Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is a guidelines-recommended single-tablet regimen for people with HIV-1 (PWH). We present 5-year cumulative outcomes of two phase 3 studies of B/F/TAF in treatment-naïve PWH.

Study 1489: B/F/TAF vs DTG/ABC/3TC and Study 1490: B/F/TAF vs DTG+F/TAF are randomized, double-blind, phase 3 studies in treatment-naïve adults. After completing 144W of blinded treatment, participants were offered continuation of B/F/TAF for 96W in open-label extensions (OLEs). Efficacy analysis included HIV-1 RNA <50 copies/mL at each visit after starting B/F/TAF (missing=excluded analysis); safety by adverse events (AEs) and laboratory results. Bone mineral density (BMD) was measured in those randomized to B/F/TAF in 1489.

252/314 participants in 1489 and 254/320 in 1490 randomized to B/F/TAF enrolled in OLE. 254/315 randomized to DTG/ABC/3TC in 1489 and 265/325 randomized to DTG+F/TAF in 1490 enrolled in OLE. Baseline (BL) demographics of B/F/TAF participants in 1489 and 1490 include: median age 31 and 33, 9% and 13% female, respectively. Efficacy was >98% after W48 at each study visit through W240 in both studies. No resistance to components of B/F/TAF was detected. During the OLE, 6/504 B/F/TAF participants experienced an AE that led to drug discontinuation, none were renal; ≤1.6% had a Grade 3 or 4 drug-related AE. All arms had numerically small median changes in eGFR and stable TC: HDL. Median change in weight from BL to W240 was 6.1kg in B/F/TAF participants; median weight change for comparators at W144: 3.5kg (1489) and 5.0kg (1490), with 2.4kg and 1.3kg additional gains observed between W144 to W240, respectively. Mean % changes (SD) in hip and spine BMD through W240 in B/F/TAF participants were -0.29% (5.29) and -0.23% (5.16), respectively.

Over 5 years of follow up in treatment naïve PWH, B/F/TAF was well tolerated and highly efficacious. These results confirm long term safety and efficacy of B/F/TAF.

Background: Rapid antiretroviral therapy (ART) initiation for persons newly diagnosed with HIV is a key strategy to ending the HIV epidemic. However, vulnerable populations such as migrants living with HIV (MLWH) often experience delays in accessing HIV care, initiating ART, and achieving viral suppression. Initiating ART rapidly in a multidisciplinary environment may reduce barriers encountered by MLWH. This study explores MLWH experiences with rapid and free ART initiation within a multidisciplinary clinic specializing in HIV.

Methods: In January 2020, we initiated a 96-week prospective longitudinal cohort study with a convergent mixed-method design at a clinic serving the largest proportion of MLWH in Montreal, Quebec. All patients received bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) free of charge. Only preliminary qualitative data are presented here. Interviews were conducted with 18 MLWH and analyzed via Gale et al.’s Framework Method.

Results: Qualitative analysis generated 4 sets of themes which highlighted: 1) facilitators which enabled MLWH to engage with HIV care and treatment (e.g., free ART and non-judgmental healthcare staff and clinicians), and MLWH’s overall satisfaction with their current care and treatment; 2) barriers that MLWH continue to encounter (e.g., navigating different clinics to access free blood tests); 3) the need to improve multidisciplinary care teams to further address challenges encountered by MLWH (e.g., through empowering patients, while also refining communication and coordination between all stakeholders); and (4) the intersectional burden experienced by MLWH due to HIV, migration, and COVID-19 (e.g., many MLWH moved to Canada just before pandemic-related lockdown measures were implemented, hindering their integration into Canada and HIV-related healthcare).

Conclusions: Results suggest that free and rapid B/F/TAF initiation can lead to satisfaction for MLWH. Despite rapid initiation and cost covered ART within a multidisciplinary model, challenges continue to impede MLWH engagement, revealing a need for targeted interventions on the issues of communication, coordination, and empowerment.

In 2017, amidst a syndemic background (HIV/HCV/substance use,) local stakeholders and community organizations were concerned about a cohort of people living with HIV (PLWH) in Saskatoon who had high hospital utilization. This cohort frequently left hospital against medical advice, did not link to outpatient care, and had poorer HIV-specific outcomes. Contributing system-level gaps included equitable hospital policies, i.e.: harm reduction, person-centered care, and coordinated outreach. The community team devised an innovative multidisciplinary intervention, the HIV/AIDS Rapid Response Team (HART), which is designed to connect with PLWH in hospital and transition them into community-based care and services. This ‘wrap-around’ care prioritizes the complex social needs of the population. The study objective was to evaluate whether this intervention improved outcomes.
Methods: This was a single group pretest-posttest analysis at 0, 3, and 6mth timepoints using routinely collected HART data. The primary outcome was viral load (VL) suppression and the secondary outcomes included housing status, number of financial supports, and self-reported health. Process outcomes included duration of the intervention.
Results: 131 patients were included at baseline. VL’s were significantly lower at the end of the intervention (238,971 p=0.0016.) Co-infection with HCV predicted a lower 3mth VL (126,990 p=0.042.) More people were receiving ARV’s at both 3 and 6mths (34.1 p=0.000 and 29.4 p=0.000.) Fewer people were living with homelessness at 3mths (25.6 p=0.00) and this was sustained at 6mths (19 p=0.0005.) Income supports increased at 3 and 6mths (9 p=0.012, 18 p=0.011.) Self-reported impaired mobility was lower at 6months (9.8 p=0.037.) Attrition was low at 3mths (N=116.)
Conclusions: HART improved HIV-specific outcomes for PLWH in this study. Intervention components seem well-matched to the needs of the target population, specifically the relationship-driven model, organizational flexibility and in-hospital advocacy. Focus-group discussions with communities for giving back knowledge and developing recommendations are upcoming.

Background: While exclusive formula feeding remains the preferred method for feeding infants born to women living with HIV (WLWH) in Canada, families can face several obstacles with infant feeding, including financial barriers. Here, we report on the impact of a free formula program for families living with HIV in the province of Quebec, launched on April 1st, 2021.
Methods: The Quebec Commercial Infant Formula Program for families affected by HIV (P3CN) was developed by CIME_Q, a multidisciplinary and multisite group of infectious diseases specialists, pediatric and adult care providers, pharmacists and nurses, and funded by Quebec’s Ministry of Health. It offers to refund the costs of infant formula to pharmacies or directly to families affected by HIV during the first year of life of their baby. The management of the program is centralized at the CHU Sainte-Justine. Data regarding HIV perinatal transmission were extracted from the Quebec HIV perinatal registry (CIME_Q), which captures all mother-infant pairs affected by HIV in pregnancy in the province of Quebec since 2017.
Results: Between 2017-2020, there were 202 live births among WLHW captured in CIME_Q’s registry. Of them, 2 (1%) chose to breastfeed. There were 2 cases of perinatal infection (unrelated to breastfeeding). Since April 2021, 35 WLWH part of the CIME_Q registry delivered in Quebec; among them, 33 benefited from P3CN, one had access to free formula through another program and one decided to breastfeed. Considering that some families whose infants were born before the program’s implementation were eligible (<1 y.o.), 59 families in total have benefited from free infant formula so far, at a mean cost of $2080 per year per family. There were no perinatal transmissions.
Conclusions: Since implementation of P3CN, uptake has been high. Further work is underway to evaluate the implementation of the program and women’s experiences with it.

Background:
Specific taxa of anaerobic bacteria in the penile microbiome have been associated with risk of HIV acquisition. Some evidence shows that this may be driven by local inflammation, resulting in HIV target cell recruitment to the foreskin. However, these anaerobes may also increase HIV susceptibility by disrupting foreskin epithelial barrier function. This hypothesis was tested by removing penile anaerobes with antimicrobials.

Methods:
A randomized trial with 125 HIV-negative uncircumcised men was conducted in Entebbe, Uganda. Participants were randomized to a control group which underwent circumcision immediately, or to defer circumcision for 4 weeks and receive either tinidazole, metronidazole, clindamycin, or hydrogen peroxide. Foreskin tissues were stained for the protein filaggrin to mark the keratin layer, as well as epithelial junction proteins E-Cadherin, Desmoglein-1, and Claudin-1. Whole-tissue fluorescence microscopy images were taken and analyzed for the following epithelial integrity metrics: keratin thickness, epithelial thickness, and epithelial junction protein expression.

Results:
Men receiving clindamycin or tinidazole treatments had a thinner inner foreskin keratin layer than control men (16.06,17.07µm vs 20.58µm, p=0.0154,0.0266). Combining all topical treatment groups, significantly higher inner foreskin E-Cadherin expression was observed than in control men (0.1264MFI vs 0.1078MFI, p=0.0477). This effect was seen especially with metronidazole (0.1311MFI, p=0.0350). Men receiving hydrogen peroxide had higher foreskin Claudin-1 expression than control men (0.1542MFI vs 0.1358MFI, p=0.0136). No significant differences were observed between groups for epithelial thickness or Desmoglein-1 expression, nor when looking at outer foreskin tissue alone for any metric.

Discussion:
A thinner keratin layer may represent compromised foreskin barrier integrity, leaving participants susceptible to HIV and other pathogens. Higher epithelial junction protein expression for some treatments provides evidence that penile anaerobes may cause downstream cleavage of epithelial junctions. Further mechanistic research is required, as well as microbiome data to determine the effects of specific bacterial taxa on epithelial integrity.

Background: In countries burdened with a high incidence of pediatric HIV there is a notable disparity in the treatment cascade for infants. In response, networks of point-of-care (POC) devices for early-infant diagnosis (EID) were established at the community level throughout certain African countries. These devices increase accessibility to diagnostic testing and linkage-to-care for HIV-exposed/diagnosed infants. To date, QASI-EID is the only international external quality assessment (EQA) program offering proficiency testing (PT) specifically for EID on POC devices.

Objective: After the successful administration of 6 QASI-EID PT sessions to participants at 331 POC sites in 8 African countries, we sought to review the accomplishments, challenges and lessons learned.

Methods: QASI-EID operates through in-country Coordinators who are responsible for distribution of panels and submission of results. Bi-annually, POC sites receive a 3-sample panel (2 positive, one negative). In each PT session, a thorough analysis of participant results, non-conformances and circumstances that prevent POC sites from participating is compiled. Responses from over 900 submissions over 6 PT sessions were evaluated and the main issues affecting EID at POC sites were identified.

Results: On average, result return rate is 70%. Of those, over 94% are proficient for the EID test. Of the 30% who were not able to participate the primary reasons cited are lack of communication, cartridge stock-out, instrument malfunction, and absence of trained personnel.

Conclusion: POC technology has contributed to a reduction in HIV-related infant mortality in Africa. This same technology is applied for adult diagnostics and viral load monitoring at the community level, thereby empowering communities, domestically and internationally, to combat the HIV crisis locally. EQA is important to provide oversight, training and support through corrective action to ensure accurate reliable results from POC sites and facilitate long-term success and sustainability of POC networks for HIV patient care and management.

Background: The GeneXpert® assay for HIV viral load (VL) has increased in use at point-of-care (POC) testing sites internationally, resulting in demand for external quality assessment (EQA). QASI®, the international program for Quality Assessment and Standardization of Indicators relevant to HIV/AIDS recently expanded its services to include EQA specifically for this test.

Objective: 1) Develop a VL proficiency testing (PT) material that simulates clinical samples (non-infectious), is stable over time under various conditions, and is compatible with development of EQA programs in resource-limited settings. 2) Pilot a 3-specimen PT panel for POC instruments with collaborating countries in Africa and South America.

Methods: A new PT material consisting of Tris-EDTA buffer spiked with heat inactivated HIV cell culture supernatant was evaluated with the GeneXpert VL assay. The stability of the new material was compared to existing VL PT material (dried tube specimens, DTS) at different temperatures. VL stability of the new PT material was further evaluated over time and under heat-stress. Panels consisting of two positive and one negative sample were distributed to 81 POC sites in 7 countries. Results were submitted to a secure QASI-VL website for group analysis.

Results: The new PT material performed better than DTS at higher temperatures and maintained a stable VL over time and under heat-stress. In the QASI-VL Pilot session, 63% of participating POC sites reported results for the pilot panel, with 82% correctly reporting results for all three samples.

Conclusion: A fit-for-purpose PT material which more accurately simulates a typical clinical sample, was successfully developed and utilized by participants in the QASI-VL pilot. This is the first HIV VL PT panel developed specifically for POC instruments. VL testing is critical for patient management, and POC technology offers an innovative approach to empower communities (domestically and internationally) with a unique alternative for monitoring HIV.

Background: Community-based exercise (CBE) can enhance health outcomes among people living with HIV (PLWH). Despite the benefits, PLWH may experience barriers to exercising in traditional gym environments. Our objectives were to describe the need for and utility of online CBE interventions with adults living with HIV and identify factors to consider in developing and implementing an online CBE intervention with adults living with HIV.

Methods: We conducted a qualitative descriptive study using web-based semi-structured interviews with adults representing at least one of five stakeholder groups with experience in CBE and/or HIV: 1) adults living with HIV, 2) rehabilitation professionals, 3) fitness personnel, 4) educators with eLearning experience, and 5) representatives from HIV community-based organizations. We asked participants to describe their experiences with online CBE, need and utility for online CBE, and factors in developing and implementing online CBE interventions. We analyzed data using group-based content analytical techniques.

Results: Among the 11 participants, most had experience working with adults living with HIV (73%) or with tele-health/rehabilitation/coaching in HIV or other chronic conditions (91%). Participants identified the need and utility for online CBE interventions to increase accessibility and continuity of care with PLWH. Six factors to consider in developing and implementing online CBE included 1) person-specific considerations with adults living with HIV, 2) accessibility of program, 3) program delivery and technology, 4) attributes of program personnel, 5) program content and design, and 6) building community.

Conclusions: There is a need and utility for online CBE in the context of HIV. Considerations for development and implementation span individual, structural and technical, and community dimensions. Results can inform the future development and implementation of online CBE with adults living with HIV and other chronic episodic conditions.

Background: HIV pre-exposure prophylaxis (PrEP) may alleviate HIV-related anxiety, defined as “significant concern about being at risk of, testing for, and/or being diagnosed with HIV”. However, the optimal tools for measuring this construct are unclear. We sought to identify candidate psychometric scales for measuring HIV-related anxiety in a prospective cohort study of PrEP users.
Methods: We searched electronic databases (APA PsycTests, Health and Psychosocial Instruments, and Mental Measurements Yearbook) from 1995-2021 to identify psychometric scales and/or questionnaires that measure HIV-related anxiety. Scales were assessed based on conceptual fit (extent to which the scale matches the variable we aim to measure), validity (construct/criterion), reliability (test-retest/Cronbach’s alpha), and feasibility (number of items/rating system).
Results: Five candidate instruments were identified and evaluated; two psychometric scales and three questionnaires (Table 1). Only Keen and Holt appeared to measure specifically HIV-related anxiety. Snell discussed the construct of sexual anxiety as opposed to anxiety regarding HIV, Yi examined fatalistic beliefs about maintaining HIV-negative serostatus, and Van de Ven measured skepticism/optimism regarding novel HIV treatments. No instrument evaluated criterion validity while three instruments assessed construct validity (Snell, Yi, and Van de Ven). Most instruments had appropriate Cronbach’s alphas (>0.70); no instrument tested test-retest reliability. All instruments appeared feasible based on appropriate number of items and rating methods.
Conclusions: A limited number of tools exist to quantitatively measure HIV-related anxiety. While further evaluation of their measurement properties may be beneficial, instruments developed by Keen and Holt are potentially well-suited for evaluating PrEP-related changes in HIV-related anxiety.

Purpose: Patient portals offer patients access to their electronic medical record and have shown a positive impact on engagement in care. To configure a patient portal for use in HIV care in Canada and France, it is important to identify and predict factors related to people living with HIV’s (PLWH) willingness to use such a portal.

Methods: A cross-sectional survey was administered to patients receiving HIV care at HIV-specialized clinics of the McGill University Health Center (Montreal, Canada) and Saint-Antoine Hospital (Paris, France) between September 2019 and February 2020. A random forest analysis with 500 classification trees was conducted to explore patient-level factors that predict willingness to use a patient portal. Pertinent candidate covariates identified in prior literature included age, gender, income, education, and technology self-efficacy. Imbalances in representation of respective outcome categories (willing vs not willing to use a patient portal) were weighted to uniformly maximize both sensitivity and specificity.

Results: A total of 114 PLWH completed the survey. Their mean age was 47.8 years old (SD=12.4) and 74% were men. The variables indicating statistically relevant capability for predicting patients’ willingness to use a patient portal were gender, income, and age. PLWH who identified as women (73%), PLWH with an annual income over $60 000 CAD (70%), and PLWH below the age of 31 (81%) were more willing to use a patient portal than their counterparts. Patient experience with health technology (86% with no experience; 68% with experience), and capability to use health technology (79%) were also identified as important factors.

Conclusions: Our analyses offer insight on predictive variables for willingness to use a patient portal in HIV care. These variables are useful to identify early adopters, while also revealing a need to tailor implementation to reach potential users facing difficulties accessing or using connected technologies.

Purpose: Patient portals can engage people with HIV (PWHIV) by allowing patients to access their medical record online as well as other services. This study aims to understand the perspectives of both PWHIV and specialized healthcare providers (HCPs) regarding benefits and risks of using a patient portal within HIV care in Canada and France.

Methods: Between August 2019 and March 2020, we held focus group discussions with PWHIV and healthcare providers, separately, in the HIV-specialized clinics of the McGill University Health Centre, Montreal, Canada, and of Saint-Antoine Hospital, Paris, France. PLWH were recruited by maximum variation sampling, while HCPs were recruited with purposeful sampling. Semi-structured interview schedules were used. Each focus group was recorded, and transcriptions were coded using NVivo 12 software and analyzed by content analysis.

Results: Participants include 28 PWHIV in four focus groups and 31 HCPs in six focus groups. PWHIV included 18 men, 9 women, and 1 person identifying as other; while, HCPs included 10 men, 20 women, and 1 person identifying as other. A multi-disciplinary team of HCPs included physicians, nurses, pharmacists, social workers, and clinical coordinators. Our analysis identified four key benefits of using a patient portal: 1) improves self-management, 2) facilitates patient visits, 3) accounts for patient preferences, and 4) meets unforeseen or evolving patient needs. Five possible risks were identified: 1) breach of confidentiality, 2) stress or uncertainty, 3) contribution to the digital divide, 4) dehumanized care, and 5) increased HCP workload.

Conclusions: Consulting with PWHIV and HCPs revealed that both groups agreed upon various benefits and risks associated with using a patient portal. The implementation of a patient portal in HIV clinical care should be informed by end-users’ input to optimize the benefits and mitigate potential risks to secure adoption, thus favoring patient health, wellbeing, and engagement in care.

Background: We previously reported that people living with HIV (PLWH) who developed COVID-19 during the first wave of the pandemic were often migrants with occupational exposure risk for SARS-CoV-2 acquisition. We describe the evolving risk profile and severity of SARS-CoV-2 infections for this population, in waves 2 and 3, comparing with previous findings and the general population in Montreal.

Methods: Retrospective chart review identified individuals with positive SARS-CoV-2 nasopharyngeal polymerase chain reaction (PCR) test/symptoms suspicious for COVID-19 from September 2020-August 2021, consistent with the 2nd and 3rd waves of the pandemic in Montreal. A descriptive analysis of extracted information (sociodemographic and economic information, risk factors for COVID-19, HIV-related clinical parameters, COVID-19-related symptoms, disease severity and clinical outcomes) was undertaken.

Results: 61 PLWH had a positive SARS-CoV-2 PCR(period prevalence of 0.04). More than half identified as black. The most common exposure risk for SARS-CoV-2 was having a family member/close contact with COVID-19(36%), followed by living in a long-term care(LTC) residence(10%) or working as a personal support worker, nurse or janitor in a health care institution(10%). Nearly all had mild disease on initial presentation, one was admitted to hospital for symptomatic COVID-19 and most had a full recovery. The cumulative incidence of COVID-19 at the CVIS was 0.0548, which was comparable to that in the general population in Montreal(0.06674) at that time.

Conclusion: COVID-19 among PLWH continues to affect ethno-racial communities disproportionately and members from these communities are more likely to have occupational risks for COVID-19. Similar to the Montreal population, the most common risk factor for SARS-CoV-2 exposure during waves 2 and 3 was having a household or close contact with COVID-19 whereas in wave one, working in a LTC home was the most frequent risk exposure. COVID-19 among PLWH appears to mirror observations regarding SARS-CoV-2 risks within the general population.

Background: The COVID-19 pandemic has resulted in disrupted health services in many sectors. In a mid-sized Ontario city, a multidisciplinary care team serves a population of people living with HIV also affected by intersections of substance use and housing instability. Our aim was to assess the impact of the COVID pandemic on HIV care for this vulnerable patient population.

Methods: We performed an audit of this study population’s HIV and general medical care in the 12 months before and after the start of the COVID pandemic (using Mar. 2020 as the beginning of the pandemic period).

Results: In this population (n=37), the median age was 44 and 45.6% female. With regards to substance use, at baseline, 90.9% reported opioid use, 87.8% methamphetamine use. In the pre-pandemic 12-month period, the mean number of HIV care visits per person was 2.76 ±0.303 (95% CI), but fell to 2.17±0.231 in the 12 months after March 2020 (p=0.001). Pre-pandemic, 3.9% of visits were conducted virtually, compared with 26% after March 2020. 51.3% of the population maintained a consistently undetectable viral load pre-pandemic vs 56.7% after March 2020. Mean number of ED visits (3.62 ±1.66 (95% CI) vs 3.11 ±1.626, p=0.33) and admissions to hospital (0.89 ±0.429 vs 0.67 ± 0.452, p= 0.25), did not fall significantly, although our small sample size may have limited the ability to detect a fall. 2 deaths were recorded in the pre-pandemic year compared with 0 in the pandemic period.

Conclusions: This patient population continued to receive HIV care throughout the pandemic that was tailored to their needs (eg phone visits when in person care was disrupted). There was a small statistically significant reduction in HIV clinical visits. In spite of this, a majority of patients were able to maintain an undetectable viral load.

Background: Mindfulness is becoming increasingly popular across Canada and beyond, and there is growing evidence that mindfulness can improve the mental wellbeing of people living with HIV (PLWH). However, little is known about adverse effects from mindfulness in this population. Cross-sectional and population-based studies show that meditation-related adverse effects are common in the general population, yet they are underreported in clinical trials of mindfulness-based interventions.
Aim: To explore the experiences of PLWH who experienced adverse effects during an 8-week mindfulness-based stress reduction course (MBSR).
Method: Semi-structured interviews were conducted with two participants who withdrew from an MBSR course. Data were originally collected and analysed as part of Positively Mindful, a mixed methods feasibility trial of MBSR for PLWH. We re-analysed interview transcripts using Interpretive Phenomenological Analysis in order to more fully explore the experiences of adverse effects.
Findings: Participants described their experiences of adverse effects and related these to their history of past trauma. They identified what they considered to be triggers for the adverse effects and reflected on the acceptability and safety of mindfulness-based interventions given their experiences. Participants thought the screening criteria were sufficient although they felt there was limited support for their experiences of adverse effects from within the MBSR course. Experiences of adverse effects did not negatively impact the perception of MBSR as a psychological intervention. The findings highlight the tension between motivation to engage and capacity to engage in particular mindfulness practices.
Conclusion: Improving understanding and knowledge of the adverse effects of mindfulness will enable clinicians and patients to weigh the risks and benefits and make informed choices about utilising mindfulness-based interventions. Furthermore, our findings highlight the importance of trauma-informed and person-centred approaches to mindfulness. Our findings are therefore relevant to clinicians and patients across Canada and globally.

Background: Antiretroviral therapy(ART) enabled people living with HIV (PLWH) to maintain or regain weight as part of a “return to health” phenomenon. More recent trends suggest that many PLWH have gained excessive weight as seen in the general population. We sought to explore the change in proportion of PLWH with obesity over time.
Methods: The data base of the Toronto General Hospital Immunodeficiency Clinic was screened for PLWH with more than one documented body mass index (BMI) between 2000-2021. When >1 BMI was recorded within a calendar year, the highest value was used. BMI was modeled using univariable and multivariable linear Generalized Estimating Equations with an exchangeable correlation matrix, adjusting for calendar year, age, gender, and race.
Results: A total of 2314 PLWH were included in the analysis. Median (IQR) age was 56 (46-62), 81% male, and 51.6% white. The proportion with obesity (defined as BMI >=30) increased from 9.4% in 2000 to 28.5% in 2021. Increasing calendar year was associated with higher BMI (adjusted β=0.11, 95% confidence interval 0.09, 0.14, per year) after adjusting for age, gender, and race.
Conclusion: Obesity rates are increasing among PLWH. This could contribute to an increased risk of metabolic syndrome and associated complications. The role of HIV-specific contributors to weight gain, such as ART is under investigation. PLWH need regular counselling on strategies to achieve and maintain healthy weight.

Background: An association between integrase strand transfer inhibitors (InSTIs) and the development of diabetes mellitus (DM) has been reported. Here we describe the development of new DM, and the worsening of DM in patients with pre-existing DM, after exposure to selected InSTIs

Methods: Adults with HIV and DM who received dolutegravir, bictegravir or elvitegravir for at least 1 month were eligible for this observational study. Patients were excluded if they had gestational DM or steroid-induced hyperglycemia. Patient demographics, clinical characteristics and DM outcome of new diagnosis or DM worsening (defined as an increase in HbA1c by ≥ 0.5% and/or the addition of new antihyperglycemic medication) were recorded from the time of most recent exposure to selected InSTIs between November 2012 and March 2021. A univariate analysis was conducted to compare clinical characteristics between those with worsening versus no worsening DM.

Results: We identified 142 patients with HIV and DM, of which 86 patients met inclusion criteria. Over an average follow up of 3.6 years from the initiation, switch between or change to an InSTI, 35 patients (40.7%) were newly diagnosed, 39 (45.3%) had a worsening and 12 (14%) did not have a worsening of DM. The time from InSTI exposure to new diagnosis or worsening was a median [IQR] of 619 [352, 885] and 330 [256, 404] days, respectively. The median absolute increase in HbA1c was by 2.1% and 1.5% in the new diagnosis and worsening groups, respectively. Weight gain was also observed in both groups. Age, gender, region of origin, InSTI and TAF use did not differ between groups.

Conclusion: This is the first analysis that describes a worsening of DM after exposure to selected modern InSTIs. New diagnoses and worsening of DM were common in our patient population and occurred over a relatively short time frame

The vaginal microbiota (VMB) plays a critical role in mediating vaginal inflammation, barrier function, and susceptibility to sexually transmitted infections. Profiling the VMB can elucidate mechanisms through which the VMB affects clinical outcomes such as bacterial vaginosis. To determine which VMB sampling method(s) provide high quality, consistent VMB profiles, a cross sectional study comparing VMB sampling methods was designed with ethics approval from the McMaster Human Ethics Board. Following informed consent, 23 cervicovaginal lavages (CVLs), corresponding vaginal swabs taken by a nurse, as well as 14 participant collected vaginal swabs were obtained from women aged 19-35 from the GTA. Extracted DNA was subjected to 16S rRNA gene and V3-V4 region nested PCR, then Illumina MiSeq sequencing to examine the VMB. Amplicon sequence variants were generated by DADA2, taxonomy assigned using SILVA, and sequencing depth, alpha and beta diversity, as well as relative abundances were assessed in RStudio. Kruskal-Wallis with Dunn’s post hoc tests were performed in GraphPad. 16S rRNA sequencing depth of VMB samples ranged from 3928-53717 reads and was not significantly different between the three sampling methods (p=0.85). No significant differences in inverse Simpson diversity index values were observed between sampling methods (p=0.81) as values were low (<3.5), except 2 participants had values >5 for each sample. Principal coordinate analysis using Bray-Curtis dissimilarity depicts most samples clustering by the participant regardless of the sampling method. Correspondingly, the bacteria identified was consistent between sampling methods from each participant, with some differences in relative abundances. Lactobacillaceae relative abundance was >90% in all samples, exception for 1 self swab (79%), 1 participant with a high abundance of Sneathia amnii, and 2 participants with polymicrobial profiles. Overall, CVLs, nurse and self-collected vaginal swabs are all suitable sampling methods for consistent VMB profiling by 16S rRNA gene sequencing, enabling mixing of different sampling methods.

Decreased Lactobacillus colonization and increased microbiota diversity in the vaginal tract are features of bacterial vaginosis (BV), which has a higher prevalence in African/Caribbean/Black (ACB) women and is associated with vaginal inflammation and increased risk of HIV infection. To modify these BV features, we investigated if administration of estradiol intravaginally alone or in combination with probiotics is safe in pre-menopausal women.

Forty-six ACB women aged 18-49 from the Toronto area enrolled in this phase I trial (CTN 308; Clinicaltrials.gov NCT03837015). Following collection of baseline samples, participants were randomized to: RepHresh™ Pro-B™ (1x10⁷ cfu total of L. rhamnosus GR-1 and L. reuteri RC-14 per capsule) probiotic vaginally twice daily in combination with the intravaginal estradiol Estring® (7.5μg/day), twice daily oral probiotics with the Estring, vaginal probiotics alone, or the Estring alone. Intervention was given for 30 days, and participants returned a week later for final assessment. Adverse events (AEs), blood glucose, complete blood count, comprehensive metabolic and lipid panels were used to evaluate safety.

A total of 83 AEs were reported by 27 (59%) participants, 59 (71%) of which were mild in intensity and 78 (94%) resolved by the end of the study. No severe AEs were reported. The most frequently reported AEs were vaginal irritation/burning/itching, cramps/abdominal pain, and headache. Vaginal irritation/burning/itching was the only AE reported more than once by multiple participants (5, 11%). Three (7%) participants reported cramps/abdominal pain, headache, light headedness and/or nausea of severe intensity 1-2 times, which resolved by study completion. Insomnia, vaginal irritation/itching, breast tenderness, and headache were ongoing at the end of the study for 3 (7%) participants. No clinically significant blood marker changes were observed.

No severe AEs were observed, and the majority of AEs were mild and short-term. Overall, administration of intravaginal estrogen and probiotics alone or in combination is safe.

Introduction: The use of Antiretroviral therapy (ART) drastically reduces vertical transmission of HIV. However, recent studies have demonstrated associations between ART use during pregnancy and placental dysfunction and inflammation, particularly within protease inhibitor (PI)-based regimens. We sought to analyze the relationship between the class of ART used during pregnancy and associated placental inflammation.
Methods: The placentas of 81 women living with HIV (WLWH) who were treated with ART since the time of conception and 30 uninfected women were collected. All pregnancies were full term. WLWH were stratified into three groups based on classes of ART: 22 women were treated with nucleoside reverse transcriptase inhibitors (NRTI) + non-nucleoside reverse transcriptase inhibitors (NNRTI), 26 were on NRTI + integrase inhibitors (II), and 33 were on NNRTI+PI. Four randomly selected areas within the villi of each placenta were used to measure cell surface expression of CD45, CD68 (M1; proinflammatory), and CD163 (M2; anti-inflammatory) using immunohistochemistry.
Results: Placentas from WLWH contained significantly more CD45+ cells than those from the uninfected controls (p<0.05). Significantly higher numbers of total and M2 macrophages were observed in placentas from the NNRTI+II (p=0.01) and NNRTI+PI (p=0.001) groups compared with uninfected controls, while significantly higher M2/M1 ratios were found in placentas from the NRTI+NNRTI group (p=0.01). There were no significant differences between placentas from WLWH and uninfected controls in terms of M1 macrophages.
Conclusion: Placentas from WLWH who were treated on any class of ART during their entire pregnancy exhibited higher levels of anti-inflammatory macrophages compared to uninfected women despite controlling for viral load. Further investigations into the role of M2 cells in the context of macrophage-mediated compensatory mechanisms are required to suggest a protective effect with regards to ART-associated placental dysfunction.

Objective: In research people are often asked to fill out questionnaires about their health and functioning. It is common that these questionnaires contain items that reflect serious health concerns. Typically, these concerns are not identified until the statistician analyses the data. An alternative is to use an individualized measure where people are asked to self-nominate areas of concern which can then be dealt with in real-time. The relevance of this approach to identify mental health concerns has not been explored in people aging with HIV.
Objective: Estimate the extent to which a self-nomination of areas related to mood, anxiety, and cognition on the PGI predict the presence or emergence of depression, anxiety, or cognitive impairment among people living with HIV at baseline and for successive assessments over 27-months.
Methods: The data comes from participants enrolled in the Positive Brain Health Now (+BHN) cohort (n=856). The nominated areas were category coded to a sentiment framework. A longitudinal design was used to link self-nominated sentiments to presence or emergence of anxiety, depression, or low cognitive ability as assessed using standardized measures of these constructs. Logistic regressions were used to estimate the goodness of fit of each model using the c-statistic.
Results: The sentiments categorized as ‘emotional’ predicted all of the mental health outcomes at all visits with adjusted odds ratios (OR) ranging from 1.61 to 2.00 and c-statistics >0.73 (good to excellent prediction). Nominating an anxiety sentiment was specific to predicting anxiety and mental health (OR: 1.65 & 1.52); nominating a cognitive concern was specific to predicting self-reported cognitive concerns (OR: 4.78). Positive sentiments predictive of good cognitive function (OR: 0.36).
Conclusions: This study indicates the value of using this semi-qualitative approach as an early-warning system in predicting brain health outcomes from spontaneously nominated life areas within the Patient Generated Index (PGI).

Background: With combination antiretroviral therapy, children living with HIV now survive to transition into young adults living with HIV (YLWH). Research has shown that transition from pediatric to adult care is associated with poor outcomes, increased mortality, loss to follow-up (LTFU), and decreased treatment adherence. We describe retention in care and health outcomes of Canadian YLWH transitioned from pediatric HIV care at CHEO to adult HIV care at The Ottawa Hospital (TOH).

Methods: Retrospective review was performed on those meeting eligibility criteria: entered TOH care between 1999-2019, HIV acquired/diagnosed in childhood, engagement in pediatric HIV care before transfer, and seen at TOH HIV clinic at least once post-transfer. LTFU was defined as not seen for ≥12 months at the time of data collection. Data collected included: viral loads (VL), CD4 counts, incidence of mental illness and substance use, and treatment adherence.

Results: We describe 22 transitioned patients (10 cis-females, 12 cis-males), median age of 18 years at the time of transition. Median CD4+ count was 521 cells/μL at first visit and 290 at 3 years post-transition. 9/22 (41%) had detectable VL at time of transition, versus 5/20 (25%) at 3 years. 63% reported substance use (marijuana, alcohol, narcotics), and 45% had experienced mental illness (anxiety, depression or schizophrenia). Half remained in care at TOH, while the remainder were LTFU. One patient died. Treatment adherence was intermittent in 18/22 (82%) patients. In the LTFU group, the shortest period in care was 138 days and the longest was 11 years (median 4.7 years).

Conclusion: In this study, long-term survivors of pediatric HIV demonstrated high levels of difficulties remaining on treatment and in care, with significant burden of substance use and mental health problems. Future research should probe YLWH’s transition experiences and determine factors that predict success or failure of the transition process.

Background
Rapid start of antiretroviral therapy (ART) for patients newly diagnosed with HIV reduces time to virologic suppression (VS) and hence transmission. Evaluation of rapid start programs in Canada may help identify at-risk populations and target future interventions.

Methods
We performed a retrospective review of the rapid start ART program at the largest HIV clinic in Edmonton, Alberta from inception (September 2019) to February 2021. All patients with a new HIV diagnosis were included and cases were followed for at least 6 months. Patient demographics, time from positive HIV report to first clinic visit, time to ART initiation, and time to VS (viral load < 200 copies/mL) and MD follow-up visit were recorded. We compared subgroups by ethnicity, residence, and presence of health coverage to analyze the impact of demographic factors on outcomes.

Results
65 patients were identified. Twenty (30%) were Indigenous and 20 (30%) were Caucasian. Median time from positive HIV report to intake visit was significantly longer for Indigenous compared to Caucasian patients (24 vs 13.8 days, p = 0.014). ART (INSTI-containing in 64) was initiated within 24 hours of visit in 66% and within 7 days in 78%. We documented VS in 61 (93.8%) patients, with a median of 35 days. Time to VS was longer in Indigenous than Caucasian patients (median 55.5 vs 35 days, p = 0.007), and in those living outside Edmonton versus in Edmonton (77.6 vs 48.7 days, p = 0.014). Median time to MD follow-up was longer for Indigenous than Caucasian patients (54 vs 46 days, p = 0.083), but this was not statistically significant.

Conclusions
Implementation of a rapid start ART program in Edmonton has had demonstrated success, with 94% of patients achieving VS in under 60 days. Targeted interventions should address Indigenous and non-Edmonton residents’ barriers to access care.

Background: The HIV program in NL provides care for all persons living with HIV (PLWH) in NL, yet progress toward 90-90-90 goals for diagnosis, linkage to care and viral suppression has not previously been documented. This analysis describes engagement in HIV care and virologic outcomes for the NL cohort in 2016 and 2019 and compares 2016 NL cohort data to the Canadian HIV Observational Cohort (CANOC).

Methods: A retrospective review of the NL clinic was performed. Individuals were considered under care and included if they were adults aged 18 years or older with at least one CD4 and one viral load (VL) measurements in the calendar year of study. Descriptive statistics for demographics, risk factors, and clinical variables were assessed and variables compared using χ2 test or Fisher’s Exact test (categorical) or Wilcoxon Sum Rank test (continuous).

Results: Characteristics of the NL HIV cohort remained consistent between 2016 and 2019 but differed significantly from CANOC (Table 1). Engagement in care and virologic outcomes were consistently from 2016 to 2019: 100% engaged in care (no change), 99% and 98% on antiretroviral therapy (ART), and 92% and 94% VL suppression. Cascade of care parameters were higher for NL than for CANOC: 100% vs. 88% engaged in care (p<0.001), 99% vs. 87% on ART (p<0.001), and 92% vs. 76% VL suppression (NS).

Conclusions: Despite being an older cohort and living with HIV longer, engagement in care and virologic outcomes among PLWH in NL is high and compares favorably to a national cohort. 

Introduction: HIV reproductive planning is informed by science and patient preferences. In 2018, a transdisciplinary team re-developed the Canadian HIV Pregnancy Planning Guidelines (CHPPG) – an evidence-based clinical guideline on HIV pregnancy planning. Our objectives were to explore Canadian HIV clinicians’ awareness and implementation of the CHPPG and willingness to counsel on pregnancy planning, as well as educational interest.

Methods: REDCap surveys were distributed by AMMI, CHAP, CANAC, and a novel listserv of ‘other’ HIV clinicians (mostly family physicians). Main outcomes included the proportion of Canadian HIV clinicians that were aware of the CHPPG, and whether those who were aware had implemented the CHPPG. Additional outcomes measured include willingness to counsel and interest in potential educational opportunities on the topic.

Results: Seventy-five participants initiated the survey [27 pharmacists (36%), 25 family physicians (33.3%), 9 infectious disease physicians (12%), 8 nurse/nurse practitioners (11%), and 6 other clinicians (8%)]. Forty-five (60%, p=0.46) participants were aware of the CHPPG; however, 21/45 (46.7%) hadn’t read it. Awareness of the guidelines varied across professionals; nurse respondents were the most likely to report being aware (6/7, 87.5%; NS). Of those who were aware and had read it, 20/24 (83.3%) reported using the guidelines. 52.5% (n=35/67) of respondents had provided pregnancy planning counselling in the prior 12 months; 3/32 (9.4%) respondents who hadn’t provided pregnancy planning counselling in the prior 12 months were unwilling to. 56/67 (83.6%) respondents expressed interest in learning more about pregnancy planning and HIV indicating that they were somewhat/very interested.

Conclusions/implications: Canadian HIV clinicians have limited awareness of the CHPPG; implementation is similarly limited. However, willingness to offer HIV pregnancy planning counselling and interest in learning more on this topic were high. Opportunities for dissemination of the CHPPG among Canadian HIV clinicians are required to ensure care based on the best available evidence.

Introduction: Saskatchewan has had the highest incidence of HIV nationally for over a decade. Beginning in urban centres, HIV spread to rural and remote areas in Saskatchewan, leading to the emergence of unique rural care models to address gaps in HIV care services. We describe a clinic-led outreach model where urban physicians, nurse practitioners and nurses travel ~200-250km from their home base to conduct monthly satellite clinics at regional local hospitals.
Methods: Existing documentation and key stakeholders engagement were used to describe the care model. Data was extracted for clients accessing care between 01/01/2018-12/31/2020 from an electronic medical record system. Demographics and clinical outcomes were described, including the proportion of active clients on treatment and virally suppressed (defined as at least one ART prescription in the calendar year and the last viral load within the calendar year <200 copies/mL, respectively).
Results: The care model, initiated in 2016, relies on local services including opioid substitution therapy and pharmacy. Phlebotomy services were introduced in 2020 by the outreach team due to limited local services. In-person clinics were temporarily suspended due to the COVID-19 pandemic and replaced by virtual care. Out of 48 HIV clients in care between 2018-2020, 70% of clients were HCV co-infected, 54% were males and the average age was 45 years (SE±2.07). 69% of clients resided in nearby First Nation communities. In 2018, 51% of clients were on treatment, of whom 55% were virally suppressed. These outcomes increased in 2019 and by 2020: 76% of clients were on treatment, of whom 66% were virally suppressed.
Conclusions: Despite the disruptions of COVID-19, this remote clinic outreach model achieved improvements in the cascade outcomes. The improvements reflect progress in establishing relationships, building trust with clients and the utility of virtual care to maintain patient care during a pandemic.

Persons living with HIV (PLWH) are disproportionately affected by COVID-19. Fortunately, vaccines improve COVID-19 immunity amidst tolerable adverse events.
ChAdOx1 nCoV-19 and BNT162b2 mRNA COVID-19 are two COVID-19 vaccines found to induce similar immune responses in both PLWH and non-HIV patients; however, post-vaccination viral loads were never quantified in the former, and interestingly increased in the latter from undetectable to 47, 52, and 92 copies/mL, in three patients over two weeks post-2nd BNT162b2 vaccination. Such viremia (‘viral blips’) are known to occur with PLWH and influenza vaccines.
The current case study describes this viremia eight weeks post-ChAdOx1, but not post-BNT162b2, vaccination.
The patient is a 65-70 year-old male in Ontario, Canada, diagnosed in 2003 with HIV (230 cells/uL CD4 cell count nadir and a 23,625 copies/mL viral load). While on TAF/FTC/RPV ART, his CD4 cell count was 391 cells/uL (February, 2020), with an undetectable viral load (January, 2021). His first ChAdOx1 vaccination was March 31st, 2021.
On May 28th, 2021, his viral load climbed to 422 copies/mL, despite a reported perfect medication compliance, with no medication changes or infections. Resistance testing showed no mutations. On June 7th, 2021, his viral load decreased to 102 copies/mL, then became undetectable ten days later. On June 22nd, 2021, he received the BNT162b2 vaccine. Viral loads on June 29th, and July 28th, 2021, remained undetectable. Of note, he requested to change from TAF/FTC/RPV to DTG/FTC on June 25th, 2021.
This case report is unique in that the viral blip was found eight weeks post-ChAdOx1, and may have been higher if it had been measured 2-3 weeks post-ChAdOx1 vaccine. Additionally, a viral blip was not observed (both one and five weeks) post-BNT162b2 vaccination. Finally, mixing COVID-19 vaccines is novel and this case may provide additional safety data and considerations for PLWH receiving mixed vaccines.

Background: Initiation of antiretroviral therapy (ART) is a critical step in the HIV continuum of care. Inpatient admission may provide an opportunity to engage vulnerable populations living with HIV (PLWH).

Methods: A retrospective study of adults (19 years or older) PLWH enrolled in the British Columbia HIV Drug Treatment Program who initiated ART January 2003 - December 2019 was conducted. A multivariable logistic model for factors associated with in-hospital vs. community ART start was performed, adjusting for age, gender, HIV transmission group and AIDS illness. Viral suppression (<50 copies/mL) at one, two and three years after treatment initiation was compared for in-hospital vs. community initiation.

Results: A total of 5434 individuals initiated ART during the study period; 5052 (93%) were initiated in the outpatient setting, and 272 (5%) in-hospital. Age per 10-year increment (adjusted Odds Ratio [aOR] 1.19, CI: 1.06-1.35), female gender (aOR 1.61, CI: 1.16 - 2.24), year of ART initiation per 1-year increment (aOR 1.19, CI: 1.15-1.23), history of AIDS defining illness prior to ART start (aOR 5.43, CI: 4.06-7.24), history of injection drug use (aOR 2.52, 1.67-3.81), and MSM with history of injection drug use (aOR 2.85, CI: 1.56-5.21) were significantly associated with ART starts in hospital. Virologic suppression at one year was lower for in-hospital vs. community (79% vs. 93%, p < 0.001) initiation, but was similar after two (94% vs. 94%, p = 0.956) and three (96% vs. 96%, p = 0.924) years.

Conclusion: Individuals initiating therapy in hospital were more likely to have advanced HIV or history of injection drug use. Long-term virologic suppression was similar for in-hospital and outpatient initiation. Efforts to improve healthcare provider comfort with ART initiation during hospital stays and linkage to outpatient follow-up may be warranted.

Several studies have demonstrated a clear link between childhood sexual abuse and HIV risk among gay, bisexual and other men who have sex with men (GBMSM). Much less is known, however, about other forms of abuse including adult sexual abuse and family/intimate partner physical violence. To explore this, data were collected from an anonymous online survey of GBMSM in Ontario conducted from June 2018 to March 2019. Of 1755 respondents, the mean age was 38.1 years (SD = 15.2), the vast majority (83%) were white and just over half (58%) lived in an urban setting. One in six (16.3%) reported a history of childhood sexual abuse and one in five (19.4%) reported being forced as an adult to have sex against their will. Just over a third (35%) indicated a history of physical abuse by a partner or family member. Among those who were physically abused, 31.7% were also sexually abused as an adult. Being out to everyone or most people was associated with an increased risk of both adult sexual and physical abuse suggesting GBMSM who are out may become targets for abuse. Further, men who were HIV+ were more likely to suffer physical violence and nearly twice as likely to be forced to have sex. In terms of HIV risk factors, sexual anxiety and substance use including recreational drug use during sex were all positively associated with a history of sexual and/or physical abuse while condom use declined with all three forms of abuse. These data indicate an alarming prevalence of abuse among GBMSM and, while we cannot distinguish cause from effect, sexual abuse and family/intimate partner violence are associated with substance use and increased sexual risk. We strongly advocate for greater awareness and more discussion of these challenges along with more research on safe disclosure and support.

Our study compares adherence depending on HIV acquisition at infancy/childhood versus adolescence/early adulthood. All patients under 30 years living with HIV, followed in three Canadian centers were included: patients with HIV diagnosed before age of 10 years (group 1) (n=66) and patients diagnosed between 10 and 25 years (group 2) (n=62). A chart review was conducted to collect data on treatment adherence according to physician, immunovirologic control and resistance. An electronic survey was sent to evaluate self-reported adherence, causes of non-adherence, and willingness to use an injectable regimen. With the retrospective chart review, we did not find a statistically significant association between group and treatment adherence (83% vs. 90%; p=0.24). Patients with poor or insufficient adherence to therapy were more at risk of poor or incomplete efficacy (aOR, 68.90; 95%CI [16.4-289.5]). There were significantly more patients with good immunological and virological ART efficacy in group 2 (93.5% vs. 78.8%; p=0.02). We observed significantly more ART classes impacted by resistance mutations in group 1 (0.89±1.10 vs. 0.29±0.69, p=0.002). On the basis of resistance, there is a trend for more eligible patients for long-acting injectable cabotegravir/rilpivirine in group 2 (90.3% vs 80.3%, p=0.12). With the electronic survey, we did not find a statistically significant association between group and treatment adherence considering the number of missed pills over seven days (0.56±1.12 vs. 0.20±0.40, p=0.13). Patients in group 2 seemed to be more interested in the injectable treatment than patients in group 1 (73.3% vs. 56.3%, p=0.32). Despite similar adherence in both groups, we were able to confirm that immunological/virological efficacy is less often achieved and that HIV presents more pharmacological resistance in the group infected from childhood. Even though many young patients may be interested in long acting injectable antivirals, it is important to consider previous genotypes to ensure eligibility.

Background: Bacterial sexually transmitted infections (STI) (syphilis, chlamydia and gonorrhea) have been increasing dramatically, disproportionately affecting gay, bisexual, and other men who have sex with men (gbMSM). Novel tools are needed to prevent STIs and reduce complications. The antibiotic doxycycline has shown promise in preventing STIs in small studies but were not adequately powered to fully address drug efficacy in the prevention of bacterial STIs. Thus, a comprehensive study is warranted on doxycycline for STI prevention to definitively assess efficacy, safety, and antimicrobial resistance (AMR) – a potential, risk factor of unclear significance. The DISCO study will assess efficacy, tolerability, and acceptability of doxycycline in preventing incident bacterial STIs over the long-term.

Methods: This prospective, open-label, three-arm randomized controlled trial will enroll 447 sexually-active, adult gbMSM and transgender women with a recent (≤12 months) STI from clinical sites in Vancouver, Calgary, Montreal, Toronto, Ottawa, and Hamilton. Randomization will occur in 1:1:1 ratio: STI pre-exposure prophylaxis (PrEP; daily doxycycline 100mg); STI post-exposure prophylaxis (PEP; doxycycline 200mg within 72h of exposure, to a maximum of 600mg weekly); standard-of-care (no doxycycline). Follow-up visits occur quarterly to Week 60. Primary outcome is incident STIs over the study period. Secondary outcomes include organism-specific STI incidence, treatment-emergent adverse events, changes in sexual-risk behaviour, AMR patterns of commensal nasopharyngeal organisms, tetracycline resistance in gonorrhea, and medication adherence.

Anticipated Results: We hypothesize that doxycycline as both STI-PrEP and -PEP will be efficacious in preventing incident STIs compared to standard-of-care, and that doxycycline will be an acceptable, well-tolerated intervention with little-to-no impact on AMR.

Conclusion/Significance: This large-scale, RCT will be the first intervention study to do a head-to-head comparison of STI PrEP and PEP, with the potential to provide evidence of their efficacy, safety, and AMR to reduce the impact of STI-related complications among gbMSM and transgender women.

Background
Annual anal pap smears have been recommended in some guidelines for MSM living with HIV. The practicality of this strategy, especially during the pandemic, is unknown.
Methods
We performed a chart review of all MSM living with HIV who received at least one anal pap smear at the HIV clinic in London, Ontario between January 2018–October 2021. During the pandemic period a large proportion of physician visits were virtual, however patients who were eligible were booked for in person visits with a nurse for anal pap screening. Patients with LSIL or higher-grade lesions were referred to colorectal surgery.
Results
301 anal pap smears were done in 200 unique patients. 17/200(8.5%) patients had at least one anal pap showing LSIL or higher-grade lesion, of which 13/17 were detected on the first anal pap. Of 32 patients who had a baseline normal anal PAP which was repeated within 9-15 months, 2(6%) progressed to LSIL or a higher-grade lesion within that time. 12/17(70%) patients attended a colorectal surgery appointment for anoscopy, and 7 of these patients required surgery. 5 patients declined referral. 3 patients had their surgery delayed more than 6 months due to COVID shutdowns. 96/386(25%) of eligible patients had anal paps done in the 18 months prior to the pandemic (Oct 1,2018-March1,2020) and 154/386(40%) patients were tested in the subsequent 18 months. No patients developed new metastatic anal cancer during this period.
Conclusions
Anal pap smears were able to be performed within the HIV clinic setting even during the COVID-19 pandemic. The rate of patient screening actually rose during this time with many patients attending with the nurse specifically to have the anal pap, but further efforts to increase the percentage of patients screened are warranted. Some patients experienced marked delays in surgery due to the pandemic.

Background
In Ontario and Manitoba, Hepatitis C therapy is not funded for inmates in the provincial correctional system. The efficacy of seeing patients while incarcerated in order to link them to subsequent outpatient care is unknown.

Methods
Two Infectious Diseases physicians and one Hepatitis C Nurse conducted consultations in a provincial jail in London, Ontario. Charts were reviewed for outcomes.

Results
209 mono-infected Hepatitis C patients were assessed between January 2017-October 2021. 11 were treated while incarcerated via obtaining coverage as a purported outpatient, prior to this option being closed in March of 2020. One patient with decompensated cirrhosis was released briefly to allow outpatient treatment before being re-incarcerated. One patient followed up for outpatient treatment and obtained sustained virologic response (SVR). In total, SVR was obtained in 6 out of 209 (2.9%) inmates assessed. Since the closure of the option to obtain outpatient HCV treatment coverage from the provincial plan while incarcerated, no further treatment has occurred.

Conclusion
Consultations while incarcerated does not lead to linkage to care post release, even when contact information to the clinic including a picture and map of the location was provided. The policy of not covering Hepatitis C medications while incarcerated in a provincial institution needs to be reconsidered.

Background: The HIV care cascade monitors the success of HIV care programs by assessing that people living with HIV (PLWH) are linked to care, on combination antiretroviral therapy (cART), and are virally suppressed. We sought to characterize and determine correlates of HIV care engagement among participants of a large Canadian clinical cohort from 2013 to 2016.

Methods: Data from PLWH were obtained from CANOC’s 11 sites in 5 provinces. We estimated annual proportions meeting the engagement in care indicators: 1) in care (1 viral load, VL, per year); 2) on cART (at least one prescription per year); and 3) viral suppression (<200 copies/mL). We assessed correlates for each indicator using generalized estimating equation with log-link and binomial distribution.

Results: From 2013 to 2016, there was an increase in the proportions of participants in care, on cART, and with suppressed viral load (Table 1). Similar increases were observed across provinces, genders, age groups, hepatitis C virus (HCV) status, and HIV risk factors. The annual proportion of participants with viral suppression was < 90% for females, age <30, people who inject drugs (PWID), HCV, non-men sex with men (non-MSM), and Saskatchewan. We found lower odds of care engagement for PLWH in Saskatchewan vs. British Columbia, and for PWID and heterosexual HIV risk category compared to MSM only.

Conclusions: We observed high proportions of HIV care engagement which increased over time and identified factors that correlated with lower odds of engagement. These findings suggest the need for targeted care engagement programs and initiatives.

OBJECTIVE: Our aim was to examine changes in body composition among people living with HIV (PLWH) engaged in a community-based exercise (CBE) intervention.

METHODS: We conducted a 22-month interrupted time series study with PLWH recruited from community. We measured body mass index (BMI)(primary outcome), weight, fat weight, fat free mass, body fat percentage bimonthly across three phases: 1)Baseline Monitoring (8 months), 2)CBE Intervention: participants were asked to exercise 3 times/week, with weekly coaching (6 months), and 3)Follow-Up: participants were asked to continue with thrice weekly exercise independently (8 months). We used segmented regression to assess the change in trend (slope) between phases.

RESULTS: Of the 108 participants who initiated the study, 80(74%) started and 67/80(84%) completed the intervention; and 52/67(77%) completed the study. Of 102 participants with body composition data, the median age was 51 years (25th,75th percentiles:44,59), with a median of 4(2,7) concurrent health conditions. Baseline BMI(sd) was 25.6(5.2)kg/m² for males (n=91) and 31.3(7.7)kg/m² for females (n=11). Median number of coaching sessions attended was 18/25(72%). Decrease in BMI attributed to the six-month Phase 2 intervention after taking the baseline into account was 0.38kg/m² (95%Confidence Interval(CI):-0.76,-0.01). Trends attributed to the intervention were observed for reductions in weight (-0.86kg; 95%CI:-1.76,0.03), fat weight (-0.45kg; 95%CI:-1.12,0.21), fat free mass (-0.50kg; 95%CI:-1.29,0.28), and body fat percentage (-0.28%; 95%CI:-0.98, 0.42). For the monthly rate of change (slope), there was a significant decrease in fat weight (-0.10kg/month; 95%CI:-0.12,-0.03) and body fat percentage (-0.1%/month; 95%CI:-0.18,-0.03) in Phase 2. During Phase 3 follow-up, there was a significant reduction in trend of benefits observed during the intervention phase for fat weight.

CONCLUSION: Little to no variation in body composition occurred across the phases. This may be because the intervention was not tailored towards changes in body composition, or because the intervention dose was not high enough to affect change.

PURPOSE: 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.

METHODS: We conducted a mixed methods study with adults living with HIV and HIV health care providers in Canada, Ireland, and United States. We electronically administered the SF-HDQ followed by a sensibility questionnaire (face and content validity, ease of usage, format) and conducted semi-structured interviews (exploring potential utility and implementation of the SF-HDQ in clinical practice). We considered the SF-HDQ sensible if median scores on the sensibility questionnaire were ≥5 out of 7 for adults living with HIV and ≥4 out of 7 for HIV health providers for ≥80% of the items. Qualitative interview data were analyzed using directed content analysis.

RESULTS: Median sensibility scores were ≥5 for adults living with HIV (n=29) and ≥4 for HIV health providers (n=16) for 95% of items (18/19 items). Qualitative data indicated that the SF-HDQ represented the health-related challenges (disability) of living with HIV and other health conditions (where HIV was not the source of disability), captured the daily episodic nature, and was easy to use or complete. Potential utility of the SF-HDQ included measurement of health challenges and change over time, guiding referrals to services, informing goal setting, facilitating communication, and fostering self-reflection of health domains living with HIV. Considerations for implementation included flexible, person-centred approaches to mode and processes of administration, and communicating scores based on personal preferences among persons living with HIV and HIV health providers.

DISCUSSION: The SF-HDQ appears to possess sensibility and utility for use in clinical settings with adults living with HIV and HIV health providers in three countries. Next steps include developing a guidance document for implementation.

INTRODUCTION:
With the introduction of integrase strand transfer inhibitors (INSTI) based combined antiretroviral therapy (cART), persons with HIV (PWH) have a well-tolerated and potent new treatment option. Metabolic effects including hyperglycemia have been reported with INSTI based cART. In this study we analyzed the magnitude of the change in hemoglobin A1C (HbA1C) seen in diabetic and non-diabetic patients who start INSTI based cART and how this change compares to other HIV classes.
METHODS:
We conducted a retrospective cohort study of PWH at the Southern Alberta Clinic who started on cART, including INSTI, protease inhibitor (PI), non-nucleoside reverse transcriptase inhibitors (NNRTI), >90 days between 2010-2019. We assessed the change in HbA1C pre-cART start and post-cART start. Diabetic and non-diabetic PWH were stratified by cART class and then further stratified by INSTI medication. In a sub-group analysis, we compared diabetic PWH with a starting HbA1C of <8.5 versus HbA1C of ≥ 8.5.
RESULTS:
A total of 1114 PWH were included (937 non-diabetic ∕ 177 diabetic, 73% male ∕ 27% female). Non-diabetic PWH had an average change in % HbA1C of 0.02 (SD 0.37) with INSTI start (n=769) versus 0.03 (SD 0.26) with NNRTI start (n=115) p=.881. Diabetic PWH had an average change in % HbA1C of 0.57 (SD 1.24, average days between HbA1C tests= 230) with INSTI start (n=105) versus 0.35 (SD 0.75, average days between HbA1C test =280) with NNRTI start (n=19) p=.461.

CONCLUSION:
In our non-diabetic PWH population there was no significant change in HbA1C in patients started on INSTI vs NNRTI. In our diabetic patient population, the HbA1C increases was larger after INSTI start versus NNRTI start but not statistically significant. There were many confounding factors which were not accounted for and additional studies on the effect of integrase inhibitors on HbA1C are recommended.

Background
Individuals’ self-perception of HIV risk does not always align with the risk assessments generated by clinical screening tools. We compared self-perceived versus clinically assessed risk of HIV and reasons for perceived low risk among GBM from large cities in Ontario and British Columbia.

Methods
Cross-sectional survey between July/2019 and August/2020. Among never PrEP users, we contrasted self-assessed HIV risk against criteria from the Canadian PrEP guideline: condomless anal sex in the past six months with any of the following: a HIRI-MSM score>11, syphilis, rectal gonorrhea/chlamydia, post-exposure prophylaxis (PEP) use>2. Participants provided a written explanation of their self-assessment, including their strategies to avoid HIV infection. The main themes were compared with number of sex partners and number of condomless anal sex acts; those with numbers exceeding the highest values of their peers, were considered to be possibly underestimating their HIV risk.

Results
Of 315 participants who perceived themselves to be at low risk, 146 (46%) were considered at high risk based on criteria from the Canadian PrEP guideline (labeled “discordant”). Reasons for perceiving themselves at low risk of HIV in the discordant group included: condom use, being in a committed relationship/having one main partner, no or infrequent anal sex and having few partners (Figure). We estimated that 39% may, possibly, underestimate their HIV risk (Figure).

Conclusions
More efforts to increase GBM’s HIV risk awareness and of evidence-based HIV prevention options are needed. Contextualizing individuals’ sexual behaviours in relation to that of their peers could aid efforts to increase PrEP uptake.

Background: Chronic pain is common among people living with HIV, affecting quality of life, mental health, and clinical care. Data describing chronic pain among women living with HIV (WLWH) are limited. This interim analysis describes chronic pain prevalence and characteristics among WLWH and HIV-negative control women.
Methods: The BC CARMA-CHIWOS Collaboration (BCC3) study examines healthy aging among WLWH in British Columbia. We used the Brief Chronic Pain Questionnaire (BCPQ) to screen for chronic pain, then validated survey instruments to describe chronic pain alongside questions about mental health, medication/substance use, sleep quality, and resilience (see Table 1). Groups were compared by t-test, Chi-Squared test, and logistic regression.
Results: Between January-November 2021, 66 WLWH and 64 controls (mean age 48.9±12.2 vs. 44.1±15.5, p=0.049) completed the survey. WLWH were more likely to screen as having chronic pain on the BCPQ (41% vs 23%, p=0.04), however the difference disappeared after adjusting for age. WLWH most frequently reported pain in lower back (70%), neck (52%), upper back (41%), and foot/ankle (37%). Controls reported pain in shoulder (53%), lower leg (47%), neck (47%), and abdomen (40%). Table 1 summarizes the study observations.
Conclusions: In this limited sample, we did not observe differences in chronic pain prevalence among WLWH vs. controls. Both groups appear to show substantial coping abilities despite high pain intensity and interference, and similar substance use to cope with pain. Further analysis of chronic pain correlates in the fully enrolled BCC3 cohort will help inform action(s) to improve quality of life for WLWH.

Background
People living with HIV have more physical health challenges such as problems with fatigue, mobility, and gait relative to their HIV-negative counterparts. Physical challenges have received little attention in the literature despite being associated with an increased fall risk, greater mortality, and reduced health-related quality of life.

Objective
The purpose of this study is to estimate the prevalence of physical health challenges from areas that patients spontaneously report as substantially affecting their quality of life.

Methods
The patient generated index (PGI), a personalized health-related quality of life instrument, was administered to 809 people living with HIV drawn from the Brain Health Now cohort across five sites in Canada. In the PGI, participants are asked to indicate, in their own words, the five most important areas of their lives affected by HIV. PGI text threads were coded according to the World Health Organization’s International Classification of Functioning, Disability, and Health (ICF). The rate and content of nominated physical health problems were tabulated.
Results
PGI text threads were coded to 18 domains of the ICF. 248 [31%; 95% CI (27.6, 33.9%)] of respondents nominated at least one physical health problem and 46 (6%) participants indicated two or more physical health problems. The most commonly nominated area was physical health unspecified (25% of total codes), followed by energy (22%), fatigue (11%), managing fitness (11%), endurance (7%), pain (5%), mobility (3.5%), sports participation (3%), effects of aging (3%), and walking (2%).
Conclusions
Physical health challenges are common among people living with HIV. Personalized health-related quality of life measures are well-suited to identify the unique physical challenges of people living with HIV and those potentially in need of a patient-centred rehabilitative approach.

Background: For people living with HIV (PLWH), their evaluation of care can help identify unmet needs. Understanding those experiences is essential to providing high quality patient-centered care.
Method: The Ontario HIV Treatment Network Cohort Study is a longitudinal cohort study of PLWH who receive care at HIV clinics in Ontario. We examined, cross-sectionally, data on the care experiences of OCS participants (January 2019-December 2020). HIV care and services were evaluated on a scale of ‘excellent/very good/good’ to ‘fair/poor’. The services of non-HIV providers (possibly specialists, ER, other family doctors) were assessed on a scale of ‘often/always’ to ‘never/rarely/sometimes’.
Results: Of the 1691 participants, 94% visited their primary HIV provider in the past year, of whom, 97% evaluated their recent visit as ‘excellent/very good/good’. 98% rated how clinic staff worked together (providing care and maintaining privacy) ‘excellent/very good/good’. Almost all participants (99%) reported that they were confident in their primary HIV provider’s knowledge treating HIV. 29% of respondents experience some challenge in accessing HIV care. The top challenges were related to transportation expenses, delays in getting appointments and health-related accessibility. 19% travelled an hour or more to their HIV clinic. Patient satisfaction was lower with some services provided by non-HIV providers. This included 87% who reported that their non-HIV providers were often/always aware of their medical history and 88% who reported that their non-HIV providers often/always had adequate knowledge of HIV to provide treatment/care.
Conclusion: HIV patients have complex needs across systems. While participants were satisfied with their care, they indicated less satisfaction for non-HIV providers due to gaps in communication. While participants indicate high quality HIV care, their care is largely in HIV specialty clinics. With challenges in travel, the expansion of virtual care and e-consult could improve access to high quality care for people living with HIV in Ontario.

Background: Bacterial vaginosis (BV) is a common clinical condition, characterized by a Lactobacillus diminished polymicrobial vaginal microbiota, inflammation of the lower female reproductive tract, and elevated risk of HIV infection. Multiple studies have shown that African/Caribbean/Black (ACB) women have higher prevalence of polymicrobial microbiota compared to Caucasian and Asian women. To determine if administration of probiotics and estrogen is an acceptable intervention to improve vaginal health, a prospective, randomized, open-label, intervention phase I trial (CTN 308) was conducted.
Methods: Pre-menopausal adult ACB women from the Toronto area received low dose intra-vaginal estradiol (Estring; 7.5g/day), a twice daily vaginal probiotic (RepHresh Pro-B; 1x107 cfu total of L. rhamnosus GR-1 and L. reuteri RC-14 per capsule), or a combination of Estring and oral or vaginal probiotic for 30 days (ClinicalTrials.gov NCT03837015). Trial feasibility was assessed by evaluating enrolment and retention rates, and intervention protocol (IP) adherence rates.
Results: Between November 2019 and August 2021, 57 ACB women from the Toronto area were screened, 46 enrolled, and 38 completed the study. Of enrolled participants, 9 (20%) reported at least one past episode of BV. 81% of screened participants were enrolled and the retention rate was 83%, exceeding targets of 70% and 80%, respectively. Five (11%) participants withdrew consent and 3 (6%) withdrew due to IP non-compliance prior to completing the study. Of those that completed the study, IP adherence was high among all treatment groups, with an overall Estring adherence rate of 93% (12% SD, IQR 92%-100%), a vaginal probiotic adherence rate of 90% (16% SD, IQR 87%-100%), and an oral probiotic adherence rate of 92% (8.0% SD, IQR 87%-99%).
Conclusion: Enrolment, retention and adherence rates suggest twice daily probiotics and/or low dose intravaginal estrogen are acceptable interventions. Analysis of biological samples will determine whether the intervention can successfully enhance Lactobacillus colonization.

Background & Purpose
A big challenge in treating people with HIV is poor retention in care, which leads to negative health outcomes.

Objective:
This study aims to describe the diversity in definitions used for retention in HIV care in randomized controlled trials.

Methods:
We conducted a study within a systematic review (SWAR). We reported definitions of retention in HIV care grouped by similarities. Descriptive statistics including frequencies and percentages were used to describe the include trials.

Data sources:
Data were drawn from an overview of systematic reviews to improve the HIV care cascade.1 We updated the search strategy from November 2019 by searching for additional trials published up to November 2020.

Study selection:
Randomized controlled trials of interventions to improve retention in people with HIV.

Data extraction and synthesis:
Data were screened and extracted in duplicate, with arbitration as needed. Randomised trials were identified by a team of reviewers. We reported definitions of retention in HIV care narratively and in tables.

Results:
A total of 45 articles were retrieved from the search strategy developed for the overview of reviews1 along with our updated search strategy.

Descriptive statistics:
Over 31% (n=11) of the trials were conducted in high-income countries.
In total, 91% (n=41) articles provided a definition. These definitions were assigned into 14 categories based on how retention is defined. The categories with the highest number of definitions were continuity in care and pharmacy refill. There was no homogeneity found in the definitions in between the categories or within each category.

Limitations and Strengths:
Some categories are not mutually exclusive. The strengths include a comprehensive and exhaustive search, and the novelty of the research question.

Conclusion:
There is a need for more uniform definitions of retention in HIV care in clinical trials to inform policy and facilitate evidence synthesis.

Background
The incidence of HHV8-induced Kaposi sarcoma (KS) in people living with HIV (PLWH) has dramatically decreased with antiretroviral treatments (ART). However, reemergence of KS in ART-treated PLWH with restored CD4 T-cell count and sustained HIV control is reported, raising concerns on HHV-8 pathogenesis and optimal management of these patients.

Method
We performed a pilot study including ART-treated PLWH (KS ART HIV+) and uninfected people (KS HIV-) with KS. We assessed CD4 and CD8 counts, anti-HHV-8 IgGs, gut permeability (LPS/I-FABP/Reg3) and senescence plasmatic markers (GDF15/suPAR). In PBMCs and skin biopsies, HHV-8 viral loads were quantified by digital-droplet PCR. In skin biopsies, cells were isolated and analyzed by flow cytometry.

Results
22 patients with KS have been recruited, 11 KS ART HIV+ and 11 KS HIV-. KS ART HIV+ were younger than KS HIV- (53yo vs 77, p<0.001). Despite similar CD4 T-cell count (p=0.30), KS ART HIV+ had a higher CD8 T-cell count (p=0.007) and lower CD4/CD8 ratio (p=0.03). Gut permeability markers were similar between both groups but GDF15 and suPAR were higher in KS HIV- (p=0.01). In PBMCs, HHV-8 DNA was detected in 6/11 of KS ART HIV+ and 3/11 KS HIV-. Anti-HHV-8 IgG titers tended to be higher in KS ART HIV+ than KS HIV- (p=0.07). In skin biopsies, HHV-8 DNA was detected for all participants and isolated CD4 and CD8 T-cells highly expressed PD1 (>50%) both in KS ART HIV+ and KS HIV- (p=0.20).

Conclusion
ART-treated PLWH with KS exhibited similar CD4 T-cell counts but higher CD8 T-cell counts and younger age compared to HIV-uninfected KS patients. HHV-8 control seems altered in KS ART HIV+, with HHV-8 DNA more frequently detected in PBMCs. Moreover, PD1 expression on tumoral lymphocytes suggests T-cell dysfunction and a potential therapeutical target. Such insights will help reducing KS-induced stigma and developing therapeutical strategies.

Background
Highly effective combination anti-retroviral therapy has drastically improved solid organ transplantation outcomes in persons living with HIV. Outcomes in HIV/HCV co-infected liver transplant recipients have been historically reported to be worse than HCV mono-infected individuals. Introduction of DAA therapy has led to successful eradication of HCV. However, it remains unclear whether this can be translated to improved outcomes in HIV/HCV co-infected liver transplant recipients in the post-DAA era.

Materials and Methods
Data was collected from UNOS database of all first-time deceased donor liver transplant recipients between January 1, 2000 until September 30, 2020. Kaplan-Meier survival curves and logistic regression were used for outcomes analysis.

Results
A total of 85,730 patients met inclusion criteria. One-year and five-year patient survival outcomes improved (93% and 80% respectively) for all liver transplants performed after 2015. This finding translated over to HIV/HCV co-infected patients, in whom transplant outcomes improved significantly from 78% (before 2015) to 92% (2015 onwards). In the multivariate analyses, advanced recipient age (OR 1.02, CI 1.01 – 1.02, p<0.001), black race (OR 1.34, CI 1.17 – 1.54, p<0.001), recipient diabetes mellitus (OR 1.18, CI 1.08 – 1.28, p<0.001) and decompensated cirrhosis were found to be risk factors associated with higher one-year mortality. Reassuringly, detectable HCV viral load at the time of transplant was not associated with poorer outcomes (OR 1.03, CI 0.77 – 1.35, p=0.9), and neither was presence of HIV/HCV co-infection at the time of transplant (OR 1.1, CI 0.56 – 2.08, p=0.7).

Conclusion
Liver transplant outcomes in HIV/HCV co-infected liver transplant recipients have significantly improved in the era of highly effective ART and DAA therapy as well as rigorous immunosuppression monitoring. Presence of HIV, HCV and HIV/HCV co-infection did not render higher mortality risk in liver transplants performed after 2015.

Lenacapavir (LEN), a potent first-in-class inhibitor of HIV-1 capsid function, is in development as a long-acting agent for treatment and prevention of HIV-1. In the ongoing Phase 2/3 study (CAPELLA) in heavily treatment-experienced (HTE) people with HIV-1 (PWH) with multidrug-resistance with ongoing viremia (≥ 400 copies/mL), (LEN) demonstrated potent antiviral activity during the functional monotherapy period (1.9 log decline) in combination with an optimized background regimen (OBR) at Week (W) 26.

In the randomized cohort, participants were randomized (2:1) to add oral LEN or placebo to their failing regimen. At Day 15 (D15), those on oral LEN received subcutaneous (SC) LEN (Q6M); those on placebo started the oral lead-in, followed by SC Q6M. In this cohort, participants initiated an OBR at D15. In the non-randomized cohort, participants initiated OBR concurrent with LEN (oral lead-in → SC). Subgroup efficacy analysis was conducted at W26 in the randomized cohort by baseline HIV-1 RNA, CD4, and OBR.

Total 72 participants enrolled: 36 randomized and 36 non-randomized. Median (range) number of prior antiretroviral (ARV) medications and ARV medications in the OBR were 11 (2, 25) and 4 (2, 7), respectively. At W26 in the randomized cohort, 81% (29 of 36) achieved HIV-1 RNA < 50 copies/mL. Rates of virologic suppression were high among participants who had low CD4 (< 200 cells/μL), INSTI resistance, and suboptimal OBR (≤1 fully active agent; not containing either dolutegravir or darunavir). Analysis is ongoing for the non-randomized cohort, as most have not yet reached W26.

In this heavily treatment experienced population with limited treatment options due to multidrug resistance (many with INSTI resistance), LEN demonstrated a clinically meaningful contribution towards virologic suppression in combination with an OBR.

Introduction: In SALSA (NCT04021290), switching to the 2-drug regimen (2DR) dolutegravir/lamivudine (DTG/3TC) had non-inferior efficacy compared with continuing 3- or 4-drug (3/4DR) current antiretroviral regimen (CAR) in treatment-experienced adults.
Objectives: We present Week 48 patient-reported health outcomes from SALSA.
Materials and Methods: SALSA is a randomized, open-label study of virologically suppressed adults on stable 3/4DR for ≥3 months who switched to DTG/3TC or continued CAR for 52 weeks. Secondary endpoints were change from baseline in patient-reported treatment satisfaction and symptom bother, assessed by HIV Treatment Satisfaction Questionnaire (HIVTSQ) and symptom distress module (SDM), respectively, at Weeks 4, 24, and 48.
Results: The DTG/3TC (N=246) and CAR (N=247) groups had similar baseline HIVTSQ total scores (median [range]: DTG/3TC, 58.0 [24-60]; CAR, 58.0 [34-60]) and lifestyle/ease (DTG/3TC, 29.0 [8-30]; CAR, 29.0 [15-30]) and general satisfaction/clinical sub-scores (DTG/3TC, 29.5 [12-30]; CAR, 29.0 [17-30]). Mean increases in HIVTSQ total score and lifestyle/ease and general satisfaction/clinical sub-scores through Week 48 were higher in the DTG/3TC vs CAR group (Table). Baseline SDM scores were comparable between groups (median [range]: DTG/3TC, 6.0 [0-59]; CAR, 4.0 [0-47]). The DTG/3TC group had small improvements in SDM score compared with CAR at Weeks 4 and 24 and a similar SDM score at Week 48.
Conclusion: Participants switching to DTG/3TC reported greater early improvements in treatment satisfaction and less symptom distress compared with those continuing CAR, observed at 4 weeks and persisting through Week 48. These findings further support greater patient satisfaction with use of the 2DR DTG/3TC vs 3/4DRs.

Introduction: Antiretroviral therapy (ART) has successfully reduced vertical transmission of HIV in high- and middle- income countries. However, concerns have followed about the impact of ART on obstetrical outcomes. Our objective was to evaluate the impact of ART regimen type and exposure duration on the risk of preterm delivery (PTD) and small-for-gestational-age (SGA) births among pregnant people living with HIV in Canada.

Methods: Data was analyzed from the Canadian Perinatal HIV Surveillance Program between 1990-2020, which captures data from twenty-two sites on infants perinatally exposed to HIV. The association between ART use and risk of PTD (<37 weeks) and SGA (<10th percentile) was explored using mixed effects logistic regression and time-dependent Cox’s proportional hazards models.

Results/Discussion: Among the PTD and SGA cohorts, there were 14.9% (654/4379) cases of PTD and 18.5% (732/3947) cases of SGA respectively. A higher risk of PTD was observed with non-nucleoside reverse transcriptase inhibitor (NNRTI)-based (aHR=1.73; 95% CI=1.10-2.73) and boosted protease inhibitor (PI)-based (aHR=1.68; 95% CI=1.15-2.45) regimens compared to integrase strand transfer inhibitor (INSTI)-based regimens. ART initiation prior to conception was associated with a lower risk of SGA compared to ART initiation post conception at 1-14 weeks (aOR=0.69; 95% CI=1.05-2.00) and > 14 weeks (aOR=0.70; 95% CI=1.11-1.86).

Conclusions: INSTI-based ART regimens were associated with lower risk of PTD compared to NNRTI-based and boosted PI-based regimens, and ART initiation before conception was associated with a lower risk of SGA. Findings with overall safety data should be considered when providing pregnancy counselling to people living with HIV.

Background:
Gay, bisexual and MSM continue to comprise the greatest number of new HIV diagnosis in BC (BCCDC, 2019). STI screening and treatment has provided opportunities to explore HIV risk with MSM and assess if BC publicly funded PrEP is an appropriate intervention strategy. COVID-19 has had major sexual health implications for all Canadians, including target groups for PrEP.

Description of model of intervention:
This novel Community Health Centre based Men’s STI Testing Clinic is staffed by STI certified practice nurses and run in partnership with AIDS Vancouver Island. Our nurse-led model enrolled 124 gbMSM in 2018, the initial year of the BC PrEP program. There have been no HIV infections amongst PrEP recipients. COVID restrictions meant a closure of Men’s Testing Night and limited access to in-person testing, with longer (120 vs 90 day) prescriptions for PrEP.

Impacts of COVID:
From January 2019 until COVID lockdown March 2020, an average of 35.3 monthly STI screenings were completed with 3.3 positive rectal chlamydia/gonorrhea and syphilis results per month. In the same time frame 5.1 clients were started on PrEP per month. In the first six months of COVID restrictions, average monthly STI tests fell to 18, with 1.8 monthly positive rectal chlamydia/gonorrhea and syphilis tests and 3.3 PrEP starts. In total, just 52 (28.7%) of those who started on PrEP in 2018-19 have continued on PrEP.

Conclusion:
While there has been an increase in connection to STI testing and PrEP as COVID restrictions have lifted, the rate of positive STI’s continues to impact the sexual health of this population.

HIV, hepatitis C (HCV) and hepatitis B (HBV) viruses represent major causes of compensated advanced chronic liver disease (cACLD). Development of esophageal varices (EV) impacts cACLD prognosis and eophagogastroduodenoscopy (EGD) is the gold standard for their diagnosis. We compared Baveno VI/expanded Baveno VI criteria, which combine liver stiffness measurement (LSM) with platelets, and simple fibrosis biomarkers to diagnose EV needing treatment (EVNT) in virus-related cACLD.

CanHep B Network and LIVEHIV cohorts were utilized to perform a cross-sectional analysis in 2014-2020. Inclusion criteria were: cACLD diagnosis (LSM>10 kPa), EGD, and platelets within 1 year of LSM. Baveno VI (LSM<20 kPa and platelets>150,000) and expanded Baveno VI criteria (LSM<25 kPa and platelets>110,000) were tested for EGD sparing. Diagnostic performance of these criteria against EGD was computed and compared to FIB-4, APRI and AST-to-ALT ratio (AAR). Optimized cut-offs of these biomarkers to diagnose EVNT were established by using AUC analysis.

340 patients were included. Prevalence of any EV & EVNT was 32.8% & 8.8% in the whole cohort (31.3% & 2.6% in HIV patients, 30.2% & 9.3% in HBV and 35% & 13% in HCV, respectively). Both Baveno VI and expanded Baveno VI criteria performed well in patients with virus-related cACLD (see Table). The optimized cut-offs for fibrosis biomarkers were: FIB-4 3.3, APRI 1.5, AAR 1.0. There was no difference on performance of the fibrosis biomarkers compared to LSM-based criteria.

This supports the use of non-invasive criteria based on LSM and platelets and simple fibrosis biomarkers to spare unnecessary EGD in virus-related cACLD.

Background. Nonalcoholic fatty liver disease (NAFLD) is a major comorbidity among people with HIV (PWH). Its aggressive nature in such population, mandates exploring less steatogenic antiretroviral therapies (ART). We aimed to evaluate the effect of switching to raltegravir (RAL) based regimen on NAFLD, BMI, and lipids among PWH with NAFLD.

Methods. In this phase IV, open–label RCT (ClinicalTrials.gov: NCT02210715), PWH without viral hepatitis coinfection were randomized 1:1 to switch arm (RAL 400mg BID) and control arm (continuing any other ART not containing integrase inhibitors). Patients with suppressed HIV viral load and NAFLD (controlled attenuation parameter (CAP)≥238 dB/m) at baseline were included. Outcomes were evaluated as changes between baseline and 24 months of follow–up. Liver fibrosis was measured as liver stiffness by Fibroscan. Nonalcoholic steatohepatitis (NASH) was determined using cytokeratin–18 (CK–18). Changes in outcomes were represented as standardized mean differences (SMD). A fixed–effect linear regression model was applied to compare outcomes between both study arms.

Results. 31 PWH were included (mean age 53.9yrs). Compared to baseline, SMD of AST decreased in switch vs control arm (switch -9.54, control 5.57 p=0.036). In the adjusted multivariate model, NASH and liver fibrosis improved in switch compared to control arm. However, these observations were not significant when comparing both arms (see Table). No changes in BMI and lipids were observed.

Conclusions. This study indicated that switching to RAL improves AST and may potentially alleviate the progression of NASH and fibrosis. However, larger interventional studies are needed to conclude the same.

Background: Lack of and/or limited access to medical care has been an ongoing concern for on-reserve Indigenous communities. The Wellness Wheel medical team provides specialized clinical care for HIV positive individuals residing on-reserve. In a rapid response to the COVID-19 pandemic, the Wellness Wheel implemented a Virtual Community Care Clinic (VC3) to ensure the continuous and ongoing access to healthcare for HIV positive patients. A virtual and hybrid community care model was initiated for the remote delivery, monitoring, diagnosis, and access to treatment to minimize the overall impact of the pandemic in partner communities. The VC3 provided real-time and multi-disciplinary care to HIV patients in communities and visits, access to treatment and viral suppression was recorded.

Findings:
Transforming healthcare through virtual care has resulted in an increase in number of visits and better clinical outcomes and suppression rates among HIV clients in on-reserve communities during the pandemic. Using virtual technology to support in-community care resulted in an increase in the engagement in care through the VC3 model, resulting in a remarkable improvement in 90-90-90 targets despite COVID-19. Establishing virtual care to on-reserve communities has expanded access to care through a hybrid model, whereby community care providers continue to provide culturally responsive care.

Significance:
The VC3 met its goal to mitigate the impact of COVID-19 for HIV patients living in on-reserve communities in Saskatchewan and due to reduced barriers, in fact, improved access to care and treatment in on-reserve communities. The VC3 established a secure platform for the continued access to care during the onset of the pandemic, and integrated virtual care into standard care to support a hybrid model. Ongoing care, knowledge sharing and mobilization provided by the VC3 has transformed care delivery, addressing health care inequities, and should be considered as an important part of HIV care going forward.

Introduction
Canadian guidelines on HIV PrEP recommend quarterly STI screening. We used data from the Ontario PrEP Cohort Study (ON-PrEP) to quantify the frequency of syphilis, gonorrhea, and chlamydia screening among PrEP users.

Methods
Adults using PrEP enrolled into ON-PrEP from 10 sites in 6 Ontarian cities since 01FEB2018. Site staff entered STI data into a database every 6-months for up to 24-months. We obtained STI test data from the Public Health Ontario Laboratory (PHOL) via health card linkage. We quantified STI testing and diagnoses with study database and PHOL data collected between participants’ enrollment date and 27FEB2021. We used generalized estimating equations to determine testing rates, infection rates, and test positivity per STI for each data source among those with at least 1 test, accounting for repeated measures. Simultaneous testing of multiple anatomic sites were counted as one test.

Results
Of 630 participants, 362-491(57.5-77.9%) participants had non-zero testing and were included in analyses. Testing rates ranged from 1.49-3.18/year while infection rates ranged from 2.75-11.11/100 person-years, varying by data source (Table).

Conclusion
STI testing and infection rates among PrEP users in Ontario are variable. Limitations include the potential for decreased testing due to the COVID-19 pandemic and lack of information on out-of-province testing. Nonetheless, reminders to integrate regular STI screening into PrEP follow-up visits are critical and future integration of data sources may improve our understanding of STI epidemiology among PrEP users.

Background:

Prolonged amenorrhea is frequent in women living with HIV (WLWH) and associates with hypothalamic dysfunction (e.g. low estrogen, progesterone). Through their endogenous antioxidant properties, these sex hormones can slow hepatic fibrosis. Hence, their loss is associated with liver fibrosis progression. The relationship between amenorrhea and the Aspartate transaminase to Platelet Ratio Index (APRI) score, a validated indicator of liver fibrosis, was examined in WLWH and controls.

Methods:

WLWH and controls ≥16 y were enrolled in the CARMA-Endo study (2013-2017). Amenorrhea was defined as past/present amenorrhea for ≥1 year unrelated to pregnancy, contraceptives, surgery, or menopause. Liver fibrosis was assessed via APRI score. Demographic and clinical variables were compared using Wilcoxon rank sum and Fisher’s exact tests. Linear multivariable models determined relationship between amenorrhea and APRI score, adjusting for potential confounders; interaction between HIV-status and amenorrhea on APRI score was examined.

Results:

WLWH (n=181) were similar to controls (n=130) in age and body mass index (BMI). More WLWH had Hepatitis C virus (HCV) antibodies (39.2% vs. 6.9%, p<0.001), while amenorrhea and mean APRI scores were higher in WLWH versus controls (23.2% vs 10.0%, p=0.003; 0.6 vs 0.4, p<0.0001). Participants with amenorrhea had 0.21 (0.03-0.38; p=0.023) higher APRI scores than participants without, after adjusting for BMI, HCV, HIV status, smoking, drug use and employment. No interaction was found between HIV and amenorrhea on APRI (p=0.07). Amongst WLWH, suppressed viral load and higher CD4 were associated with lower APRI (-0.37 [-0.61 to -0.14], p=0.002; -0.043 [-0.072 to -0.014], p=0.004 /100 units CD4 increase). Participants with longer non-NRTI exposure had higher APRI scores (0.008 [0.001 – 0.016], p=0.034 per year of non-NRTI).

Conclusion:

Women with amenorrhea history had higher APRIs than those with normal menstrual cycles, independent of HIV status, indicating that amenorrhea is a potential additional risk factor for hepatic fibrosis.

Background: Bone health can be impacted by aging, HIV and antiretroviral therapy (ART).
Methods: A cross sectional analysis of baseline bone health of women participating in a switch study of tenofovir (TDF) to tenofovir alafenamide (TAF).Canadian and 10 Italian women enrolled in the peri- (48%) or _Data was collected from 34 participants, 24early post-menopausal (52%) period. The median age 51 years, 58.8% black, 38.2% Caucasian. 12% current and 18% former smokers, median 16.5 years HIV diagnosis and 14 years ART. Median CD4 cell count was 570/mm3 (nadir 168); all had viral suppression. 17.6% had a prior HCV diagnosis. The median BMI was 26. 15% were using calcium and 59% vitamin D supplements. No participant had ever received therapy for osteoporosis. 8.8% received hormonal replacement therapy. 21% reported a prior fracture and 20% reported having one or more falls in the previous 6 months. The baseline median score on the short performance physical battery test was 11, with 23% in the intermediate and 77% in the high performance level. The median baseline grip strength was 27.3 (normal). Based on DEXA scan the median (IQR) bone mineral density (BMD) at the lumbar spine was 0.916 (0.804, 1.053) and at the femoral neck was 0.741 (.692, .845) both below normal. At baseline the median FRAX fracture risk score for 10-year probability for a major osteoporotic fracture was 4.4 (2.7, 5.0). The median (IQR) 10-year probability for hip fracture was based on DEXA was 0.2 (0.1, 0.5).
Conclusions: Low BMD was identified in the majority of our older HIV cohort of women on TDF. Although performance measures were in the intermediate to high range, falls were common. Hip fracture risk estimate varied with the calculator. Aging HIV infected women should have regular BMD scans to determine the need for anti-resorptive therapy.

Background
Long-acting injectable cabotegravir as HIV pre-exposure prophylaxis (PrEP) could address challenges with oral PrEP acceptability and adherence. With the approval of this drug anticipated soon, we assessed how its acceptability might be associated with income given that injectables are often costlier than pills.

Methods
We analyzed data from the PrEP Implementation Project (PRIMP) surveying gay, bisexual, and other men who have sex with men (GBM) in Ontario and British Columbia between July 2019 and Aug 2020. Survey respondents were HIV-negative never/former PrEP-users meeting Canadian PrEP guideline criteria (with a HIRI-MSM cut-off >25 to increase specificity for higher HIV-risk). We measured the association between participants’ personal income and willingness to use injectable PrEP in a logistic regression model adjusted for age, previous PrEP use, post-secondary education, and ethno-racial identity.

Results
Of the 238 individuals included, 185 (78%) were from Ontario, mean age was 31 years (SD=8.3), 64% were white, 89% had completed post-secondary education, and 47% were former PrEP-users. Overall, 72% were willing to use injectable PrEP. There was a negative association between willingness and annual income (Table 1). Fewer never PrEP-users appeared willing to use injectables (66% vs 77% former PrEP-users, 𝛘=3.2, p=0.07). The other variables adjusted for did not present any significant associations.

Conclusions
There was a negative association between income of never/former PrEP-using GBM and willingness to use injectable PrEP, with higher willingness in lower income groups. Understanding which individuals are most willing to use injectables may help tailor PrEP delivery in the future.

Background: People living with HIV (PLWH) experience faster cellular and immunological aging relative to their HIV-negative peers. This may be influenced by co-infection with other chronic/latent viruses such as CMV, EBV, HHV-8, HSV-1, HSV-2, HCV, and HBV. Several of these viruses are individually known to be associated with markers of aging or age-associated diseases. Our aim was to characterize the number and type of chronic/latent viral infections in a cohort of people living with or without HIV, and determine any association with HIV status.

Methods: HIV-positive (n=103) and HIV-negative (n=101) female CARMA cohort participants were selected for this analysis, with n~15 per decade of age [0-60+]. Infection status for CMV, EBV, HHV-8, HSV-1, and HSV-2 was determined serologically; HIV, HCV, and HBV were self-reported. Associations between total number of viruses, HIV status, and age were assessed using Mann-Whitney, Spearman’s correlation, and ordinal logistic regression modelling.

Results: Among HIV-positive and HIV-negative participants, having a greater number of viruses was univariately associated with older age (rho=0.38, p<0.0001), and with HIV-positive status (p=0.0014) (see Table 1). After adjusting for age and ethnicity, HIV-positive status remained independently associated with having a greater number of chronic/latent viral infections (β=0.34, p=0.01).

Discussion: These data suggest that female individuals living with HIV experience a higher prevalence of chronic/latent viral infections that could exert a heavier burden on their immune system. Determining whether this is associated with immune aging and/or co-morbidities could give insight into the value of treating and/or preventing other viral infections to improve health outcomes.

Despite development of effective antiretroviral therapy, HIV still remains uncurable and was responsible for over 680,000 global deaths in 2020. Furthermore, persons living with HIV (PLWH) are at much greater risk of developing active tuberculosis (TB) infection, which is the biggest killer of PLWH. HIV and TB are urgent global issues and further research is required for prevention, therapeutics, and cure. Humanized mice such as the humanized NOD-RAG-/--Gamma-/- (hu-NRG) model repopulate with human immune cell populations essential for HIV and TB investigation. Our lab has established a next-generation model of hu-NRG mice expressing HLA class I and II (hu-DRAG-A2) engrafted with HLA-matched stem cells that repopulate with higher levels of human cells such as CD4+ T cells, macrophages, and mature B cells. To further evaluate the functionality of hu-NRG and hu-DRAG-A2 mice, we infected both models intravaginally with HIV-1 and followed their disease course until 8 weeks post-infection. Both models established high plasma viral load beginning 2 weeks post-infection until endpoint when human CD4+ T cell depletion was also observed. Immunohistochemistry displayed reduced human CD4+ T cell and CD68+ macrophages within infected vaginal and lung tissue compared to uninfected tissue. Only the infected hu-DRAG-A2 mice produced detectable levels of HIV-specific IgG antibodies in endpoint plasma, displaying their increased immune functionality. Hu-NRG and hu-DRAG-A2 mice were also infected intranasally with Mtb and followed until 4 weeks post-infection. Both models established high bacterial load within the lung and spleen demonstrating successful lung infection and extra-pulmonary bacterial dissemination. Furthermore, lung histology showed hu-DRAG-A2 mice develop granulomas with a Mtb-containing necrotic core surrounded by a CD4+ T cell halo that is characteristic of human-like pathology. We are currently conducting HIV/TB co-infection studies as these results indicate hu-DRAG-A2 mice are promising tools for vaccination and therapeutics studies for both HIV infection and HIV/TB co-infection.

Background: Among people living with HIV (PLWH) who use opiates, there is an elevated risk of death and adverse outcomes. Opioid agonist therapy (OAT) can play a crucial role in reducing those health disparities. We aim to characterize OAT uptake among PLWH in British Columbia (BC) in a population-based cohort.

Methods: Data were derived from the Seek and Treat for Optimal Prevention of HIV/AIDS (STOP HIV/AIDS) study, which includes PLWH ≥19 years old in BC, between April 1996 and March 2017. Participants with known gender ≥12 months of follow-up were included. Receipt of OAT was identified through PharmaNet, which includes all medications dispensed by BC pharmacies, using Drug/Product Identification Numbers.

Results: We identified 2,148 (15.9%) PLWH who were ever prescribed with OAT among a sample of 13,433 PLWH, of which 67.6% (n=1,453) had their first prescription after their HIV diagnosis (i.e. after cohort entry). Characteristics of this population are presented in table 1.About 40% were women and about 80% were ≤ 44 years. At first uptake, 95.8% of OAT prescriptions were Methadone, and were mainly prescribed by general practitioners (93.3%). This cohort is characterized by high prevalence of complex conditions such substance use (69.3%), mood disorders (63.3%), depression (55%), hepatitis C (39.7%), and chronic pain (22.4%).

Conclusion: In BC, from 1996-2017, nearly 1 in 6 PLWH is prescribed OAT at least once. The syndemic of complex comorbidities among PLWH receiving OAT highlight the necessity of integrated care models that increase likelihood of long-term retention for PLWH in OAT treatment.

Purpose: The present study investigated parent and child ratings of behavioural and emotional difficulties in children who are HIV-exposed uninfected (CHEU) and children who are HIV-unexposed uninfected (CHUU).

Methods: CHEU and CHUU 6 to 10 years of age underwent developmental assessments through the Kids Imaging and Neurocognitive Development (KIND) study at the Hospital for Sick Children in Toronto, Canada between January 2020 and December 2021. A parent questionnaire, the Strengths and Difficulties Questionnaire (SDQ), evaluated aspects of problem behaviours. A self-report questionnaire, the Spence Children’s Anxiety Scale (SCAS), evaluated symptoms of anxiety. Clinically significant symptoms were identified, and group differences were evaluated using t-tests. Significance was held at p <0.05.

Results: Thirty-two CHEU (17 female, 8.53 ±1.55 years) and 30 CHUU (12 female, 8.46 ±1.54 years) children were included. Results from the SDQ indicated a greater number of CHEU (15.6%) with high parent-rated total behavioural difficulties compared to CHUU (0%). Higher scores of total behavioural difficulties (p=0.04) and emotional problems (p=0.03) were identified in CHEU compared to CHUU. A subset of children, 23 CHEU (12 female, 9.05 ±1.21 years) and 22 CHUU (10 female, 8.99 ±1.42 years) completed the SCAS. Six children in each group (26% CHEU and 27% CHUU) were identified with clinically significant levels of total anxiety symptoms. About half of these children (47.8% CHEU and 54.5% CHUU) rated clinically significant symptoms of an anxiety subtype, physical injury fears. No between-group differences in anxiety subtype T-scores were identified.

Conclusions: Parents of CHEU identified more total behavioural difficulties compared to parents of CHUU. Self-reported anxiety symptoms were similar between groups. The data were largely collected after the onset of the COVID19 pandemic, which may have contributed to anxiety symptoms. The prevalence of individual parent and self-rated concerns warrants ongoing monitoring and intervention of behavioural and emotional functioning.

Purpose: Children born to mothers living with HIV are perinatally exposed to antiretroviral drugs (ARVs). Research has demonstrated that these children are at risk for cognitive and language delays. Attention is important for optimal behavioural, cognitive, and academic skills, yet has not been thoroughly investigated in children who are HIV-exposed uninfected (CHEU) in comparison to children who are HIV-unexposed uninfected (CHUU).

Methods: Fifty-five CHEU and 51 CHUU children were recruited at 5.5 years of age from the Hospital for Sick Children and the community, respectively. Parent-reported attention deficit hyperactivity disorder (ADHD) Rating Scale-IV yielded scores on inattention (IA), hyperactivity/impulsivity (HI), and combined scores. Recommended cutoff scores were used to predict the presence of probable ADHD. Additional neurodevelopmental measures of intelligence, visuomotor skills, academics, and adaptive functioning were obtained. Analyses examined between-group differences in attention measures, neurodevelopmental measures, and demographic factors. Additional correlational and multiple regression models, accounting for maternal education and employment, were performed.

Results: The percentages of children who met clinical cut-offs for probable ADHD were low (3.6% CHEU, 2.0% CHUU). No differences in measures of IA, HI, and combined scores were found between CHEU and CHUU children. HEUs scored significantly lower on intelligence, visuomotor function, academic skills, and aspects of adaptive behavior. Lower Full-Scale IQ and Processing Speed scores were associated with higher IA scores in the CHEU group, and lower adaptive functioning scores were associated with higher IA scores in the CHUU group. Across both cohorts, children of unemployed mothers had more HI symptoms.

Conclusions: CHEU children were not at increased risk for attention difficulties at 5.5 years of age. The significance of maternal employment status in predicting attention problems, irrespective of group, highlights the contribution of sociodemographic factors in shaping children’s early behaviour and neurodevelopment.

The gap in life expectancy between people living with HIV (PLWH) and the general population continues to narrow, however, important differences in age-related comorbidities and quality of life persist. To support healthy aging in this population, goals of treatment need to expand beyond virologic control and immunologic recovery. Examining health as a multidimensional state can guide development of preventative and management strategies to address the complex social and healthcare needs of aging PLWH.

The CHANGE-HIV (Correlates of Healthy Aging iN GEriatric HIV) study, is a Canadian cohort of PLWH age >65. In this cohort, healthy aging is assessed using the Rotterdam Healthy Aging Score (HAS). Scores are calculated across 7 domains of health (chronic disease, mental health, pain, social support, quality of life, cognitive and physical function). We report on the HAS for the first 216 participants in the cohort and determine the proportion of those with healthy (13-14), intermediate (11-12), and poor aging scores (0-10). Scores were compared by sociodemographic and HIV-related factors. Kruskal-Wallis and Fisher's exact tests were used for comparisons.

Median (IQR) age was 71 (68-74), 192 (90%) were men, 19 (9%) women and 3 (1%) transgender. Majority of participants were white (78%), born in Canada (65%) and retired (77%). Median (IQR) HAS was 12 (10-13) with 34% achieving healthy, 39% intermediate and 27% poor aging scores. Women and transgender participants were more likely to have poor aging scores, compared to men (p=0.002). HAS scores did not differ by age (p=0.691), race (p=0.510) or CD4 nadir (p=0.535), but those with longer duration of HIV infection had lower HAS scores (p=0.043).

Gender and duration of HIV infection seem to impact the aging experience of PLWH. Using a multidimensional score like the HAS can identify individuals at risk of poor clinical outcomes and direct interventions that support healthy aging.