P105: GeDI System: A Novel Snapshot of Gender Literacy in PrEP Clinical Trials from 2014 - 2025
Poster Presenter
Jeremiah Lee
Research Ambassador
University of Southern California United States
Objectives
To develop and use a tool for evaluating clinical trial eligibility criteria for gender literacy or the recognition that biological ‘sex’ is distinct from personally defined ‘gender’ as a method of quantifying the inclusion of gender minority populations in PrEP clinical research.
Method
Inclusion and exclusion criteria for PrEP trials in active recruitment was downloaded from clinicaltrials.gov. Extracted data will be evaluated for gender literacy based on a validated assessment scale and recruited demographics will be analyzed for patterns through JMP software.
Results
This study is a continuation review of active Pre-Exposure Prophylaxis (PrEP) for Human Immunodeficiency Virus (HIV) clinical trials from December 2014 to April 2025. A newly restructured and revalidated rubric for clinical trial recruitment demographics, the GeDI or Gender Diversity System was developed to assess clinical trial eligibility criteria regarding inclusive language. It does so by granting a score based on the language referring to gender identity. The lowest ranking of C is for trials with no mention of gender identity. Mid-tier ranking of B is for trials that vaguely refer to gender identity but are not specific or clear. Finally, the top tier ranking of A is for trials that specify gender identity with terms like “cisgender” or “transgender.” These rankings are paired with specific recommendations to encourage improved gender literacy.
From the initial study, PrEP trials utilized gender literate language (A rank) in 48% of trials and gender illiterate language (B and C rank) in 52% of trials. This pattern will likely be observed again due to the lack of enforceable regulations around sex and gender eligibility criteria. Since sponsors and sites have the liberty to develop their protocols as they see fit, eligibility criteria often reflect their perceptions of sex and gender. Some trials recognize gender identity and actively recruit gender-diverse populations. However, a vast majority of trials fail to consider gender identity and instead only opt for sex eligibility.
It is predicted that data trends and patterns will be like those found initially. By using a new and fully validated assessment scale, we may discover some new observations. PrEP trials might feature similar rates of gender literate language, but the demographics that are being recruited may have shifted. Instead of a majority of trials recruiting cisgender males, a greater proportion of trials recruiting cisgender females or transgender women might be uncovered.
Conclusion
Transgender and gender-diverse (TGD) individuals are at a disproportionately higher risk for HIV acquisition, compared to their cisgender counterparts. Though this demographic would benefit from recruitment in PrEP clinical research, they comprise only a tiny fraction of published clinical data. Insufficient clinical data on TGD communities perpetuates medical mistrust and distrust in PrEP’s safety and efficacy, exacerbating negative health outcomes like HIV acquisition and disease progression. Industry often blames the small numerical size of the TGD population for low recruitment, but this project demonstrates that recruitment practices like exclusionary eligibility criteria play a big role in trial participation.
Current regulations leave trial design to the discretion of trial sponsors and clinical sites, resulting in the usage of unclear and often cisgenderist language. By using terms that assume a gender binary or refusing to collect gender identity from participants, trials foster an unwelcoming environment. This discourages transgender enrollment since failure to recognize gender identity foreshadows non-affirming care like misgendering, deadnaming, or aggregation of transgender individuals by biological sex. To improve clinical representation, eligibility criteria of sex and gender must be better regulated and harmonized, validating a participant’s right to self-determination of gender identity. The GeDI system is one way for trial designers, clinicians, and industry stakeholders to understand how to formulate trans-affirming eligibility criteria.
By capturing the numerical inclusion of TGD populations and rates of gender literacy in PrEP clinical research, this investigation identifies the gaps in research and the steps to bridge them. Especially in PrEP research that desperately needs TGD visibility, the observations of this project and the new assessment scale initiate conversations to improve recruitment practices for this population.
