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AbstractIntroductionCurrently, the slogan "Undetectable = Untransmittable" (U = U), launched to disseminate scientific evidence on how people living with HIV (PLHIV) on antiretroviral treatment with suppressed viral load cannot transmit HIV to their sexual partners, is still challenged by individuals with differential acceptance across populations. In this study, we documented the perceived accuracy of U = U in Brazil in three different groups: PLHIV, HIV‐negative/unknown cisgender gay/bisexual men who have sex with men (GBM) and HIV‐negative/unknown other populations (POP).MethodsAdult (age ≥ 18y) Brazilians were recruited during October 2019 to complete a web‐based survey advertised on Grindr, Facebook and WhatsApp. Perceived accuracy of U = U was assessed with the question: "With regards to HIV‐positive individuals transmitting HIV through sexual contact, how accurate do you believe the slogan U = U is?" Response options ranged from 1 (Completely inaccurate) to 4 (Completely accurate) plus a fifth option (I don't know what "undetectable" means). Participants' characteristics were described according to perceived accuracy of U = U. Logistic regression models assessed the factors associated with perceived accuracy of U = U (completely accurate vs. partially accurate/inaccurate or completely inaccurate) by group.ResultsOf 2311 individuals accessing the questionnaire, 1690 (73.1%) met inclusion/exclusion criteria and completed it. Of these, 347 (20.5%) were PLHIV, 785 (46.4%) GBM and 558 (33.0%) POP. More PLHIV perceived U = U as completely accurate (79.0%), compared to 44.2% GBM and 17.2% POP (p < 0.001). Among PLHIV, Black identity was associated with decreased odds of perceiving U = U as completely accurate while having a steady partner was associated with increased odds. Among GBM, being gay, having middle/higher income, being a resident of state capital metropolitan areas and ever testing for HIV were associated with increased odds. Lastly, among POP, ever testing for HIV increased the odds of perceiving U = U as completely accurate.ConclusionsThere was a significant difference in perceived accuracy of U = U across population groups. Accurate understanding of the slogan needs to be promoted in more vulnerable populations such as PLHIV of Black identity and GBM of lower income to maximize individual and societal prevention benefits. Moreover, broader understating of U = U among the general population can help decrease societal stigma towards PLHIV.

AbstractIntroductionAlthough strong scientific evidence of the efficacy and effectiveness of treatment‐as‐prevention (TasP) is available, full endorsement of the "Undetectable = Untransmittable" (U = U) and "zero‐risk" messages could be improved. Increasing knowledge about HIV transmission, prevention and treatment is a critical component of care efforts. The study assessed knowledge of HIV transmission and prevention strategies, and the perceived accuracy of the slogan U = U among sexual and gender minorities (SGM) in Brazil.MethodsCross‐sectional web‐based survey targeting adult SGM living in Brazil (2021−2022) recruited on social media and dating apps. We used the 12‐item HIV Knowledge Assessment (HIV‐KA) questionnaire to assess HIV knowledge, three items of which address pre‐exposure prophylaxis (PrEP), post‐exposure prophylaxis and TasP. Perceived accuracy of the U = U slogan was assessed with the question: "With regards to HIV‐positive individuals transmitting HIV through sexual contact, how accurate do you believe the slogan U = U is?". We a priori grouped the study population into three mutually exclusive groups: people living with HIV (PLHIV), HIV negative and HIV unknown. We used logistic regression models to assess factors associated with high HIV knowledge and perception of the U = U as completely accurate.ResultsOf 50,222 individuals accessing the questionnaire, 23,981 were included: 5071 (21.0%) PLHIV, 17,257 (71.5%) HIV negative and 1653 (6.9%) HIV unknown. The proportion of participants with high knowledge was significantly higher for PLHIV and HIV negative (48.1% and 45.5%, respectively) compared to 26.1% of HIV unknown. More PLHIV perceived U = U as completely accurate (80.4%), compared to 60.0% of HIV negative and 42.9% of HIV unknown. HIV knowledge correlates with perceived accuracy of the U = U slogan across all groups. Higher HIV knowledge was associated with higher income and education regardless of HIV status. Among HIV‐negative participants, PrEP awareness and use were associated with higher knowledge and accurate perception of the U = U slogan.ConclusionsOur findings show that HIV knowledge and perceived accuracy of U = U are strongly correlated, that knowledge differs according to HIV status, and that poor socio‐economic is linked to poor knowledge among SGM from Brazil. Educational strategies regarding TasP, U = U and zero risk targeting socio‐economically vulnerable populations are urgent in Brazil.

AbstractIntroductionMonitoring the HIV epidemic and identifying populations among whom HIV is spreading is critical. We aimed to provide an estimate of the annualized HIV incidence rate using recency testing among cisgender men who have sex with men (MSM) and transgender women (TGW) at a reference centre in Rio de Janeiro, Brazil.MethodsWe evaluated MSM and TGW who sought HIV testing at the Evandro Chagas National Institute of Infectious Diseases‐FIOCRUZ between March 2018 and January 2020. The Limiting Avidity assay (LAg) as part of a recent infection testing algorithm (RITA) was employed to identify recent infections (those with a normalized optical density ≤1.5 in the LAg that met all RITA criteria) among those who tested positive for HIV and the annualized HIV incidence was estimated.Results and discussionOut of 3053 individuals assessed, 2591 (84.9%) were HIV negative and 462 (15.1%) were living with HIV. Among these, 302 (65.4%) with stored samples available were evaluated and 73/302 (24.2%) were classified as recent infections. The annualized incidence rate estimate using a false recency rate of zero was 7.35% (95% CI 5.76% to 9.25%).ConclusionsOur results suggest that the HIV epidemic in Rio de Janeiro, Brazil, continues to disproportionately burden vulnerable populations, including MSM and TGW despite the existence and availability of effective preventive and therapeutic interventions.

AbstractIntroduction: Pharmacy adherence measures such as pharmacy dispensing ratios (PDRs) have previously been shown to be predictive of virologic outcomes. We aimed to determine the optimal interval of PDR assessment for predicting virologic failure for HIV‐infected patients on antiretroviral therapy (ART).Methods: Using national Brazilian ART pharmacy refill data, we examined PDRs for patients ≥18 years of age with at least one HIV RNA level ≥180 days after ART initiation on or after 1 January 2011. Patients with a documented ART change ≤270 days prior to viral load test date were excluded. Logistic regression models were used to describe associations between virologic failure, defined as an HIV RNA level ≥400 copies/mL and PDRs, defined as the number of days index drug dispensed (non‐nucleoside reverse‐transcriptase inhibitor or protease inhibitor) per 180‐ and 90‐day, interval preceding viral load testing, adjusting for sex, age, race, time since ART initiation and index drug. Backward elimination of insignificant variables was performed after adjusting for PDR. A predictive probability of virologic failure was calculated using the corresponding odds ratios for the PDR and any other significant variables. The diagnostic performance of the PDR interval was assessed by calculating the area under the receiver operating characteristic curve (AUROC) for the predictive probability with respect to virologic failure.Results and Discussion: A total of 1,025 patients were included (68% were male, median age 40 years, median time on ART 3.4 years). The PDR was found to be significantly associated with virologic failure for all of the PDR intervals (p < 0.001). There was an increased risk of virologic failure for all PDRs <0.95. The 90–180 days interval had a AUROC of 0.842, compared to 0.841 and 0.829 for the 0–180 days and 0–90 days intervals, respectively. The PDR performed well as a predictive tool to identify patients in virologic failure with the 90–180‐days interval prior to viral load testing being marginally more predictive.Conclusions: The validation and use of the pharmacy dispensing ratio using public pharmacy refill data could aid in early identification of patients with poor adherence and prevent development of treatment failure and drug resistance in Brazil.

ObjectiveIn Brazil, universal provision of antiretroviral therapy (ART) has been guaranteed free of charge to eligible HIV‐positive patients since December 1996. We sought to quantify the survival benefits of ART attributable to this programme.MethodsWe used a previously published microsimulation model of HIV disease and treatment (CEPAC‐International) and data from Brazil to estimate life expectancy increase for HIV‐positive patients initiating ART in Brazil. We divided the period of 1997 to 2014 into six eras reflecting increased drug regimen efficacy, regimen availability and era‐specific mean CD4 count at ART initiation. Patients were simulated first without ART and then with ART. The 2014‐censored and lifetime survival benefits attributable to ART in each era were calculated as the product of the number of patients initiating ART in a given era and the increase in life expectancy attributable to ART in that era.ResultsIn total, we estimated that 598,741 individuals initiated ART. Projected life expectancy increased from 2.7, 3.3, 4.1, 4.9, 5.5 and 7.1 years without ART to 11.0, 17.5, 20.7, 23.0, 25.3, and 27.0 years with ART in Eras 1 through 6, respectively. Of the total projected lifetime survival benefit of 9.3 million life‐years, 16% (or 1.5 million life‐years) has been realized as of December 2014.ConclusionsProvision of ART through a national programme has led to dramatic survival benefits in Brazil, the majority of which are still to be realized. Improvements in initial and subsequent ART regimens and higher CD4 counts at ART initiation have contributed to these increasing benefits.

AbstractIntroductionMen who have sex with men (MSM) and transgender women (TGW) in Brazil experience high rates of HIV infection. We examined the clinical and economic outcomes of implementing a pre‐exposure prophylaxis (PrEP) programme in these populations.MethodsWe used the Cost‐Effectiveness of Preventing AIDS Complications (CEPAC)‐International model of HIV prevention and treatment to evaluate two strategies: the current standard of care (SOC) in Brazil, including universal ART access (No PrEP strategy); and the current SOC plus daily tenofovir/emtracitabine PrEP (PrEP strategy) until age 50. Mean age (31 years, SD 8.4 years), age‐stratified annual HIV incidence (age ≤ 40 years: 4.3/100 PY; age > 40 years: 1.0/100 PY), PrEP effectiveness (43% HIV incidence reduction) and PrEP drug costs ($23/month) were from Brazil‐based sources. The analysis focused on direct medical costs of HIV care. We measured the comparative value of PrEP in 2015 United States dollars (USD) per year of life saved (YLS). Willingness‐to‐pay threshold was based on Brazil's annual per capita gross domestic product (GDP; 2015: $8540 USD).ResultsLifetime HIV infection risk among high‐risk MSM and TGW was 50.5% with No PrEP and decreased to 40.1% with PrEP. PrEP increased per‐person undiscounted (discounted) life expectancy from 36.8 (20.7) years to 41.0 (22.4) years and lifetime discounted HIV‐related medical costs from $4100 to $8420, which led to an incremental cost‐effectiveness ratio (ICER) of $2530/YLS. PrEP remained cost‐effective (<1x GDP) under plausible variation in key parameters, including PrEP effectiveness and cost, initial cohort age and HIV testing frequency on/off PrEP.ConclusionDaily tenofovir/emtracitabine PrEP among MSM and TGW at high risk of HIV infection in Brazil would increase life expectancy and be highly cost‐effective.

AbstractIntroduction: Evidence suggests that, of all affected populations, transgender women (transwomen) may have the heaviest HIV burden worldwide. Little is known about HIV linkage and care outcomes for transwomen. We aimed to estimate population‐level indicators of the HIV cascade of care continuum, and to evaluate factors associated with viral suppression among transwomen in Rio de Janeiro, Brazil.Methods: We conducted a respondent‐driven sampling (RDS) study of transwomen from August 2015 to January 2016 in Rio de Janeiro, Brazil and collected data on linkage and access to care, antiretroviral treatment and performed HIV viral load testing. We derived population‐based estimates of cascade indicators using sampling weights and conducted RDS‐weighted logistic regression analyses to evaluate correlates of viral suppression (viral load ≤50 copies/mL).Results: Of the 345 transwomen included in the study, 89.2% (95% CI 55–100%) had been previously tested for HIV, 77.5% (95% CI 48.7–100%) had been previously diagnosed with HIV, 67.2% (95% CI 39.2–95.2) reported linkage to care, 62.2% (95% CI 35.4–88.9) were currently on ART and 35.4% (95% CI 9.5–61.4%) had an undetectable viral load. The final adjusted RDS‐weighted logistic regression model for viral suppression indicated that those who self‐identified as black (adjusted odds ratio [aOR] 0.06, 95% CI 0.01–0.53, p < 0.01), reported earning ≤U$160/month (aOR 0.11, 95% CI 0.16–0.87, p = 0.04) or reported unstable housing (aOR 0.08, 95% CI 0.01–0.43, p < 0.01) had significantly lower odds of viral suppression.Conclusions: Our cascade indicators for transwomen showed modest ART use and low viral suppression rates. Multi‐level efforts including gender affirming care provision are urgently needed to decrease disparities in HIV clinical outcomes among transwomen and reduce secondary HIV transmission to their partners.

Background: Mathematical models have been used throughout the COVID-19 pandemic to inform policymaking decisions. The COVID-19 Multi-Model Comparison Collaboration (CMCC) was established to provide country governments, particularly low- and middle-income countries (LMICs), and other model users with an overview of the aims, capabilities and limits of the main multi-country COVID-19 models to optimise their usefulness in the COVID-19 response. Methods: Seven models were identified that satisfied the inclusion criteria for the model comparison and had creators that were willing to participate in this analysis. A questionnaire, extraction tables and interview structure were developed to be used for each model, these tools had the aim of capturing the model characteristics deemed of greatest importance based on discussions with the Policy Group. The questionnaires were first completed by the CMCC Technical group using publicly available information, before further clarification and verification was obtained during interviews with the model developers. The fitness-for-purpose flow chart for assessing the appropriateness for use of different COVID-19 models was developed jointly by the CMCC Technical Group and Policy Group. Results: A flow chart of key questions to assess the fitness-for-purpose of commonly used COVID-19 epidemiological models was developed, with focus placed on their use in LMICs. Furthermore, each model was summarised with a description of the main characteristics, as well as the level of engagement and expertise required to use or adapt these models to LMIC settings. Conclusions: This work formalises a process for engagement with models, which is often done on an ad-hoc basis, with recommendations for both policymakers and model developers and should improve modelling use in policy decision making.

AbstractIntroductionWe 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).MethodsWe 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‐value<0.10 in the univariate analysis.ResultsFrom 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.ConclusionsAlthough 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.

AbstractIntroduction: 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 São 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 (<350 fmol/punch, ≥350–699 fmol/punch and ≥700 fmol/punch).Results: 1,270 individuals were assessed for participation; n = 738 were potentially eligible and n = 450 were offered PrEP (PrEP uptake was 60.9%). Eligible but not enrolled individuals were younger, had lower HIV risk perception and had lower PrEP awareness. At week 4, 424 participants (of the 450 enrolled) had DBS TFV‐DP concentrations, 94.1% in the protective range (≥350 fmol/punch, consistent with ≥2 pills per week), and 78% were in the highly protective range (≥700 fmol/punch, ≥4 pills per week). Participants with ≥12 years of schooling had 1.9 times the odds (95%CI 1.10–3.29) of a higher versus lower drug level than participants with <12 years of schooling. Condomless receptive anal intercourse in the prior 3 months was also associated with higher drug levels (adjusted OR = 1.78; 95% CI 1.08–2.94).Conclusions: The high uptake and early adherence indicate that PrEP for high‐risk MSM and TGW can be successfully delivered in the context of the Brazilian Public Health System. Interventions to address disparities on PrEP awareness and HIV risk perception among the younger and less educated are urgently needed in order to maximize the impact of this prevention strategy on the reduction of HIV infection among MSM and TGW in Brazil.