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Objectives: The community-based, longitudinal, Canadian HIV Women's Sexual and Reproductive Health Cohort Study (CHIWOS) explored the experiences of women with HIV in Canada over the past decade. CHIWOS' high-impact publications document significant gaps in the provision of healthcare to women with HIV. We used concept mapping to analyse and present a summary of CHIWOS findings on women's experiences navigating these gaps., Design: Concept mapping procedures were performed in two steps between June 2019 and March 2021. First, two reviewers (AY and PM) independently reviewed CHIWOS manuscripts and conference abstracts written before 1 August 2019 to identify main themes and generate individual concept maps. Next, the preliminary results were presented to national experts, including women with HIV, to consolidate findings into visuals summarising the experiences and care gaps of women with HIV in CHIWOS., Setting: British Columbia, Ontario and Quebec, Canada., Participants: A total of 18 individual CHIWOS team members participated in this study including six lead investigators of CHIWOS and 12 community researchers., Results: Overall, a total of 60 peer-reviewed manuscripts and conference abstracts met the inclusion criteria. Using concept mapping, themes were generated and structured through online meetings. In total, six composite concept maps were co-developed: quality of life, HIV care, psychosocial and mental health, sexual health, reproductive health, and trans women's health. Two summary diagrams were created encompassing the concept map themes, one for all women and one specific to trans women with HIV. Through our analysis, resilience, social support, positive healthy actions and women-centred HIV care were highlighted as strengths leading to well-being for women with HIV., Conclusions: Concept mapping resulted in a composite summary of 60 peer-reviewed CHIWOS publications. This activity allows for priority setting to optimise care and well-being for women with HIV., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Our aim is to evaluate the implementation of an online telecoaching community-based exercise (CBE) intervention with the goal of reducing disability and enhancing physical activity and health among adults living with HIV., Methods and Analysis: We will conduct a prospective longitudinal mixed-methods two-phased intervention study to pilot the implementation of an online CBE intervention with ~30 adults (≥18 years) living with HIV who consider themselves safe to participate in exercise. In the intervention phase (0-6 months), participants will take part in an online CBE intervention involving thrice weekly exercise (aerobic, resistance, balance and flexibility), with supervised biweekly personal training sessions with a fitness instructor, YMCA membership providing access to online exercise classes, wireless physical activity monitor to track physical activity and monthly online educational sessions on topics related to HIV, physical activity and health. In the follow-up phase (6-12 months), participants will be encouraged to continue independent exercise thrice weekly. Quantitative assessment: Bimonthly, we will assess cardiopulmonary fitness, strength, weight, body composition and flexibility, followed by administering self-reported questionnaires to assess disability, contextual factor outcomes (mastery, engagement in care, stigma, social support), implementation factors (cost, feasibility, technology), health status and self-reported physical activity. We will conduct a segmented regression analyses to describe the change in level and trend between the intervention and follow-up phases. Qualitative assessment: We will conduct online interviews with a subsample of ~10 participants and 5 CBE stakeholders at baseline (month 0), postintervention (month 6) and end of follow-up (month 12) to explore experiences, impact and implementation factors for online CBE. Interviews will be audiorecorded and analysed using content analytical techniques., Ethics and Dissemination: Protocol approved by the University of Toronto Research Ethics Board (Protocol # 40410). Knowledge translation will occur in the form of presentations and publications in open-access peer-reviewed journals., Trial Registration Number: NCT05006391., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Risk factors for cause-specific mortality have not been widely studied among people with HIV infection. Our objectives were to estimate rates of and risk factors for all-cause and cause-specific mortality from 1995 to 2014 among HIV-infected people in Ontario., Methods: We conducted a population-based retrospective cohort study using provincial health databases of people with HIV infection who were aged 16 years or more, were residents of Ontario between 1995 and 2014, and had HIV infection according to a previously validated algorithm. We used International Classification of Diseases codes to classify the underlying cause of death and estimated age-adjusted mortality rates per 100 person-years for 1995 to 2014. We used descriptive statistics to characterize the cohort at baseline and calculated adjusted mortality rate ratios (RRs) using generalized estimating equations., Results: Among 23 043 people, the all-cause mortality rate declined from 6.69 to 1.53 per 100 person-years over the study period, and the rate of death from HIV/AIDS declined from 4.75 to 0.46 per 100 person-years. Concomitantly, the proportions of deaths due to cancer, cardiovascular disease and other noncommunicable diseases rose; however, rates remained constant or declined. Compared to males, females had higher mortality due to cardiovascular disease (adjusted RR 1.36, 95% confidence interval [CI] 1.04-1.77), noncommunicable causes (adjusted RR 1.75, 95% CI 1.39-2.20) and, by 2010-2014, any cause (adjusted RR 1.19, 95% CI 1.02-1.38). Residing in a low-income neighbourhood was associated with increased risk for most causes, including HIV/AIDS (adjusted RR in 2010-2014 1.86, 95% CI 1.49-2.31). Rural residence was associated with increased mortality due to malignant disease (adjusted RR 1.60, 95% CI 1.10-2.34) and noncommunicable disease (adjusted RR 1.86, 95% CI 1.25-2.77). Being an immigrant was associated with lower risk of death from all causes., Interpretation: Over the study period, death was increasingly due to common chronic conditions rather than to HIV infection itself. Care should incorporate the prevention and management of these conditions, especially among females and those residing in rural and low-income areas., Competing Interests: Competing interests: None declared., (Copyright 2019, Joule Inc. or its licensors.)

Introduction: Globally, prosecutions for non-disclosure, exposure or transmission of HIV frequently relate to sexual activity, biting, or spitting. This includes instances in which no harm was intended, HIV transmission did not occur, and HIV transmission was extremely unlikely or not possible. This suggests prosecutions are not always guided by the best available scientific and medical evidence., Discussion: Twenty scientists from regions across the world developed this Expert Consensus Statement to address the use of HIV science by the criminal justice system. A detailed analysis of the best available scientific and medical research data on HIV transmission, treatment effectiveness and forensic phylogenetic evidence was performed and described so it may be better understood in criminal law contexts. Description of the possibility of HIV transmission was limited to acts most often at issue in criminal cases. The possibility of HIV transmission during a single, specific act was positioned along a continuum of risk, noting that the possibility of HIV transmission varies according to a range of intersecting factors including viral load, condom use, and other risk reduction practices. Current evidence suggests the possibility of HIV transmission during a single episode of sex, biting or spitting ranges from no possibility to low possibility. Further research considered the positive health impact of modern antiretroviral therapies that have improved the life expectancy of most people living with HIV to a point similar to their HIV-negative counterparts, transforming HIV infection into a chronic, manageable health condition. Lastly, consideration of the use of scientific evidence in court found that phylogenetic analysis alone cannot prove beyond reasonable doubt that one person infected another although it can be used to exonerate a defendant., Conclusions: The application of up-to-date scientific evidence in criminal cases has the potential to limit unjust prosecutions and convictions. The authors recommend that caution be exercised when considering prosecution, and encourage governments and those working in legal and judicial systems to pay close attention to the significant advances in HIV science that have occurred over the last three decades to ensure current scientific knowledge informs application of the law in cases related to HIV., (© 2018 The Authors. Journal of the International AIDS Society published by John Wiley & sons Ltd on behalf of the International AIDS Society.)

Background: Associations between HIV-related stigma and reduced antiretroviral therapy (ART) adherence are widely established, yet the mechanisms accounting for this relationship are underexplored. There has been less attention to HIV-related stigma and its associations with ART initiation and current ART use. We examined pathways from HIV-related stigma to ART initiation, current ART use, and ART adherence among women living with HIV in Canada., Methods: We used baseline survey data from a national cohort of women living with HIV in Canada (n = 1425). Structural equation modeling using weighted least squares estimation methods was conducted to test the direct effects of HIV-related stigma dimensions (personalized, negative self-image, and public attitudes) on ART initiation, current ART use, and 90% ART adherence, and indirect effects through depression and HIV disclosure concerns, adjusting for sociodemographic factors., Results: In the final model, the direct paths from personalized stigma to ART initiation (β = -0.104, P < 0.05) and current ART use (β = -0.142, P < 0.01), and negative self-image to ART initiation (β = -0.113, P < 0.01) were significant, accounting for the mediation effects of depression and HIV disclosure concerns. Depression mediated the pathways from personalized stigma to ART adherence, and negative self-image to current ART use and ART adherence. Final model fit indices suggest that the model fit the data well [χ(25) = 90.251, P < 0.001; comparative fit index = 0.945; root-mean-square error of approximation = 0.044]., Conclusions: HIV-related stigma is associated with reduced likelihood of ART initiation and current ART use, and suboptimal ART adherence. To optimize the benefit of ART among women living with HIV, interventions should reduce HIV-related stigma and address depression.

Social inequities compromise health-related quality of life (HR-QoL) among women living with HIV (WLWH). Little is known about health impacts of intersecting stigma based on HIV status, race and gender among WLWH or potential mechanisms to promote HR-QoL. We tested pathways from multiple types of stigma (HIV-related, racial, gender) to physical and mental HR-QoL utilizing baseline survey data from a national cohort of WLWH in Canada (2013-2015). Structural equation modeling was conducted using maximum likelihood estimation methods to test the direct effects of HIV-related stigma, racial discrimination, and gender discrimination on HR-QoL and indirect effects via social support and economic insecurity, adjusting for socio-demographic factors. Among 1425 WLWH (median age: 43years [IQR=35-50]), HIV-related stigma and gender discrimination had significant direct effects on mental HR-QoL. Social support mediated the relationship between HIV-related stigma and mental HR-QoL, accounting for 22.7% of the effect. Social support accounted for 41.4% of the effect of gender discrimination on mental HR-QoL. Economic insecurity accounted for 14.3% of the effect of HIV-related stigma, and 42.4% of the effect of racial discrimination, on physical HR-QoL. Fit indices suggest good model fit (χ 2 [1]=3.319, p=0.069; CFI=0.998; RMSEA=0.042 (90% CI: 0-0.069); SRMR=0.004). Findings reveal complex relationships between intersecting stigma and HR-QoL. Strategies that address intersecting stigma and economic insecurity among WLWH may prevent the harmful impacts of HIV-related stigma and gender discrimination on physical HR-QoL. Increasing social support may mitigate the impacts of stigma on mental health. Findings can inform multi-level interventions to promote health and wellbeing among WLWH., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Engagement in care is a key component of the HIV care cascade, yet there are knowledge gaps regarding how to assess HIV care engagement. This study aimed to develop a tool to assess HIV care engagement and to assess associations between HIV care engagement and quality of life (QOL) among African, Caribbean and Black (ACB) women living with HIV (WLWH). We conducted a cross-sectional survey with ACB WLWH across Ontario, Canada. We developed the 'HIV Engagement in and Continuity of Care Scale' (HECCS). We conducted exploratory factor analysis (EFA) and confirmatory factor analysis (CFA) to test the scale's factor structure. We conducted structural equation modeling (SEM) with maximum likelihood estimation to examine the associations between the HECCS and QOL. EFA yielded four factors: access to care, care by doctor/health professionals, control of HIV care, and appointment timekeeping. The CFA of the HECCS demonstrated good model fit: χ 2 (DF: 1; n = 173) = 1.175, p = 0.278; CFI: 0.998; Tucker-Lewis Index (TLI): 0.990; RMSEA: 0.032. The HECCS was associated with increased QOL. The model fit the data well: χ 2 (DF: 31, n = 173) = 51.19, p = 0.013; CFI = 0.955; TLI = 0.934; RMSEA = 0.062. Engagement in and continuity of care is multifaceted. We recommend interventions to promote the institutional capacity to better engage ACB WLWH in HIV care.

African and Caribbean Black (ACB) women in Canada are disproportionately impacted by new HIV infections. ACB women's HIV vulnerability is shaped by contexts of stigma and discrimination. HIV-related stigma compromises quality of life (QOL) among women living with HIV (WLWH), yet scant research has examined concomitant effects of racial discrimination and HIV-related stigma on QOL. We used data from a cross-sectional survey with ACB WLWH in Ontario (n = 173) to test a conceptual model of pathways between HIV-related stigma, racial discrimination, depression, social support, and QOL. We conducted structural equation modeling using maximum likelihood estimation to test the model. In independent models, HIV-related stigma was associated with lower QOL, and depression partially mediated the association between HIV-related stigma and QOL. In the simultaneous model, HIV-related stigma had significant direct effects on depression, social support, and an indirect effect on QOL. When social support was added as a mediator, the direct effect between HIV-related stigma and QOL was no longer significant, suggesting mediation. Racial discrimination had significant direct effects on HIV-related stigma, depression, and social support and an indirect effect on QOL. QOL was associated with higher social support and lower depression scores. The model fit the data well: χ 2  = 203.266, degrees of freedom (DF): 112, p < .0001; Comparative Fit Index (CFI): 0.929, Tucker-Lewis Index (TLI): 0.912, Root-Mean Square Error of Approximation (RMSEA): 0.071. We found racial discrimination was associated with increased HIV-related stigma, and HIV-related stigma and racial discrimination compromised QOL. Findings suggest the need for multilevel interventions to reduce stigma and discrimination, address depression, and build social support to improve QOL among ACB WLWH.

HIV-related stigma is associated with many psychological challenges; however, minimal research has explored how perceived HIV-related stigma intersects with psychosocial issues that mothers living with HIV may experience including depression, perceived stress and social isolation. The present study aims to describe the correlates and predictors of HIV-related stigma in a cohort of women living with HIV (WLWH) from across Ontario, Canada during pregnancy and early postpartum. From March 2011 to December 2012, WLWH ≥ 18 years (n = 77) completed a study instrument measuring independent variables including sociodemographic characteristics, perceived stress, depression symptoms, social isolation, social support and perceived racism in the third trimester and 3, 6 and 12 months postpartum. Multivariable linear regression was employed to explore the relationship between HIV-related stigma and multiple independent variables. HIV-related stigma generally increased from pregnancy to postpartum; however, there were no significant differences in HIV-related stigma across all study time points. In multivariable regression, depression symptoms and perceived racism were significant predictors of overall HIV-related stigma from pregnancy to postpartum. The present analysis contributes to our understanding of HIV-related stigma throughout the pregnancy-motherhood trajectory for WLWH including the interactional relationship between HIV-related stigma and other psychosocial variables, most notably, depression and racism.

African and Caribbean Black women in Canada have new HIV infection rates 7 times higher than their white counterparts. This overrepresentation is situated in structural contexts of inequities that result in social, economic and health disparities among African and Caribbean Black populations. Economic insecurity is a distal driver of HIV vulnerability, reducing access to HIV testing, prevention and care. Less is known about how economic insecurity indicators, such as housing security, continue to influence the lives of women living with HIV following HIV-positive diagnoses. The aim of this study was to test a conceptual model of the pathways linking HIV-related stigma, racial discrimination, housing insecurity, and wellbeing (depression, social support, self-rated health). We implemented a cross-sectional survey with African and Caribbean Black women living with HIV in 5 Ontario cities, and included 157 participants with complete data in the analyses. We conducted structural equation modeling using maximum likelihood estimation to evaluate the hypothesized conceptual model. One-fifth (22.5%; n = 39) of participants reported housing insecurity. As hypothesized, racial discrimination had significant direct effects on: HIV-related stigma, depression and social support, and an indirect effect on self-rated health via HIV-related stigma. HIV-related stigma and housing insecurity had direct effects on depression and social support, and HIV-related stigma had a direct effect on self-rated health. The model fit the data well: χ2 (45, n = 154) = 54.28, p = 0.387; CFI = 0.997; TLI = 0.996; RMSEA = 0.016. Findings highlight the need to address housing insecurity and intersecting forms of stigma and discrimination among African and Caribbean Black women living with HIV. Understanding the complex relationships between housing insecurity, HIV-related stigma, racial discrimination, and wellbeing can inform multi-level interventions to reduce stigma and enhance health., Competing Interests: The authors have declared that no competing interests exist. Dr. Mona Loutfy is a PLOS ONE Academic Editor. This does not alter our adherence to all the PLOS ONE policies on sharing data and materials.

Background: Hepatitis B (HBV), hepatitis C (HCV) and other sexually transmitted infections (STIs) have been associated with HIV transmission risk and disease progression among gay men and other men who have sex with men (MSM), but the frequency and distribution of STIs in this community in Canada has not been extensively studied., Methods: We recruited MSM living with and without HIV from a large primary care clinic in Toronto. Participants completed a detailed socio-behavioural questionnaire using ACASI and provided blood for syphilis, HIV, HBV and HCV, herpes simplex virus type 1 (HSV-1) and type 2 (HSV-2), and human cytomegalovirus (CMV) serology, urine for chlamydia and gonorrhea, and a self-collected anal swab for human papillomavirus (HPV) molecular diagnostics. Prevalences were expressed as a proportion and compared using chi-square., Results: 442 MSM were recruited, 294 living with HIV and 148 without. Active syphilis (11.0% vs. 3.4%), ever HBV (49.4% vs. 19.1%), HCV (10.4% vs. 3.4%), HSV-2 (55.9% vs. 38.2%), CMV (98.3% vs. 80.3%) and high-risk (HR) anal HPV (67.6% vs. 51.7%) infections were significantly more common in men living with HIV. Chlamydia and gonorrhea were infrequent in both groups. Regardless of HIV infection status, age and number of lifetime male sexual partners were associated with HBV infection and lifetime injection drug use with HCV infection., Conclusions: Syphilis and viral infections, including HBV, HCV, HSV-2, CMV, and HR-HPV, were common in this clinic-based population of MSM in Toronto and more frequent among MSM living with HIV. This argues for the implementation of routine screening, vaccine-based prevention, and education programs in this high-risk population.

Background: Emergency department use may reflect poor access to primary care. Our objective was to compare rates and causes of emergency department use between adults living with and without HIV., Methods: We conducted a population-based study involving Ontario residents living with and without HIV between Apr. 1, 2011, and Mar. 31, 2012. We frequency matched adults with HIV to 4 HIV-negative people by age, sex and census division, and used random-effects negative binomial regression to compare rates of emergency department use. We classified visits as low urgency or high urgency, and also examined visits for ambulatory care sensitive conditions. Hospital admission following an emergency department visit was a secondary outcome., Results: We identified 14 534 people with HIV and 58 136 HIV-negative individuals. Rates of emergency department use were higher among people with HIV (67.3 v. 31.2 visits per 100 person-years; adjusted rate ratio 1.58, 95% confidence interval [CI] 1.51-1.65). Similar results were observed for low-urgency visits. With the exception of hypertension, visit rates for ambulatory care sensitive conditions were higher among people with HIV. People with HIV were also more likely than HIV-negative individuals to be admitted to hospital following an emergency department visit (adjusted odds ratio 1.55, 95% CI 1.43-1.69)., Interpretation: Compared with HIV-negative individuals, people with HIV had high rates of emergency department use, including potentially avoidable visits. These findings strongly support the need for comprehensive care for people with HIV.

Complex historical and cultural factors have contributed to the HIV epidemic among Aboriginal populations in Canada. This study assesses social supports, adaptive and maladaptive coping mechanisms, stress, and mastery of Canadian-born Aboriginal and Canadian-born Caucasian people living with HIV in Ontario and posits that coping and social support are important micro- and meso-level factors associated with the epidemic. This cross-sectional analysis included questionnaire data collected from 2007 to 2011 at HIV clinics in Toronto. Categorical and continuous variables were compared using chi-square and Wilcoxon rank sum tests, respectively. Correlates of social support and coping were determined using univariate and multivariable linear regression. The analysis included 70 Aboriginal and 665 Caucasian participants. Aboriginal participants had lower levels of employment, education, and annual household income. Aboriginal participants reported more overall (7 vs. 4, p = 0.0003), ongoing (4 vs. 2, p = 0.0004), and early childhood (2 vs. 1, p = 0.02) stressors. Maladaptive coping, adaptive coping, and mastery scores were similar between Aboriginal and Caucasian participants. In multivariable analysis, injection drug use and lower education levels were significant correlates of higher maladaptive coping and lower overall support scores. Despite numerous socioeconomic challenges and personal stressors, Aboriginal people living with HIV who are accessing care exhibited comparable coping and mastery scores to Canadian-born Caucasian people living with HIV, suggesting remarkable strengths within Aboriginal people living with HIV and their communities.

This study investigates the differences in severity and correlates of depression symptoms among 1069 men and 267 women living with HIV in Ontario, Canada, who completed the 20-item Center for Epidemiologic Studies Depression Scale (CES-D). Women had higher CES-D scores than that of men (median [interquartile range]: 13 [5-26] versus 9 [3-20], P=.0004). More women had total CES-D scores>15 (mild-moderate depression; 44% versus 33%, P=.002) and >21 (severe depression; 31% versus 23%, P=.003). Unlike men, at age 40, women's scores increased yearly (0.4 per increased year, P=.005). The distribution of scores differed by gender: There was no difference in the 10th percentile of depression scores, 0 (95% confidence interval [CI]: 1.0-1.0) but the 75th percentile of depression scores for women was 6 (95% CI: 2.0-10.0) points higher than that of men. Important gender differences exist in depression symptoms and in correlates of symptoms in people living with HIV., (© The Author(s) 2014.)

Having children is a growing reality for women living with HIV in Canada. It is imperative to understand and respond to women's unique experiences and psychosocial challenges during pregnancy and as mothers including HIV-related stigma. This qualitative study used a narrative methodological approach to understand women's experiences of HIV-related stigma as they navigate health services in pregnancy (n = 66) and early postpartum (n = 64). Narratives of women living with HIV expose the spaces where stigmatizing practices emerge as women seek perinatal care and support, as well as highlight the relationship between HIV-related stigma and disclosure, and the impact this has on women's pregnancy and birthing experiences.

Background: It has been proposed that initiation of antiretroviral treatment (ART) very soon after establishment of HIV infection may be beneficial by improving host control of HIV replication and delaying disease progression., Methods: People with documented HIV infection of less than 12 months' duration in Baltimore MD and seven Canadian sites were randomized to either a) observation and deferred ART, or b) immediate treatment with ART for 12 months. All subjects not receiving ART were followed quarterly and permanent ART was initiated according to contemporaneous treatment guidelines. The endpoint of the trial was total ART-free time from study entry until initiation of permanent ART., Results: One hundred thirteen people were randomized, 56 to the observation arm and 57 to the immediate treatment arm. Twenty-three had acute (<2 months) infection and 90 early (2-12 months) infection. Of those randomized to the immediate treatment arm, 37 completed 12 months of ART according to protocol, 9 declined to stop ART after 12 months, and 11 were nonadherent to the protocol or lost to follow-up. Comparing those in the observation arm to either those who completed 12 months of ART or all 56 who were randomized to immediate ART, there was no significant difference between the arms in treatment-free interval after study entry, which was about 18 months in both arms., Conclusions: This study did not find a benefit from administration of a brief, time-limited (12-month) course of ART in acute or early HIV infection., Trial Registration: ClinicalTrials.gov NCT00106171.

Background: Maternal placental syndromes are associated with adverse fetal outcomes and maternal cardiovascular disease. However, whether HIV infection increases the risk of maternal placental syndromes is unknown. Our objective was to compare the risk of maternal placental syndromes between women living with and without HIV infection in Ontario., Methods: We conducted a population-based study using health administrative data from Ontario. We identified all pregnancies resulting in a live birth between Apr. 1, 2002, and Mar. 31, 2011; we identified women living with HIV using a validated case-finding algorithm. Our primary composite outcome was maternal placental syndromes, defined as a diagnosis of preeclampsia, eclampsia, placental abruption or placental infarction. We used generalized estimating equations with a logit link function to derive adjusted odds ratios (AORs) and 95% confidence intervals (CI) for the association between HIV infection and maternal placental syndromes., Results: Data from 1 132 871 pregnancies were available for analysis; 634 (0.06%) of the pregnancies were in women living with HIV. After multivariable adjustment, we found no difference in the risk of maternal placental syndromes between women living with HIV and those without HIV infection (5.8% v. 5.6%; AOR 0.85 [95% CI 0.59-1.21]). An increased risk of maternal placental syndromes was associated with pre-existing diabetes (AOR 1.47 [95% CI 1.39-1.54]), pre-existing hypertension (AOR 4.28 [95% CI 4.15-4.42]) and chronic kidney disease (AOR 1.83 [95% CI 1.61-2.08])., Interpretation: Women with HIV are not at increased risk of maternal placental syndromes. Our results underscore the importance of optimizing the management of comorbid illness associated with maternal placental syndromes during the prenatal period for all women, irrespective of HIV status.

Introduction: Combination antiretroviral therapy (ART) significantly decreases morbidity, mortality and HIV transmission. We aimed to characterize the timing of ART initiation based on CD4 cell count from 2000 to 2012 and identify factors associated with late initiation of treatment., Methods: Participants from the Canadian Observational Cohort (CANOC), a multi-site cohort of HIV-positive adults initiating ART naively after 1 January 2000, in three Canadian provinces (British Columbia, Ontario and Québec) were included. Late initiation was defined as a CD4 count <200 cells/mm(3) or an AIDS-defining illness before ART initiation (baseline). Temporal trends were assessed using the Cochran-Armitage test, and independent correlates of late initiation were identified using logistic regression., Results: In total, 8942 participants (18% female) of median age 40 years (Q1-Q3 33-47) were included. The median baseline CD4 count increased from 190 cells/mm(3) (Q1-Q3 80-320) in 2000 to 360 cells/mm(3) (Q1-Q3 220-490) in 2012 (p<0.001). Overall, 4274 participants (48%) initiated ART with a CD4 count <200 cells/mm(3) or AIDS-defining illness. Late initiation was more common among women, non-MSM, older individuals, participants from Ontario and BC (vs. Québec), persons with injection drug use (IDU) history and individuals starting ART in earlier calendar years. In sub-analysis exploring recent (2008 to 2012) predictors using an updated CD4 criterion (<350 cells/mm(3)), IDU and residence in BC (vs. Québec) were no longer significant correlates of late initiation., Conclusions: This analysis documents increasing baseline CD4 counts over time among Canadians initiating ART. However, CD4 counts at ART initiation remain below contemporary treatment guidelines, highlighting the need for strategies to improve earlier engagement in HIV care.

Gay and bisexual men (GBM) continue to have a disproportionately higher HIV incidence than any other group in Canada and the United States. This study examined how multiple co-occurring psychosocial problems, also known as a syndemic, contribute to high-risk sexual behavior among GBM. It also examined the impact of early life adversity on high-risk sexual behavior as mediated by syndemic severity. A sample of 239 GBM completed self-report questionnaires at baseline and 6-month follow-up. Syndemic variables included depression, polysubstance use, and intimate partner violence. Early life adversity variables measured retrospectively included physical and verbal bullying by peers and physical and sexual abuse by adults. A Cochran-Armitage trend test revealed a proportionate increase between number of syndemic problems and engagement in high-risk sex (p < .0001), thereby supporting syndemic theory. All early life adversity variables were positively correlated with number of syndemic problems. A bootstrap mediation analysis revealed indirect effects of two types of early life adversity on high-risk sex via syndemic severity: verbal bullying by peers and physical abuse by adults. There was also an overall effect of physical bullying by peers on high-risk sexual behavior, but no specific direct or indirect effects were observed. Consistent with syndemic theory, results provide evidence that certain types of early life adversity impact high-risk sex later in life via syndemic problems. Behavioral interventions to reduce sexual risk among GBM should address anti-gay discrimination experienced before adulthood as well as adult psychological problems.

Background: We sought to evaluate life expectancy and mortality of HIV-positive individuals initiating combination antiretroviral therapy (ART) across Canada, and to consider the potential error introduced by participant loss to follow-up (LTFU)., Methods: Our study used data from the Canadian Observational Cohort (CANOC) collaboration, including HIV-positive individuals aged ≥18 years who initiated ART on or after January 1, 2000. The CANOC collaboration collates data from eight sites in British Columbia, Ontario, and Quebec. We computed abridged life-tables and remaining life expectancies at age 20 and compared outcomes by calendar period and patient characteristics at treatment initiation. To correct for potential underreporting of mortality due to participant LTFU, we conservatively estimated 30% mortality among participants lost to follow-up., Results: 9997 individuals contributed 49,589 person-years and 830 deaths for a crude mortality rate of 16.7 [standard error (SE) 0.6] per 1000 person-years. When assigning death to 30% of participants lost to follow-up, we estimated 1170 deaths and a mortality rate of 23.6 [SE 0.7] per 1000 person-years. The crude overall life expectancy at age 20 was 45.2 [SE 0.7] and 37.5 [SE 0.6] years after adjusting for LTFU. In the LTFU-adjusted analysis, lower life expectancy at age 20 was observed for women compared to men (32.4 [SE 1.1] vs. 39.2 [SE 0.7] years), for participants with injection drug use (IDU) history compared to those without IDU history (23.9 [SE 1.0] vs. 52.3 [SE 0.8] years), for participants reporting Aboriginal ancestry compared to those with no Aboriginal ancestry (17.7 [SE 1.5] vs. 51.2 [SE 1.0] years), and for participants with CD4 count <350 cells/μL compared to CD4 count ≥350 cells/μL at treatment initiation (36.3 [SE 0.7] vs. 43.5 [SE 1.3] years). Life expectancy at age 20 in the calendar period 2000-2003 was lower than in periods 2004-2007 and 2008-2012 in the LTFU-adjusted analyses (30.8 [SE 0.9] vs. 38.6 [SE 1.0] and 54.2 [SE 1.4])., Conclusions: Life expectancy and mortality for HIV-positive individuals receiving ART differ by calendar period and patient characteristics at treatment initiation. Failure to consider LTFU may result in underestimation of mortality rates and overestimation of life expectancy.

Objectives: Structural drivers of sexually transmitted infections (STI) among women who have sex with women (WSW) have been underexplored. The study objective was to understand sociodemographic, individual, structural, and sexual health factors associated with a lifetime history of STI among WSW., Methods: A cross-sectional survey was conducted in 2012 to engage a peer-driven recruitment sample of WSW in Toronto, Canada. Data were collected among a convenience sample of 466 WSW using an online structured interview., Results: Approximately one-fifth (n=89, 19.1%) of participants reported an STI diagnosis history. Participants identifying as bisexual were more likely, and lesbians less likely, to report an STI history than those identifying as queer. In multivariate logistic regression analyses adjusted for sociodemographic variables, STI history was associated with intrapersonal (STI knowledge, HIV/STI risk perceptions), interpersonal (male sex partners in past 3 months, number of lifetime sexual partners) and structural (sexual stigma, history of forced sex, belief healthcare provider (HCP) uncomfortable addressing sexual orientation) factors as well as sexual healthcare uptake (ever had STI/HIV test, STI/Pap test in past 2 years). Gender-non-conforming participants were less likely to report an STI history., Conclusions: This research is among the first to examine intrapersonal, interpersonal and structural factors correlated with an STI history among WSW. Findings highlight the importance of STI prevention strategies for WSW to be tailored to sexual identity, with particular attention to bisexual women's needs. Interventions should connect to sexual healthcare, address sexual stigma and train HCP to better meet the needs of WSW., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Background: Prenatal care reduces perinatal morbidity. However, there are no population-based studies examining the adequacy of prenatal care among women living with HIV. Accordingly, we compared the prevalence of adequate prenatal care among women living with and without HIV infection in Ontario, Canada., Methods: Using administrative data in a universal single-payer setting, we determined the proportions of women initiating care in the first trimester and receiving adequate prenatal care according to the Revised-Graduated Prenatal Care Utilization Index . We also determined the proportion of women with HIV receiving adequate prenatal care by immigration status. We used generalized estimating equations with a logit link function to derive adjusted odds ratios (aORs) and 95% confidence intervals (CI) for all analyses., Results: Between April 1, 2002 and March 31, 2011, a total of 1,132,135 pregnancies were available for analysis, of which 634 (0.06%) were among women living with HIV. Following multivariable adjustment, women living with HIV were less likely to receive adequate prenatal care (36.1% versus 43.3%; aOR 0.74, 95% CI 0.62 to 0.88) or initiate prenatal care in the first trimester (50.8% versus 70.0%; aOR 0.51, 95% CI 0.43 to 0.60) than women without HIV. Among women with HIV, recent (i.e. ≤ 5 years) immigrants from Africa and the Caribbean were less likely to receive adequate prenatal care (25.5% versus 38.5%; adjusted odds ratio 0.51; 95% CI, 0.32 to 0.81) than Canadian-born women., Conclusion: Despite universal health care, disparities exist in the receipt of adequate prenatal care between women living with and without HIV. Interventions are required to ensure that women with HIV receive timely and adequate prenatal care.

Background: There have been few population-based studies describing the risk of adverse neonatal outcomes among women living with HIV in Canada. Accordingly, we compared the risk of preterm birth (PTB), low birth weight (LBW) and small for gestational age births among Ontario women aged 18 to 49 years living with and without HIV infection., Methods: We conducted a population-based study using Ontario health administrative data. Generalized estimating equations with a logit link function were used to derive adjusted odds ratios (aORs) and 95% confidence intervals for the association of HIV infection with adverse neonatal outcomes., Results: Between 2002-2003 and 2010-2011, a total of 1 113 874 singleton live births were available for analysis, of which 615 (0.06%) were to women living with HIV. The proportion of singleton births that were SGA (14.6% vs. 10.3%; P < 0.001), PTB (14.6% vs. 6.3%; P < 0.001), and LBW (12.5% vs. 4.6%; P < 0.001) were higher among women living with HIV than among women without HIV. Following multivariable adjustment, the risks of PTB (aOR 1.76; 95% CI 1.38 to 2.24), SGA (aOR 1.43; 95% CI 1.12 to 1.81), and LBW (aOR 1.90; 95% CI 1.47 to 2.45) were higher for women living with HIV than for women without HIV., Conclusion: Women with HIV are at higher risk of adverse neonatal outcomes than HIV-negative women. Further research is required to develop preconception and prenatal interventions that could reduce the excess burden of poor pregnancy outcomes among women living with HIV.

Objectives: Sustained optimal use of combination antiretroviral therapy (cART) has been shown to decrease morbidity, mortality and HIV transmission. However, incomplete adherence and treatment interruption (TI) remain challenges to the full realization of the promise of cART. We estimated trends and predictors of treatment interruption and resumption among individuals in the Canadian Observational Cohort (CANOC) collaboration., Methods: cART-naïve individuals ≥ 18 years of age who initiated cART between 2000 and 2011 were included in the study. We defined TIs as ≥ 90 consecutive days off cART. We used descriptive analyses to study TI trends over time and Cox regression to identify factors predicting time to first TI and time to treatment resumption after a first TI., Results: A total of 7633 participants were eligible for inclusion in the study, of whom 1860 (24.5%) experienced a TI. The prevalence of TI in the first calendar year of cART decreased by half over the study period. Our analyses highlighted a higher risk of TI among women [adjusted hazard ratio (aHR) 1.59; 95% confidence interval (CI) 1.33-1.92], younger individuals (aHR 1.27; 95% CI 1.15-1.37 per decade increase), earlier treatment initiators (CD4 count ≥ 350 vs. <200 cells/μL: aHR 1.46; 95% CI 1.17-1.81), Aboriginal participants (aHR 1.67; 95% CI 1.27-2.20), injecting drug users (aHR 1.43; 95% CI 1.09-1.89) and users of zidovudine vs. tenofovir in the initial cART regimen (aHR 2.47; 95% CI 1.92-3.20). Conversely, factors predicting treatment resumption were male sex, older age, and a CD4 cell count <200 cells/μL at cART initiation., Conclusions: Despite significant improvements in cART since its advent, our results demonstrate that TIs remain relatively prevalent. Strategies to support continuous HIV treatment are needed to maximize the benefits of cART., (© 2014 British HIV Association.)

Background: An optimal cooling rate is critical for cryopreserving cord blood stem cells, so it is generally achieved by using controlled-rate freezers (CRFs). The cooling rate can be interrupted by many factors during cooling; therefore, a proper response to the interruption in cryopreservation is crucial to prevent the loss of valuable cells., Study Design and Methods: Cord blood samples (n = 6) containing 10% dimethyl sulfoxide were cooled from 4 to -80°C using a CRF. At different temperatures during cooling, cells were transferred either to liquid nitrogen vapor phase (LNVP) directly or a -80°C mechanical freezer where they were stored for 18.1 ± 0.6 hours before transferring to LNVP. The cells were stored in LNVP for 127 ± 48.1 hours before postthaw recovery, viability, and survival of total nucleated cells and/or CD45+ cells, CD34+ cells, and colony-forming unit-granulocyte-macrophage (CFU-GM) were assessed., Results: For all types of postthaw evaluations, there were no significant differences when cells were transferred to a -80°C freezer before LNVP, regardless of the temperature at which cooling was interrupted. In contrast, there were significant differences when cells were transferred to LNVP directly, but the differences were determined by the type of assays and how viability was calculated., Conclusions: Cord blood samples can be transferred to a -80°C freezer anytime during controlled-rate cooling, but should only be transferred to LNVP when the samples have been cooled to -40°C or lower. Percent postthaw survival of CFU-GM should be routinely assessed when controlled-rate cooling is interrupted., (© 2014 AABB.)

Background: Protease inhibitor (PI)-based combination antiretroviral therapy (cART) is administered during pregnancy to prevent perinatal human immunodeficiency virus (HIV) transmission. However, PI use has been associated with adverse birth outcomes, including preterm delivery and small-for-gestational-age (SGA) births. The mechanisms underlying these outcomes are unknown. We hypothesized that PIs contribute to these adverse events by altering progesterone levels., Methods: PI effects on trophoblast progesterone production were assessed in vitro. A mouse pregnancy model was used to assess the impact of PI-based cART on pregnancy outcomes and progesterone levels in vivo. Progesterone levels were assessed in plasma specimens from 27 HIV-infected and 17 HIV-uninfected pregnant women., Results: PIs (ritonavir, lopinavir, and atazanavir) but not nucleoside reverse transcriptase inhibitors (NRTIs) or nonnucleoside reverse transcriptase inhibitors reduced trophoblast progesterone production in vitro. In pregnant mice, PI-based cART but not dual-NRTI therapy was associated with significantly lower progesterone levels that directly correlated with fetal weight. Progesterone supplementation resulted in a significant improvement in fetal weight. We observed lower progesterone levels and smaller infants in HIV-infected women receiving PI-based cART, compared with the control group. In HIV-infected women, progesterone levels correlated significantly with birth weight percentile., Conclusions: Our data suggest that PI use in pregnancy may lead to lower progesterone levels that could contribute to adverse birth outcomes., (© The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America.)

Background: Women have historically been under-represented in HIV research, partly due to ineffective recruitment strategies., Objective: To improve the existing understanding of recruitment for HIV-positive women based on a province-wide cross-sectional study., Methods: A survey was emailed to all site coordinators who recruited participants in a study involving 490 HIV-positive women living in Ontario, Canada. The survey consisted of questions regarding the important recruitment barriers and successes. Quantitative data were then contextualized within extensive knowledge from research personnel and team members., Results: Completed surveys were received from (89%) site coordinators (34/38) and 98% (31/34) were women. The highest ranked recruitment barriers identified were: sensitivity of the research topic (59%), time/availability constraints (59%), language barriers (53%), HIV disclosure/stigma issues (47%), lack of trust of research personnel (41%), fear of research (41%) and inaccessibility to child care and transportation (41%). The respondents felt that the most important personal attributes for recruitment were research personnel who were respectful (97%), skilled (91%), flexible (88%) and empathetic (88%) and had good communication skills (88%). The most successful recruitment strategies identified were: developing a strong rapport (88%) that was facilitated by an empathetic relationship (100%), acknowledging the sensitive nature of the research topic (94%), providing cash financial compensation (88%), and developing recruitment strategies unique to women (88%)., Conclusion: There are differences in the approaches needed for the recruitment of HIV-positive women in research. For successful recruitment of HIV-positive women, a strong rapport between the research personnel and study participants is important. This rapport is facilitated by having study personnel who are respectful, trustworthy, empathetic, and flexible. Population-specific recruitment strategies are important to ensure adequate recruitment of minority groups in research with greater gender consideration for women requiring specific attention.

The objective of this study was to determine the predictors of fertility behavior (i.e., trying to become pregnant) in a large representative sample of women living with HIV of reproductive age in Ontario, Canada. The Traits-Desires-Intentions-Behavior model was used to examine the key predictors of reproductive decision making and behavior. A total of 320 women living with HIV were included in the current analysis. The women living with HIV were between the ages of 18 and 52 (mean=37.23, SD=7.53), 56.4% had at least one child living in the home, over 40% identified as being of African ethnicity, and the average time since HIV diagnosis was 10.49 years (SD=5.71). In hierarchical multilevel analysis, perceived family support for trying to become pregnant, living in a large metropolitan city (i.e., Toronto), women's fertility desires, and fertility intentions were associated with fertility behavior (χ(2)9=59.97, p<0.001). As only 10.6% of participants reported engaging in fertility-related behavior, while 57.5% intended a pregnancy in the future, identifying barriers to fertility and discrepancies between intentions and behaviors can support policy programs and assist health care providers to better facilitate the fertility goals of women living with HIV.

To characterise trends in live birth rates, adverse neonatal outcomes and socio-demographic characteristics of pregnant women with diagnosed HIV between the ages of 18 and 49 in Ontario, Canada from 1 April 2002 to 31 March 2010, we conducted a population-based study. Utilising linked administrative healthcare databases we used generalised estimating equations to characterise secular trends and examine the association between live births and socio-demographic characteristics, including age, region of birth and neighbourhood income quintile. Between 2002/2003 and 2009/2010, there were 551 live births during 15,610 person-years of follow-up. The proportion of HIV-positive mothers originally from Africa or the Caribbean increased from 26.7% to 51.6% over the study period. The risk of pre-term (risk ratio 2.13, 95% confidence interval 1.74 to 2.61) and small for gestational age births (risk ratio 1.53, 95% confidence interval 1.20 to 1.94) was higher in women with HIV compared with provincial estimates for these outcomes. Women with HIV have rates of pre-term and small for gestational age births that exceed provincial estimates for these outcomes. Further research is required to identify factors mediating these disparities that are amenable to pre-natal risk reduction initiatives., (© The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.)

Objectives: We determined the proportion and correlates of self-reported pregnancy planning discussions (that is preconception counseling) that HIV-positive women reported to their family physicians (FPs), HIV specialists, and obstetrician/gynecologists (OB/Gyns)., Methods: In a cross-sectional substudy, HIV-positive women of reproductive potential were asked whether their care providers discussed pregnancy planning. Logistic regression was used to calculate odds ratios for the correlates of preconception counseling., Results: A total of 431 eligible participants (median age 38, interquartile range = 32-43) reported having discussion with a physician (92% FP, 96% HIV specialists, and 45% OB/Gyns). In all, 34%, 41%, and 38% had their pregnancy planning discussion with FP, HIV specialist, and Ob/Gyns, respectively; 51% overall. In the multivariable model, significant correlates of preconception counseling were age (P = .02), marital status (P < .01), number of years living in Canada (P < .001), and age of youngest child (P < .01)., Conclusions: Preconception care in our cohort was suboptimal. We recommend that counseling on healthy preconception should be part of routine HIV care., (© The Author(s) 2013.)

Introduction: The limited research that exists suggests that lesbian, bisexual queer (LBQ) and other women who have sex with women are at similar risk for sexually transmitted infections (STI) as heterosexual women. However, scant research has evaluated HIV and STI prevention strategies for LBQ women. The authors present the rationale and study protocol for developing and pilot testing a psychoeducational group-based HIV and STI prevention intervention with LBQ women in Calgary and Toronto, Canada., Methods and Analysis: This is a multicentre non-randomised cohort pilot study. The target population is LBQ women in Calgary and Toronto, Canada. The authors aim to recruit 40 participants using purposive peer-driven recruitment methods. Participants will conduct a pretest followed by a 2-day group programme of six 2 h sessions addressing stigma, STI and HIV prevention, healthy relationships, safer sex self-efficacy, self-worth, social support and LBQ community engagement. Participants will conduct a post-test directly following the intervention and 6 weeks after the intervention. The primary outcome is safer sex practices; our prespecified index of clinically significant change is an effect size of 0.50. Secondary outcomes include: safer sex self-efficacy, STI testing frequency, STI knowledge, resilient coping, social support, sexual stigma, access to care, depression and self-esteem. We will conduct mixed-effects regression to calculate mean outcome pre-post test score change., Ethics and Dissemination: Research ethics approval was attained from the Office of Research Ethics (REB: 29291), University of Toronto, Toronto, Ontario, Canada. Trial results will be published according to the Transparent Reporting of Evaluations with Non-randomised Designs (TREND) statement, regardless of the outcomes., Trial Registration Number: This study is registered at http://clinicaltrials.gov, registration number NCT02067845.

Objectives: Although combination antiretroviral therapy (cART) can restore CD4 T-cell numbers in HIV infection, alterations in T-cell regulation and homeostasis persist. We assessed the incidence and predictors of reversing these alterations with cART., Methods: ART-naïve adults (n = 4459) followed within the Canadian Observational Cohort and exhibiting an abnormal T-cell phenotype (TCP) prior to cART initiation were studied. Abnormal TCP was defined as having (1) a low CD4 T-cell count (< 532 cells/μL), (2) lost T-cell homeostasis (CD3 < 65% or > 85%) or (3) CD4:CD8 ratio dysregulation (ratio < 1.2). To thoroughly evaluate the TCP, CD4 and CD8 T-cell percentages and absolute counts were also analysed for a median duration of 3.14 years [interquartile range (IQR) 1.48-5.47 years]. Predictors of TCP normalization were assessed using adjusted Cox proportional hazards models., Results: At baseline, 96% of pateints had CD4 depletion, 32% had lost homeostasis and 99% exhibited ratio dysregulation. With treatment, a third of patients had normalized CD4 T-cell counts, but only 85 individuals (2%) had normalized their TCP. In a multivariable model adjusted for age, measurement frequency and baseline regimen, higher baseline CD4 T-cell counts and time-dependent viral suppression independently predicted TCP normalization [hazard ratio (HR) for baseline CD4 T-cell count = 1.42 (1.31-1.54) per 100 cells/μL increase; P ≤ 0.0001; HR for time-dependent suppressed viral load = 3.69 (1.58-8.61); P-value ≤ 0.01]., Conclusions: Despite effective cART, complete TCP recovery occurred in very few individuals and was associated with baseline CD4 T-cell count and viral load suppression. HIV-induced alterations of the TCP are incompletely reversed by long-term ART., (© 2013 British HIV Association.)

Objective: To evaluate the trends in abacavir (ABC) prescription among antiretroviral (ARV) medication-naive individuals following the presentation of the Data Collection on Adverse Events of Anti-HIV Drugs (DAD) cohort study., Methods: We conducted a retrospective cohort study of ARV medication-naive individuals in the Canadian Observational Cohort (CANOC)., Results: Between January 1, 2000, and February 28, 2010, a total of 7280 ARV medication-naive patients were included in CANOC. We observed a significant change in the proportion of new ABC prescriptions immediately following the release of DAD (-11%; 95% confidence interval [CI]: -20% to -2.4%) and in the months following the presentation of these data (-0.66% per month; 95% CI: -1.2% to -0.073%). A post-DAD presentation decrease in the odds of being prescribed ABC versus tenofovir (TDF) was observed (adjusted odds ratio, 0.72 per year, 95% CI: 0.54-0.97)., Conclusions: Presentation of the DAD was associated with a significant decrease in ABC use among ARV medication-naive, HIV-positive patients initiating therapy.

Background: Little evidence exists regarding efficacious HIV and sexually transmitted infections (STI) prevention interventions with internally displaced populations. Internally displaced women are at elevated risk for HIV/STI due to limited access to health services, heightened poverty and social network breakdown. The FASY (Famn an Aksyon Pou Sante' Yo) (Women Taking Action For Their Health) study examined the effectiveness of a peer health worker (PHW) delivered psycho-educational HIV/STI pilot study with internally displaced women in Leogane, Haiti., Method: This was a non-randomized cohort pilot study. Participants completed a computer-assisted pre-test programmed on Android tablet PCs followed by an HIV/STI educational video-based session and a 6-week psycho-educational group program of weekly meetings. Participants completed a post-test upon completion of group sessions. The primary outcome was HIV knowledge; our pre-specified index of clinically significant change was an effect size of 0.30. Secondary outcomes included: STI knowledge, condom use, social support, resilient coping, depression and relationship control. We used mixed-effects regression to calculate mean outcome pre-post score change. This study was registered (clinicaltrials.gov, NCT01492829)., Results: Between January 1-April 30, 2012 we assigned 200 participants to the study. The majority of participants (n = 176, 88%) completed the study and were followed up at 8 weeks, finishing April 30, 2012. Adjusted for socio-demographic characteristics, HIV knowledge (β = 4.81; 95% CI 4.36-5.26), STI knowledge (β = 0.84; 95% CI 0.70-0.99), condom use (AOR = 4.05, 95% CI 1.86-8.83), and depression (β = -0.63, 95% CI -0.88--0.39) scores showed statistically significant change post-intervention (p<0.05)., Conclusions: This pilot study evaluated a PHW psycho-educational HIV/STI prevention intervention among internally displaced women in post-earthquake Haiti. Pilot studies are an important approach to understand feasibility and scientific impacts of HIV prevention strategies in disaster contexts. Study results may inform HIV prevention interventions among internally displaced women in Haiti and can be tested for applicability with internally displaced women globally. ClinicalTrials.gov: Identifier NCT01492829, URL: http://clinicaltrials.gov/ct2/show/NCT01492829?term=logie&rank=1.

Objective: Studies focusing on HIV-hepatitis C virus (HCV) coinfected individuals without a history of IDU are limited. It is plausible that poorer clinical outcomes in HIV-HCV coinfection are due to factors associated with IDU, not from HCV itself. This study compares HIV treatment outcomes and survival between HIV-HCV coinfected individuals with and without IDU history., Design: Observational cohort study., Methods: We analyzed data from a multisite Canadian cohort study of HIV-positive individuals initiating combination antiretroviral therapy (ART) after 1 January 2000. This analysis was restricted to 1254 participants with HCV coinfection and known IDU history. Cox proportional hazards regression was used to evaluate time from ART initiation to virologic suppression (two consecutive measures <250 copies/ml) and CD4 cell count recovery (+100 cells/μl). In order to account for loss to follow-up (LTFU), competing risk analysis was used to evaluate time to death., Results: A total of 1254 participants (31% women) were included. During a median follow-up time of 3.8 years (interquartile range = 2.1-6.2), 217 deaths were reported and 148 participants were LTFU. In adjusted multivariable analysis, individuals with IDU history were significantly less likely to achieve virologic suppression [adjusted hazard ratio (AHR) = 0.78, 95% confidence interval (CI) = 0.64-0.95]; marginally less likely to have CD4 cell count recovery (AHR = 0.82, 95% CI = 0.66-1.00); and had a significantly higher risk of death (AHR = 2.15, 95% CI = 1.25-3.70)., Conclusion: IDU history independently elevates risk for poorer clinical outcomes, separate from HCV coinfection. HIV-HCV coinfected persons are not homogeneous in characteristics or outcomes, suggesting care should be taken during statistical analyses if attributing poorer HIV-specific outcomes solely to HCV coinfection.

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: Two randomised, placebo-controlled trials-BENCHMRK-1 and BENCHMRK-2-investigated the efficacy and safety of raltegravir, an HIV-1 integrase strand-transfer inhibitor. We report final results of BENCHMRK-1 and BENCHMRK-2 combined at 3 years (the end of the double-blind phase) and 5 years (the end of the study)., Methods: Integrase-inhibitor-naive patients with HIV resistant to three classes of drug and who were failing antiretroviral therapy were enrolled. Patients were randomly assigned (2:1) to raltegravir 400 mg twice daily or placebo, both with optimised background treatment. Patients and investigators were masked to treatment allocation until week 156, after which all patients were offered open-label raltegravir until week 240. The primary endpoint was previously assessed at 16 weeks. We assessed long-term efficacy with endpoints of the proportion of patients with an HIV viral load of less than 50 copies per mL and less than 400 copies per mL, and mean change in CD4 cell count, at weeks 156 and 240., Findings: 1012 patients were screened for inclusion. 462 were treated with raltegravir and 237 with placebo. At week 156, 51% in the raltegravir group versus 22% in the placebo group (non-completer classed as failure) had viral loads of less than 50 copies per mL, and 54% versus 23% had viral loads of less than 400 copies per mL. Mean CD4 cell count increase (analysed by an observed failure approach) was 164 cells per μL versus 63 cells per μL. After week 156, 251 patients (54%) from the raltegravir group and 47 (20%) from the placebo group entered the open-label raltergravir phase; 221 (47%) versus 44 (19%) completed the entire study. At week 240, viral load was less than 50 copies per mL in 193 (42%) of all patients initially assigned to raltegravir and less than 400 copies per mL in 210 (45%); mean CD4 cell count increased by 183 cells per μL. Virological failure occurred in 166 raltegravir recipients (36%) during the double-blind phase and in 17 of all patients (6%) during the open-label phase. The most common drug-related adverse events at 5 years in both groups were nausea, headache, and diarrhoea, and occurred in similar proportions in each group. Laboratory test results were similar in both treatment groups and showed little change after year 2., Interpretation: Raltegravir has a favourable long-term efficacy and safety profile in integrase-inhibitor-naive patients with triple-class resistant HIV in whom antiretroviral therapy is failing. Raltegravir is an alternative for treatment-experienced patients, particularly those with few treatment options., Funding: Merck Sharp & Dohme., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

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.