ACCOUNTING FOR DEPENDENT ERRORS IN PREDICTORS AND TIME-TO-EVENT OUTCOMES USING ELECTRONIC HEALTH RECORDS, VALIDATION SAMPLES, AND MULTIPLE IMPUTATION.

Data from electronic health records (EHR) are prone to errors, which are often correlated across multiple variables. The error structure is further complicated when analysis variables are derived as functions of two or more error-prone variables. Such errors can substantially impact estimates, yet we are unaware of methods that simultaneously account for errors in covariates and time-to-event outcomes. Using EHR data from 4217 patients, the hazard ratio for an AIDS-defining event associated with a 100 cell/mm3 increase in CD4 count at ART initiation was 0.74 (95%CI: 0.68-0.80) using unvalidated data and 0.60 (95%CI: 0.53-0.68) using fully validated data. Our goal is to obtain unbiased and efficient estimates after validating a random subset of records. We propose fitting discrete failure time models to the validated subsample and then multiply imputing values for unvalidated records. We demonstrate how this approach simultaneously addresses dependent errors in predictors, time-to-event outcomes, and inclusion criteria. Using the fully validated dataset as a gold standard, we compare the mean squared error of our estimates with those from the unvalidated dataset and the corresponding subsample-only dataset for various subsample sizes. By incorporating reasonably sized validated subsamples and appropriate imputation models, our approach had improved estimation over both the naive analysis and the analysis using only the validation subsample.

Self-reported Cannabis Use and Changes in Body Mass Index, CD4 T-Cell Counts, and HIV-1 RNA Suppression in Treated Persons with HIV.

Cannabis use is prevalent among HIV-positive persons, but evidence regarding the impact of cannabis in HIV-positive persons is limited. We conducted a retrospective cohort study of HIV-positive adults initiating their first antiretroviral therapy (ART) regimen. A dedicated intake form assessed self-reported cannabis use in the preceding 7 days at each visit. The relationships between time-varying cannabis use and body mass index (BMI), CD4+ T-cell count, and HIV-1 RNA levels were assessed using random effects models adjusted for age, sex, race, and other reported substance use. 4290 patient-visits from 2008 to 2011 were available from 1010 patients. Overall, there were no statistically significant differences in CD4+ T-cell count and BMI across multiple adjusted models using different measures of cannabis use (ever use during the study period, any use, and number of times used in the preceding 7 days). Cannabis use by all three measures was associated with greater odds of having a detectable viral load at a given visit than no reported use (OR 2.02, 1.72, and 1.08, respectively; all adjusted p < 0.05). Self-reported cannabis use was not associated with changes in BMI or CD4+ T-cell count in ART-naïve HIV-positive persons starting treatment. However, reported cannabis use by multiple categories was associated with having a detectable HIV-1 RNA during the study period. Associations between cannabis use, adherence, and HIV-related outcomes merit further study.

Substance Use, Demographic and Socioeconomic Factors Are Independently Associated With Postpartum HIV Care Engagement in the Southern United States, 1999-2016.

BACKGROUND: Retention in care (RIC) and viral suppression (VS) are associated with reduced HIV transmission and mortality. Studies addressing postpartum engagement in HIV care have been limited by small sample size, short follow-up, and a lack of data from the Southeast United States. METHODS: HIV-positive adult women with ≥1 prenatal visit at the Vanderbilt Obstetrics Comprehensive Care Clinic from 1999 to 2015 were included. Poor RIC was defined as not having ≥2 encounters per year, ≥90 days apart; poor VS was a viral load >200 copies/mL. Modified Poisson regression was used to estimate adjusted relative risks (aRRs) of poor postpartum RIC and VS. RESULTS: Among 248 women over 2070 person-years of follow-up, 37.6% person-years had poor RIC and 50.4% lacked VS. Prenatal substance use was independently associated with poor RIC (aRR, 1.40; 95% confidence interval [CI], 1.08-1.80) and poor VS (aRR, 1.20; 95% CI, 1.04-1.38), and lack of VS at enrollment was associated with poor RIC (aRR, 1.64; 95% CI, 1.15-2.35) and poor VS (aRR, 1.59; 95% CI, 1.30-1.94). Hispanic women were less likely and women with lower educational attainment were more likely to have poor RIC. Women >30 years of age and married women were less likely to have poor VS. CONCLUSIONS: In this population of women in prenatal care at an HIV primary medical home in Tennessee, women with prenatal substance use and a lack of VS at enrollment into prenatal care were at greater risk of poor RIC and lack of VS postpartum. Interventions aimed at improving postpartum engagement in HIV care among these high-risk groups are needed.

The relationship between adverse neighborhood socioeconomic context and HIV continuum of care outcomes in a diverse HIV clinic cohort in the Southern United States.

Retention in care and viral suppression are critical to delaying HIV progression and reducing transmission. Neighborhood socioeconomic context (NSEC) may affect HIV care receipt. We therefore assessed NSEC's impact on retention and viral suppression in a diverse HIV clinical cohort. HIV-positive adults with ≥1 visit at the Vanderbilt Comprehensive Care Clinic and 5-digit ZIP code tabulation area (ZCTA) information between 2008 and 2012 contributed. NSEC z-score indices used neighborhood-level socioeconomic indicators for poverty, education, labor-force participation, proportion of males, median age, and proportion of residents of black race by ZCTA. Retention was defined as ≥2 HIV care visits per calendar year, >90 days apart. Viral suppression was defined as an HIV-1 RNA <200 copies/mL at last measurement per calendar year. Modified Poisson regression was used to estimate risk ratios (RR) and 95% confidence intervals (CI). Among 2272 and 2541 adults included for retention and viral suppression analyses, respectively, median age and CD4 count at enrollment were approximately 38 (1st and 3rd quartile: 30, 44) years and 351 (176, 540) cells/µL, respectively, while 24% were female, and 39% were black. Across 243 ZCTAs, median NSEC z-score was 0.09 (-0.66, 0.48). Overall, 79% of person-time contributed was retained and 74% was virally suppressed. In adjusted models, NSEC was not associated with retention, though being in the 4th vs. 1st NSEC quartile was associated with lack of viral suppression (RR = 0.88; 95% CI: 0.80-0.97). Residing in the most adverse NSEC was associated with lack of viral suppression. Future studies are needed to confirm this finding.

Health Literacy and Demographic Disparities in HIV Care Continuum Outcomes.

Studies evaluating the association between human immunodeficiency virus (HIV) infection continuum of care outcomes [antiretroviral (ART) adherence, retention in care, viral suppression] and health literacy have yielded conflicting results. Moreover, studies from the southern United States, a region of the country disproportionately affected by the HIV epidemic and low health literacy, are lacking. We conducted an observational cohort study among 575 people living with HIV (PLWH) at the Vanderbilt Comprehensive Care Clinic (Nashville, Tennessee). Health literacy was measured using the brief health literacy screen, a short tool which can be administered verbally by trained clinical personnel. Low health literacy was associated with a lack of viral suppression, but not with poor ART adherence or poor retention. Age and racial disparities in continuum of care outcomes persisted after accounting for health literacy, suggesting that factors in addition to health literacy must be addressed in order to improve outcomes for PLWH.

Brief Report: Weight Gain in Persons With HIV Switched From Efavirenz-Based to Integrase Strand Transfer Inhibitor-Based Regimens.

BACKGROUND: With the introduction of integrase strand transfer inhibitor (INSTI)-based antiretroviral therapy, persons living with HIV have a potent new treatment option. Recently, providers at our large treatment clinic noted weight gain in several patients who switched from efavirenz/tenofovir disoproxil fumarate/emtricitabine (EFV/TDF/FTC) to dolutegravir/abacavir/lamivudine (DTG/ABC/3TC). In this study, we evaluated weight change in patients with sustained virologic suppression who switched from EFV/TDF/FTC to an INSTI-containing regimen. METHODS: We performed a retrospective observational cohort study among adults on EFV/TDF/FTC for at least 2 years who had virologic suppression. We assessed weight change over 18 months in patients who switched from EFV/TDF/FTC to an INSTI-containing regimen or a protease inhibitor (PI)-containing regimen versus those on EFV/TDF/FTC over the same period. In a subgroup analysis, we compared patients switched to DTG/ABC/3TC versus raltegravir- or elvitegravir-containing regimens. RESULTS: A total of 495 patients were included: 136 who switched from EFV/TDF/FTC to an INSTI-containing regimen and 34 switched to a PI-containing regimen. Patients switched to an INSTI-containing regimen gained an average of 2.9 kg at 18 months compared with 0.9 kg among those continued on EFV/TDF/FTC (P = 0.003), whereas those switched to a PI regimen gained 0.7 kg (P = 0.81). Among INSTI regimens, those switched to DTG/ABC/3TC gained the most weight at 18 months (5.3 kg, P = 0.001 compared with EFV/TDF/FTC). CONCLUSION: Adults living with HIV with viral suppression gained significantly more weight after switching from daily, fixed-dose EFV/TDF/FTC to an INSTI-based regimen compared with those remaining on EFV/TDF/FTC. This weight gain was greatest among patients switching to DTG/ABC/3TC.

Trends in HIV Continuum of Care Outcomes over Ten Years of Follow-Up at a Large HIV Primary Medical Home in the Southeastern United States.

Longitudinal studies of retention in care (RIC) and viral suppression (VS) in the southeastern United States (US), a region disproportionately affected by HIV infection, are lacking. HIV-infected adults with ≥1 medical visit at the Vanderbilt Comprehensive Care Clinic (Nashville, Tennessee) from 2004 to 2013 were included. RIC was ≥2 (a) laboratory dates [CD4+ counts or HIV-1 viral loads (VLs)] or (b) provider encounters and/or laboratory dates in the year of interest, ≥90 days apart. VS was a VL of <200 copies/ml at last measurement in the year of interest. Modified Poisson regression estimated relative risk (RR) of RIC and VS, adjusting for age, race, sex, HIV transmission risk, and socioeconomic status (SES). Among 4,641 persons, 76.8% achieved RIC and 70.2% achieved VS. RIC and VS increased from 2004 to 2013 (p < .001 each). For lack of RIC, younger patients (RR = 1.2 and RR = 1.1, 18-24 and 25-34 vs. 35-44 year-olds, respectively), Blacks (RR = 1.3 vs. Whites), and injection drug users (IDUs) (RR = 1.2 vs. heterosexual contact [Hetero]) fared worse (p < .05 each); those with male-to-male sexual contact fared better (RR = 0.8 vs. Hetero, p < .05). For lack of VS, younger patients (RR = 1.3 and RR = 1.2, 18-24 and 25-34 vs. 35-44 year olds, respectively), Blacks (RR 1.3 vs. Whites), Females (RR = 1.1 vs. Males), IDUs (RR 1.3 vs. Hetero), and those with low SES (RR = 1.1 vs. not low SES) fared worse (p < .05, each). RIC and VS increased over time, suggesting that efforts to improve outcomes have been effective. However, disparities persist and resources should focus on groups most at risk.

Daily Marijuana Use is Associated with Missed Clinic Appointments Among HIV-Infected Persons Engaged in HIV Care.

We assessed the association between marijuana use and retention in HIV care through a retrospective cohort study of patients engaged in care at a large HIV clinic in 2011 and 2012. Two different retention outcomes were assessed: not meeting the Institute of Medicine's (IOM) retention definition (≥2 provider visits ≥90 days apart in a calendar year) and no-show visits. Any marijuana use and frequency of marijuana use were obtained from a substance use screening questionnaire administered at each clinic visit. Modified Poisson regression was used to estimate risk ratios and 95% confidence intervals for the association between marijuana use and retention outcomes. Marijuana use was reported by 17% of 1791 patients and 21% were not retained (IOM definition). Marijuana use was not associated with the IOM retention outcome, but was associated with missing the next scheduled appointment. A non-linear dose-response was observed for frequency of marijuana use and missed visits, with daily users having the highest risk compared to non-users. Daily marijuana use had a negative impact on HIV clinic attendance. Further research is needed to elucidate the mechanisms by which marijuana use affects this outcome to inform targeted interventions.

CD4+/CD8+ ratio, age, and risk of serious noncommunicable diseases in HIV-infected adults on antiretroviral therapy.

OBJECTIVE: In virologically suppressed HIV-infected adults, noncommunicable diseases (NCDs) have been associated with immune senescence and low CD4/CD8 lymphocyte ratio. Age differences in the relationship between CD4/CD8 ratio and NCDs have not been described. DESIGN: Observational cohort study. METHODS: We assessed CD4/CD8 ratio and incident NCDs (cardiovascular, cancer, liver, and renal diseases) in HIV-infected adults started on antiretroviral therapy between 1998 and 2012. Study inclusion began once patients maintained virologic suppression for 12 months (defined as baseline). We examined age and baseline CD4/CD8 ratio and used Cox proportional hazard models to assess baseline CD4/CD8 ratio and NCDs. RESULTS: This study included 2006 patients. Low baseline CD4/CD8 ratio was associated with older age, male sex, and low CD4 lymphocyte counts. In models adjusting for CD4 lymphocyte count, CD4/CD8 ratio was inversely associated with age (P < 0.01). Among all patients, 182 had incident NCDs, including 46 with coronary artery disease (CAD) events. CD4/CD8 ratio was inversely associated with risk of CAD events [adjusted HR per 0.1 increase in CD4/CD8 ratio = 0.87, 95% confidence interval (CI): 0.76-0.99, P = 0.03]. This association was driven by those under age 50 years (adjusted HR 0.83 [0.70-0.97], P = 0.02) vs. those over age 50 years (adjusted HR = 0.96 [0.79-1.18], P = 0.71). CD4/CD8 ratio was not significantly associated with incident noncardiac NCDs. CONCLUSIONS: Higher CD4/CD8 ratio after 1 year of HIV virologic suppression was independently predictive of decreased CAD risk, particularly among younger adults. Advanced immune senescence may contribute to CAD events in younger HIV patients on antiretroviral therapy.

Hormonal Contraception and Risk of Psychiatric and Other Noncommunicable Diseases in HIV-Infected Women.

BACKGROUND: Hormonal contraception use is common among human immunodeficiency virus (HIV)-infected women. Risk of psychiatric and other noninfectious complications of hormonal contraception use has not been described in this population. METHODS: We performed a retrospective cohort study of HIV-infected women receiving care in Tennessee from 1998 to 2008 to examine the risks of incident psychiatric and other noncommunicable diseases (NCDs), including cardiovascular, hepatic, renal, and malignant diseases, and hormonal contraception use, including depot medroxyprogesterone acetate (DMPA) and combined estrogen- and progestin-containing hormonal contraceptives. We used marginal structural models with inverse probability weights to account for time-varying confounders associated with hormonal contraception use. RESULTS: Of the 392 women included, 94 (24%) used hormonal contraception during the study period. Baseline psychiatric disease was similar between women who received and did not receive hormonal contraception. There were 69 incident psychiatric diagnoses and 72 NCDs. Only time-varying DMPA use was associated with increased risk of psychiatric disease (adjusted odds ratio [aOR] 3.70; 95% confidence interval [95% CI] 1.32-10.4) and mood disorders, specifically (aOR 4.70 [1.87-11.8]). Time-varying and cumulative combined hormonal contraception use were not statistically associated with other NCDs (aOR 1.64, 95% CI 0.64-4.12 and aOR 1.16, 95% CI 0.86-1.56, respectively). However, risk of incident NCDs was increased with cumulative DMPA exposure (per year exposure aOR 1.45, 95% CI 1.01-2.08). CONCLUSIONS: Among HIV-infected women, DMPA was associated with risk of incident psychiatric diseases, particularly mood disorders, during periods of use. Cumulative DMPA exposure was also associated with risk of other NCDs. However, combined estrogen and progestin-containing hormonal contraception use was not statistically associated with risk of any NCDs.

HIV and cancer: a comparative retrospective study of Brazilian and U.S. clinical cohorts.

BACKGROUND: With successful antiretroviral therapy, non-communicable diseases, including malignancies, are increasingly contributing to morbidity and mortality among HIV-infected persons. The epidemiology of AIDS-defining cancers (ADCs) and non-AIDS-defining cancers (NADCs) in HIV-infected populations in Brazil has not been well described. It is not known if cancer trends in HIV-infected populations in Brazil are similar to those of other countries where antiretroviral therapy is also widely available. METHODS: We performed a retrospective analysis of clinical cohorts at Instituto Nacional de Infectologia Evandro Chagas (INI) in Rio de Janeiro and Vanderbilt Comprehensive Care Clinic (VCCC) in Nashville from 1998 to 2010. We used Poisson regression and standardized incidence ratios (SIRs) to examine incidence trends. Clinical and demographic predictors of ADCs and NADCs were examined using Cox proportional hazards models. RESULTS: This study included 2,925 patients at INI and 3,927 patients at VCCC. There were 57 ADCs at INI (65% Kaposi sarcoma), 47 at VCCC (40% Kaposi sarcoma), 45 NADCs at INI, and 82 at VCCC. From 1998 to 2004, incidence of ADCs remained statistically unchanged at both sites. From 2005 to 2010, ADC incidence decreased in both cohorts (INI incidence rate ratio per year = 0.74, p < 0.01; VCCC = 0.75, p < 0.01). Overall Kaposi sarcoma incidence was greater at INI than VCCC (3.0 vs. 1.2 cases per 1,000 person-years, p < 0.01). Incidence of NADCs remained constant throughout the study period (overall INI incidence 3.6 per 1,000 person-years and VCCC incidence 5.3 per 1,000 person-years). Compared to general populations, overall risk of NADCs was increased at both sites (INI SIR = 1.4 [95% CI 1.1-1.9] and VCCC SIR = 1.3 [1.0-1.7]). After non-melanoma skin cancers, the most frequent NADCs were anal cancer at INI (n = 7) and lung cancer at VCCC (n = 11). In multivariate models, risk of ADC was associated with male sex and immunosuppression. Risk of NADC was associated with increased age. CONCLUSIONS: In both cohorts, ADCs have decreased over time, though incidence of KS was higher at INI than VCCC. Rates of NADCs remained constant over time at both sites.

Current drug use and lack of HIV virologic suppression: point-of-care urine drug screen versus self-report.

BACKGROUND: There have been inconsistent findings on the association between current drug use and HIV disease progression and virologic suppression. Drug use was often measured using self-report of historical use. Objective measurement of current drug use is preferred. METHODS: In this cross-sectional study, we assessed drug use through Computer-Assisted Self Interviews (CASI) and point-of-care urine drug screen (UDS) among 225 HIV-infected patients, and evaluated the association between current drug use and virologic suppression. RESULTS: About half (54%) of participants had a positive UDS, with a lower self-reported rate by CASI (42%) (Kappa score = 0.59). By UDS, 36.0% were positive for marijuana, 25.8% for cocaine, 7.6% for opiates, and 2.2% for methamphetamine or amphetamine. Factors associated with virologic suppression (plasma HIV RNA <50 copies/mL) were Caucasian race (P = 0.03), higher CD4 count (P < 0.01), current use of antiretroviral therapy (ART) (P < 0.01), and a negative UDS (P < 0.01). Among 178 current ART users, a positive UDS remained significantly associated with lower likelihood of virologic suppression (P = 0.04). CONCLUSIONS: UDS had good agreement with CASI in detecting frequently used drugs such as marijuana and cocaine. UDS at routine clinic visits may provide "real-time" prognostic information to optimize management.

Circulating interleukin-6, soluble CD14, and other inflammation biomarker levels differ between obese and nonobese HIV-infected adults on antiretroviral therapy.

Obesity and chronic, treated HIV infection are both associated with persistent systemic inflammation and a similar constellation of metabolic and cardiovascular diseases, but the combined effects of excess adiposity and HIV on circulating proinflammatory cytokines and other biomarkers previously shown to predict disease risk is not well described. We measured inflammation biomarker levels in 158 predominantly virologically suppressed adults on long-term antiretroviral therapy (ART) with a range of body mass index (BMI) values from normal to morbidly obese. We assessed the relationship between BMI and each biomarker using multivariable linear regression adjusted for age, sex, race, CD4(+) count, tobacco use, data source, protease inhibitor use, and routine nonsteroidal antiinflammatory drug (NSAID) or aspirin use. Among normal-weight (n=48) and overweight participants (n=41; BMI <30 kg/m(2)), incremental BMI increases were associated with significantly higher serum highly sensitive C-reactive protein (hsCRP; ß=2.47, p=0.02) and tumor necrosis factor (TNF)-α receptor 1 levels (ß=1.53, p=0.03), and significantly lower CD14 levels (ß=0.84, p=0.01), but similar associations were not observed in the obese participants. Among the obese (n=69; BMI ≥30 kg/m(2)), however, higher serum levels of interleukin-6 (IL-6; ß=1.30, p=0.02) and macrophage inflammatory protein-1α (ß=1.77, p<0.01) were associated with higher BMI, a finding not observed among the nonobese. Among all participants, IL-6 and TNF-α receptor 1 levels were most closely associated with hsCRP (p<0.01). Further studies are needed to determine whether higher serum inflammation biomarker levels found in obese HIV-infected individuals on ART reflect an increased likelihood of adverse health outcomes, or if novel markers to estimate mortality and disease risk are needed in this population.

Estimating the optimal CD4 count for HIV-infected persons to start antiretroviral therapy.

BACKGROUND: Optimal timing of antiretroviral therapy in HIV-infected persons is unclear, although 2 recent large observational studies have improved our understanding of the best CD4 threshold for initiation. These studies compared the effect of starting HAART on mortality and mortality/AIDS between strata defined using broad ranges of CD4 counts. We sought to expand this understanding using a novel statistical approach proposed by Robins et al. METHODS: Using observational data from 1034 antiretroviral-naive HIV-infected patients from Nashville, Tennessee, we directly estimated the optimal CD4 count for initiation of HAART to maximize patient health 6, 12, 24, and 36 months after the first instance of CD4 falling below 750. We measured health using 2 outcome metrics, one based on CD4 counts at the end of follow-up and the other based on a published quality-of-life scale; both metrics incorporated death, AIDS-defining events, serious non-AIDS events, and CD4 at the end of follow-up, if asymptomatic. RESULTS: The CD4-based metric estimated that to maximize health 6, 12, 24, and 36 months after study entry, HAART should be initiated within 3 months of CD4 first dropping below 495 (95% confidence interval [CI] = 468-522), 554 (459-750), 489 (427-750), and 509 (460-750), respectively. The quality-of-life-based metric produced CD4 initiation threshold estimates of 337 (95% CI = 201-442), 354 (288-386), 358 (294-750), and 475 (287-750) for the same time points. CONCLUSIONS: Our results support early initiation of antiretroviral therapy, although the criterion for starting therapy depends on the choice of health outcome.

Postpartum discontinuation of antiretroviral therapy and risk of maternal AIDS-defining events, non-AIDS-defining events, and mortality among a cohort of HIV-1-infected women in the United States.

This retrospective cohort study of HIV-infected women receiving highly active antiretroviral therapy (HAART) while pregnant assessed the effect of postpartum HAART discontinuation on maternal AIDS-defining events (ADEs), non-AIDS-defining events (non-ADEs), and death 1997-2008 in Nashville, Tennessee. Cox proportional hazards models compared rates of ADE or all-cause death and non-ADE or all-cause death, and competing risks analyses compared rates of ADE or ADE-related death and non-ADE or non-ADE-related death across the groups. There were two groups: women who stopped HAART postpartum (discontinuation, n = 54) and women who continued HAART postpartum (continuation, n = 69). Fifty percent were African American, 40% had prior non-HAART antiretroviral therapy (ART) use, and 38% had a history of illicit drug use. Median age was 27.5 years, baseline CD4(%) was 532 (34%) and CD4 nadir was 332 cells/mm(3), baseline and peak HIV-1 RNA were 2.6 and 4.32 log(10) copies per milliliter, respectively. Women in the continuation group were older, had lower baseline CD4, CD4%, and CD4 nadir, and had higher peak HIV-1 RNA. In multivariable proportional hazards models, the hazard ratios [95% confidence interval (CI)] of ADE or all-cause death and non-ADE or all-cause death were lower in the continuation group, but not statistically significantly: 0.50 (0.12, 2.12; p = 0.35) and 0.69 (0.24, 1.95; p = 0.48), respectively. The results were similar in competing risks analyses. Despite having characteristics associated with worse prognosis, women who continued HAART postpartum had lower hazard ratio point estimates for ADEs or death and non-ADEs or death than women who discontinued HAART. Larger studies with longer follow-up are indicated to assess this association.

Race and sex differences in antiretroviral therapy use and mortality among HIV-infected persons in care.

BACKGROUND: There are conflicting data regarding race, sex, and mortality among persons infected with human immunodeficiency virus (HIV). We studied all-cause mortality among persons in care during the highly-active antiretroviral therapy (HAART) era. METHODS: This retrospective cohort study included patients who made>or=1 clinic visit from January 1998 through December 2005. RESULTS: Of 2605 patients (with 6657 person-years of follow-up), 38% were black and 24% were female. The percentage of time in care while receiving HAART was lower for blacks than for nonblacks (47% vs. 76%; P<.001) and for females than for males (57% vs. 71%; P=.01). There were 253 deaths (38 per 1000 person-years). After adjustment for characteristics at baseline, death was associated with black race (hazard ratio [HR], 1.33; P .04), female sex (HR, 1.53; P .007), injection drug use (IDU) as a risk factor for HIV infection (HR, 1.61; P .009), older age (HR, 1.45 per 10 years; P<.001), a lower CD4 cell count (HR, 0.59 for 200 vs. 350 cells/mm3; P<.001) and a higher HIV type 1 RNA level (HR, 1.35; P<.001). After adjustment for the length of time that HAART was received, black race (HR, 1.00; P .99) and IDU (HR, 1.37; P .09) were no longer associated with death, but female sex was (HR, 1.62; P=.002). CONCLUSIONS: Race-associated differences in mortality likely resulted from HAART use. Women had an increased risk of death even after adjustment for HAART use. Addressing racial disparities will require improved HAART utilization. Increased mortality among women requires further study.

Increased detectability of plasma HIV-1 RNA after introduction of a new assay and altered specimen-processing procedures.

After changes to assay and specimen-processing methods, plasma human immunodeficiency virus type 1 (HIV-1) RNA was frequently detectable in patients who previously had well-suppressed HIV-1 RNA levels. This artifact is attributable to shipping frozen plasma in primary plasma preparation tubes and is not caused by the HIV-1 RNA detection assay; it can be avoided by shipping plasma in a secondary tube.