A prospective, randomized trial examining the efficacy and safety of clarithromycin in combination with ethambutol, rifabutin, or both for the treatment of disseminated Mycobacterium avium complex disease in persons with acquired immunodeficiency syndrome.

This multicenter, randomized, open-label phase 3 clinical trial compared the safety and efficacy of 3 clarithromycin-containing combination regimens for the treatment of disseminated Mycobacterium avium complex (MAC) disease in persons with acquired immunodeficiency syndrome. A total of 160 eligible patients with bacteremic MAC disease were randomized to receive clarithromycin with either ethambutol (C+E), rifabutin (C+R), or both (C+E+R) for 48 weeks. After 12 weeks of treatment, the proportion of subjects with a complete microbiologic response was not statistically significantly different among treatment arms: the proportion was 40% in the C+E group, 42% in the C+R group, and 51% in the C+E+R group (P=.454). The proportion of patients with complete or partial responses who experienced a relapse while receiving C+R (24%) was significantly higher than that of patients receiving C+E+R (6%; P=.027) and marginally higher than that of patients receiving C+E (7%; P=.057). Subjects in the C+E+R group had improved survival, compared with the C+E group (hazard ratio [HR], 0.44; 95% confidence interval [CI], 0.23-0.83) and the C+R group (HR, 0.49; 95% CI, 0.26-0.92).

Aerobic exercise training for depressive symptom management in adults living with HIV infection.

Aerobic exercise training may help prevent or reduce depressive symptoms experienced by persons living with HIV infection. However, the psychological effects of aerobic exercise have not been studied extensively. This study evaluated the effects of an aerobic exercise training program on self-reported symptoms of depression in HIV-infected adults and examined the convergent validity of two widely used depressive symptom scales. Sixty HIV-infected adults participated in a randomized, controlled trial of a supervised 12-week aerobic exercise training program. As compared to study controls, exercise participants showed reductions in depressive symptoms on all indices, and total depressive symptoms scores were highly correlated. Additional study of the psychological effects of aerobic exercise programs in the target population is recommended.

Illness representation and smoking behavior: a focus group study of HIV-positive men.

Focus group interviews were conducted with 13 men living with HIV (mean age = 44.7) to explore their beliefs about cigarette smoking and HIV. Interview data were audiotaped, transcribed verbatim, and systematically analyzed using inductive techniques. Participants believed cigarette smoking provides a number of benefits to persons living with HIV. Although participants acknowledged that smoking has disadvantages, smokers generally discounted health risks, noting how it improves their sense of well-being and reasoning that they would not live long enough to suffer its consequences. Although smoking is a risk factor for HIV-related morbidity and mortality, rates of smoking are high among men living with HIV. Research completed with other population groups finds beliefs are significant in explaining variance in smoking behavior change. Smoking-cessation programs targeting HIV-positive men may be more successful if illness-specific belief systems are taken into account. Additional study is warranted to substantiate the effectiveness of this approach.

Characteristics of nausea reported by HIV-infected patients initiating combination antiretroviral regimens.

Reliable data on the incidence and severity of nausea accompanying combination antiretroviral therapies is lacking. A prospective time series design was used to assess the rate, severity, and distress of nausea in a cohort of 75 HIV-positive patients who were beginning or changing a combination of two or more antiretroviral medications. Data were collected via telephone at weekly intervals for 12 weeks. The rate of nausea across regimens was greatest at Week 1 (39%) and declined progressively over time. By Week 12, the rate of nausea was only 5%. Severity of nausea was ranked as moderate or severe by a substantial proportion of patients through Week 10; however, nausea severity and distress were also found to diminish over time. The nausea associated with combination antiretroviral therapy is quite common and may adversely affect medication adherence. Findings indicate that clinicians should consider initiating interventions for management of antiretroviral-related nausea at baseline.

The forms and functions of peer social support for people living with HIV.

Peers may be important sources of coping assistance, but their impact can be better understood if we examine their influence across various contexts. Although social support studies focused on people living with HIV have examined peer support in various contexts, they do not comprehensively account for situations in which peer support might be provided. The specific aims of this study were to (a) describe the various forms and functions of peer support for people living with HIV and (b) validate the Dennis (2003) concept analysis of peer support within health contexts. Results indicate that peer support is a potentially important adjunct to clinical care for enhancing coping skills, thereby improving the psychosocial functioning of people living with HIV. It is important to (a) assess patient access to peer support, (b) provide opportunities for peer support in the clinical setting, and (c) enhance disclosure and support-seeking skills to facilitate this benefit.

Telephone support to improve antiretroviral medication adherence: a multisite, randomized controlled trial.

OBJECTIVE: To determine whether proactive telephone support improves adherence to antiretroviral therapy (ART) and clinical outcomes when compared to standard care. METHODS: A multisite, randomized controlled trial (RCT) was conducted with 109 ART-naive subjects coenrolled in AIDS Clinical Trials Group (ACTG) 384. Subjects received standard clinic-based patient education (SC) or SC plus structured proactive telephone calls. The customized calls were conducted from a central site over 16 weeks by trained registered nurses. Outcome measures (collected over 64 weeks) included an ACTG adherence questionnaire and 384 study endpoints. RESULTS: For the primary endpoint, self-reported adherence, a significantly better overall treatment effect was observed in the telephone group (P = 0.023). In a post hoc analysis, composite adherence scores, taken as the first 2 factor scores from a principal components analysis, also found significant intervention benefit (P = 0.023 and 0.019 respectively). For the 384 primary study endpoint, time to regimen failure, the Kaplan-Meier survival curve for the telephone group remained above the SC group at weeks 20 to 64; a Cox proportional hazard model that controlled for baseline RNA stratification, CD4, gender, age, race/ethnicity, and randomized ART treatment arm suggested the telephone group tended to have a lower risk for failure (hazard ratio = 0.68; 95% confidence interval: 0.38 to 1.23). CONCLUSIONS: Findings indicate that customized, proactive telephone calls have good potential to improve long-term adherence behavior and clinical outcomes.

Motivations for participating in an HIV vaccine efficacy trial.

Understanding why people join HIV vaccine efficacy trials is critical for trial recruitment and education efforts. We assessed participants' motivations for joining the VaxGen VAX004 study, a randomized, double-blind, placebo-controlled, phase 3 multicenter trial. Of 5417 participants, 94% were men who have sex with men (MSM) and 6% were women at risk for heterosexual transmission of HIV. Most participants gave altruistic reasons for trial participation: 99% reported having joined to help find an HIV vaccine, and 98% reported having joined to help their community. Some gave more personal reasons: 56% joined to reduce risk behavior and 46% joined to get protection from HIV. Additional reasons related to receiving services or compensation included to obtain information about HIV (75%), to receive free HIV testing (34%), and for financial reimbursement (14%). Multivariate logistic regression analysis showed that female participants were significantly more motivated than male participants to join the trial for protection and to receive services or compensation (all P<0.05). Participants with 13 or more sex partners in the 6 months before enrollment were more likely than those with fewer sex partners to report having joined the trial for protection but less likely to have joined to reduce risk behavior (both P<0.05). Because many participants reported personal protection from HIV as their reason for joining, vaccine trial risk-reduction counseling should continue to emphasize the placebo-controlled trial design and unknown efficacy of the test product, particularly for women and persons with large numbers of sex partners. Because a significant minority of participants reported joining to receive HIV information, HIV testing, and financial reimbursement, a need is indicated for provision of HIV prevention services outside research trials and for monitoring to ensure that participants are not motivated to join trials for financial gain.

Social support and the management of uncertainty for people living with HIV or AIDS.

People with chronic and acute illnesses experience uncertainty about their prognoses, potential treatments, social relationships, and identity concerns. In a focus group study of people living with HIV or AIDS, we examined how social support may facilitate or interfere with the management of uncertainty about health, identity, and relationships. We found that support from others helps people with HIV or AIDS to manage uncertainty by (a) assisting with information seeking and avoiding, (b) providing instrumental support, (c) facilitating skill development, (d) giving acceptance or validation, (e) allowing ventilation, and (f) encouraging perspective shifts. Respondents also reported a variety of ways in which supportive others interfered with uncertainty management or in which seeking support imposed costs. Problems associated with social support and uncertainty management included a lack of coordination in uncertainty management assistance, the addition of relational uncertainty to illness uncertainty, and the burden of others' uncertainty management. Our study reveals strategies respondents used to manage costs and complications of receiving support, including developing an active or self-advocating orientation, reframing supportive interactions, withdrawing from nonproductive social situations, selectively allowing others to be support persons, and maintaining boundaries.

The medical, personal, and social causes of uncertainty in HIV illness.

Uncertainty is an important part of the illness experience. Mishel elaborated a theory of uncertainty in acute illness and later expanded the framework to account for uncertainty in chronic illness. Researchers subsequently have investigated the causes and outcomes associated with the uncertainty in illness experience across a variety of medical conditions. The current study applies and extends Mishel's model within the context of HIV illness-related uncertainty. In this qualitative study, focus group methods were used to examine the nature of illness uncertainty experienced by persons living with HIV or AIDS. Findings confirm Mishel's contention that the causes of uncertainty extend beyond those of medical diagnosis, treatment, and recovery to personal and social aspects of daily life. Identified sources of uncertainty may have important mental health and quality of life implications.

Factors influencing medication adherence beliefs and self-efficacy in persons naive to antiretroviral therapy: a multicenter, cross-sectional study.

It is widely recognized that adherence to antiretroviral therapy is critical to long-term treatment success, yet rates of adherence to antiretroviral medications are frequently subtherapeutic. Beliefs about antiretroviral therapy and psychosocial characteristics of HIV-positive persons naive to therapy may influence early experience with antiretroviral medication adherence and therefore could be important when designing programs to improve adherence to antiretroviral therapy. As part of a multicenter AIDS Clinical Trial Group (ACTG 384) study, 980 antiretroviral-naive subjects (82% male, 47% White, median age 36 years, and median CD4 cell count 278 cells/mm3) completed a self-administered questionnaire prior to random treatment assignment of initial antiretroviral medications. Measures of symptom distress, general health and well-being, and personal and situational factors including demographic characteristics, social support, self-efficacy, depression, stress, and current adherence to (nonantiretroviral) medications were recorded. Associations among variables were explored using correlation and regression analyses. Beliefs about the importance of antiretroviral adherence and ability to take antiretroviral medications as directed (adherence self-efficacy) were generally positive. Fifty-six percent of the participants were "extremely sure" of their ability to take all medications as directed and 48% were "extremely sure" that antiretroviral nonadherence would cause resistance, but only 37% were as sure that antiretroviral therapy would benefit their health. Less-positive beliefs about antiretroviral therapy adherence were associated with greater stress, depression, and symptom distress. More-positive beliefs about antiretroviral therapy adherence were associated with better scores on health perception, functional health, social-emotional-cognitive function, social support, role function, younger age, and higher education (r values = 0.09-0.24, all p < .001). Among the subset of 325 participants reporting current use of medications (nonantiretrovirals) during the prior month, depression was the strongest correlate of nonadherence ( r = 0.33, p < .001). The most common reasons for nonadherence to the medications were "simply forgot" (33%), "away from home" (27%), and "busy" (26%). In conclusion, in a large, multicenter survey, personal and situational factors, such as depression, stress, and lower education, were associated with less certainty about the potential for antiretroviral therapy effectiveness and one's perceived ability to adhere to therapy. Findings from these analyses suggest a role for baseline screening for adherence predictors and focused interventions to address modifiable factors placing persons at high risk for poor adherence prior to antiretroviral treatment initiation.