Allen L. Gifford

Retention in Care: A Challenge to Survival with HIV Infection

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 228x10(6) 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.

Substance use and mental health correlates of nonadherence to antiretroviral medications in a sample of patients with human immunodeficiency virus infection

PURPOSE 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. METHODS 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. RESULTS 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. CONCLUSION 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.

Development and validation of a self-completed HIV symptom index.

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.

Underdiagnosis of Depression in HIV: Who Are We Missing?

AbstractOBJECTIVE: To determine the sociodemographic and service delivery correlates of depression underdiagnosis in HIV. DESIGN: Cross-sectional survey. PATIENTS/PARTICIPANTS: National probability sample of HIV-infected persons in care in the contiguous United States who have available medical record data. MEASUREMENTS AND MAIN RESULTS: 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 1,140 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 ≥3 outpatient visits (P<.05) compared to <3 visits were less likely to have their depression diagnosis missed by providers. CONCLUSIONS: Our results suggest that providers should be more attentive to diagnosing comorbid depression in HIV-infected patients.

Prevalence and predictors of Highly active antiretroviral therapy use in patients with HIV infection in the United States

Background: Highly active antiretroviral therapy (HAART) became standard for HIV in 1996. Studies at that time showed that most people infected with HIV had initiated HAART, but that members of minority groups and poor people had lower HAART use. It is not known whether high levels of HAART use have been sustained or whether socioeconomic and racial disparities have diminished over time. Objectives: To determine the proportion of patients who had received and were receiving HAART by January 1998, and to evaluate predictors of HAART receipt. Design and Participants: Prospective cohort study of a national probability sample of 2267 adults receiving HIV care who completed baseline, first follow‐up, and second follow‐up interviews from January 1996 to January 1998. Main outcome variables: Proportion currently using HAART at second follow‐up (August 1997 to January 1998), contrasted with the cumulative proportions using HAART at any time before January 1998 and before December 1996. Analyses: Bivariate and multiple logistic regression analysis of population characteristics predicting current use of HAART at the time of the second follow‐up interview. Results: The proportion of patients ever having received HAART increased from 37% in December 1996 to 71% by January 1998, but only 53% of people were receiving HAART at the time of the second follow‐up interview. Differences between sociodemographic groups in ever using HAART narrowed after 1996. In bivariate analysis, several groups remained significantly less likely to be using HAART at the time of the second follow‐up interview: blacks, male and female drug users, female heterosexuals, people with less education, those uninsured and insured by Medicaid, those in the Northeast, and those with CD4 counts of ≥500 cells/&mgr;l (all p < .05). Using multiple logistic regression analysis, low CD4 count (for CD4 <50 cells/&mgr;l: odds ratio [OR], 3.20; p < .001) remained a significant predictor of current HAART use at the time of the second follow‐up interview, but lack of insurance (OR, 0.71; p < .05) predicted not receiving HAART. Conclusions: The proportion of persons under HIV care in the United States who had ever received HAART increased to over 70% of the affected population by January 1998 and the disparities in use between groups narrowed but did not disappear. However, nearly half of those eligible for HAART according to the U.S. Department of Health and Human Services guidelines were not actually receiving it nearly 2 years after these medications were first introduced. Strategies to promote the initiation and continuation of HAART are needed for those without contraindications and those who can tolerate it.

Chronic disease self-management and adherence to HIV medications.

Summary: 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.

Predictors of Treatment in Patients with Chronic Hepatitis C Infection—Role of Patient Versus Nonpatient Factors

Treatment with interferon and ribavirin is effective in patients with chronic infection with hepatitis C virus (HCV). Previous data indicate that treatment rates are suboptimal. We sought to identify patient and provider‐level predictors of treatment receipt in HCV by conducting a retrospective cohort study of 5701 HCV patients in a large regional Veterans Administration (VA) healthcare network. We also determined the degree of variation in treatment rates attributable to patient, provider, and facility factors. Three thousand seven hundred forty‐three patients (65%) were seen by a specialist and 894 (15.7%) received treatment. Treatment rates varied from 6% to 29% across the 5 facilities included in the analysis. Patients were less likely to receive treatment if they were older [RR, 0.55; 95% CI, 0.45, 0.67), single (RR, 0.77; 95%CI, 0.67, 0.88), had hepatic dysfunction (RR, 0.73; 95%CI, 0.66, 0.89), had normal alanine aminotransferase (ALT) (RR, 0.73; 95%CI, 0.59, 0.89), had HCV genotype 1 (RR, 0.78; 95%CI, 0.71, 0.86), were African American with genotype 1 (RR, 0.78; 95% CI, 0.71, 0.86), or were anemic (RR, 0.70; CI, 0.60, 0.89). In addition, patients evaluated by less experienced providers were 77% less likely to receive treatment than those evaluated by more experienced providers. The patient, provider, and facility factors explained 23%, 25%, and 7% of variation in treatment rates, respectively. Conclusion: These data suggest that although patient characteristics are important predictors of treatment in HCV, a significant proportion of variation in treatment rates is explained by provider factors. These potentially modifiable provider‐level factors may serve as high‐yield targets for future quality improvement initiatives in HCV. (HEPATOLOGY 2007;46:1741–1749.)

Pilot randomized trial of education to improve self-management skills of men with symptomatic HIV/AIDS.

OBJECTIVE To evaluate the acceptability, practicality, and short-term efficacy of a health education program to improve disease self-management in patients with symptomatic HIV/AIDS. DESIGN Randomized controlled trial, baseline and 3-month follow-up questionnaire assessments. SETTING San Francisco Bay communities. PARTICIPANTS Seventy-one men with symptomatic HIV or AIDS were randomly assigned to a seven-session group educational intervention (N=34) or a usual-care control group (N=37). INTERVENTION Interactive health education groups were used to teach wide-ranging disease self-management skills and information: symptom assessment and management, medication use, physical exercise, relaxation, doctor-patient communication, and nutrition. Each group was led by two trained peer-leaders (one of whom was HIV-positive) recruited from the community. MAIN OUTCOME MEASURES The primary outcome of interest was symptom status. Secondary outcomes were self-efficacy and health behaviors. Analysis of covariance was used to compare experimental and control group mean outcomes, adjusting for baseline value differences. RESULTS The symptom severity index (number of symptoms moderate or greater severity) decreased in the experimental, and increased in the control group (-0.9 versus +0.5; p < .03). Pain, fatigue, and psychological symptoms were not significantly different between groups. Self-efficacy for controlling symptoms improved in the experimental, and decreased in the control group (+4 versus -7; p < .02). Changes in stress/relaxation exercises and HIV/AIDS knowledge were not different between groups. A trend was shown toward more frequent physical exercise in the experimental group compared with less in the control group (+1.3 versus -0.5 times/week; p=.06). CONCLUSIONS Health education emphasizing self-management skills for HIV/AIDS patients can be implemented and evaluated and was accepted by patients, peer-leaders, and health care providers. Whether this educational program can lead to prolonged improvement in HIV symptoms and behaviors can be adequately addressed only by a larger trial of longer duration.

Complementary and Alternative Medicine Use and Substitution for Conventional Therapy by HIV-infected Patients

Background: HIV‐infected patients commonly use complementary and alternative medicine (CAM), but it is not known how often CAM is used as a complement or as a substitute for conventional HIV therapy. Objectives: To evaluate the prevalence and factors associated with CAM use with potential for adverse effects and CAM substitution for conventional HIV medication. Design and Participants: Cross‐sectional survey of U.S. national probability sample of HIV‐infected patients (2,466 adults) in care from December 1996 to July 1997. Main Outcome Variables: Any CAM use, CAM use with potential for adverse effects, and use of CAM as a substitute for conventional HIV therapy. Substitution was defined as replacement of some or all conventional HIV medications with CAM. Results: Fifty‐three percent of patients had recently used at least one type of CAM. One quarter of patients used CAM with the potential for adverse effects, and one‐third had not discussed such use with their health care provider. Patients with a greater desire for medical information and involvement in medical decision making and with a negative attitude toward antiretrovirals were more likely to use CAM. Three percent of patients substituted CAM for conventional HIV therapy. They were more likely to desire involvement in medical decision‐making (odds ratio, 1.8; 95% confidence interval, 1.0‐3.2) and to have a negative attitude toward antiretrovirals (odds ratio, 7.8; 95% confidence interval, 3.0‐19.0). Conclusions: Physicians should openly ask HIV‐infected patients about CAM use to prevent adverse effects and to identify CAM substitution for conventional HIV therapy.

Effects of Spiritual Mantram Repetition on HIV Outcomes: A Randomized Controlled Trial

We examined the efficacy of a psycho-spiritual intervention of mantram repetition—a word or phrase with spiritual associations repeated silently throughout the day–on psychological distress (intrusive thoughts, stress, anxiety, anger, depression), quality of life enjoyment and satisfaction, and existential spiritual well-being in HIV-infected adults. Using a 2-group by 4-time repeated measures design, 93 participants were randomly assigned to mantram (n = 46) or attention control group (n = 47). Over time, the mantram group improved significantly more than the control group in reducing trait-anger and increasing spiritual faith and spiritual connectedness. Actual mantram practice measured by wrist counters was inversely associated with non-HIV related intrusive thoughts and positively associated with quality of life, total existential spiritual well-being, meaning/peace, and spiritual faith. Intent-to-treat findings suggest that a mantram group intervention and actual mantram practice each make unique contributions for managing psychological distress and enhancing existential spiritual well-being in adults living with HIV/AIDS.