Addressing Transgender Erasure in HIV Clinical Trials: The Scorecard for Transgender and Gender-Diverse Inclusion

Area of Science:

• Public Health
• Clinical Trials
• Health Equity

Background:

• Transgender and gender-diverse (TGD) individuals face unique health challenges, including a disproportionately high burden of HIV.
• Inclusion of TGD populations in clinical trials is crucial for developing effective, tailored HIV prevention and treatment strategies.
• Historical underrepresentation of TGD people in research contributes to health disparities.

Purpose of the Study:

• To develop a structured framework and actionable criteria for evaluating and improving TGD inclusion in HIV clinical trials.
• To quantify and characterize the extent of TGD inclusion in pivotal HIV studies.
• To highlight the need for TGD-responsive HIV research.

Main Methods:

• A scorecard with 14 indicators for TGD-responsive HIV research was developed with input from global TGD communities.
• A cross-sectional review of 41 randomized controlled HIV biomedical efficacy trials (1991-2023) was conducted.
• The scorecard was used to assess TGD responsiveness in selected HIV clinical trials.

Main Results:

• Transgender and gender-diverse individuals constituted only 1.4% (2532 of 178,893) of participants in the reviewed HIV clinical trials.
• The scorecard revealed a significant lack of HIV research responsive to the needs of TGD communities.
• This underrepresentation suggests historical erasure and potential public health consequences.

Conclusions:

• The current inclusion of TGD individuals in HIV clinical trials is critically low.
• A developed scorecard can guide future HIV research to be more inclusive and responsive to TGD community needs.
• Addressing TGD underrepresentation is essential for health equity and effective HIV public health strategies.