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Introduction: Globally, transgender ('trans') women experience extreme social and economic marginalisation due to intersectional stigma, defined as the confluence of stigma that results from the intersection of social identities and positions among those who are oppressed multiple times. Among trans women, gender-based stigma intersects with social positions such as engagement in sex work and substance use, as well as race-based stigma to generate a social context of vulnerability and increased risk of HIV acquisition. In Brazil, trans women are the 'most at-risk' group for HIV, with 55 times higher estimated odds of HIV infection than the general population; further, uptake of HIV testing and pre-exposure prophylaxis (PrEP) among trans women is significantly lower than other at-risk groups. Through extensive formative work, we developed Manas por Manas, a multilevel intervention using HIV prevention strategies with demonstrated feasibility and acceptability by trans women in Brazil, to address intersectional stigma and increase engagement in the HIV prevention continuum., Methods and Analysis: We are conducting a two-arm randomised wait-list controlled trial of the intervention's efficacy in São Paulo, Brazil, to improve uptake of HIV testing and PrEP among transgender women (N=400). The primary outcomes are changes in HIV testing (self-testing and clinic based), changes in PrEP uptake and changes in PrEP persistence at baseline and follow-up assessment for 12 months at 3-month intervals., Ethics and Dissemination: This study was approved by University of California, San Francisco Institutional Review Board (15-17910) and Comissão Nacional de Ética em Pesquisa (Research Ethics National Commission, CAAE: 25215219.8.0000.5479) in Brazil. Participants provided informed consent before enrolment. We are committed to collaboration with National Institutes of Health officials, other researchers, and health and social services communities for rapid dissemination of data and sharing of materials. The results will be published in peer-reviewed academic journals and scientific presentations., Trial Registration Number: NCT03081559., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Transgender women are disproportionately affected by both HIV and gender-based violence (GBV), defined as physical, sexual, or emotional violence perpetrated against an individual based on their gender identity/expression. While a growing body of evidence demonstrates that GBV leads to poor HIV care and treatment outcomes among cisgender women, less research has examined this association among transgender women. We assessed the impact of lifetime experiences of GBV on subsequent retention in HIV care and laboratory confirmed viral suppression among a sample of transgender women living with HIV (TWH) in Brazil., Methods: A pilot trial of a peer navigation intervention to improve HIV care and treatment among TWH was conducted in São Paulo, Brazil between 2018 and 2019. TWH were recruited and randomized into the intervention or control arm and participated in a baseline and 9-month follow-up survey and ongoing extraction of clinical visit, prescribing, and laboratory data. Generalized linear model regressions with a Poisson distribution estimated the relative risk (RR) for the association of lifetime physical and sexual violence reported at baseline with treatment outcomes (retention in HIV care and viral suppression) at follow-up, adjusting for baseline sociodemographic characteristics., Results: A total of 113 TWH participated in the study. At baseline, median age was 30 years, and the prevalence of lifetime physical and sexual violence was 62% and 45%, respectively. At follow-up, 58% (n = 66/113) were retained in care and 35% (n = 40/113) had evidence of viral suppression. In adjusted models, lifetime physical violence was non-significantly associated with a 10% reduction in retention in care (aRR: 0.90, 95% CI: 0.67, 1.22) and a 31% reduction in viral suppression (aRR: 0.69; 95% CI: 0.43, 1.11). Lifetime sexual violence was non-significantly associated with a 28% reduction in retention in HIV care (aRR: 0.72, 95% CI: 0.52, 1.00) and significantly associated with a 56% reduction in viral suppression (aRR: 0.44; 95% CI: 0.24, 0.79)., Conclusion: Our findings are among the first to demonstrate that lifetime experiences with physical and sexual violence are associated with poor HIV outcomes over time among transgender women. Interventions seeking to improve HIV treatment outcomes should assess and address experiences of GBV among this population., Trial Registration: ClinicalTrials.gov Identifier: NCT03525340., (© 2024. The Author(s).)

Travestis and transgender women (TrTGW) constitute the groups with the highest HIV prevalence in the world, with higher probability of infection compared with the general population and lower adherence to prevention and treatment strategies than other vulnerable groups. Considering these challenges, this study describes the factors associated with the retention of TrTGW with HIV to the TransAmigas project. Participants were recruited from April 2018 to September 2019 in a public health service in São Paulo, Brazil. A total of 113 TrTGW were randomly assigned to either a peer navigation intervention (75) or a control group (38) and followed up for nine months. To analyze the association between the selected variables and the outcome ("retention at nine months", regardless of contact at three months, defined by the "full completion of the final questionnaire"), bivariate and multivariate logistic regression models were used. Peer contact forms were qualitatively assessed to validate and complement the previous selection of quantitative component variables. Of the 113 participants, 79 (69.9%) participated in the interview after nine months, of which 54 (72%) were from the intervention group and 25 (66%) from the control group. In the final multivariate model, contact at three months (adjusted odds ratio - aOR = 6.15; 95% confidence interval - 95%CI: 2.16-17.51) and higher schooling level (≥ 12 years) (aOR = 3.26; 95%CI: 1.02-10.42) remained associated with the outcome, adjusted by race/skin color, age ≤ 35 years, and HIV serostatus disclosure. Future studies with TrTGW should include contact at regular intervals, with additional efforts aimed at participants with lower schooling level.

Trans women living with HIV (TWH) have suboptimal HIV care engagement. We pilot tested Trans Amigas, a theory-based, trans-specific peer navigation (PN) intervention to address barriers to care in São Paulo, Brazil. TWH were randomized to the PN intervention (n = 75) or control (n = 38) condition. Control participants were referred to trans-friendly HIV care. Intervention participants were assigned a navigator who conducted nine in-person one-on-one sessions and bi-weekly phone or text check-ins to help participants overcome barriers to care and work towards gender affirmation and healthcare goals. We followed participants for 9 months to determine intervention feasibility, acceptability, and preliminary efficacy in improving retention in care. Analyses were intention to treat (ITT). Intervention acceptability was high: at end line, 85.2% of PN participants said they would continue receiving services and 94.4% would recommend peer navigation to a friend. A priori feasibility criteria were met: 92% of eligible participants enrolled and 70% were retained at 9 months; however, only 47% achieved moderate or better adherence to both in-person and phone/text program components. Though the pilot was not powered for efficacy, ITT findings trended toward significance, with intervention participants 40% more likely to be retained in care at the end of the study. Population-specific peer programming to support care engagement is acceptable, feasible, and can improve HIV outcomes for Trans women living with HIV., (© 2022. The Author(s).)

The study evaluated the nutritional status of 629 people living with HIV/AIDS attended at 12 specialized services of São Paulo's Municipal Health Department, Brazil. Data were obtained from medical records and through interviews during nutritional consultation. We used the classification criteria established by World Health Organization to assess malnourished individuals, a BMI < 18.5kg/m2. The prevalence of malnutrition in people with AIDS is 3.12 times that observed among people with HIV, and among people with co-infection it is 3.41 times that obtained among people without co-infection. This indicates how these conditions can harm the maintenance of the nutritional status, and shows that they demand a comprehensive understanding of the mechanisms involved in this phenomenon, as well as the development of strategies to improve the health care of individuals at nutritional risk.

The nutritional status of people living with HIV/AIDS (PLWHA) is related to morbidity and mortality and its monitoring is important in the maintenance of the health status. This is a cross-sectional study carried out in Brazilian National Health System in the Municipality of São Paulo. It describes anthropometrical characteristics: weight and height; indices of weight for height (W/H), height for age (H/A), body mass index for age (BMI/A) and Z score for height and weight. The study includes 772 participants from all ages: children, adolescents, adults and elderly. The graphical analysis shows that in under-5s and in the 5 to 19 years old group, the W/H, the H/A and the BMI/A curves are similar to the reference population with an exception in the H/A for 5 to 19 years old group which is left-shifted (mean Z = -0.66). In the case of adults, graphics for the study population show median weight apparently lower than in the reference population for most age groups in the case of men, and when age is greater in women. The proportion of people over 20 years old with AIDS on anti-retroviral therapy is lower when coinfection is present (p < 0.001). The findings of the study showed that, for children and adolescents with HIV/AIDS, the average weight and height are lower than the values for non infected population. For adults and elderly, the weight average is lower than the reference population with a worsening among coinfected patients. This underscores the need to direct more effort in nutritional actions thus helping enhance the health status of this group.

Purpose: To describe the anthropometric and pregnancy characteristics of women with HIV/AIDS, assisted by the Brazilian National Health System and the birth weight of their newborns., Methods: The participants were women assisted at public STD/AIDS clinics of the Municipal Health system of São Paulo. The anthropometric characteristics were evaluated by trained nutritionists and other information was obtained from the medical records. For comparison of the survey data to those of the general population, secondary maternal and pregnancy data were obtained from live birth certificates through the Live Birth Information System. Continuous variables were summarized as mean and standard deviation or as the 25th, 50th and 75th percentiles and minimum and maximum values. The other variables are presented as percentages. Means were compared by the Student's t-test or Kruskal-Wallis test depending on the fulfillment of assumptions, with the decision based on the p value., Results: We found the presence of inadequate maternal nutrition according to triceps skinfold (60.9%). The BMI/gestational age showed the presence of underweight (18.5%) and overweight or obesity (40%). There was no association between disease status (HIV or AIDS) and weight, height, and lean or fat mass. Mean newborn birth weight was lower than the value for the general population without infection or disease. The results of this study indicate the need to develop adapted curves to allow a more accurate nutritional assessment of this population group.

Background: Because various HIV vaccination studies are in progress, it is important to understand how often inter- and intra-subtype co/superinfection occurs in different HIV-infected high-risk groups. This knowledge would aid in the development of future prevention programs. In this cross-sectional study, we report the frequency of subtype B and F1 co-infection in a clinical group of 41 recently HIV-1 infected men who have sex with men (MSM) in São Paulo, Brazil., Methodology: Proviral HIV-1 DNA was isolated from subject's peripheral blood polymorphonuclear leukocytes that were obtained at the time of enrollment. Each subject was known to be infected with a subtype B virus as determined in a previous study. A small fragment of the integrase gene (nucleotide 4255-4478 of HXB2) was amplified by nested polymerase chain reaction (PCR) using subclade F1 specific primers. The PCR results were further confirmed by phylogenetic analysis. Viral load (VL) data were extrapolated from the medical records of each patient., Results: For the 41 samples from MSM who were recently infected with subtype B virus, it was possible to detect subclade F1 proviral DNA in five patients, which represents a co-infection rate of 12.2%. In subjects with dual infection, the median VL was 5.3 × 10(4) copies/ML, whereas in MSM that were infected with only subtype B virus the median VL was 3.8 × 10(4) copies/ML (p > 0.8)., Conclusions: This study indicated that subtype B and F1 co-infection occurs frequently within the HIV-positive MSM population as suggested by large number of BF1 recombinant viruses reported in Brazil. This finding will help us track the epidemic and provide support for the development of immunization strategies against the HIV.

Background: Genetic variability is a major feature of human immunodeficiency virus type 1 (HIV-1) and is considered the key factor frustrating efforts to halt the HIV epidemic. A proper understanding of HIV-1 genomic diversity is a fundamental prerequisite for proper epidemiology, genetic diagnosis, and successful drugs and vaccines design. Here, we report on the partial and near full-length genomic (NFLG) variability of HIV-1 isolates from a well-characterized cohort of recently infected patients in São Paul, Brazil., Methodology: HIV-1 proviral DNA was extracted from the peripheral blood mononuclear cells of 113 participants. The NFLG and partial fragments were determined by overlapping nested PCR and direct sequencing. The data were phylogenetically analyzed., Results: Of the 113 samples (90.3% male; median age 31 years; 79.6% homosexual men) studied, 77 (68.1%) NFLGs and 32 (29.3%) partial fragments were successfully subtyped. Of the successfully subtyped sequences, 88 (80.7%) were subtype B sequences, 12 (11%) BF1 recombinants, 3 (2.8%) subtype C sequences, 2 (1.8%) BC recombinants and subclade F1 each, 1 (0.9%) CRF02 AG, and 1 (0.9%) CRF31 BC. Primary drug resistance mutations were observed in 14/101 (13.9%) of samples, with 5.9% being resistant to protease inhibitors and nucleoside reverse transcriptase inhibitors (NRTI) and 4.9% resistant to non-NRTIs. Predictions of viral tropism were determined for 86 individuals. X4 or X4 dual or mixed-tropic viruses (X4/DM) were seen in 26 (30.2%) of subjects. The proportion of X4 viruses in homosexuals was detected in 19/69 (27.5%)., Conclusions: Our results confirm the existence of various HIV-1 subtypes circulating in São Paulo, and indicate that subtype B account for the majority of infections. Antiretroviral (ARV) drug resistance is relatively common among recently infected patients. The proportion of X4 viruses in homosexuals was significantly higher than the proportion seen in other study populations.

Introduction: Nutrition currently plays a key role in the treatment of people living with HIV/AIDS (PLHA), especially in the case of metabolic alterations due to highly active antiretroviral therapy (HAART), which could be related to cardiovascular diseases (CD)., Objective: to describe the nutritional and clinical status, and the quality of diet of PLHA., Methods: It is a cross-sectional study involving a network of ambulatory care facilities for PLHA in the city of São Paulo, Brazil. Patients, in use of HAART or not, were selected from December 2004 to may 2006, through routine clinic visits. We collected: socio-demographic, clinical, biochemical, anthropometric measures and dietary data. Diet quality was evaluated according to a "protecting" or "non-protecting" pattern of consumption scores for CD., Results: The sample had 238 patients on HAART and 76 without treatment. Mean serum levels of total cholesterol, triglycerides and glucose were higher in the HAART group (p < 0.001). The majority of patients of both the treated and untreated group were eutrophic with a mean body mass index (BMI) of 24.4 (± 4.3) kg/m² and 24.3 (± 3.5), respectively. The waist-hip ratio was higher among men on HAART (0.90 ± 0.06 versus 0.87 ± 0.05) (p < 0.001). The HAART group showed a mean food pattern score indicating a higher consumption of "non-protecting" foods for CD (p = 0.001)., Conclusion: The results showed undesired nutritional and metabolic conditions among patients on HAART associated with CD. It is necessary to manage health intervention programs for PLHA in order to control cardiovascular risk factors before final outcomes.

Background: Many clinical studies have suggested a beneficial effect of GB virus type C (GBV-C) on the course of HIV-1 infection, but the mechanisms involved in such amelioration are not clear. As recent evidence has implicated cellular activation in HIV-1 pathogenesis, we investigated the effect of GBV-C viremia on T-cell activation in early HIV-1 infection., Methods: Forty-eight recently infected HIV-1 patients (23 GBV-C viremic) were evaluated for T-cell counts, expanded immunophenotyping GBV-C RNA detection, and HIV-1 viral load. Nonparametric univariate and multivariate analyses were carried out to identify variables associated with cellular activation, including GBV-C status, HIV-1 viral load, T lymphocyte counts, and CD38 and chemokine (C-C motif) receptor 5 (CCR5) surface expression., Finding: We not only confirmed the positive correlation between HIV-1 viral load and the percentage of T cells positive for CD38(+)CD8(+) but also observed that GBV-C viremic patients had a lower percentage of T cells positive for CD38(+)CD4(+), CD38(+)CD8(+), CCR5(+)CD4(+), and CCR5(+)CD8(+) compared with HIV-1-infected patients who were not GBV-C viremic. In regression models, GBV-C RNA(+) status was associated with a reduction in the CD38 on CD4(+) or CD8(+) T cells and CCR5(+) on CD8(+) T cells, independent of the HIV-1 viral load or CD4(+) and CD8(+) T-cell counts. These results were also supported by the lower expression of CD69 and CD25 in GBV-C viremic patients., Interpretation: The association between GBV-C replication and lower T-cell activation may be a key mechanism involved in the protection conferred by this virus against HIV-1 disease progression to immunodeficiency in HIV-1-infected patients.

The network of HIV counseling and testing centers in São Paulo, Brazil is a major source of data used to build epidemiological profiles of the client population. We examined HIV-1 incidence from November 2000 to April 2001, comparing epidemiological and socio-behavioral data of recently-infected individuals with those with long-standing infection. A less sensitive ELISA was employed to identify recent infection. The overall incidence of HIV-1 infection was 0.53/100/year (95% CI: 0.31-0.85/100/year): 0.77/100/year for males (95% CI: 0.42-1.27/100/year) and 0.22/100/ year (95% CI: 0.05-0.59/100/year) for females. Overall HIV-1 prevalence was 3.2% (95% CI: 2.8-3.7%), being 4.0% among males (95% CI: 3.3-4.7%) and 2.1% among females (95% CI: 1.6-2.8%). Recent infections accounted for 15% of the total (95% CI: 10.2-20.8%). Recent infection correlated with being younger and male (p = 0.019). Therefore, recent infection was more common among younger males and older females.

Background: Recent studies have sought to describe HIV infection and transmission characteristics around the world. Identification of early HIV-1 infection is essential to proper surveillance and description of regional transmission trends. In this study we compare people recently infected (RI) with HIV-1, as defined by Serologic Testing Algorithm for Recent HIV Seroconversion (STARHS), to those with chronic infection., Methodology/principal Findings: Subjects were identified from 2002-2004 at four testing sites in São Paulo. Of 485 HIV-1-positive subjects, 57 (12%) were defined as RI. Of the participants, 165 (34.0%) were aware of their serostatus at the time of HIV-1 testing. This proportion was statistically larger (p<0.001) among the individuals without recent infection (n = 158, 95.8%) compared to 7 individuals (4.2%) with recently acquired HIV-1 infection. In the univariate analysis, RI was more frequent in <25 and >59 years-old age strata (p<0.001). The majority of study participants were male (78.4%), 25 to 45 years-old (65.8%), white (63.2%), single (61.7%), with family income of four or more times the minimum wage (41.0%), but with an equally distributed educational level. Of those individuals infected with HIV-1, the predominant route of infection was sexual contact (89.4%), with both hetero (47.5%) and homosexual (34.5%) exposure. Regarding sexual activity in these individuals, 43.9% reported possible HIV-1 exposure through a seropositive partner, and 49.4% reported multiple partners, with 47% having 2 to 10 partners and 37.4% 11 or more; 53.4% of infected individuals reported condom use sometimes; 34.2% reported non-injecting, recreational drug use and 23.6% were reactive for syphilis by VDRL. Subjects younger than 25 years of age were most vulnerable according to the multivariate analysis., Conclusions/significance: In this study, we evaluated RI individuals and discovered that HIV-1 has been spreading among younger individuals in São Paulo and preventive approaches should, therefore, target this age stratum.

Introduction: HIV-1 is often acquired in the presence of pre-existing co-infections, such as Herpes Simplex Virus 2 (HSV-2). We examined the impact of HSV-2 status at the time of HIV-1 acquisition for its impact on subsequent clinical course, and total CD4+ T cell phenotypes., Methods: We assessed the relationship of HSV-1/HSV-2 co-infection status on CD4+ T cell counts and HIV-1 RNA levels over time prior in a cohort of 186 treatment naïve adults identified during early HIV-1 infection. We assessed the activation and differentiation state of total CD4+ T cells at study entry by HSV-2 status., Results: Of 186 recently HIV-1 infected persons, 101 (54%) were sero-positive for HSV-2. There was no difference in initial CD8+ T cell count, or differences between the groups for age, gender, or race based on HSV-2 status. Persons with HIV-1/HSV-2 co-infection sustained higher CD4+ T cell counts over time (+69 cells/ul greater (SD = 33.7, p = 0.04) than those with HIV-1 infection alone (Figure 1), after adjustment for HIV-1 RNA levels (-57 cells per 1 log(10) higher HIV-1 RNA, p<0.0001). We did not observe a relationship between HSV-2 infection status with plasma HIV-1 RNA levels over time. HSV-2 acquisition after HIV-1 acquisition had no impact on CD4+ count or viral load. We did not detect differences in CD4+ T cell activation or differentiation state by HSV-2+ status., Discussion: We observed no effect of HSV-2 status on viral load. However, we did observe that treatment naïve, recently HIV-1 infected adults co-infected with HSV-2+ at the time of HIV-1 acquisition had higher CD4+ T cell counts over time. If verified in other cohorts, this result poses a striking paradox, and its public health implications are not immediately clear.

Several strategies aim at characterizing the AIDS epidemic in different parts of the world. Among these, the identification of recent HIV-1 infections using the recently described serologic testing algorithm for recent human immunodeficiency virus (HIV) seroconversion (STARHS) strategy was employed in four testing sites of the City of Sao Paulo Public Health Department (CSPPHD). Those identified as recently infected were invited to participate in a prospective clinical and laboratory evaluation study. We describe the establishment of the patient identification network and the success in enrolling the participants, as well as their clinical and laboratory characteristics. From May to December 2002, 6,443 persons were tested for HIV in the four participating sites, of whom 384 (5.96%) tested HIV-1 positive; 43 (11.2%) of them were identified as recently infected. Twenty-two were successfully enrolled in the follow-up study, but three of them did not meet clinical and/or laboratory criteria for recent HIV-1 infection. After these exclusions, the laboratory findings revealed a median CD4+ T lymphocyte count of 585 cells/microL (inter-quartile range 25-75% [IQR], 372-754), a CD8+ T lymphocyte count of 886 cells/microL (IQR, 553-1098), a viral load of 11,000 HIV-RNA copies/mL (IQR, 3,650-78,150), log10 of 4.04 (IQR 3.56-4.88). The identification of recent HIV infections is an extremely valuable way to evaluate the spread of the virus in a given population, especially when cohort studies, considered the gold standard method to evaluate incidence, are not available. This work demonstrated that establishing a network to identify such patients is a feasible task, even considering the difficulties in a large, resource-limited country or city.