October 8, 2025
By Cindra Feuer and Brian Minalga
Not even a week after the American Journal of Public Health published our paper entitled, Addressing Transgender Erasure in HIV Clinical Trials: The Scorecard for Transgender and Gender-Diverse Inclusion, the US National Institutes of Health (NIH) moved to prohibit scientists from collecting data about gender, according to draft policy reported in the Chronicle of Higher Education.
It’s one of the latest blows from the Trump Administration’s anti-science antipathy for trans and gender diverse (TGD) people. Starting on his first day in office, Trump himself proclaimed, by executive order, federal recognition of only two, unchangeable, biological sexes determined at birth. And thus, he halted diversity programs. His administration has also sought to end gender-affirming medical care–deeming it chemical and surgical mutilation—while trying to prohibit changes to gender in national passports, among other moves to obliterate trans visibility.
Most glaring is the administration’s termination of more than 1,000 US NIH grants on lesbian, gay, bisexual, trans and queer (LGBTQ) health, according to the database Grant Witness. The New York Times estimates that together these grants are worth more than $800 million. More broadly, the US Supreme Court, in a 5-4 decision on August 21, sided with the Trump Administration and allowed some $783 million in cuts to NIH grants related to diversity, equity and inclusion.
Trump’s timing slaps up against a swelling undercurrent of trans resiliency, which was just starting to pay off in the field of HIV research after decades of neglect. The AJPH paper is the first cross-sectional review of trans participation in HIV clinical trials, which charts the movement from TGD invisibility to the recent uptick of inclusion. The key takeaway: a mere 1 percent (2,532 out of 178,893) of trial participants identified as TGD, between 1991-2023, in 41 milestone studies (table 1, page 4).
The first study to report TGD enrollment was the iPrEx PrEP trial in 2007, with TGD representation continuing to increase over time. However, more than two thirds of studies conducted since 2007 still failed to account for TGD participation, including studies implemented as recently as 2020. This despite evidence that no community is in greater need of HIV prevention than TGD populations. According to the most recent data from UNAIDS, the median HIV prevalence of TGD communities, among reporting countries, is 8.5 percent. The next highest is among gay men, at 7.6 percent. Data by region can show astounding prevalence in some communities, as high as 50 percent, indicating extreme levels of unmet need for HIV prevention.
This urgent need for inclusion can be advanced by attention to critical indicators, outlined in the HIV Research Scorecard for Trans and Gender Diverse Inclusivity (Figure 1, page e3), a twin-purpose tool to both guide study design and provide metrics for TGD-inclusive research. The scorecard, informed by global TGD advocates and their contributions to the Trans Manifesto: No Data No More, assesses 14 indicators under four primary areas for inclusion: study design; study implementation; study reporting; and language. As an example, within trial design, it asks if eligibility criteria explicitly include gender-nonbinary individuals, and transgender men and women. If they are not included, is their exclusion explicitly justified? Are measurable goals for the enrollment of TGD participants set forth? Is gender-affirming hormone use accounted for as a variable?
Other indicators ask if data collection captures TGD HIV status, if TGD inclusion in a study is made explicit in published findings, and if TGD participation is in alignment with best practices, such as DAIDS’ data collection recommendations. Similarly, the scorecard grades whether language related to study documents, outreach materials and communications adheres to best practices in gender-inclusive language as outlined in NIAID’s HIV Language Guide.
The scorecard’s continued use could lead to much needed and long overdue equitable representation of TGD people in HIV research. Researchers can and should use the scorecard when designing and implementing trials, and advocates must use it to hold them accountable when they do not. It’s a purpose-built tool for ensuring greater inclusivity in these challenging times.
But the inclusion of TGD populations in research relies on the very language the US administration is trying to erase, with the latest policy attack aimed at NIH research. According to the Chronicle, researchers inside and outside the agency “shall not use NIH funds to request, collect, or disseminate information related to gender…” unless that, data on sex reflects Trump’s flawed view that there are only two sexes.
To measure only sex and not gender jeopardizes scientific accuracy and equity, especially against a global backdrop where TGD communities are among the most stigmatized people. TGD communities struggle to access care, resulting in a staggering unmet need for prevention.
As we lay out in our article, “the lack of TGD representation in HIV clinical trials indicates a historical erasure of TGD communities with potential public health consequences.” These consequences are indeed grave; they result in missing data, poor access to newly proven options, a research and development pipeline that is not built to reach those who need it most, and a stalled HIV response at large, with countless lives needlessly left exposed to virus and disease.
This is not the time to scrub TGD inclusion from HIV trial designs and protocols, regardless of attacks and misguided fury aimed at our communities. In fact, now is the moment to use everything at our disposal, including the new scorecard, to set in motion an era of HIV research that meaningfully responds to TGD needs.