GAHT co-administration, especially for underrepresented groups within the transgender community, such as transgender men and non-binary people.
Collaborate with the Community: Engage with transgender communities to ensure that research is inclusive, relevant, and respectful. Consider community-based participatory research (CBPR) approaches to involve community members in the research process.
For Policymakers:
Develop Evidence-Based Guidelines: Work with medical experts and advocates to create and enforce guidelines that facilitate the safe co-administration of HIV medications and gender-affirming therapies. These guidelines should be based on the latest research and best practices.
Support Access to Care: Advocate for policies that remove barriers to accessing both HIV treatment and gender-affirming care. This includes ensuring coverage by insurance providers and addressing legal and systemic obstacles that transgender people face.
For Advocates and Community Leaders:
Raise Awareness: Use your platforms to disseminate accurate information about the safety and importance of integrating ART with GAHT. Highlight stories and data that underscore the positive impact of affirming care.
Mobilize Support: Organize campaigns to advocate for improved healthcare policies, increased research funding, and greater awareness of transgender health needs. Collaborate with healthcare providers, researchers, and policymakers to amplify your efforts.
Together, we can bridge the gaps in care and knowledge, creating a future where every transgender person living with HIV has access to the treatments they need, free from stigma and barriers. Let's commit to a healthcare environment that celebrates diversity, champions inclusivity, and ensures comprehensive care for all.
Of Pride and Prejudice: Biden Administration Combats State Discriminatory Actions
Fairly regularly, our CANN Blog tends to highlight impacts of various public health actions as they relate to LGBTQIA+ populations because these communities are disproportionately impacted by a variety of social determinants of health as found in the 2015 United States Transgender Survey, conducted and published by the National Center for Transgender Equality (NCTE). It’s important to note, NCTE will be launching data gathering efforts later this year to provide updated data. Public health programs have long been leveraged to either help or harm (often via neglect of data pointing toward broader protections and specific programming) trans and non-binary people, depending on the ideological lean of the administration issuing regulations and rules, both on the federal and state levels.
2022 has been particularly challenging for transgender youth. We’ve witnessed state legislatures and governors through administrative agencies have sought to limit access to gender-affirming care. There remains deep community concern, despite some governors vetoing sports and health care related bills, judges regularly ruling against these actions, a lack of clear political support, and commitments from the Biden Administration to defend the rights of transgender people. These actions, however, aren’t just limited to transgender youth. Florida, for example, is currently proposing a rule that would prohibit the state’s Medicaid program from covering gender-affirming care for anyone, again, despite similar rules and laws having been struck down as recently as November 2021. (Editor’s Note: Florida’s rule, by the way, is open to public comment through July 8th.) Advocates for equitable access to care in public health programs and concerned on issues of health equity should readily take the time to comment. Public comment on state and federal rulemaking is a key element for policy engagement and can sometimes be used to reflect bad faith efforts on the part of these regulatory agencies, as was seen when Kentucky’s Medicaid work requirement waiver was initially squashed for failing to adequately address concerns raised in public comments.
In response to these moves, the Biden Administration has issued new executive orders including directing various agencies to assess more appropriate data gathering of sexual orientation and gender identity (SOGI) data of people participating in federally funded programs. Additionally, Biden has directed federal agencies to review existing data for information on when LGBTQIA+ youth and parents are separated from their families in child welfare matters, and issue rules to both define discrimination and protect LGBTQIA+ people from discrimination in federally funded programs. Indeed, on June 23rd, the U.S. Department of Education released a proposed rule that would extend certain protections for transgender students and seeks to further protect sexual assault and harassment victims in educational settings. An additional rule is expected later this year which would provide guidance on integrating transgender youth into school sports. We’re also still awaiting – any day now – the U.S. Department of Health and Human Services issue a new proposed rule regarding the Affordable Care Act’s non-discrimination provision known as Section 1557. The Trump Administration sought to narrowly define these protections in 2020, but it was blocked shortly after the U.S. Supreme Court issued its decision in Bostock v. Clayton County when a federal judge ruled against the Trump Administration after noted health clinic Whitman Walker sued to stop the discriminatory rule from going into effect.
These state efforts are aimed at finding “carve outs” to the precedents and rules protecting transgender people from stigma, violence, and discrimination merely as a political tactic. But just because this population is being used as a political football, doesn’t mean there aren’t severe public health consequences, some which may reach beyond the issue of gender identity. “Trans health is the canary in the coal mine,” a long-time advocate, Riley Johnson, said to me when discussing Florida’s effort to limit access to gender affirming care in its Medicaid program. “Once they can redefine ‘medically necessary’ to mean whatever they want it to mean, despite standards of care, every legitimate medical association, and decades of data, who’s to say they don’t decide to re-define ‘medical necessity’ for people living with HIV or STIs or hepatitis C, and return us to the days of moralistic ‘you did this to yourself’ or ‘it’s a choice’.” Johnson continued, “It’s real easy to look at substance users and decide their care doesn’t matter when we’re looking for reasons to justify the cruelty of denying people life-saving care.”
Johnson is correct in highlighting how bias-driven rulemaking affecting public health programs turns into a slippery slope. Experienced advocates should be mindful of intersecting issues of public health and encourage those budding advocates to take advantage of these…interesting times to build their knowledge, engage in policy development and evaluation processes, and invest in strengthening the public health advocate pipeline.