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Purpose: This study analyzed the sociodemographic and behavioral characteristics of adolescent men who have sex with men (aMSM) and transgender women (aTGW) initiating oral pre-exposure prophylaxis (PrEP) in human immunodeficiency virus (HIV) prevention clinics., Methods: PrEP1519 is a prospective, multicenter, open-label PrEP demonstration cohort study of aMSM and aTGW aged 15-19 years living in three large Brazilian capital cities. For this analysis, we included adolescents who enrolled in PrEP1519 from February 2019 to August 2021. Adolescents who visited PrEP clinics were classified into four groups based on PrEP eligibility and on their decision to use PrEP: (1) ineligible for same-day PrEP initiation; (2) eligible for same-day PrEP initiation, initiated PrEP at first visit; (3) eligible for PrEP initiation, initiated PrEP after the first visit; and (4) eligible for same-day PrEP initiation but declined. The groups that were eligible for same-day PrEP initiation were compared using the Chi-square and Fisher's exact tests., Results: Of the 1,254 adolescents enrolled in the PrEP1519 study, 61 (4.9%) were considered ineligible for same-day PrEP initiation. Of the 1,193 eligible for same-day PrEP initiation, 1,113 (93.3%) initiated PrEP [1,054 initiated PrEP in the first visit (88.3%) and 59 in subsequent visits (4.9%)] and 80 (6.7%) did not. Despite 90% of the PrEP decliners reporting a low risk of HIV infection, most reported condomless anal sex in the past six months (70%)., Discussion: Same-day PrEP initiation among aMSM and aTGW was high, highlighting that this strategy was important to promote PrEP initiation among adolescents with increased vulnerability to HIV in Brazil., (Copyright © 2023 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.)

Purpose: This study aimed to describe pre-exposure prophylaxis (PrEP) for HIV discontinuation in adolescent men who have sex with men (aMSM) and adolescent transgender women (aTGW) and to identify factors associated with discontinuation., Methods: The PrEP1519 study included a cohort of aMSM and aTGW aged 15-19 years old, and it was conducted in three large Brazilian capital cities. For this analysis, we included adolescents who initiated PrEP. PrEP discontinuation was defined as no possession of PrEP pills for >90 days. Kaplan-Meier curves were used to analyze the probabilities of discontinuation, and survival distributions stratified by covariates were compared using log-rank or Wilcoxon tests. Cox regression models were used to estimate the adjusted hazard ratio (aHR) with a 95% confidence interval (95% CI)., Results: We included 908 adolescents, 829 (91.30%) aMSM and 79 (8.70%) aTGW, most of whom were 18-19 years (80.29%). The incidence rate of discontinuation was 75.6 per 100 person-years. The probability of discontinuation was 52.61% in the first year. The multivariate analysis demonstrated that the aTGW (aHR = 1.63; 95% CI: 1.02-1.64) and adolescents with a medium (aHR = 1.29; 95% CI: 1.02-1.64) or low (aHR = 1.65; 95% CI: 1.29-2.12) perceived risk of HIV infection had an increased risk of discontinuation, whereas the adolescents with a partner living with HIV had a lower risk of discontinuation (aHR = 0.57; 95% CI: 0.35-0.91)., Discussion: Adolescents with a high risk for discontinuation may need additional support that emphasizes the value of PrEP as a tool for HIV prevention because PrEP discontinuation was associated with a disconnect between HIV risk perception and HIV prevention., (Copyright © 2023 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.)

Purpose: This study aimed at describing the prevalence of symptoms of depression among 15-19 year old adolescent men who have sex with men (aMSM) and transgender women (aTGW), who were recruited in an HIV pre-exposure prophylaxis cohort study in three Brazilian capital cities. The study also examined potential associations, including violence and discrimination, with severe symptoms of depression among aMSM., Methods: This is a cross-sectional study of baseline data among 730 aMSM and 56 aTGW recruited between February 2019 and February 2021. Sociodemographic and behavioral data were collected. The 20-item Center for Epidemiologic Studies Depression scale was used to screen for symptoms of depression. Scores of ≥22 points indicate the presence of severe symptoms associated with major depression. Logistic regression was used to assess independent associations among aMSM, adjusting for sociodemographic variables., Results: Our findings indicate a high prevalence of symptoms of depression (overall prevalence = 58.5% and 69.6%; 21.2% and 25.0% for mild/moderate, and 37.3% and 44.6% for severe) among these aMSM and aTGW, respectively. Psychological violence (aOR = 1.74; 95% CI = 1.12-2.70), sexual violence (aOR = 1.79; 95% CI = 1.07-2.98), and discrimination due to sexual orientation (aOR = 1.71; 95% CI = 1.23-2.38) were independently associated with severe symptoms of depression in aMSM., Discussion: The high prevalence of severe symptoms of depression and its association with psychological and sexual violence and discrimination creates cycles of vulnerability and carries important public health implications. Thus, our findings indicate public policies should consider assessing depression, psychological and sexual violence, as well as discrimination, especially in populations that will be targeted by interventions, such as the use of pre-exposure prophylaxis., (Copyright © 2023 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.)

Purpose: To explore legal and ethical challenges related to adolescents' participation in human immunodeficiency virus (HIV) research that may affect their best interests., Methods: We analyzed the ethical principles and legal aspects of the participation of 15-17-year-old men who have sex with men and transgender women in the pre-exposure prophylaxis (PrEP) 1519 study, a PrEP demonstration cohort study in three Brazilian cities. The analyses of ethics review committees' (ERCs) evaluations and court decisions followed ethical and human rights principles. An HIV vulnerability score was created, and descriptive statistics and multivariate logistic regression were performed using data from 347 participants., Results: The ERCs evaluated the benefits and risks of research participation, all finding that the benefits outweighed the risks. ERCs deferred responsibility for decisions about waiving parental consent to the judiciary. State courts reached different decisions about waiving parental consent, reflecting variation in recognition of adolescents' evolving capacities and the adolescent as a subject of sexual rights and the primary agent capable of deciding on their health and best interests. The most vulnerable adolescent participants were found in sites where the blanket waiver was in place., Discussion: Judicializing the ethical review process is detrimental to fulfilling the ethical principle of justice and vulnerable adolescents' access to health research. ERCs must be sufficiently independent and autonomous and have the capacity to respect, protect, and help fulfill the rights of participants while ensuring the generation of adequate evidence to inform public health practice., (Copyright © 2023 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.)

Purpose: To evaluate the adherence, safety, and feasibility of pre-exposure prophylaxis (PrEP) in real-world settings among adolescent men who have sex with men (AMSM) and transgender women (ATGW)., Methods: PrEP1519 is a single-arm, multicentric demonstration cohort study of daily oral PrEP among AMSM and ATGW aged 15 to 19 years in Brazil. Study visits occurred at baseline, weeks 4, 12, and then quarterly until 96 weeks. Descriptive statistics and a mixed logistic model for longitudinal data evaluated the factors associated with high adherence., Results: One thousand sixteen AMSM and ATGW accessed the PrEP1519 clinics. Of those, 998 (98.2%) underwent clinical triage. Forty one were diagnosed with human immunodeficiency viruses (HIV) at baseline (4.0%) and 79 (7.9%) were not eligible for PrEP. Of the 878, 795 (90.5%) enrolled in PrEP, 82 (10.3%) were lost to follow-up, and 713 were included. There was no significant decrease in creatinine clearance; only two participants had grade-III aspartate aminotransferase elevation. Incident HIV infection occurred in eight participants (incidence rate [IR] = 1.64 per 100 person-years [PY]): two in 15-17 years (IR = 2.24 per 100 PY) and six in 18-20 years (IR = 1.51 per 100 PY). PrEP adherence was higher among those with more years of schooling, those reporting no difficulties in PrEP use due to side effects, and who had low HIV risk perception in the past three months., Discussion: PrEP for AMSM and ATGW was safe and feasible in real-world settings. However, a higher IR among young adolescents and a higher adherence among less vulnerable people indicate the need for greater care, considering the specificities of this age group., (Copyright © 2023 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.)

The Access to COVID-19 Tools Accelerator (ACT-A) is a multistakeholder initiative quickly constructed in the early months of the COVID-19 pandemic to respond to a catastrophic breakdown in global cooperation. ACT-A is now the largest international effort to achieve equitable access to COVID-19 health technologies, and its governance is a matter of broad public importance. We traced the evolution of ACT-A's governance through publicly available documents and analysed it against three principles embedded in the founding mission statement of ACT-A: participation, transparency, and accountability. We found three challenges to realising these principles. First, the roles of the various organisations in ACT-A decision making are unclear, obscuring who might be accountable to whom and for what. Second, the absence of a clearly defined decision making body; ACT-A instead has multiple centres of legally binding decision making and uneven arrangements for information transparency, inhibiting meaningful participation. Third, the nearly indiscernible role of governments in ACT-A, raising key questions about political legitimacy and channels for public accountability. With global public health and billions in public funding at stake, short-term improvements to governance arrangements can and should now be made. Efforts to strengthen pandemic preparedness for the future require attention to ethical, legitimate arrangements for governance., Competing Interests: Declaration of interests All authors are members of a WHO-led ACT-A Ethics and Governance Working Group set up to advise WHO on ethics and governance issues related to its role as a partner in the ACT-A. SM reports grants paid to her institution from the WHO Regional Office for Europe, UNICEF–UNDP–WB–WHO Special Program for Research and Training in Tropical Disease, and the Bill and Melinda Gates Foundation; reports paid membership with the Unitaid Proposal Review Committee; reports unpaid cochairmanship of the WHO Fair Pricing Forum; and is an unpaid member of the WHO ACT-A Governance and Ethics Working Group. JA reports paid WHO consultancy for work with the ACT-A Ethics and Governance Working Group, a paid consultancy with Wellcome, and unpaid board membership with Médecins sans Frontières Switzerland. EE declares payments, honoraria, or travel fees from Greenwall Foundation, RAND Corporation, Medical Home Network, Healthcare Financial Management Association, Ecumenical Center–UT Health, American Academy of Optometry, Associação Nacional de Hospitais Privados, National Alliance of Healthcare Purchaser Coalitions, Optum Labs, Massachusetts Association of Health Plans, District of Columbia Hospital Association, Washington University, Goldman Sachs, Brown University, The Atlantic, McKay Lab, American Society for Surgery of the Hand, Association of American Medical Colleges, American Essential Hospitals, Johns Hopkins University, National Resident Matching Program, Shore Memorial Health System, Tulane University, Oregon Health & Science University, United Health Group, Blue Cross Blue Shield, Center for Global Development, Informa, and Galien Foundation; and declares a leadership or fiduciary role in VillageMD, Oncology Analytics, Embedded Health Care, Oak HC/FT, and COVID-19 Recovery Partners. RF declares participation as a member of the WHO Strategic Advisory Group of Experts and the Immunization Working Group on COVID-19 Vaccines. GOS reports individual funding from WHO. SK is a member of the WHO Strategic Advisory Group of Experts on Immunization and the WHO SAGE Working Group on COVID-19 vaccines. JAS declares participating as a member of the WHO Technical Advisory Group on COVID-19 vaccines. MJS reports grants paid to their institution from the Canadian Institutes of Health Research (grant number #C150-2019-11), and travel fees to attend WHO and Global Research Collaboration for Infectious Disease Preparedness Global Research and Innovation Forum. All other authors declare no competing interests., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Detection of the SARS-CoV-2 virus in stools and sewage has recently been reported, raising the hypothesis of faecal-oral transmission. If confirmed, this could have far-reaching consequences for public health and for pandemic control strategies. In this paper, we argue that a comprehensive and more nuanced analysis is required to test this hypothesis, taking into consideration both environmental dynamics and the persistence of viral infectivity. First, we examine the evidence regarding the presence of the virus in stools and sewage. Then we discuss the current framework of disease transmission through water and excreta and how the transmission of a respiratory disease fits into it. Against this background, we propose a framework to test the faecal-oral hypothesis, unpacking the different environmental routes from faeces to the mouth of a susceptible person. This framework should not be seen as a confirmation of the hypothesis but rather as an expanded view of its complexities, which could help shaping an agenda for research into a number of unanswered questions. Finally, the paper briefly discusses practical implications, based on current knowledge, for containment of the pandemic., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Chemokines are chemoattractant cytokines involved in the immune response of a wide variety of diseases. There are few studies assessing their role in opportunistic infections in HIV-infected patients. In this study, we measured CC and CXC chemokines in cerebrospinal fluid (CSF) samples obtained from 40 HIV-infected patients with or without opportunistic infections of the central nervous system (CNS). CSF samples were also analyzed for quantification of total protein, cell count and HIV-1 RNA. HIV+ patients with cryptococcal meningitis had higher levels of CCL2, CCL3, CCL5, CXCL9 and CXCL10 when compared to patients without opportunistic neurological infections. Furthermore, HIV+ patients with associated cryptococcal meningitis had higher levels of CCL3, CXCL9 and CXCL10 when compared to HIV+ patients with associated toxoplasmic encephalitis. CCL3 and CXCL9 levels were positively correlated with CSF HIV-1 RNA levels, CSF protein concentration, and CSF cell count. CXCL10 level was correlated with the CSF viral load and the CSF cell count and CCL5 level was correlated with the CSF cell count. In conclusion, the profile of chemokines in CSF of HIV patients may differ according to the modality of the presented opportunistic infection and according to other biological markers, such as viral load in CSF. These differences are probably related to different patterns of neuroinflammatory responses displayed by patients with different opportunistic neurological infections.

Aims: To compare high-sensitivity C-reactive protein (hsCRP) in HIV-infected patients treated or not with antiretroviral (ARV) drugs and to correlate hsCRP levels with traditional cardiovascular risk factors and parameters of HIV infection., Methods: One hundred and seventy-one HIV-infected patients were included (129 ARV-treated and 42 ARV-naïve). Evaluations included anthropometric measurements, blood pressure, laboratory tests, ultrasonographic measurement of fat thickness and impedance analysis., Results: hsCRP levels were higher in ARV-treated compared to ARV-naïve patients (p<0.001). Seventy-two (56%) ARV-treated patients and 11 (26%) ARV-naïve patients had hsCRP concentrations >3 mg/dl (high risk for cardiovascular complications) (OR 3.56; 95%CI: 1.55-8.29; p=0.001, chi(2) test). hsCRP levels correlated positively with waist measurement (p=0.004), waist-to-hip ratio (p<0.001), systolic (p=0.05) and diastolic (p=0.03) blood pressure, intra-abdominal fat thickness (p=0.02), triglycerides (p=0.001), total cholesterol (p=0.01), fasting glucose (p=0.01), and glucose (p<0.001) and insulin levels (p=0.02) measured 2 h after load. No correlation was found between hsCRP levels and CD4 cell counts and HIV-viral load. Independent factors associated with hsCRP levels were therapy with current non-nucleoside reverse transcriptase inhibitors (NNRTI) (p=0.003), waist-to-hip ratio (p=0.006), fasting glucose (p=0.049) and glucose levels 2 h after load (p=0.003) in multivariate analysis model 1 and current NNRTI therapy (p<0.001), protease inhibitor therapy (p=0.016) and cardiometabolic syndrome (p=0.022) in multivariate analysis model 2., Conclusion: hsCRP in HIV-infected patients is associated with traditional cardiovascular risk factors, principally in ARV-treated patients. hsCRP levels are not associated with CD4 cell counts and HIV-viral load and may constitute a marker for cardiovascular risk related to HIV infection and ARV therapy.