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Background: Early progression of AIDS-associated Kaposi sarcoma (KS-PD) and immune reconstitution inflammatory syndrome (KS-IRIS) sometimes occur after the initiation of antiretroviral therapy (ART). Methods: Early KS-PD and KS-IRIS were assessed in the A5264/AMC-067 trial in which participants with mild-to-moderate AIDS-KS were randomized to initiate ART with either immediate or as-needed oral etoposide. Early KS-PD was defined as tumor progression within 12 weeks of ART initiation. When investigators had concern that early KS-PD was KS-IRIS, additional evaluations were performed. Suspected KS-IRIS was defined as early KS-PD accompanied by a CD4 count increase of ≥50 cells per cubic millimeter or plasma HIV-1 RNA decrease of ≥0.5 log10 copies/mL. Clinical outcome was a composite end point categorized as failure, stable, and response at 48 and 96 weeks compared with baseline. Results: Fifty of 190 participants had early KS-PD (27%): 28 had KS-IRIS and 22 were not evaluated for KS-IRIS. Early KS-PD and KS-IRIS incidences with immediate etoposide versus ART alone were 16% versus 39%, and 7% versus 21%, respectively. Week 48 clinical outcome was 45% failure, 18% stable, and 37% response for no early KS-PD; 82% failure, 2% stable, and 16% response for early KS-PD; and 88% failure, 0% stable, and 12% response for KS-IRIS. Cumulative incidence of KS tumor response by week 96 was 64% for no early KS-PD, 22% with early KS-PD, and 18% with KS-IRIS. Conclusions: Early KS-PD, including suspected KS-IRIS, was common after starting ART for AIDS-KS and was associated with worse long-term clinical outcomes. Starting ART concurrently with etoposide reduced the incidence of both early KS-PD and KS-IRIS compared with ART alone.

We conducted a web-based survey to understand the impact of social distancing measures on Brazilian MSM and transgender/non-binary lives. A total of 3486 respondents were included in this analysis and the great majority were cismen (98%). The median age was 32 years (IQR: 27–40), 44% non-white, 36% low schooling and 38% low income. Most of participants reported HIV negative/unknown status (77%). Participants on-PrEP reported more condomless anal sex than those off-PrEP. Conversely, 24% off-PrEP were at substantial HIV-risk. PrEP/ART continuation were reported by the majority, despite reports of impediments to medication refill. Transgender/non-binary reported more mental health problems and challenges to access health care. Social and racial disparities were associated with unattainability of maintaining social distancing. Tailored social and economic support policies during COVID-19 pandemic should be made available to these populations. Challenges for PrEP/ART access will demand the implementation of innovative solutions to avoid the expansion of the HIV epidemic.

Summary Background Optimal treatment regimens for AIDS-associated Kaposi sarcoma, a frequent contributor to morbidity and mortality among people with HIV, have not been systematically evaluated in low-income and middle-income countries, where the disease is most common. In this study, we aimed to investigate optimal treatment strategies for advanced stage disease in areas of high prevalence and limited resources. Methods In this open-label, non-inferiority trial, we enrolled people with HIV and advanced stage AIDS-associated Kaposi sarcoma attending 11 AIDS Clinical Trials Group sites in Brazil, Kenya, Malawi, South Africa, Uganda, and Zimbabwe. Eligible participants were randomly assigned (1:1:1) with a centralised computer system to receive either intravenous bleomycin and vincristine or oral etoposide (the investigational arms), or intravenous paclitaxel (the control arm), together with antiretroviral therapy (ART; combined efavirenz, tenofovir disoproxil fumarate, and emtricitabine). The primary outcome was progression-free survival (PFS) at week 48, using a 15% non-inferiority margin to compare the investigational groups against the active control group. Safety was assessed in all eligible treated study participants. The study was registered with ClinicalTrials.gov, NCT01435018. Findings 334 participants were enrolled between Oct 1, 2013, and March 8, 2018, when the study was closed early due to inferiority of the bleomycin and vincristine plus ART arm, as per the recommendations of the Data and Safety Monitoring Board (DSMB). The etoposide plus ART arm also closed due to inferiority in March, 2016, following a DSMB recommendation. Week-48 PFS rates were higher in the paclitaxel plus ART arm than in both investigational arms. The absolute differences in PFS were −30% (95% CI −52 to −8) for the comparison of paclitaxel plus ART (week 48 PFS 50%, 32 to 67; n=59) and etoposide plus ART (20%, 6 to 33; n=59), and −20% (−33% to −7%) for the comparison of paclitaxel plus ART (64%, 55 to 73; n=138) and bleomycin and vincristine plus ART (44%, 35 to 53; n=132). Both CIs overlapped the non-inferiority margin. The most common adverse events, in 329 eligible participants who began treatment, were neutropenia (48 [15%]), low serum albumin (33 [10%]), weight loss (29 [9%]), and anaemia (28 [9%]), occurring at similar frequency across treatment arms. Interpretation Non-inferiority of either investigational intervention was not shown, with paclitaxel plus ART showing superiority to both oral etoposide plus ART and bleomycin and vincristine plus ART, supporting its use in treating advanced AIDS-associated Kaposi sarcoma in resource-limited settings. Funding US National Institute of Allergy and Infectious Diseases and National Cancer Institute, National Institutes of Health.

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”.

BACKGROUND In many parts of the world, including Brazil, uptake for biomedical interventions has been insufficient to reverse the HIV epidemic among key populations at high risk for HIV, including men who have sex with men. Young MSM (YMSM), particularly Black YMSM, have high HIV incidence, low viral suppression, and low preexposure prophylaxis (PrEP) uptake and adherence. Therefore, novel approaches to increase the HIV biomedical interventions uptake by YMSM are urgently needed. OBJECTIVE We describe the Conectad@s Project, which aims to: (1) estimate the prevalence and incidence of HIV and other sexually transmitted infections, the onset of sexual risk behavior, and barriers to biomedical interventions among YMSM aged 18 to 24 years in Rio de Janeiro, Brazil; and (2) conduct a technology-based adherence intervention study to promote a rapid linkage of YMSM to HIV care or prevention, and support and sustain adherence. METHODS A cross-sectional survey will be conducted with 400 YMSM recruited using respondent-driven sampling (RDS) adapted for social media-based sampling, preceded by a formative phase. HIV and sexually transmitted infections testing will be conducted, including early HIV infection biomarker detection. Behavioral, partnership, network, and structural measures will be collected through structured questionnaires. All individuals recruited for the survey will have access to HIV risk assessment, antiretroviral therapy (ART), PrEP, prevention counseling, and a technology-based adherence intervention. Those who accept the adherence intervention will receive weekly text messages via a social networking app (WhatsApp) for 24 weeks, with follow-up data collected over 48 weeks. RESULTS The Conectad@s project has been approved by our local institutional review board (#CAAE 26086719.0.0000.4262) in accordance with all applicable regulations. Questionnaires for the RDS survey and intervention were developed and tested in 2020, formative interviews were conducted in January and February 2021 to guide the development of the RDS, and enrollment is planned to begin in early 2022. CONCLUSIONS The Conectad@s Project is a vanguard study that, for the first time, will apply digital RDS to sample and recruit YMSM in Brazil and rapidly connect them to ART, PrEP, or prevention counseling through a technology-based adherence intervention. RDS will allow us to estimate HIV prevalence among YMSM and measure HIV infection biomarkers in the context of the onset of risky behavior. The data will lay the groundwork to adapt and implement HIV prevention strategies, identify barriers to the earliest HIV infection diagnosis, immediate ART or PrEP initiation, and detect new clusters of HIV transmission. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/34885

IntroductionPre-exposure prophylaxis (PrEP) is an important and well-established prevention strategy for sexual acquisition of HIV. In Brazil, transgender women (TGW) and men who have sex with men (MSM) bear the largest burden among key populations. Little is known about preferences for PrEP characteristics in these vulnerable populations in Latin America. The goal of this study is to investigate preferences of TGW and MSM with respect to PrEP characteristics, whether current user or not, and to assess any attributes and levels that may improve the decision to start using PrEP (uptake) and optimal continuity of use (adherence), which are important dimensions for PrEP success.Methods and analysisWe hereby outline the protocol of a discrete choice experiment (DCE) to be conducted among TGW and MSM in Brazil. The study will be carried out in two phases. The first phase involves literature review and qualitative approaches including in-depth interviews to inform the development of the DCE (attributes and levels). The second phase entails the DCE survey and supporting questions pertaining to sociodemographic and risk behaviour information. The survey is aimed at current PrEP users and non-users, consisting of two modes of administration: face to face in five Brazilian capitals (Rio de Janeiro, Brasília, Manaus, Porto Alegre and Salvador) and online targeting the entire country. A D-efficient zero-prior blocked experimental design will be used to select 60 paired-profile DCE choice tasks, in which participants will be randomly assigned to one of four groups and presented with a set of 15 choice tasks. The planned sample size is 1000 volunteers.Ethics, timeline and disseminationThe study was approved by Comitê de Ética em Pesquisa—Instituto Nacional de Infectologia Evandro Chagas—INI/FIOCRUZ, CEP/INI, CAAE 28416220.2.1001.5262, approval number 3.979.759 in accordance with the Comissão Nacional de Ética em Pesquisa (CONEP—Brazilian National Board of Research Ethics). The study will be conducted between 2020 and 2021. The results will be disseminated to the scientific community and to the public in general through publications in published in peer-reviewed journals and in scientific conferences.

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.

We aimed to evaluate daily oral pre-exposure prophylaxis (PrEP) uptake, retention, and adherence and predictors of study non-attendance and low PrEP adherence in a Brazilian trans-specific 48-week study (PrEParadas).We enrolled transgender women (TGW) engaging in high-risk sexual behaviours between August 2017 and December 2018. PrEP adherence was based on tenofovir diphosphate concentrations in dried blood spots (DBS). We used random effects logistic regression models and ordinal models to estimate the odds of having a missed visit and of low PrEP adherence, respectively. Multivariable models were adjusted for variables with p-value0.10 in the univariate analysis.From the 271 eligible, 130 participants were enrolled in the study (PrEP uptake: 48%), out of which 111 (85.4%) were retained at 48 weeks. Multivariable model for study non-attendance included study visit, age, main sexual partner and stimulant use. The odds of missing a visit increased after the week 24. Participants aged 18-24 (adjusted odds ratio [aOR] = 8.76, 95% CI: 2.09-36.7) and 25-34 years (aOR = 6.79, 95% CI: 1.72-26.8) compared to TGW aged 35+ years had significantly higher odds of having a missed visit. The odds of a missed visit were higher among participants reporting stimulant use (aOR = 4.99, 95% CI: 1.37-18.1) compared to no stimulant use. DBS levels at week 48 showed that 42 (38.5%), 14 (12.8%) and 53 (48.6%) of 109 participants had low, moderate and high PrEP adherence. Multivariable model for low PrEP adherence included study visit, age, schooling, race/colour, housing, binge drinking, stimulant use, feminizing hormone therapy (FHT) use and received text message. Low PrEP adherence was significantly higher among participants with less years of schooling (aOR = 6.71, 95% CI: 1.30-34.5) and had a borderline association with Black colour/race (aOR = 6.72, 95% CI: 0.94-47.8). Participants using the FHT available at the site had decreased odds of low PrEP adherence (aOR = 0.38, 95% CI: 0.16-0.88). No participant seroconverted over the course of the study.Although high PrEP retention can be achieved in a gender-affirming setting, PrEP adherence may be an important challenge faced among TGW due to social disparities. The scale-up of prevention tools like PrEP will have to address systemic social determinants as these stand as important barriers for TGW's access to health services.

Pre-exposure prophylaxis (PrEP) prevents HIV infection among men who have sex with men (MSM) and transgender women (TGW) who are the groups that presents the high incidence risk in Brazil. This cross-sectional secondary analysis describes possible risk compensation, attitudes, and beliefs regarding the use of PrEP among 723 MSM and TGW evaluated in the PrEP Brazil study pre-screening phase. Possible risk compensation was reported by 31.6% individuals. In the multivariate model, factors that increased the likelihood of possible risk compensation were: self-referring as white vs. Black (AOR 2.05; CI 1.09, 3.85), perceiving high likelihood of getting HIV in next 12 months (AOR 1.78; CI 1.23, 2.56), being less afraid of HIV infection if using PrEP (AOR 1.93; CI 1.19, 3.14), feeling liberated to have more partners if using PrEP (AOR 2.93; CI 1.92, 4.49), and believing closest friends would use PrEP (AOR 2.51; CI 1.1, 5.71). We found that possible risk compensation was more common among individuals who presented high-risk perception for HIV infection, probably reflecting they feel at risk and could benefit from PrEP use.

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 GiovanellaFleury, McIntyre et al. and PenchanskyThomas. 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".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 GiovanellaFleury, McIntyre et al. e PenchanskyThomas. 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”.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 GiovanellaFleury, McIntyre et al. y PenchanskyThomas. 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”.

Objective: The aim of this study was to investigate the impact of intersubtype HIV-1 superinfection on viremia, reservoir reseeding, viral evolution and disease progression in HIV controllers (HIC). Design: A longitudinal analysis of two Brazilian HIC individuals (EEC09 and VC32) previously identified as dually infected with subtypes B and F1 viruses. Methods: Changes in plasma viremia, total HIV-1 DNA levels, CD4þ T-cell counts and HIV-1 quasispecies composition were measured over time. HIV-1 env diversity in peripheral blood mononuclear cell (PBMC) and plasma samples was accessed by single genome amplification and next-generation sequencing approaches, respectively. Viral evolution was evaluated by estimating nucleotide diversity and divergence. Results: Individual EEC09 was probably initially infected with a CCR5-tropic subtype B strain and sequentially superinfected with a CXCR4-tropic subtype B strain and with a subtype F1 variant. Individual VC32 was infected with a subtype B strain and superinfected with a subtype F1 variant. The intersubtype superinfection events lead to a moderate increase in viremia and extensive turnover of viral population in plasma but exhibited divergent impact on the size and composition of cell-associated HIV DNA population. Both individuals maintained virologic control (

(1) Background: We aimed to estimate sexualized drug use (SDU) prevalence and its predictors among sexual and gender minorities. (2) Methods: We used an online and on-site survey to enroll sexual/gender minorities people between October–December/2020, and multivariate logistic regression to obtain SDU correlates. (3) Results: We enrolled 3924 individuals (280 transgender women [TGW], 3553 men who have sex with men [MSM], and 91 non-binary), 29.0% currently on pre-exposure prophylaxis (PrEP). SDU prevalence was 28.8% (95% confidence interval [CI] 27.4–30.2). TGW had 2.44-times increased odds (95%CI 1.75–3.39) of engaging in SDU compared to MSM, regardless of PrEP use. PrEP use (aOR 1.19, 95%CI 1.00–1.41), South/Southeast region (aOR 1.26, 95%CI 1.04–1.53), younger age (18–24 years: aOR 1.41, 95%CI 1.10–1.81; 25–35 years: aOR 1.24, 95%CI 1.04–1.53), white race/color (aOR 1.21, 95%CI 1.02–1.42), high income (aOR 1.32, 95%CI 1.05–1.67), binge drinking (aOR 2.66, 95%CI 2.25–3.14), >5 sexual partners (aOR 1.88, 95%CI 1.61–2.21), condomless anal sex (aOR 1.49, 95%CI 1.25–1.79), self-reported sexually transmitted infection (aOR 1.40, 95%CI 1.14–1.71), and higher perceived HIV-risk (aOR 1.37, 95%CI 1.14–1.64) were associated with SDU. (4) Conclusions: TGW had the highest SDU odds. SDU may impact HIV vulnerability among key populations and should be addressed in HIV prevention approaches.

Background: HIV disproportionally affects key populations including men who have sex with men (MSM). HIV prevalence among MSM varies from 17% in Brazil and Mexico to 13% in Peru, whereas it is below 0.5% for the general population in each country. Pre-exposure prophylaxis (PrEP) with emtricitabine/tenofovir is being implemented in the context of combination HIV prevention. Reports on willingness to use PrEP among MSM have started to emerge over the last few years. Previously reported factors associated with willingness to use PrEP include awareness, higher sexual risk behavior, and previous sexually transmitted infection. Objective: This study aimed to evaluate the factors associated with willingness to use daily oral PrEP among MSM in 3 Latin American, middle-income countries (Brazil, Mexico, and Peru). Methods: This Web-based, cross-sectional survey was advertised in 2 gay social network apps (Grindr and Hornet) used by MSM to find sexual partners and on Facebook during 2 months in 2018. Inclusion criteria were being 18 years or older, cisgender men, and HIV-negative by self-report. Eligible individuals answered questions on demographics, behavior, and PrEP (awareness, willingness to use, barriers, and facilitators). Multivariable logistic regression modeling was performed to assess the factors associated with willingness to use daily oral PrEP in each country. Results: From a total sample of 43,687 individuals, 44.54% of MSM (19,457/43,687) were eligible and completed the Web-based survey—Brazil: 58.42% (11,367/19,457), Mexico: 30.50% (5934/19,457), and Peru: 11.08% (2156/19,457); median age was 28 years (interquartile range: 24-34), and almost half lived in large urban cities. Most participants were recruited on Grindr (69%, 13,349/19,457). Almost 20% (3862/19,352) had never tested for HIV, and condomless receptive anal sex was reported by 40% (7755/19,326) in the previous 6 months. Whereas 67.51% (13,110/19,376) would be eligible for PrEP, only 9.80% (1858/18,959) of participants had high HIV risk perception. PrEP awareness was reported by 64.92% (12,592/19,396); this was lower in Peru (46.60%, 1002/2156). Overall, willingness to use PrEP was reported by 64.23% (12,498/19,457); it was highest in Mexico (70%, 4158/5934) and lowest in Peru (58%, 1241/2156). In multivariate regression models adjusted for age, schooling, and income in each country, willingness to use PrEP was positively associated with PrEP awareness and PrEP facilitators (eg, free PrEP and HIV testing) and negatively associated with behavioral (eg, concerned by daily pill regimen) and belief barriers (eg, sexual partners may expect condomless sex). Conclusions: In this first cross-country, Web-based survey in Latin America, willingness to use PrEP was found to be high and directly related to PrEP awareness. Interventions to increase awareness and PrEP knowledge about safety and efficacy are crucial to increase PrEP demand. This study provides important information to support the implementation of PrEP in Brazil, Mexico, and Peru.

Brazil has the largest population of individuals living with HIV/AIDS in Latin America with a disproportional prevalence of infection among men who have sex with men (MSM). This study evaluated PrEP awareness by age (18-24, 25-35, ≥36 years), its associated factors and the willingness to use HIV prevention technologies among MSM using a GSN app in Brazil. Inclusion criteria were ≥18 years-old, cisgender men and HIV-negative serostatus. Of 7242 individuals, 4136 (57%) completed the questionnaire. PrEP awareness was reported by 51% (though lower among MSM aged 18-24 and ≥36 years) and its associated factors were higher family income, most friends with the same sexual orientation, high number of male sexual partners and marijuana use. HIV testing (never vs. at least once) lead to an almost 3-fold increase in the odds of PrEP awareness. High HIV risk perception led to increased PrEP awareness only among MSM aged 18-24 years. A total of 2335 (56%) was willing to use daily oral PrEP. PrEP awareness remains low in Brazil and mobile tools are key strategies to reach MSM and increase awareness of prevention technologies. Community-based interventions could add to online campaigns to reach the most vulnerable, which include young, non-white and lower-income MSM.

Some multifunctional cellular proteins, as the monocyte chemotactic protein-induced protein 1 (MCPIP1) and the cyclin-dependent kinase inhibitor p21, have also shown to be able to modulate the cellular susceptibility to the human immunodeficiency virus type 1 (HIV-1). Several studies described that p21 is expressed at high levelsex vivoin cells from individuals who naturally control HIV-1 replication (HIC). The expression level of MCPIP1 in HIC was never described before, but a recent study in a model of renal carcinoma cells showed that MCPIP1 overexpression was associated with an increase of both p21 transcripts and proteins levels. Here, we explored the potential associations between MCPIP1 and p21 expression, as well as with cellular activation in HIC, sustaining undetectable (elite controllers – EC) or low (viremic controllers – VC) viral loads. We found a selective upregulation of MCPIP1 and p21 mRNA levels in PBMC from HIC compared with both ART– suppressed and HIV–negative control groups (P ≤ 0.02) and a strong positive correlation (r ≥ 0.57; P ≤ 0.014) between expressions of both transcripts independently of the VL, treatment condition and HIV status. The mRNA levels of p21, but not of MCPIP1, were positively correlated with activated CD4+T cells levels in HIC and EC (r ≥ 0.53; P ≤ 0.017). In relation to the monocyte activation, the mRNA levels of both p21 (r = 0.74; P = 0.005) and MCPIP1 (r = 0.58; P = 0.040) were positively correlated with plasmatic levels of sCD14 only in EC. Multivariate analysis confirmed the association between MCPIP1 and p21 mRNA levels, and between the latter with the frequency of activated CD4+T cells. These data show for the first time the simultaneous overexpression and positive correlation of MCPIP1 and p21 transcripts in the setting of natural suppression of HIV-1 replicationin vivo. The positive correlation between MCPIP1 and p21 transcripts supports a common regulatory pathway connecting these multifunctional host factors and a possible synergistic effect on HIV-1 replication control. Pharmacological manipulation of these cellular proteins may open novel therapeutic perspectives to prevent HIV-1 replication and disease progression.

Background: HIV controllers (HICs) constitute a heterogeneous group of HIV-1 individuals able to suppress plasma viremia to low or undetectable levels in the absence of antiretroviral therapy. Host genetic factors may be involved in the sustained control of viral replication observed. We investigated the distribution and the potential impact of human leukocyte antigens (HLA)-B and -C alleles, killer immunoglobulin-like receptor (KIR) genes, single nucleotide polymorphisms (SNPs) of the NLRP3, CARD8 and IL-1β inflammasome genes, and CCR5Δ32 mutation on the viral control among HICs. Methods: In total, 28 HICs were categorized as persistent elite controllers (PECs, n = 7), ebbing elite controllers (EECs, n = 7), and viremic controllers (VCs, n = 14) according to the level of natural suppression of viremia. HLA alleles were assigned by sequencing-based typing, KIR alleles by polymerase chain reaction (PCR) sequence-specific amplification, SNPs by real-time PCR, and the CCR5Δ32 mutation by PCR. Results: Significant differences were observed in the pairwise comparisons of protective HLA-B alleles, KIR Bx genotype, KIR2DL3 + C1 pair, KIR2DL5, and KIR2DS5 allelic carrier frequencies among the HIC groups. Multivariate models showed that HICs without the KIR2DL3 allele or without KIR2DL3 + C1/C2 pair, with the HLA-C*08 allele or with the NLRP3 rs10754558-G SNP had a higher mean hazard of a viral load above 2,000 copies/mL, while a lower mean hazard of this event was observed for HICs with KIR2DL5, KIR2DS1, KIR2DS5, and KIR3DS1 alleles. Moreover, HICs with the KIR2DS5 allele had less risk of undergoing viral load (VL) blips within the same normalized period than those participants without this allele, while HICs without the KIR2DL3 allele had a mean higher risk of experiencing VL blips. Conclusions: These results indicate that innate immune mechanisms may play an essential role in modulating the sustained control of viral replication in HICs.

Antiretroviral pre-exposure prophylaxis (PrEP) is recommended to prevent HIV infection among high-risk men who have sex with men (MSM) though not available in Brazil where the HIV epidemic persists unabated in this group. This cross-sectional study describes PrEP awareness and willingness and associated factors among MSM and transvestite/transgender women (trans women) pre-screened for the PrEP Brasil study. Awareness was reported by 61.3 % of the participants and was associated with age, education, site, study period and prior HIV testing. Most participants (82.1 %) were willing to use PrEP, which was associated with site, study period, number of male condomless anal sexual partners and anal sex with HIV positive/unknown partners. PrEP information is need among young and less educated individuals. Willingness to use PrEP was high and future studies should be conducted to confirm PrEP acceptability and the characteristics of the population who chose to adopt this intervention.

Background: HIV epidemics disproportionately affect transwomen worldwide. Trans-specific guidance, outreach, and interventions to increase pre-exposure prophylaxis (PrEP) use among transwomen are scarce. Setting: Rio de Janeiro, Brazil. Methods: We measured awareness and willingness to use PrEP and examined factors associated with those outcomes among transwomen in Rio de Janeiro and estimated how many transwomen would be eligible for PrEP. Data originate from Transcender study, a respondent-driven sampling survey conducted from August 2015 to January 2016. We performed regression models for PrEP awareness and willingness. Results: One hundred thirty-one (38.0%) of 345 participants had heard of PrEP. Among transwomen who self-reported as HIVnegative, 162 (76.4%, N = 212 with available data) reported willingness to use it and 163 (66.8%, N = 244) met PrEP behavioral eligibility criteria. Transwomen with health access in the previous 6 months who reported HIV-infected sexual partner and with 8+ years of schooling had increased odds of PrEP awareness. Lower PrEP awareness was associated with condomless anal intercourse and newly diagnosed HIV infection. Younger age and perceiving themselves at risk of HIV infection increased the odds of PrEP willingness. Lower odds of PrEP willingness were associated with concerns about long-term effects of PrEP and with difficulties in getting access to health care due to transphobia. Conclusion: Combination of low awareness, high willingness, and substantial PrEP eligibility corroborates transwomen as a key population for HIV prevention. PrEP is a promising and empowering strategy for HIV prevention among transwomen, but trans-specific recommendations are needed to effectively implement PrEP in this population.

Background Mild-to-moderate AIDS-associated Kaposi sarcoma (KS) often responds to antiretroviral therapy (ART) alone; the role of chemotherapy is unclear. We assessed the impact of immediate vs as-needed oral etoposide (ET) among human immunodeficiency virus (HIV)-infected individuals with mild-to-moderate KS initiating ART. Methods Chemotherapy-naive, HIV type 1-infected adults with mild-to-moderate KS initiating ART in Africa and South America were randomized to ART (tenofovir/emtricitabine/efavirenz) alone (chemotherapy "as-needed" arm) vs ART plus up to 8 cycles of oral ET (immediate arm). Participants with KS progression on ART alone received ET as part of the as-needed strategy. Primary outcome was ordinal as follows: failure, stable, and response at 48 weeks. Secondary outcomes included time to initial KS progression, KS-associated immune reconstitution inflammatory syndrome (KS-IRIS), and KS response. Results Of 190 randomized participants (as-needed = 94, immediate = 96), the majority were men (71%) and African (93%). Failure (53.8% vs 56.6%), stable (16.3% vs 10.8%), and response (30% vs 32.5%) did not differ between arms (as-needed vs immediate) among those with week 48 data potential (N = 163, P = .91). Time to KS progression (P = .021), KS-IRIS (P = .003), and KS response (P = .003) favored the immediate arm. Twenty-five participants died (13%). Mortality, adverse events, CD4+ T-cell changes, and HIV RNA suppression were similar at 48 weeks. Conclusions Among HIV-infected adults with mild-to-moderate KS, immediate ET provided early, nondurable clinical benefits. By 48 weeks, no clinical benefit was observed compared to use of ET as needed. Mortality was high and tumor response was low. Clinical trials registration NCT01352117.

Background: Geosocial networking (GSN) smartphone apps are becoming the main venue for sexual encounters among Brazilian men who have sex with men (MSM). To address the increased HIV incidence in this population, preexposure prophylaxis (PrEP) was recently implemented in the Brazilian public health system in the context of combined HIV prevention. Objective: This study aimed to describe the characteristics of MSM using GSN apps for sexual encounters, their awareness of prevention strategies, and willingness to use PrEP. Methods: This study was an online cross-sectional study conducted in 10 Brazilian state capitals from July 1 to July 31, 2016. The questionnaire was programmed on SurveyGizmo and advertised in two GSN apps used by MSM to find sexual partners (Hornet and Grindr). Inclusion criteria were >18 years of age, cisgender men, with an HIV-negative status. Eligible individuals answered questions on: demographics; behavior; and knowledge, preferences, and willingness to use PrEP, nonoccupational postexposure prophylaxis (nPEP), HIV self-testing (HIVST), and condoms. Logistic regression modeling was performed to assess the factors associated with daily oral PrEP willingness. Results: During the study period, 8885 individuals provided consent and started the questionnaire. Of these, 23.05% (2048/8885) were ineligible, 6837 (6837/8885, 76.94%) initiated, and 5065 (5065/8885, 57.00%) completed the entire questionnaire and were included in the present analysis. Median age was 30 years (interquartile range: 25-36), most self-declared as MSM (4991/5065, 98.54%), white (3194/5065, 63.06%), middle income (2148/5065, 42.41%), and had 12 or more years of schooling (3106/5062, 61.36%). The majority of MSM (3363/5064, 66.41%) scored >10 points (high risk) on The HIV Incidence Risk for MSM Scale, but only 21.39% (1083/5064) had a low perceived likelihood of getting HIV in the next year. Daily use of apps for sex was reported by 35.58% (1798/5054). Most MSM (4327/5065, 85.43%) reported testing for HIV at least once in their lifetime and 9.16% (464/5065) used nPEP in the previous year. PrEP, nPEP, and HIVST awareness was reported by 57.89% (2932/5065), 57.39% (2907/5065), and 26.57% (1346/5065) of participants, respectively. Half of all respondents (2653/5065, 52.38%) were willing to use daily oral PrEP, and this finding was associated with higher numbers of male sexual partners (adjusted odds ratio [AOR] 1.26, 95% CI 1.09-1.47), condomless receptive anal intercourse (AOR 1.27, 95% CI 1.12-1.44), sex with HIV-positive partner versus no HIV-positive partner (one HIV-positive partner: AOR 1.36, 95% CI 1.11-1.67), daily use of apps for sexual encounters (AOR 1.48, 95% CI 1.17-1.87), high and unknown perceived likelihood of getting HIV in the next year (AOR 1.72, 95% CI 1.47-2.02 and AOR 1.39, 95% CI 1.13-1.70), sexually transmitted infection diagnosis (AOR 1.25, 95% CI 1.03-1.51), stimulant use (AOR 1.24, 95% CI 1.07-1.43), PrEP awareness (AOR 1.48, 95% CI 1.30-1.70), and unwillingness to use condoms (AOR 1.16, 95% CI 1.00-1.33). Conclusions: Our results evidenced high-risk scores in the studied population, suggesting the importance of PrEP use. Those individuals presenting risky sexual behaviors were more willing to use PrEP. Nonetheless, only 58% (2932/5065) of individuals had heard about this prevention strategy. Efforts to increase awareness of new prevention strategies are needed, and mobile health tools are a promising strategy to reach MSM. [JMIR Public Health Surveill 2018;4(1):e11]

BACKGROUND Geosocial networking (GSN) smartphone apps are becoming the main venue for sexual encounters among Brazilian men who have sex with men (MSM). To address the increased HIV incidence in this population, preexposure prophylaxis (PrEP) was recently implemented in the Brazilian public health system in the context of combined HIV prevention. OBJECTIVE This study aimed to describe the characteristics of MSM using GSN apps for sexual encounters, their awareness of prevention strategies, and willingness to use PrEP. METHODS This study was an online cross-sectional study conducted in 10 Brazilian state capitals from July 1 to July 31, 2016. The questionnaire was programmed on SurveyGizmo and advertised in two GSN apps used by MSM to find sexual partners (Hornet and Grindr). Inclusion criteria were >18 years of age, cisgender men, with an HIV-negative status. Eligible individuals answered questions on: demographics; behavior; and knowledge, preferences, and willingness to use PrEP, nonoccupational postexposure prophylaxis (nPEP), HIV self-testing (HIVST), and condoms. Logistic regression modeling was performed to assess the factors associated with daily oral PrEP willingness. RESULTS During the study period, 8885 individuals provided consent and started the questionnaire. Of these, 23.05% (2048/8885) were ineligible, 6837 (6837/8885, 76.94%) initiated, and 5065 (5065/8885, 57.00%) completed the entire questionnaire and were included in the present analysis. Median age was 30 years (interquartile range: 25-36), most self-declared as MSM (4991/5065, 98.54%), white (3194/5065, 63.06%), middle income (2148/5065, 42.41%), and had 12 or more years of schooling (3106/5062, 61.36%). The majority of MSM (3363/5064, 66.41%) scored >10 points (high risk) on The HIV Incidence Risk for MSM Scale, but only 21.39% (1083/5064) had a low perceived likelihood of getting HIV in the next year. Daily use of apps for sex was reported by 35.58% (1798/5054). Most MSM (4327/5065, 85.43%) reported testing for HIV at least once in their lifetime and 9.16% (464/5065) used nPEP in the previous year. PrEP, nPEP, and HIVST awareness was reported by 57.89% (2932/5065), 57.39% (2907/5065), and 26.57% (1346/5065) of participants, respectively. Half of all respondents (2653/5065, 52.38%) were willing to use daily oral PrEP, and this finding was associated with higher numbers of male sexual partners (adjusted odds ratio [AOR] 1.26, 95% CI 1.09-1.47), condomless receptive anal intercourse (AOR 1.27, 95% CI 1.12-1.44), sex with HIV-positive partner versus no HIV-positive partner (one HIV-positive partner: AOR 1.36, 95% CI 1.11-1.67), daily use of apps for sexual encounters (AOR 1.48, 95% CI 1.17-1.87), high and unknown perceived likelihood of getting HIV in the next year (AOR 1.72, 95% CI 1.47-2.02 and AOR 1.39, 95% CI 1.13-1.70), sexually transmitted infection diagnosis (AOR 1.25, 95% CI 1.03-1.51), stimulant use (AOR 1.24, 95% CI 1.07-1.43), PrEP awareness (AOR 1.48, 95% CI 1.30-1.70), and unwillingness to use condoms (AOR 1.16, 95% CI 1.00-1.33). CONCLUSIONS Our results evidenced high-risk scores in the studied population, suggesting the importance of PrEP use. Those individuals presenting risky sexual behaviors were more willing to use PrEP. Nonetheless, only 58% (2932/5065) of individuals had heard about this prevention strategy. Efforts to increase awareness of new prevention strategies are needed, and mobile health tools are a promising strategy to reach MSM.

Background Concurrent psychosocial problems may synergistically increase the risk of HIV infection (syndemics), representing a challenge for prevention. We aimed to evaluate the prevalence and associated factors of syndemics among men who have sex with men (MSM) and transgender women (TGW) enrolled in the Brazilian pre-exposure prophylaxis demonstration study (PrEP Brasil Study). Methods Secondary cross-sectional analysis of the PrEP Brasil Study was performed. Of 450 HIV-seronegative MSM/TGW enrolled in the PrEP Brasil Study– conducted at Rio de Janeiro and Sao Paulo, Brazil– 421 participants with complete data were included in the present analysis. Syndemics was defined as occurrence of ≥2 of the following conditions: polysubstance (≥2) use, binge drinking, positive depression screen, compulsive sexual behavior, and intimate partner violence (IPV). Results The prevalence of recent polysubstance use was 22.8%, binge drinking 51.1%, positive depression screening 5.2%, compulsive sexual behavior 7.1%, and IPV 7.3%. Syndemics prevalence was 24.2%, and associated factors were younger age (adjusted Odds Ratio (aOR) 0.95, 95% Confidence Interval (95% CI) 0.92–0.98 per year increase), TGW vs. MSM (aOR 3.09, 95% CI: 1.2–8.0), some college education or more vs. less than college (aOR 2.49, 95% CI: 1.31–4.75), and multiple male sexual partners in prior 3 months (aOR 1.69, 95% CI: 0.92–3.14). Conclusion Given the high prevalence of syndemics, particularly of polysubstance use and binge drinking, PrEP delivery offers an opportunity to diagnose and intervene in mental and social well-being.

Oral preexposure prophylaxis (PrEP) has been established as a pivotal strategy in HIV prevention. However, bacterial sexually transmitted infections (STIs), such as Chlamydia trachomatis and Neisseria gonorrhoeae, are also highly prevalent. Although the presence of STI-related mucosal lesions is a known risk factor for HIV acquisition, the potential increase in risk associated with asymptomatic STIs is not completely understood. Recent data demonstrated higher T-cell activation is a risk factor for sexually acquired HIV-1 infection. We examined the effect of asymptomatic C. trachomatis and N. gonorrhoeae anorectal infection on systemic immune activation, potentially increasing the risk of HIV acquisition.We analyzed samples from participants of PrEP Brasil, a demonstration study of daily oral emtricitabine/tenofovir disoproxil fumarate HIV PrEP among healthy MSM, for T-cell activation by flow cytometry. We included 34 asymptomatic participants with anorectal swab for C. trachomatis and/or N. gonorrhoeae infection, whereas negative for other STIs, and 35 controls.We found a higher frequency of human leukocyte antigen DRCD38 CD8 T cells (1.5 vs. 0.9%, P 0.005) and with memory phenotype in the group with asymptomatic C. trachomatis and/or N. gonorrhoeae infection. Exhaustion and senescence markers were also significant higher in this group. No difference was observed in the soluble CD14 levels.Our findings suggest asymptomatic anorectal C. trachomatis and/or N. gonorrhoeae increase systemic immune activation, potentially increasing the risk of HIV acquisition. Regular screening and treatment of asymptomatic STIs should be explored as adjuvant tools for HIV prevention.

PrEP Brasil was a demonstration study to assess feasibility of daily oral tenofovir diphosphate disoproxil fumarate plus emtricitabine provided at no cost to men who have sex with men (MSM) and transgender women at high risk for HIV within the Brazilian public health system. We report week 48 pre-exposure prophylaxis (PrEP) retention, engagement, and adherence, trends in sexual behaviour, and incidence of HIV and sexually transmitted infections in this study cohort.PrEP Brasil was a 48 week, open-label, demonstration study that assessed PrEP delivery at three referral centres for HIV prevention and care in Rio de Janeiro, Brazil (Fundação Oswaldo Cruz), and São Paulo, Brazil (Universidade de São Paulo and Centro de Referência e Treinamento em DST e AIDS). Eligible participants were MSM and transgender women who were HIV negative, aged at least 18 years, resident in Rio de Janeiro or São Paulo, and reported one or more sexual risk criteria in the previous 12 months (eg, condomless anal sex with two or more partners, two or more episodes of anal sex with an HIV-infected partner, or history of sexually transmitted infection [STI] diagnosis). Participants were seen at weeks 4, 12, 24, 36, and 48 for PrEP provision, clinical and laboratory evaluation, and HIV testing. Computer-assisted self-interviews were also done at study visits 12, 24, 36, and 48, and assessed sexual behaviour and drug use. PrEP retention was defined by attendance at the week 48 visit, PrEP engagement was an ordinal five-level variable combining presence at the study visit and drug concentrations, and PrEP adherence was evaluated by measuring tenofovir diphosphate concentrations in dried blood spots. Logistic regression models were used to quantify the association of variables with high adherence (≥4 doses per week). The study is registered with ClinicalTrials.gov, number NCT01989611.Between April 1, 2014, and July 8, 2016, 450 participants initiated PrEP, 375 (83%) of whom were retained until week 48. At week 48, 277 (74%) of 375 participants had protective drug concentrations consistent with at least four doses per week: 183 (82%) of 222 participants from São Paulo compared with 94 (63%) of 150 participants from Rio de Janeiro (adjusted odds ratio 1·88, 95% CI 1·06-3·34); 119 (80%) of 148 participants who reported sex with HIV-infected partners compared with 158 (70%) of 227 participants who did not (1·78, 1·03-3·08); 67 (87%) of 77 participants who used stimulants compared with 210 (71%) of 298 participants who did not (2·23, 1·02-4·92); and 232 (80%) of 289 participants who had protective concentrations of tenofovir disphosphate at week 4 compared with 42 (54%) of 78 participants who did not (3·28, 1·85-5·80). Overall, receptive anal sex with the last three partners increased from 45% at enrolment to 49% at week 48 (p=0·17), and the mean number of sexual partners in the previous 3 months decreased from 11·4 (SD 28·94) at enrolment to 8·3 (19·55) at week 48 (p0·0013). Two individuals seroconverted during follow-up (HIV incidence 0·51 per 100 person-years, 95% CI 0·13-2·06); both of these patients had undetectable tenofovir concentrations at seroconversion.Our results support the effectiveness and feasibility of PrEP in a real-world setting. Offering PrEP at public health-care clinics in a middle-income setting can retain high numbers of participants and achieve high levels of adherence without risk compensation in the investigated populations.Brazilian Ministry of Health, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Secretaria de Vigilancia em Saúde, Fundação Carlos Chagas Filho de Amparo à Pesquisa do Estado do Rio de Janeiro, and Fundação de Amparo à Pesquisa do Estado de São Paulo.

Background Ongoing intra-host HIV-1 evolution has been shown in individuals that naturally suppress the viremia to low levels (HIV controllers) by the analysis of the RNA in plasma compartment. Detection of evolution at the DNA proviral compartment in HIV controllers, however, has been more challenging and the precise correlation between the systemic viral suppression level and rate of reservoir’s reseeding in those individuals is not fully understood. In this sense, we examined the proviral DNA quasispecies by single genome amplification of the env gene in a cohort of 23 HIV controllers from Brazil, divided in three groups, according to the level of systemic viral suppression: (1) elite controllers with persistent undetectable viral load (PEC, n = 6); (2) elite controllers with occasional episodes of transient (51–400 copies/mL) viremia (EEC, n = 7); and (3) viremic controllers with persistent low-level (80–2000 copies/mL) viremia (VC, n = 10). Results The HIV-1 diversity of the PBMC-associated proviral quasispecies in EC was significantly (P

Introduction : The efficacy of pre-exposure prophylaxis (PrEP) in preventing sexual acquisition of human immunodeficiency virus (HIV) is well established. Little is known about the feasibility of PrEP implementation in middle-income settings with concentrated epidemics among men who have sex with men (MSM) and transgender women (TGW). Methods : PrEP Brasil is a prospective, multicentre, open-label demonstration project assessing PrEP delivery in the context of the Brazilian Public Health System. HIV-uninfected MSM and TGW in 3 referral centres in Rio de Janeiro and Sao Paulo were evaluated for eligibility and offered 48 weeks of daily emtricitabine/tenofovir for PrEP. Concentrations of tenofovir diphosphate in dried blood spot samples (DBS) at week 4 after enrolment (early adherence) were measured. Predictors of drug levels were assessed using ordinal logistic regression models considering the DBS drug level as a 3 level variable (

Sporotrichosis is endemic in Rio de Janeiro, Brazil, and cases have been reported to be associated with HIV. This article describes the clinical manifestations and evolution of sporotrichosis in HIV-positive patients and constitutes the largest case series reported to date. There were 21 HIV-positive patients with sporotrichosis diagnosed by the recovery of the etiologic agent from 1999 – 2009. Sixteen patients (76.2%) were men and fi ve (23.8%) were women, with a mean age of 41.2 years. Seven of these individuals were previously unaware of their HIV infection. Mean CD4 count was 346.4 cells/ μ l. The most frequent clinical presentations of sporotrichosis in these patients were the lymphocutaneous and disseminated form (seven patients each, 33.3%), followed by the widespread cutaneous form in fi ve (23.8%), and fi xed form in the remaining two (9.5%). In patients with the disseminated forms, clinical manifestations involved the skin in six, mucosa (nasal, oral, or conjunctival) in four, bone in two, and meninges in two. Eleven (52.4%) patients received itraconazole and eight (38.1%) amphotericin B contributing to an overall cure rate of 81%. Spontaneous cure was observed in one patient. The clinical forms of sporotrichosis varied according to the patients ’ immune status. The results demonstrate the importance of sporotrichosis as an opportunistic infection associated with AIDS in countries where the mycosis occurs.

We describe two cases of disseminated sporotrichosis as a manifestation of immune reconstitution inflammatory syndrome. After the initiation of highly active anti-retroviral therapy, one patient presented disseminated lesions, whereas the other patient's preexisting lesions worsened and became more extensive. Simultaneously, their CD4 T cell counts increased and HIV viral loads decreased.

Background In addition to protecting against HIV acquisition, antiretroviral preexposure prophylaxis (PrEP) using topical 1% tenofovir gel reduced Herpes simplex virus type 2 (HSV-2) acquisition by 51% among women in the CAPRISA 004 study. We examined the effect of daily oral emtricitabine/tenofovir (FTC/TDF) PrEP on HSV-2 seroincidence and ulcer occurrence among men who have sex with men (MSM) in the iPrEx trial. Methods HSV-2 serum testing was performed at screening and every six months. Among HSV-2-seronegative individuals, we used Cox regression models to estimate hazard ratios (HRs) of HSV-2 seroincidence associated with randomization to FTC/TDF. We used multiple imputation and Cox regression to estimate HRs for HSV-2 seroincidence accounting for drug exposure. We assessed ulcer occurrence among participants with prevalent or incident HSV-2 infection. Results Of the 2,499 participants, 1383 (55.3%) tested HSV-2-seronegative at baseline, 892 (35.7%) tested positive, 223 (8.9%) had indeterminate tests, and one test was not done. Of the 1,347 HSV-2-seronegative participants with follow-up, 125 (9.3%) had incident HSV-2 infection (5.9 per 100 person-years). Compared with participants receiving placebo, there was no difference in HSV-2 seroincidence among participants receiving FTC/TDF (HR 1.1, 95% CI: 0.8–1.5; P = 0.64) or among participants receiving FTC/TDF with a concentration of tenofovir diphosphate >16 per million viable cells (HR 1.0, 95% CI: 0.3–3.5; P = 0.95). Among participants with HSV-2 infection, the proportion with ≥1 moderate or severe ulcer adverse event was twice as high in the placebo vs. active arm (5.9% vs. 2.9%, P = 0.02), but there were no differences in the proportions with ≥1 clinical examination during which perianal or groin ulcers were identified. Conclusions Tenofovir in daily oral FTC/TDF PrEP may reduce the occurrence of ulcers in individuals with HSV-2 infection but does not protect against HSV-2 incidence among MSM.

Background Many countries are facing concentrated HIV epidemics among vulnerable populations, including men who have sex with men (MSM). Unprotected anal intercourse (UAI) is the main HIV transmission route among them and its understanding in the different cultures and how it relates to HIV transmission, re-infection and development of HIV antiretroviral resistance has important public health implications. Data on UAI among Brazilian MSM are scarce. This study aims to evaluate the prevalence and associated factors of UAI among HIV-infected MSM who had sex with seronegative or male partners with an unknown serostatus. Method A cross-sectional study nested in a cohort was conducted in Rio de Janeiro, Brazil. The one hundred and fifty five MSM included in the study answered an ACASI interview and provided biological samples. Generalized linear models were used to identify variables associated with UAI. Results Overall, UAI with an HIV-negative or unknown serostatus male partner was reported by 40.6% (63/155) of MSM. Lifetime sexual abuse or domestic violence was reported by 35.9%, being more frequent among MSM who reported UAI compared to those who did not (P = 0.001). Use of stimulants before sex was reported by 20% of the MSM, being slightly higher among those who reported UAI (27.0% vs. 15.2%; P = 0.072). Commercial sex was frequent among all MSM (48.4%). After multivariate modeling, the report of sexual abuse or domestic violence (OR = 2.70; 95% CI: 1.08-7.01), commercial sex (OR = 2.28; 95% CI: 1.04- 5.10), the number of male sexual partners (p = 0.039) and exclusively receptive anal intercourse (OR = 0.21; 95% CI: 0.06-0.75) remained associated with UAI. CD4 levels, HIV viral load and antiretroviral therapy were not associated with UAI. Conclusion The UAI prevalence found with negative or unknown HIV status partners points out that other interventions are needed as additional prevention tools to vulnerable MSM. The main factors associated with UAI were a lifetime history of violence, commercial sex and the number of male sexual partners. This clustering of different behavioral, health and social problems in this population reinforce the need of a comprehensive approach on treating and preventing HIV among MSM.