Discriminatory experiences among gay, bisexual, and other men who have sex with men, and transgender and non-binary individuals: a cross sectional analysis.

Background: Several systems of oppression combine in complex ways to impact the lives of minority populations. Following an intersectionality framework, we assessed the frequency and perceived reasons for discrimination among gay, bisexual, and other cisgender men who have sex with men (MSM) and transgender and non-binary individuals (TGNB), stratified by race. Methods: Online survey among MSM and TGNB ≥18 years living in Brazil, between November/2021 and January/2022. We used the 18-item Explicit Discrimination Scale to assess day-to-day experiences of differential treatment, and perceived discrimination. For each item, participants indicated their perceived reasons for differential treatment using 14 pre-defined options. Negative binomial regression models assessed if race was a significant predictor of discrimination. Subsequent models, stratified by race, examined associations of perceived reasons and number of reasons with perceived discrimination. Findings: Of 8464 MSM and TGNB, 4961 (58.6%) were White, 2173 (25.7%) Pardo (Brazil's official term for admixed populations), and 1024 (12.1%) Black. Black participants' scores for perceived discrimination (mean, standard deviation) were higher (10.2, 8.8) [Pardo (6.5, 6.8), White (5.2, 5.7)], and race was both the main reason for and the strongest predictor of perceived discrimination. The number of reasons participants used to interpret their discriminatory experiences was also a predictor of discrimination score among White, Pardo, and Black participants. Interpretation: LGBTQIA+phobia was highly prevalent among all participants. Additionally, our results indicated that Black MSM and TGNB participants were more frequently discriminated against than other racial groups, with racial discrimination uniquely contributing these experiences. Funding: Fundação Oswaldo Cruz, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação Carlos Chagas Filho de Amparo à Pesquisa do Estado do Rio de Janeiro.

Adapting mHealth Interventions (PrEPmate and DOT Diary) to Support PrEP Retention in Care and Adherence Among English and Spanish-Speaking Men Who Have Sex With Men and Transgender Women in the United States: Formative Work and Pilot Randomized Trial.

BACKGROUND: A growing number of mobile health (mHealth) technologies are being developed to support HIV preexposure prophylaxis (PrEP) adherence and persistence; however, most tools have focused on men who have sex with men (MSM), and few are available in Spanish. To maximize the potential impact of these tools in reducing gender and racial/ethnic disparities and promoting health equity, mHealth tools tailored to Spanish-speaking people and transgender women are critically needed. OBJECTIVE: The aim of this study is to adapt and tailor 2 mHealth technologies, PrEPmate and DOT Diary, to support daily PrEP adherence and persistence among Spanish-speaking MSM and English- and Spanish-speaking transgender women and to evaluate the feasibility and acceptability of these tools. METHODS: PrEPmate, an interactive, bidirectional, text messaging intervention that promotes personalized communication between PrEP users and providers, and DOT Diary, a mobile app that promotes self-management of PrEP use and sexual health through an integrated electronic pill-taking and sexual activity diary, were previously developed for English-speaking MSM. We conducted 3 focus groups with 15 English- and Spanish-speaking transgender women and MSM in San Francisco and Miami to culturally tailor these tools for these priority populations. We then conducted a 1-month technical pilot among 21 participants to assess the usability and acceptability of the adapted interventions and optimize the functionality of these tools. RESULTS: Participants in focus groups liked the "human touch" of text messages in PrEPmate and thought it would be helpful for scheduling appointments and asking questions. They liked the daily reminder messages, especially the fun facts, gender affirmations, and transgender history topics. Participants recommended changes to tailor the language and messages for Spanish-speaking and transgender populations. For DOT Diary, participants liked the adherence tracking and protection level feedback and thought the calendar functions were easy to use. Based on participant recommendations, we tailored language within the app for Spanish-speaking MSM and transgender women, simplified the sexual diary, and added motivational badges. In the technical pilot of the refined tools, mean System Usability Scale scores were 81.2/100 for PrEPmate and 76.4/100 for DOT Diary (P=.48), falling in the "good" to "excellent" range, and mean Client Satisfaction Questionnaire scores were 28.6 and 28.3 for PrEPmate and DOT Diary, respectively (maximum possible score=32). Use of both tools was high over the 1-month pilot (average of 10.5 messages received from each participant for PrEPmate; average of 17.6 times accessing the DOT Diary app), indicating good feasibility for both tools. CONCLUSIONS: Using a user-centered design approach, we culturally tailored PrEPmate and DOT Diary to support daily PrEP use among Spanish-speaking MSM and English- and Spanish-speaking transgender women. Our positive findings in a technical pilot support further testing of these mHealth interventions in an upcoming comparative effectiveness trial.

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

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

Knowledge of HIV transmission, prevention strategies and U = U among adult sexual and gender minorities in Brazil.

INTRODUCTION: Although 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. METHODS: Cross-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. RESULTS: Of 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. CONCLUSIONS: Our 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.

Perceived Accuracy Around Undetectable = Untransmitable Among Sexual and Gender Minorities Using Smartphones in India.

Sexual and gender minorities (SGM) using online venues in India are usually not reached by government HIV interventions, remaining an understudied yet important population. We investigated sociodemographic characteristics, sexual behaviours along with familiarity, knowledge, and correlated factors around perceived accuracy of the Undetectable = Untransmittable (U = U) slogan. Grindr users in India completed an online, cross-sectional survey in May-June 2022. We included individuals ≥ 18 years old who reported sex with men (excluding those who were born female and or identified as cis-gender female). Associations with perceived U = U accuracy were estimated using adjusted prevalence odds ratios (aPOR) with 95% confidence intervals (95% CI). The survey was completed by 3,126 eligible participants. The median age was 28 years and most participants lived in urban areas and had graduate or postgraduate education. HIV prevalence was 3.1%. Only 14% reported familiarity with the U = U slogan and after an explanation was provided, 25% perceived it as completely accurate. This was associated with knowing their HIV status (HIV Negative aPOR 1.37 [95%CI 1.1, 1.71], HIV Positive aPOR 3.39 [95%CI 2.11, 5.46]), having heard of PrEP (aPOR1.58 [95%CI 1.29,1.92]) or have used PrEP (aPOR1.56 [95%CI 1.15, 2.12]) along with use of party drugs (aPOR1.51 [95%CI 1.0 2.10]), being in touch with NGOs (aPOR 1.61 [95%CI 1.27, 2.02], p < .001) and having attended LGBTQIA + events (aPOR1.38 [95%CI 1.1, 1.73]). SGMs in India had low familiarity and low perceived accuracy around U = U. Education about U = U and innovating new strategies to reach this hidden population could reduce stigma around HIV in India.

RESUMEN: Las minorías sexuales y de género (MSG) que utilizan sitios en línea en la India, generalmente no son alcanzadas por el gobierno a través de sus intervenciones contra el VIH aunque siguen siendo una población importante, pero poco estudiada. Se investigaron las características sociodemográficas, el comportamiento sexual y, adicionalmente, la familiaridad, el conocimiento y la percepción de exactitud sobre el eslogan Indetectable = Intransmisible (I = I). Los usuarios indios de Grindr completaron una encuesta transversal en línea entre mayo y junio del 2022. Se incluyeron a personas ≥ 18 años que informaron haber tenido relaciones sexuales con hombres (se excluyeron aquellas asignadas como mujer al nacer y que se identificaron como mujeres cisgénero). Las asociaciones con la precisión percibida de I = I se estimaron con razones de probabilidad de prevalencia ajustadas (aPR) con intervalos de confianza a 95% (IC 95%). En total, 3,126 participantes elegibles completaron la encuesta. La mediana de edad fue de 28 años, la mayoría vivían en áreas urbanas y eran graduados o posgraduados. La prevalencia del VIH fue de 3.1%. Solo 14% informó que conocía el eslogan I = I, pero incrementó a 25% después de que se proporcionó una explicación y lo percibieron como completamente exacto. Esto se asoció con conocer su estado serológico (aPR VIH negativo = 1.37 [IC 95%: 1.1, 1.71]; aPR VIH positivo = 3.39 [IC 95%: 2.11, 5.46]), tener conocimiento de la profilaxis preexposición (PrEP) (aPR = 1.58 [IC 95%: 1.29,1.92]), haber usado la PrEP (aPR = 1.56 [IC 95% 1.15, 2.12]), usado drogas con fines recreativos (aPR = 1.51 [IC 95%: 1.0, 2.10]), estar en contacto con las ONG (aPOR 1.61 [95%CI 1.27, 2.02], p < .001) y haber asistido a eventos LGBTIQA+ (aPR = 1.38 [IC 95%: 1.0, 2.10]). Las MSG en India tuvieron poco conocimiento y poca percepción de exactitud sobre el eslogan I = I. La educación sobre I = I y otras estrategias innovadoras de prevención para el VIH en esta población podría ayudar a reducir el estigma en torno a esta enfermedad en la India.

Mpox severity and associated hospitalizations among people with HIV and related immunosuppression in Brazil.

OBJECTIVES: This study aimed to analyze characteristics of mpox hospitalization in a Brazilian cohort, further exploring the impact of HIV on mpox-related outcomes and hospitalization. DESIGN: We conducted a descriptive analysis, comparing characteristics of individuals diagnosed with mpox according to hospitalization and HIV status, and described the mpox cases among those living with HIV. METHODS: This was a single-center, prospective cohort study conducted at a major infectious diseases referral center in Rio de Janeiro, Brazil, that enrolled participants older than 18 years of age diagnosed with mpox. Information was collected on standardized forms, including data on sociodemographic, behavioral, clinical and laboratory characteristics. For comparisons, we used chi-squared, Fisher's exact and the Moods median tests whenever appropriate. RESULTS: From June to December, 2022, we enrolled 418 individuals diagnosed with mpox, of whom 52% were people with HIV (PWH). PWH presented more frequently with fever, anogenital lesions and proctitis. The overall hospitalization rate was 10.5% ( n  = 43), especially for pain control. Among hospitalized participants, PWH had more proctitis and required invasive support. Mpox severity was related to poor HIV continuum of care outcomes and low CD4 + cell counts. All deaths ( n  = 2) occurred in PWH with CD4 + less than 50 cells/µl. CONCLUSION: HIV-related immunosuppression likely impacts mpox clinical outcomes. This is of special concern in settings of poor adherence and late presentation to care related to socioeconomic inequalities, such as Brazil. The HIV continuum of care must be taken into account when responding to the mpox outbreak.

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

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

Recent HIV infection and annualized HIV incidence rates among sexual and gender minorities in Brazil and Peru (ImPrEP seroincidence study): a cross-sectional, multicenter study.

Background: HIV incidence estimation is critical for monitoring the HIV epidemic dynamics and the effectiveness of public health prevention interventions. We aimed to identify sexual and gender minorities (SGM) with recent HIV infections, factors associated with recent HIV infection, and to estimate annualised HIV incidence rates. Methods: Cross-sectional multicentre study in HIV testing services in Brazil and Peru (15 cities). Inclusion criteria: 18+ years, SGM assigned male at birth, not using pre-/post-exposure prophylaxis. We identified recent HIV infection using the Maxim HIV-1 LAg-Avidity EIA assay as part of a recent infection testing algorithm (RITA). Annualized HIV incidence was calculated using the UNAIDS/WHO incidence estimator tool. Multivariable logistic regression models were used to estimate factors associated with recent HIV infection. Trial registration: NCT05674682. Findings: From 31-Jan-2021 to 29-May-2022, 6899 individuals participated [Brazil: 4586 (66.5%); Peru: 2313 (33.5%)]; 5946 (86.2%) cisgender men, 751 (10.9%) transgender women and 202 (2.9%) non-binary/gender diverse. Median age was 27 (IQR: 23-34) years. HIV prevalence was 11.4% (N = 784/6899); 137 (2.0%) SGM were identified with recent HIV infection. The overall annualized HIV incidence rate was 3.88% (95% CI: 2.86-4.87); Brazil: 2.62% (95% CI: 1.78-3.43); Peru: 6.69% (95% CI: 4.62-8.69). Participants aged 18-24 years had higher odds of recent HIV infection compared to those aged 30+ years in both countries. Interpretation: Our results highlight the significant burden of HIV epidemic among SGM in large urban centres of Brazil and Peru. Public health policies and interventions to increase access to effective HIV prevention methods such as PrEP are urgently needed in Latin America. Funding: Unitaid, WHO (Switzerland), Ministry of Health from Brazil and Peru.

Characteristics of women diagnosed with mpox infection compared to men: A case series from Brazil.

BACKGROUND: Cisgender men were mostly affected during the 2022 mpox multinational outbreak, with few cases reported in women. This study compares the characteristics of individuals diagnosed with mpox infection according to gender in Rio de Janeiro. METHODS: We obtained surveillance data of mpox cases notified to Rio de Janeiro State Health Department (June 12 to December 15, 2022). We compared women (cisgender or transgender) to men (cisgender or transgender) using chi-squared, Fisher's exact, and Mood's median tests. RESULTS: A total of 1306 mpox cases were reported; 1188 (91.0%) men (99.8% cisgender, 0.2% transgender), 108 (8.3%) women (87.0% cisgender, 13.0% transgender), and 10 (0.8%) non-binary persons. Compared to men, women were more frequently older (40+years: 34.3% vs. 25.1%; p < 0.001), reported more frequent non-sexual contact with a potential mpox case (21.4% vs. 9.8%; p = 0.004), fewer sexual partnerships (10.9 vs. 54.8%; p < 0.001), less sexual contact with a potential mpox case (18.5% vs. 43.0%; p < 0.001), fewer genital lesions (31.8% vs. 57.9%; p < 0.001), fewer systemic mpox signs/symptoms (38.0% vs. 50.1%; p = 0.015) and had a lower HIV prevalence (8.3% vs. 46.3%; p < 0.001), with all cases among transgender women. Eight women were hospitalized; no deaths occurred. The highest number of cases among women were notified in epidemiological week 34, when the number of cases among men started to decrease. CONCLUSIONS: Women diagnosed with mpox presented differences in epidemiological, behavioral, and clinical characteristics compared to men. Health services should provide a comprehensive assessment that accounts for gender diversity.

Moderating Effect of Pre-Exposure Prophylaxis Use on the Association Between Sexual Risk Behavior and Perceived Risk of HIV Among Brazilian Gay, Bisexual, and Other Men Who Have Sex With Men: Cross-Sectional Study.

BACKGROUND: Gay, bisexual, and other men who have sex with men (MSM) with a higher perceived risk of HIV are more aware of and willing to use pre-exposure prophylaxis (PrEP). PrEP is an effective HIV prevention strategy, but there is a lack of data on how PrEP use might moderate the relationship between sexual risk behavior and perceived risk of HIV. Moreover, most studies measure perceived risk of HIV via a single question. OBJECTIVE: We estimated the moderating effect of PrEP use on the association between sexual risk behavior and perceived risk of HIV, measured with the 8-item Perceived Risk of HIV Scale (PRHS), among Brazilian MSM. METHODS: A cross-sectional, web-based survey was completed by Brazilian Hornet app users aged ≥18 years between February and March 2020. We included data from cisgender men who reported sex with men in the previous 6 months. We evaluated the moderating effect of current PrEP use on the association between sexual risk behavior, measured via the HIV Incidence Risk Index for MSM (HIRI-MSM), and perceived risk of HIV, measured by the PRHS. Higher HIRI-MSM (range 0-45) and PRHS (range 10-40) scores indicate greater sexual behavioral risk and perceived risk of HIV, respectively. Both were standardized to z scores for use in multivariable linear regression models. RESULTS: Among 4344 cisgender MSM, 448 (10.3%) were currently taking PrEP. Current PrEP users had a higher mean HIRI-MSM score (mean 21.0, SD 9.4 vs mean 13.2, SD 8.1; P<.001) and a lower mean PRHS score (mean 24.6, SD 5.1 vs mean 25.9, SD 4.9; P<.001) compared to those not currently taking PrEP. In the multivariable model, greater HIRI-MSM scores significantly predicted increased PRHS scores (ß=.26, 95% CI 0.22-0.29; P<.001). PrEP use moderated the association between HIRI-MSM and PRHS score (interaction term ß=-.30, 95% CI -0.39 to -0.21; P<.001), such that higher HIRI-MSM score did not predict higher PRHS score among current PrEP users. CONCLUSIONS: Our results suggest current PrEP users have confidence in PrEP's effectiveness as an HIV prevention strategy. PrEP's effectiveness, positive psychological impact, and the frequent HIV testing and interaction with health services required of PrEP users may jointly influence the relationship between sexual risk behavior and perceived risk of HIV among PrEP users.

Pharmacotherapeutic profile, polypharmacy and its associated factors in a cohort of people living with HIV in Brazil.

BACKGROUND: The increased survival provided by the access, development, and evolution of antiretroviral drugs (ARV) greatly increased the life expectancy of people living with HIV (PWH). This has also led to an increased occurrence of diseases or morbidities related to aging. In individuals with multiple comorbidities, the simultaneous use of multiple medications, also known as polypharmacy, is common, and rational use of medications is essential. This study aims to describe the pharmacotherapeutic profile, estimate the prevalence of polypharmacy and identify factors associated with polypharmacy in a cohort of adult PWH from a referral unit in Rio de Janeiro, Brazil. METHODS: Cross-sectional study including PWH on ARV who received at least one medical prescription (outpatient/hospitalized) in 2019. We described the proportion of prescribed medications according to ARV and Anatomical Therapeutic Chemical (ATC) classes stratified by age (< 50 vs. ≥50 years). Polypharmacy was defined as ≥ 5 medications prescribed beyond ARV. Logistic regression models assessed demographic and clinical factors associated with polypharmacy. RESULTS: A total of 143,306 prescriptions of 4547 PWH were analyzed. Median age was 44.4 years (IQR:35.4-54.1) and 1615 (35.6%) were ≥ 50 years. A total of 2958 (65.1%) participants self-identified as cisgender man, 1365 (30.0%) as cisgender woman, and 224 (4.9%) as transgender women. Most self-declared Black/Pardo (2582; 65.1%) and 1984 (44.0%) completed elementary education or less. Median time since HIV diagnosis was 10.9 years (IQR:6.2-17.7). Most frequently prescribed concomitant medications were nervous system (64.8%), antiinfectives for systemic use (60.0%), alimentary tract and metabolism (45.9%), cardiovascular system (40.0%) and respiratory system (37.1%). Prevalence of polypharmacy was 50.6% (95%CI: 49.2-52.1). Model results indicated that being older, self-identify as cisgender woman, having less education and longer time since HIV diagnosis increased the odds of polypharmacy. CONCLUSIONS: We found high rates of polypharmacy and concomitant medication use in a cohort of PWH in Brazil. Targeted interventions should be prioritized to prevent interactions and improve treatment, especially among individuals using central nervous system and cardiovascular medications, as well as certain groups such as cisgender women, older individuals and those with lower education. Standardized protocols for continuous review of patients' therapeutic regimens should be implemented.

Pharmacokinetics of Antiretroviral Drugs in Older People Living with HIV: A Systematic Review.

BACKGROUND AND OBJECTIVE: The life expectancy of people living with HIV (PLWHIV) has significantly improved in recent decades, mostly due to antiretroviral (ARV) therapy. Aging can affect the pharmacokinetics of drugs and, as a consequence, increase the risk of drug interactions and toxicity that may impact treatment. The aim of this study was to carry out a systematic review of the literature on the effect of aging on ARV pharmacokinetics. METHODS: Searches were performed in the BVS, EMBASE and PUBMED databases until November 2022. All studies available in English, Spanish and Portuguese investigating the pharmacokinetics of ARV approved by the US Food and Drug Administration (FDA) from 2005 to 2020 were selected. Peer-reviewed publications were included if they met all criteria: adults (≥ 18 years of age) living with or without HIV; report any pharmacokinetic parameter or plasma concentration of at least one of the following ARVs: tenofovir alafenamide fumarate (TAF); doravirine (DOR), rilpivirine (RIL) and etravirine (ETR); darunavir (DRV), tipranavir (TPV) and fostemsavir (FTR); dolutegravir (DTG), raltegravir (RAL), bictegravir (BIC) and elvitegravir (EVG); maraviroc (MVC); ibalizumab (IBA); cobicistat (COBI). Pharmacokinetic parameters were reported stratified per age group: young adults (aged 18-49 years) or older (age ≥ 50 years) and all studies were evaluated for quality. The review protocol was registered in the PROSPERO database (registration number CRD42021236432). RESULTS: Among 97 studies included, 20 reported pharmacokinetic evaluation in older individuals (age ≥ 50 years). Twenty five percent of the articles were phase I randomized clinical trials with HIV-negative participants and non-compartmental pharmacokinetic analysis presenting the parameters area under the curve (AUC) and peak drug concentration (Cmax). Seven age-stratified studies evaluated BIC, ETR, DRV, DTG, DOR and RAL. We found publications with discordant results for ETR and DTG pharmacokinetics in different age groups. DRV exposure was highly variable but modestly increased in aging PLWHIV. In contrast, no influence of age on BIC, DOR and RAL exposure was observed. A variability in pharmacokinetic parameters could be observed for the other ARVs (TAF and MVC) in different age groups. CONCLUSION: Exposure to DRV increases modestly with age, while exposure to BIC, DOR and RAL appears to be unaffected by age. As the available evidence to confirm a potential effect of aging on ARV pharmacokinetics is limited, further studies are necessary.

Expansion of testing, isolation, quarantine, e-health and telemonitoring strategies in socioeconomically vulnerable neighbourhoods at primary healthcare in the fight against COVID-19 in Brazil: a study protocol of a multisite testing intervention using a mixed method approach.

INTRODUCTION: The key tools for mitigating the impact of COVID-19 and reducing its transmission include testing, quarantine and isolation, as well as telemonitoring. Primary healthcare (PHC) can be essential in increasing access to these tools. Therefore, the primary objective of this study is to implement and expand an intervention consisting of COVID-19 testing, isolation, quarantine and telemonitoring (TQT) strategies and other prevention measures at PHC services in highly socioeconomically vulnerable neighbourhoods of Brazil. METHODS AND ANALYSIS: This study will implement and expand COVID-19 testing in PHC services in two large Brazilian capital cities: Salvador and Rio de Janeiro. Qualitative formative research was conducted to understand the testing context in the communities and at PCH services. The TQT strategy was structured in three subcomponents: (1) training and technical support for tailoring the work processes of health professional teams, (2) recruitment and demand creation strategies and (3) TQT. To evaluate this intervention, we will conduct an epidemiological study with two stages: (1) a cross-sectional sociobehavioural survey among individuals from these two communities covered by PHC services, presenting symptoms associated with COVID-19 or being a close contact of a patient with COVID-19, and (2) a cohort of those who tested positive, collecting clinical data. ETHICS AND DISSEMINATION: The WHO Ethics Research Committee (ERC) (#CERC.0128A and #CERC.0128B) and each city's local ERC approved the study protocol (Salvador, ISC/UFBA: #53844121.4.1001.5030; and Rio de Janeiro, INI/Fiocruz: #53844121.4.3001.5240, ENSP/Fiocruz: #53844121.4.3001.5240 and SMS/RJ #53844121.4.3002.5279). Findings will be published in scientific journals and presented at meetings. In addition, informative flyers and online campaigns will be developed to communicate study findings to participants, members of communities and key stakeholders.

A Peer-Led Digital Intervention to Reduce HIV Prevention and Care Disparities Among Young Brazilian Transgender Women (The BeT Study): Protocol for an Intervention Study.

BACKGROUND: The HIV epidemic continues to disproportionately burden marginalized populations despite the availability of effective preventive and therapeutic interventions. Transgender women are severely affected by HIV worldwide including in Brazil and other low- and middle-income countries, with evidence of increasing new infections among young people. There is an urgent need for youth-specific HIV prevention and care interventions for young transgender women in Brazil. OBJECTIVE: This study aims to (1) address stigma in the Brazilian public health system and (2) reduce barriers to HIV care and prevention with systems navigation among young transgender women aged 18-24 years in Rio de Janeiro, Brazil. METHODS: The Brilhar e Transcender (BeT) study is a status-neutral, peer-led, single-arm digital intervention study enrolling 150 young transgender women in Rio de Janeiro, Brazil. The intervention was pilot tested and refined using data from a formative phase. The BeT intervention takes place over 3 months, is delivered remotely via mobile phone and in person by peers, and comprises three components: (1) BeT sessions, (2) digital interactions, and (3) automated messages. Eligibility criteria include identifying as transgender women, being aged 18-24 years, speaking in Portuguese, and living in the Rio de Janeiro metropolitan area in Brazil. The primary outcomes are HIV incidence, pre-exposure prophylaxis uptake, linkage to HIV care, and viral suppression. Primary outcomes were assessed at baseline and quarterly for 12 months. Participants respond to interviewer-based surveys and receive tests for HIV and sexually transmitted infections. RESULTS: The study has been approved by the Brazilian and the US local institutional review boards in accordance with all applicable regulations. Study recruitment began in February 2022 and was completed in early July 2022. Plans are to complete the follow-up assessment of study participants on July 2023, analyze the study data, and disseminate intervention results by December 2023. CONCLUSIONS: Interventions to engage a new generation of transgender women in HIV prevention and care are needed to curb the epidemic. The BeT study will evaluate a digital peer-led intervention for young transgender women in Brazil, which builds on ways young people engage in systems and uses peer-led support to empower transgender youth in self-care and health promotion. A promising evaluation of the BeT intervention may lead to the availability of this rapidly scalable status-neutral HIV intervention that can be translated throughout Brazil and other low- and middle-income countries for young transgender women at high risk of or living with HIV. TRIAL REGISTRATION: ClinicalTrials.gov NCT05299645; https://clinicaltrials.gov/ct2/show/NCT05299645. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/44157.

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

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

Preferences for PrEP modalities among gay, bisexual, and other men who have sex with men from Brazil, Mexico, and Peru: a cross-sectional study.

Background: Pre-exposure prophylaxis (PrEP) scale-up is urgent to reduce new HIV cases among gay, bisexual, and other men who have sex with men (MSM) in Latin America. Different PrEP modalities may increase PrEP uptake and adherence, especially among young MSM. Objectives: To assess preferences for PrEP modalities among MSM from Brazil, Mexico, and Peru. Design: Cross-sectional web-based study (March-May 2018) targeting MSM through advertisements on Grindr, Hornet, and Facebook. We included MSM aged ⩾ 18 years and who reported HIV-negative status. Methods: We assessed preferences for PrEP modalities with the following question: 'Considering that all following PrEP modalities were available, which one would you prefer considering a scale from 1 to 3 (1 = most preferred): daily oral PrEP, event-driven PrEP (ED-PrEP), and long-acting injectable PrEP'. We assessed factors associated with each most preferred PrEP modality per country using multivariable logistic regression models. Results: A total of 19,457 MSM completed the questionnaire (Brazil: 58%; Mexico: 31%; Peru: 11%); median age was 28 years [interquartile range (IQR): 24-34]. Overall, injectable PrEP was the most preferred modality [42%; 95% confidence interval (CI): 41-43], followed by daily PrEP (35%; 95% CI: 34-35), and ED-PrEP (23%; 95% CI: 23-24). In multivariable models, preferring injectable PrEP was associated with PrEP awareness in all three countries, while PrEP eligibility only in Brazil. Preferring daily PrEP was associated with younger age and lower income in Brazil and Mexico, and lower education only in Brazil. The odds of preferring ED-PrEP were lower among MSM aware and eligible for PrEP in Brazil and Mexico. Conclusions: Long-acting injectable PrEP was the preferred PrEP modality among MSM in Brazil, Mexico, and Peru, especially those aware and eligible for PrEP. Public health interventions to increase PrEP modalities literacy and availability in Latin America are urgent especially among MSM of young age, lower income, and lower education.

The Impact of COVID-19 on HIV Care in Rio de Janeiro, Brazil 2019-2021: Disparities by Age and Gender.

We evaluated COVID-19's impact on HIV care indicators among INI/FIOCRUZ's HIV Clinical Cohort in Rio de Janeiro, Brazil: (1) Adequate care visits: two visits ≥ 90 days apart; (2) Adequate viral load monitoring: ≥ 2 viral load results ≥ 90 days apart; (3) Consistent viral suppression: all viral loads < 40 copies/mL; and (4) ART medication possession ratio (MPR) ≥ 95%. Chi-square tests compared the fraction of participants meeting each indicator per period: pre-pandemic (3/1/2019-2/29/2020) and post-pandemic (3/1/2020-2/28/2021). Logistic regression models were used to assess disparities in adequate care visits. Among 906 participants, care visits and viral load monitoring decreased pre-pandemic to post-pandemic: 77.0-55.1% and 36.6-11.6% (both p < 0.001), respectively. The optimal MPR rate improved from 25.5 to 40.0% (p < 0.001). Post-pandemic period (aOR 0.33, CI 0.28-0.40), transgender women (aOR 0.34, CI 0.22-0.53), and those aged 18-24 years (aOR 0.67, CI 0.45-0.97) had lower odds of adequate care visits. COVID-19 disrupted care access disproportionately for transgender women and younger participants.

HIV Risk Perception and Pre-Exposure Prophylaxis (PrEP) Awareness Among Transgender Women from Mexico.

This study aimed to identify factors associated with HIV risk perception among Mexican transgender women (TGW). This cross-sectional survey was conducted online and at a public HIV clinic in Mexico City. Participants were ≥ 18 years old, self-identified as TGW, and reported not living with HIV. They answered questions on sexual behavior, HIV risk perception, and pre-exposure prophylaxis (PrEP) awareness. We performed a multivariate logistic regression to accomplish the study's objective. One hundred ninety-one TGW completed the survey. High HIV risk perception was associated with > 5 sexual partners, condomless receptive anal sex, sex with a male partner(s) of unknown HIV status, and PrEP awareness. Although most TGW reported low HIV risk perception, over half had risk sexual behavior, reflecting inaccurate risk assessment. Future interventions to improve accurate risk perception among TGW should promote HIV transmission and prevention knowledge and increase PrEP awareness and uptake.

RESUMEN: Este estudio tuvo como objetivo identificar los factores asociados con la percepción de riesgo al VIH entre las mujeres trans (MT) mexicanas. El reclutamiento de esta encuesta transversal se realizó en línea y en una clínica pública de VIH en la Ciudad de México. Las participantes tenían ≥ 18 años, se autoidentificaron como MT y reportaron no vivir con VIH. Respondieron preguntas sobre su comportamiento sexual, percepción del riesgo al VIH y conocimiento de la profilaxis preexposición (PrEP). Se realizó un análisis de regresión logística multivariado para cumplir con el objetivo del estudio. Ciento noventa y uno participantes completaron la encuesta. La percepción de alto riesgo al VIH se asoció con > 5 parejas sexuales, sexo anal receptivo sin condón, sexo con una pareja masculina de estado serológico desconocido y conocimiento de la PrEP. Aunque la mayoría de las MT informaron baja percepción del riesgo al VIH, más de la mitad reportaron conductas sexuales de riesgo, lo que refleja una evaluación de riesgo inexacta. Futuras intervenciones para mejorar la percepción precisa del riesgo entre las MT deben centrarse en promover el conocimiento de transmisión y la prevención del VIH, así como aumentar el conocimiento y la aceptación de la PrEP.

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

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.

Same-day initiation of oral pre-exposure prophylaxis among gay, bisexual, and other cisgender men who have sex with men and transgender women in Brazil, Mexico, and Peru (ImPrEP): a prospective, single-arm, open-label, multicentre implementation study.

BACKGROUND: Although gay, bisexual, and other cisgender men who have sex with men (MSM) and transgender women have the highest HIV burden in Latin America, pre-exposure prophylaxis (PrEP) implementation is poor. We aimed to assess the feasibility of same-day oral PrEP delivery in Brazil, Mexico, and Peru. METHODS: Implementation PrEP (ImPrEP) was a prospective, single-arm, open-label, multicentre PrEP implementation study conducted in Brazil (14 sites), Mexico (four sites), and Peru (ten sites). MSM and transgender women were eligible to participate if they were aged 18 years or older, HIV-negative, and reported one or more prespecified criteria. Enrolled participants received same-day initiation of daily oral PrEP (tenofovir disoproxil fumarate [300 mg] coformulated with emtricitabine [200 mg]). Follow-up visits were scheduled at week 4 and quarterly thereafter. We used logistic regression models to identify factors associated with early loss to follow-up (not returning after enrolment), PrEP adherence (medication possession ratio ≥0·6), and long-term PrEP engagement (attending three or more visits within 52 weeks). This study is registered at the Brazilian Registry of Clinical Trials, U1111-1217-6021. FINDINGS: From Feb 6, 2018, to June 30, 2021, 9979 participants were screened and 9509 were enrolled (Brazil n=3928, Mexico n=3288, and Peru n=2293). 543 (5·7%) participants were transgender women, 8966 (94·3%) were cisgender men, and 2481 (26·1%) were aged 18-24 years. There were 12 185·25 person-years of follow-up. 795 (8·4%) of 9509 participants had early loss to follow-up, 6477 (68·1%) of 9509 were adherent to PrEP, and 5783 (70·3%) of 8225 had long-term PrEP engagement. Transgender women (adjusted odds ratio 1·60, 95% CI 1·20-2·14), participants aged 18-24 years (1·80, 1·49-2·18), and participants with primary education (2·18, 1·29-3·68) had increased odds of early loss to follow-up. Transgender women (0·56, 0·46-0·70), participants aged 18-24 years (0·52, 0·46-0·58), and those with primary education (0·60, 0·40-0·91) had lower odds of PrEP adherence. Transgender women (0·56, 0·45-0·71), participants aged 18-24 years (0·56, 0·49-0·64), and those with secondary education (0·74, 0·68-0·86) had lower odds of long-term PrEP engagement. HIV incidence was 0·85 per 100 person-years (95% CI 0·70-1·03) and was higher for transgender women, participants from Peru, those aged 18-24 years, Black and mixed-race participants, and participants who were non-adherent to PrEP. INTERPRETATION: Same-day oral PrEP is feasible for MSM and transgender women in Latin America. Social and structural determinants of HIV vulnerability need to be addressed to fully achieve the benefits of PrEP. FUNDING: Unitaid, WHO, and Ministries of Health in Brazil, Mexico, and Peru. TRANSLATIONS: For the Portuguese and Spanish translations of the abstract see Supplementary Materials section.