Evidence map›Paper›PMID 36416569›Full record

ReviewClinical pharmacology and therapeutics2023

Inclusion of Transgender and Gender Diverse People in Phase III Trials: Examples from HIV Pharmacologic Prevention Studies.

Lauren R Cirrincione, Victoria Luna Brennan Grieve, Jay Holloway, Mark A Marzinke

Open access · hybridAbstract readReview
In one paragraph

Review in Clinical pharmacology and therapeutics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.8field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Review
  5. Article
  6. Article
  7. Clinical Pharmacological Considerations in Transgender Medicine.Handbook of experimental pharmacology · 2023
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 4 institutions in 1 country.

Lauren R CirrincioneDepartment of Pharmacy, University of Washington, Seattle, Washington, USA.ORCID 0000-0002-9115-1060
Victoria Luna Brennan GrieveSchool of Pharmacy, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Jay HollowayIndependent Researcher, Los Angeles, California, USA.
Mark A MarzinkeDepartment of Medicine, Division of Clinical Pharmacology, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Film Independent · USJohns Hopkins University · USUniversity of Pittsburgh · USUniversity of Washington · US

Funding

LC: HIV Prevention Trials Network - Laboratory Support for the SARS-CoV-2 Seroprevalence Study (CoVPN 5002)UM1AI068613 · NIAID · JOHNS HOPKINS UNIVERSITY · PI SUSAN H ESHLEMAN, Mark A Marzinke · 2011 to 2026
$100.2M
Vaccine Response and Immunotherapeutics SWGP30AI094189 · NIAID · JOHNS HOPKINS UNIVERSITY · PI Anna Palmer Durbin · 2012 to 2026
$67.0M
Hormone mediated mechanisms of altered drug metabolism and transport in transgender adultsK23GM147350 · NIGMS · UNIVERSITY OF WASHINGTON · PI CIRRINCIONE, LAUREN · 2022 to 2025
$748k
NIAID NIH HHS P30 AI094189NIAID NIH HHS UM1 AI068613NIGMS NIH HHS K23 GM147350
6 · The paper itself

Abstract

Although at least 25 million adults are transgender worldwide, few phase III clinical trials have enrolled transgender and gender diverse (TGD) people. HIV is the only therapeutic area to include TGD people intentionally in phase III randomized clinical trials during the development of certain newer HIV pharmacologic prevention interventions. Pharmacologic assessments for HIV prevention efficacy in TGD populations are important, as there may be specific considerations for product use and potential interactions with hormone therapies. Herein, we summarize ongoing and completed phase III HIV trials that included TGD people as part of the study population, we examine investigators' strategies for recruiting and engaging TGD priority populations in these phase III trials, and we comment on the implications of these studies for prioritizing TGD populations in clinical pharmacology research within the phase III clinical trial landscape.

Indexed as

HIV InfectionsTransgender PersonsAdultClinical Trials, Phase III as TopicFemaleGender IdentityHumansMale

Identifiers

PMID36416569
PMCPMC9957832
OpenAlexW4309831855

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.