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

IF 9.6 1区医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH

American journal of public health Pub Date : 2025-08-07 DOI:10.2105/ajph.2025.308134

Brian Minalga,Cindra Feuer

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Abstract

We sought to offer a structured framework for evaluating transgender and gender-diverse (TGD) inclusion in HIV clinical trials, with actionable criteria for trial design and conduct, and to quantify and characterize TGD inclusion in pivotal HIV studies as supporting evidence of the need for this framework. We devised a tool (scorecard) consisting of 14 scoreable indicators for TGD-responsive HIV research with input from global TGD communities. We tested the scorecard in a cross-sectional review of 41 randomized controlled HIV biomedical efficacy trials to measure TGD responsiveness. Studies were selected to represent the spectrum of groundbreaking HIV therapeutic and prevention studies enrolling participants in countries around the world from 1991 to 2023. We found that TGD individuals represent a reported 2532 (1.4%) of 178 893 participants in the selected HIV clinical trials. Scorecard indicators reveal a dearth of HIV research responsive to the needs of TGD communities. The lack of TGD representation in HIV clinical trials indicates a historical erasure of TGD communities with potential public health consequences. The scorecard might guide future HIV research to be more responsive to the needs of TGD people. (Am J Public Health. Published online ahead of print August 7, 2025:e1-e10. https://doi.org/10.2105/AJPH.2025.308134).

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解决艾滋病毒临床试验中的跨性别抹除：跨性别者和性别多元化包容的记分卡。

我们试图提供一个结构化的框架来评估跨性别和性别多样化（TGD）在HIV临床试验中的纳入情况，并为试验设计和实施提供可操作的标准，并量化和表征TGD在关键HIV研究中的纳入情况，作为需要该框架的支持证据。我们设计了一个工具（记分卡），由14个可评分指标组成，用于TGD应答性HIV研究，并得到了全球TGD社区的输入。我们在41项随机对照HIV生物医学疗效试验的横断面回顾中测试了记分卡，以测量TGD反应性。入选的研究代表了1991年至2023年在世界各国招募参与者的突破性艾滋病毒治疗和预防研究的范围。我们发现在选定的HIV临床试验中，TGD个体代表了17893名参与者中的2532名（1.4%）。记分卡指标显示，缺乏针对TGD社区需求的艾滋病毒研究。在HIV临床试验中缺乏TGD代表表明TGD社区的历史消失具有潜在的公共卫生后果。该计分卡可能会指导未来的艾滋病毒研究，以更好地响应TGD患者的需求。公共卫生。2025年8月7日在线出版：e1-e10。https://doi.org/10.2105/AJPH.2025.308134)。

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来源期刊

American journal of public health 医学-公共卫生、环境卫生与职业卫生

CiteScore

9.50

自引率

3.90%

发文量

1109

审稿时长

2-4 weeks

期刊介绍： The American Journal of Public Health (AJPH) is dedicated to publishing original work in research, research methods, and program evaluation within the field of public health. The journal's mission is to advance public health research, policy, practice, and education.