A randomized controlled trial of an HIV/AIDS Symptom Management Manual for depressive symptoms.

Abstract Depressive symptoms are highly prevalent, underdiagnosed, and undertreated in people living with HIV/AIDS (PLWH), and are associated with poorer health outcomes. This randomized controlled trial examined the effects of the HIV/AIDS Symptom Management Manual self-care symptom management strategies compared with a nutrition manual on depressive symptoms in an international sample of PLWH. The sample consisted of a sub-group (N=222) of participants in a larger study symptom management study who reported depressive symptoms. Depressive symptoms of the intervention (n=124) and control (n=98) groups were compared over three months: baseline, one-month, and two-months. Use and effectiveness of specific strategies were examined. Depressive symptom frequency at baseline varied significantly by country (χ (2) 12.9; p=0.04). Within the intervention group there were significant differences across time in depressive symptom frequency [F(2, 207) = 3.27, p=0.05], intensity [F(2, 91) = 4.6, p=0.01], and impact [F(2, 252) = 2.92, p= 0.05), and these were significantly lower at one month but not at two months, suggesting that self-care strategies are effective in reducing depressive symptoms, however effects may be short term. Most used and most effective self-care strategies were distraction techniques and prayer. This study suggests that people living with HIV can be taught and will employ self-care strategies for management of depressive symptoms and that these strategies are effective in reducing these symptoms. Self-care strategies are noninvasive, have no side-effects, and can be readily taught as an adjunct to other forms of treatment. Studies are needed to identify the most effective self-care strategies and quantify optimum dose and frequency of use as a basis for evidence-based practice.

Symptoms experienced by HIV-infected Individuals on antiretroviral therapy in KwaZulu-Natal, South Africa.

Symptom management in HIV/AIDS is a critical issue that influences the quality of life of those living with the disease. Although the goals of treating the numbers living with HIV/AIDS have not yet been achieved, availability of antiretroviral therapies (ARVs) has been expanded to many clinical settings in KwaZulu-Natal, the epicenter of HIV infection in South Africa. The South African Department of Health (2007) estimates indicate that 5.54 million South Africans are living with HIV/AIDS, whereas UNAIDS (2007) estimates suggest that 18.8% of the population in South Africa is affected. Because the symptom experience may influence adherence to ARVs and quality of life, this study focused on the prevalence of symptoms reported by patients (N = 149) diagnosed with HIV/AIDS and adherence to medications and appointments. Self-report data were obtained from this community-based sample of HIV-infected patients who received care in outpatient clinics in Durban, KwaZulu-Natal, South Africa. With an average of three side effects, the most frequently reported by the study participants were fatigue/tiredness (41%), rashes (40%), headaches (32%), insomnia (31%), sadness (24%), disturbing dreams (23%), numbness (22%), pain (22%), and self-appearance (20%). On a scale of 1 to 10 (10 being worst possible), those with symptoms reported an average intensity of 4.2 (SD = 2.0), and the degree to which symptoms affected activity levels was 3.2 (SD = 2.2). Although intensity of symptoms and effects on activity levels were strongly correlated (r = .78, p < .001), there were no significant relationships between adherence and the intensity of symptoms or the relationship of symptoms with activity levels. Logistic regression analyses indicate that the presence of a greater number of symptoms was not associated with greater adherence (odds ratio = 2.27, 95% confidence interval = 0.60-8.70, ns). However, those who reported higher adherence were 1.5 times more likely to report greater physical health than low adherers (p = .04). High adherers were also 1.6 times more likely to report greater psychological health than low adherers (p = .03). This suggests that further study is needed to investigate adherence motivations for those living with HIV/AIDS in South Africa because adherence seems not to be linked to the frequency of symptoms or limitations on activity related to symptoms.

Age-related effects on symptom status and health-related quality of life in persons with HIV/AIDS.

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.

Unhealthy substance-use behaviors as symptom-related self-care in persons with HIV/AIDS.

Unhealthy substance-use behaviors, including a heavy alcohol intake, illicit drug use, and cigarette smoking, are engaged in by many HIV-positive individuals, often as a way to manage their disease-related symptoms. This study, based on data from a larger randomized controlled trial of an HIV/AIDS symptom management manual, examines the prevalence and characteristics of unhealthy behaviors in relation to HIV/AIDS symptoms. The mean age of the sample (n = 775) was 42.8 years and 38.5% of the sample was female. The mean number of years living with HIV was 9.1 years. The specific self-reported unhealthy substance-use behaviors were the use of marijuana, cigarettes, a large amount of alcohol, and illicit drugs. A subset of individuals who identified high levels of specific symptoms also reported significantly higher substance-use behaviors, including amphetamine and injection drug use, heavy alcohol use, cigarette smoking, and marijuana use. The implications for clinical practice include the assessment of self-care behaviors, screening for substance abuse, and education of persons regarding the self-management of HIV.

The development and validation of the HIV/AIDS Stigma Instrument - Nurse (HASI-N).

Illness-related stigma remains a serious problem in the management of HIV disease in Africa. This article describes a series of study phases conducted to develop and validate an instrument to measure HIV/AIDS-related stigma as perpetrated and experienced by nurses. Data were collected in Lesotho, Malawi, South Africa, Swaziland and Tanzania, from 2004-2006. The first phase was a qualitative study with focus group participants (n=251) to gather emic and etic descriptions of HIV/AIDS-related stigma in the five countries. Based on the qualitative data, a 46-item instrument was developed and tested during a second phase in the same five countries (n=244). The result of this phase was a 33-item, three-factor instrument with an average Cronbach alpha of 0.85. A third phase tested the instrument in 1474 nurses. The result was a final 19-item instrument, the HIV/AIDS Stigma Instrument - Nurse (HASI-N), comprised of two factors (Nurses Stigmatizing Patients and Nurses Being Stigmatized) with a Cronbach alpha of 0.90. Concurrent validity was tested by comparing the level of stigma with job satisfaction and quality of life. A significant negative correlation was found between stigma and job satisfaction. The HASI-N is the first inductively derived instrument measuring stigma experienced and enacted by nurses. It has the potential to be used not only to measure stigma, but also to develop stigma-reduction interventions.

Does "asymptomatic" mean without symptoms for those living with HIV infection?

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.

Social support and medication adherence in HIV disease in KwaZulu-Natal, South Africa.

BACKGROUND: A supportive social environment is critical for those with HIV/AIDS. In KwaZulu-Natal, in South Africa, antiretroviral therapy is available to some HIV-positive individuals. Antiretroviral adherence is an important issue for limiting HIV infection. Adherence to therapy may be linked to social support, particularly amidst the stigma prevalent in HIV. OBJECTIVE: The purpose of this study was to examine characteristics related to social support and antiretroviral medication adherence. DESIGN: This cross-sectional, descriptive study explored the nature of the relationships among social support and other selected variables, including sociodemographic variables, quality of life, and adherence. SETTINGS: After ethical review board approval, the sample of HIV-infected individuals who received care in outpatient clinics were recruited and completed the self-report instruments. PARTICIPANTS: The sample included English and/or isiZulu-speaking (n=149) individuals over the age of 18 years receiving treatment for HIV/AIDS. A total of 149 patients with a diagnosis of HIV/AIDS agreed to participate and completed questionnaires after completing informed consent procedures. The study participants were recruited at four outpatient settings in Durban, KwaZulu-Natal province of South Africa. METHODS: A descriptive, exploratory, cross-sectional design was utilized to explore the research questions: What are the characteristics of social support and the relationship to antiretroviral adherence in KwaZulu-Natal, South Africa? Descriptive statistics and regression analyses were used to answer the research questions. RESULTS: Data analyses indicated that social support scores on the Medical Outcomes Study Social Support Survey were moderate (M=64.4; S.D.=14.7) among the study participants. The number of close friends and family were significantly correlated with a greater sense of social support. Despite this, the lowest scores on the quality-of-life measure using the Medical Outcomes Study Short Form 36 item survey were reported on the Social Functioning Scale. CONCLUSIONS: In summary, the study findings suggest that a supportive social network is essential for those living with HIV/AIDS. However, social functioning and quality of life amidst the stigma of living with HIV in South Africa may be a concern and require further investigation.

Fatigue in HIV/AIDS patients with comorbidities.

Fatigue has been identified as a key complaint among patients with HIV/AIDS. Although having more than one disease is expected to increase symptom severity, this relationship has not been explored extensively. We investigated differences in fatigue severity together with the impact of demographic factors and the number of comorbidities and symptoms among patients with and those without comorbidities at 18 international clinical and community sites. Specific comorbidities and the number of symptoms associated with increased fatigue severity. Only by distinguishing fatigue as to its causes and patterns will health care providers be able to intervene specifically and thus more effectively.

The effectiveness of Web-based vs. non-Web-based interventions: a meta-analysis of behavioral change outcomes.

BACKGROUND: A primary focus of self-care interventions for chronic illness is the encouragement of an individual's behavior change necessitating knowledge sharing, education, and understanding of the condition. The use of the Internet to deliver Web-based interventions to patients is increasing rapidly. In a 7-year period (1996 to 2003), there was a 12-fold increase in MEDLINE citations for "Web-based therapies." The use and effectiveness of Web-based interventions to encourage an individual's change in behavior compared to non-Web-based interventions have not been substantially reviewed. OBJECTIVE: This meta-analysis was undertaken to provide further information on patient/client knowledge and behavioral change outcomes after Web-based interventions as compared to outcomes seen after implementation of non-Web-based interventions. METHODS: The MEDLINE, CINAHL, Cochrane Library, EMBASE, ERIC, and PSYCHInfo databases were searched for relevant citations between the years 1996 and 2003. Identified articles were retrieved, reviewed, and assessed according to established criteria for quality and inclusion/exclusion in the study. Twenty-two articles were deemed appropriate for the study and selected for analysis. Effect sizes were calculated to ascertain a standardized difference between the intervention (Web-based) and control (non-Web-based) groups by applying the appropriate meta-analytic technique. Homogeneity analysis, forest plot review, and sensitivity analyses were performed to ascertain the comparability of the studies. RESULTS: Aggregation of participant data revealed a total of 11,754 participants (5,841 women and 5,729 men). The average age of participants was 41.5 years. In those studies reporting attrition rates, the average drop out rate was 21% for both the intervention and control groups. For the five Web-based studies that reported usage statistics, time spent/session/person ranged from 4.5 to 45 minutes. Session logons/person/week ranged from 2.6 logons/person over 32 weeks to 1008 logons/person over 36 weeks. The intervention designs included one-time Web-participant health outcome studies compared to non-Web participant health outcomes, self-paced interventions, and longitudinal, repeated measure intervention studies. Longitudinal studies ranged from 3 weeks to 78 weeks in duration. The effect sizes for the studied outcomes ranged from -.01 to .75. Broad variability in the focus of the studied outcomes precluded the calculation of an overall effect size for the compared outcome variables in the Web-based compared to the non-Web-based interventions. Homogeneity statistic estimation also revealed widely differing study parameters (Q(w16) = 49.993, P < or = .001). There was no significant difference between study length and effect size. Sixteen of the 17 studied effect outcomes revealed improved knowledge and/or improved behavioral outcomes for participants using the Web-based interventions. Five studies provided group information to compare the validity of Web-based vs. non-Web-based instruments using one-time cross-sectional studies. These studies revealed effect sizes ranging from -.25 to +.29. Homogeneity statistic estimation again revealed widely differing study parameters (Q(w4) = 18.238, P < or = .001). CONCLUSIONS: The effect size comparisons in the use of Web-based interventions compared to non-Web-based interventions showed an improvement in outcomes for individuals using Web-based interventions to achieve the specified knowledge and/or behavior change for the studied outcome variables. These outcomes included increased exercise time, increased knowledge of nutritional status, increased knowledge of asthma treatment, increased participation in healthcare, slower health decline, improved body shape perception, and 18-month weight loss maintenance.

Engagement with Care, Substance Use, and Adherence to Therapy in HIV/AIDS.

Engagement with care for those living with HIV is aimed at establishing a strong relationship between patients and their health care provider and is often associated with greater adherence to therapy and treatment (Flickinger, Saha, Moore, and Beach, 2013). Substance use behaviors are linked with lower rates of engagement with care and medication adherence (Horvath, Carrico, Simoni, Boyer, Amico, and Petroli, 2013). This study is a secondary data analysis using a cross-sectional design from a larger randomized controlled trial (n = 775) that investigated the efficacy of a self-care symptom management manual for participants living with HIV. Participants were recruited from countries of Africa and the US. This study provides evidence that substance use is linked with lower self-reported engagement with care and adherence to therapy. Data on substance use and engagement are presented. Clinical implications of the study address the importance of utilizing health care system and policy factors to improve engagement with care.

Additive effects of numbness and muscle aches on fatigue occurrence in individuals with HIV/AIDS who are taking antiretroviral therapy.

CONTEXT: Muscle aches, numbness in the feet/toes (neuropathy), and fatigue are often reported concurrently and are among the symptoms most frequently reported by individuals with HIV/AIDS, whether or not they are taking antiretroviral therapy (ART). OBJECTIVES: This study used a longitudinal analytical methodology to analyze these symptoms together to determine whether symptom clusters are maintained over time and to determine whether there is a temporal relationship between fatigue and reports of neuropathic pain and muscle aches. METHODS: This was a secondary analysis of a subset of data from a six-month, longitudinal, randomized, controlled trial of 243 HIV-positive individuals taking ART. Self-reported symptom frequency and intensity were recorded using the Revised Sign and Symptom Checklist for Persons with HIV disease at baseline (Month 0), one, three, and six months. Multilevel, logistic regression models were used to analyze time-lagged effects of muscle aches, numbness of the feet/toes, and fatigue to estimate any predictive and interactive effects that the symptoms have upon one another. RESULTS: A significant relationship between muscle aches and fatigue intercepts was noted (odds ratio [OR]=1.80, P≤0.05). Significant relationships between numbness and fatigue also were noted for the entire measurement period (OR=2.70, P≤0.05). Time-lagged models showed persons reporting neuropathic-related numbness in one period were nearly twice as likely to report fatigue in subsequent periods (OR=1.89, P≤0.05). The final model revealed that the addition of muscle aches and numbness explained 28% of the random variance in the occurrence of fatigue. Between-person descriptive variables including years living with HIV, age, having an AIDS diagnosis, ethnicity, and nucleoside reverse transcriptase inhibitor treatment regimens with stavudine, zalactabine, or didanosine did not significantly explain any additional model variation. CONCLUSION: These findings are consistent with physiological research and provide evidence that analyzing multiple symptom change over time can provide a more accurate representation of an individual's symptom experience. When evaluating patients with muscle aches or numbness, particularly when both symptoms are present, an evaluation of fatigue should be considered. Similarly, if fatigue is reported, underlying physiological assessments for neuropathic symptoms and muscle aches may be considered.

Exploring HIV stigma and quality of life for persons living with HIV infection.

The purpose of this study was to explore the potential contribution of perceived HIV stigma to quality of life for people living with HIV infection. A cross-sectional design explored the contribution of demographic variables, symptoms, and stigma to quality of life in an international sample of 726 people living with HIV infection. Stigma independently contributed a significant 5.3% of the explained variance in quality of life, after removing contributions of HIV-related symptoms and severity of illness. This study empirically documents that perceived HIV stigma had a significantly negative impact upon quality of life for a broad sample of people living with HIV infection.

A randomized controlled trial testing the efficacy of an HIV/AIDS symptom management manual.

This study investigates whether using an HIV/AIDS symptom management manual with self-care strategies for 21 common symptoms, compared to a basic nutrition manual, had an effect on reducing symptom frequency and intensity. A 775-person, repeated measures, randomized controlled trial was conducted over three months in 12 sites from the United States, Puerto Rico, and Africa to assess the relationship between symptom intensity with predictors for differences in initial symptom status and change over time. A mixed model growth analysis showed a significantly greater decline in symptom frequency and intensity for the group using the symptom management manual (intervention) compared to those using the nutrition manual (control) (t=2.36, P=0.018). The models identified three significant predictors for increased initial symptom intensities and in intensity change over time: (1) protease inhibitor-based therapy (increased mean intensity by 28%); (2) having comorbid illness (nearly twice the mean intensity); and (3) being Hispanic receiving care in the United States (increased the mean intensity by 2.5 times). In addition, the symptom manual showed a significantly higher helpfulness rating and was used more often compared to the nutrition manual. The reduction in symptom intensity scores provides evidence of the need for palliation of symptoms in individuals with HIV/AIDS, as well as symptoms and treatment side effects associated with other illnesses. The information from this study may help health care providers become more aware of self-management strategies that are useful to persons with HIV/AIDS and help them to assist patients in making informed choices.