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1.  End-Stage Renal Disease Among HIV-Infected Adults in North America 
Abraham, Alison G. | Althoff, Keri N. | Jing, Yuezhou | Estrella, Michelle M. | Kitahata, Mari M. | Wester, C. William | Bosch, Ronald J. | Crane, Heidi | Eron, Joseph | Gill, M. John | Horberg, Michael A. | Justice, Amy C. | Klein, Marina | Mayor, Angel M. | Moore, Richard D. | Palella, Frank J. | Parikh, Chirag R. | Silverberg, Michael J. | Golub, Elizabeth T. | Jacobson, Lisa P. | Napravnik, Sonia | Lucas, Gregory M. | Kirk, Gregory D. | Benson, Constance A. | Bosch, Ronald J. | Collier, Ann C. | Boswell, Stephen | Grasso, Chris | Mayer, Ken | Hogg, Robert S. | Harrigan, Richard | Montaner, Julio | Cescon, Angela | Brooks, John T. | Buchacz, Kate | Gebo, Kelly A. | Moore, Richard D. | Moore, Richard D. | Carey, John T. | Rodriguez, Benigno | Horberg, Michael A. | Silverberg, Michael J. | Thorne, Jennifer E. | Goedert, James J. | Jacobson, Lisa P. | Klein, Marina B. | Rourke, Sean B. | Burchell, Ann | Rachlis, Anita R. | Hunter-Mellado, Robert F. | Mayor, Angel M. | Gill, M. John | Deeks, Steven G. | Martin, Jeffrey N. | Saag, Michael S. | Mugavero, Michael J. | Willig, James | Eron, Joseph J. | Napravnik, Sonia | Kitahata, Mari M. | Crane, Heidi M. | Justice, Amy C. | Dubrow, Robert | Fiellin, David | Sterling, Timothy R. | Haas, David | Bebawy, Sally | Turner, Megan | Gange, Stephen J. | Anastos, Kathryn | Moore, Richard D. | Saag, Michael S. | Gange, Stephen J. | Althoff, Keri N. | Kitahata, Mari M. | McKaig, Rosemary G. | Justice, Amy C. | Freeman, Aimee M. | Moore, Richard D. | Freeman, Aimee M. | Lent, Carol | Kitahata, Mari M. | Van Rompaey, Stephen E. | Crane, Heidi M. | Webster, Eric | Morton, Liz | Simon, Brenda | Gange, Stephen J. | Althoff, Keri N. | Abraham, Alison G. | Lau, Bryan | Zhang, Jinbing | Jing, Jerry | Golub, Elizabeth | Modur, Shari | Hanna, David B. | Rebeiro, Peter | Wong, Cherise | Mendes, Adell
Human immunodeficiency virus-infected individuals have benefited from improved viral suppression, but a discrepancy in end-stage renal disease risk between black and nonblack HIV-infected persons remains, in part due to continued disparities in antiretroviral use and viral suppression, and higher rates of comorbidities.
Background. Human immunodeficiency virus (HIV)-infected adults, particularly those of black race, are at high-risk for end-stage renal disease (ESRD), but contributing factors are evolving. We hypothesized that improvements in HIV treatment have led to declines in risk of ESRD, particularly among HIV-infected blacks.
Methods. Using data from the North American AIDS Cohort Collaboration for Research and Design from January 2000 to December 2009, we validated 286 incident ESRD cases using abstracted medical evidence of dialysis (lasting >6 months) or renal transplant. A total of 38 354 HIV-infected adults aged 18–80 years contributed 159 825 person-years (PYs). Age- and sex-standardized incidence ratios (SIRs) were estimated by race. Poisson regression was used to identify predictors of ESRD.
Results. HIV-infected ESRD cases were more likely to be of black race, have diabetes mellitus or hypertension, inject drugs, and/or have a prior AIDS-defining illness. The overall SIR was 3.2 (95% confidence interval [CI], 2.8–3.6) but was significantly higher among black patients (4.5 [95% CI, 3.9–5.2]). ESRD incidence declined from 532 to 303 per 100 000 PYs and 138 to 34 per 100 000 PYs over the time period for blacks and nonblacks, respectively, coincident with notable increases in both the prevalence of viral suppression and the prevalence of ESRD risk factors including diabetes mellitus, hypertension, and hepatitis C virus coinfection.
Conclusions. The risk of ESRD remains high among HIV-infected individuals in care but is declining with improvements in virologic suppression. HIV-infected black persons continue to comprise the majority of cases, as a result of higher viral loads, comorbidities, and genetic susceptibility.
doi:10.1093/cid/ciu919
PMCID: PMC4357817  PMID: 25409471
end-stage renal disease (ESRD); chronic kidney disease (CKD); HIV infection/AIDS; HIV/AIDS; glomerular filtration rate (GFR)
2.  Disparities in the Quality of HIV Care When Using US Department of Health and Human Services Indicators 
Althoff, Keri N. | Rebeiro, Peter | Brooks, John T. | Buchacz, Kate | Gebo, Kelly | Martin, Jeffrey | Hogg, Robert | Thorne, Jennifer E. | Klein, Marina | Gill, M. John | Sterling, Timothy R. | Yehia, Baligh | Silverberg, Michael J. | Crane, Heidi | Justice, Amy C. | Gange, Stephen J. | Moore, Richard | Kitahata, Mari M. | Horberg, Michael A. | Kirk, Gregory D. | Benson, Constance A. | Bosch, Ronald J. | Collier, Ann C. | Boswell, Stephen | Grasso, Chris | Mayer, Kenneth H. | Hogg, Robert S. | Richard Harrigan, P. | Montaner, Julio SG | Cescon, Angela | Samji, Hasina | Brooks, John T. | Buchacz, Kate | Gebo, Kelly A. | Moore, Richard D. | Moore, Richard D. | Carey, John T. | Horberg, Michael A. | Silverberg, Michael J. | Thorne, Jennifer E. | Goedert, James J. | Jacobson, Lisa P. | Klein, Marina B. | Rourke, Sean B. | Burchell, Ann N. | Rachlis, Anita R. | Hunter-Mellado, Robert F. | Mayor, Angel M. | Gill, M.John | Deeks, Steven G. | Martin, Jeffrey N. | Saag, Michael S. | Mugavero, Michael J. | Willig, James | Eron, Joseph J. | Napravnik, Sonia | Kitahata, Mari M. | Crane, Heidi M. | Justice, Amy C. | Dubrow, Robert | Fiellin, David | Sterling, Timothy R. | Haas, David | Bebawy, Sally | Turner, Megan | Gange, Stephen J. | Anastos, Kathryn | Moore, Richard D. | Saag, Michael S. | Gange, Stephen J. | Kitahata, Mari M. | Althoff, Keri N. | McKaig, Rosemary G. | Justice, Amy C. | Freeman, Aimee M. | Moore, Richard D. | Freeman, Aimee M. | Lent, Carol | Kitahata, Mari M. | Van Rompaey, Stephen E. | Crane, Heidi M. | Morton, Liz | McReynolds, Justin | Lober, William B. | Gange, Stephen J. | Althoff, Keri N. | Abraham, Alison G. | Lau, Bryan | Zhang, Jinbing | Jing, Jerry | Golub, Elizabeth | Modur, Shari | Hanna, David B. | Rebeiro, Peter | Wong, Cherise | Mendes, Adell
We estimated US Department of Health and Human Services (DHHS)–approved human immunodeficiency virus (HIV) indicators. Among patients, 71% were retained in care, 82% were prescribed treatment, and 78% had HIV RNA ≤200 copies/mL; younger adults, women, blacks, and injection drug users had poorer outcomes. Interventions are needed to reduce retention- and treatment-related disparities.
doi:10.1093/cid/ciu044
PMCID: PMC3967825  PMID: 24463281
HIV; quality of care; retention in care; antiretroviral therapy; HIV RNA suppression
3.  Hepatitis C Viremia and the Risk of Chronic Kidney Disease in HIV-Infected Individuals 
Lucas, Gregory M. | Jing, Yuezhou | Sulkowski, Mark | Abraham, Alison G. | Estrella, Michelle M. | Atta, Mohamed G. | Fine, Derek M. | Klein, Marina B. | Silverberg, Michael J. | Gill, M. John | Moore, Richard D. | Gebo, Kelly A. | Sterling, Timothy R. | Butt, Adeel A. | Kirk, Gregory D. | Benson, Constance A. | Bosch, Ronald J. | Collier, Ann C. | Boswell, Stephen | Grasso, Chris | Mayer, Ken | Hogg, Robert S. | Harrigan, Richard | Montaner, Julio | Cescon, Angela | Brooks, John T. | Buchacz, Kate | Gebo, Kelly A. | Moore, Richard D. | Carey, John T. | Rodriguez, Benigno | Horberg, Michael A. | Silverberg, Michael J. | Horberg, Michael A. | Thorne, Jennifer E. | Goedert, James J. | Jacobson, Lisa P. | Klein, Marina B. | Rourke, Sean B. | Burchell, Ann | Rachlis, Anita R. | Rico, Puerto | Hunter-Mellado, Robert F. | Mayor, Angel M. | Gill, M. John | Deeks, Steven G. | Martin, Jeffrey N. | Patel, Pragna | Brooks, John T. | Saag, Michael S. | Mugavero, Michael J. | Willig, James | Eron, Joseph J. | Napravnik, Sonia | Kitahata, Mari M. | Crane, Heidi M. | Justice, Amy C. | Dubrow, Robert | Fiellin, David | Sterling, Timothy R. | Haas, David | Bebawy, Sally | Turner, Megan | Gange, Stephen J. | Anastos, Kathryn | Moore, Richard D. | Saag, Michael S. | Gange, Stephen J. | Kitahata, Mari M. | McKaig, Rosemary G. | Justice, Amy C. | Freeman, Aimee M. | Moore, Richard D. | Freeman, Aimee M. | Lent, Carol | Kitahata, Mari M. | Van Rompaey, Stephen E. | Crane, Heidi M. | Webster, Eric | Morton, Liz | Simon, Brenda | Gange, Stephen J. | Althoff, Keri N. | Abraham, Alison G. | Lau, Bryan | Zhang, Jinbing | Jing, Jerry | Golub, Elizabeth | Modur, Shari | Hanna, David B. | Rebeiro, Peter | Wong, Cherise | Mendes, Adell
The Journal of Infectious Diseases  2013;208(8):1240-1249.
Background. The role of active hepatitis C virus (HCV) replication in chronic kidney disease (CKD) risk has not been clarified.
Methods. We compared CKD incidence in a large cohort of HIV-infected subjects who were HCV seronegative, HCV viremic (detectable HCV RNA), or HCV aviremic (HCV seropositive, undetectable HCV RNA). Stages 3 and 5 CKD were defined according to standard criteria. Progressive CKD was defined as a sustained 25% glomerular filtration rate (GFR) decrease from baseline to a GFR < 60 mL/min/1.73 m2. We used Cox models to calculate adjusted hazard ratios (HRs) and 95% confidence intervals (CIs).
Results. A total of 52 602 HCV seronegative, 9508 HCV viremic, and 913 HCV aviremic subjects were included. Compared with HCV seronegative subjects, HCV viremic subjects were at increased risk for stage 3 CKD (adjusted HR 1.36 [95% CI, 1.26, 1.46]), stage 5 CKD (1.95 [1.64, 2.31]), and progressive CKD (1.31 [1.19, 1.44]), while HCV aviremic subjects were also at increased risk for stage 3 CKD (1.19 [0.98, 1.45]), stage 5 CKD (1.69 [1.07, 2.65]), and progressive CKD (1.31 [1.02, 1.68]).
Conclusions. Compared with HIV-infected subjects who were HCV seronegative, both HCV viremic and HCV aviremic individuals were at increased risk for moderate and advanced CKD.
doi:10.1093/infdis/jit373
PMCID: PMC3778973  PMID: 23904290
HIV; hepatitis C virus; chronic kidney disease; hepatitis C RNA; cohort study; glomerular filtration rate; injection drug use
4.  Trends and Disparities in Antiretroviral Therapy Initiation and Virologic Suppression Among Newly Treatment-Eligible HIV-Infected Individuals in North America, 2001–2009 
Hanna, David B. | Buchacz, Kate | Gebo, Kelly A. | Hessol, Nancy A. | Horberg, Michael A. | Jacobson, Lisa P. | Kirk, Gregory D. | Kitahata, Mari M. | Korthuis, P. Todd | Moore, Richard D. | Napravnik, Sonia | Patel, Pragna | Silverberg, Michael J. | Sterling, Timothy R. | Willig, James H. | Lau, Bryan | Althoff, Keri N. | Crane, Heidi M. | Collier, Ann C. | Samji, Hasina | Thorne, Jennifer E. | Gill, M. John | Klein, Marina B. | Martin, Jeffrey N. | Rodriguez, Benigno | Rourke, Sean B. | Gange, Stephen J. | Benson, A. | Bosch, Ronald J. | Collier, Ann C. | Boswell, Stephen | Grasso, Chris | Mayer, Ken | Hogg, Robert S. | Harrigan, Richard | Montaner, Julio | Cescon, Angela | Brooks, John T. | Buchacz, Kate | Gebo, Kelly A. | Moore, Richard D. | Rodriguez, Benigno | Horberg, Michael A. | Silverberg, Michael J. | Thorne, Jennifer E. | Goedert, James J. | Jacobson, Lisa P. | Klein, Marina B. | Rourke, Sean B. | Burchell, Ann | Rachlis, Anita R. | Hunter-Mellado, Robert F. | Mayor, Angel M. | Gill, M. John | Deeks, Steven G. | Martin, Jeffrey N. | Saag, Michael S. | Mugavero, Michael J. | Willig, James | Eron, Joseph J. | Napravnik, Sonia | Kitahata, Mari M. | Crane, Heidi M. | Justice, Amy C. | Dubrow, Robert | Fiellin, David | Sterling, Timothy R. | Haas, David | Bebawy, Sally | Turner, Megan | Gange, Stephen J. | Anastos, Kathryn | Moore, Richard D. | Saag, Michael S. | Gange, Stephen J. | Kitahata, Mari M. | McKaig, Rosemary G. | Justice, Amy C. | Freeman, Aimee M. | Moore, Richard D. | Freeman, Aimee M. | Lent, Carol | Platt, Aaron | Kitahata, Mari M. | Van Rompaey, Stephen E. | Crane, Heidi M. | Webster, Eric | Morton, Liz | Simon, Brenda | Gange, Stephen J. | Abraham, Alison G. | Lau, Bryan | Althoff, Keri N. | Zhang, Jinbing | Jing, Jerry | Golub, Elizabeth | Modur, Shari | Hanna, David B. | Rebeiro, Peter | Wong, Cherise | Mendes, Adell
In the last decade, timely initiation of antiretroviral therapy and resulting virologic suppression have greatly improved in North America concurrent with the development of better tolerated and more potent regimens, but significant barriers to treatment uptake remain.
Background. Since the mid-1990s, effective antiretroviral therapy (ART) regimens have improved in potency, tolerability, ease of use, and class diversity. We sought to examine trends in treatment initiation and resulting human immunodeficiency virus (HIV) virologic suppression in North America between 2001 and 2009, and demographic and geographic disparities in these outcomes.
Methods. We analyzed data on HIV-infected individuals newly clinically eligible for ART (ie, first reported CD4+ count <350 cells/µL or AIDS-defining illness, based on treatment guidelines during the study period) from 17 North American AIDS Cohort Collaboration on Research and Design cohorts. Outcomes included timely ART initiation (within 6 months of eligibility) and virologic suppression (≤500 copies/mL, within 1 year). We examined time trends and considered differences by geographic location, age, sex, transmission risk, race/ethnicity, CD4+ count, and viral load, and documented psychosocial barriers to ART initiation, including non–injection drug abuse, alcohol abuse, and mental illness.
Results. Among 10 692 HIV-infected individuals, the cumulative incidence of 6-month ART initiation increased from 51% in 2001 to 72% in 2009 (Ptrend < .001). The cumulative incidence of 1-year virologic suppression increased from 55% to 81%, and among ART initiators, from 84% to 93% (both Ptrend < .001). A greater number of psychosocial barriers were associated with decreased ART initiation, but not virologic suppression once ART was initiated. We found significant heterogeneity by state or province of residence (P < .001).
Conclusions. In the last decade, timely ART initiation and virologic suppression have greatly improved in North America concurrent with the development of better-tolerated and more potent regimens, but significant barriers to treatment uptake remain, both at the individual level and systemwide.
doi:10.1093/cid/cit003
PMCID: PMC3657490  PMID: 23315317
antiretroviral therapy; healthcare disparities; HIV; time factors; viral load
5.  Rising Obesity Prevalence and Weight Gain Among Adults Starting Antiretroviral Therapy in the United States and Canada 
Abstract
The proportion of overweight and obese adults in the United States and Canada has increased over the past decade, but temporal trends in body mass index (BMI) and weight gain on antiretroviral therapy (ART) among HIV-infected adults have not been well characterized. We conducted a cohort study comparing HIV-infected adults in the North America AIDS Cohort Collaboration on Research and Design (NA-ACCORD) to United States National Health and Nutrition Examination Survey (NHANES) controls matched by sex, race, and age over the period 1998 to 2010. Multivariable linear regression assessed the relationship between BMI and year of ART initiation, adjusting for sex, race, age, and baseline CD4+ count. Temporal trends in weight on ART were assessed using a generalized least-squares model further adjusted for HIV-1 RNA and first ART regimen class. A total of 14,084 patients from 17 cohorts contributed data; 83% were male, 57% were nonwhite, and the median age was 40 years. Median BMI at ART initiation increased from 23.8 to 24.8 kg/m2 between 1998 and 2010 in NA-ACCORD, but the percentage of those obese (BMI ≥30 kg/m2) at ART initiation increased from 9% to 18%. After 3 years of ART, 22% of individuals with a normal BMI (18.5–24.9 kg/m2) at baseline had become overweight (BMI 25.0–29.9 kg/m2), and 18% of those overweight at baseline had become obese. HIV-infected white women had a higher BMI after 3 years of ART as compared to age-matched white women in NHANES (p = 0.02), while no difference in BMI after 3 years of ART was observed for HIV-infected men or non-white women compared to controls. The high prevalence of obesity we observed among ART-exposed HIV-infected adults in North America may contribute to health complications in the future.
doi:10.1089/aid.2015.0147
PMCID: PMC4692122  PMID: 26352511
6.  Rising Obesity Prevalence and Weight Gain Among Adults Starting Antiretroviral Therapy in the United States and Canada 
The proportion of overweight and obese adults in the United States and Canada has increased over the past decade, but temporal trends in body mass index (BMI) and weight gain on antiretroviral therapy (ART) among HIV-infected adults have not been well characterized. We conducted a cohort study comparing HIV-infected adults in the North America AIDS Cohort Collaboration on Research and Design (NA-ACCORD) to United States National Health and Nutrition Examination Survey (NHANES) controls matched by sex, race, and age over the period 1998 to 2010. Multivariable linear regression assessed the relationship between BMI and year of ART initiation, adjusting for sex, race, age, and baseline CD4+ count. Temporal trends in weight on ART were assessed using a generalized least-squares model further adjusted for HIV-1 RNA and first ART regimen class. A total of 14,084 patients from 17 cohorts contributed data; 83% were male, 57% were nonwhite, and the median age was 40 years. Median BMI at ART initiation increased from 23.8 to 24.8 kg/m2 between 1998 and 2010 in NA-ACCORD, but the percentage of those obese (BMI ≥30 kg/m2) at ART initiation increased from 9% to 18%. After 3 years of ART, 22% of individuals with a normal BMI (18.5–24.9 kg/m2) at baseline had become overweight (BMI 25.0–29.9 kg/m2), and 18% of those overweight at baseline had become obese. HIV-infected white women had a higher BMI after 3 years of ART as compared to age-matched white women in NHANES (p = 0.02), while no difference in BMI after 3 years of ART was observed for HIV-infected men or non-white women compared to controls. The high prevalence of obesity we observed among ART-exposed HIV-infected adults in North America may contribute to health complications in the future.
doi:10.1089/aid.2015.0147
PMCID: PMC4692122  PMID: 26352511
7.  Laboratory Measures as Proxies for Primary Care Encounters: Implications for Quantifying Clinical Retention Among HIV-Infected Adults in North America 
American Journal of Epidemiology  2015;182(11):952-960.
Because of limitations in the availability of data on primary care encounters, patient retention in human immunodeficiency virus (HIV) care is often estimated using laboratory measurement dates as proxies for clinical encounters, leading to possible outcome misclassification. This study included 83,041 HIV-infected adults from 14 clinical cohorts in the North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD) who had ≥1 HIV primary care encounters during 2000–2010, contributing 468,816 person-years of follow-up. Encounter-based retention (REB) was defined as ≥2 encounters in a calendar year, ≥90 days apart. Laboratory-based retention (RLB) was defined similarly, using the dates of CD4-positive cell counts or HIV-1 RNA measurements. Percentage of agreement and the κ statistic were used to characterize agreement between RLB and REB. Logistic regression with generalized estimating equations and stabilized inverse-probability-of-selection weights was used to elucidate temporal trends and the discriminatory power of RLB as a predictor of REB, accounting for age, sex, race/ethnicity, primary HIV risk factor, and cohort site as potential confounders. Both REB and RLB increased from 2000 to 2010 (from 67% to 78% and from 65% to 77%, respectively), though REB was higher than RLB throughout (P < 0.01). RLB agreed well with REB (80%–86% agreement; κ = 0.55–0.62, P < 0.01) and had a strong, imperfect ability to discriminate between persons retained and not retained in care by REB (C statistic: C = 0.81, P < 0.05). As a proxy for REB, RLB had a sensitivity and specificity of 84% and 77%, respectively, with misclassification error of 18%.
doi:10.1093/aje/kwv181
PMCID: PMC4655744  PMID: 26578717
clinical encounters; clinical retention; HIV; laboratory measurements; measurement error; misclassification; proxies
8.  Interacting effects of obesity, race, ethnicity and sex on the incidence and control of adult-onset asthma 
Background
To improve care and control for patients with adult-onset asthma, a better understanding of determinants of their risk and outcomes is important. We investigated how associations between asthma, asthma control and obesity may be modified by patient demographic characteristics.
Methods
This retrospective study of adults enrolled in several health plans across the U.S. (n = 2,860,305) examined the interacting effects of obesity, age, race, and sex on adult-onset asthma and asthma control. Multivariable adjusted Cox and logistic regression models estimated hazard ratios (HR), and 95 % confidence intervals (CI) for the associations between body mass index (BMI) and study outcomes, and interactions of BMI with demographic characteristics.
Results
Compared with individuals who had a BMI <25 kg/m2, the hazard of adult-onset asthma progressively increased with increasing BMI, from a 12 % increase among persons with a BMI of 25.0–29.9 kg/m2 (HR 1.12, 95 % CI 1.10, 1.14) to an almost 250 % increase among persons with a BMI ≥50 kg/m2 (HR 2.49, 95 % CI 2.38, 2.60). The magnitude of the association between obesity and asthma risk was greater for women (compared with men) and lower for Blacks (compared with non-Hispanic Whites). Among individuals with asthma, obesity was associated with poorly controlled and high-risk asthma.
Conclusions
The present study demonstrates that the magnitude of the associations between obesity and adult-onset asthma incidence and control are modified by race, age, and sex. Understanding the role of obesity in the development of adult-onset asthma will help to improve asthma treatment algorithms and to develop targeted interventions.
doi:10.1186/s13223-016-0155-8
PMCID: PMC5069790  PMID: 27777591
Asthma; Adult-onset; Obesity; Race; Sex; Ethnicity
9.  Survival Among HIV-Infected and HIV-Uninfected Individuals with Common Non-AIDS-Defining Cancers 
Background
Non-AIDS-defining cancers increasingly contribute to mortality among human immunodeficiency virus (HIV)-infected individuals. However, few studies have compared cancer prognosis by HIV status with adjustment for risk factors.
Methods
We conducted a cohort study of HIV-infected and HIV-uninfected adults in Kaiser Permanente California during 1996–2011, following subjects diagnosed with Hodgkin lymphoma (HL) or anal, prostate, colorectal, or lung cancers. We used Kaplan-Meier curves and Cox regression to assess cancer-related mortality within five years, comparing HIV-infected with HIV-uninfected subjects. Adjusted models included age, race/ethnicity, sex, cancer stage, cancer treatment, and smoking.
Results
Among HIV-infected and HIV-uninfected subjects, there were 68 and 51 cases of HL, 120 and 28 of anal cancer, 150 and 2050 of prostate cancer, 53 and 646 of colorectal cancer, and 80 and 507 of lung cancer, respectively. Five-year cancer-related survival was reduced for HIV-infected compared with HIV-uninfected subjects, reaching statistical significance for lung cancer (10% vs. 19%, P=0.002) but not HL (83% vs. 89%, P=0.40) or anal (64% vs. 74%, P=0.38), prostate (86% vs. 92%, P=0.074), or colorectal cancers (49% vs. 58%, P=0.55). Adjusted results were similar, with lung cancer (hazard ratio [HR] 1.3, 95% confidence interval [CI]: 1.0–1.7) and prostate cancer (HR 2.1, 95% CI: 1.1–4.1) reaching significance.
Conclusions
Cancer-related mortality was higher among HIV-infected compared with HIV-uninfected individuals for prostate and lung cancers, but not HL, anal cancer, or colorectal cancer.
Impact
Our findings emphasize the need for a focus on prevention, early detection, and adequate treatment of cancer among HIV-infected individuals.
doi:10.1158/1055-9965.EPI-14-1079
PMCID: PMC4526437  PMID: 25713023
cancer; prognosis; human immunodeficiency virus (HIV); immunodeficiency; anal cancer; lung cancer; colorectal cancer; Hodgkin lymphoma; prostate cancer
10.  Differences in Response to Antiretroviral Therapy by Sex and Hepatitis C Infection Status 
AIDS Patient Care and STDs  2015;29(7):370-378.
Abstract
Hepatitis C virus (HCV) co-infection and biological sex may each affect response to antiretroviral therapy (ART), yet no studies have examined HIV-associated outcomes by both HCV status and sex. We conducted a cohort study of HIV-infected adults initiating ART in Kaiser Permanente California during 1996–2011. We used piecewise linear regression to assess CD4 changes by sex and HCV status over 5 years. We used Cox regression to estimate hazard ratios (HR) by sex and HCV status for HIV RNA <500 copies/mL over 1 year, and for AIDS and death over the follow-up period. Among 12,865 subjects, there were 154 HIV/HCV-co-infected women, 1000 HIV/HCV-co-infected men, 1088 HIV-mono-infected women, and 10,623 HIV-mono-infected men. CD4 increases were slower in the first year for HIV/HCV-co-infected women (75 cells/μL) and men (70 cells/μL) compared with HIV-mono-infected women (145 cells/μL) and men (120 cells/μL; p<0.001). After 5 years, women had higher CD4 than men in both HIV-mono-infected (598 vs. 562 cells/μL, p=0.003) and HIV/HCV-co-infected individuals (567 vs. 509 cells/μL, p=0.003). Regardless of sex, HIV/HCV co-infection was associated with 40% higher mortality [95% confidence interval (CI): 1.2–1.6] compared with HIV mono-infection, but was not associated with AIDS (HR 1.1, 95% CI: 0.9–1.3) or achieving HIV RNA <500 copies/mL (HR 1.0, 95% CI: 0.9–1.1). HIV/HCV-co-infected men and women have slower CD4 recovery after starting ART and have increased mortality compared with HIV-mono-infected men and women. HCV should be aggressively treated in HIV/HCV-co-infected adults, regardless of sex.
doi:10.1089/apc.2015.0040
PMCID: PMC4808272  PMID: 26061798
11.  The Patient Outcomes Research To Advance Learning (PORTAL) Network Adult Overweight and Obesity Cohort: Development and Description 
JMIR Research Protocols  2016;5(2):e87.
Background
The Patient-Centered Outcomes Research Institute (PCORI) created a new national network infrastructure to enable large-scale observational comparative effectiveness research across diverse clinical care settings. As part of testing the feasibility of this effort, each clinical data research network (CDRN) was required to construct cohorts of patients, including one of patients with overweight and obesity.
Objective
The aim of this paper is to report on the development of the Patient Outcomes Research to Advance Learning (PORTAL) overweight and obese cohort, which includes patients from 10 health plans located across the United States.
Methods
Information was gathered from each plan’s electronic health records (EHR). Eligibility included 18 years of age or older, a valid height and weight in 2012 or 2013, and body mass index (BMI) greater than 22.9 kg/m2. Pre-diabetes and diabetes status was defined using the American Diabetes Association (ADA) criteria, using lab values of glycated hemoglobin (HbA1c) or fasting glucose available in the EHR. Hypertension was identified from the International Classification of Diseases (ICD) diagnosis codes. Individuals were classified into BMI categories: healthy weight (23.0-24.9 kg/m2), overweight (25.0-29.9 kg/m2), obese class 1 (30.0-34.9 kg/m2), obese class 2 (35.0-39.9 kg/m2), obese class 3 (40.0-49.0 kg/m2), and obese class 4 (>50.0 kg/m2).
Results
A cohort of 5,293,458 non-pregnant adults was created. Weight status was 20.39% (1,079,289/5,293,458) healthy weight, 40.40% (2,138,520/5,293,458) overweight, 22.78% (1,205,866/5,293,458) obese class 1, 9.86% (521,872/5,293,458) obese class 2, 5.59% (295,786/5,293,458) obese class 3, and 0.98% (52,125/5,293,458) obese class 4. Race/ethnicity was 49.02% (2,594,776/5,293,458) non-Hispanic white, 22.89% (1,211,677/5,293,458) Hispanic, 10.40% (550,608/5,293,458) Asian, 10.83% (573,506/5,293,458) black, and 6.59% (348,830/5,293,458) other. About 34.33% (1,817,438/5,293,458) met the definition of hypertension, 20.49% (1,660,940/5,293,458) of individuals met the criteria for pre-diabetes, and 14.98% (793,069/5,293,458) met criteria for diabetes. Prevalence of pre-diabetes and diabetes varied across health plans to a greater extent than expected based on hypertension prevalence and BMI status variability.
Conclusions
This large, race, ethnic, and geographically diverse cohort will be useful for future studies of rare exposures or outcomes and differences in health care practices.
doi:10.2196/resprot.5589
PMCID: PMC4927804  PMID: 27307352
overweight; obesity; race and ethnic diversity; pre-diabetes; diabetes
12.  Antiretroviral therapy adherence and use of an electronic shared medical record among people living with HIV 
AIDS and behavior  2015;19(0 2):177-185.
Electronic shared medical records (SMR) are emerging healthcare technologies that allow patients to engage in their healthcare by communicating with providers, refilling prescriptions, scheduling appointments, and viewing portions of medical records. We conducted a pre-post cohort study of HIV-positive adults who used and did not use SMR in two integrated healthcare systems. We compared the difference in antiretroviral refill adherence between SMR users and age- and sex-frequency matched non-users from the 12-month period prior to SMR use to the 12-month period starting six months after initiation of SMR use. High adherence was maintained among SMR users (change=−0.11%) but declined among non-users (change=−2.05%; p=0.003). Among SMR users, there was a steady improvement in adherence as monthly frequency of SMR use increased (p=0.009). SMR use, particularly more frequent use, is associated with maintaining high adherence and non-use is associated with declines in adherence over time among patients with access to these online services.
doi:10.1007/s10461-014-0982-x
PMCID: PMC4497945  PMID: 25572829
HIV; electronic health records; medication adherence; antiretroviral therapy; integrated healthcare system
13.  Low Back Imaging When Not Indicated: A Descriptive Cross-System Analysis 
The Permanente Journal  2016;20(2):25-33.
Context:
Guideline-discordant imaging to evaluate incident low back pain is common.
Objective:
We compared rates of guideline-discordant imaging in patients with low back pain in two care delivery systems with differing abilities to track care through an electronic health record (EHR), and in their patients’ insurance status, to measure the association between these factors and rates of ordered low back imaging.
Design:
We used data from two Kaiser Permanente (KP) Regions and from OCHIN, a community health center network. We extracted data on imaging performed after index visits for low back pain from June 1, 2011, to May 31, 2012, in these systems. Adjusted logistic regression measured associations between system-level factors and imaging rates.
Main Outcome Measures:
Imaging rates for incident low back pain using 2 national quality metrics: Clinical Quality Measure 0052, a measure for assessing Meaningful Use of EHRs, and the Healthcare Effectiveness Data and Information Set measure “Use of Imaging Studies for Low Back Pain.”
Results:
Among 19,503 KP patients and 2694 OCHIN patients with incident low back pain, ordered imaging was higher among men and whites but did not differ across health care systems. OCHIN’s publicly insured patients had higher rates of imaging compared with those with private or no insurance.
Conclusion:
Rates of ordered imaging to evaluate incident low back pain among uninsured OCHIN patients were lower than in KP overall; among insured OCHIN patients, rates were higher than in KP overall. Research is needed to establish causality and develop interventions.
doi:10.7812/TPP/15-081
PMCID: PMC4867822  PMID: 26934626
14.  Cumulative Incidence of Cancer among HIV-infected Individuals in North America 
Annals of internal medicine  2015;163(7):507-518.
Background
Cancer is increasingly common among HIV patients given improved survival.
Objective
To examine calendar trends in cumulative cancer incidence and hazard rate by HIV status.
Design
Cohort study
Setting
North American AIDS Cohort Collaboration on Research and Design during 1996–2009
Patients
86,620 HIV-infected and 196,987 uninfected adults
Measurements
We estimated cancer-type-specific cumulative incidence by age 75 years by HIV status and calendar era, and examined calendar trends in cumulative incidence and hazard rates.
Results
Cumulative incidences (%) of cancer by age 75 (HIV+/HIV−) were: Kaposi sarcoma (KS), 4.4/0.01; non-Hodgkin’s lymphoma (NHL), 4.5/0.7; lung, 3.4/2.8; anal, 1.5/0.1; colorectal, 1.0/1.5; liver, 1.1/0.4; Hodgkin lymphoma (HL), 0.9/0.1; melanoma, 0.5/0.6; and oral cavity/pharyngeal, 0.8/0.8. Among HIV-infected subjects, we observed decreasing calendar trends in cumulative incidence and hazard rate for KS and NHL. For anal, colorectal and liver cancers, increasing cumulative incidence, but not hazard rate trends, were due to the decreasing mortality rate trend (−9% per year), allowing greater opportunity to be diagnosed with these cancer types. Despite decreasing hazard rate trends for lung, HL, and melanoma, we did not observe cumulative incidence trends due to the compensating effect of the declining mortality rate on cumulative incidence.
Limitations
Secular trends in screening, smoking, and viral co-infections were not evaluated.
Conclusions
Our analytic approach helped disentangle the effects of improved survival and changing cancer-specific hazard rates on cumulative incidence trends among HIV patients. Cumulative cancer incidence by age 75, approximating lifetime risk in HIV patients, may have clinical utility in this population. The high cumulative incidences by age 75 for KS, NHL, and lung cancer supports early and sustained ART and smoking cessation.
Primary Funding Source
National Institutes of Health
doi:10.7326/M14-2768
PMCID: PMC4711936  PMID: 26436616
15.  A picture is worth a thousand words: maps of HIV indicators to inform research, programs, and policy from NA-ACCORD and CCASAnet clinical cohorts 
Introduction
Maps are powerful tools for visualization of differences in health indicators by geographical region, but multi-country maps of HIV indicators do not exist, perhaps due to lack of consistent data across countries. Our objective was to create maps of four HIV indicators in North, Central, and South American countries.
Methods
Using data from the North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD) and the Caribbean, Central, and South America network for HIV epidemiology (CCASAnet), we mapped median CD4 at presentation for HIV clinical care, proportion retained in HIV primary care, proportion prescribed antiretroviral therapy (ART), and the proportion with suppressed plasma HIV viral load (VL) from 2010 to 2012 for North, Central, and South America. The 15 Canadian and US clinical cohorts and 7 clinical cohorts in Argentina, Brazil, Chile, Haiti, Honduras, Mexico, and Peru represented approximately 2–7% of persons known to be living with HIV in these countries.
Results
Study populations were selected for each indicator: median CD4 at presentation for care was estimated among 14,811 adults; retention was estimated among 87,979 adults; ART use was estimated among 84,757 adults; and suppressed VL was estimated among 51,118 adults. Only three US states and the District of Columbia had a median CD4 at presentation >350 cells/mm3. Haiti, Mexico, and several states had >85% retention in care; lower (50–74%) retention in care was observed in the US West, South, and Mid-Atlantic, and in Argentina, Brazil, and Peru. ART use was highest (90%) in Mexico. The percentages of patients with suppressed VL in the US South and Northeast were lower than in most of Central and South America.
Conclusions
These maps provide visualization of gaps in the quality of HIV care and allow for comparison between and within countries as well as monitoring policy and programme goals within geographical boundaries.
doi:10.7448/IAS.19.1.20707
PMCID: PMC4821890  PMID: 27049052
Map; HIV indicators; CD4 T-lymphocyte count; retention in care; antiretroviral therapy; HIV RNA suppression; North America; Central America; South America; implementation science
16.  The Impact of Age on Retention in Care and Viral Suppression 
Background
Retention in care is important for all HIV-infected persons and is strongly associated with initiation of antiretroviral therapy and viral suppression. However, it is unclear how retention in care and age interact to effect viral suppression. We evaluated whether the association between retention and viral suppression differed by age at entry into care.
Methods
Cross-sectional analysis (2006-2010) involving 17,044 HIV-infected adults in 14 clinical cohorts across the U.S. and Canada. Patients contributed one year of data during their first full calendar year of clinical observation. Poisson regression examined associations between retention measures [U.S. National HIV/AIDS Strategy (NHAS), U.S. Department of Health and Human Services (DHHS), 6-month gap, and 3-month visit constancy] and viral suppression (HIV RNA ≤200 copies/mL) by age group: 18-29, 30-39, 40–49, 50–59, and ≥60 years old.
Results
Overall, 89% of patients were retained in care using the NHAS measure, 74% with the DHHS indicator, 85% did not have a 6-month gap, and 62% had visits in 3-4 quarters of the year; 54% achieved viral suppression. For each retention measure, the association with viral suppression was significant for only the younger age groups (18-29 and 30-39 years): 18-29 [adjusted prevalence ratio (APR)=1.33, 95% confidence interval (CI)=1.03-1.70]; 30-39 (APR=1.23, CI=1.01-1.49); 40-49 (APR=1.06, CI=0.90-1.22); 50-59 (APR=0.92, CI=0.75-1.13); ≥60 years (APR=0.99, CI=0.63-1.56) using the NHAS measure as a representative example.
Conclusions
These results have important implications for improving viral control among younger adults, emphasizing the crucial role retention in care plays in supporting viral suppression in this population.
doi:10.1097/QAI.0000000000000489
PMCID: PMC4334738  PMID: 25559604
Retention in Care; Viral Suppression; Age; Engagement; HIV
17.  Building a Governance Strategy for CER: The Patient Outcomes Research to Advance Learning (PORTAL) Network Experience 
eGEMs  2016;4(2):1216.
Introduction:
The Patient Outcomes Research to Advance Learning (PORTAL) Network was established with funding from the Patient-Centered Outcomes Research Institute (PCORI) in 2014. The PORTAL team adapted governance structures and processes from past research network collaborations. We will review and outline the structures and processes of the PORTAL governance approach and describe how proactively focusing on priority areas helped us to facilitate an ambitious research agenda.
Background:
For years a variety of funders have supported large-scale infrastructure grants to promote the use of clinical datasets to answer important comparative effectiveness research (CER) questions. These awards have provided the impetus for health care systems to join forces in creating clinical data research networks. Often, these scientific networks do not develop governance processes proactively or systematically, and address issues only as problems arise. Even if network leaders and collaborators foresee the need to develop governance approaches, they may underestimate the time and effort required to develop sound processes. The resulting delays can impede research progress.
Innovation:
Because the PORTAL sites had built trust and a foundation of collaboration by participating with one another in past research networks, essential elements of effective governance such as guiding principles, decision making processes, project governance, data governance, and stakeholders in governance were familiar to PORTAL investigators. This trust and familiarity enabled the network to rapidly prioritize areas that required sound governance approaches: responding to new research opportunities, creating a culture of trust and collaboration, conducting individual studies, within the broader network, assigning responsibility and credit to scientific investigators, sharing data while protecting privacy/security, and allocating resources. The PORTAL Governance Document, complete with a Toolkit of Appendices is included for reference and for adaptation by other networks.
Credibility:
As a result of identifying project-based governance priorities (IRB approval, subcontracting, selection of new research including lead PI and participating sites, and authorship) and data governance priorities (reciprocal data use agreement, analytic plan procedures, and other tools for data governance), PORTAL established most of its governance structure by Month 6 of the 18 month project. This allowed science to progress and collaborators to experience first-hand how the structures and procedures functioned in the remaining 12 months of the project, leaving ample time to refine them and to develop new structures or processes as necessary.
Discussion:
The use of procedures and processes with which participating investigators and their home institutions were already familiar allowed project and regulatory requirements to be established quickly to protect patients, their data, and the health care systems that act as stewards for both. As the project progressed, PORTAL was able to test and adjust the structures it put place, and to make substantive revisions by Month 17. As a result, priority processes have been predictable, transparent and effective.
Conclusion/Next steps:
Strong governance practices are a stewardship responsibility of research networks to justify the trust of patients, health plan members, health care delivery organizations, and other stakeholders. Well-planned governance can reduce the time necessary to initiate the scientific activities of a network, a particular concern when the time frame to complete research is short. Effective network and data governance structures protect patient and institutional data as well as the interests of investigators and their institutions, and assures that the network has built an environment to meet the goals of the research.
doi:10.13063/2327-9214.1216
PMCID: PMC4827785  PMID: 27141524
Governance; Comparative Effectiveness Research; Research Networks; Patient-Centered Outcomes Research
18.  Predictive Value of HIV-1 Genotypic Resistance Test Interpretation Algorithms 
The Journal of infectious diseases  2009;200(3):453-463.
Background
Interpreting human immunodeficienc virus type 1 (HIV-1) genotypic drug-resistance test results is challenging for clinicians treating HIV-1–infected patients. Multiple drug-resistance interpretation algorithms have been developed, but their predictive value has rarely been evaluated using contemporary clinical data sets.
Methods
We examined the predictive value of 4 algorithms at predicting virologic response (VR) during 734 treatment-change episodes (TCEs). VR was define as attaining plasma HIV-1 RNA levels below the limit of quantification Drug-specifi genotypic susceptibility scores (GSSs) were calculated by applying each algorithm to the baseline genotype. Weighted GSSs were calculated by multiplying drug-specifi GSSs by antiretroviral (ARV) potency factors. Regimen-specifi GSSs (rGSSs) were calculated by adding unweighted or weighted drug-specif c GSSs for each salvage therapy ARV. The predictive value of rGSSs were estimated by use of multivariate logistic regression.
Results
Of 734 TCEs, 475 (65%) were associated with VR. The rGSSs for the 4 algorithms were the variables most strongly predictive of VR. The adjusted rGSS odds ratios ranged from 1.6 to 2.2 (P < .001). Using 10-fold cross-validation, the averaged area under the receiver operating characteristic curve for all algorithms increased from 0.76 with unweighted rGSSs to 0.80 with weighted rGSSs.
Conclusions
Unweighted and weighted rGSSs of 4 genotypic resistance algorithms were the strongest independent predictors of VR. Optimizing ARV weighting may further improve VR predictions.
doi:10.1086/600073
PMCID: PMC4774893  PMID: 19552527
19.  Geographic Variations in Retention in Care among HIV-Infected Adults in the United States 
PLoS ONE  2016;11(1):e0146119.
Objective
To understand geographic variations in clinical retention, a central component of the HIV care continuum and key to improving individual- and population-level HIV outcomes.
Design
We evaluated retention by US region in a retrospective observational study.
Methods
Adults receiving care from 2000–2010 in 12 clinical cohorts of the North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD) contributed data. Individuals were assigned to Centers for Disease Control and Prevention (CDC)-defined regions by residential data (10 cohorts) and clinic location as proxy (2 cohorts). Retention was ≥2 primary HIV outpatient visits within a calendar year, >90 days apart. Trends and regional differences were analyzed using modified Poisson regression with clustering, adjusting for time in care, age, sex, race/ethnicity, and HIV risk, and stratified by baseline CD4+ count.
Results
Among 78,993 adults with 444,212 person-years of follow-up, median time in care was 7 years (Interquartile Range: 4–9). Retention increased from 2000 to 2010: from 73% (5,000/6,875) to 85% (7,189/8,462) in the Northeast, 75% (1,778/2,356) to 87% (1,630/1,880) in the Midwest, 68% (8,451/12,417) to 80% (9,892/12,304) in the South, and 68% (5,147/7,520) to 72% (6,401/8,895) in the West. In adjusted analyses, retention improved over time in all regions (p<0.01, trend), although the average percent retained lagged in the West and South vs. the Northeast (p<0.01).
Conclusions
In our population, retention improved, though regional differences persisted even after adjusting for demographic and HIV risk factors. These data demonstrate regional differences in the US which may affect patient care, despite national care recommendations.
doi:10.1371/journal.pone.0146119
PMCID: PMC4708981  PMID: 26752637
20.  Study protocol for “Study of Practices Enabling Implementation and Adaptation in the Safety Net (SPREAD-NET)”: a pragmatic trial comparing implementation strategies 
Background
Little research has directly compared the effectiveness of implementation strategies in any setting, and we know of no prior trials directly comparing how effectively different combinations of strategies support implementation in community health centers. This paper outlines the protocol of the Study of Practices Enabling Implementation and Adaptation in the Safety Net (SPREAD-NET), a trial designed to compare the effectiveness of several common strategies for supporting implementation of an intervention and explore contextual factors that impact the strategies’ effectiveness in the community health center setting.
Methods/design
This cluster-randomized trial compares how three increasingly hands-on implementation strategies support adoption of an evidence-based diabetes quality improvement intervention in 29 community health centers, managed by 12 healthcare organizations. The strategies are as follows: (arm 1) a toolkit, presented in paper and electronic form, which includes a training webinar; (arm 2) toolkit plus in-person training with a focus on practice change and change management strategies; and (arm 3) toolkit, in-person training, plus practice facilitation with on-site visits. We use a mixed methods approach to data collection and analysis: (i) baseline surveys on study clinic characteristics, to explore how these characteristics impact the clinics’ ability to implement the tools and the effectiveness of each implementation strategy; (ii) quantitative data on change in rates of guideline-concordant prescribing; and (iii) qualitative data on the “how” and “why” underlying the quantitative results. The outcomes of interest are clinic-level results, categorized using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework, within an interrupted time-series design with segmented regression models. This pragmatic trial will compare how well each implementation strategy works in “real-world” practices.
Discussion
Having a better understanding of how different strategies support implementation efforts could positively impact the field of implementation science, by comparing practical, generalizable methods for implementing clinical innovations in community health centers. Bridging this gap in the literature is a critical step towards the national long-term goal of effectively disseminating and implementing effective interventions into community health centers.
Trial registration
ClinicalTrials.gov, NCT02325531
doi:10.1186/s13012-015-0333-y
PMCID: PMC4609090  PMID: 26474759
Diabetes mellitus; Cardiovascular disease; Quality improvement; Community health centers; Evidence-based; Translational medical research
21.  Exposure to Antiretroviral Therapy and Risk of Cancer in HIV-infected Persons 
AIDS (London, England)  2012;26(17):2223-2231.
Objective
The incidence of certain non-AIDS-defining cancers (NADC) in HIV patients has been reported to have increased in the combination antiretroviral therapy (ART) era. Studies are needed to directly evaluate the effect of ART use on cancer risk.
Design
We followed 12,872 HIV+ Kaiser Permanente members whose complete ART history was known for incident cancers between 1996-2008.
Methods
Cancers, identified from SEER-based cancer registries, were grouped as AIDS-defining cancers (ADC), infection-related NADC or infection-unrelated NADC. We also evaluated the most common individual cancer types. Rate ratios (RR) for ART use (yes/no) and cumulative duration of any ART, PI and NNRTI therapy were obtained from Poisson models adjusting for demographics, pre-treatment or recent CD4 count and HIV RNA levels, years known HIV-infected, prior antiretroviral use, HIV risk, smoking, alcohol/drug abuse, overweight/obesity, and calendar year.
Results
The cohort experienced 32,368 person-yrs (py) of ART, 21,249 py of PI therapy, and 15,643 py of NNRTI therapy. The mean follow-up duration was 4.5 years. ADC rates decrease with increased duration of ART use [RR/year=0.61, 95% CI (0.56-0.66)]; the effect was similar by therapy class. ART, PI or NNRTI therapy duration was not associated with infection-related or infection-unrelated NADC [RR/year ART=1.00 (0.91-1.11) and 0.96 (0.90-1.01), respectively], except a higher anal cancer risk with longer PI therapy [RR/year=1.16 (1.02-1.31)].
Conclusions
No therapy class-specific effect was found for ADC. ART exposure was generally not associated with NADC risk, except for long term use of PI, which might be associated with increased anal cancer risk.
doi:10.1097/QAD.0b013e32835935b3
PMCID: PMC4562666  PMID: 22951631
Combination antiretroviral therapy; HIV infection; protease inhibitor; non-nucleotide reverse transcriptase inhibitor; cancer; cohort study
22.  Hepatitis C screening trends in a large integrated health system 
The American journal of medicine  2014;127(5):398-405.
Background
As new hepatitis C virus (HCV) therapies emerge, only 1–12% of individuals are screened in the U.S. for HCV infection. Presently, HCV screening trends are unknown.
Methods
We utilized the Kaiser Permanente Mid-Atlantic States’ (KPMAS) data repository to investigate HCV antibody screening between 1/1/2003 and 12/31/2012. We identified the proportion screened for HCV and 5-year cumulative incidence of screening, the screening positivity rate, the provider types performing HCV screening, patient-level factors associated with being screened, and trends in screening over time.
Results
444,594 patients met the inclusion criteria. Overall, 15.8% of the cohort was ever screened for HCV. Adult primary care and obstetrics and gynecology providers performed 75.9% of all screening. The overall test positivity rate was 3.8%. Screening was more frequent in younger age groups (p<0.0001) and those with a documented history of illicit drug use (p<0.0001). Patients with missing drug use history (46.7%) were least likely to be screened (p<0.0001). While the rate of HCV screening increased in the later years of the study, among those enrolled in KPMAS 2009–2012, only 11.8% were screened by the end of follow-up.
Conclusion
Screening for HCV is increasing, but remains incomplete. Targeting screening to those with a history of injection drug will not likely expand screening, as nearly half of patients have no documented drug use history. Routine screening is likely the most effective approach to expand HCV screening.
doi:10.1016/j.amjmed.2014.01.012
PMCID: PMC3999187  PMID: 24486288
hepatitis c virus; screening trends; screening rates
23.  Expanding Access to Care and Improving Quality in the Mid-Atlantic States Safety-Net Clinics: Kaiser Permanente’s Community Ambassador Program 
The Permanente Journal  2015;19(2):22-27.
The Community Ambassador Program (CAP) in the Mid-Atlantic States Region places Kaiser Permanente-employed nurse practitioners, midwives, and physician assistants to work in the safety-net clinics and share best practices through a long-term community collaboration. The authors conducted an evaluation of 18 safety-net clinics that participated in the CAP in 2012. The Community Ambassadors provided an estimated 32,249 encounters to 11,988 patients. Performance was at or near 90% for 2 adult quality measures (weight screening and tobacco use assessment). For breast cancer screenings, however, performance among the Community Ambassadors was much lower (48%). The program expanded access and improved quality of care.
Context:
As part of its longstanding commitment to improve the health of the communities it serves, Kaiser Permanente (KP) established the Community Ambassador Program (CAP) in the Mid-Atlantic States Region. The CAP places KP-employed nurse practitioners, midwives, and physician assistants to work in the safety-net clinics and to share best practices through a long-term community collaboration.
Objective:
To share the early experiences of the CAP and describe the initial results of the program’s impact on the safety-net clinics.
Methods:
We conducted an evaluation of 18 safety-net clinics that participated in the CAP in 2012 to determine the program’s early impact in expanding access to care, increasing the capacity of safety-net providers, and improving the quality of care on evidence-based measures in the year following program implementation. The safety-net clinics are comprised of federally qualified health centers, free clinics, and other community-based organizations. The clinics were asked to respond to questions regarding their evidence-based practices promoted by KP and on primary care-related utilization.
Results:
The Community Ambassadors provided an estimated 32,249 encounters to 11,988 patients. Performance by the Community Ambassadors was at or near 90% for 2 adult quality measures (weight screening and tobacco use assessment). For breast cancer screenings, however, performance among the Community Ambassadors was much lower (48%).
Conclusion:
The CAP demonstrated some early success in expanding access and improving quality of care on several key measures for certain subpopulations. Despite these achievements, opportunities remain for quality improvement, expanded capacity, and enhanced data reporting infrastructure.
doi:10.7812/TPP/14-109
PMCID: PMC4403577  PMID: 25785638
24.  Strong Agreement of Nationally Recommended Retention Measures from the Institute of Medicine and Department of Health and Human Services 
PLoS ONE  2014;9(11):e111772.
Objective
We sought to quantify agreement between Institute of Medicine (IOM) and Department of Health and Human Services (DHHS) retention indicators, which have not been compared in the same population, and assess clinical retention within the largest HIV cohort collaboration in the U.S.
Design
Observational study from 2008–2010, using clinical cohort data in the North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD).
Methods
Retention definitions used HIV primary care visits. The IOM retention indicator was: ≥2 visits, ≥90 days apart, each calendar year. This was extended to a 2-year period; retention required meeting the definition in both years. The DHHS retention indicator was: ≥1 visit each semester over 2 years, each ≥60 days apart. Kappa statistics detected agreement between indicators and C statistics (areas under Receiver-Operating Characteristic curves) from logistic regression analyses summarized discrimination of the IOM indicator by the DHHS indicator.
Results
Among 36,769 patients in 2008–2009 and 34,017 in 2009–2010, there were higher percentages of participants retained in care under the IOM indicator than the DHHS indicator (80% vs. 75% in 2008–2009; 78% vs. 72% in 2009–2010, respectively) (p<0.01), persisting across all demographic and clinical characteristics (p<0.01). There was high agreement between indicators overall (κ = 0.83 in 2008–2009; κ = 0.79 in 2009–2010, p<0.001), and C statistics revealed a very strong ability to predict retention according to the IOM indicator based on DHHS indicator status, even within characteristic strata.
Conclusions
Although the IOM indicator consistently reported higher retention in care compared with the DHHS indicator, there was strong agreement between IOM and DHHS retention indicators in a cohort demographically similar to persons living with HIV/AIDS in the U.S. Persons with poorer retention represent subgroups of interest for retention improvement programs nationally, particularly in light of the White House Executive Order on the HIV Care Continuum.
doi:10.1371/journal.pone.0111772
PMCID: PMC4222946  PMID: 25375099
25.  Missed Office Visits and Risk of Mortality Among HIV-Infected Subjects in a Large Healthcare System in the United States 
AIDS Patient Care and STDs  2013;27(8):442-449.
Abstract
Linkage and retention in care soon after HIV diagnosis improves clinical outcomes. Conversely, missed visits after diagnosis are associated with increased mortality in the public care setting. We analyzed mortality among newly diagnosed HIV patients ≥18 years old in a large private care setting between 01/01/1997 and 12/31/2009, comparing patients who missed visits in their first year following diagnosis (index period) with those who did not. Patients who died during the index period were excluded. Hazard ratios (HR) for association of missed visits and mortality were obtained by Cox proportional hazards regression, adjusting for patient demographics, CD4+ counts, and AIDS-defining conditions (CDC, 1993) at diagnosis. We also evaluated risk factors of missed visits by multivariable logistic regression. 2811 patients were included, of whom 65% had ≥1 missed visit, and 226 patients died during follow-up. Patients with ≥1 missed visit had a 71% increased mortality risk (HR=1.71, p=0.001) with 12% increased rate per missed visit (HR=1.12, p<0.001). Factors associated with missed visits were younger age (OR=1.69 compared to 60+ years), Black and Latino race/ethnicity (OR=1.54, 1.48 respectively, compared to Caucasians), injection drug use (OR=2.50 compared to men who have sex with men), and lower CD4+ (OR=1.43 for CD4+ 100–199 cells/μL, OR=1.39 for 50–99 cells/μL, and OR=1.63 for CD4+ <50 cells/μL, compared with CD4+ >500 cells/μL). In an insured patient population, missed visits in the first year of HIV care are common and associated with increased mortality. Early retention in HIV care is critical to improving outcomes.
doi:10.1089/apc.2013.0073
PMCID: PMC3739947  PMID: 23869466

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