Background:For the 11th version of the International Classification of Diseases, the WHO recommended to rename transgender transidentity as “gender incongruence”, to remove it from the chapter of mental and behavioral disorders, and to put it in a new category titled “Conditions related to sexual health”. This should contribute to reduce stigmatisation while maintaining access to medical care. One argument in favor of depsychiatrisation is to demonstrate that essential features of gender identity disorders, namely psychological distress and functional impairment, are not necessarily reported by every transgender person, and may result from social rejection and violence rather than dysphoria itself. Initially confirmed in Mexico, these hypotheses were tested in a specific French medical context, where access to care does not require any prior mental health evaluation or diagnosis.Method:In 2017, 72 transgender persons completed retrospective interviews which focused on the period when they became aware that they might be transgender and perhaps would need to do something about it.Results:Results showed that psychological distress and functional impairment were not reported by every participant, that they may result from rejection and violence, and especially from rejection and violence coming from coworkers and schoolmates. Additional data showed that the use of health services for body transformation did not depend on distress and dysfunction. Finally, participants preferred ICD 11 to employ “transgender” or “transidentity” rather than “gender incongruence”.Conclusion:Results support depsychiatrisation. They are discussed in terms of medical, ethical, legal, and social, added values and implications of depsychiatrisation.
The prevalence of AO in northern France ranged from 9.5 to 16.0%, depending on the centre and definition used. The high underdiagnosis rate observed here suggests that greater efforts should be made to identify individuals presenting with the symptoms and/or risk factors associated with AO.
Introduction
The Ebola virus disease (EVD) outbreak in 2014–2016 in West Africa was the largest on record and provided an opportunity for large clinical trials and accelerated efforts to develop an effective and safe preventative vaccine. Multiple questions regarding the safety, immunogenicity, and efficacy of EVD vaccines remain unanswered. To address these gaps in the evidence base, the Partnership for Research on Ebola Vaccines (PREVAC) trial was designed. This paper describes the design, methods, and baseline results of the PREVAC trial and discusses challenges that led to different protocol amendments.
Methods
This is a randomized, double-blind, placebo-controlled phase 2 clinical trial of three vaccine strategies against the Ebola virus in healthy volunteers 1 year of age and above. The three vaccine strategies being studied are the rVSVΔG-ZEBOV-GP vaccine, with and without a booster dose at 56 days, and the Ad26.ZEBOV,MVA-FN-Filo vaccine regimen with Ad26.ZEBOV given as the first dose and the MVA-FN-Filo vaccination given 56 days later. There have been 4 versions of the protocol with those enrolled in Version 4.0 comprising the primary analysis cohort. The primary endpoint is based on the antibody titer against the Ebola virus surface glycoprotein measured 12 months following the final injection.
Results
From April 2017 to December 2018, a total of 5002 volunteers were screened and 4789 enrolled. Participants were enrolled at 6 sites in four countries (Guinea, Liberia, Sierra Leone, and Mali). Of the 4789 participants, 2560 (53%) were adults and 2229 (47%) were children. Those < 18 years of age included 549 (12%) aged 1 to 4 years, 750 (16%) 5 to 11 years, and 930 (19%) aged 12–17 years. At baseline, the median (25th, 75th percentile) antibody titer to Ebola virus glycoprotein for 1090 participants was 72 (50, 116) EU/mL.
Discussion
The PREVAC trial is evaluating—placebo-controlled—two promising Ebola candidate vaccines in advanced stages of development. The results will address unanswered questions related to short- and long-term safety and immunogenicity for three vaccine strategies in adults and children.
Trial registration
ClinicalTrials.gov NCT02876328. Registered on 23 August 2016.
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