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Background: The Episodic Disability Questionnaire (EDQ) is a generic 35-item patient-reported outcome measure of presence, severity and episodic nature of disability. We assessed the measurement properties of the Episodic Disability Questionnaire (EDQ) with adults living with HIV., Methods: We conducted a measurement study with adults living with HIV in eight clinical settings in Canada, Ireland, United Kingdom, and United States. We electronically administered the EDQ followed by three reference measures (World Health Organization Disability Assessment Schedule; Patient Health Questionnaire; Social Support Scale) and a demographic questionnaire. We administered the EDQ only 1 week later. We assessed the internal consistency reliability (Cronbach's alpha; > 0.7 acceptable), and test-retest reliability (Intra Class Correlation Coefficient; > 0.7 acceptable). We estimated required change in EDQ domain scores to be 95% certain that a change was not due to measurement error (Minimum Detectable Change (MDC95%)). We evaluated construct validity by assessing 36 primary hypotheses of relationships between EDQ scores and scores on the reference measures (> 75% hypotheses confirmed indicated validity)., Results: Three hundred fifty nine participants completed the questionnaires at time point 1, of which 321 (89%) completed the EDQ approximately 1 week later. Cronbach's alpha for internal consistency ranged from 0.84 (social domain) to 0.91 (day domain) for the EDQ severity scale, and 0.72 (uncertainty domain) to 0.88 (day domain) for the EDQ presence scale, and 0.87 (physical, cognitive, mental-emotional domains) to 0.89 (uncertainty domain) for the EDQ episodic scale. ICCs for test-retest reliability ranged from 0.79 (physical domain) to 0.88 (day domain) for the EDQ severity scale and from 0.71 (uncertainty domain) to 0.85 (day domain) for the EDQ presence scale. Highest precision was demonstrated in the severity scale for each domain (MDC95% range: 19-25 out of 100), followed by the presence (MDC95% range: 37-54) and episodic scales (MDC95% range:44-76). Twenty-nine of 36 (81%) construct validity hypotheses were confirmed., Conclusions: The EDQ possesses internal consistency reliability, construct validity, and test-retest reliability, with limited precision when administered electronically with adults living with HIV across in clinical settings in four countries. Given the measurement properties, the EDQ can be used for group level comparisons for research and program evaluation in adults living with HIV., (© 2024. The Author(s).)

We investigated the association between fentanyl injection frequency and sharing of injection equipment among people who inject drugs. We surveyed 249 people who inject drugs in Toronto in 2019. We estimated predicted probabilities of associations between fentanyl injection frequency and injection risk practices. In prior 6 months, 117 (47.0%) of participants injected fentanyl daily, 49 (19.7%) less than daily, and 78 (31.3%) did not inject fentanyl. Participants who injected fentanyl daily shared syringes more often than those not injecting fentanyl (25.0% vs. 4.9%; χ 2  = 11.54, p = 0.0007). Participants who injected fentanyl daily (42.4% vs. 11.3%; χ 2  = 18.05, p < 0.0001) and less than daily (37.2% vs. 11.3%; χ 2  = 5.88 p = 0.02) shared cookers more often than those not injecting fentanyl. Participants who injected fentanyl daily (30.2% vs. 9.7%; χ 2  = 9.05, p = 0.003) and less than daily (30.3% vs. 9.7%; χ 2  = 4.11, p = 0.04) shared filters more often than those not injecting fentanyl. No differences in probabilities of sharing equipment were detected between participants who injected fentanyl daily and less than daily. People using fentanyl reported injection practices that increased risk for infectious disease transmission., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: Preliminary evidence suggests that people who inject drugs (PWID) may be at an increased risk of developing infective endocarditis (IE), hepatitis C virus (HCV) infection, and/or human immunodeficiency virus (HIV) infection from hydromorphone controlled-release formulation. The hypothesized mechanism is related to insolubility of the drug, which promotes reuse, leading to contamination of injecting equipment. However, this relationship has not been confirmed. We aimed to conduct a systematic review including adult PWID exposed to controlled-release hydromorphone and the risk of acquiring IE, HCV, and HIV., Methods: We searched MEDLINE, EMBASE, and Evidence Based Medicine reviews from inception until September 2021. Following pilot testing, two reviewers conducted all screening of citations and full-text articles, as well as abstracted data, and appraised risk of bias using the Newcastle-Ottawa scale and Effective Practice and Organization of Care tool. Equity issues were examined using the PROGRESS-PLUS framework. Discrepancies were resolved consistently by a third reviewer. Meta-analysis was not feasible due to heterogeneity across the studies., Results: After screening 3,231 citations from electronic databases, 722 citations from unpublished sources/reference scanning, and 626 full-text articles, five studies were included. Five were cohort studies, and one was a case-control study. The risk of bias varied across the studies. Two studies reported on gender, as well as other PROGRESS-PLUS criteria (race, housing, and employment). Three studies focused specifically on the controlled-release formulation of hydromorphone, whereas two studies focused on all formulations of hydromorphone. One retrospective cohort study found an association between controlled-release hydromorphone and IE, whereas a case-control study found no evidence of an association. One retrospective cohort study found an association between the number of hydromorphone controlled-release prescriptions and prevalence of HCV. None of the studies specifically reported on associations with HIV., Discussion: Very few studies have examined the risk of IE, HCV, and HIV infection after exposure to controlled-release hydromorphone. Very low-quality and scant evidence suggests uncertainty around the risks of blood-borne infections, such as HCV and IE to PWID using this medication., (© 2023. The Author(s).)

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.)

Objectives: The Short-Form HIV Disability Questionnaire (SF-HDQ) was developed to measure the presence, severity and episodic nature of health challenges across six domains. Our aim was to assess the sensibility, utility and implementation of the SF-HDQ in clinical practice., Design: Mixed methods study design involving semistructured interviews and questionnaire administration., Participants: We recruited adults living with HIV and HIV clinicians in Canada, Ireland and the USA., Methods: We electronically administered the SF-HDQ followed by a Sensibility Questionnaire (face and content validity, ease of usage, format) and conducted semistructured interviews to explore the utility and implementation of the SF-HDQ in clinical practice. The threshold for sensibility was a median score of > 5/7 (adults living with HIV) and > 4/7 (HIV clinicians) for ≥80% of items. Qualitative interview data were analysed using directed content analysis., Results: Median sensibility scores were > 5 (adults living with HIV; n=29) and > 4 (HIV clinicians; n=16) for 18/19 (95%) items. Interview data indicated that the SF-HDQ represents the health-related challenges of living with HIV and other concurrent health conditions; captures the daily episodic nature of HIV; and is easy to use. Clinical utility included measuring health challenges and change over time, guiding referral to specialists and services, setting goals, facilitating communication and fostering a multidisciplinary approach to care. Considerations for implementation included flexible, person-centred approaches to administration, and communicating scores based on personal preferences., Conclusions: The SF-HDQ possesses sensibility and utility for use in clinical settings with adults living with HIV and HIV clinicians in three countries., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To describe team-based care use among a cohort of people who use drugs (PWUD) and to determine factors associated with receipt of team-based care., Design: A cohort study using survey data collected between March and December 2013. These data were then linked to provincial-level health administrative databases to assess patterns of primary care among PWUD in the 2 years before survey completion., Setting: Ottawa, Ont., Participants: Marginalized PWUD 16 years of age or older., Main Outcome Measures: Patients were assigned to primary care models based on survey responses and then were categorized as attached to team-based medical homes, attached to non-team-based medical homes, not attached to a medical home, and no primary care. Descriptive statistics and multinomial logistic regression were used to determine associations between PWUD and medical home models., Results: Of 663 total participants, only 162 (24.4%) received team-based care, which was associated with high school level of education (adjusted odds ratio [AOR] = 2.18; 95% CI 1.13 to 4.20), receipt of disability benefits (AOR = 2.47; 95% CI 1.22 to 5.02), and HIV infection (AOR = 2.88; 95% CI 1.28 to 6.52), and was inversely associated with recent overdose (AOR = 0.49; 95% CI 0.25 to 0.94). In comparison, 125 (18.8%) received non-team-based medical care, which was associated with university or college education (AOR = 2.31; 95% CI 1.04 to 5.15) and mental health comorbidity (AOR = 4.18; 95% CI 2.33 to 7.50), and was inversely associated with being detained in jail in the previous 12 months (AOR = 0.51; 95% CI 0.28 to 0.90)., Conclusion: Although team-based, integrated models of care will benefit disadvantaged groups the most, few PWUD receive such care. Policy makers should mitigate barriers to physician care and improve integration across health and social services., (Copyright © 2022 the College of Family Physicians of Canada.)

Background: Events associated with the COVID-19 pandemic, such as physical distancing, closure of community services, postponement of health appointments, and loss of employment can lead to social isolation, financial uncertainty, and interruption of antiretroviral adherence, resulting in additional health-related challenges (disability) experienced among adults living with chronic illness such as HIV. 'Living strategies' is a concept derived from the perspectives of people living with HIV, defined as behaviors, attitudes and beliefs adopted by people living with HIV to help deal with disability associated with HIV and multi-morbidity. Our aim was to describe disability among adults living with HIV and self-care living strategies used during the COVID-19 pandemic., Methods: Adults living with HIV in Toronto, Ontario, Canada, including some with pre-pandemic HIV Disability Questionnaire (HDQ) data, completed a cross-sectional web-based survey between June-August 2020. The survey included the HDQ and questions about self-care living strategy use during the pandemic. We compared disability (HDQ) scores prior to versus during the pandemic using paired t-tests. We reported the proportion of participants who engaged in various living strategies at least 'a few times a week' or 'everyday' during the pandemic., Results: Of the 63 respondents, 84% were men, median age 57 years, and 62% lived alone. During the pandemic the greatest disability severity was in the uncertainty [median 30; Interquartile range (IQR): 16, 43] and mental-emotional (25; IQR: 14, 41) domains. Among the 51 participants with pre-pandemic data, HDQ severity scores were significantly greater (worse) during the pandemic (vs prior) in all domains. Greatest change from prior to during the pandemic was in the mental-emotional domain for presence (17.7; p < 0.001), severity (11.4; p < 0.001), and episodic nature (9.3; p < 0.05) of disability. Most participants (> 60%) reported engaging a 'few times a week' or 'everyday' in self-care strategies associated with maintaining sense of control and adopting positive attitudes and beliefs., Conclusions: People living with HIV reported high levels of uncertainty and mental-emotional health challenges during the pandemic. Disability increased across all HDQ dimensions, with the greatest worsening in the mental-emotional health domain. Results provide an understanding of disability and self-care strategy use during the COVID-19 pandemic., (© 2021. The Author(s).)

New forms of HIV pre-exposure prophylaxis (PrEP) include long-acting injectables and topical microbicides, each with unique attributes that may appeal to distinct users. We used a discrete choice experiment to characterize preferences for new PrEP formulations among Toronto men who have sex with men. MSM undergoing anonymous HIV testing completed a discrete choice experiment with 12 choice sets by selecting their preferred option within each set. Each set included "usual methods to prevent HIV" (excluding PrEP) as one alternative and two hypothetical PrEP alternatives, which differed according formulation/dosing, side effects (none/mild), risk of drug resistance (none/low/moderate), and HIV prevention efficacy (50%, 65%, 80% or 99% risk reduction). We used mixed logistic regression to infer preferences for PrEP attributes and calculate the marginal rate of substitution between efficacy and other PrEP attributes. 306 men with median (interquartile range) age = 29 (25, 36) years participated, and reported 6 (3, 10) partners and 0 (0, 2) condomless receptive anal sex acts in the preceding six months. An on-demand pill was the most preferred formulation, followed by a monthly injection, daily pill, and on-demand rectal gel. Drug resistance was an important determinant of preferences if the risk was moderate, but not if it was low. The minimum efficacy required for an on-demand pill to be preferred over no PrEP was 32.6% (95%CI = 21.2-43.9%); for a daily pill, injections, and rectal gel, minimum efficacy was 57.9% (95%CI = 44.1-71.7%), 40.1% (27.0-53.2%), and 71.3% (60.5-82.1%), respectively. Attitudes towards PrEP formulations vary among men who have sex with men, with on-demand pills and monthly injections having the highest average preference scores. Understanding these preferences may help to predict uptake., (© 2021. The Author(s).)

Purpose: Our aim was to examine the impact of a community-based exercise (CBE) intervention on cardiorespiratory fitness, cardiovascular health, strength, flexibility, and physical activity outcomes among adults living with HIV., Methods: We conducted a longitudinal intervention study with community-dwelling adults living with HIV in Toronto, Canada. We measured cardiopulmonary fitness (V̇O2peak (primary outcome), heart rate, blood pressure), strength (grip strength, vertical jump, back extension, push-ups, curl ups), flexibility (sit and reach test), and self-reported physical activity bimonthly across three phases. Phase 1 included baseline monitoring (8 months); Phase 2 included the CBE Intervention (6 months): participants were asked to exercise (aerobic, strength, balance and flexibility training) for 90 minutes, 3 times/week, with weekly supervised coaching at a community-based fitness centre; and Phase 3 included follow-up (8 months) where participants were expected to continue with thrice weekly exercise independently. We used segmented regression (adjusted for baseline age and sex) to assess the change in trend (slope) among phases. Our main estimates of effect were the estimated change in slope, relative to baseline values, over the 6 month CBE intervention., Results: Of the 108 participants who initiated Phase 1, 80 (74%) started and 67/80 (84%) completed the intervention and 52/67 (77%) completed the study. Most participants were males (87%), with median age of 51 years (interquartile range (IQR): 45, 59). Participants reported a median of 4 concurrent health conditions in addition to HIV (IQR: 2,7). Participants attended a median of 18/25 (72%) weekly supervised sessions. Change in V̇O2peak attributed to the six-month Phase 2 CBE intervention was 0.56 ml/kg/min (95% Confidence Interval (CI): -1.27, 2.39). Significant effects of the intervention were observed for systolic blood pressure (-5.18 mmHg; 95% CI: -9.66, -0.71), push-ups (2.30 additional push-ups; 95% CI: 0.69, 3.91), curl ups (2.89 additional curl ups; 95% CI: 0.61, 5.17), and sit and reach test (1.74 cm; 95% CI: 0.21, 3.28). More participants engaged in self-reported strength (p<0.001) and flexibility (p = 0.02) physical activity at the end of intervention. During Phase 3 follow-up, there was a significant reduction in trend of benefits observed during the intervention phase for systolic blood pressure (1.52 mmHg/month; 95% CI: 0.67, 2.37) and sit and reach test (-0.42 cm/month; 95% CI: -0.68, -0.16)., Conclusion: Adults living with HIV who engaged in this six-month CBE intervention demonstrated inconclusive results in relation to V̇O2peak, and potential improvements in other outcomes of cardiovascular health, strength, flexibility and self-reported physical activity. Future research should consider features tailored to promote uptake and sustained engagement in independent exercise among adults living with HIV., Clinicaltrials.gov Identifier: NCT02794415. https://clinicaltrials.gov/ct2/show/record/NCT02794415., Competing Interests: The authors have declared that no competing interests exist.

Abstract: We surveyed 383 men who have sex with men attending sexual health clinics regarding interest in hypothetical preexposure prophylaxis against herpes simplex virus. Overall interest was 62.5% and was associated with the number of different sexually transmitted infections previously diagnosed (adjusted odds ratio, 1.9; 95% confidence interval, 1.5-2.6) and previous HIV preexposure prophylaxis use (adjusted odds ratio, 2.9; 95% confidence interval, 1.1-8.3)., Competing Interests: Conflict of Interest and Sources of Funding: D.H.S.T. reports grants from Gilead Sciences Inc, Viiv Healthcare, and Abbvie, outside the submitted work. D.H.S.T. is also a site principal investigator for clinical trials sponsored by GlaxoSmithKline, outside the submitted work. M.W.H. reports honoraria for speaking engagements and advisory boards from Gilead and Merck, and honoraria for advisory boards from Viiv, outside the submitted work and paid to his institution. All remaining authors have nothing to disclose., (Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Sexually Transmitted Diseases Association.)

Pre-exposure prophylaxis (PrEP) is traditionally prescribed by HIV specialist physicians. Given finite specialist resources, there is a need to scale up PrEP delivery by decentralizing services via other healthcare professionals. We aimed to assess the feasibility of delivering PrEP to men who have sex with men (MSM) through primary care physicians and sexual health clinic nurses. We piloted a multi-component, implementation and dissemination research program to increase provision of PrEP through primary care physicians and sexual health clinic nurses in Toronto, Canada. Community-based organizations (CBOs) provided prospective participants with information cards that contained links to an online module on engaging providers in a conversation about PrEP. In our patient-initiated continuing medical education (PICME) strategy, participants saw their family doctors and gave them the card, which also contained a link to a Continuing Medical Education module. In the nurse-led strategy, participants visited one of two participating clinics to obtain PrEP. We administered an optional online questionnaire to patients and providers at baseline and six months. CBOs distributed 3043 cards. At least 339 men accessed the online module and 196 completed baseline questionnaires. Most (55%) intended to visit nurses while 21% intended to consult their physicians. Among 45 men completing follow-up questionnaires at 6 months, 31% reported bringing cards to their physicians and obtaining PrEP through them; sexual health clinics delivered PrEP to 244 patients. Participants who went through the PICME approach reported no changes in relationships with their providers. Nurses showed fidelity to PrEP prescribing guidelines. Nurse-led PrEP and patient-initiated continuing medical education (PICME) for primary care physicians are feasible strategies to increase PrEP uptake. Nurse-led PrEP delivery was preferred by most patients., Competing Interests: The authors have read the journal’s policy, and the authors of this study have the following competing interests to declare: DHST’s institution has received investigator-driven grants from Gilead Sciences, Abbvie and Viiv Healthcare, and DHST has served as a Site Principal Investigator for clinical trials sponsored by Glaxo Smith Kline, all outside the submitted work. DCK has been a consultant for Merck, Gilead Sciences and Viiv Healthcare, all outside of the submitted work. This does not alter our adherence to PLOS ONE policies on sharing data and materials. There are no patents, products in development or marketed products associated with this research to declare. All other authors have declared that no competing interests exist.

Background: We assessed the acceptability of doxycycline-based syphilis pre-exposure and post-exposure prophylaxis (PrEP/PEP) as well as human immunodeficiency virus (HIV) PrEP/PEP in gay, bisexual, and other men who have sex with men (gbMSM)., Methods: We recruited gbMSM from Toronto and Vancouver sexually transmitted infection (STI) clinics during routine visits from June 2018 to August 2018. We analyzed data using descriptive statistics and constructed multivariable logistic regression models for willingness to use syphilis and HIV PrEP and PEP respectively., Results: Among 424 participants (56.4% Toronto, 43.6% Vancouver), median (interquartile range [IQR]) age was 31.0 years (26.0-39.0 years), 61.7% had completed postsecondary education and 54.4% were white. Median (IQR) number of male partners in the past 6 months was 6.0 (3.0-13.0), and 18.2% had 1 or more prior syphilis diagnosis. 60.1%/44.1% indicated willingness to use syphilis PEP/PrEP; 36.6% were unwilling to use either. Among HIV-negative participants, 74.0% and 75.2% were willing to use HIV PrEP and PEP, respectively. Most participants were familiar with antibiotic resistance (89.0%) and agreed that syphilis rates are rising in Canada (68.2%), but only 55.4% believed they were at risk for syphilis. Agreement with the latter statement was associated with willingness to use syphilis PrEP (adjusted odds ratio [aOR], 1.6; 95% confidence interval [95%CI], 1.0-2.5), as was previous/existing HIV PrEP use (aOR, 2.2; 95% CI, 1.1-4.3) and being "very concerned" about STI acquisition (aOR, 1.9; 95% CI, 1.0-3.4). Odds of being willing to use syphilis PEP were higher in Toronto versus Vancouver (aOR, 2.0; 95% CI, 1.2-3.4) and increased with the number of different STIs previously diagnosed (aOR, 1.4; 95% CI, 1.2,1.7)., Conclusions: There is considerable interest in syphilis PrEP/PEP in gbMSM attending Toronto/Vancouver STI clinics.

Background: Incidence of syphilis continues to increase among HIV-positive men who have sex with men (MSM) in Ontario. Our objective was to determine the effect of acute syphilis on virologic failure (VF) among virally suppressed HIV-positive MSM taking antiretroviral therapy (ART) and determine if the relationship is confounded by drug use., Setting: The OHTN Cohort Study is a voluntary cohort of people receiving HIV care in Ontario. Syphilis and viral load (VL) data were retrieved via linkage with the provincial laboratory., Methods: Analyses included 2632 MSM from 2008 to 2015, on ART, with ≥1 questionnaire and 2 consecutive VL of <50 copies per milliliter 6 months apart. VF was defined as (1) VL of ≥1000 copies per milliliter or (2) 2 consecutive VLs of ≥200 copies per milliliter ≥1 month apart. We modeled acute syphilis as a time-varying covariate on VF using Poisson regression. Time-varying drug use was assessed for confounding using an iterative process where potential confounders were removed and then reintroduced into the model. Our model allowed for repeat observations using generalized estimating equations., Results: VF incidence was 3.5 per 100 person-years [95% confidence interval (CI): 3.4 to 4.2]. The rate ratio for VF for acute syphilis was 1.5 (95% CI: 0.9 to 2.4) in the unadjusted model; 1.6 (95% CI: 1.0 to 2.4) in the model adjusted for age, education, region, and income; and 1.2 (95% CI: 0.7 to 1.9) in the final model with additional adjustment for drug use., Conclusions: Acute syphilis was not associated with VF among virologically suppressed MSM on ART. Consequently, ART may still reduce HIV transmission risk to sexual partners.

Background: The real-world effectiveness of pre-exposure prophylaxis (PrEP) may be influenced by circulating HIV strains resistant to either tenofovir or emtricitabine. Yet, few studies have examined rates of resistance to these drugs in clinical settings., Methods: We conducted a retrospective cohort study of antiretroviral-naive participants in the Canadian Observational Cohort collaboration who initiated antiretroviral therapy between 2006 and 2014. In separate analyses, we determined the prevalence of pretherapy resistance and cumulative incidence of follow-up resistance to tenofovir and emtricitabine. We used multivariable proportional hazards models to examine associations between baseline variables and the development of resistance., Results: We studied 6,622 antiretroviral-naive participants initiating therapy, of whom 5,428 (82.0%) had a baseline resistance test. Baseline resistance to tenofovir and emtricitabine was observed in 83 (1.5%) and 21 (0.4%) patients, respectively. Among patients without baseline resistance, the cumulative incidence of resistance to tenofovir and emtricitabine 5 years following treatment initiation was 0.0070 (95% CI 0.0046, 0.0095) and 0.033 (95% CI 0.028, 0.038), respectively. Following multivariable analysis, a baseline viral load ≥100,000 copies/ml was associated with emergence of tenofovir (hazard ratio [HR] 2.88; 95% CI 1.35, 6.15) and emtricitabine (HR 2.27; 95% CI 1.64, 3.15) resistance. Initiating an integrase inhibitor-based regimen and CD4 + T-cell count below 200 cells/mm 3 were also associated with resistance to each drug., Conclusions: We observed a low prevalence of baseline resistance and a low incidence of emergence of resistance to tenofovir and emtricitabine among antiretroviral-naive patients in routine clinical care.

Timely presentation to care for people newly diagnosed with HIV is critical to optimize health outcomes and reduce onward HIV transmission. Studies describing presentation to care following diagnosis during a hospital admission are lacking. We sought to assess the timeliness of presentation to care and to identify factors associated with delayed presentation. We conducted a population-level study using health administrative databases. Participants were all individuals older than 16 and newly diagnosed with HIV during hospital admission in Ontario, Canada, between April 1, 2007 and March 31, 2015. We used modified Poisson regression models to derive relative risk ratios for the association between sociodemographic and clinical variables and the presentation to out-patient HIV care by 90 days following hospital discharge. Among 372 patients who received a primary HIV diagnosis in hospital, 83.6% presented to care by 90 days. Following multivariable analysis, we did not find associations between patient sociodemographic or clinical characteristics and presentation to care by 90 days. In a secondary analysis of 483 patients diagnosed during hospitalization but for whom HIV was not recorded as the principal reason for admission, 73.1% presented to care by 90 days. Following multivariable adjustment, we found immigrants from countries with generalized HIV epidemics (RR 1.265, 95% CI 1.133-1.413) were more likely to present to care, whereas timely presentation was less likely for people with a mental health diagnosis (RR 0.817, 95% CI 0.742-0.898) and women (RR 0.748, 95% CI 0.559-1.001). Future work should evaluate mechanisms to facilitate presentation to care among these populations.

Background: Gay, bisexual and other men who have sex with men (gbMSM) in Canada continue to experience high rates of incident HIV. Pre-exposure prophylaxis (PrEP, the regular use of anti-HIV medication) reduces HIV acquisition and could reduce incidence. However, there are too few physicians with expertise in HIV care to meet the projected demand for PrEP. To meet demand and achieve greater public health impact, PrEP delivery could be 'decentralized' by incorporating it into front-line prevention services provided by family physicians (FPs) and sexual health clinic nurses., Methods: This PrEP decentralization project will use two strategies. The first is an innovative knowledge dissemination approach called 'Patient-Initiated CME' (PICME), which aims to empower individuals to connect their family doctors with online, evidence-based, continuing medical education (CME) on PrEP. After learning about the project through community agencies or social/sexual networking applications, gbMSM interested in PrEP will use a uniquely coded card to access an online information module that includes coaching on how to discuss their HIV risk with their FP. They can provide their physician a link to the accredited CME module using the same card. The second strategy involves a pilot implementation program, in which gbMSM who do not have a FP may bring the card to designated sexual health clinics where trained nurses can deliver PrEP under a medical directive. These approaches will be evaluated through quantitative and qualitative methods, including: questionnaires administered to patients and physicians at baseline and at six months; focus groups with patients, FPs, and sexual health clinic staff; and review of sexual health clinic charts. The primary objective is to quantify the uptake of PrEP achieved using each decentralization strategy. Secondary objectives include a) characterizing barriers and facilitators to PrEP uptake for each strategy, b) assessing fidelity to core components of PrEP delivery within each strategy, c) measuring patient-reported outcomes including satisfaction with clinician-patient relationships, and d) conducting a preliminary costing analysis., Discussion: This study will assess the feasibility of a novel strategy for disseminating knowledge about evidence-based clinical interventions, and inform future strategies for scale-up of an underutilized HIV prevention tool.

To compare outcomes following psychiatric hospitalization between people with and without HIV. Population-based study of people with (n = 1,089) and without (n = 280,888) HIV who were hospitalized for psychiatric illness between January 1, 2006 and December 31, 2014. Overall, 9 (0.8%) people with HIV died within 30 days of discharge, compared with 3,710 (1.3%) HIV-negative individuals. Following multivariable adjustment, there was no difference in the risk of readmission or emergency department (ED) visits for psychiatric illness in the 90 days following discharge. Conversely, people with HIV were at higher risk of ED visits for substance use disorders and less likely to receive psychiatry follow-up during this period. HIV is associated with ED use for substance use disorders and less psychiatry follow-up within 90 days of hospital discharge for psychiatric illness. Interventions facilitating continuity of care following discharge are warranted.

Objectives: Pre-exposure prophylaxis (PrEP) with daily oral tenofovir/emtricitabine dramatically reduces HIV risk in men who have sex with men (MSM). However, uptake is slow worldwide., Methods: We administered anonymous cross-sectional questionnaires to MSM presenting for anonymous HIV testing at a Toronto sexual health clinic at four successive time points during the period 2013-2016. We assessed trends in PrEP awareness, acceptability, and use over time using the Cochran-Armitage Trend Test, and identified barriers to using PrEP by constructing "PrEP cascades" using 2016 data. We assumed that to use PrEP, MSM must (a) be at risk for HIV, (b) be at objectively high risk (HIRI-MSM score ≥ 10), (c) perceive themselves to be at medium-to-high risk, (d) be aware of PrEP, (e) be willing to use PrEP, (f) have a family doctor, (g) be comfortable discussing sexual health with that doctor, and (h) have drug coverage/be willing to pay out of pocket., Results: MSM participants were mostly white (54-59.5%), with median age 31 years (IQR = 26-38). PrEP awareness and use increased significantly over time (both p < 0.0001), reaching 91.3% and 5.0%, respectively, in the most recent wave. Willingness to use PrEP rose to 56.5%, but this increase did not reach statistical significance (p = 0.06). The full cascade, ABCDEFGH, suggested few could readily use PrEP under current conditions (11/400 = 2.8%). The largest barriers, in descending order, were low self-perceived HIV risk, unwillingness to use PrEP, and access to PrEP providers., Conclusion: To maximize its potential public health benefits, PrEP scale-up strategies must address self-perceived HIV risk and increase access to PrEP providers.

Describe the prevalence and covariates of viral suppression and subsequent rebound among younger (≤29 years old) compared with older adults.A retrospective clinical cohort study; eligibility criteria: documented HIV infection; resident of Canada; 18 years and over; first antiretroviral regimen comprised of at least 3 individual agents on or after January 1, 2000.Viral suppression and rebound were defined by at least 2 consecutive viral load measurements <50 or >50 HIV-1 RNA copies/mL, respectively, at least 30 days apart, in a 1-year period. Time to suppression and rebound were measured using the Kaplan-Meier method and Life Table estimates. Accelerated failure time models were used to determine factors independently associated with suppression and rebound.Younger adults experienced lower prevalence of viral suppression and shorter time to viral rebound compared with older adults. For younger adults, viral suppression was associated with being male and later era of combination antiretroviral initiation (cART) initiation. Viral rebound was associated with a history of injection drug use, Indigenous ancestry, baseline CD4 cell count >200, and initiating cART with a protease inhibitor (PI) containing regimen.The influence of age on viral suppression and rebound was modest for this cohort. Our analysis revealed that key covariates of viral suppression and rebound for young adults in Canada are similar to those of known importance to older adults. Women, people who use injection drugs, and people with Indigenous ancestry could be targeted by future health interventions.

We sought to characterize non-communicable disease (NCD)-related and overall health service use among African and Caribbean immigrants living with HIV between April 1, 2010 and March 31, 2013. We conducted two population-based analyses using Ontario's linked administrative health databases. We studied 1525 persons with HIV originally from Africa and the Caribbean. Compared with non-immigrants with HIV (n = 11,931), African and Caribbean immigrants had lower rates of hospital admissions, emergency department visits and non-HIV specific ambulatory care visits, and higher rates of health service use for hypertension and diabetes. Compared with HIV-negative individuals from these regions (n = 228,925), African and Caribbean immigrants with HIV had higher rates of health service use for chronic obstructive pulmonary disease [rate ratio (RR) 1.78; 95% confidence interval (CI) 1.36-2.34] and malignancy (RR 1.20; 95% CI 1.19-1.43), and greater frequency of hospitalizations for mental health illness (RR 3.33; 95% CI 2.44-4.56), diabetes (RR 1.37; 95% CI 1.09-1.71) and hypertension (RR 1.85; 95% CI 1.46-2.34). African and Caribbean immigrants with HIV have higher rates of health service use for certain NCDs than non-immigrants with HIV. The evaluation of health services for African and Caribbean immigrants with HIV should include indicators of NCD care that disproportionately affect this population.

Cervical cancer caused by oncogenic types of the human papillomavirus (HPV) is of concern among HIV-positive women due to impairment of immune responses required to control HPV infection. Our objectives were to describe patterns of cervical cancer screening using Pap cytology testing among HIV-positive women in Ontario, Canada from 2008 to 2013 and to identify factors associated with adequate screening. We conducted a retrospective, population-based cohort study among screen-eligible HIV-positive women using provincial administrative health data. We estimated annual proportions tested and reported these with 95% confidence intervals (CI). Next, using person-years as the unit of analysis, we identified factors associated with annual Pap testing using log-binomial regression. A total of 2271 women were followed over 10,697 person-years. In 2008, 34.0% (95%CI 31.1-37.0%) had a Pap test. By 2013, the proportion of HIV-positive women tested was 25.9% (95%CI 23.6-28.2%). Women who were most likely to undergo testing were younger, were immigrants from countries with generalized HIV epidemics, lived in the highest income neighbourhoods, had a female primary care physician, had two or more encounters per year with an infectious disease or internal medicine specialist, and had greater comorbidity. Nearly three in four HIV-positive women were under-screened despite all having universal insurance for medically-necessary services. Annual Pap testing decreased following the 2011-2013 release of new guidelines for a lengthened screen interval for average risk women and a billing disincentive. Clinic-based intervention such as physician alerts or reminders may be needed to improve screening coverage among HIV-positive women., (Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.)

Increased awareness of the secondary preventive benefits of antiretroviral treatment (ART) has strengthened the desire to optimize health care systems' response to HIV/AIDS. We identified clusters of health resource utilization (HRU) among people living with HIV (PLHIV) to inform targeted interventions aimed to optimize the cascade of HIV care. Using linked population-level health databases in British Columbia, Canada, we selected two analytic samples of PLHIV with 3 years of follow-up between 2006-2011 that were classified as intermittently retained in care or intermittently engaged in ART, and executed a probabilistic model-based clustering analysis for each sample with 5 and 9 quarterly HRU variables, respectively. We found clear HRU profile differences among both samples with similar HIV-related care: one featured active involvement in non-HIV care, the other little or no health care interaction following linkage to care. Differential reengagement intervention strategies capitalizing on missed opportunities in non-HIV care and further engaging physicians delivering HIV care are needed to optimize the response to the HIV epidemic.

People with HIV have higher rates of acute myocardial infarction (AMI) than HIV-negative individuals. We compared mortality risk and health service use following AMI among people with and without HIV between January 1, 2002, and March 31, 2015. We conducted a population-based study using Ontario's administrative databases. Our primary outcomes were risk of inpatient death and death at 30 days following hospital discharge. In secondary analyses, we compared use of revascularization procedures within 90 days of AMI, as well as readmission or emergency department visits for heart disease and cardiology follow-up within 90 days of discharge. We studied 259,475 AMI patients, of whom 345 (0.13%) were people with HIV. AMI patients with HIV were younger than HIV-negative patients (mean age ± standard deviation: 54.4 ± 10.5 years vs. 69.3 ± 14.3 years). Following multivariable adjustment, the odds ratios for inpatient death and death at 30 days following discharge were 1.04 [95% confidence intervals (CI) 0.64-1.56] and 2.42 (95% CI 1.00-4.92), respectively. In secondary analyses, no differences were observed in receipt of revascularization procedures (hazard ratio (HR) 0.98; 95% CI 0.85-1.12), readmission or emergency department visit for heart disease (HR 1.18; 95% CI 0.85-1.62), or cardiology follow-up (HR 0.88; 95% CI 0.76-1.01). People with HIV experience AMI at younger ages and may be at higher risk of death in the 30 days following hospital discharge, underscoring the importance of targeting modifiable cardiovascular disease risk factors in these patients.

Background: Atazanavir/ritonavir and darunavir/ritonavir are common protease inhibitor-based regimens for treating patients with HIV. Studies comparing these drugs in clinical practice are lacking., Methods: We conducted a retrospective cohort study of antiretroviral naïve participants in the Canadian Observational Cohort (CANOC) collaboration initiating atazanavir/ritonavir- or darunavir/ritonavir-based treatment. We used separate Fine and Gray competing risk regression models to compare times to regimen failure (composite of virologic failure or discontinuation for any reason). Additional endpoints included virologic failure, discontinuation due to virologic failure, discontinuation for other reasons, and virologic suppression., Results: We studied 222 patients treated with darunavir/ritonavir and 1791 patients treated with atazanavir/ritonavir. Following multivariable adjustment, there was no difference between darunavir/ritonavir and atazanavir-ritonavir in the risk of regimen failure (adjusted hazard ratio 0.76, 95% CI 0.56 to 1.03) Darunavir/ritonavir-treated patients were at lower risk of virologic failure relative to atazanavir/ritonavir treated patients (aHR 0.50, 95% CI 0.28 to 0.91), findings driven largely by high rates of virologic failure among atazanavir/ritonavir-treated patients in the province of British Columbia. Of 108 discontinuations due to virologic failure, all occurred in patients starting atazanavir/ritonavir. There was no difference between regimens in time to discontinuation for reasons other than virologic failure (aHR 0.93; 95% CI 0.65 to 1.33) or virologic suppression (aHR 0.99, 95% CI 0.82 to 1.21)., Conclusions: The risk of regimen failure was similar between patients treated with darunavir/ritonavir and atazanavir/ritonavir. Although darunavir/ritonavir was associated with a lower risk of virologic failure relative to atazanavir/ritonavir, this difference varied substantially by Canadian province and likely reflects regional variation in prescribing practices and patient characteristics.

Background: Little is known about the mechanisms that influence the success or failure of programs to facilitate re-engagement with health and social services for formerly incarcerated persons with HIV. This review aims to identify how interventions to address such transitions work, for whom and under what circumstances., Methods: We will use realist review methodology to conduct our analysis. We will systematically search electronic databases and grey literature for English language qualitative and quantitative studies of interventions. Two investigators will independently screen citations and full-text articles, abstract data, appraise study quality and synthesize the literature. Data analysis will include identifying context-mechanism-outcome configurations, exploring and comparing patterns in these configurations, making comparisons across contexts and developing explanatory frameworks., Discussion: This review will identify mechanisms that influence the success or failure of transition interventions for formerly incarcerated individuals with HIV. The findings will be integrated with those from complementary qualitative and quantitative studies to inform future interventions., Systematic Review Registration: PROSPERO CRD42016040054.

Objectives: Rates of chlamydia and gonorrhoea have been rising in urban centres in Canada, particularly among HIV-positive men who have sex with men (MSM). Our objective was to identify behavioural risk factors for diagnosis with chlamydia and gonorrhoea in this population, with a focus on the HIV status of sexual partners., Methods: The OHTN Cohort Study follows people in HIV care across Ontario. We restricted the analysis to 1997 MSM who completed questionnaires in 2010-2013 at one of seven clinics that submit all chlamydia and gonorrhoea tests to the provincial public health laboratory; we obtained test results via record linkage. We estimated cumulative incidences using Kaplan-Meier methods and identified risk factors for diagnosis of a composite outcome (chlamydia or gonorrhoea infection) using Cox regression., Results: At follow-up, there were 74 new chlamydia/gonorrhoea diagnoses with a 12-month cumulative incidence of 1.7% (95% CI 1.1% to 2.2%). Risk factors for chlamydia/gonorrhoea diagnosis were: 5+ HIV-positive partners (HR=3.3, 95% CI 1.4 to 7.8; reference=none) and recreational drug use (HR=2.2, 95% CI 1.2 to 3.9)., Conclusions: Heightened risks with recreational drug use and multiple HIV-positive partners suggest that chlamydia/gonorrhoea may have achieved high prevalence in certain sexual networks among HIV-positive MSM. Interventions to promote safer sex and timely testing among MSM are needed., Competing Interests: Competing interests: None declared., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)

Background: Common measures of engagement in care fail to acknowledge that infrequent follow-up may occur either intentionally among patients with sustained virologic suppression or unintentionally among patients with poor clinical outcomes., Methods: Five states of HIV care were defined within the Canadian Observational Cohort Collaboration following combination antiretroviral therapy (cART) initiation: (1) guidelines HIV care [suppressed viral load (VL) and CD4 >200 cells per cubic millimeter, no gaps in cART >3 months, no gaps in CD4 or VL measurement >6 months], (2) successful care with decreased frequency of follow-up (as above except no gaps in CD4 or VL measurement >12 months), (3) suboptimal care (unsuppressed VL, CD4 <200 cells per cubic millimeter on 2 consecutive visits, ≥1 gap in cART >3 months, or ≥1 gap in CD4 or VL measurement >12 months), (4) loss to follow-up (no contact for 18 months), and (5) death. Multi-state models were used to determine factors associated with transitioning among states., Results: In total, 7810 participants were included. Younger age, female gender, Indigenous ethnicity, and people who have injected drugs were associated with increased likelihoods of transitioning from guidelines to suboptimal care and decreased likelihoods of transitioning from suboptimal to guidelines care. One-fifth of individuals in successful, decreased follow-up after cART initiation (mean sojourn time 0.72 years) were in suboptimal care in subsequent years., Conclusions: Using routinely collected data, we have developed a flexible framework that characterizes patient transitions among states of HIV clinical care. We have demonstrated that multi-state models provide a useful approach to supplement "cascade of care" work., Competing Interests: There are no conflicts of interest for this study.

Introduction: Our aim was to evaluate a community-based exercise (CBE) intervention with the goal of reducing disability and enhancing health for community-dwelling people living with HIV (PLWH)., Methods and Analysis: We will use a mixed-methods implementation science study design, including a prospective longitudinal interrupted time series study, to evaluate a CBE intervention with PLWH in Toronto, Canada. We will recruit PLWH who consider themselves medically stable and safe to participate in exercise. In the baseline phase (0-8 months), participants will be monitored bimonthly. In the intervention phase (8-14 months), participants will take part in a 24-week CBE intervention that includes aerobic, resistance, balance and flexibility exercise at the YMCA 3 times per week, with weekly supervision by a fitness instructor, and monthly educational sessions. In the follow-up phase (14-22 months), participants will be encouraged to continue to engage in unsupervised exercise 3 times per week. Quantitative assessment: We will assess cardiopulmonary fitness, strength, weight, body composition and flexibility outcomes followed by the administration of self-reported questionnaires to assess disability and contextual factor outcomes (coping, mastery, stigma, social support) bimonthly. We will use time series regression analysis to determine the level and trend of outcomes across each phase in relation to the intervention. Qualitative assessment: We will conduct a series of face-to-face interviews with a subsample of participants and recreation providers at initiation, midpoint and completion of the 24-week CBE intervention. We will explore experiences and anticipated benefits with exercise, perceived impact of CBE for PLWH and the strengths and challenges of implementing a CBE intervention. Interviews will be audio recorded and analysed thematically., Ethics and Dissemination: Protocol approved by the University of Toronto HIV/AIDS Research Ethics Board. Knowledge translation will occur with stakeholders in the form of presentations and publications in open access peer-reviewed journals., Trial Registration Number: NCT02794415; Pre-results., Competing Interests: Conflicts of Interest: None declared., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)

Background and Aims: Supervised injection facilities (legally sanctioned spaces for supervised consumption of illicitly obtained drugs) are controversial public health interventions. We determined the optimal number of facilities in two Canadian cities using health economic methods., Design: Dynamic compartmental model of HIV and hepatitis C transmission through sexual contact and sharing of drug use equipment., Setting: Toronto and Ottawa, Canada., Participants: Simulated population of each city., Interventions: Zero to five supervised injection facilities., Measurements: Direct health-care costs and quality-adjusted life-years (QALYs) over 20 years, discounted at 5% per year; incremental cost-effectiveness ratios., Findings: In Toronto, one facility cost $4.1 million and resulted in a gain of 385 QALYs over 20 years, for an incremental cost-effectiveness ratio (ICER) of $10,763 per QALY [95% credible interval (95CrI): cost-saving to $278,311]. Establishing one facility in Ottawa had an ICER of $6127 per QALY (95CrI: cost-saving to $179,272). At a $50,000 per QALY threshold, three facilities would be cost-effective in Toronto and two in Ottawa. The probability that establishing three, four, or five facilities in Toronto was cost-effective was 17, 21, and 41%, respectively. Establishing one, two, or three facilities in Ottawa was cost-effective with 13, 35, and 41% probability, respectively. Establishing no facility was unlikely to be the most cost-effective option (14% in Toronto and 10% in Ottawa). In both cities, results were robust if the reduction in needle-sharing among clients of the facilities was at least 50% and fixed operating costs were less than $2.0 million., Conclusions: Using a $50,000 per quality-adjusted life-years threshold for cost-effectiveness, it is likely to be cost-effective to establish at least three legally sanctioned spaces for supervised injection of illicitly obtained drugs in Toronto, Canada and two in Ottawa, Canada., (© 2015 Society for the Study of Addiction.)

Background: As the average age of the HIV-positive population increases, there is increasing need to monitor patients for the development of comorbidities as well as for drug toxicities., Methods: We examined factors associated with the frequency of measurement of liver enzymes, renal function tests, and lipid levels among participants of the Canadian Observational Cohort (CANOC) collaboration which follows people who initiated HIV antiretroviral therapy in 2000 or later. We used zero-inflated negative binomial regression models to examine the associations of demographic and clinical characteristics with the rates of measurement during follow-up. Generalized estimating equations with a logit link were used to examine factors associated with gaps of 12 months or more between measurements., Results: Electronic laboratory data were available for 3940 of 7718 CANOC participants. The median duration of electronic follow-up was 3.5 years. The median (interquartile) rates of tests per year were 2.76 (1.60, 3.73), 2.55 (1.44, 3.38) and 1.42 (0.50, 2.52) for liver, renal and lipid parameters, respectively. In multivariable zero-inflated negative binomial regression models, individuals infected through injection drug use (IDU) were significantly less likely to have any measurements. Among participants with at least one measurement, rates of measurement of liver, renal and lipid tests were significantly lower for younger individuals and Aboriginal Peoples. Hepatitis C co-infected individuals with a history of IDU had lower rates of measurement and were at greater risk of having 12 month gaps between measurements., Conclusions: Hepatitis C co-infected participants infected through IDU were at increased risk of gaps in testing, despite publicly funded health care and increased risk of comorbid conditions. This should be taken into consideration in analyses examining factors associated with outcomes based on laboratory parameters.

Postpartum maternal and neonatal readmissions in the period shortly following birth are indicators of serious morbidity. We compared the risk of postpartum maternal and neonatal hospitalizations in women living with and without HIV in Ontario, Canada. We conducted a population-based study of pregnancies in Ontario between April 1, 2002 and March 31, 2011 using Ontario's administrative health care databases. Generalized estimating equations were used to derive adjusted odds ratios (aORs) and 95% confidence intervals (CI) for the association of HIV infection with postpartum maternal hospitalizations within 30 days of hospital discharge and neonatal hospitalizations within 30 and 60 days of hospital discharge. Between 2002/2003 and 2010/2011, 1,133,505 pregnancies were available for analysis, of which 634 (0.06%) were to women living with HIV. The proportion of postpartum maternal hospitalizations (2.8% versus 1.1%; odds ratio 2.53; 95% CI 1.57 to 4.07) was higher among women with HIV. The multivariable adjusted odds ratio was 1.54 (95% CI 0.93 to 2.55). The proportions of neonates hospitalized within 30 (2.6% versus 3.7%; aOR 0.68, 95% CI 0.42 to 1.10) and 60 days (4.9% versus 4.9%; aOR 0.86, 95% CI 0.60 to 1.24) of discharge were similar among infants born to women with and without HIV. Women living with HIV are at a higher risk of postpartum maternal hospitalizations than women not living with HIV. The effect of HIV infection was attenuated by multivariable adjustment, suggesting that sociodemographic or health care factors are responsible for much of the difference in outcomes.

Background: The re-emergence of syphilis among HIV-positive gay and other men who have sex with men (MSM) requires vigilance. We estimated incidence of and risk factors for first and subsequent syphilis diagnoses among MSM in HIV care in Ontario, Canada., Methods: We analyzed data from 2,280 MSM under follow-up from 2006 to 2010 in the Ontario HIV Treatment Network Cohort Study (OCS), a multi-site clinical cohort. We obtained syphilis serology results via record linkage with the provincial public health laboratory. Rates were calculated using Poisson regression., Results: First syphilis diagnoses occurred at a rate of 2.0 per 100 person-years (95 % CI 1.7, 2.4; 121 cases) whereas the re-diagnosis rate was 7.5 per 100 person-years (95 % CI 6.3, 8.8; 136 cases). We observed higher rates over time and among men who were aged <30 years, receiving care in the two largest urban centers, or had a previous syphilis diagnosis. Syphilis diagnosis was less common among Indigenous men, men with higher CD4 cell counts, and, for first diagnoses only, among men with less than high school education., Conclusions: Compared to reported cases in the general male population, incidence of a new syphilis diagnosis was over 300 times greater among HIV-positive MSM but year-to-year changes reflected provincial trends. Re-diagnosis was common, suggesting treatment failure or re-infection. Novel syphilis control efforts are needed among HIV-positive MSM.

Background: Our aim was to assess internal consistency reliability, construct validity, and test-retest reliability of the HDQ with adults living with HIV in Canada and Ireland., Methods: We recruited adults 18 years of age or older living with HIV from hospital clinics and AIDS service organizations in Canada and Ireland. We administered the HDQ paired with reference measures (World Health Organization Disability Assessment Schedule, SF-36 Questionnaire, Medical Outcomes Study Social Support Survey), and a demographic questionnaire. We calculated HDQ disability presence, severity and episodic scores (scored from 0-100). We calculated Cronbach's alpha and Intraclass Correlation Coefficients (ICC) (Canada only) for the disability severity and episodic scores and considered coefficients >0.80 and >0.70 as acceptable, respectively. To assess construct validity, we tested 40 a priori hypotheses of correlations between scores on the HDQ and reference measures and two known group hypotheses comparing HDQ presence and severity scores based on age and comorbidity. We considered acceptance of at least 75% of hypotheses as demonstrating support for construct validity., Results: Of the 235 participants (139 Canada; 96 Ireland), the majority were men (74% Ireland; 82% Canada) and were taking antiretroviral therapy (88% Ireland; 91% Canada). Compared with Irish participants, Canadian participants were older (median age: 48 versus 41 years) and reported living with a higher median number of comorbidities (4 versus 1). Cronbach's alpha for Irish and Canadian participants were 0.97 (95% confidence interval (CI): 0.97-0.98) and 0.96 (95 % CI: 0.95-0.98), respectively, for the severity scale and 0.98 (95 % CI: 0.97-0.98) and 0.96 (95 % CI: 0.95-0.98), respectively, for the episodic scale. Of the 40 construct validity correlation hypotheses, 32 (80%) and 22 (55%) were supported among the Canadian and Irish samples respectively; both (100%) known group hypotheses were also supported. ICC values for Canadian participants ranged from 0.80 (95 % CI: 0.71, 0.86) in the cognitive domain to 0.89 (95 % CI: 0.83, 0.92) in the social inclusion domain., Conclusions: The HDQ demonstrates internal consistency reliability and a variable degree of construct validity when administered to adults living with HIV in Canada and Ireland. The HDQ demonstrates test-retest reliability when administered to adults with HIV in Canada. Further validation of the HDQ outside of Canada is needed.

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.

Background: Without a national pharmacare plan in Canada, HIV-infected patients across the nation differ in their ability to obtain essential HIV therapy. Despite the fact there are public insurance programs in Ontario, patients are unable to access medication. The authors described how frequently patients in their urban clinic could not access medications and why they required a compassionate supply of HIV drugs, with the goals of minimizing treatment delays and avoiding interruptions., Methods: The authors conducted a retrospective review and collected information about demographic characteristics, current drug insurance and the challenges encountered., Results: Over one year, the authors provided 2,886 days of free HIV drugs to 42 patients who were predominantly citizens or permanent residents of Canada (88%). The most common obstacles were associated with the Trillium Drug Program and the total value of all drugs supplied was $134,860., Interpretation: This study suggests that Ontario's catastrophic drug insurance plan leaves some patients with significant gaps in drug coverage., (Copyright © 2015 Longwoods Publishing.)

Purpose: To assess the dimensions of disability measured by the HIV Disability Questionnaire (HDQ), a newly developed 72-item self-administered questionnaire that describes the presence, severity and episodic nature of disability experienced by people living with HIV., Methods: We recruited adults living with HIV from hospital clinics, AIDS service organizations and a specialty hospital and administered the HDQ followed by a demographic questionnaire. We conducted an exploratory factor analysis using disability severity scores to determine the domains of disability in the HDQ. We used the following steps: (a) ensured correlations between items were >0.30 and <0.80; (b) conducted a principal components analysis to extract factors; (c) used the Scree Test and eigenvalue threshold >1.5 to determine the number of factors to retain; and d) used oblique rotation to simplify the factor loading matrix. We assigned items to factors based on factor loadings of >0.30., Results: Of the 361 participants, 80% were men and 77% reported living with at least two concurrent health conditions in addition to HIV. The exploratory factor analysis suggested retaining six factors. Items related to symptoms and impairments loaded on three factors (physical [20 items], cognitive [3 items], and mental and emotional health [11 items]) and items related to worrying about the future, daily activities, and personal relationships loaded on three additional factors (uncertainty [14 items], difficulties with day-to-day activities [9 items], social inclusion [12 items])., Conclusions: The HDQ has six domains: physical symptoms and impairments; cognitive symptoms and impairments; mental and emotional health symptoms and impairments; uncertainty; difficulties with day-to-day activities and challenges to social inclusion. These domains establish the scoring structure for the dimensions of disability measured by the HDQ. Implications for Rehabilitation As individuals live longer and age with HIV, they may be living with the health-related consequences of HIV and concurrent health conditions, a concept that may be termed disability. Measuring disability is important to understand the impact of HIV and its comorbidities. The HIV Disability Questionnaire (HDQ) is a self-administered questionnaire developed to describe the presence, severity and episodic nature of disability experienced by people living with HIV. The HDQ is comprised of six domains of disability including: physical symptoms and impairments (20 items); cognitive symptoms and impairments (3 items); mental and emotional health symptoms and impairments (11 items); uncertainty (14 items); difficulties with day-to-day activities (9 items) and challenges to social inclusion (12 items). These domains represent the dimensions of disability measured by the HDQ. The HDQ is the first known HIV-specific disability measure for adults living with HIV. The HDQ may be used by clinicians and researchers to assess disability experienced by adults living with HIV.

Objectives: We described patterns of testing for chlamydia and gonorrhoea infection among persons in specialty HIV care in Ontario, Canada, from 2008 to 2011., Methods: We analysed data from 3165 participants in the OHTN Cohort Study attending one of seven specialty HIV care clinics. We obtained chlamydia and gonorrhoea test results via record linkage with the provincial public health laboratory. We estimated the proportion of participants who underwent testing annually, the positivity rate among those tested and the proportion diagnosed with chlamydia or gonorrhoea among all under observation. We explored risk factors for testing and diagnosis using multiple logistic regression analysis., Results: The proportion tested annually rose from 15.2% (95% CI 13.6% to 16.7%) in 2008 to 27.0% (95% CI 25.3% to 28.6%) in 2011 (p<0.0001). Virtually all were urine-based nucleic acid amplification tests. Testing was more common among men who have sex with men (MSM), younger adults, Toronto residents, persons attending primary care clinics and persons who had tested in the previous year or who had more clinic visits in the current year. We observed a decrease in test positivity rates over time. However, the annual proportion diagnosed remained stable and in 2011 this was 0.97% (95% CI 0.61% to 1.3%) and 0.79% (95% CI 0.46% to 1.1%) for chlamydia and gonorrhoea, respectively. Virtually all cases were among MSM., Conclusions: Chlamydia and gonorrhoea testing increased over time while test positivity rates declined and the overall proportion diagnosed remained stable, suggesting that the modest increase in testing did not improve case detection., (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: People with HIV face a variety of health-related challenges from HIV, concurrent health conditions, and side effects of treatment. These health-related challenges may be termed disability. Community involvement in conceptualizing and understanding disability is essential to developing appropriate measurement tools., Objective: To describe a community-academic partnership in the development of a new self-administered health status instrument, the HIV Disability Questionnaire (HDQ), using a community-engaged approach., Methods: With a Community Advisory Committee, we used categories from the Episodic Disability Framework, a conceptual framework developed in an earlier stage of research, as a foundation for item generation., Results: The purpose of the 70-item HDQ is to characterize the presence, severity, and episodic nature of disability experienced by adults with HIV. The Community Advisory Committee suggested items beyond those in the Episodic Disability Framework, refined item phrasing, order, response options, and questionnaire instructions to enhance feasibility and relevance of the HDQ to adults with HIV, advised on how to structure the questionnaire to capture the episodic nature of disability, and suggested next steps for testing and implementation., Conclusions: The HDQ is the first HIV-specific questionnaire to describe disability experienced by adults with HIV. Engaging community research partners in the development of the HDQ enhanced the questionnaire's relevance, feasibility, and face and content validities. This approach may be considered by others interested in health status instrument development.

The Mombasa Cohort is an open cohort study following HIV-seronegative women reporting transactional sex. Established in 1993, the cohort provides regular HIV counseling and testing at monthly visits. Over time, HIV acquisition risk has declined steadily in this cohort. To evaluate whether this decline may reflect changes in sexual risk behavior, we investigated trends in condom use and partner numbers among women who participated in the Mombasa Cohort between 1993 and 2007. Multinomial logistic regression and generalized estimating equations were used to evaluate the association of calendar time and follow-up time with key risk behaviors, after adjustment for potential confounding factors. At enrollment visits by 1,844 women, the adjusted probability of never using condoms decreased over time, from 34.2% to 18.9%. Over 23,911 follow-up visits, the adjusted probabilities of reporting >2 partners decreased from 9.9% to 4.9% and inconsistent condom use decreased from 7.9% to 5.3% after ≥12 cohort visits. Important predictors of risk behavior were work venue, charging low fees for sex, and substance abuse. Women with a later sexual debut had less risky behavior. Although sexual risk has declined among women participating in the Mombasa Cohort, HIV acquisition continues to occur and interventions to promote and reinforce safer sex are clearly needed.

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: To assess the construct validity of the HIV Disability Questionnaire (HDQ), a self-administered questionnaire that describes the presence, severity and episodic nature of disability experienced by people living with HIV., Design: We conducted a confirmatory factor analysis. We hypothesised that domains in the HDQ characterised six dimensions of disability, each represented by HDQ items: physical symptoms and impairments (20 items); cognitive symptoms and impairments (3 items); mental and emotional health symptoms and impairments (11 items); uncertainty (14 items); difficulties with day-to-day activities (9 items) and challenges to social inclusion (12 items). We developed a measurement model to test these hypotheses. We used maximum likelihood methods of estimation to determine model fit. We considered a threshold for the Root Mean Square Error of Approximation (RMSEA) of <0.05 as an indication of overall goodness of model fit. We considered variables with factor loadings of >0.30 as representing a given domain of disability., Setting: We recruited adults with HIV from hospital clinics, AIDS service organisations and a specialty hospital in Ontario., Participants: Of the 361 adults with HIV who completed the HDQ, 80% were men, 36% were 50 or older and 77% reported living with at least two concurrent health conditions in addition to HIV., Outcome Measures: We administered the HDQ followed by a demographic questionnaire., Results: The model achieved good overall fit as indicated by a RMSEA of 0.030 (90% CI 0.028 to 0.033). All HDQ items represented our hypothesised dimensions of disability (factor loadings >0.30). Factor loadings ranged from 0.34 to 0.90. Domains of disability correlated with each other ranging from r=0.47 (between difficulties with day-to-day activities and uncertainty) to r=0.88 (between mental-emotional health challenges and challenges to social inclusion)., Conclusions: The six domain structure of the HDQ demonstrated construct validity when administered to adults living with HIV., (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.)

Objectives: To determine the association between preexisting characteristics and current health and the cost of different types of advanced human immunodeficiency virus (HIV) care., Methods: Treatment-experienced patients failing highly active antiretroviral treatment (ART) in the United States, Canada, and the United Kingdom were factorial randomized to an antiretroviral-free period and ART intensification. Cost was estimated by multiplying patient-reported utilization by a unit cost., Results: A total of 367 participants were followed for a mean of 15.3 quarters (range 1-26). Medication accounted for most (61.8%) of the $26,832 annual cost. Cost averaged $4147 per quarter for ART, $1981 for inpatient care, $580 for outpatient care, and $346 for other medications. Cost for inpatient stays, outpatient visits, and other medications was 171% higher (P <.01) and cost of ART was 32% lower (P <.01) when cluster of differentiation 4 (CD4) count was <50 cells/μL compared with periods when CD4 count was >200 cells/μL. Some baseline characteristics, including low CD4 count, high viral load, and HIV from injection drug use with hepatitis C coinfection, had a sustained effect on cost., Conclusions: The association between health status and cost depended on the type of care. Indicators of poor health were associated with higher inpatient and concomitant medication costs and lower cost for ART medication. Although ART has supplanted hospitalization as the most important cost in HIV care, some patients continue to incur high hospitalization costs in periods when they are using less ART. The cost of interventions to improve the use of ART might be offset by the reduction of other costs.

As individuals age with HIV it is increasingly important to consider the health-related consequences of HIV and multiple morbidities, known as disability. We assessed relationships between four dimensions of disability among adults living with HIV. We conducted a structural equation modeling analysis using data from 913 participants in the Ontario HIV Treatment Network Cohort Study to determine relationships between four latent variables of disability in the Episodic Disability Framework: physical symptoms and impairments, mental health symptoms and impairments, difficulties with day-to-day activities, and challenges to social inclusion. Results indicated that physical symptoms and impairments, mental health symptoms and impairments and difficulties with day-to-day activities directly or indirectly predicted challenges to social inclusion for adults living with HIV. Challenges to social inclusion were directly predicted by mental health symptoms and indirectly by physical health symptoms via (mediated by) having difficulties carrying out day-to-day activities and mental health symptoms and impairments. These findings provide a basis for conceptualizing disability experienced by people living with HIV.

Purpose: To assess the validity of dimensions of disability in the Episodic Disability Framework, a conceptual framework derived from the perspective of adults living with HIV., Methods: We conducted confirmatory factor analyses with 913 adults living with HIV in an observational cohort study called the Ontario HIV Treatment Network Cohort Study (OCS). We tested hypotheses that dimensions of disability in the Episodic Disability Framework were represented by a group of measured variables in the observational database., Results: A model comprised of four latent variables and 43 indicator variables with one cross-loading was superior to models with fewer latent variables and more indicator variables and supported the validity of disability dimensions: physical health symptoms (represented by 21 indicator variables), mental health symptoms (10 variables), difficulties with day-to-day activities (5 variables) and challenges to social inclusion (8 variables). Overall goodness of fit statistics were χ(2 )= 2621.50 (p < 0.001), Comparative Fit Index = 0.912, Tucker Lewis Index = 0.907 and root mean square error of approximation = 0.048. Dimensions of disability correlated with each other ranging from r = 0.44 (between physical symptoms and challenges to social inclusion) to r = 0.81 (between physical symptoms and difficulties with day-to-day activities)., Conclusions: This study supports the validity of four disability dimensions in the Episodic Disability Framework. This framework provides a new way to conceptualize disability and can lay the foundation for developing a future HIV disability measure for clinical and health services research., Implications for Rehabilitation: The Episodic Disability Framework is the first known conceptual framework of disability developed from the perspective of adults living with HIV. Results from this confirmatory factor analysis support the validity of four dimensions of disability experienced by adults living with HIV in the Episodic Disability Framework including: physical symptoms and impairments, mental health symptoms and impairments, difficulties carrying out day-to-day activities, and challenges to social inclusion. The Episodic Disability Framework provides a new way to conceptualize disability experienced by adults living with HIV. Clinicians can use this Framework to better understand episodic disability experienced by adults living with HIV. Clinicians can frame their assessments of disability to include physical and mental health symptoms and impairments as well as consider a patient's ability to participate in society, and indicate areas to apply interventions or strategies to prevent or mitigate disability experienced by adults living with HIV.

Objective: Newer antiretroviral drugs provide substantial benefits but are expensive. The cost-effectiveness of using antiretroviral drugs in combination for patients with multidrug-resistant HIV disease was determined., Design: A cohort state-transition model was built representing treatment-experienced patients with low CD4 counts, high viral load levels, and multidrug-resistant virus. The effectiveness of newer drugs (those approved in 2005 or later) was estimated from published randomized trials. Other parameters were estimated from a randomized trial and from the literature. The model had a lifetime time horizon and used the perspective of an ideal insurer in the United States. The interventions were combination antiretroviral therapy, consisting of 2 newer drugs and 1 conventional drug, compared with 3 conventional drugs. Outcome measures were life-years, quality-adjusted life-years (QALYs), costs, and incremental cost-effectiveness., Results: Substituting newer antiretroviral drugs increased expected survival by 3.9 years in advanced HIV disease. The incremental cost-effectiveness ratio of newer, compared with conventional, antiretroviral drugs was $75,556/QALY gained. Sensitivity analyses showed that substituting only one newer antiretroviral drug cost $54,559 to $68,732/QALY, depending on assumptions about efficacy. Substituting 3 newer drugs cost $105,956 to $117,477/QALY. Cost-effectiveness ratios were higher if conventional drugs were not discontinued., Conclusions: In treatment-experienced patients with advanced HIV disease, use of newer antiretroviral agents can be cost-effective, given a cost-effectiveness threshold in the range of $50,000 to $75,000 per QALY gained. Newer antiretroviral agents should be used in carefully selected patients for whom less expensive options are clearly inferior.

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.

Background: Since 2000, reported syphilis cases increased ten-fold in Canada, particularly among men who have sex with men (MSM) co-infected with HIV. We characterized temporal patterns of of syphilis testing in a large cohort of HIV patients in Ontario, Canada., Methods: We analyzed data from a multi-site cohort of people in HIV care from 2000 to 2009. Data were obtained from medical charts, interviews and record linkage with the syphilis test database at the Public Health Ontario Laboratories. We estimated the proportion that had syphilis testing at least once per year and the period and annual prevalence of reactive tests., Results: Among 4232 participants, the annual proportion tested rose from 2.7% (95%CI 1.9, 3.5) in 2000 to 54.6% (95%CI 52.9, 56.3) in 2009. Testing was most common for participants who were men who have sex with men (MSM), aged <30, recently diagnosed with HIV, were antiretroviral treatment naive, had routine HIV lab testing at least twice in that year, or tested for syphilis in the preceding year. The proportion with at least one reactive test in 2000-09 was 21.0% (95%CI 19.4, 22.7) for MSM, 5.3% (95%CI 3.3, 7.4) for non-MSM males, and 2.6% (95%CI 1.2, 4.0) for women. Among MSM, the annual prevalence of reactive syphilis tests with high RPR titre (≥1:16) peaked at 3.8% in 2009., Conclusions: The burden of syphilis co-infection rose considerably among HIV-positive MSM, such that by 2009, at least 1 in 5 men had laboratory evidence of current or past infection. Interventions may be needed to boost syphilis testing to achieve goals set by guidelines even in settings with universal health care.

The Ontario HIV Treatment Network Cohort Study (OCS) is an observational, open dynamic cohort of people who are receiving medical care for human immunodeficiency virus (HIV) infection in Ontario, Canada. Established in the mid-1990s, the OCS has its roots in AIDS activists' demands for research that would improve the quality of life of people living with HIV while respecting their privacy. It is a collaborative and community-driven study, including a Governance Committee made up of people with HIV and other stakeholders that evaluates analysis project proposals for community relevance and ethics. From 1995 to 2010, a total of 5644 participants were enrolled and 27,720 person-years of observation were accumulated; follow-up will continue until at least 2015. In the initial years of study, the focus was on clinical data from medical chart reviews. It has since evolved into a comprehensive study that collects extensive de-identified information on clinical, laboratory and psychosocial and behavioural measures based on medical chart abstractions, interviews using a standardized questionnaire and linkage with external administrative health databases in Ontario. Interested collaborators are encouraged to submit analysis project proposals as instructed on the study website (www.ohtncohortstudy.ca).

Purpose: Our purpose was to assess the sensibility of the human immunodeficiency virus (HIV) Disability Questionnaire (HDQ), the first HIV-specific disability questionnaire., Methods: We administered the HDQ, a sensibility questionnaire and a structured qualitative interview to 22 adults living with HIV and five experienced clinicians. We considered the HDQ sensible if median scores on the sensibility questionnaire were ≥5 for adults living with HIV and ≥4 for clinicians for at least 80% of the items. We analyzed the interview data using directed qualitative content analytical techniques., Results: Questionnaire scores were ≥5 for 88% (15/17) of the items and ≥4 for 100% (17/17) of the items for adults living with HIV and clinicians, respectively. The interview analysis indicated participants felt the HDQ possessed face and content validity in all disability dimensions, had adequate response options, was easy to complete, and adequately captured the episodic nature of disability. Participants had mixed responses about the questionnaire title and provided recommendations to refine item wording and response options., Conclusions: The HDQ appears sensible for use with adults living with HIV. Next steps include further measurement property assessment. The HDQ may be used by rehabilitation clinicians and researchers to assess disability experienced by adults living with HIV., Implications for Rehabilitation: • As people with HIV infection live longer, individuals may face a range of health-related challenges due to the disease, concurrent health conditions and the potential adverse effects of treatment. Together, these health-related challenges may be termed disability. • The HIV Disability Questionnaire (HDQ) is the first HIV-specific instrument developed to describe the presence, severity and episodic nature of the disability experienced by adults living with HIV. The HDQ is comprised of four domains including symptoms and impairments, uncertainty about future health, difficulties carrying out day-to-day activities, and challenges to social inclusion. • The HDQ appears sensible for use with adults living with HIV, possessing face and content validity and ease of use in all four domains as well as describing the daily episodic nature of disability. • The HDQ may be used by rehabilitation clinicians and researchers to assess disability experienced by adults living with HIV.

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.