Frailty and health-related quality of life among older people living with HIV pre- and post-COVID-19 pandemic onset: A cross-sectional study

ABSTRACT Introduction: Antiretroviral therapy increased the survival and life expectancy of People living With HIV (PWH). Frailty-related syndromes among older PWH (aged 50+ years) may affect their Health-related Quality of Life (HQoL). Additionally, the COVID-19 pandemic has impacted health-related outcomes. This study aimed to estimate the prevalence of frailty and pre-frailty among older PWH, and to explore associations of HQoL with the study assessment period and frailty status. Methods: Cross-sectional study conducted pre- (23-Mar-2019 to 5-Mar-2020) and post-COVID-19 pandemic onset (23-Jun-2021 to 5-May-2022), among older PWH at INI-Fiocruz, the largest cohort of PWH in Rio de Janeiro, Brazil. We measured frailty using Fried assessment, consisting of five domains: unintentional weight loss; self-reported exhaustion, weakness, slow walking speed, low physical activity. HQoL was assessed using the ACTG SF-21, which contains 21 questions divided into 8 domains. We used Chi-Square test, Fisher's exact test, Kruskal-Wallis and ranksum test for comparisons. Results: We included 250 older PWH: 109 (43.6 %) pre- and 141 (56.4 %) post-COVID-19 pandemic onset. Median age was 60-years (IQR: 55‒64). Most self-identified as cisgender men 152 (60.8 %), Pardo/Black 146 (58.4 %), with completed secondary education or less 181 (72.7 %) and low income 132 (52.8 %). Overall, prevalence of frailty and pre-frailty were 9.2 % (95 % CI: 8.1‒10.3) and 61.6 % (95 % CI: 54.0‒69.2). Prevalence of frailty in the pre- and pos-COVID-19 pandemic periods were 7.3 % and 10.6 % (p = 0.66). HQoL scores were lower among participants with frailty compared to those with non-frailty and pre-frailty in all eight domains, and among those included in the post-COVID-19 compared to pre-COVID-19 period for four domains. Conclusions: We observed low prevalence of frailty, but high prevalence of pre-frailty among older PWH. Frailty status did not differ according to the COVID-19 assessment period. Assessment of frailty and HQoL should be incorporated in clinical practice for older PWH. Programs to reverse or prevent frailty should be implemented within the public health system.

Safety of the yellow fever vaccine in people living with HIV: a longitudinal study exploring post-vaccination viremia and hematological and liver kinetics

ABSTRACT Background: Safety data on the yellow fever vaccine 17DD in People Living with HIV (PLWH) are limited. This study explored the occurrence of post-vaccination 17DD viremia and the kinetics of hematological and liver laboratorial parameters in PLWH and HIV-uninfected participants [HIV(-) controls]. Methods: We conducted a secondary analysis of a longitudinal interventional trial (NCT03132311) study that enrolled PLWH and HIV(-) controls to receive a single 17DD dose and were followed at 5, 30 and 365 days after vaccination in Rio de Janeiro, Brazil. 17DD viremia (obtained throughreal-time PCR and plaque forming units' assays), hematological (neutrophils, lymphocytes and platelets counts) and liver enzymes (ALT and AST) results were assessed at baseline and Days 5 and 30 post-vaccination. Logistic regression models explored factors associated with the odds of having positive 17DD viremia. Linear regression models explored variables associated with hematological and liver enzymes results at Day 5. Results: A total of 202 PLWH with CD4 > 200 cells/μL and 68 HIV(-) controls were included in the analyses. 17DD viremia was found in 20.0 % of the participants and was twice more frequent in PLWH than in HIV(-) controls (22.8% vs. 11.8 %, p-value < 0.001). Neutrophils, lymphocytes and platelets counts dropped at Day 5 and returned to baseline values at Day 30. 17DD viremia was associated with lower nadir of lymphocytes and platelets at Day 5. ALT levels did not increase post-vaccination and were not associated with 17DD viremia. Conclusions: 17DD was safe and well-tolerated in PLWH with CD4 > 200 cells/μL. Post-vaccination viremia was more frequent in PLWH than in controls. Transient and self-limited decreases in lymphocytes and neutrophils occurred early after vaccination. 17DD viremia was associated with lower lymphocytes and platelets nadir after vaccination. We did not observe elevations in ALT after 17DD vaccination.

Variability in life expectancy among people with HIV in Brazil by gender and sexual orientation

Abstract Introduction In Brazil, though Antiretroviral Therapy (ART) is available to all, the benefits may not be experienced uniformly. We projected Life Expectancy (LE) for People Living with HIV (PLHIV) in care as currently observed and estimated the impact of guideline-concordant care. Methods Using a microsimulation model, we projected LE for a cohort of PLHIV and for four population groups: cisgender Men who have Sex with Men (MSM), cisgender Men who have Sex with Women (MSW), Cisgender Women (CGW), and Transgender Women (TGW). Cohort data from Evandro Chagas National Institute of Infectious Diseases/Oswaldo Cruz Foundation (INI/Fiocruz) informed model parameters. We modeled five scenarios: 1) Current care: ART initiation, adherence, and retention in care as currently observed, 2) Guideline-concordant care: immediate ART initiation, full adherence to treatment, and consistent retention in care, 3) Immediate ART initiation with observed adherence to treatment and retention in care, 4) Full adherence to treatment with observed timing of ART initiation and retention in care, and 5) Consistent retention in care with observed timing of ART initiation and adherence. Results With current care, LE from age 15 would be 45.9, 44.4, 54.2, and 42.3 years, for MSM, MSW, CGW, and TGW. With guideline-concordant care, LE would be 54.2, 54.4, 63.1, and 53.2 years, for MSM, MSW, CGW and TGW, with TGW experiencing the greatest potential increase in LE (10.9 years). When investigating the components of care separately, MSW and CGW would gain most LE with immediate ART initiation, whereas for MSM and TGW consistent retention in care would be most impactful. Conclusions In settings like INI/Fiocruz, MSW and CGW would benefit most from interventions focused on earlier diagnosis and linkage to care, whereas TGW and MSM would benefit from interventions to sustain engagement in care. Assessment of the HIV care continuum for specific populations should inform care priorities.

Pregnancy incidence, outcomes and associated factors in a cohort of women living with HIV/AIDS in Rio de Janeiro, Brazil, 1996-2016 / Incidência, desfechos e fatores associados à gravidez em uma coorte de mulheres vivendo com HIV/aids no Rio de Janeiro, Brasil, 1996-2016 / Incidencia, resultados y factores asociados con el embarazo en una cohorte de mujeres que viven con VIH/SIDA en Río de Janeiro, Brasil, 1996-2016

Abstract The aim of this research was to analyze pregnancy incidence and associated factors in a cohort of 753 women living with HIV/AIDS (WLWHA) in Rio de Janeiro, Brazil, from 1996 to 2016. Women aged 18-49 years who were not on menopause (surgical or natural) and did not have a tubal ligation were eligible for the study. Data were collected by medical professionals during initial and follow-up visits. Person-time pregnancy incidence rates were calculated throughout the follow-up period. Pregnancy incidence-associated factors were investigated by univariate and multiple analyzes, using an extension of the Cox survival model. Follow-up visits recorded 194 pregnancies, with an incidence rate of 4.01/100 person-years (95% CI: 3.47; 4.60). A higher pregnancy incidence was associated with CD4 nadir ≥ 350 cells/mm³, use of an antiretroviral regimen not containing Efavirenz, and prior teenage pregnancy. In turn, women with a viral load ≥ 50 copies/mL, age ≥ 35 years old, with two or more children and using a highly effective contraceptive method showed a lower incidence. Results showed a significant reduction in pregnancy incidence after 2006, a significant reduction in female sterilization from 1996 to 2016, and a high rate of cesarean sections. The association found between pregnancy incidence and the use of contraceptive methods and virological control markers suggests a good integration between HIV/AIDS and reproductive health services. The high rate of cesarean section delivery indicates the need to improve childbirth care.

Resumo O objetivo deste estudo foi analisar a incidência de gravidez e fatores associados em uma coorte de mulheres vivendo com HIV/aids (MVHA) no Rio de Janeiro, Brasil. Foi realizada uma coorte clínica com 753 MVHA entre 1996 e 2016. Mulheres com idade entre 18-49 anos que não estavam na menopausa natural ou cirúrgica e que não tinham laqueadura tubária foram elegíveis para o estudo. Os dados foram coletados durante as consultas iniciais e de acompanhamento por profissionais médicos. As taxas de incidência por pessoa-tempo foram calculadas durante todo o período de acompanhamento. Análises univariadas e múltiplas foram realizadas para investigar fatores associados à incidência de gravidez, utilizando uma extensão do modelo de sobrevida de Cox. Foram registradas 194 gestações durante as consultas de acompanhamento, com uma taxa de incidência de 4,01/100 pessoas-ano (IC95%: 3,47-4,60). Uma maior incidência de gravidez foi associada a nadir CD4 ≥ 350 células/mm³, terapia antirretroviral sem Efavirenz e gravidez anterior na adolescência, enquanto uma menor incidência foi observada em mulheres com carga viral ≥ 50 cópias/mL, idade ≥ 35 anos, com dois ou mais filhos e que usavam um método contraceptivo altamente eficaz. Houve uma redução significativa na incidência de gestações após 2006, uma redução significativa na esterilização feminina entre 1996 e 2016 e uma alta taxa de cesarianas. A associação entre a incidência de gestações e o uso de métodos contraceptivos e marcadores de controle virológico sugere uma boa integração entre HIV/aids e serviços de saúde reprodutiva. A alta taxa de cesarianas indica a necessidade de melhoria na assistência ao parto.

Resumen El objetivo de este estudio fue analizar la incidencia del embarazo y los factores asociados en una cohorte de mujeres que viven con VIH/SIDA (MVHA) en Río de Janeiro, Brasil. Se realizó una cohorte clínica con 753 MVHA entre 1996 y 2016. Las mujeres de 18-49 años que no estaban en la menopausia natural o quirúrgica y que no tenían ligadura de trompas fueron elegibles para el estudio. Los datos se recopilaron durante las consultas iniciales y de seguimiento por parte de profesionales médicos. Las tasas de incidencia por persona-tiempo se calcularon durante todo el período de seguimiento. Se realizaron análisis univariados y múltiples para investigar los factores asociados con la incidencia del embarazo utilizando una extensión del modelo de supervivencia de Cox. Se registraron 194 embarazos durante las consultas de seguimiento, con una tasa de incidencia de 4,01/100 personas-año (IC95%: 3,47-4,60). Una mayor incidencia de embarazo se asoció con nadir CD4 ≥ 350 células/mm3, terapia antirretroviral sin Efavirenz y embarazo previo en la adolescencia, mientras que una menor incidencia se observó en mujeres con carga viral ≥ 50 copias/mL, edad ≥ 35 años, con dos o más hijos y que usaban un método anticonceptivo muy eficaz. Hubo una reducción significativa en la incidencia de embarazos después de 2006, una reducción significativa en la esterilización femenina entre 1996 y 2016 y una alta tasa de cesáreas. La asociación entre la incidencia de embarazos y el uso de métodos anticonceptivos y marcadores de control virológico sugiere una buena integración entre el VIH/SIDA y los servicios de salud reproductiva. La alta tasa de cesáreas indica la necesidad de mejorar la asistencia al parto.

Mortality rates by gender and sexual orientation reveal a disproportionally high mortality among cisgender men of unknown sexual orientation and men who have sex with women in a cohort of people living with HIV in Rio de Janeiro, Brazil

ABSTRACT Background: Antiretroviral therapy use has led to a decline in HIV-related mortality yet disparities by gender and/or sexual orientation may exist. In this study, we estimated hazards of death in people living with HIV (PLWH) according to gender and sexual orientation. Methods: We included PLWH ≥ 18 years enrolled between 2000 and 2018 at INI/Fiocruz, Rio de Janeiro, Brazil. Participants were grouped as cisgender or transgender women, cisgender men who have sex with men (MSM) or men who have sex with women, or cisgender men with unknown sexual orientation. We assessed disparities in the hazard of death using Cox proportional hazards models. Results: Among 5,576 PLWH, median age at enrollment was 35 years, 39% were MSM, 28% cisgender women, 23% men who have sex with women, 5% transgender women, and 5% men with unknown sexual orientation. A total of 795 deaths occurred in 39,141 person-years of follow-up. Mortality rates per 1,000 person-years were: 82.4 for men with unknown sexual orientation, 24.5 for men who have sex with women, 18.3 for cisgender, 16.6 for transgender women, and 15.1 for MSM. Compared to MSM, men with unknown sexual orientation had the highest death hazard ratio (adjusted hazard ratio [aHR] 2.93, 95% confidence interval [CI] 2.35-3.81), followed by men who have sex with women (aHR 1.17, 95%CI 0.96, 1.43); death hazard ratios for cisgender and transgender women were not statistically different. Conclusion: We observed disparities in the hazard of death for men with unknown sexual orientation and men who have sex with women despite universal access to antiretroviral therapy in Brazil. Future work should characterize and assist men with unknown sexual orientation with tailored policies and interventions. Increased hazard of death was not observed for transgender women, which probably results from interventions implemented in our service to reach, engage, retain, and support this population.

The first case of acute HIV and monkeypox coinfection in Latin America

ABSTRACT Monkeypox (MPX) transmission outside non-endemic countries has been reported since May 2022, rapidly evolving into a multi-country outbreak. A potential role of sexual contact in transmission dynamics, as well as a predominance of anogenitallesions, are remarkable features of current cases. Screening for sexually transmitted infections (STIs) plays an important role in the evaluation of patients with suspected MPX infection. Herein we report the first case of a patient diagnosed with both MPX and acute HIV infection in Latin America. He had no major complications during his clinical course, and antiretroviral therapy was promptly initiated. Diagnosis of acute HIV requires a high level of suspicion and appropriate laboratory investigation. Health practitioners need to consider this diagnosis while evaluating patients with suspected MPX with a recent unprotected sexual contact.

Ongoing HIV-1 evolution and reservoir reseeding in two elite controllers with genetically diverse peripheral proviral quasispecies

BACKGROUND Elite controllers (EC) are human immunodeficiency virus (HIV)-positive individuals who can maintain low viral loads for extended periods without antiretroviral therapy due to multifactorial and individual characteristics. Most have a small HIV-1 reservoir composed of identical proviral sequences maintained by clonal expansion of infected CD4+ T cells. However, some have a more diverse peripheral blood mononuclear cell (PBMC)-associated HIV-1 reservoir with unique sequences. OBJECTIVES To understand the turnover dynamics of the PBMC-associated viral quasispecies in ECs with relatively diverse circulating proviral reservoirs. METHODS We performed single genome amplification of the env gene at three time points during six years in two EC with high intra-host HIV DNA diversity. FINDINGS Both EC displayed quite diverse PBMCs-associated viral quasispecies (mean env diversity = 1.9-4.1%) across all time-points comprising both identical proviruses that are probably clonally expanded and unique proviruses with evidence of ongoing evolution. HIV-1 env glycosylation pattern suggests that ancestral and evolving proviruses may display different phenotypes of resistance to broadly neutralising antibodies consistent with persistent immune pressure. Evolving viruses may progressively replace the ancestral ones or may remain as minor variants in the circulating proviral population. MAIN CONCLUSIONS These findings support that the high intra-host HIV-1 diversity of some EC resulted from long-term persistence of archival proviruses combined with the continuous reservoir's reseeding and low, but measurable, viral evolution despite undetectable viremia.

Travestis, transgender women and young MSM are at high risk for PrEP early loss to follow-up in Rio de Janeiro, Brazil

Abstract Introduction Oral pre-exposure prophylaxis (PrEP) with emtricitabine/tenofovir (FTC/TDF) is highly effective in preventing HIV infection. This study aimed to identify factors associated with PrEP early loss to follow-up (ELFU) among gay, bisexual and other men who have sex with men (MSM), travestis and transgender women (TGW). Methodology This was a prospective cohort study evaluating TGW and MSM who initiated PrEP at the Evandro Chagas National Institute of Infectious Diseases (INI-Fiocruz) from 2014 to 2020. ELFU was defined as not returning for a PrEP visit within 180 days after first dispensation. Exposure variables included age, gender, race, education, transactional sex, condomless anal intercourse [CAI] (both in the past six months), binge drinking and substance use (both in past three months) and syphilis diagnosis at baseline. Multilevel logistic regression models with random intercepts and fixed slopes were used to identify factors associated with ELFU accounting for clustering of participants according to their PrEP initiation study/context (PrEP Brasil, PrEParadas, ImPrEP and PrEP SUS). Results Among 1,463 participants, the median age was 29 years (interquartile range 24-36), 83% self-identified as MSM, 17% as TGW, 24% were black, 37% mixed-black/pardo and 30% had < 12 years of education. Fifteen percent reported transactional sex, 59% reported CAI, 67% binge drinking, 33% substance use, and 15% had a syphilis diagnosis. Overall, 137 participants (9.7%) had ELFU. Younger age (18-24 years) (adjusted odds ratio [aOR] 1.9, 95%CI:1.2-3.2), TGW (aOR 2.8, 95%CI:1.6-4.8) and education < 12 years (aOR 1.9, 95%CI:1.2-2.9) were associated with greater odds of ELFU. Conclusion TGW, young individuals and those with lower education were at higher risk of PrEP ELFU. Our results suggest that the development of specific strategies targeting these populations should be a priority, through policies that aim to reduce the incidence of HIV infection.

Monkeypox (Mpox) virus isolation and ultrastructural characterisation from a Brazilian human sample case

BACKGROUND According to the last 2023 Monkeypox (Mpox) Outbreak Global Map from the Centres for Disease Control and Prevention (CDC), more than 100 countries with no Mpox infection report cases. Brazil stands out in this group and is the second country with the highest number of cases in the last outbreak. OBJECTIVE To contribute to knowledge of the virus infection effects in a cellular model, which is important for diagnosis infections not yet included in a provider´s differential diagnosis and for developing viral inhibition strategies. METHODS We describe a virus isolation protocol for a human clinical sample from a patient from Brazil, the viral growth in a cell model through plaque forming units (PFU) assay, reverse transcriptase polymerase chain reaction (RT-PCR) and transmission electron microscopy (TEM). FINDINGS We follow the viral isolation in Vero cell culture from a Mpox positive clinically diagnosed sample and show the infection effects on cellular structures using a TEM. MAIN CONCLUSIONS Understanding the impact of viral growth on cellular structures and its replication kinetics may offer better strategies for the development of new drugs with antiviral properties.

Custos de implementação do cabotegravir injetável de longa duração como profilaxia ao HIV no Brasil / Costs of implementing long-acting injectable cabotegravir as HIV prophylaxis in Brazil

Resumo O artigo descreve a estimação dos custos potenciais, sob a ótica do Ministério da Saúde (MS), da implementação do medicamento cabotegravir injetável de longa duração (CAB LA) no Sistema Único de Saúde, como alternativa para a prevenção à infecção pelo HIV e parte da estratégia nacional de prevenção combinada. Utilizou-se o instrumental analítico de cadeias de valor para elaborar a cadeia de valor do CAB LA com a identificação dos seus elos e atividades. Foram definidos três cenários de demanda com base em dados da população-alvo, variando em abrangência geográfica, e calculados os custos potenciais. A cadeia de valor do CAB LA é dividida em três grandes elos: produção, incorporação e assistência farmacêutica. Somente o último é considerado para o cálculo dos custos sob responsabilidade orçamentária do MS. Os custos potenciais são estimados em R$ 15 milhões, R$ 19 milhões e R$ 21,8 milhões, nos cenários de demanda baixa, média e alta, respectivamente. O estudo apresenta os custos potenciais para o MS, incluindo a necessidade de testes e procedimentos, de forma a orientar os gestores públicos e o próprio processo de incorporação. A ausência de preço do CAB LA é uma importante limitação para os resultados.

Abstract The article describes the estimation of the potential costs, from the perspective of the Ministry of Health (MoH), of incorporating the long-acting injectable cabotegravir (CAB LA) within the Brazilian Unified Health System, as an alternative for the prevention of HIV infection and part of the national combination prevention strategy. The analytical tools of value chains were used to elaborate the CAB LA value chain by identifying its links and activities. Three demand scenarios were defined based on target population data, varying geographic scope, and potential costs were calculated. CAB LA's value chain is divided into three major links: production, incorporation, and pharmaceutical assistance. Only the latter is considered for the calculation of costs under the budgetary responsibility of the MoH. Potential costs are estimated at R$15 million, R$19 million and R$21.8 million, in low, medium, and high demand scenarios, respectively. The study presents the potential costs for the MoH, including the need for tests and procedures, to guide public managers and the incorporation process. The lack of price for CAB LA is an important limitation of the results.

Reproductive health syndemics impact retention in care among women living with HIV in Rio de Janeiro, Brazil

ABSTRACT Syndemic psychosocial and reproductive factors affecting women's retention in HIV care remain understudied. We analyzed correlates of non-retention in a cohort of women with HIV in Brazil from 2000-2015. Participants self-reported exposure to physical/sexual violence, illicit drug use, adolescent pregnancy, or induced abortion. Lifetime history of these psychosocial stressors were used to create a syndemic score based on the presence or absence of these conditions. All dichotomous variables were summed (range 0 to 4), with greater scores indicating more syndemic factors experienced. Logistic regression models identified predictors of non-retention, defined as < 2 HIV viral load or CD4 results within the first year of enrollment. Of 915 women, non-retention was observed for 18%. Prevalence of syndemic factors was adolescent pregnancy (53.2%), physical/sexual violence (38.3%), induced abortion (27.3%), and illicit drug use (17.2%); 41.2% experienced > 2 syndemic conditions. Syndemic scores of 2 and 3 were associated with non-retention, as well as low education, years with HIV and seroprevalent syphilis. Psychosocial and reproductive syndemics can limit women's retention in HIV care. Syphilis infection predicted non-retention and could be explored as a syndemic factor in future studies.

Epidemiological-clinical profile and mortality in patients coinfected with Trypanosoma cruzi/HIV: experience from a Brazilian reference center

ABSTRACT Background: The recent urbanization of Chagas disease (CD) has contributed to a greater risk of coexistence with human immunodeficiency virus (HIV) and AIDS. Methods: This retrospective observational study included patients who were followed at INI-Fiocruz between July 1986 and October 2021. All patients underwent an assessment protocol that included sociodemographic profile, epidemiological history, and clinical evaluation. Descriptive data analyses included reports of the medians and frequencies of variables of interest. Differences in medians between groups were tested using the Mann-Whitney U test. Differences in frequency were tested using Fisher's exact test. Results: Among 2201 patients, 11 (0.5%) were identified with Trypanosoma cruzi/HIV coinfection. Of these, 63.6% were women with a median age of 51.0 years old. Two patients had the indeterminate form of CD, six had the cardiac form, two had the digestive form and one had the cardio-digestive form. Half of the patients were undergoing antiretroviral treatment at the time of coinfection diagnosis with a median CD4+ count of 350 cells/μL and a viral load of 1500 copies/μL. Four patients underwent a xenodiagnosis test at coinfection diagnosis, which all yielded positive results; two of them presented high parasitemia under the risk of reactivation. Prophylaxis for CD reactivation was administered to four patients; two with ketoconazole and two with benznidazole. Six patients died after a median follow-up of 22.5 months, with AIDS being the most common cause of death. Only one case of reactivation was observed. Conclusions: Early diagnosis and prompt treatment of CD reactivation dramatically reduced mortality. Identification of Trypanosoma cruzi/HIV co-infection is crucial to planning a close follow-up of coinfected patients.

Barreiras e facilitadores do acesso de populações vulneráveis à PrEP no Brasil: Estudo ImPrEP Stakeholders / Barriers and facilitators for access to PrEP by vulnerable populations in Brazil: the ImPrEP Stakeholders Study / Barreras y facilitadores de acceso de poblaciones vulnerables a la PrEP en Brasil: Estudio ImPrEP Stakeholders

Resumo: A profilaxia pré-exposição ao HIV (PrEP) tem sido considerada uma estratégia fundamental para o controle da epidemia de HIV/aids, e desde 2018 tem sido objeto de estudo de implementação (Estudo ImPrEP Stakeholders), realizado no Brasil, no México e no Peru. Um componente qualitativo desse estudo foi desenvolvido com o objetivo de identificar os contextos sociais e estruturais que envolvem e organizam a oferta de serviços de PrEP no Brasil, as subjetividades dos atores envolvidos e as diferentes percepções que podem impactar a efetivação dessa estratégia. O presente artigo teve como foco de análise o acesso das populações vulneráveis aos serviços de PrEP, na perspectiva de gestores, profissionais de saúde, lideranças ou ativistas e usuários de PrEP. É um estudo qualitativo com o uso de metodologia compreensiva, realizado em seis capitais brasileiras, em que foram entrevistados 71 atores-chave no período de novembro de 2018 a maio de 2019. A análise foi pautada pelos modelos analíticos sobre acesso propostos por Giovanella & Fleury, McIntyre et al. e Penchansky & Thomas. Os resultados são apresentados com base em três eixos: "percepções sobre prevenção combinada e PrEP"; "disponibilidade e adequação: perfil e estrutura dos serviços no contexto do ImPrEP"; e "aceitabilidade: atitudes e práticas dos profissionais de saúde e usuários".

Abstract: HIV preexposure prophylaxis (PrEP) has been considered a fundamental strategy for controlling the HIV/AIDS epidemic, and since 2018 it has been the object of an implementation study (ImPrEP Stakeholders Study), conducted in Brazil, México, and Peru. A qualitative component of this study was developed with the objective of identifying the social and structural contexts that involve and organize the supply of PrEP services in Brazil, the stakeholders' subjectivities, and the different perceptions that can impact the strategy's implementation. The current article's focus was to analyze access by vulnerable populations to PrEP services from the perspective of managers, health professionals, leaders or activists, and users of PrEP. This was a qualitative study using a comprehensive methodology, conducted in six Brazilian state capitals, interviewing 71 key actors from November 2018 to May 2019. The analysis was based on access analysis models as proposed by Giovanella & Fleury, McIntyre et al. and Penchansky & Thomas. The results are presented along three lines: "perceptions of combined prevention and PrEP", "availability and adequacy: profile and structure of services in the context of ImPrEP", and "acceptability: attitudes and practices of health professionals and users".

Resumen: La profilaxis preexposición al VIH (PrEP) ha sido considerada una estrategia fundamental para el control de la epidemia de VIH/sida y desde 2018 ha sido objeto de estudio de implementación (Estudio ImPrEP Stakeholders), realizado en Brasil, México y Perú. Un componente cualitativo de este estudio se desarrolló con el objetivo de identificar los contextos sociales y estructurales que engloban y organizan la oferta de servicios de PrEP en Brasil, las subjetividades de los actores implicados y las diferentes percepciones que pueden impactar en hacer efectiva esa estrategia. El objetivo de este artículo es el análisis del acceso de las poblaciones vulnerables a los servicios de PrEP, desde la perspectiva de los gestores, profesionales de salud, líderes o activistas y usuarios de la PrEP. Se trata de un estudio cualitativo con uso de metodología comprensiva, realizado en seis capitales brasileñas, en las que fueron entrevistados 71 actores-clave, durante el período de noviembre de 2018 a mayo de 2019. El análisis se pautó mediante modelos analíticos sobre acceso, propuestos por Giovanella & Fleury, McIntyre et al. y Penchansky & Thomas. Los resultados se presentan a partir de tres ejes: "percepciones sobre prevención combinada y PrEP", "disponibilidad y adecuación: perfil y estructura de los servicios en el contexto de la ImPrEP" y "aceptabilidad: actitudes y prácticas de los profesionales de salud y usuarios".

High acceptability of PrEP teleconsultation and HIV self-testing among PrEP users during the COVID-19 pandemic in Brazil

ABSTRACT In March 2020, telemedicine and HIV self-testing were adopted by Brazilian Public Health services to minimize disruptions in pre-exposure prophylaxis (PrEP) access and delivery during the COVID-19 pandemic. To understand the acceptability of PrEP teleconsultation and HIV self-testing, we conducted a web-based study during social distancing period (April-May, 2020) among men who have sex with men and transgender/non-binary individuals using social media. Out of the 2375 HIV negative respondents, 680 reported PrEP use and were included in this analysis. Median age was 33 years (IQR: 28-40), 98% cisgender men, 56% white, 74% high education, and 68% middle/high income. Willingness to use HIVST was 79% and 32% received an HIV self-testing during social distancing period. The majority reported preference for PrEP/HIV self-testing home delivery instead of collecting at the service. PrEP teleconsultation was experienced by 21% and most reported feeling satisfied with the procedures. High acceptability of PrEP teleconsultation was reported by 70%. In ordinal logistic model, having higher education was associated with high aceptability of PrEP teleconsultation (aOR:1.62; 95%CI: 1.07-2.45). Our results point out that PrEP teleconsultation and PrEP/HIV self-testing home delivery could be implemented by PrEP services in Brazil to avoid PrEP shortage during the COVID-19 pandemic and thereafter as an option to increase retention and adherence.

SARS-CoV-2 testing disparities across geographical regions from a large metropolitan area in Brazil: Results from a web-based survey among individuals interested in clinical trials for COVID-19 vaccines

ABSTRACT After more than a year since the novel coronavirus (SARS-CoV-2) disease 2019 or COVID-19 has reached the status of a global pandemic, the number of COVID-19 cases continues to rise in Brazil. As no effective treatment been approved yet, only mass vaccination can stop the spread of SARS-CoV-2 and end the COVID-19 pandemic. Multiple COVID-19 vaccine candidates are under development and some are currently in use. This study aims to describe the characteristics of individuals who have registered in an online platform to participate in clinical trials for COVID-19 vaccines. Additionally, participants' characteristics according to age and presence of comorbidities associated with severe COVID-19 and differences of SARS-CoV-2 testing across different geographical areas/neighborhoods are provided. This was a cross-sectional web-based study conducted between September and December/2020, aiming to reach individuals aged ≥18 years who live in Rio de Janeiro metropolitan area, Brazil. Among 21,210 individuals who completed the survey, 20,587 (97.1%) were willing to participate in clinical trials for COVID-19 vaccines. Among those willing to participate, 57.8% individuals were aged 18-59 years and had no comorbidity, 33.7% were aged 18-59 years and had at least one comorbidity, and 8.6% were aged ≥ 60 years regardless the presence of any comorbidity. Almost half (42.6%) reported ever testing for COVID-19, and this proportion was lower among those aged ≥ 60 years (p < 0.001). Prevalence of positive PCR results was 16.0%, higher among those aged 18-59 years (p < 0.009). Prevalence of positive antibody result was 10.0%, with no difference across age and comorbidity groups. Participants from areas/neighborhoods with higher Human Development Index (HDI) reported ever testing for SARS-CoV-2 more frequently than those from lower HDI areas. Interest to participate in clinical trials for COVID-19 vaccines candidates in Rio de Janeiro was significantly high. The online registry successfully reached out a large number of individuals with diverse sociodemographic, economic and clinical backgrounds.

Telemedicine as a tool for PrEP delivery during the COVID-19 pandemic in a large HIV prevention service in Rio de Janeiro-Brazil

Abstract COVID-19 public health responses such as social distancing and community containment measures protocols are critical to preventing and containing the spread of coronavirus. Brazil accounts for almost half of Latin American HIV cases and Rio de Janeiro is the city with the second largest number of AIDS. Clinical appointments and pharmacy antiretroviral refills may be impaired due to restricted traffic and possible lockdowns, preventing people living with HIV and those using PrEP from accessing needed antiretrovirals. We hereby describe the telemedicine procedures implemented in a large PrEP delivery service in Rio de janeiro in the context of the COVID-19 pandemic. At the initial teleconsultation, individuals undergoe HIV rapid testing and are assessed by phone for PrEP related procedures. Individuals receive a digital prescription to retrieve a 120-day PrEP supply plus two HIV self-test kits. Subsequent follow-up teleconsultations will be performed remotely by phone call, including instructions for the HIV self-test performance, which results are to be sent using a digital picture. Participants will attend the service only for PrEP refill. The use of telemedicine procedures is being effective to avoid PrEP shortage and reduce the time PrEP users spend at the service during the COVID-19 pandemic and social distancing recommendations.

COVID-19: a meta-analysis of diagnostic test accuracy of commercial assays registered in Brazil

ABSTRACT The accuracy of commercially available tests for COVID-19 in Brazil remains unclear. We aimed to perform a meta-analysis to describe the accuracy of available tests to detect COVID-19 in Brazil. We searched at the Brazilian Health Regulatory Agency (ANVISA) online platform to describe the pooled sensitivity (Se), specificity (Sp), diagnostic odds ratio (DOR) and summary receiver operating characteristic curves (SROC) for detection of IgM/IgG antibodies and for tests using naso/oropharyngeal swabs in the random-effects models. We identified 16 tests registered, mostly rapid-tests. Pooled diagnostic accuracy measures [95%CI] were: (i) for IgM antibodies Se = 82% [76-87]; Sp = 97% [96-98]; DOR = 168 [92-305] and SROC = 0.98 [0.96-0.99]; (ii) for IgG antibodies Se = 97% [90-99]; Sp = 98% [97-99]; DOR = 1994 [385-10334] and SROC = 0.99 [0.98-1.00]; and (iii) for detection of SARS-CoV-2 by antigen or molecular assays in naso/oropharyngeal swabs Se = 97% [85-99]; Sp = 99% [77-100]; DOR = 2649 [30-233056] and SROC = 0.99 [0.98-1.00]. These tests can be helpful for emergency testing during the COVID-19 pandemic in Brazil. However, it is important to highlight the high rate of false negative results from tests which detect SARS-CoV-2 IgM antibodies in the initial course of the disease and the scarce evidence-based validation results published in Brazil. Future studies addressing the diagnostic performance of tests for COVID-19 in the Brazilian population are urgently needed.

Perfis de mortalidade em pessoas vivendo com HIV/aids: comparação entre o Rio de Janeiro e as demais unidades da federação entre 1999 e 2015 / Mortality profiles among people living with HIV/AIDS: comparison between Rio de Janeiro and other federative units between 1999 and 2015

RESUMO: Introdução: A aparente estabilidade da mortalidade por aids no país na última década encobre uma gama de cenários, com dois terços dos estados apresentando taxa padronizada de mortalidade por aids (TPMA) significativamente acima da média nacional e/ou em tendência ascendente. No Rio de Janeiro, a TPMA vem mantendo-se alta e estável ao longo dos anos; atualmente o estado ocupa a segunda posição no ranking nacional desse indicador. Objetivo: Examinar tendências temporais em causas de óbito na busca de padrões diferenciais que contribuam para o entendimento da mortalidade por aids no estado. Metodologia: Foram analisadas causas de óbito em qualquer campo das declarações de óbito constantes do Sistema de Informação sobre Mortalidade (SIM) entre 1999 e 2015 para indivíduos ≥ 15 anos. Doenças cardiovasculares, malignidades não relacionadas à aids, causas externas, diabetes melito e tuberculose foram estabelecidas pela menção ou não de seus códigos conforme a Classificação Estatística Internacional de Doenças e Problemas Relacionados com a Saúde (CID-10) nas declarações de óbito. Modelos lineares generalizados com efeitos mistos foram usados para descrever odds ratios relativas a 1999 e variações anuais médias ajustadas. Resultados: Verificaram-se o aumento proporcional em causas externas e doenças geniturinárias e, sobretudo, o persistente papel desempenhado pela tuberculose, impactando diferencialmente a mortalidade por aids no estado, em um cenário de alta mortalidade por doenças infecciosas. Conclusão: Os achados reforçam a manutenção da tuberculose na mortalidade de pessoas vivendo com HIV/aids (PVHA) no Rio de Janeiro e chamam a atenção para a necessidade de avaliar determinantes individuais atuando na redução da sobrevida desses pacientes, de forma a aprimorar o programa de controle do HIV/aids no estado.

ABSTRACT: Introduction: The trend toward stabilization regarding the AIDS epidemic in Brazil over the past decade hides a very complex scenario, where two-thirds of the Brazilian federative units exhibit AIDS standardized mortality rates (ASMR) significantly above the national average and/or in upward tendency. ASMR in Rio de Janeiro State remains virtually unchanged over the years; the state currently occupies the second position in the national ranking of this indicator. Objective: To assess temporal trends in causes of death searching for differential profiles that could be useful for understanding mortality among patients with HIV in the state. Methodology: Causes of death were analyzed in any field of the death certificates from the Mortality Information System between 1999 and 2015 for individuals ≥ 15 years of age. Cardiovascular diseases, non-AIDS-related cancers, external causes, diabetes mellitus, and tuberculosis were established by the mention or not of their codes according to the 10th edition of International Statistical Classification of Diseases and Related Health Problems (ICD-10) in death certificates. Generalized linear mixed-effects models were used to describe odds ratios in relation to 1999 and adjusted mean annual variations. Results: The results point to the emerging role of external causes and genitourinary diseases and the persistent role played by tuberculosis, differentially affecting AIDS mortality in the state, in a scenario of high mortality due to infectious diseases. Conclusion: These data suggest that tuberculosis remains a major cause of death among people living with HIV/AIDS (PLWHA) in Rio de Janeiro, highlighting the need for studies that identify individual-level factors impacting their survival, thus improving local HIV/AIDS control measures.

Prevalência e fatores associados ao aborto induzido no ingresso em uma coorte de mulheres vivendo com HIV/aids, Rio de Janeiro, Brasil, 1996-2016 / Prevalencia y factores asociados al aborto inducido en el ingreso en una cohorte de mujeres que viven con VIH/SIDA, Río de Janeiro, Brasil, 1996-2016 / Prevalence of induced abortion and associated factors in a cohort of women living with HIV/AIDS, Rio de Janeiro, Brazil, 1996-2016

O objetivo deste estudo é verificar a prevalência e os fatores associados ao aborto induzido no ingresso em uma coorte de mulheres vivendo com HIV/aids, no Município do Rio de Janeiro, Brasil, no período 1996-2016. O critério de elegibilidade para o ingresso na coorte era ser do sexo feminino ao nascimento, ter mais de 18 anos de idade e ter infecção comprovada pelo HIV. Na visita inicial, dados sobre aspectos sexuais, reprodutivos, comportamentais e da infecção pelo HIV foram obtidos durante entrevista face a face com o médico assistente. Foi calculada a prevalência de aborto induzido na vida e verificados os fatores associados ao aborto induzido por meio de regressão logística múltipla, para o total de mulheres e entre aquelas com gestação prévia. Do total de mulheres, 30,4% referiram algum aborto induzido na vida, sendo este valor de 33,5% em mulheres com gestação prévia. A frequência de aborto induzido relatado apresentou queda significativa no período analisado (41,7% de 1996-2000 vs. 22,5% de 2011-2016, p < 0,001). Os fatores associados ao aborto induzido, tanto para o total de mulheres quanto para aquelas com gestação prévia, foram o aumento da idade, escolaridade mais elevada, número de parceiros sexuais na vida ≥ 5, gestação na adolescência, uso de qualquer droga ilícita na vida e período de ingresso na coorte após 2005. Mudanças no perfil socioeconômico, sexual, reprodutivo e da infecção pelo HIV são explicações possíveis para a redução da prática do aborto no período. Estudos que utilizem métodos de aferição direta do aborto devem ser conduzidos em outras populações, para confirmar a tendência de queda do aborto induzido no país e seus determinantes.

El objetivo de este estudio es verificar la prevalencia y los factores asociados al aborto inducido en el ingreso en una cohorte de mujeres, que viven con VIH/sida, en el municipio de Rio de Janeiro, durante el período 1996-2016. El criterio de elegibilidad para el ingreso en la cohorte era ser del sexo femenino al nacer, tener más de 18 años de edad y sufrir una infección comprobada por VIH. En la visita inicial, datos sobre aspectos sexuales, reproductivos, comportamentales y de infección por el VIH se obtuvieron durante la entrevista cara a cara con el médico asistente. Se calculó la prevalencia del aborto inducido en la vida y se verificaron los factores asociados al aborto inducido mediante regresión logística múltiple, para el total de mujeres y entre aquellas con gestación previa. Del total de mujeres, un 30,4% refería algún aborto inducido en la vida, siendo ese valor de un 33,5% en mujeres con gestación previa. La frecuencia de aborto inducido relatado presentó una caída significativa durante el período analizado (un 41,7% en el período 1996-2000 vs. 22,5% en el período 2011-2016, p < 0,001). Los factores asociados al aborto inducido, tanto para el total de mujeres, como para aquellas con gestación previa, fueron el aumento de la edad de la mujer, escolaridad más elevada, número de parejas sexuales en la vida ≥ 5, gestación en la adolescencia, consumo de cualquier droga ilícita en la vida y período de ingreso en la cohorte tras 2005. Cambios en el perfil socioeconómico, sexual, reproductivo y de infección por VIH son explicaciones posibles para la reducción de la realización de abortos durante el período. Se deben llevar a cabo estudios que utilicen métodos de medición directa del aborto en otras poblaciones para confirmar la tendencia de caída del aborto inducido en el país y sus determinantes.

The aim of this study was to verify the prevalence of induced abortion and associated factors at the time of inclusion in a cohort of women living with HIV/AIDS in the city of Rio de Janeiro, Brazil, from 1996 to 2016. Eligibility criteria for inclusion in the cohort were female sex at birth, age 18 years and older, and confirmed HIV infection. At the baseline visit, data on sexual, reproductive, and behavioral aspects and HIV infection were obtained through a face-to-face interview with the attending physician. Lifetime prevalence of induced abortion was calculated, and factors associated with induced abortion were verified by multiple logistic regression for all the women and for those with previous pregnancy. In the entire cohort of women, 30.4% reported a history of induced abortion, compared to 33.5% in women with previous pregnancy. Frequency of reported induced abortion showed a significant reduction during the period (41.7% in 1996-2000 versus 22.5% in 2011-2016, p < 0.001). Factors associated with induced abortion, both for the entire cohort and for the women with previous pregnancy, were age, schooling, ≥ 5 lifetime sexual partners, teenage pregnancy, lifetime use of any illicit drug, and inclusion in the cohort after the year 2005. Changes in the socioeconomic, sexual, reproductive, and HIV infection profile are possible explanations for the reduction in abortions during the period. Studies that use direct methods to measure abortion should be conducted in other populations to confirm the downward trend in induced abortion and its determinants in Brazil.

Hybrid capture as a tool for cervical lesions screening in HIV-infected women: insights from a Brazilian cohort

ABSTRACT Introduction: Cervical cancer remains an important burden for HIV-infected women in the era of combination antiretroviral therapy. Recommendations for cervical screening in these women diverge and may include high-risk HPV (HRHPV) testing. We aimed to evaluate the clinical usefulness of a single HRHPV testing for cervical screening of HIV-infected women. Methods: 723 HIV-infected women from a Brazilian prospective cohort were included between 1996 and 2012. Inclusion criteria were: normal cervical cytology at baseline and having a HRHPV-test at baseline. We calculated incidence rates of any squamous intraepithelial lesion (SIL) and high grade SIL+ (HSIL+) and negative predictive values (NPV) within 12 and 36 months. Hazard Ratios were obtained using Cox proportional hazards regression models. Results: Incidence rate for both outcomes was low (9.9 cases per 100 PY [95% CI 8.8-11.0] for any SIL and 1.3 cases per 100 PY [95% IC 0.9-1.8] for HSIL+). Women with a HRHPV positive status at baseline had 1.7-fold (95% CI 1.3-2.2) and 3.2-fold (95% CI 1.5-7.1) increased risk of presenting any SIL and HSIL+, respectively, during follow-up. Negative-HRHPV test presented high NPV for both periods and outcomes (any SIL: 92.4% [95% CI 89.7-94.6] for 12 months and 80.9% [95% CI 77.2-84.3] for 36 months; and HSIL+: 99.8% [95% CI 98.9-100.0] for 12 months and 99.0 [95% CI 97.6-99.7] for 36 months). Conclusions: Incidence of any and high grade cytological abnormality was significantly higher among HIV-infected women with positive-HRHPV test. A single negative-HRHPV test helped reassure follow-up free of cytological abnormalities through three years of follow-up in HIV-infected women with negative cytology.