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1.  Effect of Persistency of First-Line HIV Antiretroviral Therapy on Clinical Outcomes 
Abstract
Persistency is the time from initiation to discontinuation of therapy. Previous research has described factors that affect the persistency of initial antiretroviral therapy (ART); however, the impact of persistency on clinical outcomes is unknown. A retrospective study was conducted of treatment-naive HIV patients initiating ART between January 1, 2000 and December 31, 2010 at an academic medical center. Descriptive statistics and Cox proportional hazards regression models with persistency as a time‐varying covariate were fit for (1) immunologic failure (subsequent CD4 lower than initial CD4); (2) development of an opportunistic infection (OI) or malignancy; and (3) mortality. Analyses were repeated with an interaction term of persistency (per 180 days) and time (before and after 1 year of ART). Among 879 patients who started ART, the mean age was 38 years (±10) and most patients were racial/ethnic minority (59%), males (80%), and with baseline CD4 <200 cells/mm3 (52%). There were 100 deaths, 94 OIs/malignancy, and 183 immunologic failures; the mean persistency=723 days. In multivariable modeling, increased persistency decreased the overall and long-term hazard for immunologic failure (0.84 per 180 additional days; 0.70–1.00; 0.045). Increased persistency exhibited a potential trend toward decreased hazard for the occurrence of OI/malignancy (0.91; 0.80–1.03; 0.124) overall and after 1 year. Persistency exhibited a trend toward less risk of mortality in the first year of ART (0.42; 0.17–1.06; 0.067). In this study of the relationship between initial ART persistency and clinical outcomes, increased persistency was associated with a decreased hazard for the development of immunologic failure, a trend toward a decreased hazard for OI/malignancy, and a trend toward a decreased risk of first year mortality. Given these findings, the relationship between persistency and clinical outcomes merits further study.
doi:10.1089/aid.2012.0241
PMCID: PMC3607971  PMID: 23151191
2.  Closing the Feedback Loop: An Interactive Voice Response System to Provide Follow-up and Feedback in Primary Care Settings 
Journal of medical systems  2013;37(2):9905.
In primary care settings, follow-up regarding the outcome of acute outpatient visits is largely absent. We sought to develop an automated interactive voice response system (IVRS) for patient follow-up with feedback to providers capable of interfacing with multiple pre-existing electronic medical records (EMRs). A system was designed to extract data from EMRs, integrate with the IVRS, call patients for follow-up, and provide a feedback report to providers. Challenges during the development process were analyzed and summarized. The components of the technological solution and details of its implementation are reported. Lessons learned include: (1) Modular utilization of system components is often needed to adapt to specific clinic workflow and patient population needs (2) Understanding the local telephony environment greatly impacts development and is critical to success, and (3) Ample time for development of the IVRS questionnaire (mapping all branching paths) and speech recognition tuning (sensitivity, use of barge-in tuning, use of “known voice”) is needed. With proper attention to design and development, modular follow-up and feedback systems can be integrated into existing EMR systems providing the benefits of IVRS follow-up to patients and providers across diverse practice settings.
doi:10.1007/s10916-012-9905-4
PMCID: PMC3662799  PMID: 23340825
Interactive voice response system; Primary care; Follow-up; Feedback
3.  Evaluation of the Single-Item Self-Rating Adherence Scale for Use in Routine Clinical Care of People Living with HIV 
AIDS and behavior  2013;17(1):307-318.
The Self-Rating Scale Item (SRSI) is a single-item self-report adherence measure that uses adjectives in a 5-point Likert scale, from “very poor” to “excellent,” to describe medication adherence over the past 4 weeks. This study investigated the SRSI in 2,399 HIV-infected patients in routine care at two outpatient primary HIV clinics. Correlations between the SRSI and four commonly used adherence items ranged from 0.37–0.64. Correlations of adherence barriers, such as depression and substance use, were comparable across all adherence items. General estimating equations suggested the SRSI is as good as or better than other adherence items (p’s <0.001 vs. <0.001–0.99) at predicting adherence-related clinical outcomes, such as HIV viral load and CD4+ cell count. These results and the SRSI’s low patient burden suggest its routine use could be helpful for assessing adherence in clinical care and should be more widespread, particularly where more complex instruments may be impractical.
doi:10.1007/s10461-012-0326-7
PMCID: PMC3549002  PMID: 23108721
HIV; adherence; self-report; visual analogue scale
4.  Maraviroc Observational Study: The Impact of Expanded Resistance Testing and Clinical Considerations for Antiretroviral Regimen Selection in Treatment-Experienced Patients 
Abstract
Maraviroc (MVC) use has trailed that of other post-2006 antiretroviral therapy (ART) options for treatment-experienced patients. We explored the impact of free tropism testing on MVC utilization in our cohort and explored barriers to MVC utilization. The Maraviroc Outcomes Study (MOS) is an investigator-initiated industry-sponsored trial where consecutive ART-experienced patients receiving routine care with viral loads ≥1,000 copies/ml, and whose provider requested resistance testing and received standardized resistance testing (SRT; phenotype, genotype, coreceptor/tropism). Sociodemographic, clinical, and ART characteristics of those receiving SRT were compared to a historical cohort (HC). Subsequently, providers were surveyed regarding factors influencing selection of salvage ART therapy. The HC (n=165) had resistance testing 7/08–9/09, while prospective SRT (n=83) patients were enrolled 9/09–8/10. In the HC, 92% had genotypes, 2% had tropism assays, and 62% (n=102) changed ART after resistance testing (raltegravir 37%, etravirine 25%, darunavir 24%, MVC 1%). In the SRT cohort, 57% (n=48) changed regimens after standardized resistance testing (darunavir 48%, raltegravir 40%, and etravirine 19%). CCR5-tropic virus was identified in 43% of the SRT group, and MVC was used in 10% [or 20% of R5 tropic patients who underwent a subsequent regimen change (n=25)], a statistically significant (p=0.01) increase in utilization. The factors most strongly influencing utilization were unique patient circumstances (60%), clinical experience (55%), and potential side effects (40%). The addition of routine tropism testing to genotypic/phenotypic testing was associated with increased MVC utilization, raising the possibility that tropism testing may present a barrier to MVC use; however, additional barriers exist, and merit further evaluation.
doi:10.1089/aid.2012.0157
PMCID: PMC3608020  PMID: 22881368
5.  Multimorbidity Patterns in HIV-Infected Patients: The Role of Obesity in Chronic Disease Clustering 
Background
Increases in multimorbidity and obesity have been noted in HIV infected populations in the current treatment era. Patterns of multimorbid disease clustering as well as the impact of obesity on multimorbidity are understudied in this population.
Methods
We examined obesity and multimorbidity patterns among 1844 HIV-infected patients in the UAB 1917 Clinic. Exploratory factor analysis (EFA) was used to identify the underlying factor structure responsible for clustering. Patterns among the resulting morbidity factors by body mass index (BMI) category were explored. Multivariable logistic regression models were fit to identify predictors of multimorbidity cluster patterns.
Results
The prevalence of multimorbidity was 65% (1205/1844). Prevalence increased with progressive BMI categories from underweight (64%) to obese (79%). Three multimorbidity clusters were identified: “Metabolic” including hypertension (HTN), gout, diabetes mellitus, and chronic kidney disease (CKD) (range: 0.41 to 0.84; P<0.001); “Behavioral“ including mood disorders, dyslipidemia, chronic obstructive pulmonary disease (COPD), chronic ulcer disease, osteoarthritis, obstructive sleep apnea (OSA), and cardiac disorders (range: 0.32 to 0.57; P<0.001); “Substance Use” including alcohol abuse, substance abuse, tobacco abuse, and hepatitis C (range: 0.53 to 0.89; P<0.001). Obesity was associated with increased odds of multimorbidity (Obese vs. Normal BMI category: OR=1.52, 95%CI=1.15-2.00).
Conclusions
Three patterns of disease clustering were identified. Obesity was associated with a higher likelihood of multimorbidity. The management of multimorbidity and obesity will need to be addressed in future clinical practice guidelines to enhance long term outcomes of HIV-infected patients in the current treatment era.
doi:10.1097/QAI.0b013e31827303d5
PMCID: PMC3508375  PMID: 23023101
Multimorbidity; Obesity; HIV; Factor Analysis; Tetrachoric
6.  Underutilization of Aspirin for Primary Prevention of Cardiovascular Disease Among HIV-Infected Patients 
Aspirin for primary prevention of cardiovascular events is underutilized in human immunodeficiency virus (HIV)–infected patients. As these patients are at increased risk for events compared with HIV-negative persons, interventions are needed to increase HIV provider awareness of and adherence to existing guidelines.
Background. Individuals infected with human immunodeficiency virus (HIV) are at increased risk for cardiovascular disease (CVD) events compared with uninfected persons. However, little is known about HIV provider practices regarding aspirin (ASA) for primary prevention of CVD.
Methods. A cross-sectional study was conducted among patients attending the University of Alabama at Birmingham 1917 HIV Clinic during 2010 to determine the proportion receiving ASA for primary prevention of CVD and identify factors associated with ASA prescription. Ten-year risk for CVD events was calculated for men aged 45–79 and women aged 55–79. The 2009 US Preventive Services Task Force (USPSTF) guidelines were used to determine those qualifying for primary CVD prevention.
Results. Among 397 patients who qualified to receive ASA (mean age, 52.2 years, 94% male, 36% African American), only 66 (17%) were prescribed ASA. In multivariable logistic regression analysis, diabetes mellitus (odds ratio [OR], 2.60; 95% confidence interval [CI], 1.28–5.27), hyperlipidemia (OR, 3.42; 95% CI, 1.55–7.56), and current smoking (OR, 1.87; 95% CI, 1.03–3.41) were significantly associated with ASA prescription. Odds of ASA prescription more than doubled for each additional CVD-related comorbidity present among hypertension, diabetes, hyperlipidemia, and smoking (OR, 2.13, 95% CI, 1.51–2.99).
Conclusions. In this HIV-infected cohort, fewer than 1 in 5 patients in need received ASA for primary CVD prevention. Escalating likelihood of ASA prescription with increasing CVD-related comorbidity count suggests that providers may be influenced more by co-occurrence of these diagnoses than by USPSTF guidelines. In the absence of HIV-specific guidelines, interventions to improve HIV provider awareness of and adherence to existing general population guidelines on CVD risk reduction are needed.
doi:10.1093/cid/cis752
PMCID: PMC3491860  PMID: 22942209
7.  Pain, Mood, and Substance Abuse in HIV: Implications for Clinic Visit Utilization, ART Adherence, and Virologic Failure 
Introduction
Co-occurring pain, mood disorders, and substance abuse are common in HIV-infected patients. Our objective was to investigate the relationship between pain, alone and in the context of mood disorders and substance abuse, on clinic utilization, antiretroviral therapy (ART) adherence, and virologic suppression.
Methods
Pain, mood disorders, and substance abuse were assessed at the first visit. No-show and urgent visits were measured over a one-year period. Models were adjusted for age, race, sex, insurance status, CD4+ T-lymphocyte count, and HIV risk factor.
Results
Among 1521 participants, 509 (34%) reported pain, 239 (16%) had pain alone, 189 (13%) had pain and a mood disorder, and 30 (2%) had pain and substance abuse. In univariate models, participants with pain, mood disorders, and substance abuse had higher odds of a no-show visit than participants without these conditions [OR 1.4 (95% CI 1.1–1.8); OR 1.5 (95% CI 1.2–1.9); OR 2.0 (95% CI 1.4–2.8), respectively]. In the multivariable model, pain increased the odds of a no-show visit only in participants without substance abuse [OR 1.5 (95% CI 1.1–1.9)], and pain reduced the odds of a no-show visit in participants with substance abuse [OR 0.5 (95% CI 0.2–0.9), p for interaction=0.0022].
Conclusions
In this study, pain increased the odds of no-show visits, but only for participants without substance abuse. Because pain, mood disorders, and substance abuse are highly prevalent in HIV-infected patients, our findings have implications for HIV treatment success. Interventions that incorporate pain management may be important for improving health outcomes in patients living with HIV infection.
doi:10.1097/QAI.0b013e3182662215
PMCID: PMC3459261  PMID: 22766967
HIV; Pain; Psychiatric Illness; Substance Abuse; ART Adherence; Health Care Utilization
8.  Medication Possession Ratio Predicts Antiretroviral Regimens Persistence in Peru 
PLoS ONE  2013;8(10):e76323.
Objectives
In developing nations, the use of operational parameters (OPs) in the prediction of clinical care represents a missed opportunity to enhance the care process. We modeled the impact of multiple measurements of antiretroviral treatment (ART) adherence on antiretroviral treatment outcomes in Peru.
Design And Methods
Retrospective cohort study including ART naïve, non-pregnant, adults initiating therapy at Hospital Nacional Cayetano Heredia, Lima-Peru (2006-2010). Three OPs were defined: 1) Medication possession ratio (MPR): days with antiretrovirals dispensed/days on first-line therapy; 2) Laboratory monitory constancy (LMC): proportion of 6 months intervals with ≥1 viral load or CD4 reported; 3) Clinic visit constancy (CVC): proportion of 6 months intervals with ≥1 clinic visit.
Three multi-variable Cox proportional hazard (PH) models (one per OP) were fit for (1) time of first-line ART persistence and (2) time to second-line virologic failure. All models were adjusted for socio-demographic, clinical and laboratory variables.
Results
856 patients were included in first-line persistence analyses, median age was 35.6 years [29.4-42.9] and most were male (624; 73%). In multivariable PH models, MPR (per 10% increase HR=0.66; 95%CI=0.61-0.71) and LMC (per 10% increase 0.83; 0.71-0.96) were associated with prolonged time on first-line therapies.
Among 79 individuals included in time to second-line virologic failure analyses, MPR was the only OP independently associated with prolonged time to second-line virologic failure (per 10% increase 0.88; 0.77-0.99).
Conclusions
The capture and utilization of program level parameters such as MPR can provide valuable insight into patient-level treatment outcomes.
doi:10.1371/journal.pone.0076323
PMCID: PMC3788135  PMID: 24098475
9.  HIV infection and obesity: Where did all the wasting go? 
Antiviral therapy  2012;17(7):1281-1289.
Background
The success of antiretroviral therapy (ART) has led to dramatic changes in causes of morbidity and mortality in HIV-infected individuals. As chronic diseases rates have increased in HIV+ populations, modifiable risk factors such as obesity have increased in importance. Our objective was to evaluate factors associated with weight change among patients receiving ART.
Methods
ART-naïve patients initiating therapy at the University of Alabama - Birmingham 1917 HIV/AIDS Clinic from 2000– 2008 were included. Body Mass Index (BMI) was categorized as: underweight (<18.5), normal weight (18.5–24.9), overweight (25–29.9) and obese (≥30). Linear regression models were used to evaluate overall change in BMI and factors associated with increased BMI category 24 months following ART initiation.
Results
Among 681 patients, the mean baseline BMI was 25.4 ± 6.1; 44% of patients were overweight/obese. At 24 months, 20% of patients moved from normal to overweight/obese or overweight to obese BMI categories. Greater increases in BMI were observed in patients with baseline CD4 count < 50 cells/μl (3.4 ± 4.1, P<0.01) and boosted protease inhibitor use (2.5±4.1 P=0.01), but did not account for all of the variation observed in weight change.
Conclusions
The findings that almost half of patients were overweight or obese at ART initiation, and 1 in 5 patients moved to a deleterious BMI category within 2 years of ART initiation are alarming. ART therapy provides only a modest contribution to weight gain in patients. Obesity represents a highly prevalent condition in patients with HIV infection and an important target for intervention.
doi:10.3851/IMP2348
PMCID: PMC3779137  PMID: 22951353
obesity; HIV; body mass index
10.  Underutilization of the AIDS Drug Assistance Program: Associated Factors and Policy Implications 
Health Services Research  2011;46(3):982-995.
Background
The AIDS Drug Assistance Program (ADAP) provides antiretroviral medications to low-income individuals with HIV infection.
Methods
A prospective cohort study of ADAP utilization, measured using medication possession ratio (MPR), was conducted during the 2008 calendar year at the University of Alabama at Birmingham 1917 HIV Clinic. Multivariable ordinal logistic regression evaluated factors associated with ADAP utilization.
Results
Among 245 patients, MPR quartiles (Q) were the following: Q1<69 percent, Q2 = 69–83 percent, Q3 = 84–93 percent, Q4>93 percent. In ordinal logistic regression, younger age (OR = 0.59 per 10 years; 95 percent CI = 0.44–0.79), nonwhite males (2.18; 1.18–4.04), lower CD4 count (2.79 for <200 cells/mm3; 1.44–5.43), and a history of alcohol abuse (2.11; 1.02–4.37) were associated with poor ADAP utilization.
Conclusions
One quarter of ADAP enrollees had MPR below 69 percent, a level well below that associated with optimal HIV treatment outcomes, indicating a need for programmatic interventions to improve ADAP utilization.
doi:10.1111/j.1475-6773.2010.01223.x
PMCID: PMC3097412  PMID: 21210795
HIV; adherence; public health
11.  Early Retention in HIV Care and Viral Load Suppression: Implications for a Test and Treat Approach to HIV Prevention 
Background
Following HIV diagnosis and linkage to care, achieving and sustaining viral load (VL) suppression has implications for patient outcomes and secondary HIV prevention. We evaluated factors associated with expeditious VL suppression and cumulative VL burden among patients establishing outpatient HIV care.
Methods
Patients initiating HIV medical care from January 2007-October 2010 at the University of Alabama at Birmingham and University of Washington were included. Multivariable Cox proportional hazards and linear regression models were used to evaluate factors associated with time to VL suppression (<50 copies/mL) and cumulative VL burden, respectively. Viremia copy-years (VCY), a novel area under the longitudinal VL curve measure, was used to estimate 2-year cumulative VL burden from clinic enrollment.
Results
Among 676 patients, 63% achieved VL<50 copies/mL in a median 308 days. In multivariable analysis, patients with more time-updated “no show” visits experienced delayed VL suppression (HR=0.83 per “no show” visit, 95%CI=0.76,0.91). In multivariable linear regression, visit non-adherence was independently associated with greater cumulative VL burden (log10VCY) during the first two years in care (Beta coefficient=0.11 per 10% visit non-adherence, 95%CI=0.04-0.17). Across increasing visit adherence categories, lower cumulative VL burden was observed (mean ± standard deviation log10 copy × years/mL); 0-79% adherence: 4.6 ± 0.8; 80-99% adherence: 4.3 ± 0.7; and 100% adherence: 4.1 ± 0.8 log10 copy × years/mL, respectively (P<0.01).
Conclusions
Higher rates of early retention in HIV care are associated with achieving VL suppression and lower cumulative VL burden. These findings are germane for a test and treat approach to HIV prevention.
doi:10.1097/QAI.0b013e318236f7d2
PMCID: PMC3237801  PMID: 21937921
HIV; Viral load; Retention in care; Adherence; Engagement in care
12.  Patient Reported Outcomes in Routine Care: Advancing Data Capture for HIV Cohort Research 
Diagnoses of substance abuse and depression made using patient reported outcomes (PROs) correlate better with nonadherence to medication than do diagnoses captured in traditional electronic medical records. PROs are an important resource in HIV/AIDS clinics for research and clinical care.
Introduction. Computerized collection of standardized measures of patient reported outcomes (PROs) provides a novel paradigm for data capture at the point of clinical care. Comparisons between data from PROs and Electronic Health Records (EHR) are lacking. We compare EHR and PRO for capture of depression and substance abuse and their relationship to adherence to antiretroviral therapy (ART).
Methods. This retrospective study includes HIV-positive patients at an HIV clinic who completed an initial PRO assessment April 2008–July 2009. The questionnaire includes measures of depression (PHQ-9) and substance abuse (ASSIST). Self-reported ART adherence was modeled using separate logistic regression analyses (EHR vs PRO).
Results. The study included 782 participants. EHR vs PRO diagnosis of current substance abuse was 13% (n = 99) vs 6% (n = 45) (P < .0001), and current depression was 41% (n = 317) vs 12% (n = 97) (P < .0001). In the EHR model, neither substance abuse (OR = 1.25; 95% CI = 0.70–2.21) nor depression (OR = 0.93; 95% CI = 0.62–1.40) was significantly associated with poor ART adherence. Conversely, in the PRO model, current substance abuse (OR = 2.78; 95% CI = 1.33–5.81) and current depression (OR = 1.93; 95% CI = 1.12–3.33) were associated with poor ART adherence.
Discussions. The explanatory characteristics of the PRO model correlated best with factors known to be associated with poor ART adherence (substance abuse; depression). The computerized capture of PROs as a part of routine clinical care may prove to be a complementary and potentially transformative health informatics technology for research and patient care.
doi:10.1093/cid/cir727
PMCID: PMC3243652  PMID: 22042879
13.  Risk factors for chronic kidney disease in a large cohort of HIV-1 infected individuals initiating antiretroviral therapy in routine care 
AIDS (London, England)  2012;26(15):1907-1915.
Objective
To examine long-term effects of antiretroviral therapy (ART) on kidney function, we evaluated the incidence and risk factors for chronic kidney disease (CKD) among ART-naive, HIV-infected adults and compared changes in estimated glomerular filtration rates (eGFR) before and after starting ART.
Methods
Multicenter observational cohort study of patients with at least one serum creatinine measurement before and after initiating ART. Cox proportional hazard models, and marginal structure models examined CKD risk factors; mixed-effects linear models examined eGFR slopes.
Results
Three thousand, three hundred and twenty-nine patients met entry criteria, contributing 10 099 person-years of observation on ART. ART was associated with a significantly slower rate of eGFR decline (from −2.18 to −1.37 ml/min per 1.73 m2 per year; P = 0.02). The incidence of CKD defined by eGFR thresholds of 60, 45 and 30 ml/min per 1.73 m2 was 10.5, 3.4 and 1.6 per 1000 person-years, respectively. In adjusted analyses black race, hepatitis C coinfection, lower time-varying CD4 cell count and higher time-varying viral load on ART were associated with higher CKD risk, and the magnitude of these risks increased with more severe CKD. Tenofovir and a ritonavir-boosted protease inhibitor (rPI) was also associated with higher CKD risk [hazard odds ratio for an eGFR threshold <60 ml/min per 1.73 m2: 3.35 (95% confidence interval (CI) = 1.40–8.02)], which developed in 5.7% of patients after 4 years of exposure to this regimen-type.
Conclusion
ART was associated with reduced CKD risk in association with CD4 cell restoration and plasma viral load suppression, despite an increased CKD risk that was associated with initial regimens that included tenofovir and rPI.
doi:10.1097/QAD.0b013e328357f5ed
PMCID: PMC3531628  PMID: 22824630
antiretroviral therapy; chronic kidney disease; tenofovir
14.  Long-Term Albendazole Effectiveness for Hepatic Cystic Echinococcosis 
Little is known about the long-term effectiveness of albendazole in the medical therapy of non-complicated hepatic cystic echinococcosis (HCE) in resource-constrained settings. We performed a retrospective review of patients starting albendazole for HCE in Lima, Peru from January 1997 to December 2007. Patients successfully recontacted underwent chart abstraction and clinical and ultrasonographic reevaluation. Descriptive statistics were used to delineate patient characteristics and treatment effectiveness at the conclusion of albendazole and after reevaluation. Patients (N = 27) were primarily female, mean age was 51. Initial treatment success at albendazole conclusion was 26% (N = 7) per patient and 37.5% (N = 24) per cyst. After 3.8 ± 2.5 years, albendazole success was 34% (N = 9) per patient and 40% (N = 24) per cyst. We found a gap in the effectiveness of albendazole HCE therapy compared with the efficacy reported in clinical trials. This underscores the need for further investigation into alternate therapeutic strategies for this neglected disease.
doi:10.4269/ajtmh.2011.11-0382
PMCID: PMC3225155  PMID: 22144447
15.  Viremia Copy-Years Predicts Mortality Among Treatment-Naive HIV-Infected Patients Initiating Antiretroviral Therapy 
Viremia copy-years predicted all-cause mortality independent of traditional, cross-sectional viral load measures and time-updated CD4+ T-lymphocyte count in antiretroviral therapy-treated patients suggesting cumulative human immunodeficiency virus replication causes harm independent of its effect on the degree of immunodeficiency.
Background. Cross-sectional plasma human immunodeficiency virus (HIV) viral load (VL) measures have proven invaluable for clinical and research purposes. However, cross-sectional VL measures fail to capture cumulative plasma HIV burden longitudinally. We evaluated the cumulative effect of exposure to HIV replication on mortality following initiation of combination antiretroviral therapy (ART).
Methods. We included treatment-naive HIV-infected patients starting ART from 2000 to 2008 at 8 Center for AIDS Research Network of Integrated Clinical Systems sites. Viremia copy-years, a time-varying measure of cumulative plasma HIV exposure, were determined for each patient using the area under the VL curve. Multivariable Cox models were used to evaluate the independent association of viremia copy-years for all-cause mortality.
Results. Among 2027 patients contributing 6579 person-years of follow-up, the median viremia copy-years was 5.3 log10 copy × y/mL (interquartile range: 4.9–6.3 log10 copy × y/mL), and 85 patients (4.2%) died. When evaluated separately, viremia copy-years (hazard ratio [HR] = 1.81 per log10 copy × y/mL; 95% confidence interval [CI], 1.51–2.18 per log10 copy × y/mL), 24-week VL (1.74 per log10 copies/mL; 95% CI, 1.48–2.04 per log10 copies/mL), and most recent VL (HR = 1.89 per log10 copies/mL; 95% CI: 1.63–2.20 per log10 copies/mL) were associated with increased mortality. When simultaneously evaluating VL measures and controlling for other covariates, viremia copy-years increased mortality risk (HR = 1.44 per log10 copy × y/mL; 95% CI, 1.07–1.94 per log10 copy × y/mL), whereas no cross-sectional VL measure was independently associated with mortality.
Conclusions. Viremia copy-years predicted all-cause mortality independent of traditional, cross-sectional VL measures and time-updated CD4+ T-lymphocyte count in ART-treated patients, suggesting cumulative HIV replication causes harm independent of its effect on the degree of immunodeficiency.
doi:10.1093/cid/cir526
PMCID: PMC3189165  PMID: 21890751
16.  The Role of Toxicity-Related Regimen Changes in the Development of Antiretroviral Resistance 
Abstract
In an effort to evaluate factors associated with the development of antiretroviral (ARV) resistance, we assessed the prevalence of toxicity-related regimen changes and modeled its association to the subsequent development of ARV resistance in a cohort of treatment-naive individuals initiating ARV therapy (ART). A retrospective analysis of patients initiating ART was conducted at the UAB 1917 Clinic from 1 January 2000 to 30 September 2007. Cox proportional hazards models were fit to identify factors associated with the development of resistance to ≥1 ARV drug class. Among 462 eligible participants, 14% (n=64) developed ARV resistance. Individuals with ≥1 toxicity-related regimen change (HR=3.94, 95% CI=1.09–14.21), initiating ART containing ddI or d4T (4.12, 1.19–14.26), and from a minority race (2.91, 1.16–7.28) had increased risk of developing resistance. Achieving virologic suppression within 12 months of ART initiation (0.10, 0.05–0.20) and higher pretreatment CD4 count (0.85 per 50 cells/mm3, 0.75–0.96) were associated with decreased hazards of resistance. Changes in ART due to drug intolerance were associated with the subsequent development of ARV resistance. Understanding the role of ARV drug selection and other factors associated with the emergence of ARV resistance will help inform interventions to improve patient care and ensure long-term treatment success.
doi:10.1089/aid.2010.0291
PMCID: PMC3192056  PMID: 21342052
17.  Temporal Trends in Presentation for Outpatient HIV Medical Care 2000–2010: Implications for Short-term Mortality 
Background
Many newly diagnosed patients present to outpatient care with advanced HIV infection. More timely HIV diagnosis and initiation of care has the potential to improve individual health outcomes and has public health implications.
Objective
To assess temporal trends in late presentation for outpatient HIV medial care as measured by CD4 count <200 cells/mm3 and the implications on short-term (1-year) mortality.
Design
We conducted a cohort study nested in a prospective HIV clinical cohort including patients establishing initial outpatient HIV treatment between 2000–2010. Time series regression analysis evaluated temporal trends in late presentation for care measured by the proportion of patients with a CD4 count <200 cells/mm3 or an opportunistic infection at enrollment, and also evaluated trends in short-term mortality.
Participants
Patients establishing initial outpatient HIV treatment between 2000–2010 at an academic HIV clinic.
Main Measures
The proportion of patients with a CD4 count <200 cells/mm3 or an opportunistic infection at initial presentation and short-term (1-year) mortality following clinic enrollment.
Key Results
Among 1121 patients, 41% had an initial CD4 count <200 cells/mm3, 25% had an opportunistic infection and 2.4% died within 1-year of their initial visit. Time series regression analysis demonstrated significant reductions in late presentation for HIV care and decreases in short-term mortality with temporal improvement preceding updated CDC HIV testing recommendations.
Conclusion
We observed a significant decline in the number of patients presenting for outpatient HIV care with advanced disease, particularly in 2006–2010. A significant trend in improved short-term survival among patients establishing HIV care was also observed, likely related to more timely presentation for outpatient care in more recent years.
doi:10.1007/s11606-011-1693-x
PMCID: PMC3138583  PMID: 21465301
HIV; HIV testing; mortality; disparity; health policy
18.  Short Communication Routine HIV Testing in the Emergency Department: Assessment of Patient Perceptions 
Abstract
The CDC released revised HIV testing guidelines in 2006 recommending routine, opt-out HIV testing in acute care settings including emergency departments (ED). Patient attitudes have been cited as a barrier to implementation of routine HIV testing in the ED. We assessed patients' perceptions of HIV testing in the ED through a contextual qualitative approach. The study was conducted during a 72-h period. All adults presenting to the ED without life-threatening trauma or psychiatric crisis completed a standardized questionnaire. The questionnaire explored HIV testing history, knowledge of testing resources, and qualitative items addressing participant perceptions about advantages and disadvantages to ED testing. After completion of the interview, participants were offered a free, confidential, rapid HIV test. Among 329 eligible individuals approached, 288 (87.5%) completed the initial interview. Participants overwhelmingly (n=247, 85.8%) reported support for testing and identified increased knowledge (41%), prevention (12.5%), convenience (11.8%), and treatment (4.9%) among the advantages. Fear and denial about one's HIV status, reported by <5% of patients, were identified as the most significant barriers to ED testing. Bivariate analysis determined race and ethnicity differences between individuals completing the interview and those who refused (p<0.05). Among individuals consenting for testing (n=186, 64.6%), no positives were detected. Most patients support HIV testing in the ED, noting knowledge of status, prevention, convenience, and linkage to early treatment as distinct advantages. These data are of particular benefit to decision makers considering the addition of routine HIV testing in EDs.
doi:10.1089/aid.2011.0074
PMCID: PMC3316117  PMID: 21790474
19.  Comparative Effectiveness and Toxicity of Statins Among HIV-Infected Patients 
This study compared the effectiveness and toxicity of different statins among 700 HIV-infected patients in routine clinical care. Findings suggest that atorvastatin and rosuvastatin are preferable to pravastatin leading to greater declines in lipid levels with similar low rates of toxicity.
Background. Dyslipidemia is common and is often treated with 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase inhibitors (statins). Little is known about the comparative effectiveness of statins among human immunodeficiency virus (HIV)–infected patients. This study compared the effectiveness and toxicity of statins among HIV-infected patients in clinical care.
Methods. We conducted a retrospective cohort study of patients starting their initial statin medications at 2 large HIV clinics (N = 700). The primary observation was change in lipid levels during statin therapy. Secondary observations included whether individualized National Cholesterol Education Program (NCEP) goals for low density lipoprotein cholesterol (LDL-C) and non–high density lipoprotein cholesterol (non-HDL-C) levels were reached, and toxicity rates. We used linear regression to examine change in lipid levels, controlling for baseline lipid values and demographic and clinical characteristics. We conducted secondary analyses using propensity scores to address confounding by indication.
Results. The most commonly prescribed statins were atorvastatin (N = 303), pravastatin (N = 280), and rosuvastatin (N = 95). One year after starting a statin therapy, patients who received atorvastatin or rosuvastatin had significantly greater decreases in total cholesterol, LDL-C, and non-HDL-C than patients on pravastatin. The likelihood of reaching NCEP goals for LDL-C levels was higher with the use of rosuvastatin (OR 2.1; P = .03) and atorvastatin (odds ratio [OR], 2.1; P = .001) compared with that of pravastatin. The likelihood of reaching NCEP goals for non-HDL-C levels was higher for rosuvastatin (OR 2.3; P = .045) but not atorvastatin (OR, 1.5; P = .1) compared with pravastatin. Toxicity rates were similar for all 3 statins: 7.3% for atorvastatin, 6.1% for pravastatin, and 5.3% for rosuvastatin.
Conclusions. Our findings suggest that atorvastatin and rosuvastatin are preferable to pravastatin for treatment of HIV-infected patients with dyslipidemia, due to greater declines in total cholesterol, LDL-C, and non-HDL-C, with similar lower toxicity rates.
doi:10.1093/cid/ciq111
PMCID: PMC3106249  PMID: 21189273
20.  Darunavir Outcomes Study: Comparative Effectiveness of Virologic Suppression, Regimen Durability, and Discontinuation Reasons for Three-Class Experienced Patients at 48 Weeks 
AIDS Research and Human Retroviruses  2010;26(12):1279-1285.
Abstract
Several new antiretroviral (ARV) agents for treatment experienced HIV-infected patients have been approved since June 2006, including darunavir (DRV) and raltegravir (RAL). While efficacious in clinical trials, the effectiveness, durability, and tolerability of these new ARVs remains understudied in the context of routine clinical care. The Darunavir Outcomes Study is a prospective cohort study of three-class ARV-experienced patients changing regimens at the 1917 Clinic after 1/7/2006. All treatment decisions were at the discretion of primary providers. Multivariate (MV) logistic regression for 48 week VL <400c/ml and Cox models for regimen durability were completed. Propensity score methods controlled for sociodemographics. Among 108 patients, mean age of 46, 48% were white, 80% male, with prior exposure to a mean 10.5 ARVs. Overall, 64% of patients achieved 48-week VL <400 c/ml. In MV modeling DRV/rll (OR = 5.77;95%CI = 1.62–20.58) and RAL (OR = 3.84;95%CI = 1.23–11.95) use increased odds of 48-week suppression. Use of these agents exhibited a trend towards prolonged regimen durability in Cox models. Among those highly ARV-experienced, regimens containing DRV/r and/or RAL were more likely to achieve 48-week VL <400 c/ml and exhibited a trend towards prolonged durability. New agents have transformed the treatment landscape for ARV-experienced patients, with effectiveness in routine clinical care mirroring efficacy in clinical trials.
doi:10.1089/aid.2010.0059
PMCID: PMC3011996  PMID: 20961276
22.  Routine Self-administered, Touch-Screen Computer Based Suicidal Ideation Assessment Linked to Automated Response Team Notification in an HIV Primary Care Setting 
Summary
The implementation of routine computer-based screening for suicidal ideation and other psychosocial domains through standardized patient reported outcome instruments in two high volume urban HIV clinics is described. Factors associated with an increased risk of self-reported suicidal ideation were determined.
Background
HIV/AIDS continues to be associated with an under-recognized risk for suicidal ideation, attempted as well as completed suicide. Suicidal ideation represents an important predictor for subsequent attempted and completed suicide. We sought to implement routine screening of suicidal ideation and associated conditions using computerized patient reported outcome (PRO) assessments.
Methods
Two geographically distinct academic HIV primary care clinics enrolled patients attending scheduled visits from 12/2005 to 2/2009. Touch-screen-based, computerized PRO assessments were implemented into routine clinical care. Substance abuse (ASSIST), alcohol consumption (AUDIT-C), depression (PHQ-9) and anxiety (PHQ-A) were assessed. The PHQ-9 assesses the frequency of suicidal ideation in the preceding two weeks. A response of “nearly every day” triggered an automated page to pre-determined clinic personnel who completed more detailed self-harm assessments.
Results
Overall 1,216 (UAB= 740; UW= 476) patients completed initial PRO assessment during the study period. Patients were white (53%; n=646), predominantly males (79%; n=959) with a mean age of 44 (± 10). Among surveyed patients, 170 (14%) endorsed some level of suicidal ideation, while 33 (3%) admitted suicidal ideation nearly every day. In multivariable analysis, suicidal ideation risk was lower with advancing age (OR=0.74 per 10 years;95%CI=0.58-0.96) and was increased with current substance abuse (OR=1.88;95%CI=1.03-3.44) and more severe depression (OR=3.91 moderate;95%CI=2.12-7.22; OR=25.55 severe;95%CI=12.73-51.30).
Discussion
Suicidal ideation was associated with current substance abuse and depression. The use of novel technologies to incorporate routine self-reported screening for suicidal ideation and other health domains allow for timely detection and intervention for this life threatening condition.
doi:10.1086/651420
PMCID: PMC2841210  PMID: 20210646
23.  Comparative efficacy versus effectiveness of initial antiretroviral therapy in clinical trials versus routine care 
Summary
The generalizability of clinical trial findings (efficacy) to routine care (effectiveness) may be limited. The present study found similar first year virologic and CD4 outcomes among antiretroviral-naïve patients treated through routine care vs. those participating in clinical trials.
Background
The generalizability of clinical trial findings (efficacy) to routine care (effectiveness) may be limited due to study eligibility criteria and volunteer bias. While well chronicled in many conditions, the efficacy vs. effectiveness of antiretroviral therapy (ART) remains understudied.
Methods
A retrospective study of the UAB 1917 Clinic Cohort evaluated naïve patients starting ART between 1/1/00–12/31/06. Patients received ART through clinical trials or routine care. Multivariable logistic and linear regression models were fit to evaluate factors associated with virologic failure (VF=VL>50 copies/mL) and change from baseline CD4 count 6 and 12 months after ART initiation. Sensitivity analyses evaluated the impact of missing data on outcomes.
Results
Among 570 patients starting ART during the study period, 121 (21%) enrolled in clinical trials vs. 449 (79%) receiving ART via routine care. ART receipt through routine care was not associated with VF at either 6 (OR=1.00;95%CI=0.54–1.86) or 12 (OR=1.56;95%CI=0.80–3.05) months in primary analyses. No significant differences in CD4 count responses at 6 and 12 months were observed.
Conclusions
Though marked differences in efficacy vs. effectiveness have been observed in the therapeutic outcomes of other conditions, our analyses found no evidence of such divergence among our patients initiating antiretroviral therapy for HIV.
doi:10.1086/650004
PMCID: PMC2848720  PMID: 20067423
Efficacy; effectiveness; ART; HIV
24.  Antiretroviral Prescribing Patterns in Treatment-Naïve Patients in the United States 
AIDS Patient Care and STDs  2010;24(2):79-85.
Abstract
Numerous antiretroviral therapy (ART) regimens are recommended for first-line and subsequent HIV care, but regimen selection for clinical use may not represent the full range of options. We hypothesized that despite an increase in available antiretrovirals, clinical trial data on regimen efficacy and fixed-dose combination options have lead to uniformity in initial ART. We evaluated regimen selection for ART-naïve patients at the University of Alabama at Birmingham (UAB) 1917 Clinic between January 2000 and December 2007. The annual number of unique initial regimens was quantified. Initial regimen variability was expressed as regimens per 100 patients. Subsequent ART regimens were characterized for complexity via regimen sequence trees detailing the first three generations of regimens for patients starting the two most common initial combinations. Four hundred eighty-two ART-naïve patients were treated with 39 unique initial regimens (8.0 regimens per 100 patients). Variability in initial regimen selection was highest in the first 6 years (14.9–24.4 regimens per 100 patients). A sharp decline was observed in 2006 (16.1 regimens per 100 patients) and 2007 (6.5 regimens per 100 patients). The most dramatic shift in drug selection involved an increase in emtricitabine plus tenofovir plus efavirenz, from 0% in 2003 to 85% in 2007. During the study period, 205 of 482 (43%) patients required a change in initial therapy. Of these, 156 of 205 (76%) had a unique sequence of regimens. A shift toward homogeneity of initial ART was observed (85% of patients received the same first-line regimen in 2007). In contrast, regimen sequencing beyond the first regimen remained complex. These shifts in ART prescribing patterns may have implications for collaborative HIV care.
doi:10.1089/apc.2009.0220
PMCID: PMC3826470  PMID: 20059309
25.  New Syphilis Cases and Concurrent STI Screening in a Southeastern U.S. HIV Clinic: A Call to Action 
AIDS Patient Care and STDs  2010;24(1):23-29.
Abstract
Syphilis outbreaks in the United States have been reported since 2000 with highest rates in the South and many cases among HIV-infected individuals. We evaluated incident syphilis cases and concurrent gonorrhea and chlamydia screening at a southern HIV clinic. A retrospective cohort study included HIV-infected patients with at least one reactive plasma reagin (test for serum reagin antibodies to cardiolipin-cholesterol-lecithin antigen) and primary care visit from July 2004 to June 2007. Primary, secondary, and early latent syphilis cases were identified as incident syphilis and evaluation for gonorrhea and chlamydia within 1 month were described. Logistic regression was performed to determine factors associated with incident syphilis. Among 1544 patients, 40 incident syphilis cases were identified (5 primary, 29 secondary, and 6 early latent). The majority of patients were not virologically suppressed and only 25% had gonorrhea and chlamydia testing. In adjusted analyses, younger age (0.57 per 10 years, 95% confidence interval [CI] 0.41–0.80) and minority race (2.26, 95% CI 1.12–4.59) were associated with incident syphilis. Among 40 incident syphilis cases, only 1 in 4 were further tested for gonorrhea and chlamydia. These low rates are concerning as concurrent sexually transmitted infections (STIs) increase risk for HIV transmission. HIV care provider education with emphasis on STI testing in the setting of incident syphilis is key in prevention.
doi:10.1089/apc.2009.0255
PMCID: PMC2859761  PMID: 20095902

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