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Jordan E Lake1, Ruth K Friedman2, Cynthia B Cunha2, Sandra W Cardoso2, Valdilea G Veloso2, Judith S Currier1, Beatriz Grinsztejn21Division of Infectious Diseases, University of California at Los Angeles, Los Angeles, CA, USA; 2Fundação Oswaldo Cruz – Instituto de Pesquisa Clínica Evandro Chagas/IPEC, Rio de Janeiro, State of Rio de Janeiro, BrazilBackground: Fifty percent of people living with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) worldwide are female. In Brazil, for example, 240,000 women are infected with HIV, rates of infection in women have increased over the last two decades, and addressing HIV prevention and treatment for women at risk for, or living with, HIV/AIDS remains a challenge. To better address the needs of women living with HIV in Brazil, the Instituto de Pesquisa Clínica Evandro Chagas – Fundação Oswaldo Cruz (IPEC-FIOCRUZ) HIV Women’s Cohort was established in 1996 to study the natural history of women seeking HIV care. This analysis describes the characteristics of women in the cohort who participated in HIV clinical trials between 1999 and 2008.Methods: A total of 736 Women’s Cohort participants were in active follow-up and 665 participants from the Women’s Cohort were included in univariable and multivariable analyses to determine socioeconomic and sociodemographic factors associated with women’s participation in HIV clinical trials at our site.Results: Of the complete cohort, 23% participated in a clinical trial between January 1999 and July 2008. Odds of participation decreased for women who were younger than 35 years old, currently employed, had an HIV-positive sexual partner, and/or who reported a lifetime history of illicit drug use. Alternatively, the odds of participation increased for women who had more than 8 years of formal education, were living independently, and/or were married or cohabitating.Conclusion: The rate of participation in HIV clinical trials by women in the IPEC-Fiocruz Cohort was similar to other published cohorts, but identification of local risk factors and barriers to participation remains important. Our analysis offers a novel description of the factors associated with participation in HIV clinical trials among women in care at IPEC-FIOCRUZ in Rio de Janeiro, Brazil.Keywords: AIDS, Brazil, South America, clinical trial participation

Condoms continue to be used by many gay, bisexual, and other men who have sex with men (GBM) to reduce the risk of HIV transmission. However this is impacted by condom failure events, defined here as condom breakage and slippage. In a prospective, observational cohort study of 343 HIV serodiscordant male couples recruited through high HIV caseload clinics and hospitals between 2012 and 2016 in Australia, Brazil, and Thailand, condom failure rates and associated factors were analysed, including with the study partner versus other sexual partners. There were 717 reported instances of condom failure from an estimated total of 25,831 sex acts with condoms, from over 588.4 participant years of follow up. Of the HIV-negative partners (n = 343) in the study, more than a third (n = 117, 36.7%) reported at least one instance of condom failure with any partner type during study follow-up. Condom failure with their study partner was reported by 91/343 (26.5%) HIV-negative partners, compared with 43/343 (12.5%) who reported condom failure with other partners. In total, there were 86 events where the HIV-negative partner experienced ano-receptive condom failure with ejaculation, representing 12.0% of all failure events. In multivariable analysis, compared to Australia, HIV-negative men in Brazil reported a higher incidence risk rate of condom failure (IRR = 1.64, 95%CI 1.01-2.68, p = 0.046) and HIV-negative men who reported anal sex with other partners reported an increased risk of condom failure compared with men who only had sex with their study partner (IRR = 1.89, 95%CI 1.08-3.33, p = 0.025). Although at least one event of condom failure was reported by a significant proportion of participants, overall condom failure events represented a small proportion of the total condom protected sex acts., (© 2024. The Author(s).)

Background: Abortion is a public health problem in Latin America and is more common among women living with HIV., Objective: to verify the incidence and factors associated with induced abortion in a cohort of women living with HIV assisted in a reference service for care for individuals with HIV/AIDS in Rio de Janeiro/Brazil., Methods: Prospective cohort during the period 1996-2016. We estimated the incidence of induced abortions during follow-up in the cohort by calculating person-time incidence rates [per 100 persons-years (PY)] and investigated the factors associated with the outcome "induced abortion" using a generalized linear mixed model., Results: 753 women and 210 pregnancies were included in the present analysis. We estimated an induced abortion incidence rate of 0.68/100 persons-years (95% confidence interval [CI]: 0.47; 0.94) in the study period, with a significant reduction after 2006. The main factors associated with an induced abortion were currently living with a partner (adjusted OR [AdjOR] 0.32 95% CI: 0.10-0.98), number of children (2 children AdjOR 0.12, 95% CI: 0.02-0.95) and the type of antiretroviral treatment used (regimen without Efavirenz: AdjOR: 0.11, 95% CI 0.02-0.70)., Conclusions: We showed a significant reduction in the incidence of induced abortions in a cohort of women living with HIV in Rio de Janeiro, Brazil, probably due to a decrease in the incidence of pregnancies observed in the same period. The factors associated with a lower occurrence of induced abortion suggest a good integration between the clinical and reproductive assistance offered to those women.

Male HIV serodiscordant couples have diverse relationship agreements regarding sex outside the relationship. We examined the relationship agreements as described by 343 male HIV-negative partners in HIV serodiscordant relationships in Australia, Brazil and Thailand participating in a multi-year cohort study. At baseline, 125 (34.1%) HIV-negative partners reported no agreement, 115 (33.5%) had a monogamous agreement, and 103 (37.9%) had an open agreement allowing sex outside the relationship. Relationship agreements were largely stable over time, with 76% of HIV-negative men reporting the same agreement across follow up, while changes were predominantly towards having an open agreement. Behaviour largely matched relationship agreements, and the predictors of breaking an agreement by having condomless anal intercourse (CLAI) with an outside partner were CLAI within the relationship (OR = 3.17, 95%CI: 1.64-6.14, p < 0.001) and PrEP use in the last three months (OR = 3.42, 95%CI: 1.48-7.92, p = 0.004). When considering HIV transmission risk for HIV-negative men in serodiscordant relationships, greater focus needs to be placed on sex that is occurring outside the relationship and the agreements that facilitate this., (© 2023. The Author(s).)

The aim of this research was to analyze pregnancy incidence and associated factors in a cohort of 753 women living with HIV/AIDS (WLWHA) in Rio de Janeiro, Brazil, from 1996 to 2016. Women aged 18-49 years who were not on menopause (surgical or natural) and did not have a tubal ligation were eligible for the study. Data were collected by medical professionals during initial and follow-up visits. Person-time pregnancy incidence rates were calculated throughout the follow-up period. Pregnancy incidence-associated factors were investigated by univariate and multiple analyzes, using an extension of the Cox survival model. Follow-up visits recorded 194 pregnancies, with an incidence rate of 4.01/100 person-years (95% CI: 3.47; 4.60). A higher pregnancy incidence was associated with CD4 nadir ≥ 350 cells/mm³, use of an antiretroviral regimen not containing Efavirenz, and prior teenage pregnancy. In turn, women with a viral load ≥ 50 copies/mL, age ≥ 35 years old, with two or more children and using a highly effective contraceptive method showed a lower incidence. Results showed a significant reduction in pregnancy incidence after 2006, a significant reduction in female sterilization from 1996 to 2016, and a high rate of cesarean sections. The association found between pregnancy incidence and the use of contraceptive methods and virological control markers suggests a good integration between HIV/AIDS and reproductive health services. The high rate of cesarean section delivery indicates the need to improve childbirth care.

Syndemic psychosocial and reproductive factors affecting women's retention in HIV care remain understudied. We analyzed correlates of non-retention in a cohort of women with HIV in Brazil from 2000‒2015. Participants self-reported exposure to physical/sexual violence, illicit drug use, adolescent pregnancy, or induced abortion. Lifetime history of these psychosocial stressors were used to create a syndemic score based on the presence or absence of these conditions. All dichotomous variables were summed (range 0 to 4), with greater scores indicating more syndemic factors experienced. Logistic regression models identified predictors of non-retention, defined as < 2 HIV viral load or CD4 results within the first year of enrollment. Of 915 women, non-retention was observed for 18%. Prevalence of syndemic factors was adolescent pregnancy (53.2%), physical/sexual violence (38.3%), induced abortion (27.3%), and illicit drug use (17.2%); 41.2% experienced ≥ 2 syndemic conditions. Syndemic scores of 2 and 3 were associated with non-retention, as well as low education, years with HIV and seroprevalent syphilis. Psychosocial and reproductive syndemics can limit women's retention in HIV care. Syphilis infection predicted non-retention and could be explored as a syndemic factor in future studies., Competing Interests: Conflicts of interest The authors declare no conflicts of interest., (Copyright © 2023 Sociedade Brasileira de Infectologia. Published by Elsevier España, S.L.U. All rights reserved.)

Trans women are specifically vulnerable to interpersonal violence. Being perceived as the gender that a transgender person identifies with, defined in some contexts as passing, may influence violence ratings. The EVAS (Violence and Health Self-Evaluation) study was a cross-sectional study that enrolled 121 trans women between 2019 and 2020 in Rio de Janeiro, Brazil, aiming to investigate the association between self-reported passing and different types of interpersonal violence. We enrolled 121 participants who had a median age of 36.3 (interquartile range [IQR] 13.7). Most of them were Black/mixed (78.5%) and had at least a high school education (63%). Most participants considered themselves as trans women (71.9%). Their median monthly income was $252.50 (IQR $302.50). Only 40 (33.1%) trans women had a main partner. Trans women with high passing had a higher prevalence of family violence and lower prevalence of observed police violence, violence in open and closed public spaces. Participants that reported a high passing had higher prevalence of family violence (p = .016); moreover, they reported observing less frequently police violence in the neighborhood they lived in for the last 12 months (p = .012) as well as having lower rates of suffering violence. Trans women who reported high passing had 81% (56%-92%) lower chance of suffering violence in open public places more than once, while prior racism experience had a positive association with violence in an open public place (aOR = 3.93, 95% CI [.48, 15.40]). Passing seems to protect from violence in public spaces, whilst it increases family violence. Data also suggest that observing police violence and violence in close public spaces. There is an urgent need to better understand the complex relationships around violence and foster its prevention.

The use of undetectable viral load (VL) to negotiate condomless anal intercourse (CLAI) in HIV serodiscordant male relationships has become more common as more data regarding the effectiveness of antiretroviral treatments for the prevention of HIV transmission has been described. We examined viral load agreements (VLAs) for condomless sex in the presence of an undetectable VL in 343 HIV serodiscordant male couples in Australia, Brazil and Thailand. Factors associated with having a VLA included having agreements for the HIV-positive partner to report his VL result (p < 0.001), agreeing that VL affects agreements about sexual practice (p < 0.001), the HIV-negative partner's perception of his partner's undetectable VL (p < 0.001), the couple's belief in the efficacy of undetectable VL in preventing HIV transmission (p < 0.001), and the couple engaging in CLAI with each other (p < 0.001). Over time, these agreements became more common although 49.3% of couples in the sample never had a viral load agreement. As these agreements become more common, further education is required to support male couples in using them safely., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: Little is known about the long-term outcomes of children living with HIV in Latin America. Few studies have examined antiretroviral therapy (ART) regimen switches in the years after the introduction of ART in this population. This study aimed to assess clinical outcomes among children who started second-line ART in the Caribbean, Central and South America network for HIV epidemiology., Methods: Children (<18 years old) with HIV who switched to second-line ART at sites within Caribbean, Central and South America network for HIV epidemiology were included. The cumulative incidence and relative hazards of virologic failure while on second-line ART, loss to follow-up, additional major ART regimen changes, and all-cause mortality were evaluated using competing risks methods and Cox models., Results: A total of 672 children starting second-line ART were included. Three years after starting second-line ART, the cumulative incidence of death was 0.10 [95% confidence interval (CI) 0.08 to 0.13], loss to follow-up was 0.14 (95% CI: 0.11 to 0.17), and major regimen change was 0.19 (95% CI: 0.15 to 0.22). Of those changing regimens, 35% were due to failure and 11% due to toxicities/side effects. Among the 312 children with viral load data, the cumulative incidence of virologic failure at 3 years was 0.62 (95% CI: 0.56 to 0.68); time to virologic failure and regimen change were uncorrelated (rank correlation -0.001; 95% CI -0.18 to 0.17)., Conclusions: Poor outcomes after starting second-line ART in Latin America were common. The high incidence of virologic failure and its poor correlation with changing regimens was particularly worrisome. Additional efforts are needed to ensure children receive optimal ART regimens., Competing Interests: P.F.R. has received an honorarium from Gilead. All authors are currently receiving a grant (U01AI069923) from NIH (NICHD, NCI, NIAID, NIMH, and OD); this work was also supported by separate grants from the NIH/NIAID (K01-AI131895, P.F.R.). The remaining authors have no conflicts of interest to disclose., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Menopausal transition is a physiological process encompassing hormonal and body changes that impact women's health and life quality. This period may be characterized by the Stages of Reproductive Aging Workshop (STRAW + 10) criteria using menstrual patterns. Use of the STRAW + 10 is uncertain in HIV infection. We aimed to characterize menopausal transition in women with HIV (WWH) using the STRAW + 10 criteria, hormonal measures and menopause symptoms., Methods: We performed a cross-sectional study, nested to the HIV-Infected Women's Cohort, in Rio de Janeiro, Brazil. Eligible women included those aged 30 years or older, without clinical or surgical menopause, hormonal contraception, replacement therapy and ovarian disorders. We conducted face-to-face interviews and collected blood samples for follicle stimulating hormone (FSH) and estradiol measures., Results: We enrolled 328 WWH (28.3% of women in the cohort). The distribution of age, hormonal levels and reported symptoms per each STRAW + 10 stage was consistent with the expected distribution in the menopausal transition. Age and FSH significantly increased and estradiol decreased from stage -2 (7 + days of menstrual delay) to stage +2 (8 + years of amenorrhea)., Conclusions: The present results support use of the STRAW + 10 to characterize the menopausal transition of WWH with good clinical and immunological control.

Background: HIV incidence among women of reproductive age and vertical HIV transmission rates remain high in Latin America. We, therefore, quantified HIV care continuum barriers and outcomes among pregnant women living with HIV (WLWH) in Latin America., Methods: WLWH (aged ≥16 years) enrolling at Caribbean, Central and South America network for HIV epidemiology (CCASAnet) sites from 2000 to 2017 who had HIV diagnosis, pregnancy and delivery dates contributed. Logistic regression produced adjusted odds ratios (aOR) and 95% confidence intervals (CI) for retention in care (≥2 visits ≥3 months apart) and virological suppression (viral load <200 copies/mL) 12 months after pregnancy outcome. Cumulative incidences of loss to follow-up (LTFU) postpartum were estimated using Cox regression. Evidence of HIV status at pregnancy confirmation was the exposure. Covariates included pregnancy outcome (born alive vs. others); AIDS diagnosis prior to delivery; CD4, age, HIV-1 RNA and cART regimen at first delivery and CCASAnet country., Results: Among 579 WLWH, median postpartum follow-up was 4.34 years (IQR 1.91, 7.35); 459 (79%) were HIV-diagnosed before pregnancy confirmation, 445 (77%) retained in care and 259 (45%) virologically suppressed at 12 months of postpartum. Cumulative incidence of LTFU was 21% by 12 months and 40% by five years postpartum. Those HIV-diagnosed during pregnancy had lower odds of retention (aOR = 0.58, 95% CI: 0.35 to 0.97) and virological suppression (aOR = 0.50, 95% CI: 0.31 to 0.82) versus those HIV-diagnosed before., Conclusion: HIV diagnosis during pregnancy was associated with poorer 12-month retention and virological suppression. Young women should be tested and linked to HIV care earlier to narrow these disparities., (© 2021 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

Introduction: As 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., Methods: Transwomen 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., Results: Out 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., Conclusions: Brazilian 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., (© 2021 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

Background: Gender reassignment surgery is a procedure some transgender women (TW) undergo for gender-affirming purposes. This often includes the construction of a neovagina using existing penile and scrotal tissue and/or a sigmoid colon graft. There are limited data regarding the composition and function of the neovaginal microbiome representing a major gap in knowledge in neovaginal health., Results: Metaproteomics was performed on secretions collected from the neovaginas (n = 5) and rectums (n = 7) of TW surgically reassigned via penile inversion/scrotal graft with (n = 1) or without (n = 4) a sigmoid colon graft extension and compared with secretions from cis vaginas (n = 32). We identified 541 unique bacterial proteins from 38 taxa. The most abundant taxa in the neovaginas were Porphyromonas (30.2%), Peptostreptococcus (9.2%), Prevotella (9.0%), Mobiluncus (8.0%), and Jonquetella (7.2%), while cis vaginas were primarily Lactobacillus and Gardnerella. Rectal samples were mainly composed of Prevotella and Roseburia. Neovaginas (median Shannon's H index = 1.33) had higher alpha diversity compared to cis vaginas (Shannon's H = 0.35) (p = 7.2E-3, Mann-Whitney U test) and were more similar to the non-Lactobacillus dominant/polymicrobial cis vaginas based on beta diversity (perMANOVA, p = 0.001, r 2 = 0.342). In comparison to cis vaginas, toll-like receptor response, amino acid, and short-chain fatty acid metabolic pathways were increased (p < 0.01), while keratinization and cornification proteins were decreased (p < 0.001) in the neovaginal proteome., Conclusions: Penile skin-lined neovaginas have diverse, polymicrobial communities that show similarities in composition to uncircumcised penises and host responses to cis vaginas with bacterial vaginosis (BV) including increased immune activation pathways and decreased epithelial barrier function. Developing a better understanding of microbiome-associated inflammation in the neovaginal environment will be important for improving our knowledge of neovaginal health. Video Abstract.

One in five transgender women (TW) are living with HIV, yet little has been published about their health outcomes. We analyzed data from TW ( n  = 37), cisgender women (CW, n  = 165), and cisgender men who have sex with men (MSM, n  = 151) in Thailand and Brazil. We hypothesized: (1) TW will have higher odds of depressive symptoms, lower odds of condom use and greater odds of a detectable viral load compared to MSM and CW; and (2) TW will have lower odds of condom use and higher odds of detectable viral load. We found that TW had higher odds of depression (OR 2.2, 95%CI: 1.0, 4.8, p  = 0.04) and were less likely than MSM (22% v. 42%, p  = 0.01) to use condoms with partners of unknown serostatus. In multivariable models, TW had lower odds than MSM of using condoms with partners with unknown serostatus (OR 0.38, 95%CI: 0.15, 0.90) and CW had lower odds than MSM of using condoms with HIV-negative partners (0.60 [0.38, 0.95], p  = 0.029). We found no significant differences in detectable viral load. Disaggregating data by gender is important to understand factors that contribute to viral suppression and HIV transmission risk among people living with HIV.

The aim of this study was to verify the prevalence of induced abortion and associated factors at the time of inclusion in a cohort of women living with HIV/AIDS in the city of Rio de Janeiro, Brazil, from 1996 to 2016. Eligibility criteria for inclusion in the cohort were female sex at birth, age 18 years and older, and confirmed HIV infection. At the baseline visit, data on sexual, reproductive, and behavioral aspects and HIV infection were obtained through a face-to-face interview with the attending physician. Lifetime prevalence of induced abortion was calculated, and factors associated with induced abortion were verified by multiple logistic regression for all the women and for those with previous pregnancy. In the entire cohort of women, 30.4% reported a history of induced abortion, compared to 33.5% in women with previous pregnancy. Frequency of reported induced abortion showed a significant reduction during the period (41.7% in 1996-2000 versus 22.5% in 2011-2016, p < 0.001). Factors associated with induced abortion, both for the entire cohort and for the women with previous pregnancy, were age, schooling, ≥ 5 lifetime sexual partners, teenage pregnancy, lifetime use of any illicit drug, and inclusion in the cohort after the year 2005. Changes in the socioeconomic, sexual, reproductive, and HIV infection profile are possible explanations for the reduction in abortions during the period. Studies that use direct methods to measure abortion should be conducted in other populations to confirm the downward trend in induced abortion and its determinants in Brazil.

Background: Drug-drug interactions between orally administered antiretroviral therapy (ART) and hormones released from an intravaginal ring are not known. We hypothesised that ART containing either efavirenz or ritonavir-boosted atazanavir would alter plasma concentrations of vaginally administered etonogestrel and ethinylestradiol but that ART concentrations would be unchanged during use of an intravaginal ring., Methods: We did a parallel, three-group, pharmacokinetic evaluation at HIV clinics in Asia (two sites), South America (five), sub-Saharan Africa (three), and the USA (11) between Dec 30, 2014, and Sept 12, 2016. We enrolled women with HIV who were either ART-naive (control group; n=25), receiving efavirenz-based ART (n=25), or receiving atazanavir-ritonavir-based ART (n=24). Women receiving ART were required to be on the same regimen for at least 30 days, with 400 copies or less per mL of plasma HIV-1 RNA; women not receiving ART had CD4 counts of 350 cells per μL or less. We excluded participants who had a bilateral oophorectomy or conditions that were contraindicated in the intravaginal ring product labelling. An intravaginal ring releasing etonogestrel and ethinylestradiol was inserted at entry (day 0). Single plasma samples for hormone concentrations were collected on days 7, 14, and 21 after intravaginal ring insertion. The primary outcome was the plasma concentration of etonogestrel and ethinylestradiol on day 21. Etonogestrel and ethinylestradiol concentrations were compared between each ART group and the control group by geometric mean ratio (GMR) with 90% CIs and Wilcoxon rank-sum test. As secondary outcomes, efavirenz or ritonavir-boosted atazanavir concentrations were assessed by 8-h intensive pharmacokinetic sampling at entry before intravaginal ring insertion and before intravaginal ring removal on day 21. Antiretroviral areas under the concentration-time curve (AUC 0-8 h ) were compared before and after intravaginal ring insertion by GMR (90% CI) and Wilcoxon signed-rank test. This study is registered with ClinicalTrials.gov, number NCT01903031., Findings: Between Dec 30, 2014, and Sept 12, 2016, we enrolled 84 participants in the study; ten participants were excluded from the primary hormone analysis. 74 participants met the primary endpoint: 25 in the control group, 25 in the efavirenz group, and 24 in the atazanavir group. On day 21 of intravaginal ring use, participants receiving efavirenz had 79% lower etonogestrel (GMR 0·21, 90% CI 0·16-0·28; p<0·0001) and 59% lower ethinylestradiol (0·41, 0·32-0·52; p<0·0001) concentrations compared with the control group. By contrast, participants receiving ritonavir-boosted atazanavir had 71% higher etonogestrel (1·71, 1·37-2·14; p<0·0001), yet 38% lower ethinylestradiol (0·62, 0·49-0·79; p=0·0037) compared with the control group. The AUC 0-8 h of efavirenz or atazanavir did not differ between the groups., Interpretation: Hormone exposure was significantly lower when an intravaginal ring contraceptive was combined with efavirenz-based ART. Further studies designed to examine pharmacodynamic endpoints, such as ovulation, when intravaginal ring hormones are combined with efavirenz are warranted., Funding: National Institutes of Health, through the AIDS Clinical Trials Group and the International Maternal Pediatric Adolescent AIDS Clinical Trials Network, National Institute of Allergy and Infectious Diseases, Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Comprehensive care for sexual and reproductive health (SRH) and social needs for women living with HIV remains limited globally. We aimed to assess trends in baseline sociodemographic, clinical, sexual, and reproductive characteristics among a cohort of HIV-infected women in Rio de Janeiro from 1996 to 2016. Participants were stratified into four time periods based on year of enrollment; we compared cross-sectional data from each period. Of 1361 participants (median age 36), most were black or mixed race (60.1%), unemployed (52.1%), and without secondary education (54%). Adolescent pregnancy was common (51.5%), and 18.3% reported sexual debut at < 15 years old. Nearly half (45.2%) had < 5 lifetime sexual partners, yet prior syphilis and oncogenic human papillomavirus prevalence were 10.9% and 43.1%, respectively. Lifetime prevalence of induced abortion was 30.3%, and 16% used no contraceptive method. Future research should explore interactions between social vulnerability, HIV, and poor SRH outcomes and healthcare models to alleviate these disparities.

Purpose: Worldwide, the burden of adverse health conditions is substantial among travestis and transgender women (trans women). Transcendendo, the first trans-specific cohort in a low- or middle-income country, is an open cohort established in August 2015 to longitudinally evaluate the health aspects of trans women aged ≥18 years in Rio de Janeiro, Brazil. Methods: Study visits occur on an annual basis. Data on sociodemographics, behavioral, gender transition, affirmation procedures, hormone use, discrimination, violence, clinical and mental health, HIV prevention, and care (for those HIV-infected) are collected. Physical examination, anthropometric measurements, and laboratory tests are performed. Results: As of July 2017, 322 trans women were enrolled in the cohort with a median age of 31.5 years (interquartile range 25.7-39.5), of whom 174 (54%) were HIV-infected. The Transcendendo baseline information reinforces the scenario of marginalization and deprivation surrounding trans women. Most participants had low income (62.0% were living with below US$ 10.00/day), showed a very high engagement in sex work (78.6%), and reported increased occurrence of sexual (46.3%) and physical (54.0%) violence. Pre-exposure peophylaxis (PReP) was used by 18.8% of the HIV-uninfected trans women, only through research participation. Positive screening for depression (57.8%) and problematic use of tobacco (56.6%), cannabis (28.9%), cocaine (23.8%), and alcohol (21.5%) were high. Almost all participants (94.8%) reported hormone use at some point, mostly without medical supervision (78.7%). Conclusion: Our results describe a context of exclusion experienced by trans women, exposing vulnerabilities of this population in a middle-income country, with poor access to trans-specific care, HIV prevention and care, and mental health care. Addressing transgender experiences and needs can help the development of strategies to diminish stigma, improve health care environment, guide future research on trans morbidities, substance use, and trans-specific interventions to support health-related recommendations. Ultimately, it contributes to close the gaps concerning transgender health and reinforces that trans care cannot be disentangled from the social environment that surrounds trans women., Competing Interests: No competing financial interests exist.

Purpose: To assess health-related quality of life (HRQoL) and its associated factors among people living with HIV/AIDS (PLWHA) in Rio de Janeiro, Brazil., Methods: A cross-sectional study including PLWHA receiving usual HIV-care at Instituto Nacional de Infectologia Evandro Chagas (INI/Fiocruz) was conducted between 2014 and 2016 in Rio de Janeiro, Brazil. The EQ-5D-3L assessed HRQoL; PHQ-2 and ASSIST were used for screening depression and substance use, respectively. Clinical variables were obtained from the INI/Fiocruz cohort database, and structured questions evaluated intimate partner violence, sexual abstinence and relationship status. Data were analysed using multivariable Tobit regression model., Results: A total of 1480 PLWHA were included: 64.7% were male at birth (38.4% men who have sex with men [MSM], 24.3% heterosexual men and 2% transgender women [TGW]); median age was 43.1 years, and 95.8% were receiving antiretroviral therapy. The median EQ-5D-3L utility score was 0.801. Results showed that the following factors: MSM and women; older age; lower educational level; no engagement in a relationship; depression screening positive; polysubstance use; and, detectable viral load were independently associated with worse HRQoL., Conclusions: PLWHA under care at INI/Fiocruz presented good HRQoL. Polysubstance use, depression and lower educational level were among the factors negatively associated with HRQoL. This was the first time that the EQ-5D-3L utility scores were calculated for a considerable number of PLWHA in Brazil, which is a fundamental piece of information for future cost-effectiveness analysis.

The effect of non-injection substance use on HIV viral load (VL) is understudied in international settings. Data are from HPTN063, a longitudinal observational study of HIV-infected individuals in Brazil, Thailand, and Zambia, with focus on men with VL data (Brazil = 146; Thailand = 159). Generalized linear mixed models (GLMM) assessed whether non-injection substance use (stimulants, cannabis, alcohol, polysubstance) was associated with VL undetectability. ART adherence and depressive symptoms were examined as mediators of the association. In Thailand, substance use was not significantly associated with VL undetectability or ART adherence, but alcohol misuse among MSM was associated with increased odds of depression (AOR = 2.75; 95% CI 1.20, 6.32, p = 0.02). In Brazil, alcohol misuse by MSM was associated with decreased odds of undetectable VL (AOR = 0.34; 95% CI 0.13, 0.92, p = 0.03). Polysubstance use by heterosexual men in Brazil was associated with decreased odds of ART adherence (AOR = 0.25; 95% CI 0.08, 0.78, p = 0.02). VL suppression appears attainable among non-injection substance users. Substance use interventions among HIV-positive men should address depression, adherence, and VL undetectability.

Purpose: There have been significant biomedical improvements in the treatment and prevention of HIV over the past few decades. However, new transmissions continue to occur. Alcohol use is a known barrier to medication adherence and consistent condom use and therefore may affect treatment as prevention (TasP) efforts. The purpose of this study was to further explore how alcohol is associated with condom use and sexual transmission behavior in three international cities., Method: HIV Prevention Trials Network 063 was an observational mixed-methods study of HIV-infected patients currently in care in Rio de Janeiro, Brazil; Chiang Mai, Thailand; and Lusaka, Zambia. Across these three global cities, 80 qualitative interviews were conducted from 2010 to 2012. From these interviews, quotes related to substance use, almost all of which were alcohol, were analyzed using thematic analysis to identify how the use was related to sexual transmission behaviors., Results: Overall, the theme that alcohol impairs cognitive abilities emerged from the data and included the following subthemes: expectancies, impaired decision-making, loss of control, and less concern for others. Themes specific to international settings and risk subgroups were also identified., Conclusion: Our analysis identified how alcohol influences sexual transmission behavior in HIV patients in three international settings. These findings may provide direction for content development for future secondary prevention interventions to effectively implement TasP internationally.

Early and sustained antiretroviral therapy (ART) adherence can suppress the HIV virus in individuals and reduce onward transmission of HIV in the population. Religiosity has been associated with better HIV clinical outcomes. Data are from a longitudinal, observational study of 749 HIV-infected individuals from Brazil, Zambia, and Thailand (HPTN 063). Ordered logistic regression assessed whether religious service attendance was associated with ART adherence (self-reported and plasma HIV-RNA) and moderated the association between alcohol problems and ART adherence. In each country, > 80% of participants reported high self-reported ART adherence (good/very good/excellent). Religious service attendance exceeded 85% but was statistically unrelated to adherence. In combined-country models, (p = 0.03) as alcohol problems increased, the probability of high self-reported ART adherence, as well as viral-load, became weaker at higher compared to low service attendance frequency. Future studies should evaluate spirituality variables and replicate the moderation analyses between religious attendance and alcohol problems.

Introduction: Cervical cancer remains an important burden for HIV-infected women in the era of combination antiretroviral therapy. Recommendations for cervical screening in these women diverge and may include high-risk HPV (HRHPV) testing. We aimed to evaluate the clinical usefulness of a single HRHPV testing for cervical screening of HIV-infected women., Methods: 723 HIV-infected women from a Brazilian prospective cohort were included between 1996 and 2012. Inclusion criteria were: normal cervical cytology at baseline and having a HRHPV-test at baseline. We calculated incidence rates of any squamous intraepithelial lesion (SIL) and high grade SIL+ (HSIL+) and negative predictive values (NPV) within 12 and 36 months. Hazard Ratios were obtained using Cox proportional hazards regression models., Results: Incidence rate for both outcomes was low (9.9 cases per 100 PY [95% CI 8.8-11.0] for any SIL and 1.3 cases per 100 PY [95% IC 0.9-1.8] for HSIL+). Women with a HRHPV positive status at baseline had 1.7-fold (95% CI 1.3-2.2) and 3.2-fold (95% CI 1.5-7.1) increased risk of presenting any SIL and HSIL+, respectively, during follow-up. Negative-HRHPV test presented high NPV for both periods and outcomes (any SIL: 92.4% [95% CI 89.7-94.6] for 12 months and 80.9% [95% CI 77.2-84.3] for 36 months; and HSIL+: 99.8% [95% CI 98.9-100.0] for 12 months and 99.0 [95% CI 97.6-99.7] for 36 months)., Conclusions: Incidence of any and high grade cytological abnormality was significantly higher among HIV-infected women with positive-HRHPV test. A single negative-HRHPV test helped reassure follow-up free of cytological abnormalities through three years of follow-up in HIV-infected women with negative cytology., (Copyright © 2017 Sociedade Brasileira de Infectologia. Published by Elsevier Editora Ltda. All rights reserved.)

Introduction: Successful global treatment as prevention (TasP) requires identifying HIV-positive individuals at high risk for transmitting HIV, and having impact via potential infections averted. This study estimated the frequency and predictors of numbers of HIV transmissions and bacterial sexually transmitted infection (STI) acquisition among sexually active HIV-positive individuals in care from three representative global settings., Methods: HIV-positive individuals ( n= 749), including heterosexual men, heterosexual women and men who have sex with men (MSM) in HIV care, were recruited from Chiang Mai (Thailand), Rio De Janeiro (Brazil) and Lusaka (Zambia). Participants were assessed on HIV and STI sexual transmission risk variables, psychosocial characteristics and bacterial STIs at enrolment and quarterly for 12 months (covering 15 months). Estimated numbers of HIV transmissions per person were calculated using reported numbers of partners and sex acts together with estimates of HIV transmissibility, accounting for ART treatment and condom use., Results: An estimated 3.81 (standard error, (SE)=0.63) HIV transmissions occurred for every 100 participants over the 15 months, which decreased over time. The highest rate was 19.50 (SE=1.68) for every 100 MSM in Brazil. In a multivariable model, country×risk group interactions emerged: in Brazil, MSM had 2.85 (95% CI=1.45, 4.25, p <0.0001) more estimated transmissions than heterosexual men and 3.37 (95% CI=2.01, 4.74, p <0.0001) more than heterosexual women over the 15 months. For MSM and heterosexual women, the combined 12-month STI incidence rate for the sample was 22.4% (95% CI=18.1%, 27.3%; incidence deemed negligible in heterosexual men). In the multivariable model, MSM had 12.3 times greater odds (95% CI=4.44, 33.98) of acquiring an STI than women, but this was not significant in Brazil. Higher alcohol use on the Alcohol Use Disorders Identification Test (OR=1.04, 95% CI=1.01, 1.08) was also significantly associated with increased STI incidence. In bivariate models for both HIV transmissions and STI incidence, higher depressive symptoms were significant predictors., Conclusions: These data help to estimate the potential number of HIV infections transmitted and bacterial STIs acquired over time in patients established in care, a group typically considered at lower transmission risk, and found substantial numbers of estimated HIV transmissions. These findings provide an approach for evaluating the impact (in phase 2 studies) and potentially cost-effectiveness of global TasP efforts., Competing Interests: The authors have no competing interests to declare.

Objective: The aim of this study was to evaluate secretory leukocyte protease inhibitor (SLPI) expression in anal biopsies from HIV-positive (HIV+) individuals, and compare that to anal intraepithelial neoplasia (AIN) diagnoses and human papillomavirus (HPV) status., Design: This is a cross-sectional study of a cohort of 54 HIV+ (31 males and 23 females) from an AIDS clinic in Rio de Janeiro, Brazil., Methods: The study material consisted of anorectal tissue biopsies obtained from HIV+ subjects, which were used to construct tissue microarray paraffin blocks for immunohistochemical analysis of SLPI expression. Biopsies were evaluated by an expert pathologist and classified as low-grade AIN1, high-grade AIN2/3, or normal squamous epithelium. In addition, DNA from the biopsies was extracted and analyzed for the presence of low- or high-risk HPV DNA., Results: Histologically, normal squamous epithelium from the anorectal region showed strong positive SLPI staining in 17/20 (85%) samples. In comparison, 9/17 (53%) dysplastic squamous epithelial samples from AIN1 patients showed strong SLPI staining, and only 5/17 (29%) samples from AIN2/3 patients exhibited strong SPLI staining, which both were significantly fewer than those from normal tissue (P = 0.005). Furthermore, there was a significantly higher proportion of samples in which oncogenic high-risk HPV genotypes were detected in low SLPI-expressing tissues than that in tissues with high SLPI expression (P = 0.040)., Conclusions: Taken together these results suggest that low SLPI expression is associated with high-risk HPV infections in the development of AIN.

Background: Carotid intima-media thickness (cIMT) has been used as an early marker of atherosclerotic disease in the general population. Recently its role among HIV-infected patients has been questioned. To date, no Brazilian study has compared cIMT in respect to HIV status., Methods: We compared data from 535 patients actively followed in a prospective cohort in Rio de Janeiro (HIV group); 88 HIV-negative individuals who were nominated by patients (friend controls-FCs); and 10,943 participants of the ELSA-Brasil study. Linear regression models were used to study associations of the 3 groups and several covariables with cIMT. Propensity scores weighting (PSW) were also employed to balance data., Results: Median thickness in mm (IQR) were 0.54 (0.49,0.62); 0.58 (0.52,0.68); and 0.57 (0.49,0.70), HIV, FCs and ELSA-Brasil groups, respectively (p-value<0.001). The best linear model chosen did not include the group variables, after adjusting for all the variables chosen, showing no difference of cIMT across groups. Similar results were obtained with PSW. Several traditional CVD risk factors were also significantly associated with cIMT: female gender, higher education and higher HDL were negatively associated while risk factors were older age, current/former smoker, AMI/stroke family history, CVD history, hypertension, DM, higher BMI and total cholesterol., Conclusions: We show for the first time in a middle-income setting that cIMT, is not different in HIV-infected patients in Rio de Janeiro compared with 2 different groups of non-HIV-infected individuals. Traditional CVD risk factors are associated with this outcome. Our results point out that high standards of care and prevention for CVD risk factors should always be sought both in the HIV-infected and non-infected populations to prevent CVD-related events.

Successful biomedical prevention/treatment-as-prevention (TasP) requires identifying individuals at greatest risk for transmitting HIV, including those with antiretroviral therapy (ART) nonadherence and/or 'amplified HIV transmission risk,' defined as condomless sex with HIV-uninfected/unknown-status partners when infectious (i.e., with detectable viremia or STI diagnosis according to Swiss criteria for infectiousness). This study recruited sexually-active, HIV-infected patients in Brazil, Thailand, and Zambia to examine correlates of ART nonadherence and 'amplified HIV transmission risk'. Lower alcohol use (OR = .71, p < .01) and higher health-related quality of life (OR = 1.10, p < .01) were associated with greater odds of ART adherence over and above region. Of those with viral load data available (in Brazil and Thailand only), 40 % met Swiss criteria for infectiousness, and 29 % had 'amplified HIV transmission risk.' MSM had almost three-fold (OR = 2.89, p < .001) increased odds of 'amplified HIV transmission risk' (vs. heterosexual men) over and above region. TasP efforts should consider psychosocial and contextual needs, particularly among MSM with detectable viremia.

Objectives: HIV-infected women are at increased risk of human papillomavirus (HPV) infection. Time trends in annual prevalences of cervical high-risk human papillomavirus (HR-HPV) genotypes among a non-vaccinated, HIV-infected female cohort in urban Brazil were assessed for the period 2006-2012., Methods: Cervical specimens were collected for HPV genotyping yearly between January 2006 and December 2012 in a cross-sectional analysis of participants aged ≥18 years enrolled in the Women's HIV Cohort at Fiocruz in Rio de Janeiro, Brazil. Age-adjusted generalized estimating equation models with an exchangeable matrix were used to estimate odds ratios (OR) and 95% confidence intervals (CI) for annual HPV positivity (reference year: 2006)., Results: Among the 590 participants, the median age across all study years ranged from 35.5 to 40.0 years. The prevalence of any HR-HPV was ≥53% every year; prevalences of HR-HPV 16, 58, 59, and 68 were ≥24% in at least 1 year. The odds of HPV 16 and 68 decreased in 2012. HPV 58 prevalence followed a U-shape, beginning and ending at >20%. HPV 59 prevalence followed a linear trend, with increased odds in 2012 (OR 16.0, 95% CI 3.8-67.3; Bonferroni-adjusted p-value <0.01)., Conclusions: The prevalences of HR-HPV 58, 59, and 68 were high in this cohort. Given current HR-HPV vaccine coverage and availability, further investigations are needed to optimize vaccine recommendations for this population., (Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.)

HPV is associated with cervical cancer and plays a crucial role in tumor formation. Apoptosis is regulated by different pathways involving genes that either promote (BCL2 gene) or inhibit (BAX gene) cell death. Our goal was to determine whether the BCL2-938C>A (rs2279115) and BAX-248G>A (rs4645878) single nucleotide polymorphisms (SNPs) are associated with squamous intraepithelial neoplasia (SIL) risk, and whether their phenotypic expression was impaired in these lesions. Two hundred and thirty-one cases showing SIL were classified as low SIL (LSIL, n = 101) or high SIL (HSIL, n = 130), and control subjects (n = 266) with no gynecologically proven SIL were recruited. No statistical difference in the genotype and allelic frequency of the BCL-2-938C>A polymorphism was observed among the groups. BCL2-938C/A and A/A homozygotes carriers had higher distribution of BCL-2-expressing cells in stroma in the SIL group. BCL2 mRNA-expression was not correlated with BCL2-938C>A SNPs in both groups. We did find a strong association of the BAX GG genotype and risk for SIL. No difference was observed between LSIL and HSIL groups. In BAX-248G/A and A/A homozygote carriers, the number of BAX-expressing cells was lower the epithelium area in SIL. However, mRNA expression was higher in SIL patients than in the control group. In conclusion, our data provide evidence that allele G carriers in the BAX-248G>A promoter SNP may influence the development of SIL. However, this genotype does not influence the SIL outcome. Additionally, we suggest a possible role of HPV infection in the inhibition of the expression of BAX protein, decreasing cell death, and favoring cervical carcinogenesis.

Background: Sexually transmitted diseases (STD) are frequently asymptomatic and increase the likelihood of transmitting and acquiring HIV. In Brazil, the guidelines for STDs diagnosis and treatment are based on the syndromic approach. Nucleic acid amplification tests (NAAT) has been recommended as routine STDs screening in some countries, especially for men who have sex with men (MSM). Limited data are available about how to best define target groups for routine screening by NAATs within this population. We aimed to assess the prevalence of rectal and urethral Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections and syphilis, and the factors associated with having at least one STD among HIV-infected and uninfected MSM in Rio de Janeiro, Brazil., Methods: From August 2010 to June 2012, 391 MSM were enrolled into the Evandro Chagas National Institute of Infectious Diseases-INI-Fiocruz cohort, and 292 MSM (HIV-infected:211 and HIV-uninfected:81) were included in this study. NAATs were performed on the rectal swabs and urine for CT and NG. The rapid plasma reagin test and microhemagglutination assay for Treponema pallidum were performed for syphilis diagnosis., Results: The overall prevalence of STD was 20.0% (95%CI:15.7-25.1): 10% anorectal chlamydia; syphilis 9.9%; anorectal gonorrheae 2.5%; and urethral chlamydia 2.2%; no case of urethral gonorrheae was detected. The proportion of HIV-positive MSM who had at least one STD was nearly two times that of HIV-negative MSM (22.6% vs 13.2%; P = 0.09). The frequency of each STD, except for anorectal NG (1.5% vs.5.2%), was higher among HIV-positive than HIV-negative individuals. Among the 211 asymptomatic participants, 17.5% (n = 37) were identified as having at least one STD; 10.4% (n = 22/211) tested positive for anorectal chlamydia. Sixty five percent of HIV-positive MSM were asymptomatic at the time of the STD diagnosis, while 100.0% of the HIV-negative MSM. Age (APR = 0.78; 95%CI:0.60-1.00 for each additional ten years) and a positive-HIV serostatus (APR = 2.05; 95%CI:1.03-4.08) were significantly associated with STD diagnosis., Conclusion: An overall high STD-prevalence rate was observed, especially among HIV-infected and in younger individuals, and the majority of STDs were asymptomatic. STD screening using NAATs among asymptomatic MSM is a potentially cost-effective intervention for the prevention of HIV infection among MSM.

Background: In Brazil, the rate of cervical cancer remains high despite the availability of screening programs. With ongoing vaccine development and implementation, information on the prevalence of specific HPV types is needed, particularly among high-risk populations, such as HIV-infected women., Methods: We performed a study of HIV-infected women in Rio de Janeiro, Brazil, who underwent cervical HPV genotype testing between 2005-2013. We examined the prevalence of high-risk HPV types and the patterns of high-risk HPV type clustering. Using logarithmic binomial regression, we estimated the risk of abnormal cytology by HPV genotype result., Results: Of the 562 women included, 498 (89 %) had at least one HPV type detected. 364 women (65 %) had at least one high-risk HPV type detected and 181 (32 %) had more than one high-risk type detected. HPV 58 was the most frequent HPV type detected overall (prevalence 19.8 % [95 % confidence interval 16.4-23.1]), followed by HPV 53 (prevalence 15.5 % [12.5-18.5]) and HPV 16 (prevalence 13 % [10.2-15.8]). Women infected with more than one high-risk HPV type were younger, had lower CD4+ lymphocyte counts, and were more likely to be infected with HPV 16 or 18. In adjusted analyses, presence of more than one high-risk HPV type was associated with a two-fold increased risk of abnormal cytology after adjusting for presence of individual high-risk type, age, and CD4+ lymphocyte count (adjusted prevalence ratios 1.88-2.07, all p <0.001). No single high-risk HPV type was statistically associated with abnormal cytology after adjusting for the presence of more than one high-risk HPV type., Conclusions: In the largest study of cervical HPV genotypes among HIV-infected women in Latin America, infection by high-risk HPV types other than 16 or 18 and infection by more than one high-risk HPV types were common. Infection by more than one high-risk type was more strongly associated with abnormal cervical cytology than any individual high-risk HPV type, highlighting the need for multi-valent HPV vaccines.

Objective: This study sought to investigate the age at natural menopause and its predictors in a cohort of human immunodeficiency virus (HIV)-infected women in Rio de Janeiro, Brazil., Study Design: HIV-infected women ≥30 years of age were included. Menopause was defined as having ≥1 year since the last menstrual period. Early age at natural menopause was defined as the onset of menopause at ≤45 years of age. Multivariate Cox proportional hazards analysis was applied., Results: A total of 667 women were included, and the median age at baseline was 34.9 years (interquartile range, 30.9-40.5 years). In all, 507 (76%) women were premenopausal, and 160 (24%) reached menopause during the observational period; of these, 36 of 160 (27%) had early menopause. The median age at natural menopause was 48 years (interquartile range, 45-50 years). Menarche at <11 years of age (hazard ratio [HR], 2.03; 95% confidence interval [CI], 1.23-3.37), cigarette smoking during the observational period (HR, 1.59; 95% CI, 1.08-2.33), chronic hepatitis C virus (HCV) infection (HR, 2.53; 95% CI, 1.27-5.07), and CD4 count <50 cells/mm(3) (HR, 3.07; 95% CI, 1.07-8.80) were significantly associated with an earlier age at natural menopause. The magnitudes of the effects of menarche at <11 years of age (HR, 2.7; 95% CI, 1.23-5.94), cigarette smoking during the observational period (HR, 3.00; 95% CI, 1.39-6.45), chronic HCV infection (HR, 6.26; 95% CI, 2.12-18.52), and CD4 count <50 cells/mm(3) (HR, 6.64; 95% CI, 1.91-23.20) were much higher and significantly associated with early natural menopause., Conclusion: Early natural menopause was frequent among the HIV-infected women. In addition to menarche and cigarette smoking, which are menopausal factors among women in general, HIV-related immunodeficiency and chronic HCV were additional predictors for an earlier age at natural menopause. Adequate management of HIV in women is critical, as early onset of menopause has been associated with increased morbidity and mortality., (Copyright © 2015 Elsevier Inc. All rights reserved.)

The success of global treatment as prevention (TasP) efforts for individuals living with HIV/AIDS (PLWHA) is dependent on successful implementation, and therefore the appropriate contribution of social and behavioral science to these efforts. Understanding the psychosocial context of condomless sex among PLWHA could shed light on effective points of intervention. HPTN 063 was an observational mixed-methods study of sexually active, in-care PLWHA in Thailand, Zambia, and Brazil as a foundation for integrating secondary HIV prevention into HIV treatment. From 2010-2012, 80 qualitative interviews were conducted with PLWHA receiving HIV care and reported recent sexual risk. Thirty men who have sex with women (MSW) and 30 women who have sex with men (WSM) participated in equal numbers across the sites. Thailand and Brazil also enrolled 20 biologically-born men who have sex with men (MSM). Part of the interview focused on the impact of HIV on sexual practices and relationships. Interviews were recorded, transcribed, translated into English and examined using qualitative descriptive analysis. The mean age was 25 (SD = 3.2). There were numerous similarities in experiences and attitudes between MSM, MSW and WSM across the three settings. Participants had a high degree of HIV transmission risk awareness and practiced some protective sexual behaviors such as reduced sexual activity, increased use of condoms, and external ejaculation. Themes related to risk behavior can be categorized according to struggles for intimacy and fears of isolation, including: fear of infecting a sex partner, guilt about sex, sexual communication difficulty, HIV-stigma, and worry about sexual partnerships. Emphasizing sexual health, intimacy and protective practices as components of nonjudgmental sex-positive secondary HIV prevention interventions is recommended. For in-care PLWHA, this approach has the potential to support TasP. The overlap of themes across groups and countries indicates that similar intervention content may be effective for a range of settings.

Background: Combination antiretroviral therapy (cART) had a dramatic impact on the mortality profile in human immunodeficiency virus (HIV) infected individuals and increased their life-expectancy. Conditions associated with the aging process have been diagnosed more frequently among HIV-infected patients, particularly, cardiovascular diseases., Methods: Patients followed in the Instituto de Pesquisa Clínica Evandro Chagas (IPEC) prospective cohort in Rio de Janeiro were submitted to the general procedures from the Brazilian Longitudinal Study of Adult Health, comprising several anthropometric, laboratory and imaging data. Carotid intima-media thickness (cIMT) was measured by ultrasonography, following the Mannheim protocol. Linear regression and proportional odds models were used to compare groups and covariables in respect to cIMT. The best model was chosen with the adaptive lasso procedure., Results: A valid cIMT exam was available for 591 patients. Median cIMT was significantly larger for men than women (0.56mm vs. 0.53mm; p = 0.002; overall = 0.54mm). In univariable linear regression analysis, both traditional risk factors for cardiovascular diseases (CVD) and HIV-specific characteristics were significantly associated with cIMT values, but the best multivariable model chosen included only traditional characteristics. Hypertension presented the strongest association with higher cIMT terciles (OR = 2.51; 95%CI = 1.69-3.73), followed by current smoking (OR = 1,82; 95%CI = 1.19-2.79), family history of acute myocardial infarction or stroke (OR = 1.60; 95%CI = 1.10-2.32) and age (OR per year = 1.12; 95%CI = 1.10-1.14)., Conclusions: Our results show that traditional cardiovascular disease (CVD) risk factors are the major players in determining increased cIMT among HIV infected patients in Brazil. This finding reinforces the need for thorough assessment of those risk factors in these patients to guarantee the incidence of CVD events remain under control.

Combined antiretroviral therapy is now acknowledged for preventing new HIV infections, besides decreasing mortality and morbidity. However, in many Latin America countries the epidemic is still driven by unprotected sexual intercourse. This study aims to describe sexual practices related to HIV/STD and to evaluate factors associated to unprotected sex among men who have sex with women (MSW) and men who have sex with men (MSM) under care at a reference center for HIV in Rio de Janeiro, Brazil. A cross-sectional study, nested in a Brazilian clinical cohort, evaluated the sexual practices of 404 sexually active HIV-positive MSW and men who have MSM. Approximately 30 % of them reported unprotected sexual practices during the 6 months prior to the interview. Most frequent risky practices reported were unprotected vaginal sex among MSW and unprotected receptive anal sex among MSM. Factors increasing the chance of unprotected sexual practices among MSW were the partner's desire of becoming pregnant (OR 2.81; CI 95 %: 1.36-5.95). To have received comments about excessive consumption of alcohol (OR 2.43; CI 95 %: 1.01-5.83), illicit drug use (OR 4.41; CI 95 %: 1.75-11.60) and lived in marital situation (OR 2.10; CI 95 %: 1.09-4.08) were significantly associated with unsafe sexual practices among MSM. The results highlight that health care of men living with HIV, as well as the prevention strategies, must consider the particularities of sexual behavior practiced by people who differ in sexual orientation.

Identifying factors, including human papillomavirus (HPV) genotypes, associated with abnormal anal cytology in HIV-infected women have implications for anal squamous cell cancer (SCC) prevention in HIV-infected women. Anal and cervical samples were collected for cytology, and tested for high-(HR-HPV) and low-risk HPV (LR-HPV) genotypes in a cross-sectional analysis of the IPEC Women's HIV Cohort (Rio de Janeiro, Brazil). Multivariate log-binomial regression models estimated prevalence ratios for factors associated with abnormal anal cytology [≥ atypical squamous cells of undetermined significance, (ASC-US)]. Characteristics of the 863 participants included: median age 42 years, 57% non-white, 79% current CD4+ T-cell count >350 cells/mm(3), 53% HIV-1 viral load <50 copies/mL, median ART duration 5.8 years. Fifty-one percent of anal specimens contained ≥ 1 HR-HPV genotype; 31% had abnormal anal cytology [14% ASC-US, 11% low-grade squamous intra-epithelial lesion, (LSIL); 2% atypical squamous cells-cannot exclude high-grade SIL (ASC-H); 4% high-grade SIL/cancer (HSIL+)]. In multivariate analysis, cervical LSIL+, nadir CD4+ T-cell count ≤ 50 cells/mm(3), HIV-1 viral load ≥ 50 copies/mL, and anal HPV 6, 11, 16, 18, 33, 45, 52, 56, and 58 were associated with ≥ anal ASC-US (p<0.05). Abnormal anal cytology and HR-HPV prevalences were high. HIV-infected women with cervical LSIL+, low nadir CD4+ counts, or detectable HIV-1 viral loads should be a particular focus for enhanced anal SCC screening efforts., Competing Interests: Author Disclosure Statement JEL has served as a consultant to Gilead Sciences and GSK.

Mother-to-child transmission (MTCT) of human immunodeficiency virus (HIV) infection remains an important cause of new HIV infections worldwide, especially in low and middle-resource limited countries. Safety data from studies involving pregnant women and prenatal antiretroviral (ARV) exposure are still needed once these studies are often small and with a limited duration to assess adverse drug reactions (ADR). The aim of this study was to estimate the incidence of ADR related to the use of antiretroviral therapy (ART) in pregnant women in two referral centers in Rio de Janeiro State. A prospective study was carried out from February 2005 to May 2006. Women were classified according to their ART status during pregnancy diagnosis: ARV-experienced (ARTexp) or ARV-naïve (ARTn). Two hundred fourteen HIV-infected pregnant women were included: 36 ARTexp and 178 ARTn. ARTexp women have not experienced ADR. Among ARTn, 20.2% presented ADR. Incidence rate of ADR was 70.8 per 1000 person-months and the most common ADRs observed were: gastrointestinal (belly or abdominal cramps, diarrhea, nausea and vomit) in 16.3%, cutaneous (pruritus and rash) in 6.2%, anemia (2.2%) and hepatitis (1.7%). The frequency of obstetrical complications, pre-term delivery, low birth weight and birth abnormalities was low in this population. ADRs ranged from mild to moderate intensity, none of them being potentially fatal. Only in a few cases it was necessary to discontinue ART. In conclusion, the high effectiveness of ARV for HIV prevention of MTCT (PMTCT) overcomes the risk of ADR., (Copyright © 2014 Elsevier Editora Ltda. All rights reserved.)

Background: Many countries are facing concentrated HIV epidemics among vulnerable populations, including men who have sex with men (MSM). Unprotected anal intercourse (UAI) is the main HIV transmission route among them and its understanding in the different cultures and how it relates to HIV transmission, re-infection and development of HIV antiretroviral resistance has important public health implications. Data on UAI among Brazilian MSM are scarce. This study aims to evaluate the prevalence and associated factors of UAI among HIV-infected MSM who had sex with seronegative or male partners with an unknown serostatus., Method: A cross-sectional study nested in a cohort was conducted in Rio de Janeiro, Brazil. The one hundred and fifty five MSM included in the study answered an ACASI interview and provided biological samples. Generalized linear models were used to identify variables associated with UAI., Results: Overall, UAI with an HIV-negative or unknown serostatus male partner was reported by 40.6% (63/155) of MSM. Lifetime sexual abuse or domestic violence was reported by 35.9%, being more frequent among MSM who reported UAI compared to those who did not (P = 0.001). Use of stimulants before sex was reported by 20% of the MSM, being slightly higher among those who reported UAI (27.0% vs. 15.2%; P = 0.072). Commercial sex was frequent among all MSM (48.4%). After multivariate modeling, the report of sexual abuse or domestic violence (OR = 2.70; 95% CI: 1.08-7.01), commercial sex (OR = 2.28; 95% CI: 1.04- 5.10), the number of male sexual partners (p = 0.039) and exclusively receptive anal intercourse (OR = 0.21; 95% CI: 0.06-0.75) remained associated with UAI. CD4 levels, HIV viral load and antiretroviral therapy were not associated with UAI., Conclusion: The UAI prevalence found with negative or unknown HIV status partners points out that other interventions are needed as additional prevention tools to vulnerable MSM. The main factors associated with UAI were a lifetime history of violence, commercial sex and the number of male sexual partners. This clustering of different behavioral, health and social problems in this population reinforce the need of a comprehensive approach on treating and preventing HIV among MSM.

With the introduction of combined active antiretroviral therapy and the improved survival of HIV-infected patients, degenerative diseases and drug toxicity have emerged as long-term concerns. We studied the prevalence of decreased glomerular filtration rate (GFR) and associated risk factors in a cohort of HIV-infected patients from a middle-income country. Our cross-sectional study included all adult patients who attended an urban outpatient clinic in 2008. GFR was estimated using the CKD-EPI equation. The prevalence ratio (PR) of decreased GFR (defined as <60 mL/min/1.73 m(2)) was estimated using generalizing linear models assuming a Poisson distribution. We analyzed data from 1,970 patients, of which 82.9% had been exposed to ART. A total of 249 patients (12.6%) had a GFR between 60 and 89 mL/min/1.73 m(2), 3.1% had a GFR between 30 and 59, 0.3% had a GFR between 15 and 29, and 0.4% had a GFR <15. Decreased GFR was found in only 74 patients (3.8%). In the multivariate regression model, the factors that were independently associated with a GFR below 60 mL/min/1.73 m(2) were as follows: age ≥ 50 years (PR = 3.4; 95% CI: 1.7-6.8), diabetes (PR = 2.0; 95% CI: 1.2-3.4), hypertension (PR = 2.0; 95% CI: 1.3-3.2), current CD4+ cell count <350 cells/mm3 (PR = 2.1; 95% CI: 1.3-3.3), past exposure to tenofovir (PR = 4.7; 95% CI: 2.3-9.4) and past exposure to indinavir (PR =1.7; 95% CI: 1.0-2.8). As in high-income countries, CKD was the predominant form of kidney involvement among HIV-infected individuals in our setting. The risk factors associated with decreased glomerular filtration were broad and included virus-related factors as well as degenerative and nephrotoxic factors. Despite the potential for nephrotoxicity associated with some antiretroviral drugs, in the short-term, advanced chronic renal disease remains very rare.

Objective: To compare the effectiveness of first-line combination antiretroviral therapy (cART) between premenopausal and postmenopausal women., Methods: ART-naïve women initiating cART between January 2000/June 2010 at the Instituto de Pesquisa Clínica Evandro Chagas Cohort were studied. Women were defined as postmenopausal after 12 consecutive months of amenorrhea. CD4 cell counts and HIV-1 RNA viral load (VL) measurements were compared between pre- and postmenopausal at 6, 12 and 24 months after cART initiation. Women who modified/discontinued a drug class or died due to an AIDS defining illness were classified as ART-failures. Variables were compared using Wilcoxon test, χ2 or Fisher's exact test. The odds of cART effectiveness (VL<400 copies/mL and/or no need to change cART) were compared using logistic regression. Linear model was used to access relationship between CD4 change and menopause., Results: Among 383 women, 328 (85%) were premenopausal and 55 (15%) postmenopausal. Median pre cART CD4 counts were 231 and 208 cells/mm(3) (p = 0.14) in pre- and postmenopausal women, respectively. No difference in the median pre cART VL was found (both 4.8 copies/mL). Median CD4 changes were similar at 6 and 12 months. At 24 months after cART initiation, CD4 changes among postmenopausal women were significantly lower among premenopausal women (p = 0.01). When the analysis was restricted to women with VL<400 copies/mL, no statistical difference was observed. Overall, 63.7% achieved cART effectiveness at 24 months without differences between groups at 6, 12 and 24 months., Conclusion: Menopause status at the time of first-line cART initiation does not impact CD4 cell changes at 24 months among women with a virologic response. No relationship between menopause status and virologic response was observed.

Caution, alkyl acyl azides can rapidly decompose with heat to release large amounts of nitrogen. Care should be taken during handling: do not attempt to convert neat and avoid handling neat.

Background: Information on vaccine-type HPV seroprevalence is essential for vaccine strategies; however, limited data are available on past exposure to HPV-quadrivalent vaccine types in HIV-infected woman in Brazil., Objectives: To assess the seroprevalence for HPV types 6, 11, 16 and 18 in HIV-infected and uninfected women, from Rio de Janeiro, Brazil and to investigate potential associations with age and pregnancy status., Study-Design: 1100-sera were tested by virus-like particle (VLPs)-based ELISA for antibodies to HPV types 16, 18, 6 and 11. Statistical analysis was carried out by STATA/SE 10.1 and comparisons among HIV-infected and HIV-uninfected women were assessed by Poisson regression models with robust variance., Results: HPV-6, 11, 16 and 18 seroprevalence was significantly higher among HIV-positive women (29.9%, 8.5%, 56.2% and 38.0%, respectively) compared to HIV-negative women (10.9%, 3.5%, 30.8% and 21.7%, respectively), when adjusted by age and pregnancy status. Overall, 69.4% of HIV-infected and 41.5% of HIV-uninfected women tested positive for any HPV quadrivalent vaccine type. However 4.7% and 1.1%, respectively, tested positive for all HPV vaccine type. In HIV-uninfected women who were pregnant, we found a higher HPV-11 seroprevalence (8.5% vs. 1.5%; P < 0.001) and a lower HPV 16 seroprevalence (22.6% vs. 34.2%; P = 0.010) compared to not pregnant women. HIV-uninfected women, aged 40 or more years old had a higher HPV 16 seroprevalence compared to women aged less than 40 years old., Conclusions: We did not observe a strong association between age and positive HPV antibodies nor an association between pregnancy and HPV seroprevalence. HPV seroprevalence was significantly higher among HIV-infected women compared to HIV negative women. In both populations the seroprevalence to all four HPV vaccine types was low suggesting that women may potentially benefit from the HPV vaccines., (Copyright © 2013 Elsevier B.V. All rights reserved.)

Transmission of drug-resistant HIV-1 strains has been gaining attention and is becoming a growing problem throughout the world. The aim of this study was to determine the prevalence of transmitted drug resistance mutations (TDRM) among antiretroviral (ARV)-naive HIV-infected pregnant women in Rio de Janeiro, Brazil. ARV-naive pregnant women were recruited at Hospital Geral de Nova Iguacu (HGNI), Rio de Janeiro, from 2005 to 2008. HIV genotyping was carried out using ViroSeq (Abbott v. 2.0). TDRM were detected using the Calibrated Population Resistance Tool-CPR v. 6.0.The prevalence of mutations associated with resistance in the protease and reverse transcriptase regions of the HIV genome were assessed in samples collected prior to initiation of ARV prophylaxis or treatment. Among 238 eligible specimens that were collected, 197 samples were successfully amplified using reverse transcription polymerase chain reaction. Eighty-one percent of women were infected with HIV subtype B, 10% with subtype F1 viruses, 1.0% with subtype C virus, and 8.0% with recombinant forms of the virus. The prevalence of HIV TDRM was 5.6% for nucleoside reverse transcriptase inhibitors, 2.0% for nonnucleoside reverse transcriptase inhibitors, and 3.0% for protease inhibitors. The overall prevalence of any drug resistance was 10.7%. There were no multiclass resistant strains identified in the analyzed samples. The prevalence of HIV TDRM among the pregnant women in our cohort was moderate. Resistance testing should be encouraged in Rio de Janeiro, among other locations, for all HIV-infected pregnant women prior to prevention of mother-to-child transmission of HIV.

Context and Objective: Human immunodeficiency virus (HIV)-infected women have higher incidence, prevalence, persistence and recurrence of pre-invasive cervical lesions (CIN II or III). The aim here was to investigate the risk of recurrence of CIN II/III among HIV-infected women (HIV+) and uninfected women in a cohort treated by means of large-loop excision of the transformation zone (LLETZ)., Design and Setting: Cohort study conducted at Instituto Fernandes Figueira/Fundação Oswaldo Cruz (IFF/Fiocruz)., Methods: 60 HIV+ and 209 HIV-negative patients were included in a cohort for follow-up after undergoing LLETZ to treat CIN II/III. A histopathological diagnosis of CIN II/III during the follow-up was taken to constitute recurrence. The following possible confounding variables were assessed: age at treatment and at end of follow-up; histological grade of intraepithelial disease treated; surgical margin involvement; adequacy of colposcopy during the follow-up; CD4+ lymphocyte count; HIV viral load; and type of antiretroviral therapy., Results: Among the 60 HIV+ women, six showed recurrent disease during the follow-up. However, among the 209 HIV-negative women, seven showed a new precursor lesion. The relative risk of disease recurrence in the HIV+ women was 4.21 (95% CI = 1.42 to 12.43). The Kaplan-Meyer curve showed that the risk of recurrence was significantly higher among HIV+ women (log-rank test: P = 0.0111)., Conclusion: The HIV+ women in our cohort presented a risk of CIN II/III recurrence at least 42% higher than among the HIV-negative women. These patients should form part of a rigorous screening and follow-up protocol for identification and appropriate treatment of cervical cancer precursor lesions.

Although several studies have evaluated the role of p16(INK4a) as a diagnostic marker of cervical intraepithelial neoplasia (CIN) and its association with disease progression, studies regarding the role of p16(INK4a) in human immunodeficiency virus (HIV)-infected patients remain scarce. The present study was designed to determine the potential utility of p16(INK4a) as a diagnostic marker for CIN and invasive cervical cancer in HIV-positive and negative cervical specimens. An immunohistochemical analysis of p16(INK4a) was performed in 326 cervical tissue microarray specimens. Performance indicators were calculated and compared using receiving operating characteristics curve (ROC)/area under the curve. In HIV-1-negative women, the percentage of cells that was positive for p16(INK4a) expression was significantly correlated with the severity of CIN (p < 0.0001). A ROC curve with a cut-off value of 55.28% resulted in a sensitivity of 89%, a specificity of 81%, a positive predictive value of 91% and a negative predictive value of 78%. HIV-seropositive women exhibited decreased expression of p16(INK4a) in CIN2-3 specimens compared with HIV-negative specimens (p = 0.031). The ROC data underscore the potential utility of p16(INK4a) under defined conditions as a diagnostic marker for CIN 2-3 staging and invasive cervical cancer. HIV-1 infection, however, is associated with relatively reduced p16(INK4a) expression in CIN 2-3.

Background: Minichromosome maintenance proteins (MCM) are highly expressed in actively replicating cells. The need for biological markers for cervical carcinoma and its precursor lesions is emerging. Our main aim was to determine the immunohistochemical expression of MCM-2 in HIV-positive and -negative dysplastic cervical specimens., Methods: Immunohistochemical analysis of MCM-2 was performed in a total of 352 cervical TMA specimens of normal control, low-grade CIN, high-grade CIN and invasive tumor. 38 specimens were from HIV-positive women. A receiver operating characteristic (ROC) curve was constructed to determine the best cutoff to diagnose high-grade CIN and invasive cervical cancer., Results: In the progression from normal epithelium to high-grade CIN and invasive tumor we found significant differences in the MCM-2 expression (p<0.05). Based on the ROC curve of 80% with an area under the curve (AUC) of 0.78, expression of MCM-2 to diagnose high-grade CIN and invasive tumor resulted in sensitivity of 81%, specificity of 66%, a positive predictive value (PPV) of 86% and a negative predictive value (NPV) of 57%. HIV-positive cervices revealed a decreasing expression of MCM-2 in both LGCIN and HGCIN compared with HIV-negative specimens (p<0.0001)., Conclusions: The present study suggests that immunohistochemical MCM-2 may not be a promising biomarker for diagnosing high-grade CIN and invasive cancer.

Although cervical cancer remains a major public health problem in Brazil, knowledge of cervical cytological abnormalities among HIV-infected women remains scarce. At baseline evaluation of a cohort followed in Rio de Janeiro, Brazil, 703 HIV-infected women underwent cytology-based cervical cancer screening and human papillomavirus (HPV) DNA testing. Poisson regression analysis was used to evaluate the association of factors with the presence of high-grade squamous intraepithelial lesions (HSIL). Cervical cytology was abnormal in 24.3% of the women; 4.1% had HSIL. Beyond HPV infection, factors independently associated with the presence of HSIL was age (≥25 and ≤40 years, prevalence ratio [PR] 2.60, 95% confidence interval [CI] 1.11-6.10), and more than three pregnancies was protective (PR 0.33, 95% CI 0.11-0.94). High coverage of cervical cancer screening is warranted to prevent morbidity and mortality from cervical cancer in this population.

HIV-infected women are at increased risk of developing high-grade squamous intraepithelial lesions (HSIL), the precursor lesions for cervical cancer. This study estimated and compared the performance of cytology and hybrid capture II in screening for precursor lesions of cervical cancer among HIV-infected women. The study population consisted of women from the open prospective cohort at the Evandro Chagas Clinical Research Institute, Oswaldo Cruz Foundation (IPEC/Fiocruz). Colposcopy and histology were considered jointly in defining the gold standard. Cytology showed 31.8% sensitivity and 95.5% specificity, while hybrid capture II showed higher sensitivity (100%) and lower specificity (52%). The positive likelihood ratio was 7.1 for cytology and 2.1 for hybrid capture II, while the negative likelihood ratio was 0.7 for cytology and 0.0 for hybrid capture II.

Highly active antiretroviral therapy (HAART) has changed the morbidity pattern affecting HIV-infected individuals to include non-AIDS-defining cancers. We describe the breast cancer cases occurring in a cohort of 860 HIV-infected women followed in Rio de Janeiro, Brazil, and estimate the incidence rate of breast cancer for this population. Nine cases were identified; median age at diagnosis was 46 years. Median survival after breast cancer diagnosis was 12 months. Breast cancer diagnosis was made within 2 to 15 years of HIV-infection diagnosis. At breast cancer diagnosis, CD4 counts ranged from 135 to 782 cells/mm3; six women were receiving HAART. Histological analysis indicated infiltrating ductal carcinoma in all cases. The incidence rate of breast cancer was 133 cases per 100,000 persons-year. Patients from our case series were late diagnosed with breast cancer and thus suffered from worse prognosis. Strategies targeting earlier diagnosis and prompt initiation of treatment are needed.

Objective: To evaluate the effectiveness and safety of assisted reproduction techniques (ART) in human immunodeficiency virus (HIV) serodiscordant couples., Design: Systematic review of five databases of noncomparative open intervention and observational studies of serodiscordant couples undergoing ART, with study selection and data extraction performed independently and in duplicate., Setting: Tertiary fertility centers., Patient(s): HIV serodiscordant couples where the man is HIV positive., Intervention(s): Intrauterine insemination (IUI), in vitro fertilization (IVF), or intracytoplasmic injection (ICSI) performed after washed semen viral testing., Main Outcome Measure(s): Pregnancy rates per cycle, cumulative pregnancy, abortion rate, and HIV seroconversion in newborns or women., Result(s): Of the 658 abstracts retrieved, 41 were selected for review, and 17 full articles were included (3,900 IUI cycles in 1,184 couples in 11 aggregated studies and 738 ICSI/IVF cycles in 579 couples across 10 studies). The IUI and ICSI results were, respectively: pregnancy rates per cycle, 18% and 38.1%; cumulative pregnancy, 50% and 52.9%; and abortion rate, 15.6% and 20.6%. No seroconversions in women or newborns were detectable at birth or after 3 to 6 months., Conclusion(s): Cumulative evidence suggests that ART is safe and effective for avoiding horizontal and vertical transmission in HIV serodiscordant couples., (Copyright © 2011 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)