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Motherhood is personally, culturally, and historically rooted. Recent publications have focused on medical issues related to pregnancy and HIV, with attention on fetal well-being. There is limited literature on the importance of motherhood for HIV-positive women. Our study's purpose was to investigate the importance of motherhood among HIV-positive women of reproductive age in Ontario, Canada and to analyze the correlates thereof. We present our findings using a secondary analysis of cross-sectionally collected data from a study assessing fertility desires and intentions of HIV-positive women. The sub-analysis's outcome of interest was based on the question: "Being a mother is important to me" with a 5-point Likert scale that was dichotomized into strongly agree/agree vs. neutral/disagree/strongly disagree. Logistic regression models were fit to calculate unadjusted and adjusted odds ratios (ORs) for significant correlates. Of the 497 respondents, median age was 38 (interquartile range [IQR] 32-43), 46% were African, 74% had given birth, and 57% intended to give birth. A total of 452 (91%) agreed (N = 75) or strongly agreed (N = 377) that being a mother was important to them. Age less than 40 years (OR 3.0; 95% confidence interval [CI] 1.6-5.7, African ethnicity (OR 9.2; 95% CI 3.2-26.3), immigration within 10 years (OR 19.6, 95% CI 4.6-83.1), and partner or family desire for a pregnancy (OR 3.3; 95% CI 1.5-7.3) were significant correlates of the importance of motherhood in a univariate analysis. Importance of motherhood was associated with desire (OR 6.2, 95% CI 3.1-12.3) and intention to give birth (OR 6.9, 95% CI 3.1-15.2), and previous birth (OR 8.5, 95% CI 4.2-16.8). In the multivariable model, the significant correlates were of age less than 40 years (OR 3.9; 95% CI 1.8-8.4), immigration within 10 years (OR 14.1; 95% CI 3.2-61.5), and having previously given birth (OR 11.2; 95% CI 5.1-24.4). The majority of women felt strongly that motherhood was important to them particularly among younger women, recent immigrants, and women who were mothers.

The concept of psychological distress includes a range of emotional states with symptoms of depression and anxiety and has yet to be reported in HIV-positive women living in Ontario, Canada, who are known to live with contributing factors. This study aimed to determine the prevalence, severity, and correlates of psychological distress among women accessing HIV care participating in the Ontario HIV Treatment Network Cohort Study using the Kessler Psychological Distress Scale (K10). The K10 is a 10-item, five-level response scale. K10 values range from 10 to 50 with values less than or equal to 19 categorized as not clinically significant, scores between 20 and 24 as moderate levels, 25-29 as high, and 30-50 as very high psychological distress. Correlates of psychological distress were assessed using the Pearson's chi-square test and univariate and multivariate logistic regression analysis. Moderate, high, and very high levels of psychological distress were experienced by 16.9, 10.4, and 15.1% of the 337 women in our cohort, respectively, with 57.6% reporting none. Psychological distress levels greater than 19, correlated with being unemployed (vs. employed/student/retired; AOR = 0.33, 95% CI: 0.13-0.83), living in a household without their child/children (AOR = 2.45, 95% CI: 1.33-4.52), CD4 counts < 200 cells/mm(3) (AOR = 2.07, 95% CI: 0.89-4.80), and to a lesser degree an education of some college or less (vs. completed college or higher; AOR=1.71, 95% CI: 0.99-2.95). Age and ethnicity, a priori variables of interest, did not correlate with psychological distress. Findings suggest that socioeconomic factors which shape the demography of women living with HIV in Ontario, low CD4 counts, and losing the opportunity to care for their child/children has a significant relationship with psychological distress. Approaches to manage psychological distress should address and make considerations for the lived experiences of women since they can act as potential barriers to improving psychological well-being.

Initiating highly active antiretroviral therapy (HAART) with low CD4 counts or AIDS-defining illnesses (ADIs) increases risk of treatment failure and death. We examined factors associated with late initiation among 18- to 29-year-olds within the Canadian Observational Cohort (CANOC) collaboration, a multi-site study of HIV-positive persons who initiated HAART after 2000. Late initiation was defined as beginning HAART with a CD4 count <200 cells/mm(3) and/or having a baseline ADI. Multivariable logistic regression was used to identify independent correlates of late initiation. In total, 1026 individuals (422 from British Columbia, 400 from Ontario, and 204 from Quebec) met our age criteria. At HAART initiation, median age was 27 years (interquartile range, 24, 28 years). A total of 412 individuals (40%) identified as late initiators. Late initiation was associated with female gender, age >25 years at initiation, initiating treatment in earlier years, and having higher baseline viral load. The high number of young adults in our cohort starting HAART late indicates important target populations for specialized services, increased testing, and linkages to care.

Background: We sought to determine the pharmacokinetic disposition of raltegravir in the blood and seminal plasma of HIV-infected men., Methods: We conducted a pharmacokinetic study using a staggered sampling approach. A total of 16 HIV-infected men receiving raltegravir-based therapy were recruited into the study. Each participant provided six blood plasma and six seminal plasma samples for quantification of drug concentrations in both compartments. Blood and semen samples were obtained within 1 h of each other and were collected prior to the morning dose and at 1, 2, 4, 8 and 12 h post-ingestion. Drug concentrations were determined by liquid chromatography tandem mass spectrometry., Results: A total of 96 semen samples and 96 blood samples were obtained from all participants during the study period. The median age and baseline CD4(+) T-cell count of the study participants were 48 years (IQR 42-53) and 450 cells/mm(3) (IQR 289-585). Virological suppression to <50 copies/ml had been maintained for a median of 21 months (IQR 7-35) at the time of study enrolment. The median seminal plasma-to-blood plasma ratios and AUC0-12 h seminal plasma-to-blood plasma ratios of raltegravir were 3.25 (IQR 1.46-5.37) and 2.26 (IQR 1.05-4.45), respectively., Conclusions: Concentrations of raltegravir in seminal plasma are several fold higher than those attained in blood plasma and those required to inhibit viral replication in this compartment. Further research examining the therapeutic and prophylactic implications of these findings is warranted.

Background: Cohort data examining differences by gender in clinical responses to combination antiretroviral therapy (ART) remain inconsistent and have yet to be explored in a multi-province Canadian setting. This study investigates gender differences by injection drug use (IDU) history in virologic responses to ART and mortality., Methods: Data from the Canadian Observational Cohort (CANOC) collaboration, a multisite cohort study of HIV-positive individuals initiating ART after January 1, 2000, were included. This analysis was restricted to participants with a follow-up HIV-RNA plasma viral load measure and known IDU history. Weibull hazard regression evaluated time to virologic suppression (2 consecutive measures <50 copies/mL), rebound (>1000 copies/mL after suppression), and all-cause mortality. Sensitivity analyses explored the impact of presumed ART use in pregnancy on virologic outcomes., Results: At baseline, women (1120 of 5442 participants) were younger (median 36 vs. 41 years) and more frequently reported IDU history (43.5% vs. 28.8%) (both p<0.001). Irrespective of IDU history, in adjusted multivariable analyses women were significantly less likely to virologically suppress after ART initiation and were at increased risk of viral load rebound. In adjusted time to death analysis, no differences by gender were noted. After adjusting for presumed ART use in pregnancy, observed gender differences in time to virologic suppression for non-IDU, and time to virologic rebound for IDU, became insignificant., Conclusions: HIV-positive women in CANOC are at heightened risk for poor clinical outcomes. Further understanding of the intersections between gender and other factors augmenting risk is needed to maximize the benefits of ART.

Objective(s): We investigated the probability of transitioning in or out of the CD3⁺ T-cell homeostatic range during antiretroviral therapy, and we assessed the clinical impact of lost T-cell homeostasis (TCH) on AIDS-defining illnesses (ADIs) or death., Design: Within the Canadian Observational Cohort (CANOC), we studied 4463 antiretroviral therapy (ART)-naive HIV-positive patients initiating combination ART (cART) between 2000 and 2010., Methods: CD3⁺ trajectories were estimated using a four state Markov model. CD3⁺ T-cel percentage states were classified as follows: very low (<50%), low (50-64%), normal (65-85%), and high (>85%). Covariates associated with transitioning between states were examined. The association between CD3⁺ T-cell percentage states and time to ADI/death from cART initiation was determined using Cox proportional hazards models., Results: A total of 4463 patients were followed for a median of 3 years. Two thousand, five hundred and eight (56%) patients never transitioned from their baseline CD3⁺ T-cell percentage state; 85% of these had normal TCH. In multivariable analysis, individuals with time-updated low CD4⁺ cell count, time-updated detectable viral load, older age, and hepatitis C virus (HCV) coinfection were less likely to maintain TCH. In the multivariable proportional hazards model, both very low and high CD3⁺ T-cell percentages were associated with increased risk of ADI/death [adjusted hazard ratio=1.91 (95% confidence interval, CI: 1.27-2.89) and hazard ratio=1.49 (95% CI: 1.13-1.96), respectively]., Conclusion: Patients with very low or high CD3⁺ T-cell percentages are at risk for ADIs/death. To our knowledge, this is the first study linking altered TCH and morbidity/mortality in cART-treated HIV-positive patients.

Background: HIV leads to CD4:CD8 ratio inversion as immune dysregulation progresses. We examined the predictors of CD4:CD8 normalization after combination antiretroviral therapy (cART) and determined whether normalization is associated with reduced progression to AIDS-defining illnesses (ADI) and death., Methods: A Canadian cohort of HIV-positive adults with CD4:CD8<1.2 prior to starting cART from 2000-2010 were analyzed. Predictors of (1) reaching a CD4:CD8 ≥ 1.2 on two separate follow-up visits >30 days apart, and (2) ADI and death from all causes were assessed using adjusted proportional hazards models., Results: 4206 patients were studied for a median of 2.77 years and 306 (7.2%) normalized their CD4:CD8 ratio. Factors associated with achieving a normal CD4:CD8 ratio were: baseline CD4+ T-cells >350 cells/mm(3), baseline CD8+ T-cells <500 cells/mm(3), time-updated HIV RNA suppression, and not reporting sex with other men as a risk factor. There were 213 ADIs and 214 deaths in 13476 person-years of follow-up. Achieving a normal CD4:CD8 ratio was not associated with time to ADI/death., Conclusions: In our study, few individuals normalized their CD4:CD8 ratios within the first few years of initiating modern cART. This large study showed no additional short-term predictive value of the CD4:CD8 ratio for clinical outcomes after accounting for other risk factors including age and HIV RNA.

Background: Population-based estimates of HIV prevalence, rates of new HIV diagnoses, and mortality rates among persons with HIV who have entered care are needed to optimize health service delivery and to improve the health outcomes of these individuals. However, these data have been lacking for Ontario., Methods: Using a validated case-finding algorithm and linked administrative health care databases, we conducted a population-based study to determine the prevalence of HIV and rates of new HIV diagnoses among adults aged 18 years or older in Ontario between fiscal year 1996/1997 and fiscal year 2009/2010, as well as all-cause mortality rates among persons with HIV over the same period., Results: Between 1996/1997 and 2009/2010, the number of adults living with HIV increased by 98.6% (from 7608 to 15,107), and the age- and sex-standardized prevalence of HIV increased by 52.8% (from 92.8 to 141.8 per 100,000 population; p < 0.001). Women and individuals 50 years of age or older accounted for increasing proportions of persons with HIV, rising from 12.8% to 19.7% (p < 0.001) and from 10.4% to 29.9% (p < 0.001), respectively, over the study period. During the study period, age- and sex-standardized rates of new HIV diagnoses decreased by 32.5% (from 12.3 to 8.3 per 100,000 population; p < 0.001) and mortality rates among adults with HIV decreased by 71.9% (from 5.7 to 1.6 per 100 adults with HIV; p < 0.001)., Interpretation: The prevalence of HIV infection in Ontario increased considerably between 1996/1997 and 2009/2010, with a greater relative burden falling on women and individuals aged 50 years of age or older. These trends may be due to the decreased rate of new diagnoses among younger men. All-cause mortality rates declined among persons with HIV who entered care.

Introduction: In the management of HIV, women and men generally undergo the same treatment pathway, with gender differences being given limited consideration. This is in spite of accumulating evidence that there are a number of potential differences between women and men which may affect response to treatment, pharmacokinetics, toxicities and coping. There are also notable psychological, behavioural, social and structural factors that may have a unique impact on women living with HIV (WLWH). Despite our increasing knowledge of HIV and advances in treatment, there are significant gaps in the data relating specifically to women. One of the factors contributing to this situation is the under-representation of women in all aspects of HIV clinical research. Furthermore, there are clinical issues unique to women, including gynaecologic and breast diseases, menopause-related factors, contraception and other topics related to women's and sexual health., Methods: Using scoping review methodology, articles from the literature from 1980 to 2012 were identified using appropriate MeSH headings reflecting the clinical status of WLWH, particularly in the areas of clinical management, sexual health, emotional wellbeing and treatment access. Titles and abstracts were scanned to determine whether they were relevant to non-reproductive health in WLWH, and papers meeting inclusion criteria were reviewed., Results: This review summarizes our current knowledge of the clinical status of WLWH, particularly in the areas of clinical management, sexual health, emotional wellbeing and treatment access. It suggests that there are a number of gender differences in disease and treatment outcomes, and distinct women-specific issues, such as menopause and co-morbidities, that pose significant challenges to the care of WLWH., Conclusions: Based on a review of this evidence, outstanding questions and areas where further studies are required to determine gender differences in the efficacy and safety of treatment and other clinical and psychological issues specifically affecting WLWH have been identified. Well-controlled and adequately powered clinical studies are essential to help provide answers to these questions and to contribute to activities aimed at improving the health and wellbeing of WLWH.

Background: Although some studies show higher antiretroviral concentrations in women compared to men, data are limited. We conducted a cross-sectional study of HIV-positive women to determine if protease inhibitor (PI) and non-nucleoside reverse transcriptase inhibitor (NNRTI) C(min) and Cmax values were significantly different than historical general population (predominantly male) averages and to evaluate correlates of higher concentrations., Methods: HIV-positive women with virologic suppression (viral load < 50copies/mL) on their first antiretroviral regimen were enrolled. Timed blood samples for C(min) and Cmax were drawn weekly for 3 weeks. The ratio of each individual's median C(min) and Cmax to the published population mean values for their PI or NNRTI was calculated and assessed using Wilcoxon sign-rank. Intra- and inter-patient variability of antiretroviral drug levels was assessed using coefficient of variation and intra-class correlation. Linear regression was used to identify correlates of the square root-transformed C(min) and Cmax ratios., Results: Data from 82 women were analyzed. Their median age was 41 years (IQR=36-48) and duration of antiretrovirals was 20 months (IQR=9-45). Median antiretroviral C(min) and Cmax ratios were 1.21 (IQR=0.72-1.89, p=0.003) (highest ratios for nevirapine and lopinavir) and 0.82 (IQR=0.59-1.14, p=0.004), respectively. Nevirapine and efavirenz showed the least and unboosted atazanavir showed the most intra- and inter-patient variability. Higher CD4+ count correlated with higher C(min). No significant correlates for Cmax were found., Conclusions: Compared to historical control data, C(min) in the women enrolled was significantly higher whereas Cmax was significantly lower. Antiretroviral C(min) ratios were highly variable within and between participants. There were no clinically relevant correlates of drug concentrations., Trial Registration: NCT00433979.

Background: Participation bias is a well-known phenomenon in epidemiologic research, where individuals consenting to research studies differ from individuals who are not able or willing to participate. These dissimilarities may limit the generalizability of results of research studies. Quantification of the participation bias is essential for the interpretation of research findings., Methods: The Ontario HIV Treatment Network Cohort Study (OCS) is an ongoing open cohort study of HIV positive individuals receiving care at one of 11 sites in Ontario. OCS participants from 4 sites were compared to non-participants (those who declined or were not approached) at those sites with regard to gender, age, HIV risk factor, CD4 count and viral load (VL). Generalized logit regression models were used to identify predictors of declining to participate or not being approached to participate., Results: Compared to participants (P) in the OCS, individuals who declined to participate (D) and those who were not approached (NA) were slightly younger (D:45, NA:44 vs P:46), less likely to be male (D: 71%, NA:75% vs P:88%), less likely to be Caucasian (D:41%, NA:57% vs P:72%) and less likely to be Canadian-born (D: 39%, NA: 52% vs P: 69%). Patients who were not approached to participate were less likely to have VL < 50 copies/mL than other patients (D: 75%, NA: 62%, P: 74%) and had lower CD4 counts than OCS participants (D: 450 cells/mm3, NA: 420 cells/mm3, P: 480 cells/mm3)., Conclusions: Significant demographic and clinical differences were found between OCS participants and non-participants. Extrapolation of research findings to other populations should be undertaken cautiously.

The impact of antiretroviral therapy (ART) on the natural history of HIV-1 infection has resulted in dramatic reductions in disease-associated morbidity and mortality. Additionally, the epidemiology of HIV-1 infection worldwide is changing, as women now represent a substantial proportion of infected adults. As more highly effective and tolerable antiretroviral regimens become available, and as the prevention of mother-to-child transmission becomes an attainable goal in the management of HIV-infected individuals, more and more HIV-positive women are choosing to become pregnant and have children. Consequently, it is important to consider the efficacy and safety of antiretroviral agents in pregnancy. Protease inhibitors are a common class of medication used in the treatment of HIV-1 infection and are increasingly being used in pregnancy. However, several studies have raised concerns regarding pharmacokinetic alterations in pregnancy, particularly in the third trimester, which results in suboptimal drug concentrations and a theoretically higher risk of virologic failure and perinatal transmission. Drug level reductions have been observed with each individual protease inhibitor and dose adjustments in pregnancy are suggested for certain agents. Furthermore, studies have also raised concerns regarding the safety of protease inhibitors in pregnancy, particularly as they may increase the risk of pre-term birth and metabolic disturbances. Overall, protease inhibitors are safe and effective for the treatment of HIV-infected pregnant women. Specifically, ritonavir-boosted lopinavir- and atazanavir-based regimens are preferred in pregnancy, while ritonavir-boosted darunavir- and saquinavir-based therapies are reasonable alternatives. This paper reviews the use of protease inhibitors in pregnancy, focusing on pharmacokinetic and safety considerations, and outlines the recommendations for use of this class of medication in the HIV-1-infected pregnant woman.

Objective: Malaria and HIV-1 adversely interact, with HIV-positive individuals suffering higher parasite burdens and worse clinical outcomes. However, the mechanisms underlying these disease interactions are unclear. We hypothesized that HIV coinfection impairs the innate immune response to malaria, and that combination antiretroviral therapy (cART) may restore this response. Our aim was to examine the innate inflammatory response of natural killer (NK), natural killer T (NKT), and γδ T-cells isolated from the peripheral blood of HIV-infected therapy-naive donors to malaria parasites, and determine the effect of cART on these responses., Methods: Freshly isolated peripheral blood mononuclear cells from 25 HIV-infected individuals pre-cART (month 0) and post-cART (months 3 and 6), and HIV-negative individuals at matched time-points, were cultured in the presence of Plasmodium falciparum parasitized erythrocytes. Supernatants and cells were collected to assess cytokine production and phenotypic changes., Results: Compared to HIV-negative participants, NKT, NK, and γδ T-cell subsets from participants with chronic HIV infection showed marked differences, including decreased production of interferon γ (IFNγ) and tumor necrosis factor (TNF) in response to malaria parasites. IFNγ production was linked to interleukin-18 receptor (IL-18R) expression in all three cell types studied. Six months of cART provided partial cellular reconstitution but had no effect on IL-18R expression, or IFNγ and TNF production., Conclusion: These data suggest that HIV infection impairs the inflammatory response of innate effector cells to malaria, and that the response is not fully restored within 6 months of cART. This may contribute to higher parasite burdens and ineffective immune responses, and have implications for vaccination initiatives in coinfected individuals.

Introduction: The increasing proportion of women living with HIV has evoked calls for tailored services that respond to women's specific needs. The objective of this investigation was to explore the concept of women-specific HIV/AIDS services to identify and define what key elements underlie this approach to care., Methods: A comprehensive review was conducted using online databases (CSA Social Service Abstracts, OvidSP, Proquest, Psycinfo, PubMed, CINAHL), augmented with a search for grey literature. In total, 84 articles were retrieved and 30 were included for a full review. Of these 30, 15 were specific to HIV/AIDS, 11 for mental health and addictions and four stemmed from other disciplines., Results and Discussion: The review demonstrated the absence of a consensual definition of women-specific HIV/AIDS services in the literature. We distilled this concept into its defining features and 12 additional dimensions (1) creating an atmosphere of safety, respect and acceptance; (2) facilitating communication and interaction among peers; (3) involving women in the planning, delivery and evaluation of services; (4) providing self-determination opportunities; (5) providing tailored programming for women; (6) facilitating meaningful access to care through the provision of social and supportive services; (7) facilitating access to women-specific and culturally sensitive information; (8) considering family as the unit of intervention; (9) providing multidisciplinary integration and coordination of a comprehensive array of services; (10) meeting women "where they are"; (11) providing gender-, culture- and HIV-sensitive training to health and social care providers; and (12) conducting gendered HIV/AIDS research., Conclusions: This review highlights that the concept of women-specific HIV/AIDS services is a complex and multidimensional one that has been shaped by diverse theoretical perspectives. Further research is needed to better understand this emerging concept and ultimately assess the effectiveness of women-specific services on HIV-positive women's health outcomes.

The study of pregnancy and motherhood in women living with HIV (WLWH) has concentrated on the health of the unborn baby and the prevention of mother-to-child transmission, whereas consideration of the broader aspects of women's reproductive health has been largely overlooked. The rights of WLWH with respect to their reproductive health should be exactly the same as non-HIV-positive women, however, inequalities exist due to discrimination and also because the treatment guidelines used in the care of women are often based on insufficient evidence. The purpose of this article is to review the available literature on reproductive health issues for WLWH and to identify gaps requiring further investigation. Our review indicates that further research is warranted into a number of aspects of reproductive health among WLWH. Currently, access to the relevant reproductive health resources and services, such as advice on contraception and fertility services, for WLWH is far from optimal in many developed countries and most developing countries. More data are needed on the most appropriate family planning options with the consideration of drug interactions between contraceptives and antiretroviral therapy and the risk of HIV transmission. Also, more research is needed to improve understanding of the maternal health challenges facing WLWH. Similarly, our understanding of the impact of HIV on the physical and emotional health of pregnant women and new mothers is far from complete. Answering these questions and countering these inequalities will help to ensure the reproductive health and child-bearing intentions of WLWH become an integral part of HIV medicine.

Background: The risk of sexual HIV transmission in serodiscordant couples when the HIV-positive partner has full virologic suppression on combination antiretroviral therapy (cART) is debated. This study aims to systematically review observational studies and randomized controlled trials (RCTs), evaluating rates of sexual HIV transmission between heterosexual serodiscordant couples when the HIV-positive partner has full suppression on cART., Methods and Findings: We searched major bibliographic databases to November 2012 for relevant observational studies and RCTs without language restrictions. Conference proceedings, key journals and bibliographies were also searched. Studies reporting HIV transmission rates, cART histories and viral loads of the HIV-positive partners were included. Two reviewers extracted methodologic characteristics and outcomes. Of 20,252 citations, 3 studies met all eligibility criteria with confirmed full virologic suppression in the HIV-positive partner. We included 3 additional studies (2 cohort studies, 1 RCT) that did not confirm viral suppression in the HIV-positive partner at transmission in a secondary meta-analysis. Methodologic quality was reasonable. The rate of transmission in the 3 studies confirming virologic suppression was 0 per 100 person-years (95% CI = 0-0.05), with low heterogeneity (I(2) = 0%). When we included the 3 studies that did not confirm virologic suppression, the rate of transmission was 0.14 per 100 person-years (95%CI = 0.04-0.31) (I(2) = 0%). In a sensitivity analysis including all 6 studies, the rate of transmission was 0 per 100 person-years (95%CI = 0-0.01) after omitting all transmissions with known detectable or unconfirmed viral loads, as full suppression in these cases was unlikely. Limitations included lack of data on same-sex couples, type of sexual intercourse (vaginal vs. anal), direction of HIV transmission, exact viral load at the time of transmission, sexually transmitted infections (STI) rates, and extent of condom use., Conclusions: Our findings suggest minimal risk of sexual HIV transmission for heterosexual serodiscordant couples when the HIV-positive partner has full viral suppression on cART with caveats regarding information on sexual intercourse type, STIs, and condom use. These findings have implications when counseling heterosexual serodiscordant couples on sexual and reproductive health. More research is needed to explore HIV transmission risk between same-sex couples.

Background: Human immunodeficiency virus (HIV)-related facial lipoatrophy is a devastating adverse effect of antiretroviral therapy. At this time, the most viable treatment option is cosmetic surgery with synthetic fillers. Bio-Alcamid has many advantages over other fillers, and has become widely used. The objective of this study was to determine the incidence rate of infectious complications associated with Bio-Alcamid facial filler in patients with HIV-related facial lipoatrophy (FLA)., Methods: This retrospective study identified patients who had received treatment with Bio-Alcamid, and reviewed their long-term outcomes., Results: Two hundred sixty-seven patients with Bio-Alcamid were reviewed. Infectious complications were documented in 56 (19%) patients. The incidence rate of infection was 0.07 per patient-year of follow-up. Among patients with infections, the median time from first Bio-Alcamid treatment to infection was 32 months (interquartile range, 21-42). We did not find an association between the development of infection and the level of immune suppression by HIV. Surgical drainage in addition to antibiotics was required for the majority of patients. Potential risk factors for infection include severity of FLA and a preceding history of facial manipulation, including Bio-Alcamid touch-up treatments, cosmetic surgery, facial trauma, and dental work., Conclusions: Bio-Alcamid treatment of HIV-related FLA was associated with a high rate of infectious complications, often presenting years after treatment. Antibiotic prophylaxis should be considered in patients with Bio-Alcamid prior to dental work or facial manipulation.

Background: Studies have found that Aboriginal people living with HIV/AIDS (APHAs) are more likely than non-APHAs to receive suboptimal HIV care, yet achieve similar clinical outcomes with proper care., Objective: To compare the proportions of individuals diagnosed late with HIV between APHAs and non-APHAs within the Ontario HIV Treatment Network Cohort Study (OCS)., Methods: The analysis included OCS participants who completed the baseline visit by November 2009. Two definitions of the outcome of late HIV diagnosis were used: the proportion of participants with an AIDS-defining illness (ADI) before or within three months of HIV diagnosis; and the proportion of participants with a CD4(+) count <200 cells/mL at diagnosis. Logistic regression analysis was used to assess the association between Aboriginal ethnicity and late HIV diagnosis., Results: APHAs were more likely to be female and have lower income, education and employment. No statistically significant differences were noted in the proportions receiving a late HIV diagnosis defined by ADI (Aboriginal 5.2% versus non-Aboriginal 6.3%; P=0.40). Multivariate logistic regression analysis revealed a significant association between Aboriginal ethnicity and late HIV diagnosis defined by CD4(+) count after adjusting for age and HIV risk factor (OR 1.55; P=0.04)., Discussion: APHAs were more likely to have a CD4(+) count <200 cells/mL at diagnosis but had similar clinical outcomes from late diagnosis when defined by ADI. However, differences may be underestimated due to recruitment limitations and selection bias., Conclusion: Additional work is needed to address the socioeconomic and health care needs of APHAs.

Background: Among people living with HIV infection in the era of combination antiretroviral therapy (cART), admission to hospital may indicate inadequate community-based care. As such, population-based assessments of the utilization of inpatient services represent a necessary component of evaluating the quality of HIV-related care., Methods: We used a validated algorithm to search Ontario's administrative health care databases for all persons living with HIV infection aged 18 years or older between 1992/93 and 2008/09. We then conducted a population-based study using time-series and longitudinal analyses to first quantify the immediate effect of cART on hospital admission rates and then analyze recent trends (for 2002/03 to 2008/09) in rates of total and HIV-related admissions., Results: The introduction of cART in 1996/97 was associated with more pronounced reductions in the rate of hospital admissions among men than among women (for total admissions, -89.9 v. -60.5 per 1000 persons living with HIV infection, p = 0.003; for HIV-related admissions, -56.9 v. -36.3 per 1000 persons living with HIV infection, p < 0.001). Between 2002/03 and 2008/09, higher rates of total hospital admissions were associated with female sex (adjusted relative rate [RR] 1.15, 95% confidence interval [CI] 1.05-1.27) and low socio-economic status (adjusted RR 1.21, 95% CI 1.14-1.29). Higher rates of HIV-related hospital admission were associated with low socio-economic status (adjusted RR 1.30, 95% CI 1.17-1.45). Recent immigrants had lower rates of both total admissions (adjusted RR 0.70, 95% CI 0.61-0.80) and HIV-related admissions (adjusted RR 0.77, 95% CI 0.61-0.96)., Interpretation: We observed important socio-economic- and sex-related disparities in rates of hospital admission among people with HIV living in Ontario, Canada.

Background: Family and pregnancy planning are important for HIV-infected individuals and couples. There is a paucity of data regarding physician attitudes with respect to reproduction in this population, but some evidence suggests that attitudes can influence the information, advice, and services they will provide., Objective: To determine physician attitudes toward pregnancy, fertility care, and access to assisted reproductive technologies for HIV-infected individuals, and to determine whether attitudes differed based on specific physician characteristics., Methods: A survey was sent electronically to obstetrician/gynecologists and infectious disease specialists in Canada. Items were grouped into 5 key domains: physician demographics, physician attitudes toward pregnancy and adoption, physician attitudes toward fertility care, physician attitudes toward assisted reproductive technology, and challenges for an HIV-infected population. Attitudes were determined based on answers to individual questions and also for each domain. Univariate and logistic regression analyses were used to determine the influence of specific physician characteristics on attitudes., Results: Completed surveys were received from 165 physicians. Most had positive attitudes regarding pregnancy or adoption (89%), fertility care (72%), and assisted reproductive technology (79%). In multivariate analyses, having cared for HIV-infected patients was significantly associated with having a positive attitude toward fertility care or assisted reproductive technology., Conclusions: In this national survey of Canadian physicians, most had positive attitudes toward pregnancy, adoption, fertility care, and use of assisted reproductive technology among HIV-infected persons. Physicians who had cared for HIV-infected individuals in the past were more likely to have positive attitudes than those who had not.

Prior investigations suggest that women living with HIV (WLWH) experience higher rates of anxiety compared to the general population. This study investigates correlates of anxiety among 361 WLWH of reproductive age in Ontario, Canada who completed a series of self-reported measures. Anxiety was assessed using the Hospital Anxiety and Depression Scale (HADS-A). Thirty-seven percent of the sample had high anxiety (HADS-A ≥ 11). HIV-related stigma, reproductive health-related worries, having experienced judgment from family and friends for trying to become pregnant and use of antiretrovirals were associated with high anxiety. Being in a romantic/sexual relationship, older age, and undetectable viral load were associated with low anxiety. Findings highlight the importance of HIV-related stigma and having experienced judgment from family and friends for trying to become pregnant as important predictors of anxiety among WLWH of reproductive age. There is a need for appropriate management of anxiety and stigma for WLWH of childbearing age.

Objective: Four main clinical issues need to be considered for HIV-positive individuals and couples with respect to pregnancy planning and counselling: (1) pre-conceptional health; (2) transmission from mother to infant, which has been significantly reduced by combined antiretroviral therapy; (3) transmission between partners during conception, which requires different prevention and treatment strategies depending on the status and needs of those involved; and (4) management of infertility issues. The objective of the Canadian HIV Pregnancy Planning Guidelines is to provide clinical information and recommendations for health care providers to assist HIV-positive individuals and couples with their fertility and pregnancy planning decisions. These guidelines are evidence- and community-based and flexible, and they take into account diverse and intersecting local/population needs and the social determinants of health., Outcomes: Intended outcomes are (1) reduction of risk of vertical transmission and horizontal transmission of HIV, (2) improvement of maternal and infant health outcomes in the presence of HIV, (3) reduction of the stigma associated with pregnancy and HIV, and (4) increased access to pregnancy planning and fertility services., Evidence: PubMed and Medline were searched for articles published in English or French to December 20, 2010, using the following terms: "HIV" and "pregnancy" or "pregnancy planning" or "fertility" or "reproduction" or "infertility" or "parenthood" or "insemination" or "artificial insemination" or "sperm washing" or "IVF" or "ICSI" or "IUI." Other search terms included "HIV" and 'horizontal transmission" or "sexual transmission" or "serodiscordant." The following conference databases were also searched: Conference on Retroviruses and Opportunistic Infections, International AIDS Conference, International AIDS Society, Interscience Conference on Antimicrobial Agents and Chemotherapy, the Canadian Association of HIV/AIDS Research, and the Ontario HIV Treatment Network Research Conference. Finally, a hand search of key journals and conferences was performed, and references of retrieved articles were reviewed for additional citations. Subsequently, abstracts were categorized according to their primary topic (based on an outline of the guidelines) into table format with the following headings: author, title, study purpose, participants, results and general comments. Finally, experts in the field were consulted for their opinions as to whether any articles were missed., Values: The quality of evidence was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care. Recommendations for practice were ranked according to the method described in that report (Table) and through use of the Appraisal of Guidelines Research and Evaluation instrument for the development of clinical guidelines., Sponsors: The Society of Obstetricians and Gynecologists of Canada, Women and HIV Research Program, Women's College Research Institute, Women's College Hospital, University of Toronto, Abbott Laboratories Canada, the Ontario HIV Treatment Network, the Canadian Institutes of Health Research, and the Canadian HIV Trials Network.

We discuss ethical challenges and opportunities experienced by peer research assistants (PRAs) in a multi-method HIV community-based research study in Ontario, Canada. We review lessons learned and best practices based on our experience conducting a qualitative investigation of research priorities with diverse women living with HIV (WLWH) and implementation of a cross-sectional survey with African, Caribbean, and Black WLWH. While some opportunities were similar across research phases for PRAs (e.g., skill building), distinct challenges emerged in qualitative and quantitative phases. For example, our training did not adequately prepare PRAs with focus group facilitation skills; at times, survey implementation became counseling sessions. Researchers should assess how best to support PRAs as part of multi-method research processes.

Background: Lesbian, bisexual, queer and transgender (LBQT) women living with HIV have been described as invisible and understudied. Yet, social and structural contexts of violence and discrimination exacerbate the risk of HIV infection among LBQT women. The study objective was to explore challenges in daily life and experiences of accessing HIV services among HIV-positive LBQT women in Toronto, Canada., Methods: We used a community-based qualitative approach guided by an intersectional theoretical framework. We conducted two focus groups; one focus group was conducted with HIV-positive lesbian, bisexual and queer women (n = 7) and the second with HIV-positive transgender women (n = 16). Participants were recruited using purposive sampling. Focus groups were digitally recorded and transcribed verbatim. Thematic analysis was used for analyzing data to enhance understanding of factors that influence the wellbeing of HIV-positive LBQT women., Results: Participant narratives revealed a trajectory of marginalization. Structural factors such as social exclusion and violence elevated the risk for HIV infection; this risk was exacerbated by inadequate HIV prevention information. Participants described multiple barriers to HIV care and support, including pervasive HIV-related stigma, heteronormative assumptions in HIV-positive women's services and discriminatory and incompetent treatment by health professionals. Underrepresentation of LBQT women in HIV research further contributed to marginalization and exclusion. Participants expressed a willingness to participate in HIV research that would be translated into action., Conclusions: Structural factors elevate HIV risk among LBQT women, limit access to HIV prevention and present barriers to HIV care and support. This study's conceptualization of a trajectory of marginalization enriches the discussion of structural factors implicated in the wellbeing of LBQT women and highlights the necessity of addressing LBQT women's needs in HIV prevention, care and research. Interventions that address intersecting forms of marginalization (e.g. sexual stigma, transphobia, HIV-related stigma) in community and social norms, HIV programming and research are required to promote health equity among LBQT women.

Introduction: Haiti has the highest HIV infection rate in the Western hemisphere, with approximately one in 50 people infected. The January 2010 earthquake led to the collapse of Haiti's social, economic and health infrastructure, exacerbating social and structural HIV risk factors. Internally displaced (ID) women are particularly at high risk for HIV infection due to breakdown of community networks, increased poverty and sexual violence. The authors present the rationale and study protocol for pilot-testing FASY (Famn an Aksyon Pou Santé Yo) (Women Taking Action For Their Health), a psychoeducational HIV/STI prevention intervention with ID women in Haiti., Methods and Analysis: This is a single-centre pragmatic N-of-1 pilot study. The target population is ID women in Leogane, Haiti. The authors aim to recruit 200 participants using purposive peer-driven recruitment methods. ID women will be trained as community health workers to deliver the FASY intervention in Kreyol. Participants will conduct a pretest that involves an individual HIV/STI educational video-based component followed by a 6-week group programme of 2 h women's health meetings. The primary outcome is HIV knowledge; our prespecified index of clinically significant change is an effect size of 0.30. Secondary outcomes include: sexually transmitted infections knowledge, condom use, social support, resilient coping, depression and relationship control. Multivariate analysis of variance will be used to compare pretest and post-test differences across variables to assess if the intervention influenced primary or secondary outcomes. Significant multivariate analysis of variance will be followed up with both univariate tests and discriminant function analyses to understand significant effects., Ethics and Dissemination: Research Ethics Board approval (2011-0033-E) was attained from the Women's College Hospital, University of Toronto, Toronto, Ontario, Canada. Trial results will be published according to the CONSORT statement, modified for the N-of-1 pilot study design, regardless of the outcomes., Trial Registration Number: This study is registered at http://clinicaltrials.gov, registration number NCT01492829.

Objectives: To characterise the help-seeking experiences of heterosexual men living with HIV infection and explain these experiences in relation to the broader social relations and discourses in which they are embedded., Design: Qualitative study using focus groups and theoretically informed constructionist grounded theory., Setting: With one exception, focus groups were conducted in the offices of community-based AIDS service organisations across Ontario, Canada., Participants: 40 HIV-infected heterosexual men aged 18 years or older., Results: Heterosexual men living with HIV perceive themselves to be relegated to the margins of a health care and service field that was developed historically within a context that privileges the priorities of gay men and heterosexual women living with the virus. Specifically, gay men are better positioned than heterosexual men when vying for the services and recognition of AIDS service organisations due to their social capital within these agencies, thereby benefiting by virtue of their membership with the group perceived to control the decision-making apparatuses when resource allocation and programme development are at stake. Relative to women, heterosexual men are poorly positioned due to their negative symbolic capital, derived from being perceived as the 'guilty' parties in the context of heterosexual HIV transmission. As a result, the material and support needs of women have been prioritised, while those of heterosexual men living with HIV remain largely unaddressed., Conclusions: Heterosexual men living with HIV are operating within a health and service field that has not kept pace with their increased representation among the population of persons living with the virus. Researchers, clinicians and policy makers should strive to integrate heterosexual men living with HIV in decision making and community-based research initiatives that build capacity among this group while simultaneously generating a research and policy agenda specific to the concerns of this growing demographic.

Objective: Four main clinical issues need to be considered for HIV-positive individuals and couples with respect to pregnancy planning and counselling: (1) pre-conceptional health; (2) transmission from mother to infant, which has been significantly reduced by combined antiretroviral therapy; (3) transmission between partners during conception, which requires different prevention and treatment strategies depending on the status and needs of those involved; and (4) management of infertility issues. The objective of the Canadian HIV Pregnancy Planning Guidelines is to provide clinical information and recommendations for health care providers to assist HIV-positive individuals and couples with their fertility and pregnancy planning decisions. These guidelines are evidence- and community-based and flexible, and they take into account diverse and intersecting local/population needs and the social determinants of health., Outcomes: Intended outcomes are (1) reduction of risk of vertical transmission and horizontal transmission of HIV, (2) improvement of maternal and infant health outcomes in the presence of HIV, (3) reduction of the stigma associated with pregnancy and HIV, and (4) increased access to pregnancy planning and fertility services., Evidence: PubMed and Medline were searched for articles published in English or French to December 20, 2010, using the following terms: "HIV" and "pregnancy" or "pregnancy planning" or "fertility" or "reproduction" or "infertility" or "parenthood" or "insemination" or "artificial insemination" or "sperm washing" or "IVF" or "ICSI" or "IUI." Other search terms included "HIV" and "horizontal transmission" or "sexual transmission" or "serodiscordant." The following conference databases were also searched: Conference on Retroviruses and Opportunistic Infections, International AIDS Conference, International AIDS Society, Interscience Conference on Antimicrobial Agents and Chemotherapy, the Canadian Association of HIV/AIDS Research, and the Ontario HIV Treatment Network Research Conference. Finally, a hand search of key journals and conferences was performed, and references of retrieved articles were reviewed for additional citations. Subsequently, abstracts were categorized according to their primary topic (based on an outline of the guidelines) into table format with the following headings: author, title, study purpose, participants, results and general comments. Finally, experts in the field were consulted for their opinions as to whether any articles were missed., Values: The quality of evidence was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care. Recommendations for practice were ranked according to the method described in that report (Table) and through use of the Appraisal of Guidelines Research and Evaluation instrument for the development of clinical guidelines., Sponsors: The Society of Obstetricians and Gynaecologists of Canada, Women and HIV Research Program, Women's College Research Institute, Women's College Hospital, University of Toronto, Abbott Laboratories Canada, the Ontario HIV Treatment Network, the Canadian Institutes of Health Research, and the Canadian HIV Trials Network. KEY POINTS AND RECOMMENDATIONS: HIV-positive people who are considering pregnancy should be counselled on the following issues so they can make an informed decision.

A cohort of human immunodeficiency virus (HIV)-infected individuals with documented vaccine-induced hepatitis B surface antibody (HBsAb) seroconversion was evaluated retrospectively to determine factors associated with loss of protective levels of HBsAb. After a median follow-up of 43 months, 111 of the 152 participants (73%) maintained protective levels of HBsAb. HIV RNA suppression at vaccination was associated with persistence of protective levels of HBsAb (odds ratio, 3.83; P < .01). Booster doses were provided for those with loss of protective antibody levels, and hepatitis B virus-specific immune memory, as evaluated with T-cell proliferation assays, was poor despite the observation that boosters successfully reinduced protective levels of HBsAb.

Background: The importance of human immunodeficiency virus (HIV) blip magnitude on virologic rebound has been raised in clinical guidelines relating to viral load assays., Methods: Antiretroviral-naive individuals initiating combination antiretroviral therapy (cART) after 1 January 2000 and achieving virologic suppression were studied. Negative binomial models were used to identify blip correlates. Recurrent event models were used to determine the association between blips and rebound by incorporating multiple periods of virologic suppression per individual., Results: 3550 participants (82% male; median age, 40 years) were included. In a multivariable negative binomial regression model, the Amplicor assay was associated with a lower blip rate than branched DNA (rate ratio, 0.69; P < .01), controlling for age, sex, region, baseline HIV-1 RNA and CD4 count, AIDS-defining illnesses, year of cART initiation, cART type, and HIV-1 RNA testing frequency. In a multivariable recurrent event model controlling for age, sex, intravenous drug use, cART start year, cART type, assay type, and HIV-1 RNA testing frequency, blips of 500-999 copies/mL were associated with virologic rebound (hazard ratio, 2.70; P = .002), whereas blips of 50-499 were not., Conclusions: HIV-1 RNA assay was an important determinant of blip rates and should be considered in clinical guidelines. Blips ≥500 copies/mL were associated with increased rebound risk.

Background: The influence of chronic hepatitis C virus (HCV) infection on the risk, timing, and type of AIDS-defining illnesses (ADIs) is not well described. To this end, rates of ADIs were evaluated in a Canadian cohort of HIV seropositive individuals receiving highly active antiretroviral therapy (HAART)., Methods: ADIs were classified into 6 Centers for Disease Control and Prevention (CDC)-defined etiological subgroups: non-Hodgkin lymphoma, viral infection, bacterial infection, HIV-related disease, protozoal infection, and mycotic infection. Generalized estimating equation (GEE) Poisson regression models were used to estimate the effect of HCV on rates of ADIs after adjusting for covariates., Results: Among 2,706 HAART recipients, 768 (28%) were HCV coinfected. Rates of all ADIs combined and of bacterial infection, HIV-related disease, and mycotic infection were increased in HCV-coinfected persons and among those with CD4 counts <200 cells/mm3 HCV was associated with an increased risk of ADIs (rate ratio [RR], 1.38; 95% CI, 1.01-1.88) and a 2-fold increased risk of mycotic infections (RR, 2.21; 95% CI, 1.35-3.62) in univariate analyses and after adjusting for age, baseline viral load, baseline CD4 count, and region of Canada. However, after further adjustment for HAART interruptions, HCV was no longer associated with an increased rate of ADIs overall (RR, 1.13; 95% CI, 0.80-1.59), but remained associated with an increased rate of mycotic infections (RR, 1.97, 95% CI, 1.08-3.61)., Conclusion: Although HCV coin-fected individuals are at increased risk of developing ADIs overall, our analysis suggests that behavioral variables associated with HCV (including rates of retention on HAART), and not biological interactions with HCV itself, are primarily responsible.

Background: Highly active antiretroviral therapy (HAART) dramatically reduces plasma HIV-1 viremia. However, despite completely suppressive HAART, it has been suggested that low-levels of viral replication may persist in the gut mucosa and elsewhere in individuals on long-term HAART., Objective: We conducted a double-blind randomized, placebo-controlled trial evaluating whether intensification of HAART in long-term virologically suppressed individuals with raltegravir is associated with a reduction in the level of proviral HIV-1 DNA in CD4(+) T cells in blood and the sigmoid colon (gut)., Methods: Long-term (>4 years) virologically suppressed HIV-infected individuals on standard HAART were randomized 1 : 1 in a double-blind fashion to receive raltegravir (400  mg twice/day) or placebo for 48 weeks. After week 48, all participants were treated with raltegravir to week 96. Blood and sigmoid biopsies were sampled and the frequency of CD4(+) T cells carrying HIV-1 proviral DNA was determined., Results: Twenty-four study patients were recruited. At 48 weeks, no difference was apparent between participants receiving raltegravir or placebo in blood HIV-1 proviral levels (P = 0.62), CD4(+) T-cell counts (P = 0.25) and gut proviral loads (P = 0.74). Similarly, prolonged raltegravir intensification up to week 96 had no further effect on both blood and gut HIV-1 proviral loads and blood CD4(+) T-cell counts., Conclusion: In long-term virologically suppressed patients on standard HAART, intensification with raltegravir did not result in further decay of CD4(+) T cells carrying HIV-1 proviral DNA in either the blood or gut after 48 or 96 weeks of therapy, or in any increase in CD4(+) T-cell counts.

The purpose of this cross-sectional study is to assess the desire, need, perceptions, and knowledge of assisted reproductive technologies (ARTs) for women living with HIV (WLWHIV) and determine correlates of ART knowledge desire. WLWHIV of reproductive age were surveyed using the survey instrument "The HIV Pregnancy Planning Questionnaire" at HIV/AIDS service organizations across Ontario, Canada. Of our cohort of 500 WLWHIV, median age was 38, 88% were previously pregnant, 78% desired more information regarding ART, 59% were open to the idea of receiving ART, 39% felt they could access a sperm bank, and 17% had difficulties conceiving (self-reported). Age, African ethnicity, and residence in an urban center were correlated with desire for more ART information. Of participants, 50% wanted to speak to an obstetrician/gynecologist regarding pregnancy planning, and 74% regarded physicians as a main source of fertility service information. While the majority of participants in our cohort desire access to ART information, most do not perceive these services as readily accessible. Healthcare practitioners were viewed as main sources of information regarding fertility services and need to provide accurate information regarding access. Fertility service professionals need to be aware of the increasing demand for ART among WLWHIV.

This study aimed to understand gender and ethnicity differences in HIV-related stigma experienced by 1026 HIV-positive individuals living in Ontario, Canada that were enrolled in the OHTN Cohort Study. Total and subscale HIV-related stigma scores were measured using the revised HIV-related Stigma Scale. Correlates of total stigma scores were assessed in univariate and multivariate linear regression. Women had significantly higher total and subscale stigma scores than men (total, median = 56.0 vs. 48.0, p<0.0001). Among men and women, Black individuals had the highest, Aboriginal and Asian/Latin-American/Unspecified people intermediate, and White individuals the lowest total stigma scores. The gender-ethnicity interaction term was significant in multivariate analysis: Black women and Asian/Latin-American/Unspecified men reported the highest HIV-related stigma scores. Gender and ethnicity differences in HIV-related stigma were identified in our cohort. Findings suggest differing approaches may be required to address HIV-related stigma based on gender and ethnicity; and such strategies should challenge racist and sexist stereotypes.

Purpose: To evaluate polyalkylamide gel (PAIG) use in treating HIV-associated facial lipoatrophy (FLA) 4 years after its injection in an open-label, randomized controlled trial (RCT)., Methods: Five patients were treated with PAIG in a pilot study, and 31 patients were subsequently enrolled in the RCT of immediate or delayed (12 weeks later) PAIG injections. Endpoints included proportion of participants with complications; changes in FLA severity score (FLSS); and quality of life (QoL), depression, anxiety, and satisfaction scores. Infections were classified as "confirmed" if purulent material was extracted and/or an organism cultured. Infections were classified as "possible" if only clinical signs were present without purulent discharge or microbiologic confirmation., Results: Year 4 results were available for 5 pilot and 27 full-scale study participants. Delayed complications included 5 confirmed infections (15.6%), 3 possible infections (9.4%), nodules (25%), and bleeding (3%). No significant changes were observed between years 2 to 4 in patient-graded FLSS, QoL, depression, and anxiety scores. Whereas 94% of participants were satisfied with their overall treatment, only 69% were satisfied with PAIG treatment specifically., Conclusion: Even though PAIG treatment was associated with delayed complications including high rates of infection and nodules, most patients were satisfied with the treatment.

Background: HIV infection rates are increasing among marginalized women in Ontario, Canada. HIV-related stigma, a principal factor contributing to the global HIV epidemic, interacts with structural inequities such as racism, sexism, and homophobia. The study objective was to explore experiences of stigma and coping strategies among HIV-positive women in Ontario, Canada., Methods and Findings: We conducted a community-based qualitative investigation using focus groups to understand experiences of stigma and discrimination and coping methods among HIV-positive women from marginalized communities. We conducted 15 focus groups with HIV-positive women in five cities across Ontario, Canada. Data were analyzed using thematic analysis to enhance understanding of the lived experiences of diverse HIV-positive women. Focus group participants (n = 104; mean age = 38 years; 69% ethnic minority; 23% lesbian/bisexual; 22% transgender) described stigma/discrimination and coping across micro (intra/interpersonal), meso (social/community), and macro (organizational/political) realms. Participants across focus groups attributed experiences of stigma and discrimination to: HIV-related stigma, sexism and gender discrimination, racism, homophobia and transphobia, and involvement in sex work. Coping strategies included resilience (micro), social networks and support groups (meso), and challenging stigma (macro)., Conclusions: HIV-positive women described interdependent and mutually constitutive relationships between marginalized social identities and inequities such as HIV-related stigma, sexism, racism, and homo/transphobia. These overlapping, multilevel forms of stigma and discrimination are representative of an intersectional model of stigma and discrimination. The present findings also suggest that micro, meso, and macro level factors simultaneously present barriers to health and well being--as well as opportunities for coping--in HIV-positive women's lives. Understanding the deleterious effects of stigma and discrimination on HIV risk, mental health, and access to care among HIV-positive women can inform health care provision, stigma reduction interventions, and public health policy.

We studied the association of once-daily dosing with self-reported adherence among participants of the Ontario Cohort Study who were currently taking ART and who had completed a 90-min interviewer-administered questionnaire. Suboptimal adherence was defined as missing ≥1 dose of ART in the 4 days prior to the interview. Participants (n = 779) were 85% male, 69% men having sex with men, 67% white, median age 48 years (IQR 42-54), median years of ART 9 (IQR 5-13) and median CD4 count 463 cells/mm(3) (IQR 320-638). Fifteen percent of participants reported suboptimal adherence in the 4 days prior to the interview. In a multivariable logistic regression model, participants on once daily regimens were half as likely to miss a dose during the 4 days prior to the interview. Other independent correlates of suboptimal adherence were younger age, lower positive social interaction and increased frequency of consuming > 6 alcoholic drinks on one occasion.

Background: Controversy about the relative performance of abacavir (ABC)/lamivudine (3TC) and tenofovir (TDF)/emtricitabine (FTC) in initial combination antiretroviral therapy (cART) exists., Methods: We compared the times to regimen failure (composite of virologic failure or switching/stopping nucleosides for any reason) according to nucleoside backbone in treatment-naive patients starting cART in a retrospective observational cohort study. Additional endpoints included virologic failure, switching/stopping nucleosides for nonvirologic reasons, and virologic suppression. Treatment-naive noninjection drug user individuals in the Canadian Observational Cohort initiating ABC/3TC-containing or TDF/FTC-containing cART with efavirenz, nevirapine, lopinavir/ritonavir, or atazanavir/ritonavir with ≥6 months follow-up were included. Multivariable proportional hazards regression models accounting for competing risks were used to model outcomes., Results: One thousand seven hundred sixty-four individuals (588 ABC/3TC, 1176 TDF/FTC) were included. Median (interquartile range) follow-up times were 34 (23-50) and 20 (13-30) months, respectively. Time to regimen failure was similar for ABC/3TC versus TDF/FTC [adjusted hazard ratio, (aHR) = 0.96, 95% CI = 0.80 to 1.17] after adjusting for baseline viral load (VL), sex, province, third antiretroviral agent, year of cART initiation, HLA-B*5701 test availability, and rate of VL testing. No differences were observed in time to virologic failure (aHR = 0.84, 95% CI = 0.58 to 1.20), switching/stopping nucleosides for nonvirologic reasons (aHR = 1.02, 95% CI = 0.81 to 1.28), or virologic suppression (aHR = 0.96, 95% CI = 0.83 to 1.10). There was no statistical interaction between backbone and baseline VL for any outcome. Results were similar when stratified by baseline VL ≤ 100,000 or > 100,000 copies per milliliter., Conclusions: In our naive noninjection drug user HIV-infected patients starting cART, there was no difference in time to regimen failure, virologic failure, switching/stopping nucleosides, or virologic suppression with ABC/3TC versus TDF/FTC.

Objective: The aim of the study was to evaluate time to virological suppression in a cohort of individuals who started highly active antiretroviral therapy (HAART), and to explore the factors associated with suppression., Methods: Eligible participants were HIV-positive individuals from a multi-site Canadian cohort of antiretroviral-naïve patients initiating HAART on or after 1 January 2000. Viral load and CD4 measurements within 6 months prior to HAART initiation were assessed. Univariate and multivariate analyses were conducted using piecewise survival exponential models where time scale was divided into intervals (<10 months; ≥10 months). Virological suppression was defined as the time to the first of at least two consecutive viral load measurements <50 HIV-1 RNA copies/mL., Results: A total of 3555 individuals were included in the study, of median age 40 years [interquartile range (IQR) 34-47 years]. Eighty per cent were male, 18% had a history of injecting drug use (IDU), and 13% presented with an AIDS-defining illness at baseline. The median time to suppression was 4.55 months (IQR 2.99-7.89 months). In multivariate analyses, older age, male sex, treatment in Ontario rather than British Columbia, non-IDU history, and having an AIDS diagnosis at baseline predicted increased likelihood of suppression. Patients with low baseline viral load were more likely to have suppression [4-5 log(10) copies/mL, hazard ratio (HR) 1.27, 95% confidence interval (CI) 1.18-1.38; <4 log(10) copies/mL, HR 1.49, 95% CI 1.32-1.68] than patients with baseline viral load ≥5 log(10) copies/mL; however, this effect ceased after 18 months of follow-up. Suppression was more likely with nonnucleoside reverse transcriptase inhibitors and ritonavir-boosted HAART., Conclusion: Identification of patients at risk for diminished likelihood of virological suppression will allow focusing of efforts and the utilization of resources to maximize the benefits of HAART., (© 2010 British HIV Association.)

Purpose: This study assessed ethnicity and gender differences in prevalence, type, and severity of antiretroviral-associated lipodystrophy in HIV-positive individuals in Ontario., Methods: This was a cross-sectional analysis of the Ontario Cohort Study (OCS), a prospective study of HIV-positive patients in Ontario. Lipodystrophy was defined as at least 1 major or 2 minor self-reported changes of peripheral lipoatrophy and/or central lipohypertrophy. Prevalence, type, and severity were compared by ethnicity (Black, White, or Other) and gender. Univariate and multivariate logistic regression analyses identified predictors of lipodystrophy., Results: Data were available for 778 participants (659 men, 119 women). There were 517 Whites, 121 Blacks, and 140 patients of Other ethnicities. In univariate analyses, Whites reported more peripheral lipoatrophy (P = .004) and abdominal lipohypertrophy (P = .04); these ethnic differences were observed in males (P = .05 and P = .03, respectively) but not females. Males reported more peripheral lipoatrophy (P = .01), whereas females had more central lipohypertrophy (P < .0001) and mixed fat redistribution (P < .0001). Multivariable regression analyses revealed Black women to be most vulnerable to lipodystrophy (P = .02), particularly lipohypertrophy (P < .0001)., Conclusions: Ethnicity and gender are important factors influencing lipodystrophy. Combining lipoatrophy and lipohypertrophy into a single entity is not appropriate. Black women were most vulnerable to lipohypertrophy, which has important implications for antiretroviral therapy roll-out in Africa.

Background: The most important objective for cord blood banks is to store cord blood units of high quality, which is determined by total nucleated cells (TNCs) and CD34+ cells. Determining the factors affecting the stored life-saving cells would be beneficial to the field., Study Design and Methods: A total of 4930 cord blood units were collected between January 2007 and October 2009 and processed using a double extraction technique to sediment red blood cells with variable centrifugation time determined by the formula CT = KL - M, where CT is centrifuge time, K is 7.7227, M is 29.742, and L is ln (volume of cord blood with anticoagulant). The recovery rate of TNCs and other relevant factors affecting banking quality were analyzed., Results: The mean recovery rate of TNCs was 97.7 ± 2.5% with 0.04% (2/4930) units below 80% and 10.8% (532/4930) units below 95%. The TNCs per unit was affected by gestation duration (p < 0.01), sex of infant (p < 0.01), mode of delivery (p < 0.01), collection method (p < 0.01), and ethnicity (p < 0.001). The number of postprocessing CD34+ cells was affected only by sex of the infant (p < 0.05). The viability of nucleated cells after processing was 94.8 ± 4.8% and was affected by the number of hours between collection and processing (p < 0.01). In contrast, the viability of CD34+ cells was 99.5 ± 1.0% (n = 30) when samples with low viability of TNCs were assessed. The results did not reveal a significant correlation (r = 0.07, p = 0.38)., Conclusion: The double extraction technique provides a high and consistent recovery of TNCs, which ensures that more life-saving cells will be banked for transplants., (© 2010 American Association of Blood Banks.)

The success of combination antiretroviral therapies for the treatment of human immunodeficiency virus (HIV) has resulted in prolonged life expectancy (over 40 years from diagnosis) and an improved quality of life for people living with HIV. The risk of vertical HIV transmission during pregnancy has been reduced to less than 1%. As a result of these breakthroughs and as many of these individuals are of reproductive age, fertility issues are becoming increasingly important for this population. One population in which conception planning and reduction of horizontal HIV transmission warrants further research is HIV-discordant couples where the male partner is HIV-positive and the female partner is HIV-negative. Sperm washing is a technique carried out in a fertility clinic that separates HIV from the seminal fluid. Although sperm washing followed by intrauterine insemination significantly reduces the risk of horizontal HIV transmission, there has been limited access to the procedure in North America. Furthermore, little is known about the conception decision-making experiences of HIV-discordant couples who might benefit from sperm washing. Chart reviews and semi-structured interviews were completed with 12 HIV-discordant couples in Ontario, Canada. Couples were recruited through HIV clinics and one fertility clinic that offered sperm washing. Participants identified a number of factors that affected their decision-making around pregnancy planning. Access to sperm washing and other fertility services was an issue (cost, travel and few clinics). Participants identified a lack of information on the procedure (availability, safety). Sources of support (social networks, healthcare providers) were unevenly distributed, especially among those who did not disclose their HIV status to friends and family. Finally, the stigmatisation of HIV continues to have a negative affect on HIV-discordant couples and their intentions to conceive. Access to sperm washing and fertility service is significantly limited for this population and is accompanied with a number of challenges.

Objective: We sought to validate a case-finding algorithm for human immunodeficiency virus (HIV) infection using administrative health databases in Ontario, Canada., Methods: We constructed 48 case-finding algorithms using combinations of physician billing claims, hospital and emergency room separations and prescription drug claims. We determined the test characteristics of each algorithm over various time frames for identifying HIV infection, using data abstracted from the charts of 2,040 randomly selected patients receiving care at two medical practices in Toronto, Ontario as the reference standard., Results: With the exception of algorithms using only a single physician claim, the specificity of all algorithms exceeded 99%. An algorithm consisting of three physician claims over a three year period had a sensitivity and specificity of 96.2% (95% CI 95.2%-97.9%) and 99.6% (95% CI 99.1%-99.8%), respectively. Application of the algorithm to the province of Ontario identified 12,179 HIV-infected patients in care for the period spanning April 1, 2007 to March 31, 2009., Conclusions: Case-finding algorithms generated from administrative data can accurately identify adults living with HIV. A relatively simple "3 claims in 3 years" definition can be used for assembling a population-based cohort and facilitating future research examining trends in health service use and outcomes among HIV-infected adults in Ontario.

This article examines the challenges and successes of recruiting participants and maintaining momentum in a small qualitative study on the experiences of HIV-discordant couples (where the male is HIV-positive and the female is HIV-negative) undergoing fertility assessment and/or treatment in Ontario, Canada, to reduce the risk of HIV transmission to the woman and fetus. The purpose of this article is to identify barriers and successes encountered in our study, consider how these are addressed in the literature, and highlight specific factors that need to be considered when studying a unique population similar to ours.

This study explored challenges to continuing an HIV post-exposure prophylaxis (PEP) program of care provided to sexual assault survivors in the province of Ontario, Canada. Data were collected as part of an implementation and evaluation of a universal offering of HIV PEP (known as the HIV PEP Program) at 24 of 34 provincial hospital-based sexual assault treatment centres. Experienced health care providers were surveyed (n = 132) and interviewed in four focus groups (n = 26) about their perceptions of what, if any, factors threatened their ability to maintain the HIV PEP Program. All focus groups were audio-recorded and the recordings transcribed. The transcriptions and open-ended survey responses were analyzed using content analysis. Administrator, nurse, physician, social worker, and pharmacist respondents perceived important barriers to sustainability of the HIV PEP Program. Eight constructs were identified within four broad themes: resources (inadequate funds, overworked and unacknowledged staff), expertise (insufficient external supports, insufficiently trained and knowledgeable staff), commitment (lack of institutional support, physician resistance to offering HIV PEP), and accommodation (lack of flexibility in addressing specific client and community needs, inaccessibility and lack of clarity of tools). We discuss the implications of these findings and the actions that were taken to address the challenges.

Infectious and inflammatory diseases have repeatedly shown strong genetic associations within the major histocompatibility complex (MHC); however, the basis for these associations remains elusive. To define host genetic effects on the outcome of a chronic viral infection, we performed genome-wide association analysis in a multiethnic cohort of HIV-1 controllers and progressors, and we analyzed the effects of individual amino acids within the classical human leukocyte antigen (HLA) proteins. We identified >300 genome-wide significant single-nucleotide polymorphisms (SNPs) within the MHC and none elsewhere. Specific amino acids in the HLA-B peptide binding groove, as well as an independent HLA-C effect, explain the SNP associations and reconcile both protective and risk HLA alleles. These results implicate the nature of the HLA-viral peptide interaction as the major factor modulating durable control of HIV infection.

Objective: To determine the long-term impact of immunologic discordance (viral load <50 copies/mL and CD4+ count <=200 cells/mm3) in antiretroviral-naive patients initiating combination antiretroviral therapy (cART)., Methods: Our analysis included antiretroviral-naive individuals from a population-based Canadian Observational Cohort that initiated cART after January 1, 2000, and achieved virologic suppression. Multivariable Cox proportional hazards regression was used to examine the association between 1-year and 2-year immunologic discordance and time to death from all-causes. Correlates of immunologic discordance were assessed with logistic regression., Results: Immunologic discordance was observed in 19.9% (404 of 2028) and 10.2% (176 of 1721) of individuals at 1 and 2 years after cART initiation, respectively. Two-year immunologic discordance was associated with an increased risk of death [adjusted hazard ratio = 2.69; 95% confidence interval (CI): 1.26 to 5.78]. One-year immunologic discordance was not associated with death (adjusted hazard ratio = 1.12; 95% CI: 0.54 to 2.30). Two-year immunologic discordance was associated with older age (aOR per decade = 1.23; 95% CI: 1.03 to 1.48), male gender (aOR = 1.86; 95% CI: 1.09 to 3.16), injection drug use (aOR = 2.75; 95% CI: 1.81 to 4.17), and lower baseline CD4+ count (aOR per 100 cells = 0.24; 95% CI: 0.19 to 0.31) and viral load (aOR per log10 copies/mL = 0.46; 95% CI: 0.33 to 0.65)., Conclusions: Immunologic discordance after 2 years of cART in antiretroviral-naive individuals was significantly associated with an increased risk of mortality.

Background: Although both tipranavir and darunavir are important options for the management of patients with multidrug resistant HIV, there are at present no studies comparing the effectiveness and safety of these 2 antiretroviral drugs in this population of patients., Objective: To compare the effectiveness and safety of ritonavir (TPV/r)- and darunavir/ritonavir (DRV/ r)-based therapies in treatment-experienced patients (n = 38 and 47, respectively)., Methods: Multicenter, retrospective cohort study., Results: The median baseline viral load and CD4 count were 4.7 copies/mL (interquartile range [IQR] 4.3, 5.2) and 168 cells/mm( 3) (IQR 80, 252) for TPV/r patients and 4.7 copies/mL (IQR 3.7, 5.1) and 171 cells/mm(3) (IQR 92, 290) for DRV/r patients. The median number of years on antiretroviral therapy (ART) prior to starting DRV/r or TPV/r were 12.7 (10.2-15.5) and 10.5 (8.4-12.6), respectively (P < .01). Current raltegravir (RAL) use (odds ratio [OR] 5.53, 95% CI 1.08-28.34) was significantly associated with virologic suppression at week 24 in multivariable logistic regression models, whereas the use of TPV/r was not significantly associated with virologic suppression compared to DRV/r (OR 0.93, 95% CI 0.27-3.18, P = .91)., Conclusion: No significant difference was observed between DRV/r and TPV/r in terms of virologic suppression.

Purpose: To determine the effects of gender and calendar year on time to and duration of virologic suppression among HIV-infected antiretroviral-naïve individuals initiating combination antiretroviral therapy (cART)., Methods: Ontario Cohort Study antiretroviral-naïve participants who initiated cART after December 31, 1998, and who had ≥2 follow-up viral loads were included. Multivariable Cox proportional hazard models were used to estimate the effects of gender and calendar year on times to virologic suppression and rebound., Results: Of the 840 patients, 81% were male (median age 40 years; interquartile range [IQR], 34-46). Time to virologic suppression was shorter among women (hazard ratio [HR]=1.27, P=.01) and in more recent calendar time periods (2002-2004: HR, 1.04, P=.67; 2005-2006: HR, 1.22, P=.06; 2007-2008: HR, 1.36, P=.004) compared to 1999-2001 after adjusting for age and type of cART regimens. Women had shorter times to virologic rebound (HR, 1.57; P<.01) after adjusting for age, injection drug use, and type of cART regimen. However, 14/18 (78%) women suspected to be taking cART only for prevention of mother-to-child transmission of HIV experienced virologic rebound compared to 28% of women who required cART for their own health, suggesting that the increased rate of virologic rebound was due to women stopping ART at the termination of a pregnancy if they did not need it for their own health. Rates of rebound did not differ by calendar year period., Conclusion: Time to virologic suppression has steadily decreased over time while duration of suppression remained stable. Time to virologic suppression was shorter for women than for men, whereas durability of virologic suppression was slightly longer for men than women. However, gender differences in virologic rebound were likely due to women discontinuing cART at the end of the pregnancy if it was not needed for their own health.