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.

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.

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”.

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”.

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.

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.

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.