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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.

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.

AbstractIntroductionNon‐alcoholic fatty liver disease is characterized by the presence of hepatic steatosis and can be associated with fibrosis progression, development of cirrhosis and liver‐related complications. Data on the prevalence of liver fibrosis and steatosis in HIV patients remain contradictory in resource‐limited settings. We aimed to describe the prevalence and factors associated with liver fibrosis and steatosis in patients with HIV mono‐infection under long‐term antiretroviral therapy (ART) in Rio de Janeiro, Brazil.MethodsClinical assessment, fasting blood collection and liver stiffness measurement (LSM)/controlled attenuation parameter (CAP) by transient elastography were performed on the same day for this cross‐sectional study (PROSPEC‐HIV study; NCT02542020). Patients with viral hepatitis co‐infection, ART‐naïve or missing data were excluded. Liver fibrosis and steatosis were defined by LSM ≥ 8.0 kPa and CAP ≥ 248 dB/m respectively. HIV history, cumulative and current ART regimens were evaluated. Multivariate logistic regression models adjusted for age and gender were performed.ResultsIn total, 395 patients (60% female; median age of 45 (IQR, 35 to 52) years, body mass index = 25.7 (23.2 to 29.4) kg/m2, alanine aminotransferase = 30 (23 to 42) IU/L, duration of ART for 7 (4 to 14) years) were included. LSM and CAP were reliable in 93% (n = 367) and 87% (n = 344) respectively. The prevalence of fibrosis and steatosis were 9% (95% confidence interval (CI), 7 to 13) and 35% (95% CI, 30 to 40) respectively. The following factors were associated with fibrosis (odds ratio (OR) (95% CI)): older age (per 10 years; 1.80 (1.27 to 2.55); p = 0.001) and CD4+ count <200 cells/mm3 (7.80 (2.09 to 29.09), p = 0.002). Type 2 diabetes had a trend towards the presence of liver fibrosis (2.67 (0.96 to 7.46), p = 0.061). Central obesity (10.74 (4.40 to 26.20), p < 0.001), type 2 diabetes (9.74 (3.15 to 30.10), p < 0.001), dyslipidaemia (2.61 (1.35 to 5.05), p = 0.003) and metabolic syndrome (4.28 (2.45 to 7.46), p < 0.001) were associated with steatosis. A dominant backbone ART regimen of zidovudine (AZT), d4T, ddI or ddC was associated with steatosis (1.90 (1.07 to 3.38), p = 0.028) independently of metabolic features.ConclusionIntegrated strategies for preventing non‐communicable diseases in people with HIV mono‐infection are necessary to decrease the burden of liver diseases.Clinical Trial Number: NCT02542020.

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.

AbstractIntroductionAs the leading sexually transmitted infection worldwide, human papillomavirus (HPV) may disproportionately affect transwomen. We aimed to estimate anal HPV prevalence, especially focusing on high‐risk (hr)‐HPV types and evaluate their associated factors among transwomen living in Rio de Janeiro, Brazil.MethodsTranswomen enrolled in a respondent‐driven sampling (RDS)‐based survey conducted between August 2015 and January 2016 self‐collected anal samples, which were promptly stored at minus 80°C. After DNA extraction, HPV detection and genotyping were performed using the PapilloCheck test. We estimated HPV prevalences and evaluated the correlates of anal hr‐HPV infection using a regression logistic model.ResultsOut of 345 transwomen, 272 (78.8%) were included in this analysis (122 [44.9%] HIV‐positive). No participant had ever received HPV vaccination. Among participants enrolled, 212 (77.9%) were positive for any anal HPV type and 165 (60.7%) for hr‐HPV. Most common hr‐HPV were as follows: HPV16 (17.6%), HPV68 (14.7%), HPV39 (14.3%), HPV56 (12.5%), HPV51 (11.4%) and HPV52 (11.0%). HIV‐positive transwomen had three times the odds of having an hr‐HPV compared to HIV‐negative transwomen. Participants who had a current rectal Neisseria gonorrhoeae infection had 3.7 times the odds of being coinfected with hr‐HPV. Among HIV‐positive transwomen, neither antiretroviral therapy use, undetectable viral load, current and nadir CD4 counts were associated with anal hr‐HPV infection.ConclusionsBrazilian transwomen in our study exhibit some of the highest population‐specific rates of HPV and hr‐HPV. There is an urgent need to elucidate the burden of HPV infection, prevalence of HPV‐related diseases and access to and uptake of HPV vaccination among transwomen, especially from low‐ and middle‐income settings.

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.

AbstractIntroductionIdentification of persons living with human immunodeficiency virus (HIV)‐associated tuberculosis (TB) at increased risk for unfavourable TB outcomes would inform efforts to improve such outcomes. We sought to identify factors associated with a decreased risk of unfavourable TB treatment outcomes among people living with HIV‐infection (PLHIV) in low‐ and middle‐income countries (LMIC), with a specific focus on directly observed therapy (DOT) compared with self‐administered therapy (SAT) during the continuation phase of anti‐TB therapy.MethodsWe conducted a retrospective cohort study among adults diagnosed with HIV‐associated TB in Africa, Asia and the Americas from 2012 to 2013; data were collected from 2012 to 2016. Unfavourable TB treatment outcomes (death during TB treatment, and TB treatment failure or recurrence) were defined according to World Health Organization criteria. Receipt of DOT was obtained at the site level and defined as ≥5 days of DOT per week. The person administering DOT and treatment location varied by site. Lack of receipt of DOT was defined as SAT. Multivariable logistic regression estimated the adjusted odds of unfavourable TB treatment outcomes.ResultsAmong 1862 adults with HIV‐associated TB included, 252 (13.5%) had unfavourable TB outcomes (226 deaths, 26 recurrences/failures). Overall, 1825 (98%) received DOT in the intensive phase and 1617 (87%) received DOT in the continuation phase. DOT in the continuation phase was not significantly associated with unfavourable TB outcomes (aOR 1.43, 95% CI 0.86 to 2.38) compared to SAT. Body mass index (BMI) change during anti‐TB treatment (per 2 units increase, aOR 0.74, 95% CI 0.68 to 0.82) and CD4+ count at TB diagnosis (200 vs. 50 cells/µL, aOR 0.54, 95% CI 0.39 to 0.73) were both independently associated with decreased odds of unfavourable TB treatment outcomes.ConclusionsIn this large, international cohort of people living with HIV‐associated TB in LMIC who received intensive phase DOT, DOT during the continuation phase of anti‐TB therapy was not associated with a decreased odds of unfavourable TB treatment outcomes compared to SAT. Randomized trials evaluating the effect of continuation‐phase DOT on TB outcomes among PLHIV are needed.

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.

AbstractIntroductionThe HIV epidemic continues to disproportionately impact Latin‐American transgender women (TGW). We assessed factors associated with long‐term pre‐exposure prophylaxis (PrEP) engagement and adherence among TGW enrolled in the Implementation of PrEP (ImPrEP) study, the largest PrEP demonstration study in Latin America.MethodsHIV‐negative TGW aged ≥18 years reporting 1+eligibility criteria in the 6 months prior to enrolment (e.g. sex partner known to be living with HIV, condomless anal sex [CAS], transactional sex or having a sexually transmitted infection [STI]) who could safely take PrEP were enrolled. Follow‐up visits were conducted at 4 weeks and then quarterly. We conducted logistic regression to identify factors associated with long‐term PrEP engagement (3+ follow‐up visits in 52 weeks) and complete self‐reported adherence (no missed pills in the past 30 days) during follow‐up. For both outcomes, we constructed multivariable models controlling for country, socio‐demographics, sexual behaviour, substance use, STIs and self‐reported adherence at 4 weeks (long‐term engagement outcome only).ResultsFrom March 2018 to June 2021, ImPrEP screened 519 TGW, enrolled 494 (Brazil: 190, Mexico: 66 and Peru: 238) and followed them for 52 weeks. At baseline, 27.5% of TGW were aged 18–24 years, 67.8% were mixed‐race and 31.6% had >secondary education. Most, 89.9% reported CAS, 61.9% had >10 sex partners and 71.9% reported transactional sex. HIV incidence was 1.82 cases per 100 person‐years (95% confidence interval [CI]: 0.76–4.38). Almost half of TGW (48.6%) had long‐term PrEP engagement, which was positively associated with reporting complete adherence at week 4 (aOR:2.94 [95%CI:1.88–4.63]) and was inversely associated with reporting CAS with unknown‐HIV partner (aOR:0.52 [95%CI:0.34–0.81]), migration (aOR:0.54 [95%CI:0.34–0.84]), and being from Mexico (aOR:0.28 [95%CI:0.14–0.53]). Self‐reported adherence was associated with TGW aged >34 (aOR:1.61 [95%CI:1.10–2.34]) compared to those aged 25–34 and those with >secondary education (aOR:1.55 [95%CI:1.10–2.19]) and was lower among TGW from Peru (aOR:0.29 [95%CI:0.21–0.41]) or reporting PrEP‐related adverse effects (aOR:0.63 [95%CI:0.42–0.92]).ConclusionsAlthough TGW were willing to enrol in ImPrEP, long‐term PrEP engagement and complete self‐reported adherence were limited, and HIV incidence remained relatively high. A successful HIV prevention agenda should include trans‐specific interventions supporting oral PrEP and exploring long‐acting PrEP strategies for TGW.

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.