Evidence map›Paper›PMID 31176538›Full record

Trial reportVaccine2019

A descriptive analysis of transgender participants in phase 1-2a trials of the HIV Vaccine Trials Network (HVTN) in the United States and Peru.

Michele Andrasik, Doug Grove, Gail Broder, Hyman Scott, Mary Allen, Shelly Karuna

Open access · greenAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Vaccine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.1field-weighted citation impact, top 20% 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

5 citing papers in PubMed, 6 citations in OpenAlex.

  1. Building Trust and Engaging Communities for HIV Prevention Research Globally.AIDS education and prevention : official publication of the International Society for AIDS Education · 2026
    Article
  2. Article
  3. Trans Adults Amidst the COVID-19 Pandemic: Quality of Life, Pandemic Impact, and Vaccine Preferences.International journal of environmental research and public health · 2021
    Article
  4. Article
  5. Engaging Transgender People in NIH-Funded HIV/AIDS Clinical Trials Research.Journal of acquired immune deficiency syndromes (1999) · 2016
    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

6 authors at 2 institutions in 1 country.

Michele AndrasikFred Hutch HIV Vaccine Trials Network, United States. Electronic address: mandrasik@fredhutch.org.
Doug GroveFred Hutch, Statistical Center for HIV/AIDS Research and Prevention, United States. Electronic address: dgrove@scharp.org.
Gail BroderFred Hutch HIV Vaccine Trials Network, United States. Electronic address: gbroder@fredhutch.org.
Hyman ScottBridge HIV, San Francisco Department of Public Health, United States. Electronic address: hyman.scott@sfdph.org.
Mary AllenNIH/NIAID, United States. Electronic address: MAllen@niaid.nih.gov.
Shelly KarunaFred Hutch HIV Vaccine Trials Network, United States. Electronic address: mkaruna@fredhutch.org.
Cancer Research And Biostatistics · USSan Francisco Department of Public Health · US

Funding

LOC: HIV Vaccine Trials NetworkUM1AI068614 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Dan H. Barouch, Lawrence Corey · 2011 to 2026
$1175.6M
SDMC: HIV Vaccine Trials NetworkUM1AI068635 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Peter B. Gilbert, Yunda Huang · 2011 to 2026
$385.9M
NIAID NIH HHS UM1 AI068614NIAID NIH HHS UM1 AI068635
6 · The paper itself

Abstract

backgroundHIV disproportionately impacts transgender populations globally, creating challenges to inclusion in trials requiring low HIV risk profiles (LHRP) for acquisition. Our knowledge of transgender individuals with LHRP is limited. We conducted an analysis of transgender and cisgender individuals in HVTN trials enrolling individuals with LHRP.

methodsWe analyzed data from 694 participants enrolled in the phase 1-2a HVTN trials in the US and Peru from 2009 to 2014 that included individuals who reported gender identity (GI) differing from assigned birth sex (transgender [TG]), and compared them with those who reported a congruent GI (cisgender [CG]).

results681 participants (98%) were CG and 13 (2%) were TG. Mean age was 25 years. 16% were Hispanic and most (69%) were White. Reasons for enrolling included to help find an effective vaccine (TG 100%; CG 98%) and help their community (TG 100%; CG 96%). Significant differences by GI were observed in reported pre-existing conditions (p = 0.004); however, approximately 10% of pre-existing conditions reported by TG were GI-related (e.g., gender dysphoria). Significant differences were observed in hormone therapy use (p < 0.001) and mental health medications (p = 0.007). Retention was excellent with 2.1% missed visits and no discontinuations of vaccination for TG and 3% missed visits and 7.1% discontinuations among CG. There was no statistically significant difference in HIV incidence.

conclusionsPrimary reasons for participation were altruistic for all participants. Comparable to CG counterparts, TG participants maintained LHRP, followed trial procedures, and had high retention, facilitating meaningful early phase HIV preventive vaccine trial contributions.

Indexed as

Patient SelectionAdolescentAdultAIDS VaccinesDemographyFemaleGender IdentityHispanic or LatinoHIV InfectionsHumansMaleMiddle AgedPeruRisk FactorsSexual BehaviorTransgender PersonsAIDS VaccinesBiomedical interventionsHIV/AIDSHIV preventionTransgenderVaccine clinical trials

Identifiers

PMID31176538
PMCPMC6699617
OpenAlexW2952515457

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.