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

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Title: Addressing Transgender Erasure in HIV Clinical Trials: The Scorecard for Transgender and Gender-Diverse Inclusion.
Authors: Minalga, Brian, Feuer, Cindra
Source: American Journal of Public Health. Oct2025, Vol. 115 Issue 10, p1621-1630. 10p.
Subjects: HIV prevention, Patient selection, Health services accessibility, Gender-nonconforming people, Trans men, Self-evaluation, Diversity & inclusion policies, Gender identity, Research funding, Human research subjects, Clinical trials, Gender affirming care, Gender-neutral language, Descriptive statistics, Experimental design, Eligibility (Social aspects), Hormone therapy, Trans women
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. [ABSTRACT FROM AUTHOR]
Copyright of American Journal of Public Health is the property of American Public Health Association and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Psychology and Behavioral Sciences Collection
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  Data: Addressing Transgender Erasure in HIV Clinical Trials: The Scorecard for Transgender and Gender-Diverse Inclusion.
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  Data: <searchLink fieldCode="AR" term="%22Minalga%2C+Brian%22">Minalga, Brian</searchLink><br /><searchLink fieldCode="AR" term="%22Feuer%2C+Cindra%22">Feuer, Cindra</searchLink>
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  Data: <searchLink fieldCode="JN" term="%22American+Journal+of+Public+Health%22">American Journal of Public Health</searchLink>. Oct2025, Vol. 115 Issue 10, p1621-1630. 10p.
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  Data: <searchLink fieldCode="DE" term="%22HIV+prevention%22">HIV prevention</searchLink><br /><searchLink fieldCode="DE" term="%22Patient+selection%22">Patient selection</searchLink><br /><searchLink fieldCode="DE" term="%22Health+services+accessibility%22">Health services accessibility</searchLink><br /><searchLink fieldCode="DE" term="%22Gender-nonconforming+people%22">Gender-nonconforming people</searchLink><br /><searchLink fieldCode="DE" term="%22Trans+men%22">Trans men</searchLink><br /><searchLink fieldCode="DE" term="%22Self-evaluation%22">Self-evaluation</searchLink><br /><searchLink fieldCode="DE" term="%22Diversity+%26+inclusion+policies%22">Diversity & inclusion policies</searchLink><br /><searchLink fieldCode="DE" term="%22Gender+identity%22">Gender identity</searchLink><br /><searchLink fieldCode="DE" term="%22Research+funding%22">Research funding</searchLink><br /><searchLink fieldCode="DE" term="%22Human+research+subjects%22">Human research subjects</searchLink><br /><searchLink fieldCode="DE" term="%22Clinical+trials%22">Clinical trials</searchLink><br /><searchLink fieldCode="DE" term="%22Gender+affirming+care%22">Gender affirming care</searchLink><br /><searchLink fieldCode="DE" term="%22Gender-neutral+language%22">Gender-neutral language</searchLink><br /><searchLink fieldCode="DE" term="%22Descriptive+statistics%22">Descriptive statistics</searchLink><br /><searchLink fieldCode="DE" term="%22Experimental+design%22">Experimental design</searchLink><br /><searchLink fieldCode="DE" term="%22Eligibility+%28Social+aspects%29%22">Eligibility (Social aspects)</searchLink><br /><searchLink fieldCode="DE" term="%22Hormone+therapy%22">Hormone therapy</searchLink><br /><searchLink fieldCode="DE" term="%22Trans+women%22">Trans women</searchLink>
– Name: Abstract
  Label: Abstract
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  Data: 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. [ABSTRACT FROM AUTHOR]
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  Data: <i>Copyright of American Journal of Public Health is the property of American Public Health Association and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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RecordInfo BibRecord:
  BibEntity:
    Identifiers:
      – Type: doi
        Value: 10.2105/AJPH.2025.308134
    Languages:
      – Code: eng
        Text: English
    PhysicalDescription:
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        PageCount: 10
        StartPage: 1621
    Subjects:
      – SubjectFull: HIV prevention
        Type: general
      – SubjectFull: Patient selection
        Type: general
      – SubjectFull: Health services accessibility
        Type: general
      – SubjectFull: Gender-nonconforming people
        Type: general
      – SubjectFull: Trans men
        Type: general
      – SubjectFull: Self-evaluation
        Type: general
      – SubjectFull: Diversity & inclusion policies
        Type: general
      – SubjectFull: Gender identity
        Type: general
      – SubjectFull: Research funding
        Type: general
      – SubjectFull: Human research subjects
        Type: general
      – SubjectFull: Clinical trials
        Type: general
      – SubjectFull: Gender affirming care
        Type: general
      – SubjectFull: Gender-neutral language
        Type: general
      – SubjectFull: Descriptive statistics
        Type: general
      – SubjectFull: Experimental design
        Type: general
      – SubjectFull: Eligibility (Social aspects)
        Type: general
      – SubjectFull: Hormone therapy
        Type: general
      – SubjectFull: Trans women
        Type: general
    Titles:
      – TitleFull: Addressing Transgender Erasure in HIV Clinical Trials: The Scorecard for Transgender and Gender-Diverse Inclusion.
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              M: 10
              Text: Oct2025
              Type: published
              Y: 2025
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