[Show abstract][Hide abstract] ABSTRACT: In medication adherence-promotion trials, participants in the intervention arm are often cognizant of the researcher's aim to improve adherence; this may lead to their inflating reports of their own adherence compared to control arm participants. Using data from 1,247 HIV-positive participants across eight U.S. Studies in the Multi-site Adherence Collaboration on HIV (MACH14) collaboration, we evaluated the validity of self-reported adherence by examining whether its association with two more objective outcomes , electronically monitored adherence and  viral load, varied by study arm. After adjusting for potential confounders, there was no evidence of greater overestimation of self-reported adherence among intervention arm participants, supporting its potential as a trial outcome indicator.
[Show abstract][Hide abstract] ABSTRACT: Background
Research on self- and family management of chronic conditions has advanced over the past six years, but the use of simple frameworks has hampered the understanding of the complexities involved.
We sought to update our previously published model with new empirical, synthetic, and theoretical work.
We used synthesis of previous studies to update the framework.
We propose a revised framework that clarifies facilitators and barriers, processes, proximal outcomes, and distal outcomes of self- and family management, and their relationships.
We offer the revised framework as a model that can be used in studies aimed at advancing self- and family management science. Use of the framework to guide studies would allow for the design of studies that can address more clearly how self-management interventions work and under what conditions.
[Show abstract][Hide abstract] ABSTRACT: Researchers designing clinical trials often specify usual care received by participants as the control condition expecting that all participants receive usual care regardless of group assignment. The assumption is that the groups in the study are affected similarly. We describe the assessment of usual care within the 16 studies in Multisite Adherence Collaboration in HIV (MACH 14), a multisite collaboration on adherence to antiretroviral therapy. Only five of the studies in MACH 14 assessed usual care. Assessment protocols varied as did the timing and frequency of assessments. All usual care assessments addressed patient education focused on HIV, HIV medications, and medication adherence. Our findings support earlier work that calls for systematic assessments of usual care within the study design, inclusion of descriptions of usual care in reports of the study, and the influence of usual care on the experimental condition in clinical trials.
Western Journal of Nursing Research 03/2014; · 1.38 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To use electronic drug monitoring to determine if adherence to HIV antiretroviral therapy (ART) changes over time, whether changes are linear, and how the declines vary by study.
We conducted a longitudinal study of pooled data from 11 different studies of HIV-infected adults using ART. The main outcome was ART adherence (percent of prescribed doses taken) measured by electronic drug monitoring. We modeled and compared changes in adherence over time using repeated measures linear mixed effects models and generalized additive mixed models (GAMMs). Indicator variables were used to examine the impact of individual studies, and the variation across studies was evaluated using study-specific parameter estimates calculated by using interaction terms of study and time.
The mean age of the subjects was 41 years, 35% were female, most had high school education or less, and 46% were African American. In GAMMs, adherence declined over time. The GAMMs further suggested that the decline was nonlinear, and in both sets of models, there was considerable study-to-study variability in how adherence changed over time.
Findings may not be generalizable to non-US populations or to patients not in clinical studies.
Although overall ART adherence declined with time, not all studies showed declines, and a number of patterns of change were seen. Studies that identify clinical and organizational factors associated with these different patterns are needed. Models of changes in adherence with time should take account of possible nonlinear effects.
[Show abstract][Hide abstract] ABSTRACT: Objective: Hepatocellular carcinoma (HCC) presents a major health problem with its steadily increasing incidence in Western countries, and persistent high fatality rates worldwide. The well-recognized complexity and toxicity of its treatment as well as inadequate care and limited resources in mainland China exacerbate the difficulty of maintaining quality of remaining life of patients living with this illness. The goal of this comprehensive literature review was to identify promising clinical interventions for improving quality of life (QOL) of people with advanced HCC in mainland China. Method: A comprehensive literature review was performed in China Academic Journals (CAJ), Cochrane, and PubMed databases. The review was confined to studies of randomized controlled trials (RCT) for adults, in Chinese and English, from 1980 to 2012. Results: A total of 676 studies in Chinese and 391 studies in English were identified. Eighteen RCTs were selected for the final review, among which three were conducted in mainland China. Significance of results: Nurse-led home-based comprehensive interventions using a collaborative care approach addressing multiple dimensions of QOL show promise for enhancing clinical outcomes for people with advanced HCC in mainland China. Education and psychosocial support combined with symptom management early in the illness trajectory and ongoing close attention to physical symptoms, emotional distress, as well as spiritual well-being are crucial for maintaining QOL of people with advanced HCC. Telephone monitoring appears to be a feasible way in rural as well as urban areas. Families are advised to be part of overall interventions. It is warranted that promising interventions aiming at improving QOL for advanced cancer patients reported in Western literature be further tested in mainland China.
Palliative and Supportive Care 02/2013; · 0.98 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Background: Effective and easy to implement interventions to improve adherence to antiretroviral therapy are needed. Objective: To compare site nurse-initiated adherence and symptom support telephone calls for HIV-positive individuals starting antiretroviral therapy to the study site's standard of care. Methods: A randomized controlled trial of site nurse-initiated adherence and symptom support telephone calls for HIV-positive individuals starting antiretroviral therapy. Subjects were randomized to receive site nurse-initiated telephone calls (intervention) or no additional calls to the site's standard of care (control). Subjects received calls 1 to 3 days after initiating antiretrovirals, on weeks 1, 2, 3, 6, 10, 14, 18, 22, and 26, and every 8 weeks thereafter. Self-reported adherence was captured during study visits. Results: A total of 333 subjects starting antiretrovirals as part of ACTG 384 were co-enrolled into ACTG 5031. Subjects were followed for up to 160 weeks and were contacted for 74% of scheduled calls. There was no significant difference in proportion of patients with ≯95% mean total adherence (87.9% and 91.2%; P = .34) and mean self-reported total adherence (97.9% and 98.4%) in the intervention and control groups, respectively, or in symptom distress and clinical endpoints. Conclusions: In the context of a clinical trial where self-reported adherence was exceptionally high, the site nurse-initiated telephone calls did not further improve self-reported adherence, symptom distress, or clinical outcomes.
HIV Clinical Trials 01/2013; 14(5):235-53. · 2.14 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The integration of original data from multiple antiretroviral (ARV) adherence studies offers a promising, but little used method to generate evidence to advance the field. This paper provides an overview of the design and implementation of MACH14, a collaborative, multi-site study in which a large data system has been created for integrated analyses by pooling original data from 16 longitudinal ARV adherence studies. Studies selected met specific criteria including similar research design and data domains such as adherence measured with medication event monitoring system, psychosocial factors related to adherence behavior, and virologic and clinical outcomes. The data system created contains individual data (collected between 1997 and 2009) from 2,860 HIV patients. Collaboration helped resolve the challenges inherent in pooling data across multiple studies, yet produced a data system with strong statistical power and potentially greater capacity to address key scientific questions than possible with single-sample studies or even meta-analytic designs.
[Show abstract][Hide abstract] ABSTRACT: Adherence to antiretroviral therapies (ART) is the strongest predictor of viral suppression among individuals infected with HIV, however, limited data exists to understand the patterns of adherence that confer the greatest benefit across different ART regimens.
Longitudinal data pooled from 16 studies conducted between 1997 and 2009 across the United States.
Adherence was measured using Medication Event Monitoring System. Percentage of time with sufficient drug concentrations (covered time) and the length of the longest treatment interruption during the 28 days prior to plasma HIV-RNA measurements were calculated. Logistic regression with generalized estimating equations was used to estimate medication-specific adherence estimates on detectable HIV-RNA (>400 copies/ml).
One thousand and eighty-eight participants with 3795 HIV-RNA measures were studied. Both lower covered time and greater longest interruption showed dose-response relationships with the odds of detectable HIV-RNA; however, estimates did not vary by medication regimen. Compared with 93-100% coverage, periods of 0-25% covered time had a three-fold increased risk of detectable HIV-RNA [odds ratio (OR) = 3.22, 95% confidence interval (CI): 2.48-4.19]. Similarly, compared to longest interruptions of 0-48 h, longest interruptions of 21-28 days had a nearly four-fold increased risk of detectable HIV-RNA (OR = 3.65, 95% CI: 2.77, 4.81).
We found that adherence was consistently strongly associated with treatment response across ART regimens. Of the patterns of adherence, longer interruptions may have greater impact than covered time. Future research should investigate additional methods for examining adherence patterns, understanding the determinants of consecutive missed doses and the evaluation of interventions designed to address interruptions in treatment.
AIDS (London, England) 07/2012; 26(11):1415-23. · 6.56 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Minority race/ethnicity is generally associated with antiretroviral therapy nonadherence in US-based studies. Limitations of the existing literature include small samples, subjective adherence measures, and inadequate control for potential confounders such as mental health and substance use, which have been consistently associated with poorer adherence.
Individual-level data were pooled from 13 US-based studies employing electronic drug monitoring to assess adherence. Adherence was operationalized as percent of prescribed doses taken from the first 12 (monthly) waves of data in each study. Depression symptoms were aggregated from several widely used assessments, and substance use was operationalized as any use of cocaine/stimulants, heroin/opiates, ecstasy, hallucinogens, or sedatives in the 30-365 days preceding baseline.
The final analytic sample of 1809 participants ranged in age from 18 to 72 years and was 67% male. Participants were 53% African American, 14% Latino, and 34% White. In a logistic regression adjusting for age, gender, income, education, and site, race/ethnicity was significantly associated with adherence (P < 0.001) and persisted in a model that also controlled for depression and substance use (P < 0.001), with African Americans having significantly lower adherence than Latinos [odds ratio (OR) = 0.72, P = 0.04] and whites (OR = 0.60, P < 0.001). Adherence did not differ between whites and Latinos (OR = 0.84, P = 0.27).
Racial/ethnic differences in demographics, depression, and substance abuse do not explain the lower level of antiretroviral therapy adherence in African Americans observed in our sample. Further research is needed to explain the persistent disparity and might examine factors such as mistrust of providers, health literacy, and inequities in the health care system.
[Show abstract][Hide abstract] ABSTRACT: INTRODUCTION: The prevalence of smoking is high among the human immunodeficiency virus (HIV)-infected population, yet there are few studies of tobacco dependence treatment in this population. This paper reports the safety of varenicline versus nicotine replacement therapy (NRT) and describes preliminary results about the effectiveness of varenicline versus NRT in HIV-infected smokers. METHODS: Participants completed 12 weeks of telephone counseling and either varenicline or NRT. Varenicline was encouraged as the preferred intervention; NRT was used for those unable/unwilling to take varenicline. Adverse events (AEs), related to pharmacotherapy, were monitored. Biochemically confirmed abstinence at 3 months was examined. Inverse probability of treatment weighted logistic regression models was fit to compare participants on varenicline to those on NRT. RESULTS: Among participants on varenicline (n = 118), the most common AEs were nausea, sleep problems, and mood disturbances. One person reported suicidal ideation; there were no cardiovascular complications. There were no differences in the varenicline AE profile between participants on combination antiretroviral therapy (ART) and those not on ART. The percentages of confirmed abstainers were 11.8% in the NRT group and 25.6% in the varenicline group. The odds of being abstinent were 2.54 times as great in the varenicline group compared with the NRT group in the propensity weighted model (95% CI 1.43-4.49).Conclusions:In this preliminary study, the safety profile of varenicline among HIV-infected smokers resembles findings among smokers without HIV. In addition, varenicline may be more effective at promoting abstinence in this population. Future randomized clinical trials are warranted.
Nicotine & Tobacco Research 05/2012; · 2.48 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Self-management is a dynamic process in which individuals actively manage a chronic illness. Self-management models are limited in their specification of the processes of self-management. The purpose of this article is to delineate processes of self-management in order to help direct interventions and improve health outcomes for individuals with a chronic illness.
Qualitative metasynthesis techniques were used to analyze 101 studies published between January 2000 and April 2011 that described processes of self-management in chronic illness.
Self-management processes were extracted from each article and were coded. Similar codes were clustered into categories. The analysis continued until a final categorization was reached.
Three categories of self-management processes were identified: focusing on illness needs; activating resources; and living with a chronic illness. Tasks and skills were delineated for each category.
This metasynthesis expands on current descriptions of self-management processes by specifying a more complete spectrum of self-management processes.
Healthcare providers can best facilitate self-management by coordinating self-management activities, by recognizing that different self-management processes vary in importance to patients over time, and by having ongoing communication with patients and providers to create appropriate self-management plans.
Journal of Nursing Scholarship 05/2012; 44(2):136-44. · 1.61 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: As mortality due to AIDS-related causes has decreased with the use of antiretroviral therapy, there has been a rise in deaths related to non-AIDS-defining illnesses. Given the exceedingly high prevalence of cigarette smoking among individuals living with HIV infection, tobacco has been implicated as a major contributor to this paradigm shift. Evidence suggests that smoking-related illnesses, such as cardiovascular disease, respiratory illnesses, and certain malignancies, contribute substantially to morbidity and mortality among HIV-infected persons. In this review, we summarize the adverse health consequences of smoking relevant to HIV-infected individuals and discuss smoking cessation in this unique population, including a discussion of barriers to quitting and a review of studies that have examined smoking cessation interventions.
Proceedings of the American Thoracic Society 06/2011; 8(3):313-9.
[Show abstract][Hide abstract] ABSTRACT: A greater number of older adults now live with coronary heart disease (CHD). This poses a significant public health problem, because older adults are at high risk for CHD-related mortality and morbidity. Overwhelming data support the benefits of cardiac rehabilitation for secondary prevention, yet only a small portion of eligible older adults receive it.
Whereas many studies examined factors that affect the use of cardiac rehabilitation among older adults, few interventions aimed to improve their cardiac rehabilitation participation rates. A substantial body of evidence indicates that an individual's illness perceptions play a pivotal role in health behavior, and may be a promising target for intervention. Drawing from the theoretic and empiric findings of others, a self-regulatory model is proposed that explicates how CHD perceptions of older adults may influence participation in cardiac rehabilitation.
The model may provide a useful guide for the development of effective interventions tailored to older adults.
Heart & lung: the journal of critical care 11/2010; 39(6):504-11. · 1.04 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Depressive symptoms are highly prevalent yet undertreated in people living with HIV/AIDS (PLHAs). As part of a larger study of symptom self-management (N=1217), this study examined the prevalence, correlates, and characteristics (intensity, distress, and impact) of depressive symptoms, and the self-care strategies used to manage those symptoms in PLHAs in five countries. The proportion of respondents from each country in the total sample reporting depressive symptoms in the past week varied and included Colombia (44%), Norway (66%), Puerto Rico (57%), Taiwan (35%), and the USA (56%). Fifty-four percent (n=655) of the total sample reported experiencing depressive symptoms in the past week, with a mean of 4.1 (SD 2.1) days of depression. Mean depression intensity 5.4 (SD 2.7), distressfulness 5.5 (SD 2.86), and impact 5.5 (SD 3.0) were rated on a 1-10 scale. The mean Center for Epidemiologic Studies Depression Scale score for those reporting depressive symptoms was 27 (SD 11; range 3-58), and varied significantly by country. Respondents identified 19 self-care behaviors for depressive symptoms, which fell into six categories: complementary therapies, talking to others, distraction techniques, physical activity, medications, and denial/avoidant coping. The most frequently used strategies varied by country. In the US sample, 33% of the variance in depressive symptoms was predicted by the combination of education, HIV symptoms, psychological and social support, and perceived consequences of HIV disease.
AIDS Care 09/2010; 22(9):1159-70. · 1.60 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Health-related quality of life (HRQOL) is linked to symptom status and may be related to age in HIV-positive persons. Data were collected in a multisite HIV-positive sample (N = 1,217) using an HIV-specific HRQOL and three symptom status instruments according to the Wilson and Cleary HRQOL model. Multiple stepwise linear regression analysis found that younger age predicted higher sexual function (ΔR(2) = .12, p < .01) and older age predicted greater provider trust (ΔR(2) = .04, p < .01). No significant differences were found in symptom status or the other seven HRQOL dimensions. Although older HIV-positive persons reported more comorbidities, they did not report more symptoms.
[Show abstract][Hide abstract] ABSTRACT: As many as 50-70% of persons infected with HIV are current smokers. Compelling evidence concerning the risks of cigarette smoking to persons living with HIV urges the inclusion of smoking treatment protocols in contemporary models of HIV care. Yet in spite of growing awareness of this problem, persons living with HIV are not being effectively treated for tobacco use. To further an understanding of contributing factors and define directions for evidenced-based intervention, factors associated with smoking behavior among persons living with HIV are examined.
AIDS education and prevention: official publication of the International Society for AIDS Education 07/2009; 21(3 Suppl):106-21. · 1.51 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Persons living with HIV/AIDS use self-care for symptom management. This study assesses the use of marijuana as a symptom management approach for six common symptoms for persons living with HIV/AIDS--anxiety, depression, fatigue, diarrhea, nausea, and peripheral neuropathy. This sub-analysis of the efficacy of a symptom management manual encompasses the experiences of participants from sites in the U.S., Africa, and Puerto Rico. Baseline data are analyzed to examine differences in the use and efficacy of marijuana as compared with prescribed and over-the-counter medications as well as the impact on adherence and quality of life.
Clinical Nursing Research 06/2009; 18(2):172-93. · 0.87 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Thirteen to 20% of lung cancer patients continue to smoke after diagnosis. Guided by Self-regulation Theory, the purpose of this study was to examine illness perceptions over time in a sample of lung cancer patients. This prospective 1-group descriptive longitudinal design study included participants 18 years or older, with a lung cancer diagnosis within the past 60 days who self-reported smoking within the past 7 days. At baseline, patients completed a sociodemographics and tobacco use history questionnaire. The Illness Perception Questionnaire-Revised (IPQ-R) was repeated at 3 time points (baseline, 2-4 weeks, and 6 months). Fifty-two participants provided data for the IPQ-R at baseline, 47 at 2 to 4 weeks, and 29 at 6 months. Differences between mean scores for each illness representation attribute of the IPQ-R at repeated time points were calculated by within-subjects repeated-measures analysis of variance and Wilcoxon Signed-Rank Tests. Identity (baseline vs 2-4 weeks: P = .026; baseline vs 6 months: P = .005) and acute/chronic timeline (P = .018) mean scores significantly increased over time; personal and treatment control mean scores significantly decreased over time (P = .007 and P = .047, respectively). Understanding the context in which a patient perceives disease and smoking behavior may contribute to developing interventions that influence behavior change.
Cancer nursing 06/2009; 32(4):E15-25. · 1.88 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Throughout the history of the HIV epidemic, HIV-positive patients with relatively high CD4 counts and no clinical features of opportunistic infections have been classified as "asymptomatic" by definition and treatment guidelines. This classification, however, does not take into consideration the array of symptoms that an HIV-positive person can experience long before progressing to AIDS. This short report describes two international multi-site studies conducted in 2003-2005 and 2005-2007. The results from the studies show that HIV-positive people may experience symptoms throughout the trajectory of their disease, regardless of CD4 count or classification. Providers should discuss symptoms and symptom management with their clients at all stages of the disease.
AIDS Care 04/2009; 21(3):322-8. · 1.60 Impact Factor