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1.  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.
PMCID: PMC3778973  PMID: 23904290
HIV; hepatitis C virus; chronic kidney disease; hepatitis C RNA; cohort study; glomerular filtration rate; injection drug use
2.  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.
PMCID: PMC3657490  PMID: 23315317
antiretroviral therapy; healthcare disparities; HIV; time factors; viral load
3.  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.
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.
Observational study from 2008–2010, using clinical cohort data in the North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD).
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.
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.
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.
PMCID: PMC4222946  PMID: 25375099
4.  Herpes Zoster among Persons Living with HIV in the Current ART Era 
Previously, herpes zoster (HZ) was found to occur at a higher rate in the HIV population than the general population. There are, however, limited data about the incidence, risk factors, and clinical outcomes of HZ in the current antiretroviral therapy (ART) era.
We identified HZ episodes in an urban HIV clinic cohort between 2002-2009. Three controls were matched to each case and conditional logistic regression was used to assess for risk factors associated with incident HZ cases. Logistic regression to assess for factors associated with complicated HZ.
183 new HZ cases were identified in 4,353 patients with 19,752 person-years (PY) of follow-up—an incidence rate 9.3/1000 PY. Cases were majority male (62%), and African-American (75%), with a mean age of 39 (IQR 32-44). 50 patients (28%) had complicated HZ with 12% developing post-herpetic neuralgia. In multivariate regression, having started ART within 90 days of the episode (Adjusted OR 4.02, 95% CI:[1.31,12.41]), having a viral load of > 400 copies/mL (1.49, [1.00,2.24]), and having a CD4 <350 cells/mm3 (2.46, [1.42,4.23]) or 350-500 (2.02, [1.14,3.57]) as compared to CD4 > 500 were associated with increased risk of HZ.
The incidence of HZ is lower than previously reported in HIV cohorts, but remains higher than the general population. Over one-fourth of patients developed complicated HZ, which is remarkable given the young age of our population. Risk factors for HZ include markers of poor immune function, suggesting that appropriate ART may reduce the burden of HZ in this population.
PMCID: PMC4154488  PMID: 22766968
AIDS (London, England)  2013;27(13):10.1097/QAD.0b013e3283623d5f.
Thirty-day hospital readmission rate is receiving increasing attention as a quality of care indicator. The objective of this study was to determine readmission rates and to identify factors associated with readmission among persons living with HIV.
Prospective multicenter observational cohort.
Nine U.S. HIV clinics affiliated through the HIV Research Network.
Patients engaged in HIV care during 2005–2010.
Main outcome measure(s)
Readmission rate was defined as the proportion of hospitalizations followed by a readmission within 30 days. Factors in multivariate analyses included diagnostic categories, patient demographic and clinical characteristics, and having an outpatient follow-up visit.
Among 11,651 total index hospitalizations, the 30-day readmission rate was 19.3%. AIDS defining illnesses (ADI, 9.6% of index hospitalizations) and non-AIDS defining infections (26.4% of index hospitalizations) had readmission rates of 26.2% and 16.6%, respectively. Factors independently associated with readmission included lower CD4 count (AOR 1.80 [1.53, 2.11] for CD4 <50 vs. ≥351 cells/μl), longer length of stay (1.77 [1.53, 2.04] for ≥9 days vs. 1–3 days), and several diagnostic categories including ADI. Having an outpatient follow-up clinic visit was not associated with lower readmission risk (AHR 0.98 [0.88, 1.08]).
The 19.3% readmission rate exceeds the 13.2% rate reported for the general population of 18–64 year-olds. HIV providers may use the 19.3% rate as a basis of comparison. Policymakers may consider the impact of HIV when estimating expected readmissions for a hospital or region. Preventing or recovering from severe immune dysfunction may be the most important factor to reducing readmissions.
PMCID: PMC3796165  PMID: 23612008
Readmission; HIV; AIDS defining illness; Outpatient hospital follow-up; Healthcare utilization
7.  Hepatitis C Virus Testing in Adults Living with HIV: A Need for Improved Screening Efforts 
PLoS ONE  2014;9(7):e102766.
Guidelines recommend hepatitis C virus (HCV) screening for all people living with HIV (PLWH). Understanding HCV testing practices may improve compliance with guidelines and can help identify areas for future intervention.
We evaluated HCV screening and unnecessary repeat HCV testing in 8,590 PLWH initiating care at 12 U.S. HIV clinics between 2006 and 2010, with follow-up through 2011. Multivariable logistic regression examined the association between patient factors and the outcomes: HCV screening (≥1 HCV antibody tests during the study period) and unnecessary repeat HCV testing (≥1 HCV antibody tests in patients with a prior positive test result).
Overall, 82% of patients were screened for HCV, 18% of those screened were HCV antibody-positive, and 40% of HCV antibody-positive patients had unnecessary repeat HCV testing. The likelihood of being screened for HCV increased as the number of outpatient visits rose (adjusted odds ratio 1.02, 95% confidence interval 1.01–1.03). Compared to men who have sex with men (MSM), patients with injection drug use (IDU) were less likely to be screened for HCV (0.63, 0.52–0.78); while individuals with Medicaid were more likely to be screened than those with private insurance (1.30, 1.04–1.62). Patients with heterosexual (1.78, 1.20–2.65) and IDU (1.58, 1.06–2.34) risk compared to MSM, and those with higher numbers of outpatient (1.03, 1.01–1.04) and inpatient (1.09, 1.01–1.19) visits were at greatest risk of unnecessary HCV testing.
Additional efforts to improve compliance with HCV testing guidelines are needed. Leveraging health information technology may increase HCV screening and reduce unnecessary testing.
PMCID: PMC4102540  PMID: 25032989
8.  Conformity of Pediatric/Adolescent HIV Clinics to the Patient-Centered Medical Home Care Model 
AIDS Patient Care and STDs  2013;27(5):272-279.
The patient-centered medical home (PCMH) has been introduced as a model for providing high-quality, comprehensive, patient-centered care that is both accessible and coordinated, and may provide a framework for optimizing the care of youth living with HIV (YLH). We surveyed six pediatric/adolescent HIV clinics caring for 578 patients (median age 19 years, 51% male, and 82% black) in July 2011 to assess conformity to the PCMH. Clinics completed a 50-item survey covering the six domains of the PCMH: (1) comprehensive care, (2) patient-centered care, (3) coordinated care, (4) accessible services, (5) quality and safety, and (6) health information technology. To determine conformity to the PCMH, a novel point-based scoring system was devised. Points were tabulated across clinics by domain to obtain an aggregate assessment of PCMH conformity. All six clinics responded. Overall, clinics attained a mean 75.8% [95% CI, 63.3–88.3%] on PCMH measures—scoring highest on patient-centered care (94.7%), coordinated care (83.3%), and quality and safety measures (76.7%), and lowest on health information technology (70.0%), accessible services (69.1%), and comprehensive care (61.1%). Clinics moderately conformed to the PCMH model. Areas for improvement include access to care, comprehensive care, and health information technology. Future studies are warranted to determine whether greater clinic PCMH conformity improves clinical outcomes and cost savings for YLH.
PMCID: PMC3651683  PMID: 23651104
9.  Invasive cervical cancer risk among HIV-infected women: A North American multi-cohort collaboration prospective study 
HIV infection and low CD4+ T-cell count are associated with an increased risk of persistent oncogenic HPV infection – the major risk factor for cervical cancer. Few reported prospective cohort studies have characterized the incidence of invasive cervical cancer (ICC) in HIV-infected women.
Data were obtained from HIV-infected and -uninfected female participants in the NA-ACCORD with no history of ICC at enrollment. Participants were followed from study entry or January, 1996 through ICC, loss-to follow-up or December, 2010. The relationship of HIV infection and CD4+ T-cell count with risk of ICC was assessed using age-adjusted Poisson regression models and standardized incidence ratios (SIR). All cases were confirmed by cancer registry records and/or pathology reports. Cervical cytology screening history was assessed through medical record abstraction.
A total of 13,690 HIV-infected and 12,021 HIV-uninfected women contributed 66,249 and 70,815 person-years (pys) of observation, respectively. Incident ICC was diagnosed in 17 HIV-infected and 4 HIV-uninfected women (incidence rate of 26 and 6 per 100,000 pys, respectively). HIV-infected women with baseline CD4+ T-cells of ≥ 350, 200–349 and <200 cells/uL had a 2.3-times, 3.0-times and 7.7-times increase in ICC incidence, respectively, compared with HIV-uninfected women (Ptrend =0.001). Of the 17 HIV-infected cases, medical records for the 5 years prior to diagnosis showed that 6 had no documented screening, 5 had screening with low grade or normal results, and 6 had high-grade results.
This study found elevated incidence of ICC in HIV-infected compared to -uninfected women, and these rates increased with immunosuppression.
PMCID: PMC3633634  PMID: 23254153
Human papilloma virus; HIV-infection; Invasive Cervical Cancer; Immunosuppression
10.  Retention Among North American HIV–infected Persons in Clinical Care, 2000–2008 
Retention in care is key to improving HIV outcomes. Our goal was to describe “churn” in patterns of entry, exit, and retention in HIV care in the US and Canada.
Adults contributing ≥1 CD4 count or HIV-1 RNA (HIV-lab) from 2000–2008 in North American Cohort Collaboration on Research and Design (NA-ACCORD) clinical cohorts were included. Incomplete retention was defined as lack of 2 HIV-labs (≥90 days apart) within 12 months, summarized by calendar year. We used beta-binomial regression models to estimate adjusted odds ratios (OR) and 95% confidence intervals (CI) of factors associated with incomplete retention.
Among 61,438 participants, 15,360 (25%) with incomplete retention significantly differed in univariate analyses (p<0.001) from 46,078 (75%) consistently retained by age, race/ethnicity, HIV risk, CD4, ART use, and country of care (US vs. Canada). From 2000–2004, females (OR=0.82, CI:0.70–0.95), older individuals (OR=0.78, CI:0.74–0.83 per 10 years), and ART users (OR= 0.61, CI:0.54–0.68 vs all others) were less likely to have incomplete retention, while black individuals (OR=1.31, CI:1.16–1.49, vs. white), those with injection drug use (IDU) HIV risk (OR=1.68, CI:1.49–1.89, vs. non-IDU) and those in care longer (OR=1.09, CI:1.07–1.11 per year) were more likely to have incomplete retention. Results from 2005–2008 were similar.
From 2000 to 2008, 75% of the NA-ACCORD population was consistently retained in care with 25% experiencing some change in status, or churn. In addition to the programmatic and policy implications, our findings identify patient groups who may benefit from focused retention efforts.
PMCID: PMC3661708  PMID: 23242158
retention; churn; HIV clinical care; North America; HRSA HAB; National HIV/AIDS Strategy
11.  Clostridium difficile in a HIV-Infected Cohort: Incidence, Risk Factors, and Clinical Outcomes 
AIDS (London, England)  2013;27(17):10.1097/01.aids.0000432450.37863.e9.
C. difficile is the most commonly reported infectious diarrhea in HIV-infected patients in the United States. We set out to determine the incidence, risk factors, and clinical presentation of C. difficile infections (CDI) in a cohort of HIV-infected subjects.
We performed a nested, case-control analysis with four non-CDI controls randomly selected for each case.
We assessed the incidence of CDI in the Johns Hopkins HIV Clinical Cohort between July 1, 2003 and December 31, 2010. Incident cases were defined as first positive C. difficile cytotoxin assay or PCR for toxin B gene. We used conditional logistic regression models to assess risk factors for CDI. We abstracted data on the clinical presentation and outcomes from case chart review.
We identified 154 incident CDI cases for an incidence of 8.3 cases/1000 patient years. No unique clinical features of HIV-associated CDI were identified. In multivariate analysis, risk of CDI was independently increased for: CD4 count ≤50 cells/mm3 (Adjusted Odds Ratio (AOR) 20.7, 95% CI 2.8–151.4), hospital onset CDI (AOR 26.7 [3.1–231.2]), and use of clindamycin (AOR 27.6 [2.2–339.4]), fluoroquinolones (AOR 4.5 [1.2–17.5]), macrolides (AOR 6.3 [1.8–22.1]), gastric acid suppressants (AOR 3.1 [1.4–6.9]), or immunosuppressive agents (AOR 6.8 [1.2–39.6]).
The incidence of CDI in HIV-infected patients was twice that previously reported. Our data show compromised cellular immunity, as defined by CD4 ≤50 cells/ mm3is a risk factor for CDI. Clinicians should be aware of the increased CDI risk, particularly in those with severe CD4 count suppression.
PMCID: PMC3880635  PMID: 23842125
case-control; Clostridium difficile; HIV; incidence; risk factors
12.  Closing the Gap: Increases in Life Expectancy among Treated HIV-Positive Individuals in the United States and Canada 
PLoS ONE  2013;8(12):e81355.
Combination antiretroviral therapy (ART) has significantly increased survival among HIV-positive adults in the United States (U.S.) and Canada, but gains in life expectancy for this region have not been well characterized. We aim to estimate temporal changes in life expectancy among HIV-positive adults on ART from 2000–2007 in the U.S. and Canada.
Participants were from the North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD), aged ≥20 years and on ART. Mortality rates were calculated using participants' person-time from January 1, 2000 or ART initiation until death, loss to follow-up, or administrative censoring December 31, 2007. Life expectancy at age 20, defined as the average number of additional years that a person of a specific age will live, provided the current age-specific mortality rates remain constant, was estimated using abridged life tables.
The crude mortality rate was 19.8/1,000 person-years, among 22,937 individuals contributing 82,022 person-years and 1,622 deaths. Life expectancy increased from 36.1 [standard error (SE) 0.5] to 51.4 [SE 0.5] years from 2000–2002 to 2006–2007. Men and women had comparable life expectancies in all periods except the last (2006–2007). Life expectancy was lower for individuals with a history of injection drug use, non-whites, and in patients with baseline CD4 counts <350 cells/mm3.
A 20-year-old HIV-positive adult on ART in the U.S. or Canada is expected to live into their early 70 s, a life expectancy approaching that of the general population. Differences by sex, race, HIV transmission risk group, and CD4 count remain.
PMCID: PMC3867319  PMID: 24367482
14.  Association between U.S. State AIDS Drug Assistance Program (ADAP) Features and HIV Antiretroviral Therapy Initiation, 2001–2009 
PLoS ONE  2013;8(11):e78952.
U.S. state AIDS Drug Assistance Programs (ADAPs) are federally funded to provide antiretroviral therapy (ART) as the payer of last resort to eligible persons with HIV infection. States differ regarding their financial contributions to and ways of implementing these programs, and it remains unclear how this interstate variability affects HIV treatment outcomes.
We analyzed data from HIV-infected individuals who were clinically-eligible for ART between 2001 and 2009 (i.e., a first reported CD4+ <350 cells/uL or AIDS-defining illness) from 14 U.S. cohorts of the North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD). Using propensity score matching and Cox regression, we assessed ART initiation (within 6 months following eligibility) and virologic suppression (within 1 year) based on differences in two state ADAP features: the amount of state funding in annual ADAP budgets and the implementation of waiting lists. We performed an a priori subgroup analysis in persons with a history of injection drug use (IDU).
Among 8,874 persons, 56% initiated ART within six months following eligibility. Persons living in states with no additional state contribution to the ADAP budget initiated ART on a less timely basis (hazard ratio [HR] 0.73, 95% CI 0.60–0.88). Living in a state with an ADAP waiting list was not associated with less timely initiation (HR 1.12, 95% CI 0.87–1.45). Neither additional state contributions nor waiting lists were significantly associated with virologic suppression. Persons with an IDU history initiated ART on a less timely basis (HR 0.67, 95% CI 0.47–0.95).
We found that living in states that did not contribute additionally to the ADAP budget was associated with delayed ART initiation when treatment was clinically indicated. Given the changing healthcare environment, continued assessment of the role of ADAPs and their features that facilitate prompt treatment is needed.
PMCID: PMC3832515  PMID: 24260137
15.  Disparities in Receipt of Antiretroviral Therapy Among HIV-infected Adults (2002–2008) 
Medical care  2012;50(5):419-427.
Prior research has documented sociodemographic disparities in the use of antiretroviral therapy (ART). Recent therapeutic developments and changing epidemiological profiles may have altered such disparities. We examine the extent to which socio-demographic differences in prescribed ART have changed between 2002 and 2008.
We analyzed data abstracted from medical records at 13 US sites participating in the Human Immunodeficiency Virus Research Network. Prescription of ART was assessed for each year in care for each patient. A total of 14,092 patients were followed up for 39,251 person-years. We examined ART use as a function of sex, race/ethnicity, human immunodeficiency virus risk group, age, and CD4 history (no test <500 cells/mm3, one or more tests between 500 and 350 cells/mm3, 1 test ≤350 cells/mm3, and 2 or more tests ≤350 cells/mm3). Using multiple logistic regression, we ascertained interactions between each of these variables and calendar year.
The overall percentage prescribed ART increased from 60% to 80% between 2002 and 2008. Among those with 2 or more CD4 tests ≤350 cells/mm3, the percentage increased from 82% to 92%. ART rates were higher for those with lower CD4 counts but increased over time for all CD4 groups and for all demographic groups. Nevertheless, sex and racial/ethnic disparities persisted. Significant interactions were obtained for CD4 history by year, age by year, and age by CD4 history.
Although prescription of ART became more widespread from 2002 to 2008, patients who were female, black, or younger still had lower ART rates than male, white, or older patients.
PMCID: PMC3779806  PMID: 22410406
ART; disparities; time trends; utilization; sociodemographic differences
16.  Antiretroviral Medication Errors Remain High but Are Quickly Corrected Among Hospitalized HIV-Infected Adults 
Antiretroviral therapy medication errors are common among hospitalized patients with human immunodeficiency virus (HIV) infection (29% of admissions on hospital day 1) but are quickly corrected (7% of admissions on hospital day 2). Compared with those admitted to the HIV/AIDS service, patients admitted to surgical services were at increased risk of errors.
Background. Antiretroviral therapy (ART) medication errors can lead to drug resistance, treatment failure, and death. Prior research suggests that ART medication errors are on the rise in US hospitals. This analysis provides a current estimate of inpatient antiretroviral prescribing errors.
Methods. Retrospective review of medication orders during the first 48 hours of hospitalization for patients with human immunodeficiency virus (HIV) infection admitted to the Johns Hopkins Hospital between 1 January and 31 December 2009. Errors were classified as (1) incomplete regimen, (2) incorrect dosage, (3) incorrect schedule, and (4) nonrecommended drug-drug combinations. Multivariable regression was used to identify factors associated with errors.
Results. A total of 702 admissions occurred in 2009. Of these, 380 had ART medications prescribed on the first day and 308 on the second day of hospitalization. A total of 145 ART medication errors in 110 admissions were identified on the first day (29%), and 22 errors were identified in 21 admissions on the second day (7%). The most common errors were incomplete regimen and incorrect dosage or schedule. Protease inhibitors accounted for the majority of dosing and scheduling errors (71%–73%). Compared with patients admitted to the HIV/AIDS service, those admitted to surgical services were at increased risk of errors (adjusted odds ratio, 3.10; 95% confidence interval, 1.18–8.18).
Conclusions. ART medication errors are common among hospitalized HIV-infected patients on the first day of admission, but most are corrected within 48 hours. Interventions are needed to safeguard patients and prevent serious complications of ART medication errors especially during the first 24 hours of hospitalization.
PMCID: PMC3520383  PMID: 22610923
17.  Establishment, Retention, and Loss to Follow-Up in Outpatient HIV Care 
For optimal clinical benefit, HIV-infected patients should receive periodic outpatient care indefinitely. However, initially establishing HIV care and subsequent retention in care are problematic. This study examines establishment, retention, and loss to follow-up (LTFU) in a large, multi-site cohort over a 2-8 year period.
Medical record data were reviewed for 22,984 adult HIV patients receiving care at 12 clinics in the HIV Research Network between 2001-2009. Three dichotomous outcome measures were based on each patient's history of outpatient visits. Establishment reflects whether the patient made outpatient visits for longer than 6 months after initial enrollment. The retention measure reflects whether the patient had at least 2 outpatient visits separated by 90 days in each year in care. LTFU reflects whether the patient had no outpatient visits for more than 12 months without returning. Multiple logistic regression examined demographic and clinical correlates of each outcome, as well as the combined outcome of meeting all three measures.
Overall, 21.7% of patients never established HIV care after an initial visit. Among established patients, 57.4% did not meet the retention criterion in all years, and 34.9% were LTFU. Only 20.4% of all patients met all three criteria. The odds of successfully meeting all three criteria were higher for women, for older patients, for Hispanics compared with whites, and for those with CD4 levels ≤50 cells/mm3.
These data highlight the need to improve establishment and retention in HIV care.
PMCID: PMC3383913  PMID: 22531758
HIV; Loss to follow-up; retention in care; outpatient use
19.  Predictors of HAART Utilization for Behaviorally HIV-1 Infected Youth: Impact of Adult vs. Pediatric Clinical Care Site 
The Journal of Adolescent Health  2011;50(5):471-477.
We evaluated highly active antiretroviral therapy (HAART) utilization in youth infected with HIV through risk behaviors (BIY) who met treatment criteria for HAART. We assessed the impact of receiving care at an adult or pediatric HIV clinical site on initiation and discontinuation of the first HAART regimen in BIY.
This was a retrospective analysis of treatment-naive BIY, aged 12–24, who enrolled in the HIV Research Network (HIVRN) between 2002 and 2008 and who met criteria for HAART. The outcomes were time from meeting criteria to initiation of HAART and time to discontinuation of the first HAART regimen. Analyses were conducted using Cox proportional hazards regression.
Of 287 treatment-eligible youth, 198 (69%) received HAART and 58/198 (29.3%) subsequently discontinued HAART. In multivariable analyses, there was no significant difference in the time between meeting treatment criteria and initiating HAART for BIY followed at adult or pediatric HIV clinical sites. However, BIY followed at adult sites discontinued HAART sooner than BIY followed at pediatric HIV clinical sites (AHR 3.19 [1.26–8.06]).
Two thirds of treatment-eligible BIY in the HIVRN cohort initiated HAART; however, one third who initiated HAART discontinued HAART during the study period. Identifying factors associated with earlier HAART initiation and HAART sustainability can inform interventions to enhance HAART utilization among treatment-eligible youth. The finding of earlier HAART discontinuation for youth at adult care sites deserves further study.
PMCID: PMC3338204  PMID: 22525110
adolescents; youth; highly active antiretroviral therapy (HAART); disparities; utilization; HIV Research Network; clinical site
20.  Risk of Anal Cancer in HIV-Infected and HIV-Uninfected Individuals in North America 
In a large North American cohort study, anal cancer incidence rates were substantially higher for HIV-infected men who have sex with men, other men, and women compared with HIV-uninfected individuals. Rates increased from 1996–1999 to 2000–2003 but plateaued by 2004–2007.
Background. Anal cancer is one of the most common cancers affecting individuals infected with human immunodeficiency virus (HIV), although few have evaluated rates separately for men who have sex with men (MSM), other men, and women. There are also conflicting data regarding calendar trends.
Methods. In a study involving 13 cohorts from North America with follow-up between 1996 and 2007, we compared anal cancer incidence rates among 34 189 HIV-infected (55% MSM, 19% other men, 26% women) and 114 260 HIV-uninfected individuals (90% men).
Results. Among men, the unadjusted anal cancer incidence rates per 100 000 person-years were 131 for HIV-infected MSM, 46 for other HIV-infected men, and 2 for HIV-uninfected men, corresponding to demographically adjusted rate ratios (RRs) of 80.3 (95% confidence interval [CI], 42.7–151.1) for HIV-infected MSM and 26.7 (95% CI, 11.5–61.7) for other HIV-infected men compared with HIV-uninfected men. HIV-infected women had an anal cancer rate of 30/100 000 person-years, and no cases were observed for HIV-uninfected women. In a multivariable Poisson regression model, among HIV-infected individuals, the risk was higher for MSM compared with other men (RR, 3.3; 95% CI, 1.8–6.0), but no difference was observed comparing women with other men (RR, 1.0; 95% CI, 0.5–2.2). In comparison with the period 2000–2003, HIV-infected individuals had an adjusted RR of 0.5 (95% CI, .3–.9) in 1996–1999 and 0.9 (95% CI, .6–1.2) in 2004–2007.
Conclusions. Anal cancer rates were substantially higher for HIV-infected MSM, other men, and women compared with HIV-uninfected individuals, suggesting a need for universal prevention efforts. Rates increased after the early antiretroviral therapy era and then plateaued.
PMCID: PMC3297645  PMID: 22291097
Hospitalization rates for comorbid conditions among persons living with HIV in the current HAART era are unknown.
Hospitalization data from 2001 – 2008 were obtained on 11,645 adults receiving longitudinal HIV care at 4 geographically diverse U.S. HIV clinics within the HIV Research Network. Modified clinical classification software from the Agency for Healthcare Research and Quality assigned primary ICD-9 codes into diagnostic categories. Analysis was performed with repeated measures negative binomial regression.
During 2001 – 2008, the rate of AIDS defining illness (ADI) hospitalizations declined from 6.7 to 2.7 per 100 person years (PY), incidence rate ratio per year, 0.89 [0.87, 0.91]. Among the other diagnostic categories with average rates > 2 per 100 PY, cardiovascular hospitalizations increased over time (1.07 [1.03, 1.11]), while non-AIDS defining infection (0.98 [0.96, 1.00]), psychiatric (0.96 [0.93, 1.00]), and gastrointestinal/liver (0.96 [0.92, 1.00]) were slightly decreasing or stable. While less frequent overall, renal and pulmonary admissions also increased over time in univariate and multivariate analyses. Of all diagnostic categories, ADI admissions had the longest mean length of stay, 10.5 days.
ADI hospitalizations have continued to decline in recent years but are still relatively frequent and potentially costly given long lengths of stay. Increases or stability in the rates of chronic end-organ disease admissions imply a need for broader medical knowledge among individual clinicians and/or teams who care for persons living with HIV and a need for long-term access to medications for these conditions.
PMCID: PMC3299935  PMID: 22240460
22.  Incidence of and Risk Factors for Community Acquired Pneumonia in US HIV-Infected Children, 2000–2005 
AIDS (London, England)  2011;25(5):717-720.
The incidence of and risk factors for community-acquired pneumonia (CAP) are described from 2000–2005 in a multicenter US cohort of HIV-infected children. In 736 patients, 87 episodes of CAP (33.2 events/1,000 PY) had a mean CD4% of 23% (controls: 30%) and mean CD4 count of 668 cells/mm3 (controls: 870 cells/mm3). CAP incidence decreased 44% from 2000–2001 to 2002–2005. On multivariate analysis, viral load ≥100,000 copies/mL (OR 3.98; CI: 1.05–15.13) was associated with CAP. Herd immunity through pneumococcal immunization may have diluted the effect of individual immunization in this cohort.
PMCID: PMC3576877  PMID: 21252630
HIV; Pneumonia; Pediatric
23.  HIV-Related Medical Service Use by Rural/Urban Residents: A Multi-state Perspective 
AIDS care  2011;23(8):971-979.
Geographic location may be related to the receipt of quality HIV healthcare services. Clinical outcomes and healthcare utilization were evaluated in rural, urban and peri-urban patients seen at high-volume U.S. urban-based HIV care sites.
Zip codes for 8,773 HIV patients followed in 2005 at 7 HIV Research Network sites were categorized as rural (population<10K), peri-urban (10K – 100K) and urban (>100K). Clinical and demographic characteristics, inpatient and outpatient (OP) utilization, AIDS defining illness rates, receipt of highly active antiretroviral therapy (HAART), opportunistic infection (OI) prophylaxis usage and virologic suppression were compared among patients, using Χ2 tests for categorical variables, t-tests for means, and logistic regression for HAART utilization.
HIV-infected rural (n=170) and peri-urban (n=215) patients were less likely to be Black or Hispanic than urban HIV patients. Peri-urban subjects were more likely to report MSM as their HIV risk factor than rural or urban subjects. Age, gender, CD4 or HIV-RNA distribution, virologic suppression, HAART usage or OI prophylaxis did not differ by geographic location. In multivariate analysis, rural and peri-urban patients were less likely to have ≥4 annual outpatient visits than urban patients. Rural patients were less likely to receive HAART if they were Black. Overall, geographic location (as defined by home zip code) did not affect receipt of HAART or OI prophylaxis.
Although demographic and healthcare utilization differences were seen among rural, peri-urban, and urban HIV patients, most HIV outcomes and medication use were comparable across geographic areas. As with HIV care for urban-dwelling patients, areas for improvement for non-urban HIV patients include access to HAART among minorities and IDUs.
PMCID: PMC3569088  PMID: 21400307
rural; HIV/AIDS Care; HAART; Outcomes; Quality of care; highly active antiretroviral therapy; HIV Research Network
24.  Patterns of Use and Outcomes in Patients Treated with Etravirine in the HIV Research Network 
AIDS Research and Treatment  2013;2013:492831.
This observational analysis examined the clinical outcomes of patients receiving etravirine-(ETR-) based therapy, particularly with protease inhibitors (PIs) other than darunavir (DRV) and with raltegravir (RAL). Data included treatment-experienced adults in the HIV Research Network who began ETR-containing antiretroviral regimens in 2008–2010. The primary objective was to assess 6-month outcomes (durability, i.e., still on an ETR-containing regimen; change in CD4+ cell count and HIV-1 RNA <400 copies/mL). The cohort included 587 patients receiving ETR; 42% of ETR use was in patients not on DRV/ritonavir (r). Patients receiving ETR plus DRV/r had longer durability versus those on ETR plus a PI other than DRV/r at months 6 (91.2% versus 85.5%) and 12 (77.4% versus 65.2%), respectively. Patients on regimens with a PI other than DRV/r were the least likely to be receiving ETR at month 6 (85.5%) versus patients on other ETR-based regimens. Patients on regimens without a PI and without RAL had lower virologic suppression (month 6, 54.2%; month 12, 63.2%) versus patients on other ETR-based regimens. In a clinical care, nontrial setting, ETR was used in regimens without DRV/r. In this population, the 6-month response rates were similar and durable across all regimens, except when ETR was used without RAL and without a PI.
PMCID: PMC3603589  PMID: 23533731
25.  Contemporary Costs of HIV Health Care in the HAART Era 
AIDS (London, England)  2010;24(17):2705-2715.
PMCID: PMC3551268  PMID: 20859193
cost; HIV; utilization; CD4 count; HAART; HIV Research Network

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