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AbstractIntroductionWith recent approvals of long‐acting (LA) HIV pre‐exposure prophylaxis (PrEP) in the form of injectable cabotegravir and the dapivirine ring, programmes need to consider how to optimize the delivery of PrEP methods, including by leveraging lessons from the past decade of oral PrEP delivery.DiscussionFramed around differentiated service delivery building blocks, the major considerations for the delivery of LA PrEP are how to reach the populations who would most benefit from PrEP, where to locate PrEP services, how to reduce the user burden of accessing and continuing with PrEP, and how to integrate PrEP with other services. Demand creation for LA PrEP and education about new LA PrEP options should be co‐developed with communities and be positively framed. Client‐facing clinical decision support tools provide information about HIV prevention and PrEP options in non‐technical ways and can support their informed decision‐making about PrEP. Training for providers is needed to increase their ability to ask about sexual and drug use behaviours in a non‐judgmental and comfortable manner as part of risk assessment, discuss harm reduction strategies and counsel about available PrEP options that fit clients' circumstances and needs. PrEP adherence support should include supportive counselling and be tailored to address an individual's particular barriers and needs. Reminders through text messaging or calls can foster PrEP persistence, given the narrow the window around dosing for injectable cabotegravir. Strategies are needed to expand PrEP delivery options, including telePrEP, pharmacy‐based PrEP, key population‐led services and mobile venues. Integrated delivery models are needed which include sexually transmitted infection testing and treatment, contraception for cis‐women not desiring to become pregnant, PrEP for pregnant women in high HIV prevalence settings, and gender‐affirming hormones and support for transgender persons.ConclusionsThe outcome of expanding PrEP options through LA PrEP formulations is to increase PrEP coverage, adherence, persistence and effectiveness by offering a choice of PrEP that meets the needs of persons who would benefit from PrEP. The lessons learned from the delivery of oral PrEP about demand creation, informed client decision‐making, provider training, adherence support and service delivery model are relevant to the delivery of LA PrEP and integration with other services.

IntroductionThe World Health Organization recently released guidelines on the use of pre‐exposure prophylaxis (PrEP) for prevention of HIV infection among men and transgender women (TGW) who have sex with men based on results of randomized clinical trials. The aim of this commentary is to discuss the opportunities and challenges of incorporating PrEP into the Brazilian continuum of HIV care and prevention for men who have sex with men (MSM) and TGW.DiscussionKey aspects of the AIDS epidemic among MSM and TGW in Brazil and the comprehensive Brazilian response to the epidemic are presented. The universal access to health care provided through the Brazilian Unified Health System (SUS) and the range of prevention and care services already available countrywide to HIV‐positive individuals and at‐risk MSM and TGW are identified as the main facilitators for the implementation of PrEP. Limited PrEP awareness among MSM, TGW and health care providers, low HIV testing frequency and low HIV risk perception among MSM and TGW represent the core challenges to be addressed. Data generated by demonstration projects in Brazil will provide an important contribution to PrEP rollout in Brazil.ConclusionsThe implementation of PrEP in Brazil is feasible. A synergistic rollout of treatment as prevention and PrEP will maximize public health and individual benefits of the country's comprehensive response to the AIDS epidemic.

IntroductionDespite progress in scaling up antiretroviral treatment, HIV prevention strategies have not been successful in significantly curbing HIV incidence in Latin America. HIV prevention interventions need to be expanded to target the most affected key populations with a combination approach, including new high impact technologies. Oral pre‐exposure prophylaxis (PrEP) is recommended as additional prevention choice for individuals at higher risk of infection and could become a cost‐effective prevention tool. We discuss the barriers and solutions for a fair consideration of PrEP as part of combination HIV prevention strategies in Latin America.DiscussionAlthough demonstration projects are ongoing or being planned in a number of countries, to date no Latin American country has implemented a public PrEP programme. The knowledge of policymakers about PrEP implementation needs to be strengthened, and programmatic guidance and cost estimate tools need to be developed to support adequate planning. Despite high levels of awareness among health providers, especially if engaged in HIV or key population care, willingness to prescribe PrEP is still low due to the lack of national policies and guidelines. Key populations, especially men who have sex with men, transgender women and sex workers, have been engaged in demonstration projects, and qualitative research shows high awareness and willingness to use PrEP, especially if accessible in the public sector for free or at affordable price. Concerns of safety, adherence, effectiveness and risk compensation need to be addressed through targeted social communication strategies to improve PrEP knowledge and stimulate demand. Alliance among policymakers, civil society and representatives from key populations, healthcare providers and researchers will be critical for the design and successful implementation of PrEP demonstration projects of locally adapted delivery models. The use of mechanisms of joint negotiation and procurement of antiretrovirals could reduce costs and significantly increase the cost‐effectiveness of PrEP.ConclusionsPrEP is an additional prevention tool and should be implemented in combination and synergy with other prevention interventions. PrEP programmes should target high‐risk individuals from key populations for higher cost‐effectiveness. Demonstration projects may generate strategic information for and lead to the implementation of full‐scale PrEP programmes.

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.

IntroductionDespite significant progress in improving access to antiretroviral therapy over the past decade, substantial numbers of people living with HIV (PLHIV) in all regions continue to experience severe illness and require hospitalization. We undertook a global review assessing the proportion of hospitalizations and in‐hospital deaths because of tuberculosis (TB) in PLHIV.MethodsSeven databases were searched to identify studies reporting causes of hospitalizations among PLHIV from 1 January 2007 to 31 January 2015 irrespective of age, geographical region or language. The proportion of hospitalizations and in‐hospital mortality attributable to TB was estimated using random effects meta‐analysis.ResultsFrom an initial screen of 9049 records, 66 studies were identified, providing data on 35,845 adults and 2792 children across 42 countries. Overall, 17.7% (95% CI 16.0 to 20.2%) of all adult hospitalizations were because of TB, making it the leading cause of hospitalization overall; the proportion of adult hospitalizations because of TB exceeded 10% in all regions except the European region. Of all paediatric hospitalizations, 10.8% (95% CI 7.6 to 13.9%) were because of TB. There was insufficient data among children for analysis by region. In‐hospital mortality attributable to TB was 24.9% (95% CI 19.0 to 30.8%) among adults and 30.1% (95% CI 11.2 to 48.9%) among children.DiscussionTB remains a leading cause of hospitalization and in‐hospital death among adults and children living with HIV worldwide.

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.

IntroductionWe report the SVR12 final analysis of a phase 3 study of telaprevir in combination with peginterferon (P)/ribavirin (R) in HCV‐genotype 1, treatment‐naïve and ‐experienced patients with HCV/HIV co‐infection (INSIGHT).Materials and MethodsPatients receiving stable, suppressive HIV antiretroviral (ARV) therapy, containing atazanavir/ritonavir, efavirenz, darunavir/ritonavir, raltegravir, etravirine or rilpivirine, received telaprevir 750 mg q8h (1125 mg q8h if on efavirenz) plus P (180 µg once‐weekly) and R (800 mg/day) for 12 weeks, followed by an additional 12 weeks (non‐cirrhotic HCV treatment‐naïve and relapse patients with extended rapid viral response [eRVR]) or 36 weeks (all others) of PR alone. Analysis was performed when all patients had completed the follow‐up visit of 12 weeks after last planned dose.ResultsOne hundred sixty‐two patients were enrolled and treated (65 efavirenz, 59 atazanavir/ritonavir, 17 darunavir/ritonavir, 17 raltegravir, 4 etravirine). Mean age was 45 years, 78% were male, 92% were Caucasian; mean CD4 count was 687 cells/mm3. Sixty four patients (40%) were HCV treatment‐naïve and 98 (60%) were treatment experienced (29 relapsers, 18 partial responders and 51 null responders). 64% were subtype 1a. 30% had bridging fibrosis (17%) or cirrhosis (13%). 19% of patients discontinued telaprevir, including 9% due to an adverse event (AE), 8% reaching a virologic endpoint and 2% for other reasons (non compliance or not defined). Treatment responses are shown in Table 1. There were no HIV RNA breakthroughs. Most frequently reported (≥20% patients) AEs were pruritus 43%; fatigue 27%; rash 34%, anorectal events 30% and influenza‐like illness (25%). Anemia was reported in 15% of patients; grade ≥3 haemoglobin decrease occurred in 2.5% of patients. 6% of patients experienced serious AEs.ConclusionsIn this phase 3 study of HIV‐infected, HCV treatment‐naïve and ‐experienced patients, 49% achieved eRVR and 57% reached SVR12. In patients with an eRVR, SVR12 rates were >80%, irrespective of prior treatment history.

AbstractIntroductionThe International AIDS Society convened a multidisciplinary committee of experts in December 2020 to provide guidance and key considerations for the safe and ethical management of clinical trials involving people living with HIV (PLWH) during the SARS‐CoV‐2 pandemic. This consultation did not discuss guidance for the design of prevention studies for people at risk of HIV acquisition, nor for the programmatic delivery of antiretroviral therapy (ART).DiscussionThere is strong ambition to continue with HIV research from both PLWH and the research community despite the ongoing SARS‐CoV‐2 pandemic. How to do this safely and justly remains a critical debate. The SARS‐CoV‐2 pandemic continues to be highly dynamic. It is expected that with the emergence of effective SARS‐CoV‐2 prevention and treatment strategies, the risk to PLWH in clinical trials will decline over time. However, with the emergence of more contagious and potentially pathogenic SARS‐CoV‐2 variants, the effectiveness of current prevention and treatment strategies may be compromised. Uncertainty exists about how equally SARS‐CoV‐2 prevention and treatment strategies will be available globally, particularly for marginalized populations, many of whom are at high risk of reduced access to ART and/or HIV disease progression. All of these factors must be taken into account when deciding on the feasibility and safety of developing and implementing HIV research.ConclusionsIt can be assumed for the foreseeable future that SARS‐CoV‐2 will persist and continue to pose challenges to conducting clinical research in PLWH. Guidelines regarding how best to implement HIV treatment studies will evolve accordingly. The risks and benefits of performing an HIV clinical trial must be carefully evaluated in the local context on an ongoing basis. With this document, we hope to provide a broad guidance that should remain viable and relevant even as the nature of the pandemic continues to develop.