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BackgroundThe incidence of anal squamous cell carcinoma has been increasing, particularly in people living with HIV (PLWH). There is concern that radiosensitizing drugs, such as protease inhibitors, commonly used in the management of HIV, may increase toxicities in patients undergoing chemoradiation. This study examines treatment outcomes and toxicities in PLWH managed with and without protease inhibitors who are receiving chemoradiation for anal cancer.MethodsPatient demographic, HIV management, and cancer treatment information were extracted from multiple Veterans Affairs databases. Patients were also manually chart reviewed. Among PLWH undergoing chemoradiation for anal carcinoma, therapy outcomes and toxicities were compared between those treated with and without protease inhibitors at time of cancer treatment. Statistical analysis was performed using chi-square, Cox regression analysis, and logistic regression.ResultsA total of 219 PLWH taking anti-retroviral therapy undergoing chemoradiation for anal cancer were identified and included in the final analysis. The use of protease inhibitors was not associated with any survival outcome including colostomy-free survival, progression-free survival, or overall survival (all adjusted hazard ratiop-values> 0.05). Regarding toxicity, protease inhibitor use was not associated with an increased odds of hospitalizations or non-hematologic toxicities; however, protease inhibitor use was associated with increased hospitalizations for hematologic toxicities, including febrile neutropenia (p ConclusionThe use of protease inhibitors during chemoradiation for anal carcinoma was not associated with any clinical outcome or increase in non-hematologic toxicity. Their use was associated with increased hospitalizations for hematologic toxicities. Further prospective research is needed to evaluate the safety and efficacy of protease inhibitors for patients undergoing chemoradiation.

Background People living with HIV/AIDS (PLWH) have an excess risk for head and neck squamous cell carcinoma (HNSCC) compared to the general U.S. population, but little is known about HIV‐specific risk factors associated with the incidence and outcomes HNSCC. We aim to identify clinical and HIV‐specific risk factors associated with oropharyngeal and non‐oropharyngeal HNSCC incidence and outcomes separately. Methods We constructed a retrospective cohort study of 45,052 PLWH aged 18 or above from the national Veteran Affairs (VA) Corporate Data from 1999 to 2015. We extracted demographic data and risk factor information, including history of alcohol abuse, smoking, CD4 count (cells/μl), and percent of follow‐up time with undetectable HIV viral load as time‐updated variables. We calculated the age‐standardized incidence rates of oropharyngeal and non‐oropharyngeal HNSCC and estimated adjusted hazard ratios (HR). We also examined overall survival using Kaplan–Meier curves and adjusted HR. Results The standardized incidence rate of oropharyngeal and non‐oropharyngeal HNSCC in this veteran cohort of PLWH is 23.0 (95% confidence intervals (CIs): 17.1‐28.9) and 55.4 (95% CI: 46.5‐64.3) per 100,000 person‐years, respectively. Nadir CD4 count ≤200 was associated with an increased risk of non‐oropharyngeal HNSCC (HR: 1.78; 95% CI: 1.31‐2.30 vs >200). Five‐year overall survival of OPSCC (37.0%) was significantly lower than non‐oropharyngeal HNSCC (49.1%). Conclusions PLWH who receive care in the VA had higher age‐adjusted HNSCC incidence rates than reported in the general population, suggesting that HIV and immunosuppression play a role. Additional studies should be conducted to study the interaction between HPV and HIV., The elevated risk of both oropharynx cancer and non‐oropharyngeal head and neck cancer and poor survival among people living with HIV in the VA healthcare system suggests the host immune system interacts with smoking and HPV.

To evaluate the risks of esophageal and stomach carcinomas in people living with HIV (PLWH) compared with the general population and risk factors for these cancers in PLWH.Retrospective cohort study in the Veterans Health Administration.We compared incidence rates for esophageal and stomach cancers in 44,075 HIV-infected male veterans with those in a matched HIV-uninfected cohort (N = 157,705; 4:1 matched on age and HIV-index date). We used Cox regression models to estimate Hazard ratios (HRs) and 95% confidence intervals (CIs) for associations with HIV infection and for cancer risk factors in PLWH.In unadjusted models, HIV infection was associated with increased risks of esophageal squamous cell carcinoma (ESCC; HR, 2.21; 95% CI: 1.47 to 3.13) and gastric cardia cancer (HR, 1.69; 95% CI: 1.00 to 2.85) but associated with lower risk of esophageal adenocarcinoma (EAC; HR, 0.48; 95% CI: 0.31 to 0.74). After adjusting for age, race/ethnicity, smoking and alcohol use, HIV infection remained statistically significantly associated with elevated risk for ESCC [adjusted hazard ratio (aHR), 1.58; 95% CI: 1.02 to 2.47], especially among HIV-infected patients with CD4 count ≤200 (aHR, 2.20; 95% CI: 1.35 to 3.60). HIV infection was not associated with risks of EAC (aHR, 0.82; 95% CI: 0.53 to 1.26), gastric cardia (aHR, 0.80; 95% CI: 0.33 to 1.94), or noncardia (aHR, 1.06; 95% CI: 0.61 to 1.84) cancers. Risk factors for these cancers in HIV-infected patients were otherwise similar to those in general population (eg, Helicobacter pylori for gastric noncardia cancer).HIV-infected individuals with low CD4 count are at highest risk for ESCC, but HIV infection was not independently associated with EAC or gastric cancer after adjusting for confounders.

Among people living with HIV (PWH), there has been an increasing incidence of non-small cell lung cancer (NSCLC) and metabolic abnormalities, including dyslipidemia, which can modulate NSCLC risk. In this article, we evaluate which metabolic risk factors are associated with incident risk among PWH who smoke. This is done through a retrospective cohort study, using data of HIV+ veterans who smoke from the nationwide Veterans Affairs (VA) healthcare system. Data on diagnostic codes, medication, and laboratory values of 33,351 veterans were obtained using the VA&rsquo, s Corporate Data Warehouse and Central Cancer Registry. We calculated NSCLC incidence and utilized Cox regression to determine metabolic factors associated with NSCLC risk. HIV+ cohort was 97.4% male, median age = 47 years and 20,050 (60.1%) well-controlled (&ge, 80% follow-up time undetectable viral load). Crude incidence rates were lower in well-controlled PWH (1.46 vs. 2.06/1000 PY). Metabolic factors associated with incident NSCLC risk included lower BMI at HIV diagnosis and cachexia history in both groups, while HDL and triglycerides were significant in non-well-controlled smokers only. Our findings that lower BMI at HIV diagnosis, history of cachexia among individuals with well-controlled HIV, and cachexia presence at diagnosis are associated with increased risk of developing NSCLC in PWH with a history of smoking have important implications.

BACKGROUND: Oropharyngeal squamous cell carcinoma (OPSCC) epidemiology has not been examined previously in the nationwide Veterans Affairs (VA) population. METHODS: Joinpoint regression analysis was applied to OPSCC cases identified from VA administrative data from 2000 to 2012. RESULTS: We identified 12 125 OPSCC cases (incidence: 12.2 of 100 000 persons). OPSCC incidence declined between 2000 and 2006 (annual percent change [APC] = −4.27, P < .05), then increased between 2006 and 2012 (APC = 7.02, P < .05). Significant incidence increases occurred among white (APC = 7.19, P < .05) and African American (APC = 4.87, P < .05) Veterans and across all age cohorts. The percentage of never-smokers increased from 8% in 2000 to 15.7% in 2012 (P < .001), and 2-year overall survival improved from 31.2% (95% confidence interval (CI) [30-33.4]) to 55.7% (95% CI [54.4-57.1]). CONCLUSIONS: OPSCC incidence is increasing across all racial and age cohorts in the VA population. Smoking rates remain high among Veterans with OPSCC and gains in survival lag those reported in the general population.

To evaluate HIV-related and other clinical risk factors associated with oropharynx cancer (OPSCC) in HIV-infected U.S. Veterans.Retrospective cohort study utilizing Veterans Affairs HIV Clinical Case Registry (CCR) data from 1985 to 2010. Outcome was incident OPSCC as indicated by 1 inpatient or 2 outpatient ICD-9 codes. Cox proportional hazard models were used to determine hazard ratios (HR) and 95% confidence intervals (CI) for each risk factor on the time to OPSCC diagnosis.A total of 40,996 HIV-infected male veterans were included in the cohort with 97 cases of OPSCC. The age adjusted incidence rate was 23.2/100,000 [95% CI 17.8-29.2]. Age50 (aHR=3.8, 95% CI 1.9-7.8), recent CD4200 (aHR=3.8, 95% CI 2.0-7.3), and undetectable HIV viral loads 40-79% of the time (aHR=1.8, 95% CI 1.1-3.0) were associated with an increased risk of OPSCC. Era of HIV diagnosis, utilization of cART, nadir CD4 count, race, smoking history, and previous risk of HPV disease, including condyloma or invasive squamous cell carcinoma of the anus (SCCA) were not associated with increased risk of OPSCC.Patients who were older at beginning of follow up, had lower CD4 counts around the time of OPSCC diagnosis, and moderate HIV viral control during follow-up had an increased risk of OPSCC. Other HPV-related diseases such as SCCA and condyloma did not increase the risk for OPSCC.

Objectives The US Department of Veterans Affairs (VA) is the largest integrated health care provider for HIV-infected patients in the USA. VA data for HIV-specific clinical and quality improvement research are an important resource. We sought to determine the accuracy of using the VA Corporate Data Warehouse (CDW), a fully automated medical records database for all VA users nationally, to identify HIV-infected patients compared with a gold-standard VA HIV Clinical Case Registry (CCR). Methods We assessed the test performance characteristics of each of our CDW criteria-based algorithms (presence of one, two or all of the following: diagnostic codes for HIV, positive HIV laboratory tests, and prescription for HIV medication) by calculating their sensitivity (proportion of HIV-positive patients in the CCR accurately detected as HIV-positive by the CDW algorithm) and positive predictive value (PPV; the proportion of patients identified by the CDW algorithm who were classified as HIV-positive from the CCR). Results We found that using a CDW algorithm requiring two of three HIV diagnostic criteria yielded the highest sensitivity (95.2%) with very little trade-off in PPV (93.5%). Conclusions A two diagnostic criteria-based algorithm can be utilized to accurately identify HIV-infected cohorts seen in the nationwide VA health care system.

INTRODUCTION Chronic HIV/hepatitis C virus (HCV) coinfection carries increased risk of cirrhosis, hepatocellular carcinoma, and death. Due to anti-inflammatory properties, 3-hydroxy-3methylglutaryl coenzyme A (HMG-CoA) inhibitors (statins) may be useful adjunctive therapy to reduce liver disease progression. METHODS Clinical information was extracted from the Veterans Affairs HIV and HCV Clinical Case Registries (1999-2010). HIV-related variables included combination antiretroviral therapy era of diagnosis, CD4 cell count, and percentage time with undetectable HIV viral load. Metabolic variables included diabetes, low high-density lipoprotein (HDL), and hypertension. Statin use was measured as percentage time with active prescription (time-updated throughout the follow-up period). Cox proportional hazards analysis was used to determine risk factors for cirrhosis (International Classification of Diseases-9 or aminotransferase-to-platelet ratio index >2) overall and in groups stratified by alanine aminotransferase (ALT) level above and below 40 IU/l. RESULTS The cohort included 5985 HIV/HCV coinfected veterans. The majority was black race, and the mean age at index date was 45 years. Statin use was significantly protective of cirrhosis for patients with ALT 40 IU/l or less; for every 30% increase in time on statin, there was a 32% decreased risk of developing cirrhosis (hazard ratio 0.68, 95% confidence interval 0.47-0.98). Diabetes and low HDL were significantly associated with cirrhosis in patients with ALT greater than 40 IU/l (hazard ratio 1.15, P

Cross-sectional studies have shown an association between better patient experiences and health outcomes. However, the direction of causality remains unclear. Our prospective study seeks to determine whether better initial patient experiences predict subsequent retention in HIV care. We enrolled patients new to an HIV clinic in Houston, Texas, from August 26, 2013 to November 18, 2013. The patients’ overall experience with the HIV provider was based on six items; overall experience with the HIV clinic was based on five items. We measured subsequent retention over the first 6 months and entire first year of HIV care. Analyses included 140 patients. Sixty-one percent were non-Hispanic black, 41 % were diagnosed with HIV within the last 3 months, and 36 % had a CD4 cell count

Nivolumab is a standard treatment option in several advanced malignancies, but safety and efficacy are still unknown in patients with human immunodeficiency virus (HIV) infection. We describe a case series of people living with HIV (PLWH) receiving nivolumab in the Veterans Health Administration (VA) and report responses and toxicities. We identified all PLWH who received nivolumab at any VA facility since 2000 in the Corporate Data Warehouse (CDW), which provides nationwide research access to VA electronic medical records. We identified 16 HIV-infected nivolumab recipients. The median number of nivolumab doses received was 6 (range, 1-32). Changes in CD4 count during therapy were variable, with 70% (7/10) of patients experiencing increases. Half of PLWH were treated for non-small-cell lung cancer; 2 for Hodgkin lymphoma (HL), 2 for renal cell carcinoma, and 4 for off-label cancers. For non-small-cell lung cancer, 7 patients had evaluable responses. Although 5 of 7 patients immediately progressed, 1 had a partial response and 1 had stable disease, which were both durable. Two of 16 (14%) PLWH had complete responses; both with HL (2/2 HL, 100%). The prevalence of immune-related adverse effects was 40% overall (6/15); 27% (4/15) had pneumonitis. To our knowledge, this is the largest case series reporting outcomes with nivolumab in PLWH. Outcomes were comparable with those seen in studies of HIV-uninfected patients, and particularly interesting for HL. The reason for the high proportions of immune-related adverse effects is unclear, but needs to be confirmed in larger studies.

Injection site reactions (ISRs) and other adverse side effects are commonly observed during therapy with biologics. These hypersensitivity-related side effects can vary from simple rash to life-threatening anaphylactic reaction and may be linked to the immunogenicity of the drug including formation of antidrug antibodies. Reactions can also occur as a consequence of excipients in the product. We report the case of a patient who developed erythematous ISRs to both commercial PCSK9i formulations and had to go off therapy even though efficacy was not impacted. Skin testing showed that the patient was reacting to the polysorbates. Polysorbates are added to stabilize the biotherapeutic. Polysorbates can also activate complement and lead to a range of acute hypersensitivity and systemic immunostimulation reactions. Oxidative degradation products can function as haptens by reacting with proteins at the injection site. Reactive degradation products may even form adducts with the biologic itself, creating a potential neoantigen. Further research is needed to understand the fundamental causes of ISRs. It is critical that only the highest quality raw material is used, and proper storage conditions are employed to minimize degradation of polysorbates in the product. Although complete elimination of ISRs is unlikely, all efforts must be made to minimize them.

Objectives: Veterans have an increased risk of laryngeal cancer, yet their oncologic and functional outcomes remain understudied. We sought to determine the longitudinal impact of tracheoesophageal puncture and voice prosthesis on quality-of-life measures in veterans following total laryngectomy (TL). Methods: We performed a cross-sectional analysis of TL patients (n = 68) treated at the Michael E. DeBakey Veterans Affairs Medical Center using the Voice Handicap Index (VHI), MD Anderson Dysphagia Index (MDADI), and University of Washington Quality of Life Index (UW-QOL). Results: Using tracheoesophageal (TE) speech was associated with significantly better VHI, MDADI, and UW-QOL scores compared to other forms of communication. The association between TE speech use on VHI, MDADI, and UQ-QOL persisted even when the analysis was limited to patients with >5-year follow-up and was maintained on multivariate analysis that accounted for a history of radiation and laryngectomy for recurrent laryngeal cancer. Conclusions: Using tracheoesophageal speech after total laryngectomy is associated with durable improvements in quality of life and functional outcomes in veterans. Tracheoesophageal voice restoration should be attempted whenever technically feasible in patients that meet the complex psychosocial and physical requirements to appropriately utilize TE speech.

Background A significant fraction of oropharyngeal squamous cell carcinoma (SCC) cases is associated with traditional carcinogens; in these patients, treatment response and clinical outcomes remain poor. Methods We evaluated patient, tumor, and treatment characteristics for 200 veterans with oropharyngeal SCC treated at the Michael E. DeBakey Veterans Affairs Medical Center (MEDVAMC) between 2000 and 2012. Results Most patients (77%) were white and heavy smokers. Twenty-seven patients required tracheostomy and 63 required gastrostomy placement during treatment. Overall survival (OS) at 5 years was 40%. Survival was impacted by T classification, treatment intensity, completion of treatment, and p16 tumor status. Almost 30% of patients were unable to complete a treatment regimen consistent with National Comprehensive Cancer Network (NCCN) guidelines. Conclusion Oropharyngeal SCC in veterans is associated with traditional carcinogens and poor clinical outcomes. Despite heavy smoking exposure, p16 tumor status significantly impacts survival. Careful consideration must be given to improving treatment paradigms for this cohort given their limited tolerance for treatment escalation. © 2014 Wiley Periodicals, Inc. Head Neck 37: 1246–1253, 2015

Background Racial disparities in oropharyngeal squamous cell carcinoma (SCC) have been demonstrated and attributed to differences in human papillomavirus (HPV) status. The purpose of this study was to examine racial disparities in oropharyngeal SCC among veterans. Methods Retrospective review of patients with oropharyngeal SCC at a tertiary-care Veterans Affairs (VA) hospital. Adjusted Cox proportional hazards models were conducted to examine the effect of race on oropharyngeal SCC outcomes. Results Of 158 patients, 126 (79.7%) were white and 32 (20.3%) were African American. No difference in p16 tumor expression was noted between the groups. Five-year disease-free survival (DFS) was 42.6% and 55.1% for African Americans and whites, respectively (p = .372). Five-year overall survival (OS) for African Americans and whites was 54.6% and 51.8%, respectively (p = .768). On multivariate analysis, there was no significant difference in risk of recurrence or death by race. Conclusion Racial disparities are largely ameliorated in patients with oropharyngeal SCC treated within the VA, there were no racial differences in p16 tumor expression, and outcomes remain poor. © 2015 Wiley Periodicals, Inc. Head Neck, 2015

The hospital setting provides an opportunity to re-engage people living with HIV (PLWH) in HIV care. We developed and implemented a protocol to identify PLWH in a hospital setting. The aim of the current study was to report on our strategy to recruit hospitalized HIV patients into an intervention study, and to report on lessons learned for future studies.Our protocol was developed based on experience of our research staff in recruiting HIV patients as well as clinical input from providers and administrators on delivering care in hospitalized settings. We identified hospitalized PLWH between 2010 and 2013 who were potentially eligible for an intervention study. Patients were identified by review of electronic medical records and clinician referral, followed by in-person screening to confirm eligibility. We examined factors related to identifying and enrolling hospitalized patients, and documented lessons learned.Key strategies included systematic medical record review followed by in-person screening, collaboration with staff, and flexibility in recruitment logistics. We identified 1801 PLWH hospitalized during the 3-year study period. Eighty-four percent (n = 1514) met the met the inclusion criteria based on medical record review. Of these, 48% (n = 733) were ineligible. Among eligible patients, 59% (n = 460) were enrolled. Only 3% (n = 23) of eligible patients declined; 84% (n = 321) were not enrolled because they were discharged before enrollment. Lessons learned included (1) needing to identify patients and deliver the intervention before hospital discharge, (2) limiting the complexity of the intervention, and (3) having research staff available on weekends and after hours.Targeted recruitment of hospitalized populations is a feasible and productive approach for finding and engaging PLWH who are newly diagnosed or out of routine care.

BACKGROUND Thyroid cancer incidence has increased in the last several decades and may represent either a true increase in the number of cases or increased screening. The objective of this study was to examine thyroid cancer incidence and the use of thyroid ultrasound and fine-needle aspiration (FNA) screening in the Veterans Affairs (VA) health care system. The authors hypothesized that the incidence of thyroid cancer would correspond to increases in the use of these diagnostic modalities. METHODS This was a multiyear, cross-sectional study using VA administrative data from 2000 to 2012. Joinpoint regression analysis was used to identify trends in thyroid cancer incidence and the use of thyroid ultrasound and FNA. RESULTS An increase in thyroid cancer incidence occurred from 10.3 per 100,000 individuals in 2000 to 21.5 per 100,000 individuals in 2012. The rate of thyroid ultrasound use increased from 125.6 per 100,000 individuals in 2001 to 572.1 per 100,000 individuals in 2012, and the rate of thyroid FNA use increased from 7.0 per 100,000 individuals in 2000 to 46.2 per 100,000 individuals in 2012. A statistically significant increase in thyroid cancer incidence between 2000 and 2008 (annual percent change [APC], 3.81; P

(a) Although prostate cancer is projected to be one of the most frequently diagnosed cancers in HIV-infected men overall, little is known about its risk in the sub-group with well-controlled HIV-infection. (b) We performed a retrospective cohort study to determine age-adjusted incidence of prostate adenocarcinoma in HIV-positive male veterans utilizing Veterans Administration (VA) healthcare between 10/01/1999 and 12/31/2016. HIV infection and prostate adenocarcinoma diagnosis as well as related clinical, sociodemographic, and lifestyle risk factors were obtained using extant VA administrative healthcare databases, the VA cancer registry, and augmented prostate cancer diagnosis with direct electronic medical record (EMR) review. We defined well controlled HIV as >60% of time with an undetectable HIV viral load and limited our analyses to those with a minimum of 90 days between HIV and prostate diagnosis, death, their last recorded health care encounter, or study end. We employed time-varying Cox proportional hazard regression models and used backward elimination to identify risk factors associated with incident prostate adenocarcinoma; effects are reported as Hazard ratios (HR) and 95% confidence intervals (CI). (c) During an average 10.26 years of follow-up, we identified 587 incident prostate adenocarcinomas among our cohort of 19,079 HIV positive men with well-controlled infection (age-adjusted incidence rate [IR] = 83.31 per 100,000-person years, 95% CI: 76.83-90.33); with a significant increasing trend over time. We identified several factors associated with significant increased risk of incident prostate adenocarcinoma, after adjusting for HIV medication use, in our well-controlled HIV-positive cohort including substance abuse (HR=1.68, 95% CI: 1.27-2.24, p=0.0003), age at HIV diagnosis (HR=1.73, 95% CI: 1.25-2.39, p=0.0010), and black race (HR=2.07, 95% CI: 1.58-2.72, p (d) Further research is needed to confirm our findings and to better identify sub-groups of well-controlled HIV-positive men at greatest increased prostate cancer risk. Citation Format: Kathryn E. Royse, Jose M. Garcia, Donna L. White, Jennifer R. Kramer, Yongquan Dong, Suchismita Raychaudhury, Peter A. Richardson, Christine Hartman, Elizabeth Y. Chiao. Prostate adenocarcinoma incidence and risk factors in Veterans with well controlled HIV infection [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2019; 2019 Mar 29-Apr 3; Atlanta, GA. Philadelphia (PA): AACR; Cancer Res 2019;79(13 Suppl):Abstract nr 5044.

Background Few interventions have been shown to improve retention in human immunodeficiency virus (HIV) care, and none have targeted the hospitalized patient. Peer mentoring has not been rigorously tested. Methods We conducted a randomized, controlled clinical trial of a peer mentoring intervention. Eligible adults were hospitalized and were either newly diagnosed with HIV infection or out of care. The intervention included 2 in-person sessions with a volunteer peer mentor while hospitalized, followed by 5 phone calls in the 10 weeks after discharge. The control intervention provided didactic sessions on avoiding HIV transmission on the same schedule. The primary outcome was a composite of retention in care (completed HIV primary care visits within 30 days and between 31 and 180 days after discharge) and viral load (VL) improvement (≥1 log10 decline) 6 months after discharge. Results We enrolled 460 participants in 3 years; 417 were in the modified intent-to-treat analysis. The median age was 42 years; 74% were male; and 67% were non-Hispanic black. Baseline characteristics did not differ between the randomized groups. Twenty-eight percent of the participants in both arms met the primary outcome (P = .94). There were no differences in prespecified secondary outcomes, including retention in care and VL change. Post hoc analyses indicated interactions between the intervention and length of hospitalization and between the intervention and receipt of linkage services before discharge. Conclusions Peer mentoring did not increase reengagement in outpatient HIV care among hospitalized, out-of-care persons. More intense and system-focused interventions warrant further study. Clinical trials registration NCT01103856.

Objective: Relatively little attention has focused on the impact of psychiatric conditions on human subjects' comprehension of consent information. The purpose of this randomized study was to determine whether depression affects comprehension and recall of informed consent information among persons with Parkinson's disease and their caregivers and to evaluate the effects of support on comprehension and recall during the consent process. Method: Comprehension and recall of information were assessed using a modified version of the Modified Quality of Informed Consent Questionnaire, taken 1 week and 1 month later, and scored using a consensus-based algorithm. Participants also completed the Center for Epidemiologic Studies Depression Scale. Data analyses were conducted on 129 patients and caregivers ( t-tests, Fisher's exact tests, and ANCOVAs). Results: T-tests showed no significant differences in comprehension and recall between depressed and nondepressed participants at 1 week and 1 month. However, ANCOVA showed patients with a support person present had significantly higher comprehension and recall at 1 week but not at 1 month compared with controls. Caregivers present with a patient had lower comprehension/recall than those without a patient present ( p = 0.02). Conclusions: Having a support person present during the informed consent process helps depressed PD patients better retain information in the short term, but effects diminish over the long term. Implications for interventions will be discussed.

Lack of trust by the patient in the physicians or the healthcare system has been associated with poorer health outcomes. The present study was designed to determine if trust in physicians and the healthcare system among persons newly diagnosed with HIV infection was predictive of patients' subsequent linkage, retention, and adherence to HIV care. 178 newly diagnosed HIV infected patients were administered the trust-in-physicians and trust-in-healthcare system scales. Median trust-in-physicians and trust-in-healthcare system scores were compared for all the mentioned subsequent linkage, retention, and adherence to HIV care. Univariate logistic regression using the trust-in-physician scale confirmed significant association with retention in care (p = 0.04), which persisted in multivariate analyses (p = 0.04). No significant association was found between trust-in-physicians and linkage to care or adherence to antiretroviral therapy. Trust in the healthcare system was not associated with any of the outcomes. Patients with higher trust in physicians were more likely to be retained in HIV care. Trust at diagnosis may not be a barrier to better clinical outcomes, either because trust changes based on subsequent interactions, or because trust is not a determining feature. Interventions to improve retention in care could include improving trust in physicians or target persons with low trust in physicians.

To compare the performance of self-report instruments assessing adherence to antiretroviral therapy (ART) in patients starting ART for the first time and in a predominately Hispanic population.Of 184 patients in a prospective observational cohort study of newly diagnosed, minority patients of low socioeconomic status, 54 were given Medication Event Monitoring System (MEMS) caps for their boosted protease inhibitor (PI) or non-nucleoside reverse transcriptase inhibitor (NNRTI). They completed a 4-week recall visual analogue scale (VAS), the Adult AIDS Clinical Trial Group (AACTG) 4-day recall instrument, and a 1-month recall qualitative single-item measure every 3 months for up to 18 months in English or Spanish. Electronic pharmacy records recorded refill dates. Spearman correlation coefficients were calculated to compare self-report measures with MEMS data and pharmacy data.Of 46 patients with MEMS data, mean adherence was 84.7% (SD 35.6) by MEMS, 84.5% (SD 15.1) by pharmacy, 95.4% (SD 11.9) by VAS, 95.8% (SD 17.2) by AACTG, and 87.6% (SD 28.2) by qualitative single item. The correlation coefficient (CC) of VAS with MEMS was 0.37 (P.01), and with pharmacy it was 0.34 (P.01). The CC of the AACTG with MEMS was 0.32 (P.01), and with pharmacy it was 0.28 (P.01). The qualitative single item had a CC with MEMS of 0.24 (P.01) and with pharmacy of 0.32 (P.01). Spanish-speaking patients' VAS adherence had a CC of 0.40 (P.01) with MEMS.The VAS, AACTG, and qualitative single-item measures correlated significantly with MEMS and pharmacy data. Our data support self-administration of the VAS, even in Span-ish speakers.

Little is known about the prevalence and impact of depression in persons newly diagnosed with HIV infection. The Steps Study is a prospective, observational cohort study of persons newly diagnosed with HIV infection. Participants were administered a battery of instruments, including the CES-D. Linkage to care was defined as attending at least one clinic appointment in each of the first two 90-day intervals following diagnosis. Of 180 participants, 67% screened positive for depression. In multivariate analysis, depression was associated with female sex, income

The objective of this study was to compare the efficacy and safety of nivolumab in the HIV-infected and HIV-uninfected veteran populations. WHAT IS NEW: Most clinical trials highlighting checkpoint inhibitors excluded people living with HIV (PLWH). This is the first study to report equivalent nivolumab tumor response rates in PLWH, but higher rates of pneumonitis.METHODS: We searched the Corporate Data Warehouse (CDW) to identify all HIV-positive patients who used the Veterans Health Administration (VA) between 2000 and 2016. For this cohort of 46,916 PLWH, we obtained a 4:1 age-matched HIV-negative control cohort. We used pharmacy database to identify all nivolumab recipients through July 26, 2017. We reviewed patients' electronic medical records using Compensation and Pension Records Interchange (CAPRI) to obtain age, sex, geographic location, cancer type, number of nivolumab doses received, previous cancer therapy, adverse events, and response to therapy. We calculated summary descriptive measures for both groups and compared the proportion of patients experiencing adverse event or pneumonitis in groups by HIV status, using chi-square or Fisher's exact test. RESULTS: Sixteen PLWH and 68 HIV-negative controls received nivolumab during the study period. Only 51 controls had accessible data. Median age at nivolumab initiation was 65 years in both groups (range, 47-85 [IQR, 59-68] in PLWH; range, 42-79 [IQR 59-68] in controls); all patients were male. Overall, 63% received nivolumab for non-small cell lung cancer (NSCLC): 8/16 (50%) in PLWH, 34/51 (67%) in controls. Other indications in PLWH included renal cell carcinoma (RCC) (2/16 [13%]), Hodgkin lymphoma (HL) (2/16 [13%]), hepatocellular carcinoma (HCC) (2/16 [13%]). Other indications in controls were RCC (9/51 [18%]), melanoma (5/51, [10%]), and head and neck squamous cell carcinoma (3/51 [6%]).Regardless of HIV status, the median number of prior lines of therapy was 1, median number of nivolumab doses received was 6, and median progression-free survival (PFS) in NSCLC was 2.75 months. Half of each NSCLC group received radiation; fewer PLWH had COPD (50%, vs. 82% of controls). PLWH had a trend towards more adverse events (AEs) (6/15 [40%], vs. 13/51 [26%] of controls, p=0.28). A significantly higher proportion of PLWH experienced pneumonitis (4/15 [27%], vs. 2/51 [4%] of controls, p=0.007).Other AEs among PLWH were rash, hypothyroidism, and autoimmune diabetes mellitus. Other AEs among controls were fatigue, colitis, rash, hypothyroidism, arthritis, and hepatitis (1-3 patients each). CONCLUSION: Among veteran PLWH, rates of nivolumab administration, and PFS in NSCLC, were comparable to those of HIV-uninfected counterparts. Pneumonitis was significantly more frequent in PLWH. Further studies should investigate the mechanism of pneumonitis in this population, confirm the high frequency in larger cohorts of PLWH, and identify clinical risk factors for pneumonitis. Citation Format: Elaine Chang, Aaron P. Thrift, Donna L. White, Jennifer Kramer, Anita L. Sabichi, Christine Hartman, Kathryn E. Royse, Peter A. Richardson, Elizabeth Y. Chiao. Nivolumab efficacy and safety in veterans with and without HIV infection [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2018; 2018 Apr 14-18; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2018;78(13 Suppl):Abstract nr 617.

Poor retention in HIV care leads to poor survival. The predictors of poor retention in HIV care are not well understood, especially from US nationwide datasets. We determined the predictors of poor retention in HIV care among a group of US veterans and examined whether poor retention was confounded by other predictors of survival.We conducted a retrospective cohort study of 2,619 male US veterans who started antiretroviral therapy after January 1, 1998. Poor retention in HIV care was defined as having had at least 1 quarter-year without any primary care visit in the year after starting antiretroviral therapy. Survival was assessed through 2002. Logistic regression and Cox models were constructed.Thirty-six percent of patients had poor retention in care. In multivariable analysis, younger age, Black race/ethnicity, CD4 cell count350 x10(6)/L, hepatitis C infection, and illicit drug use were predictive of poor retention in care. Having a chronic medical comorbidity and being identified as a man having sex with men (MSM) were associated with improved retention in care. In multivariable survival analyses, poor retention in care was not a confounder or moderator for other variables that predicted survival.Retention in HIV care is an independent predictor of survival. As routine HIV screening increases, more people with the characteristics predictive of poor retention in care will be identified. Interventions to improve retention in care are needed.

We sought to determine the prevalence of HIV conspiracy beliefs in patients with HIV and how those beliefs correlate with access and adherence to HIV care and health outcomes. From March to December 2005, 113 patients at four public facilities in Houston, Texas, diagnosed with HIV for 3 years or less, participated in a cross-sectional survey. Conspiracy beliefs were assessed with five items that dealt with HIV origin, cure, and vaccine. Medical records were reviewed for CD4 cell counts, HAART use, and appointment dates. Statistical analyses (including analysis of variance [ANOVA], chi(2) testing, and regression) determined the predictors of conspiracy beliefs and correlated them with outcomes. Sixty-three percent of the participants endorsed 1 or more conspiracy beliefs. African American patients more often held HIV conspiracy beliefs than white and other/mixed race patients (73%, 52%, 47%; p = 0.045). Persons holding 1 or more conspiracy beliefs had higher CD4 cell counts at diagnosis (254 cells/mm(3) versus 92, p = 0.03); and similar rates of highly active antiretroviral therapy (HAART) use (73% versus 71%), 100% adherence to HAART by self-report (53% versus 45%,), mean adherence by pharmacy refill (83% versus 87%), and gaps in care greater than 120 days (49% versus 53%), compared to subjects who did not hold any conspiracy beliefs (all p0.40). Since recruitment focused on patients in care, patients with extreme conspiracy beliefs may be underrepresented. Despite this, more than 50% of the study population endorsed 1 or more conspiracy belief. However, these beliefs did not negatively impact access or adherence to HIV care. Efforts to improve adherence to HIV care may not need to focus on eliminating conspiracy beliefs.

SUMMARY Background Upper gastrointestinal events (UGIE), myocardial infarction (MI) and cerebrovascular accident (CVA) are known morbities among recent NSAID users. Aim To assess all-cause mortality following UGIE, MI or CVA among recent NSAID users. Methods Veterans >65 prescribed an NSAID at any Veterans Affairs (VA) facility were identified using prescription fill data and their records linked to a merged VA-Medicare database. Each person-day was assessed for NSAID, coxib or proton pump inhibitor (PPI) exposure. Incidence density ratios and hazard rates of death were calculated following UGIE, MI and CVA adjusting for demographics, co-morbidity, prescription channeling, geographic location and pharmacological covariates. Results Among 474 495 patients [97.8% male; 85.3% white; 73.9 years (s.d. 5.6)], death followed at a rate of 5.5 per 1000 person-years (95% CI: 5.4‐5.6) post-UGIE, 17.7 per 1000 person-years (95% CI: 17.5‐17.9) post-MI and 21.8 per 1000 person-years (95% CI: 21.6‐22.0) post-CVA. CVA was associated with greatest risk of death [hazard ratio (HR) 12.4; 95% CI: 10.9‐14.3] followed by MI (HR 10.7; 95% CI: 9.2‐11.6) and UGIE (HR 3.3; 95% CI: 2.8‐3.9). Predictors of mortality were advancing age and co-morbidity, increased use of coxibs and failure to ensure adequate gastroprotection.

Our aim was to quantify the effect of provider adherence on the risk of NSAID-related upper gastrointestinal events (UGIE).We identified from national pharmacy records veteransor = 65 yr prescribed an NSAID, a coxib, or salicylate (325 mg/day) at any Veterans Affairs (VA) facility (January 1, 2000 to December 31, 2002). Prescription fill data were linked in longitudinal fashion to VA inpatient, outpatient, and death files and merged with demographic, inpatient, outpatient, and provider data from Medicare. Each person-day of follow-up was assessed for exposure to NSAID alone, NSAID+proton pump inhibitor (PPI), coxib, or coxib+PPI. UGIE was defined using our published, validated algorithm. Unadjusted incidence density ratios were calculated for the 365 days following exposure. We assessed risk of UGIE using Cox proportional hazards models, while adjusting for demographics, UGIE risk factors, comorbidity, prescription channeling (i.e., propensity score), geographic location, and multiple time-dependent pharmacological covariates, including aspirin, steroids, anticoagulants, antiplatelets, statins, and selective serotonin reuptake inhibitors.In our cohort of 481,980 (97.8% male, 85.3% white, mean age 73.9, standard deviation 5.6), a safer strategy was prescribed for 19.8%, and 2,753 UGIE occurred in 220,662 person-years of follow-up. When adjusted for prescription channeling, confounders, and effect modification-associated PPI, risk of UGIE was 1.8 (95% confidence interval [CI] 1.6-2.0) on NSAID alone, 1.8 (95% CI 1.5-2.0) on coxib alone, 1.1 (95% CI 0.7-4.6) on NSAID+PPI, and 1.1 (0.6-5.2) on coxib+PPI. When the analysis was adjusted for cumulative percent time spent on a PPI, risk of UGIE decreased from HR 3.0 (95% CI 2.6-3.7) when a PPI was prescribed 0-20% of the time to 1.1 (95% CI 1.0-1.3) when a PPI was prescribed 80-100% of the time.Provider adherence to safer NSAID prescribing strategies is associated with fewer UGIE among the elderly. An adherent strategy lowers, but does not eliminate, risk of an NSAID-related UGIE.

Background. Patients with human immunodeficiency virus (HIV) infection need lifelong medical care, but many do not remain in care. The effect of poor retention in care on survival is not known, and we sought to quantify that relationship.Methods. We conducted a retrospective cohort study involving persons newly identified as having HIV infection during 1997–1998 at any United States Department of Veterans Affairs hospital or clinic who started antiretroviral therapy after 1 January 1997. To be included in the study, patients had to have seen a clinician at least once after receiving their first antiretroviral prescription and to have survived for at least 1 year. Patients were divided into 4 groups on the basis of the number of quarters in that year during which they had at least 1 HIV primary care visit. Survival was measured through 2002. Because data were available for only a small number of women, female patients were excluded from the study.Results. A total of 2619 men were followed up for a mean of >4 years each. The median baseline CD4 + cell count and median log 10 plasma HIV concentration were 228 × 10 6 cells/L and 4.58 copies/mL, respectively. Thirty-six percent of the patients had visits in

SUMMARY Aim To assess degree of cyclooxygenase-2 (COX-2) selectivity of a non-steroidal anti-inflammatory drug (NSAID) and risk of myocardial infarction (MI) or cerebrovascular accident (CVA). Methods Prescription fill data were linked to medical records of a merged VA-Medicare dataset. NSAIDs were categorized by Cox-2 selectivity. Incidence of CVA and MI within 180 days of index prescription was assessed using Cox-proportional hazards models adjusted for gender, race, cardiovascular and pharmacological risk factors and propensity for prescription of highly COX-2 selective NSAIDs. Results Of 384 322 patients (97.5% men and 85.4% white), 79.4% were prescribed a poorly selective, 16.4% a moderately selective and 4.2% a highly selective NSAID. There were 985 incident cases of MI and 586 cases of CVA in >145 870 person-years. Highly selective agents had the highest rate of MI (12.3 per 1000 person-years; [95% CI: 12.2–12.3]) and CVA (8.1 per 1000 person-years; [95% CI: 8.0–8.2]). Periods without NSAID exposure were associated with lowest risk. In adjusted models, highly selective COX-2 selective NSAIDs were associated with a 61% increase in CVA and a 47% increase in MI, when compared with poorly selective NSAIDs. Conclusions The risk of MI and CVA increases with any NSAID. Highly COX-2 selective NSAIDs confer the greatest risk.

We sought to operationalize, test, and validate an outpatient pharmacy-based case-mix adjuster.Outpatients from the Department of Veterans Affairs (VA) prescribed a nonsteroidal anti-inflammatory drug (NSAID) or cyclooxygenase-2 selective drug during 2002 were identified. We updated and extended the Rx-Risk-V by adding 26 additional disease categories and mapping them to VA drug-class codes; derived empirical weights for each from a logistic model of 1-year mortality; adjusted for age, race and sex; and scored the weights into 1 measure of comorbidity. We compared the weighted score to the Deyo diagnosis-based comorbidity index and validated it in a national cohort of 260,321 outpatients with chronic heart failure (CHF).One-year mortality among the 724,270-outpatient NSAID cohort was 1.6% (n = 11,766). Using a baseline model of age, race, and gender (c-index = 0.716), we found that the Deyo measure improved the prediction of mortality (c-index = 0.765), and the pharmacy comorbidity score further improved the prediction (c-index = 0.782), an increase of 25.8%. Using both, we found further improvement (c-index = 0.792). Among the CHF cohort, 9.7% (n = 25,251) died within 1 year. Performance of the baseline model controlling for age, race, and gender (c index = 0.620) improved with addition of the pharmacy comorbidity score (c index = 0.689), compared with the addition of the Deyo measure (c index = 0.651), an increase of 55.1%. Together, they slightly improved prediction in CHF patients (c index = 0.695).The updated and extended Rx-Risk-V is useful for case-mix adjustment of mortality in an outpatient population.

To measure the success with which patients newly entering outpatient care establish regular care, and assess whether race/ethnicity was a predictive factor, we conducted a medical record review of new patients seen 20 April 1998 to 31 December 1998 at The Thomas Street Clinic, a county clinic for uninsured persons. Patients were considered 'not established' if they never saw a physician in the 6 months after intake (the 'initial period'), 'poorly established' if seen but a6-month gap in care began in the initial period, and 'established' if there were no such gaps. Of 404 patients, 11% were 'not established', 37% 'poorly established', and 53% 'established'. Injection drug use as HIV risk factor (IDU), admitted current alcohol and drug use, age35 years, and CD4 countor = 200 cells/mm(3) were most common in the 'not established' group and least common in the 'established' group. In multivariate ordinal logistic regression, difficulty establishing care was associated with IDU, admitted current alcohol use, and admitted former drug use. Age35 years was protective. Half the indigent patients entering care in this single-site study fail to establish regular care. Substance use and younger age are predictors of failure to establish care.

Objective Geographic and racial disparities may contribute to variation in the incidence and outcomes of HIV-associated cancers in the United States. Method Using the Surveillance, Epidemiology, and End Results (SEER) database, we analyzed Kaposi sarcoma (KS) incidence and survival by race and geographic region during the combined antiretroviral therapy era. Reported cases of KS in men from 2000 to 2013 were obtained from 17 SEER cancer registries. Overall and age-standardized KS incidence rates were calculated and stratified by race and geographic region. We evaluated incidence trends using joinpoint analyses and calculated adjusted hazard ratios (aHR) for overall and KS-specific mortality using multivariable Cox proportional hazards models. Results Of 4,455 KS cases identified in men younger than 55 years (median age 40 years), the annual percent change (APC) for KS incidence significantly decreased for white men between 2001 and 2013 (APC -4.52, p = 0.02). The APC for AA men demonstrated a non-significant decrease from 2000–2013 (APC -1.84, p = 0.09). Among AA men in the South, however, APC has significantly increased between 2000 and 2013 (+3.0, p = 0.03). In addition, compared with white men diagnosed with KS during the same time period, AA men were also more likely to die from all causes and KS cancer-specific causes (aHR 1.52, 95% CI 1.34–1.72, aHR 1.49, 95% CI 1.30–1.72 respectively). Conclusion Although overall KS incidence has decreased in the U.S., geographic and racial disparities in KS incidence and survival exist.

Background— Complex antithrombotic therapy (CAT) prescribed to elderly patients increases the risk of gastrointestinal bleeding. We quantified upper (UGIE) and lower gastrointestinal (LGIE) events, transfusions, and hospitalizations in a national cohort of elderly veterans prescribed CAT. Methods and Results— Veterans ≥60 years of age prescribed anticoagulant-antiplatelet, aspirin (ASA)-antiplatelet, ASA-anticoagulant, or triple therapy (ie, TRIP, anticoagulant-antiplatelet-ASA) were identified from the national pharmacy database (October 1, 2002 to September 30, 2008). Prescription-fill data were linked to Veteran Affairs and Medicare encounter files, each person-day of follow-up was assessed for CAT exposure, and outcomes were defined by using diagnostic code algorithms derived following chart abstraction. Incidence density ratios (compared with the reference category of no CAT) and survival analysis was conducted. Among 78 133 veterans (98.6% white; mean age, 72.3 [standard deviation 7.7]), 64% were prescribed ASA-antiplatelet and anticoagulant-antiplatelet and 6% were prescribed TRIP. The incidence of UGIE was 20.1/1000 patient-years, and the incidence of LGIE was 70.1/1000 patient-years. ASA-anticoagulant and TRIP were associated with the highest incidence of transfusion and hospitalization. A 40% to 60% increased risk of UGIE was observed with all strategies. LGIE was 30% higher with anticoagulant-antiplatelet, and transfusion increased with ASA-anticoagulant (hazard ratio, 6.1; 95% confidence interval, 5.2–7.1) and TRIP (hazard ratio, 5.0; 95% confidence interval, 4.2–5.8). Increased risk of hospitalization was noted with all strategies. The number needed to harm for UGIE or LGIE ranged from 52 to 65 and 15 to 23, respectively. The number needed to harm for hospitalization was 39 (anticoagulant-antiplatelet), 34 (ASA-anticoagulant), 67 (ASA-antiplatelet), and 45 (TRIP) patients. Conclusions— Among elderly patients, CAT-related LGIE and UGIE are clinically relevant risks resulting in increased hospitalizations and transfusions.

BACKGROUND Recent studies have shown that the incidence of squamous cell cancer of the anus (SCCA) has increased in the combined antiretroviral therapy (cART) era. The effect of undetectable HIV viral loads as a result of successful cART has not been evaluated. METHODS We performed a retrospective cohort study among male US veterans diagnosed with HIV and followed between 1985 and 2009 using the Veterans Affairs Immunologic Case Registry (VA-ICR). We calculated age-adjusted incidence rates and rate ratios for SCCA. We conducted Cox proportional hazards ratios of SCCA in a multivariable model including time-varying covariates of nadir CD4 count and overall percentage of time with an undetectable HIV viral load. RESULTS The age-adjusted SCCA incidence rate among the group who ever received cART was 146.8/100,000 person-years (95% confidence interval, 124.1 to 172.6) and was not significantly higher than the SCCA rate of those who never received cART (134.3/100,000 person-years; 95% confidence interval, 112.5 to 159.0). In a multivariable model limited to veterans who had ever received cART (adjusted for demographic variables, nadir, and most recent CD4 counts) individuals who had 61%-80% or 81%-100% of follow-up time with undetectable HIV viral loads had significantly decreased SCCA risk compared with those who had undetectable HIV viral loads

Social support predicts adherence to antiretroviral therapy (ART) in some settings but has not been well studied in persons newly diagnosed with HIV infection as a predictor of success through the cascade of HIV care. One hundred sixty-eight persons newly diagnosed with HIV completed the Medical Outcomes Study Social Support Survey at diagnosis, and 129 were successfully followed for more than 12 months. Outcomes were earlier diagnosis of HIV infection, linkage to care, retention in care, ART use by 1 year, and adherence to ART. Higher social support scores (either overall or on a subscale) were associated with earlier HIV diagnosis, timely linkage to care, and adherence to ART. Social support did not predict use of ART or retention in HIV care. Success navigating some of the steps of HIV care is more likely with social support, but it is not sufficient to ensure success across the continuum of care.

Objective Little is known about the treatment outcomes of undocumented Hispanic immigrants with HIV infection. We sought to compare the treatment outcomes of undocumented and documented patients 12-months after entering HIV care. Methods We conducted a retrospective cohort study of antiretroviral-naive patients 18 years and older attending their first visit at Thomas Street Health Center in Houston, Texas, between 1/1/2003 and 6/30/2008. The study population of 1,620 HIV-infected adults included 186 undocumented Hispanic, 278 documented Hispanic, 986 Black, and 170 White patients. The main outcome measures were retention in care (quarter years with at least one completed HIV primary care provider visit) and HIV suppression (HIV RNA

e18072Background: With advances in combined antiretroviral therapy (ART), Kaposi’s sarcoma (KS) incidence has decreased over the past decade. Geographical and racial disparities may contribute to v...

There has been little research on the causes of hospitalization when patients are first diagnosed with HIV in the hospital. Reduced access to care could partially explain inpatient diagnosis. We sought to determine if the patients diagnosed as inpatients are hospitalized due to a HIV-related cause versus some other causes, to compare access to care of patients diagnosed with HIV in hospital and outpatient settings, and to determine factors associated with access to care. Participants were newly diagnosed with HIV and recruited between January 2006 and August 2007. The reason for hospitalization was classified as HIV-related, other infectious cause, noninfectious cause, or miscellaneous cause. Access to care was self-reported using a six-item scale and scores were compared with the t test. Multivariate linear regression determined factors associated with improved access to care. Of 185 participants in the study, 78 were diagnosed in hospital and 107 in outpatient settings. Thirty-two percent of participants were female, 90% were racial/ethnic minority, 45% had no high school diploma, and 85% were uninsured. HIV-related conditions accounted for 60% of admissions, followed by non-infectious causes (20%) and other infectious causes (17%). Inpatients did not report less access to care than patients diagnosed while outpatients. Multivariate analysis demonstrated improvement in access to care with better health insurance (p = 0.01) and greater education (p = 0.08). HIV-related preventable conditions account for many hospitalizations when patients are first diagnosed with HIV. While socioeconomic factors are associated with perceived access to care, persons diagnosed in the inpatient setting do not report lower perceived access to care than persons diagnosed as outpatients, suggesting other barriers to earlier diagnosis.

Protease inhibitors (PIs) have been shown to have anti-tumor activity in addition to their antiretroviral properties. We sought to assess the association between PI use and the incidence of squamous cell carcinoma of the anus (SCCA) in HIV-infected individuals. We performed a retrospective cohort study among male US veterans diagnosed with HIV who were diagnosed between 1985 and 2010, using the Veterans Affairs HIV Clinical Case Registry (CCR). We calculated hazards ratios associated with PI use (both as percent time on PI and as 12-month intervals of PI use), utilizing time-dependent Cox models. We adjusted for risk factors, including age, race, year of enrolment into CCR, recent and nadir CD4, and percent time undetectable HIV viral load. A total of 28, 886 HIV-infected men met inclusion criteria. Of these, 373 were newly diagnosed with SCCA during the study period. In multivariate analysis, increasing percent time on PIs was associated with an increased risk of SCCA (aHR 1.07; 95% CI = 1.03–1.10 per 10% increase in time on PI). Poor immunologic recovery and virologic control, a history of condylomata acuminata, and CCR enrolment in the late combined antiretroviral therapy era were also associated with increased SCCA risk. Increasing percent time on a PI-based combined antiretroviral therapy regimen may be associated with an increased risk of developing SCCA in HIV-infected male US veterans. Future studies, better accounting for HIV control and treatment compliance, are necessary to further clarify this association.

Background & Aims Despite prescription of gastroprotection among elderly nonsteroidal anti-inflammatory drug (NSAID) users, residual bleeding can still occur. We sought to determine the effect of proton pump inhibitors (PPI) on hospitalization and resource use among veterans in whom an upper gastrointestinal event (UGIE) occurred. Methods We identified from national pharmacy records veterans ≥65 years prescribed an NSAID, cyclooxygenase-2 selective NSAID (coxib), or salicylate (>325 mg/day) at any Veterans Affairs (VA) facility (01/01/00–12/31/04). Prescription fill data were linked longitudinally to a Veterans Affairs-Medicare dataset of inpatient, outpatient, and death files, and demographic and provider data. Among veterans in whom a UGIE occurred, we assessed the effect of prescription strategy on hospitalization, using a multivariate logistic regression model. Results A total of 3566 UGIEs occurred among a cohort that was predominantly male (97.5%), white (77%), with a mean age of 73.5 (SD, 5.7). Hospitalization occurred in 47.5%, and gastroprotection was associated with a 30% reduction in hospitalization compared with no PPI. Five-year pharmacy costs associated with the PPI strategy exceeded the no-PPI strategy ($742,406 vs $184,282); however, a substantial reduction in medical costs was observed with PPI ($9,948,738 vs $18,686,081). Conclusions Even if an NSAID-UGIE occurs in the PPI-protected older veteran, the reduction in need for hospitalization results in a cost saving to the Department of Veterans Affairs.

Neena S Abraham,1,2 Aanand D Naik,3,4 Richard L Street Jr,3–5 Diana L Castillo,3 Anita Deswal,6 Peter A Richardson,3,4 Christine M Hartman,3 George Shelton Jr,3,4 Liana Fraenkel7,8 1Division of Gastroenterology, Mayo Clinic, Scottsdale, AZ, USA; 2Divison of Healthcare Policy and Research, Department of Health Services Research, Rochester, MN, USA; 3Center for Innovations in Quality, Effectiveness, and Safety at the Michael E DeBakey VA Medical Center, Houston, TX, USA; 4Department of Medicine, Baylor College of Medicine, Houston, TX, USA; 5Department of Communication, Texas A&M University, College Station, TX, USA; 6Cardiology, Michael E DeBakey VAMC, Houston, TX, USA; 7Veterans Affairs Connecticut Healthcare System, West Haven, CT, USA; 8Department of Medicine, Yale University, New Haven, CT, USA Purpose: For years, older patients have been prescribed multiple blood-thinning medications (complex antithrombotic therapy [CAT]) to decrease their risk of cardiovascular events. These therapies, however, increase risk of adverse bleeding events. We assessed patient-reported trade-offs between cardioprotective benefit, gastrointestinal bleeding risk, and burden of self-management using adaptive conjoint analysis (ACA). As ACA could be a clinically useful tool to obtain patient preferences and guide future patient-centered care, we examined the clinical application of ACA to obtain patient preferences and the impact of ACA on medication adherence.Patients and methods: An electronic ACA survey led 201 respondents through medication risk–benefit trade-offs, revealing patients’ preferences for the CAT risk/benefit profile they valued most. The post-ACA prescription regimen was categorized as concordant or discordant with elicited preferences. Adherence was measured using VA pharmacy refill data to measure persistence of use prior to and 1 year following preference-elicitation. Additionally, we analyzed qualitative interviews of 56 respondents regarding their perception of the ACA and the preference elicitation experience.Results: Participants prioritized 5-year cardiovascular benefit over preventing adverse events. Medication side effects, medication-associated activity restrictions, and regimen complexity were less important than bleeding risk and cardioprotective benefit. One year after the ACA survey, a 15% increase in adherence was observed in patients prescribed a preference-concordant CAT strategy. An increase of only 6% was noted in patients prescribed a preference-discordant strategy. Qualitative interviews showed that the ACA exercise contributed to increase inpatient activation, patient awareness of preferences, and patient engagement with clinicians abouttreatment decisions.Conclusion: By working through trade-offs, patients actively clarified their preferences, learning about CAT risks, benefits, and self-management. Patients with medication regimens concordant with their preferences had increased medication adherence at 1 year compared to those with discordant medication regimens. The ACA task improved adherence through enhanced patient engagement regarding treatment preferences. Keywords: patient preference, patient activation, medication adherence, risk–benefit communication, cardiovascular medications, gastrointestinal bleeding

Disparities in survival for black patients with HIV in the United States have been reported. The VA is an equal access health care system.To determine whether such disparities are present in the VA health care system.Retrospective cohort study using national VA administrative databases.Two thousand three hundred and four white and 3,641 black HIV-infected patients first hospitalized for HIV between October 1, 1996 and September 30, 2000.Thirty-day mortality after first hospitalization with HIV, and subsequent long-term survival. Follow-up ended at death or September 30, 2002. Data were adjusted for age, sex, HIV disease severity, non-HIV-related comorbidities, primary discharge diagnosis, hepatitis C status, and facility effects.The mean follow-up was 3.2 years. Overall survival was similar for black patients compared with white patients (adjusted hazard ratio 1.09, P=.09). Hospital mortality was 7.0% for black and 6.4% for white patients (P=.35). Adjusted hospital mortality for black patients was similar to that of white patients (odds ratio 1.20, P=.10). Long-term survival after hospitalization did not significantly differ by race (adjusted hazard ratio 1.07, P=.21, for black patients compared with white patients).Survival during and after first hospitalization with HIV in the VA did not significantly differ for white and black patients, possibly indicating similar effectiveness of care for HIV. Further research is needed to understand the reasons for the lack of disparities for VA patients with HIV and whether the VA's results could be replicated.

Background & Aims: Our objective was to assess adherence to evidence-based guidelines by providers of the Department of Veterans Affairs nationwide. Methods: This was a cross-sectional study among veterans prescribed a nonsteroidal anti-inflammatory drug (NSAID) from January 1, 2002, to December 31, 2002. Prescription data were linked to inpatient and outpatient medical records and death files. The population was characterized as high risk based on the following: age 65 years or older, concurrent corticosteroid or anticoagulant use, history of peptic ulcer, and high average daily dose of NSAIDs. Adherence was defined as the prescription of a traditional NSAID with gastroprotection or a coxib in high-risk NSAID users. Univariate and multivariate analyses assessed the potential predictors of adherence. Results: Three hundred three thousand seven hundred eighty-seven met our definition of high risk. Most (97.3%) were male; 55.6% were white, 9.6% black, and 34.8% of other/unknown race. Age 65 years or older was the largest high-risk subset (87.1%). Overall, only 27.2% of high-risk veterans (n = 82,766) were prescribed an adherent strategy. Among veterans with at least 2 risk factors, adherence was 39.7%; among those with 3 risk factors, adherence was 41.8%. Predictors of adherence included history of upper gastrointestinal events, anticoagulant use, rheumatologic disease, high Deyo comorbidity index score, use of low-dose salicylates, and concurrent corticosteroid use. Predictors of nonadherence included prescriptions ≥90 days and high average daily dose of NSAIDs. Conclusions: Adherence to evidence-based guidelines for safe prescription of NSAIDs in the Department of Veterans Affairs is low (27.2%). The likelihood of adherence is further decreased if veterans are prescribed NSAIDs for ≥90 days.