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 log10 plasma HIV concentration were 228 × 106 cells/L and 4.58 copies/mL, respectively. Thirty-six percent of the patients had visits in <4 quarters, and 16% died during follow-up. In Cox multivariate regression analysis, compared with persons with visits in all 4 quarters during the first year, the adjusted hazard ratio of death was 1.42 (95% confidence interval, 1.11–1.83; P < .01), 1.67 (95% confidence interval, 1.24–2.25; P < .001), and 1.95 (95% confidence interval, 1.37–2.78; P < .001) for persons with visits in 3 quarters, 2 quarters, and 1 quarter, respectively. Conclusions. Even in a system with few financial barriers to care, a substantial portion of HIV-infected patients have poor retention in care. Poor retention in care predicts poorer survival with HIV infection. Retaining persons in care may improve survival, and optimal methods to retain patients need to be defined.
Mental health and substance use problems are common among patients infected with human immunodeficiency virus (HIV) and may impede adherence to antiretroviral regimens. This study investigated ...associations of antiretroviral medication nonadherence with specific types of psychiatric disorders and drug use, and varying levels of alcohol use.
Data were drawn from a survey of a national probability sample of 2267 (representing 181,557) adults enrolled in the HIV Cost and Services Utilization Study. This study focused on 1910 patients who reported their antiretroviral medication adherence during the past week.
Patients with depression (odds ratio OR = 1.7; 95% confidence interval CI: 1.3 to 2.3), generalized anxiety disorder (OR = 2.4; 95% CI: 1.2 to 5.0), or panic disorder (OR = 2.0; 95% CI: 1.4 to 3.0) were more likely to be nonadherent than those without a psychiatric disorder. Nonadherence was also associated with use of cocaine (OR = 2.2; 95% CI: 1.2 to 3.8), marijuana (OR = 1.7; 95% CI: 1.2 to 2.3), amphetamines (OR = 2.3; 95% CI: 1.2 to 4.2), or sedatives (OR = 1.6; 95% CI: 1.0 to 2.4) in the previous month. Compared with patients who did not drink, those who were moderate (OR = 1.6; 95% CI: 1.3 to 2.0), heavy (OR = 1.7; 95% CI: 1.3 to 2.3), or frequent heavy (OR = 2.7; 95% CI: 1.7 to 4.5) drinkers were more likely to be nonadherent. These associations could not be explained by demographic, clinical, and treatment factors.
These findings suggest the need for screening and treatment for mental health and substance use problems among HIV-positive patients to improve adherence to antiretroviral medications.
The AIDS Clinical Trials Group (ACTG) Adherence Questionnaire is used extensively, but investigators frequently only use the first item of the questionnaire (4-day recall).
A secondary analysis was ...conducted to (1) estimate the validity and reliability of each of the 5 scale items and (2) compare the approach commonly used to summarize adherence data collected with the instrument (average 4-day recall) with alternate approaches derived using principal component (PC) analysis and the full questionnaire. We hypothesized that an estimate of adherence taking all items of the questionnaire into account would provide a stronger measure of adherence.
Logistic regression analyses showed that the first PC identified (PC1) was significantly correlated with plasma HIV RNA outcome (P < 0.0001 for ACTG 370 data and P = 0.006 for ACTG 398 data) and correlated with plasma HIV RNA better than average 4-day recall. An adherence index formulated using weights of PC1 showed substantially greater variability in the range of adherence scores in comparison to average 4-day adherence recall alone. PC1 compared favorably with 2 indices derived from medication event monitoring system data as well.
Findings indicate that a superior assessment of antiretroviral adherence may be obtained with the ACTG Adherence Questionnaire by using the method employed in this analysis.
Traditional, open-ended provider questions regarding patient symptoms are insensitive. Better methods are needed to measure symptoms for clinical management, patient-oriented research, and adverse ...drug-event reporting. Our objective was to develop and initially validate a brief, self-reported HIV symptom index tailored to patients exposed to multidrug antiretroviral therapies and protease inhibitors, and to compare the new index to existing symptom measures. The research design was a multistage design including quantitative review of existing literature, qualitative and quantitative analyses of pilot data, and quantitative analyses of a prospective sample. Statistical analyses include frequencies, chi-square tests for significance, linear and logistic regression. The subjects were from a multisite convenience sample (
n = 73) within the AIDS Clinical Trials Group and a prospective sample from the Cleveland Veterans Affairs Medical Center (
n = 115). Measures were patient-reported symptoms and health-related quality of life, physician-assessed disease severity, CD4 cell count, and HIV-1 RNA viral quantification. A 20-item, self-completed HIV symptom index was developed based upon prior reports of symptom frequency and bother and expert opinion. When compared with prior measures the index included more frequent and bothersome symptoms, yet was easier to use (self-report rather than provider interview). The index required less than 5 minutes to complete, achieved excellent completion rates, and was thought comprehensive and comprehensible in a convenience sample. It was further tested in a prospective sample of patients and demonstrated strong associations with physical and mental health summary scores and with disease severity. These associations were independent of CD4 cell count and HIV-1 RNA viral quantification. This 20-item HIV symptom index has demonstrated construct validity, and offers a simple and rational approach to measuring HIV symptoms for clinical management, patient-oriented research, and adverse drug reporting.
Approximately 3.2 million persons are chronically infected with the hepatitis C virus (HCV) in the U.S.; most are not aware of their infection. Our objectives were to examine HCV testing practices to ...determine which patient characteristics are associated with HCV testing and positivity, and to estimate the prevalence of HCV infection in a high‐risk urban population. The study subjects were all patients included in the baseline phase of the Hepatitis C Assessment and Testing Project (HepCAT), a serial cross‐sectional study of HCV screening strategies. We examined all patients with a clinic visit to Montefiore Medical Center from 1/1/08 to 2/29/08. Demographic information, laboratory data and ICD‐9 diagnostic codes from 3/1/97–2/29/08 were extracted from the electronic medical record. Risk factors for HCV were defined based on birth date, ICD‐9 codes and laboratory data. The prevalence of HCV infection was estimated assuming that untested subjects would test positive at the same rate as tested subjects, based on risk‐factors. Of 9579 subjects examined, 3803 (39.7%) had been tested for HCV and 438 (11.5%) were positive. The overall prevalence of HCV infection was estimated to be 7.7%. Risk factors associated with being tested and anti‐HCV positivity included: born in the high‐prevalence birth‐cohort (1945–64), substance abuse, HIV infection, alcohol abuse, diagnosis of cirrhosis, end‐stage renal disease, and alanine transaminase elevation. In a high‐risk urban population, a significant proportion of patients were tested for HCV and the prevalence of HCV infection was high. Physicians appear to use a risk‐based screening strategy to identify HCV infection.
Adherence to prescribed medications is a central feature of good clinical HIV care, but little is known about the factors associated with multidrug antiretroviral adherence, or about how such ...adherence is related to plasma HIV suppression.
We collected data from 133 HIV-infected adults receiving antiretroviral therapy. Study subjects completed customized adherence self-report instruments and provided blood samples to measure plasma HIV-1 RNA concentrations and CD4+ lymphocyte counts. Regression models were used to determine the independent predictors of antiretroviral adherence and plasma HIV concentration, and the relationships between the two.
Adherence was poor (average, <80% antiretrovirals/day) in 28% (95% confidence interval CI, 20%-36%), fair (80%-99% per day) in 23% (95% CI, 15%-30%), and excellent (100% per day) in 50% (95% CI, 41%-58%) of study subjects. Mean decreases in HIV-1 concentration from highest-ever levels were 1.3, 1.6, and 2.0 log10 copies/ml in these three groups, respectively (chi2; p < .02). Two-stage least squares regression demonstrated a -1.3 log difference in viral load associated with each category improvement in adherence. In multivariate models, confidence in medication-taking ability, or perceived self-efficacy, and convenience of the medication regimen, or "fit" with routine and daily activities, were also associated with greater medication adherence (odds ratios OR 5.3; 95% CI, 2.4-11.8, and 9.0; 95% CI, 1.8-45.3, respectively). The latter was also independently associated with a lower plasma HIV concentration (p < .02).
Nonadherence to combination antiretroviral medications is common and is associated with increased levels of plasma HIV. Programs and clinical efforts to improve medication taking should strive to integrate medications better into patients' daily routines and to improve patients' confidence in their ability to take medications correctly.
To determine the sociodemographic and service delivery correlates of depression underdiagnosis in HIV.
Cross-sectional survey.
National probability sample of HIV-infected persons in care in the ...contiguous United States who have available medical record data.
We interviewed patients using the Composite International Diagnostic Interview (CIDI) survey from the Mental Health Supplement. Patients also provided information regarding demographics, socioeconomic status, and HIV disease severity. We extracted patient medical record data between July 1995 and December 1997, and we defined depression underdiagnosis as a diagnosis of major depressive disorder based on the CIDI and no recorded depression diagnosis by their principal health care provider in their medical records between July 1995 and December 1997. Of the 1140 HIV Cost and Services Utilization Study patients with medical record data who completed the CIDI, 448 (37%) had CIDI-defined major depression, and of these, 203 (45%) did not have a diagnosis of depression documented in their medical record. Multiple logistic regression analysis revealed that patients who had less than a high school education (P <.05) were less likely to have their depression documented in the medical record compared to those with at least a college education. Patients with Medicare insurance coverage compared to those with private health insurance (P <.01) and those with >or=3 outpatient visits (P <.05) compared to <3 visits were less likely to have their depression diagnosis missed by providers.
Our results suggest that providers should be more attentive to diagnosing comorbid depression in HIV-infected patients.
This paper describes the AACTG Adherence Instruments, which are comprised of two self-report questionnaires for use in clinical trials conducted by the Adult AIDS Clinical Trials Group (AACTG). The ...questionnaires were administered to 75 patients at ten AACTG sites in the USA. All patients were taking combination antiretroviral therapy (ART), including at least one protease inhibitor. Eleven per cent of patients reported missing at least one dose the day before the interview, and 17% reported missing at least one dose during the two days prior. The most common reasons for missing medications included 'simply forgot' (66%) and a number of factors often associated with improved health, including being busy (53%), away from home (57%) and changes in routine (51%). Less adherent patients reported lower adherence self-efficacy (p = 0.006) and were less sure of the link between non-adherence and the development of drug resistance (p = 0.009). They were also more likely to consume alcohol, to be employed outside the home for pay and to have enrolled in clinical trials to gain access to drugs (all p < 0.05). Twenty-two per cent of patients taking drugs requiring special instructions were unaware of these instructions. Each questionnaire took approximately ten minutes to complete. Responses to the questionnaires were favourable. These questionnaires have been included in six AACTG clinical trials to date and have been widely disseminated to investigators both in the USA and abroad.
Although there is concern that minority groups and women are underrepresented in research involving patients with human immunodeficiency virus (HIV) infection, the available data are inconclusive.
We ...used nationally representative data from the HIV Cost and Services Utilization Study to determine the characteristics of the participants and nonparticipants in trials of medications for HIV infection and whether or not patients had access to experimental treatments. A probability sample of 2864 persons, representing all 231,400 adults with known HIV infection who are cared for in the contiguous United States, were interviewed on three occasions between 1996 and 1998. They were asked about participation in clinical research studies of medications and past receipt of experimental medications for HIV.
We estimate that 14 percent of adults receiving care for HIV infection participated in a medication trial or study; 24 percent had received experimental medications; and 8 percent had tried and failed to obtain experimental treatments. According to multivariate models, non-Hispanic blacks and Hispanics were less likely to be participating in trials than non-Hispanic whites (odds ratio for participation among non-Hispanic blacks, 0.50 95 percent confidence interval, 0.28 to 0.91; odds ratio among Hispanics, 0.58 95 percent confidence interval, 0.37 to 0.93) and to have received experimental medications (odds ratios, 0.41 95 percent confidence interval, 0.32 to 0.54 and 0.56 95 percent confidence interval, 0.41 to 0.78, respectively). Patients who were cared for in private health maintenance organizations were less likely to participate in trials than those with fee-for-service insurance (odds ratio, 0.43 95 percent confidence interval, 0.21 to 0.88). Women were not underrepresented in research trials and had a similar likelihood of receiving experimental treatments.
Among patients with HIV infection, participation in research trials and access to experimental treatment is influenced by race or ethnic group and type of health insurance.
Although it is widely recognized that potent antiretroviral therapies have transformed HIV from an acute to a chronic illness, it is less often recognized that with this change, a different model of ...care is appropriate. People living with chronic HIV must function independently, taking personal long-term, day-to-day responsibility for care. The role of doctors and the healthcare system is to help them do this. The authors present a conceptual framework for the self-management of chronic HIV disease and discuss the components of an HIV self-management program. The ability to take antiretroviral medications well and consistently is a key part of self-management but should be nested within an array of important skills, including symptom-management skills, goal setting and planning, communication, and accessing information and resources.
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