PrEP15-19 Choices: an implementation study protocol of HIV prevention with oral and long-acting injectable cabotegravir PrEP in real-word settings among sexual and gender minority adolescents in Brazil

Introduction
Long-acting injectable (LAI) cabotegravir is a promising new method for preventing HIV. Safe and effective long-acting agents for pre-exposure prophylaxis (PrEP) for HIV infection are needed to increase preventive options among sexual and gender minority adolescents.

Methods and analysis
This is a multisite, prospective implementation study of three PrEP modalities (LAI-PrEP, event-driven (ED) and daily oral), using a mixed-method design with quantitative and qualitative approaches. The study will include a sample of 550 HIV-negative adolescent men who have sex with men, non-binary individuals assigned male at birth, transgender men and women, aged 15–19 years, in three Brazilian capital cities. Participants will be allocated into two arms, according to their choice of PrEP modalities, and followed up to 36 months. Switching between oral and LAI-PrEP will be allowed, according to the participants’ needs and preferences. The qualitative studies will focus on investigating the processes involved in linkage and retention in care, switching between PrEP modalities and strategies of the implementation process of LAI-PrEP in the current PrEP programming and acceptability from health providers, policymakers and stakeholders’ perspectives.

Ethics and dissemination
The adolescent’s autonomy for consenting to their participation and understanding of PrEP will be assessed by the project team before any care is given and will be recorded in their medical record. Adolescents aged 15–17 years will sign an informed assent form, waiving the need for the approval of a legal guardian, except in cases where the adolescent is found not to have the necessary autonomy. The study was approved by the WHO Ethics Review Committee and by the local IRBs from the universities coordinating the study, the University of São Paulo, the Federal University of Bahia and the Federal University of Minas Gerais. This project is part of an effort to expedite the inclusion of new modalities in the Brazilian PrEP Programme, based on the development of studies to evaluate the implementation of LAI-PrEP and ED-PrEP as a choice. The results will be published in peer-reviewed journals and presented to the study participants and communities.

Trial registration number
https://ensaiosclinicos.gov.br/rg/RBR-104736f4. The trial registration number: RBR-104736f4

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Gennaio 2025

[Viewpoint] Post infectious fatigue and circadian rhythm disruption in long-COVID and other infections: a need for further research

Chronic fatigue syndrome (CFS) remains a subject of scientific research specifically with regards to its association with infections, including the more recently described Long COVID condition. Chronic fatigue and sleep disturbances in Long COVID are intricately linked to disruptions in circadian rhythms, driven by distinct molecular and cellular mechanisms triggered by SARS-CoV-2 infection. This can be driven by various mechanisms including dysregulation of key clock genes (CLOCK, BMAL1, PER2), mitochondrial dysfunction impairing oxidative phosphorylation, and cytokine-induced neuroinflammation (e.g., interleukin-6, tumor necrosis factor-alpha).

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Gennaio 2025

Impact of the COVID-19 pandemic on epidemiological and clinical characteristics of inpatients with burns in a Northwest China burn centre: a retrospective study

Objective
This study aimed to assess the impact of the COVID-19 pandemic on the characteristics and outcomes of patients with burns in a burn centre situated in Northwest China.

Design
A retrospective descriptive study.

Setting
This study was conducted in Tangdu Hospital, a major regional burn centre in Xi’an, Shaanxi Province of China.

Participants
A total of 1413 patients with burns were included in the study, with the admission period spanning from 2017 to 2019 (before the pandemic) and 2020 to 2022 (during the pandemic).

Results
Burn hospitalisations decreased during the pandemic for both children (9.80%) and adults (24.68%). The pandemic was associated with a decrease in work-related burns and a corresponding increase in the risk of domestic burns (both p

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Gennaio 2025

Tracking Persistent Symptoms in Scotland (TraPSS): a longitudinal prospective cohort study of COVID-19 recovery after mild acute infection

Background
COVID-19 disease results in disparate responses between individuals and has led to the emergence of long coronavirus disease (Long-COVID), characterised by persistent and cyclical symptomology. To understand the complexity of Long-COVID, the importance of symptom surveillance and prospective longitudinal studies is evident.

Methods
A 9-month longitudinal prospective cohort study was conducted within Scotland (n=287), using a mobile app to determine the proportion of recovered individuals and those with persistent symptoms and common symptoms, and associations with gender and age.

Results
3.1% of participants experienced symptoms at month 9, meeting the criteria for Long-COVID, as defined by the National Institute for Health and Care Excellence terminology. The random effects model revealed a significant time (month) effect for infection recovery (p

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Gennaio 2025

Development of a core patient-reported outcome set for use in HIV care at the individual patient level in Montreal: protocol for a two-phased multimethod project

Introduction
There is international interest in using patient-reported outcome measures in HIV care to improve the well-being of people with HIV, but the prioritisation of specific outcomes and measures remains unclear. This project’s objective is to engage both people with HIV and healthcare, social and community service providers to develop a French and English-language core set of patient-reported outcomes and measures for use in HIV care at the patient level in Montreal (Canada).

Methods and analysis
This multimethod project will follow guidance from the Core Outcome Measures in Effectiveness Trials Initiative and involve two phases. Phase 1 will see the selection of the core set of outcomes (ie, the health concepts to target) and include a rapid scoping review to inform a Delphi study with a panel of 50 people with HIV and providers in Montreal. It will end with a multidisciplinary consensus meeting to make final decisions on the outcomes. Phase 2 will be devoted to choosing the measures to assess the selected outcomes. It will include a systematic search for instruments, an appraisal of the quality and feasibility of the identified instruments and a consensus meeting for the final selection.

Ethics and dissemination
Research ethics board (REB) approval was obtained on 9 December 2024, from the institutional REB of the Research Institute of the McGill University Health Centre (reference number: 2024-9695). Findings will primarily be disseminated to (1) healthcare and social service providers through academic rounds and a provincial continuing education programme for HIV clinicians; (2) to people with HIV through partner community organisations and (3) a range of stakeholders at local, national and international conferences and through peer-reviewed publications.

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Gennaio 2025

[Articles] A core outcome set for maternal and neonatal health research and surveillance of emerging and ongoing epidemic threats (MNH-EPI-COS): a modified Delphi-based international consensus

This COS could contribute to standardize maternal and neonatal outcomes selection and reporting in observational and experimental studies, facilitating efficient data comparison and timely evidence-based decision-making in the context of ongoing and emerging epidemic threats.

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Gennaio 2025

Protocol for the development of a global core outcome set for the surgical treatment of differentiated thyroid cancer: a literature review and international Delphi survey

Introduction
There is a lack of consensus on the optimal surgical strategy for differentiated thyroid cancer (DTC), partly due to inconsistent reporting of outcomes. This limits the ability to compare study results, hindering the ability to draw conclusions regarding novel treatment strategies. The development of a core outcome set (COS) reduces heterogeneity in the selection and reporting of clinical trial outcomes. Currently, there is no COS for the surgical treatment of DTC. We aim to reach a global consensus among patients and physicians on the COS for the surgical treatment for patients with DTC of all ages.

Methods and analysis
The DTC-COS development will consist of three phases: first, an extensive literature review will be performed to identify reported outcomes in studies regarding surgical treatment for DTC in patients of all ages. Second, a 2-step or 3-step Delphi procedure will be performed to identify a final set of core outcomes out of the selected outcomes from the literature review. For this Delphi survey, both healthcare professionals and patients will be invited. Third, an (online) expert meeting with participants from every stakeholder group is organised to ratify the final core outcome set. The final COS will be reported in accordance with the COS-Standards for Reporting statement.

Ethics and dissemination
The medical research ethics committee of the Amsterdam UMC confirmed that the Dutch Medical Research Involving Human Subjects Act (WMO) does not apply to this study and that full approval by the committee is not required. The study is registered in the COMET initiative database (registration number 2597). Results will be presented in peer-reviewed academic journals and at (international) conferences.

Trial registration number
COMET initiative database 2597

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Gennaio 2025