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The Ending the HIV Epidemic initiative aims to decrease new HIV infections and promote test-and-treat strategies. Our aims were to establish a baseline of HIV outcomes among newly diagnosed PWH in Washington, DC (DC), a ‘hotspot’ for the HIV epidemic. We also examined sociodemographic and clinical factors associated with retention in care (RIC), antiretroviral therapy (ART) initiation and viral suppression (VS) among newly diagnosed PWH in the DC Cohort from 2011–2016. Among 455 newly diagnosed participants, 92% were RIC at 12 months, ART was initiated in 65% at 3 months and 91% at 12 months, VS in at least 17% at 3 months and 82% at 12 months and 55% of those with VS at 12 months had sustained VS for an additional 12 months. AIDS diagnosis was associated with RIC (aOR 2.99; 1.13–2.28), ART initiation by 3 months (aOR 2.58; 1.61–4.12) and VS by 12 months (aOR4.87; 1.69–14.03). This analysis contributes to our understanding of the HIV treatment dynamics of persons with recently diagnosed HIV infection in a city with a severe HIV epidemic.

With more effective antiretroviral therapy (ART), people with HIV (PWH) are living longer and have more chronic diseases, including diabetes mellitus (DM). The prevalence of DM has been estimated in PWH previously, however there is less research regarding DM control. Our objectives were to determine the prevalence of DM and DM control and determine factors associated with DM control in a large urban cohort of PWH in care. We examined DC Cohort participants aged ≥18 years old to determine DM prevalence and to assess DM control (HbA1c measurement

Background Using the results of a site assessment survey performed at clinics throughout Washington, DC, we studied the impact of clinic-level factors on antiretroviral therapy (ART) initiation and viral suppression (VS) among people living with human immunodeficiency virus (HIV; PLWH). Methods This was a retrospective analysis from the District of Columbia (DC) Cohort, an observational, clinical cohort of PLWH from 2011–2018. We included data from PLWH not on ART and not virally suppressed at enrollment. Outcomes were ART initiation and VS (HIV RNA < 200 copies/mL). A clinic survey captured information on care delivery (eg, clinical services, adherence services, patient monitoring services) and clinic characteristics (eg, types of providers, availability of evenings/weekends sessions). Multivariate marginal Cox regression models were generated to identify those factors associated with the time to ART initiation and VS. Results Multiple clinic-level factors were associated with ART initiation, including retention in care monitoring and medication dispensing reviews (adjusted hazard ratios [aHRs], 1.34 to 1.40; P values < .05 for both). Furthermore, multiple factors were associated with VS, including retention in HIV care monitoring, medication dispensing reviews, and the presence of a peer interventionist (aHRs, 1.35 to 1.72; P values < .05 for all). In multivariable models evaluating different combinations of clinic-level factors, enhanced adherence services (aHR, 1.37; 95% confidence interval [CI], 1.18–1.58), medication dispensing reviews (aHR, 1.22; 95% CI, 1.10–1.36), and the availability of opioid treatment (aHR, 1.26; 95% CI, 1.01–1.57) were all associated with the time to VS. Conclusions The observed association between clinic-level factors and ART initiation/VS suggests that the presence of specific clinic services may facilitate the achievement of HIV treatment goals.

Introduction Prior studies found renal disease was common among HIV-infected outpatients. We updated incident renal disease estimates in this population, comparing those with and without tenofovir exposure. Methods We conducted a retrospective analysis of the DC Cohort, a longitudinal study of HIV patients in Washington, DC, from 2011 to 2015. We included adults prescribed antiretroviral therapy (ART) with baseline glomerular filtration rate (GFR) ≥15 ml/min per 1.73 m2. We defined renal disease as 50% decrease in GFR or doubled serum creatinine (Cr) within 3 months. We defined cumulative viral load as area under the curve (AUC) of log10 transformed longitudinal HIV RNA viral load (VL). Correlates of time to incident renal disease were identified using Cox proportional hazard regression models, adjusted for demographics and known risk factors for kidney disease. Results Among 6068 adults, 77% were Black and median age was 48 years. Incident renal disease rate was 0.77 per 100 person-years (95% confidence interval [CI]: 0.65–0.9). Factors associated with renal disease were age (adjusted hazard ratio [aHR]: 1.4; CI 1.1–1.7 per 10 years), public non-Medicaid, non-Medicare insurance (aHR: 3.4; CI: 1.9–6.4), AUC VL (aHR: 1.1; CI: 1.1–1.2), diabetes mellitus (aHR: 1.6; CI: 1.0–2.4), and mildly reduced GFR (60–89 ml/min per 1.73 m2) (aHR: 1.5; CI: 1.0–2.3); recent tenofovir exposure was not associated with renal disease (aHR: 0.7; CI: 0.5–1.1). Conclusion Our study revealed a substantial burden of renal disease among HIV patients. Cumulative VL was associated with renal disease, suggesting that early VL suppression may decrease its incidence., Graphical abstract

Introduction: People living with HIV (PLWH) with hypertension (HTN) have a higher risk of cardiovascular events and all-cause mortality compared with PLWH with normal blood pressure (BP) and HIV-uninfected adults with HTN. The prevalence and control of HTN among PLWH have not been widely studied since the release of newer 2017 ACC/AHA guidelines (new guidelines). To address this research gap, we evaluated and compared the prevalence and control of HTN using both 2003 JNC 7 (old guidelines) and new guidelines in a large clinical cohort of PLWH. Methods: We identified 3206 PLWH with HTN from the DC Cohort study in Washington, D.C, from 01/2018 to 06/2019. We defined HTN using International Classification of Diseases (ICD) -9/-10 diagnosis codes for HTN or ≥ 2 BP measurements obtained at least one month apart (>139/89 mm Hg per old or >129/79 mm Hg per new guidelines). We defined HTN control based on recent BP (≤139/≤89 mm Hg per old or ≤129/≤79 mm Hg per new guidelines). We identified socio-demographics, cardiovascular risk factors and co-morbidities associated with HTN control (per new guidelines) using multivariable logistic regression (adjusted Odds Ratio; 95% CI). Results: The prevalence of HTN was 50.9% per old versus 62.2% per new guidelines. Of the 3,206 PLWH with HTN based on 2017 ACC/AHA guidelines, 887 (27.7%) had a recent BP ≤129/≤79 mm Hg, 1,196 (37.3%) had a BP between 130-139/80-89 mm Hg and 1,123 (35.0%) had a BP ≥140/≥90mm Hg. After adjusting for socio-demographics, cardiovascular risk factor and co-morbidities, factors associated with HTN control included age 60-69 (vs. Conclusion: In a large urban cohort of PLWH, nearly two-thirds had HTN and less than one-third of those met new guideline criteria. Older PLWH were more likely to have their HTN controlled compared to the younger PLWH. Our data suggests that more aggressive HTN control is warranted among PLWH, with attention to younger patients.

The process of recruiting racial and ethnic minority persons living with HIV (PLWH) is important for research studies to ensure inclusivity of underrepresented groups. To understand factors associated with recruitment of minority PLWH, this study examined the recruitment process of PLWH for an observational study of their routine medical care at 14 clinics in Washington, DC. Research assistant (RA) recruiters were interviewed to assess their consenting processes and strategies. Data were collected on clinic services, patient demographics, and recruitment logs of patient approaches for obtaining informed consent resulting in agreement or refusal. A median of 96% of eligible patients was approached to obtain consent, yielding a median consent rate of 78% across all sites. A total of 8438 patients consented and 1326 refused study participation. Clinical sites with more comprehensive services had higher consent rates. black/African American and Hispanic/Latinx PLWH consented or refused study participation in similar proportions, while significantly more white patients enrolled than refused. More men, compared with women, enrolled than refused study participation. The most frequent reasons for refusing study participation were the lack of interest in research (33.2%) and no specific reason provided (28%). RAs identified that effective recruitment strategies used culturally sensitive approaches, built rapport with patients, and obtained provider support for the study. Recruitment strategies that are gender sensitive to address the disparity of underrepresentation of women, address perceived barriers, and examine clinic-specific services are needed to maximize research participation for minority PLWH to improve prevention and health outcomes.

BACKGROUND: Optimal management of noncommunicable diseases, including diabetes mellitus (DM), is crucially important as people with HIV (PWH) live longer with antiretroviral therapy. Our objective was to assess patient-level and clinic-level factors associated with achieving hemoglobin A1c (HbA1c) ≤7.0% among PWH and DM. SETTING: The DC Cohort, an observational clinical cohort of PWH, followed from 2011 to 2019 at 12 sites in Washington, DC. METHODS: Among PWH with diagnosed DM and elevated HbA1c (>7.0%), we examined the association between achieving HbA1c ≤7.0% and demographic and clinical factors, including time-updated medication data, and clinic-level factors related to services and structure. A multilevel marginal extended Cox regression model was generated to identify factors associated with time to HbA1c ≤7.0%. RESULTS: Over half (52.3%) of 419 participants achieved HbA1c ≤7.0%. Individual-level factors associated with HbA1c ≤7.0% included a diagnosis of DM after enrollment and a longer time since HIV diagnosis [hazard ratio (HR) = 2.65 and 1.13, P < 0.05 for both]. Attending a clinic with an endocrinologist was associated with the outcome [adjusted HR (aHR) = 1.41 95% confidence interval (CI): (1.01 to 1.97)]. In addition, comparing clinics that treat everyone, refer everyone or have a mix of treating and referring, showed an association between attending a clinic that treats everyone [aHR = 1.52 95% CI: (1.21 to 1.90)] or a clinic that refers everyone [aHR = 2.24 95% CI: (1.63 to 3.07)] compared with clinics with a mix in achieving glycemic control. CONCLUSION: Multiple factors are associated with achieving glycemic control in an urban cohort of PWH. Determining if specific services or structures improve DM outcomes may improve health outcomes for PWH and DM.

Study Objective To assess whether a robotic simulation curriculum for novice surgeons can improve performance of a suturing task in a live porcine model. Design Randomized controlled trial (Canadian Task Force classification I). Setting Academic medical center. Patients Thirty-five medical students without robotic surgical experience. Interventions Participants were enrolled in an online session of training modules followed by an in-person orientation. Baseline performance testing on the Mimic Technologies da Vinci Surgical Simulator (dVSS) was also performed. Participants were then randomly assigned to the completion of 4 dVSS training tasks (camera clutching 1, suture sponge 1 and 2, and tubes) versus no further training. The intervention group performed each dVSS task until proficiency or up to 10 times. A final suturing task was performed on a live porcine model, which was video recorded and blindly assessed by experienced surgeons. The primary outcomes were Global Evaluative Assessment of Robotic Skills (GEARS) scores and task time. The study had 90% power to detect a mean difference of 3 points on the GEARS scale, assuming a standard deviation (SD) of 2.65, and 80% power to detect a mean difference of 3 minutes, assuming an SD of 3 minutes. Measurements and Main Results There were no differences in demographics and baseline skills between the 2 groups. No significant differences in task time in minutes or GEARS scores were seen for the final suturing task between the intervention and control groups, respectively (9.2 [2.65] vs 9.9 [2.07] minutes, p = .406; and 15.37 [2.51] vs 15.25 [3.38], p = .603). The 95% confidence interval for the difference in mean task times was –2.36 to .96 minutes and for mean GEARS scores −1.91 to 2.15 points. Conclusions Live suturing task performance was not improved with a proficiency-based virtual reality simulation suturing curriculum compared with standard orientation to the da Vinci robotic console in a group of novice surgeons.

OBJECTIVE: To evaluate associations of mood, anxiety, stress-/trauma-related, and psychotic disorders, both treated and untreated, with duration of unsuppressed HIV viral load (VL) among persons living with HIV (PLWH). SETTING: The DC Cohort, an observational clinical cohort of PLWH followed from 2011–2018 at 14 sites in Washington, DC. METHODS: Among PLWH ≥18 years old who received primary care at their HIV clinic, we determined in a time-updated manner whether participants had diagnoses and pharmacologic prescriptions for mood, anxiety, stress-/trauma-related, and/or psychotic disorders. Associations between psychiatric disorders/treatments and the proportion of subsequent days with VL ≥200 copies/mL were assessed using multivariable Poisson regression with generalized estimating equations. RESULTS: Among 5,904 participants (median age 51; 70% male; 82% Black), 45% had ≥1 psychiatric disorder, including 38% with mood disorders (50% treated), 18% with anxiety or stress-/trauma-related disorders (64% treated), and 4% with psychotic disorders (52% treated). Untreated major depressive disorder (adjusted rate ratio=1.17; 95% confidence interval: 1.00–1.37), untreated other/unspecified depressive disorder (1.23; 1.01–1.49), untreated bipolar disorder (1.39; 1.15–1.69), and treated bipolar disorder (1.25; 1.02–1.53) (vs. no mood disorder) predicted more time with VL ≥200 copies/mL. Treated anxiety disorders (vs. no anxiety disorder) predicted less time (0.78; 0.62–0.99). Associations were weaker and non-significant for treated depressive disorders (vs. no mood disorder) and untreated anxiety disorders (vs. no anxiety disorder). CONCLUSIONS: PLWH with depressive and bipolar disorders, particularly when untreated, spent more time with unsuppressed VL than PLWH without a mood disorder. Treatment of mood disorders may be important for promoting sustained viral suppression.

e18695 Background: The treatment paradigm for advanced HR+/HER2- breast cancer has been rapidly evolving since the approval of the first CDK4/6 inhibitor in the U.S. in 2015. Available literature on real-world utilization of various treatment options available to these patients remains limited. The objective of this study was to describe how advanced HR+/HER2- breast cancer treatment patterns have changed over time since the approval of novel CDK4/6 inhibitors. Methods: IBM MarketScan Research Databases, a nationally representative source of U.S. insurance claims data, was used to identify women diagnosed with advanced breast cancer between January 2015 and December 2019 via ICD-9/10 codes. Algorithms were applied to capture patients with HR+/HER2- subtype and advanced disease diagnosis. Patients were indexed on their advanced breast cancer diagnosis date and were required to have six months continuous enrollment in the insurance claims database prior to and after the index date to ensure patients included in the cohort were alive and contributed at least 12 months of data for analysis. Lines of therapy (LOTs) were constructed and treatment patterns were reported over time. Descriptive analyses were conducted using Instant Health Data software. Results: A total of 4,128 women (mean age: 58 years, IQR: 50-64 years) had received at least one systemic breast cancer treatment and were included in the analysis. During a mean follow-up time of two years, nearly 29% of patients received at least four LOTs for advanced disease. A high number of unique regimens were reported in each LOT (30 in 1L, 48 in 2L, 53 in 3L and 50 in 4L+). The distribution of the top 1L regimens changed significantly over time (Table). CDK4/6 inhibitor use in the 2L setting also increased substantially from 43% in 2015 to 68% in early 2019, while chemotherapy and endocrine monotherapy utilization decreased. Conclusions: These data reflect a significant shift in the treatment landscape for HR+/HER2- advanced breast cancer patients in real-world practice since the availability of CDK4/6 inhibitors. However, there remains significant heterogeneity in the use of other treatments in these patients and in treatment sequencing, suggesting potential unmet need with current therapies. Further insight into patient, clinical and community-level factors guiding treatment decisions in the real world is needed. [Table: see text]

Distance to HIV care may be associated with retention in care (RIC) and viral suppression (VS). RIC (≥ 2 HIV visits or labs ≥ 90 days apart in 12 months), prescribed antiretroviral therapy (ART), VS (

Background Among persons living with HIV (PLWH) with type 2 diabetes mellitus (DM) there is limited research on the effect of DM control on CD4 count. Current guidelines recommend that PLWH with DM maintain a hemoglobin A1c (HbA1c) Methods We used data from the DC Cohort, a longitudinal observational cohort of patients receiving HIV care at 14 clinics between 2011–2018. Participants with DM on an ongoing antiretroviral regimen with ≥1 year of follow-up, ≥2 HbA1c results, and ≥2 CD4 count results were included. Participants were compared based on the most recent HbA1c result categorized into one of three control levels control: strict, HbA1c < 7.5%; moderate, HbA1c between 7.5–9.0%; and uncontrolled, HbA1c >9.0%. All statistical tests were performed within the framework of the linear mixed-effects (LME) model. The rates of increase in CD4 count by DM control were compared using an LME model with random slopes and random intercepts, adjusted for sex, BMI, nadir CD4, a history of AIDS, or cancer diagnosis. Results Among 554 participants (median age 53.5; 70.8% male; 82.7% Black), there were 5,138 total CD4 count measurements. In unadjusted analysis, participants with moderate or uncontrolled HbA1c had higher mean CD4 counts over the follow-up period than those with strict HbA1c control (strict: 690 cells/μL, moderate: 712 cells/μL uncontrolled: 711 cells/μL; P = 0.0156 strict vs. moderate, 0.049 strict vs. uncontrolled). All DM control groups had a similar temporal increase over time in CD4 count (P = 0.46). In multivariate analysis, only moderate vs. strict control showed a significant difference in CD4 count (mean difference=18.1; P = 0.02). Results showed CD4 count change was not affected by the duration of HIV diagnosis or diabetes diagnosis. See Table 1 for additional results. Conclusion PLWH and DM with moderate HbA1c control had higher CD4 counts than those with strict HbA1c control and similar CD4 counts compared with those with uncontrolled HbA1c levels, while the rate of increase in CD4 count was similar in the three groups. These results show that moderate DM control may benefit CD4 count, which should be considered when revising DM control guidelines for PLWH. Disclosures All authors: No reported disclosures.

Background In 2019, the US Administration announced the Ending the HIV Epidemic plan to decrease new infections. A key component is the Test and Treat plan to diagnose early, treat rapidly and achieve viral suppression (VS) among persons living with HIV (PLWH). We assessed retention in care (RIC), antiretroviral therapy (ART) initiation and VS among newly diagnosed PLWH in Washington, DC. Methods We conducted a cross-sectional analysis using data from the DC Cohort, an observational longitudinal cohort of PLWH in care in 14 clinics in DC. We included participants enrolled from 2011 to 2016 whose HIV diagnosis was within 1 year of enrollment and with at least 12 months follow-up. RIC was defined as ≥2 visits or HIV lab results 90 days apart in the first year of follow-up. ART initiation was defined as being prescribed ART, VS was defined as HIV RNA Results Among the 455 newly diagnosed participants (6% of all enrollees), median age was 33 years (IQR 25, 45), 69% were Black, 79% male, 60% MSM. Median duration of HIV at enrollment was 4.9 months (IQR 2.3, 7.7). Median nadir CD4 count was 346 cells/μL (IQR 224, 494). Of the 455, 38% had a history of AIDS, 92% were RIC, 65% initiated ART by 3 months and 17% had VS by 3 months. There were no differences by sex or race for RIC, ART initiation and VS. An AIDS diagnosis at enrollment was associated with RIC (aOR 2.28; 1.01–5.15), ART initiation by 3 months (aOR 2.41; 1.54–3.76), and VS by 12 months (aOR 1.92; 1.06–3.46). Lower nadir CD4 (aOR 0.89 per 50 cell increase; 0.84–0.94) and younger age (aOR 0.747 per 10-year increase; 0.584–0.995) were associated with ART initiation by 12 months. Conclusion Although the majority of newly diagnosed PLWH were RIC, fewer started ART or achieved VS. With a large proportion of our sample having an AIDS diagnosis at enrollment, we illustrate the ongoing challenge of late HIV diagnosis in DC. Those with AIDS at diagnosis were more likely to initiate ART within the first 3 months. As same-day ART initiation is scaled up in DC, future research can evaluate if all PLWH, regardless of AIDS status, will achieve this milestone earlier. Disclosures All authors: No reported disclosures.

One goal of the HIV care continuum is achieving viral suppression (VS), yet disparities in suppression exist among subpopulations of HIV-infected persons. We sought to identify disparities in both the ability to achieve and sustain VS among an urban cohort of HIV-infected persons in care. Data from HIV-infected persons enrolled at the 13 DC Cohort study clinical sites between January 2011 and June 2014 were analyzed. Univariate and multivariate logistic regression were conducted to identify factors associated with achieving VS (viral load 200 copies/ml) at least once, and Kaplan-Meier (KM) curves and Cox proportional hazards models were used to identify factors associated with sustaining VS and time to virologic failure (VL ≥ 200 copies/ml after achievement of VS). Among the 4311 participants, 95.4% were either virally suppressed at study enrollment or able to achieve VS during the follow-up period. In multivariate analyses, achieving VS was significantly associated with age (aOR: 1.04; 95%CI: 1.03-1.06 per five-year increase) and having a higher CD4 (aOR: 1.05, 95% CI 1.04-1.06 per 100 cells/mm(3)). Patients infected through perinatal transmission were less likely to achieve VS compared to MSM patients (aOR: 0.63, 95% CI 0.51-0.79). Once achieved, most participants (74.4%) sustained VS during follow-up. Blacks and perinatally infected persons were less likely to have sustained VS in KM survival analysis (log rank chi-square p ≤ .001 for both) compared to other races and risk groups. Earlier time to failure was observed among females, Blacks, publically insured, perinatally infected, those with longer standing HIV infection, and those with diagnoses of mental health issues or depression. Among this HIV-infected cohort, most people achieved and maintained VS; however, disparities exist with regard to patient age, race, HIV transmission risk, and co-morbid conditions. Identifying populations with disparate outcomes allows for appropriate targeting of resources to improve outcomes along the care continuum.

Background: Triangulation of data from multiple sources such as clinical cohort and surveillance data can help improve our ability to describe care patterns, service utilization, comorbidities, and ultimately measure and monitor clinical outcomes among persons living with HIV infection. Objectives: The objective of this study was to determine whether linkage of clinical cohort data and routinely collected HIV surveillance data would enhance the completeness and accuracy of each database and improve the understanding of care patterns and clinical outcomes. Methods: We linked data from the District of Columbia (DC) Cohort, a large HIV observational clinical cohort, with Washington, DC, Department of Health (DOH) surveillance data between January 2011 and June 2015. We determined percent concordance between select variables in the pre- and postlinked databases using kappa test statistics. We compared retention in care (RIC), viral suppression (VS), sexually transmitted diseases (STDs), and non-HIV comorbid conditions (eg, hypertension) and compared HIV clinic visit patterns determined using the prelinked database (DC Cohort) versus the postlinked database (DC Cohort + DOH) using chi-square testing. Additionally, we compared sociodemographic characteristics, RIC, and VS among participants receiving HIV care at ?3 sites versus

Objective Electronic medical records (EMRs) are being increasingly utilized to conduct clinical and epidemiologic research in numerous fields. To monitor and improve care of HIV-infected patients in Washington, DC, one of the most severely affected urban areas in the United States, we developed a city-wide database across 13 clinical sites using electronic data abstraction and manual data entry from EMRs. Materials and Methods To develop this unique longitudinal cohort, a web-based electronic data capture system (Discovere®) was used. An Agile software development methodology was implemented across multiple EMR platforms. Clinical informatics staff worked with information technology specialists from each site to abstract data electronically from each respective site’s EMR through an extract, transform, and load process. Results Since enrollment began in 2011, more than 7000 patients have been enrolled, with longitudinal clinical data available on all patients. Data sets are produced for scientific analyses on a quarterly basis, and benchmarking reports are generated semi-annually enabling each site to compare their participants’ clinical status, treatments, and outcomes to the aggregated summaries from all other sites. Discussion Numerous technical challenges were identified and innovative solutions developed to ensure the successful implementation of the DC Cohort. Central to the success of this project was the broad collaboration established between government, academia, clinics, community, information technology staff, and the patients themselves. Conclusions Our experiences may have practical implications for researchers who seek to merge data from diverse clinical databases, and are applicable to the study of health-related issues beyond HIV.