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

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 fra...

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Publicado en:American Journal of Public Health Vol. 115; no. 10; pp. 1621 - 1631
Autores principales: Minalga, Brian, Feuer, Cindra
Formato: Artículo
Publicado: American Public Health Association Oct2025
Materias:
Acceso en línea:Ver este registro en EBSCOhost
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      dt: Oct2025
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      pub: American Public Health Association
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        10.2105/AJPH.2025.308134
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        atl: Addressing Transgender Erasure in HIV Clinical Trials: The Scorecard for Transgender and Gender-Diverse Inclusion.
      aug:
        au:
          Minalga, Brian
          Feuer, Cindra
        affil:
          Office of HIV/AIDS Network Coordination, Fred Hutchinson Cancer Center, Seattle, WA.
          AVAC, New York, NY.
      su:
        Health services accessibility
        Gender-nonconforming people
        Trans men
        Self-evaluation
        Gender identity
        Human research subjects
        Clinical trials
        Gender-neutral language
        Trans women
        HIV prevention
        Patient selection
        Diversity & inclusion policies
        Research funding
        Gender affirming care
        Descriptive statistics
        Experimental design
        Eligibility (Social aspects)
        Hormone therapy
      sug:
        subj:
          Health services accessibility
          Gender-nonconforming people
          Trans men
          Self-evaluation
          Gender identity
          Human research subjects
          Clinical trials
          Gender-neutral language
          Trans women
          Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
          HIV prevention
          Patient selection
          Diversity & inclusion policies
          Research funding
          Gender affirming care
          Descriptive statistics
          Experimental design
          Eligibility (Social aspects)
          Hormone therapy
      ab: 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.
      pubtype: Academic Journal
      doctype: Article
      src: R
    language: English
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