Outcomes Study HIV Health Survey Research Articles

Short Communication: The Impact of Switching from Atripla to Darunavir/Ritonavir Monotherapy on Neurocognition, Quality of Life, and Sleep: Results from a Randomized Controlled Study.

We investigated whether a treatment switch from Atripla® (tenofovir, emtricitabine, and efavirenz) to DRV/r monotherapy may improve neuropsychological performance, health-related quality of life, and sleep function. Virologically suppressed subjects and asymptomatic on Atripla for ≥6 months were randomized 1:1 to continue Atripla or switch to boosted darunavir (DRV/r) 800/100 mg once daily for 48 weeks. Neurocognitive tests, the International HIV Dementia Scale (IHDS), Medical Outcomes Study HIV Health Survey (MOS-HIV), EQ-5D-3L, and the Hospital Anxiety and Depression Scale (HADS) were completed at baseline and at week 48. Sleep function was evaluated at week 48. Twenty-six patients on DRV/r and 31 on Atripla completed the 48-week study. No significant difference in the change in scores from week 0 to week 48 between the two arms was observed in neurocognitive outcomes, IHDS, health outcomes (EQ-5D-3L and QOL), and HADS score. By contrast, the HADS score and sleep quality were both significantly better in the DRV/r arm. In conclusion, switching to DRV/r monotherapy did not affect neurocognitive function or quality of life but improved anxiety, and sleep quality was significantly better than in continued Atripla.

Health-related quality of life and associated factors in people with HIV: an Irish cohort study.

BackgroundConsidering the chronic and debilitating nature of HIV infection, health-related quality of life (HRQoL) is an important patient-reported clinical outcome to better understand the effects of this infection and its treatment on patients’ lives. The purpose of this study was to assess the HRQoL and its association with sociodemographic, behavioural, clinical, nutrition-related factors and social support in an Irish HIV cohort.MethodsA cross-sectional, prospective study using the Medical Outcomes Study HIV Health survey assessed the 10 dimensions of HRQoL and summarised as Physical Health Summary (PHS) and Mental Health Summary (MHS) scores. Participants were categorised as having good or poor PHS and MHS using the standardised mean score of 50. The variables independently associated with PHS and MHS were identified using multivariable logistic regression models.ResultsOverall, 521 participants completed the HRQoL questionnaire. The median (IQR) PHS and MHS scores were 56 (47–60) and 51 (41–58) respectively. All the covariate groups had lower MHS than PHS. Participants with symptoms of HIV reported the lowest median (IQR) PHS score 44.7 (32.–54.5) and MHS score 36.1 (28.6–48.4). Of the 10 dimensions of HRQoL, the lowest scores were for the energy level and general health. Symptoms of HIV, co-morbidities, social support, employment and ethnicity had independent association with both PHS and MHS. Gender, education, alcohol intake and HIV-complications were associated with PHS. Age, illicit drugs, BMI and malnutrition were associated with MHS. However, CD4 count and viral load were not independently associated with PHS and MHS in multivariable regression models.ConclusionOverall, HIV-infected people in this cohort had an average level of HRQoL. However, it is impaired in people with symptoms and co-morbidities, and not independently associated with CD4 and viral load. Alleviating HIV symptoms and preventing co-morbidities are important in managing HIV. Providing psychosocial supports for behaviour modification and return to work or exploring new opportunities will help to improve HRQoL. Healthcare providers and policy makers need to plan and implement programs to routinely assess the HRQoL in a systematic method to facilitate a holistic management of HIV.

Social Capital and Quality of Life Among People Living With HIV/AIDS in Southeast China.

A cross-sectional study was conducted with 261 people living with HIV (PLWH) in Southeast China. A social capital questionnaire was used to measure social capital dimensions (trust, social connection, and social participation). A Chinese version of the Medical Outcomes Study HIV Health Survey (MOS-HIV) was used to assess Quality of Life (QoL); Physical Health Summary Scores (PHS) and Mental Health Summary Scores (MHS) were calculated. Multiple regression assessed whether social capital and its dimensions were associated with PHS and MHS. After controlling for sociodemographics and HIV-related factors, lower PHS scores were found among participants with low overall social capital (P < .01) and low trust (P < .001). Lower MHS scores were found among participants with low overall social capital (P < .001), low trust (P < .001) and low social connection (P < .01). Our findings identify potential intervention targets to improve QoL among PLWH in Southeast China, including the promotion of social capital.

Related Factors Associated with Quality of life Assessed Using a Chinese Version of the MOS-HIV Health Survey in People with HIV/AIDS in China

Objectives: To evaluate the Chinese version of the 35-item Medical Outcomes Study HIV Health Survey (MOSHIV) in people living with HIV/AIDS (PLWHA) in mainland China and to study its relationship with socio-demographic characteristics and disease-related factors. Methods: 222 PLWHA recruited from outpatient clinics in Hunan province completed measures of quality of life and related factors. Results: Internal consistency of the overall score on the Chinese version of the MOS-HIV was high (α=0.95); internal consistency of the eight subscales was also high (α=0.79-0.91). Factor analysis of the MOS-HIV revealed a one-factor solution, accounting for 54.97% of the total variance. At linear regression analysis, all domains of quality of life (QOL) and Total Health Summary Score (THS) were correlated with KPS scores (r2 range 0.06-0.32), but only physical function and social function scores showed a significant correlation with CD4 cell count; the MOS-HIV however, did not distinguish between HIV disease stage. Using logistic regression analysis, KPS scores, as well as the variables of marriage, employment status, occupation before diagnosis, somebody to talk to, transmission modality of injection drug use and sex partner HIV positive showed statistically associated with a lower quality of life. Conclusions: This study presents the first evidence for the reliability and validity of the Chinese version of MOSHIV among PLWHA in mainland China. Lower scores of the MOS-HIV indicate that the QOL of the PLWHA in our study sample have been poor. This was irrespective of the stage of their disease and CD4 cell counts. This questionnaire has the potential to inform interventions aimed at enhancing and maintaining QOL of PLWHA.

Reproductive health and lifestyle factors associated with health-related quality of life among perinatally HIV-infected adolescents in Uganda.

BackgroundWith increased survival of perinatally HIV - infected adolescents due to antiretroviral therapy (ART), the focus of HIV care has shifted to health-related quality of life (HRQoL) as a measure of disease progression, effects of ART co-morbidity and prognosis. We assessed factors associated with better HRQoL in perinatally HIV -infected adolescents in Uganda by determining the associations between sexual and reproductive health (SRH) or lifestyle experiences on HRQoL.MethodsIn a cross-sectional study, data on SRH, lifestyle experiences, socio demographic factors, communication with parents on sexuality and satisfaction of SRH services in ART clinics were collected from 614 HIV perinatally infected adolescents aged 10–19 using an interviewer-administered survey questionnaire. HRQoL data were collected using the Medical Outcomes Study HIV Health Survey instrument (MOS-HIV). Factors associated with better HRQoL were analysed using multiple logistic regression.ResultsThe mean age was 16.2 ± 2.1 years, 362 (58.8 %) were females and 210 (34.2 %) were sexually active. Adolescents on ART were twice likely to present with better physical health (AOR = 2.07, 95 % CI: 1.24–3.46) and four times more likely to present with better mental health (AOR = 3.9, 95 % CI: 2.22–6.92) than those who were not on ART. There were no statistically significant associations between SRH (ever had sex, ever been pregnant, condom use, contraceptive use) or life style factors and physical health or mental health. Those with secondary or tertiary education were more likely to present with a better mental health (AOR = 5.3, 95 % CI: 1.86–15.41) compared those who had attained primary or no education. Participants who desired to have a child in future more likely (AOR 1.7, 95 % CI: 1.05–3.00) to present with a better mental health. Lack of communication with guardians on sexuality (AOR = 0.6, 95 % CI: 0.40–0.89), or dissatisfaction with SRH services (AOR 0.34, 95 % CI: 0.18–0.62) were associated with poorer mental health.ConclusionAmong perinatally HIV-infected adolescents in Uganda, being on ART was associated with better physical and mental health while lack of communication with guardians on sexuality or dissatisfaction with SRH services was associated with poor mental health. Adolescents with pregnancy intentions were more likely to have a better mental health.

Relationship between CD4 count and quality of life over time among HIV patients in Uganda: a cohort study.

BackgroundImmunological markers (CD4 count) are used in developing countries to decide on initiation of antiretroviral therapy and monitor HIV/AIDS disease progression. HIV is an incurable chronic illness, making quality of life paramount. The direct relationship between quality of life and CD4 count is unclear. The purpose of this study is to determine the relationship between change in CD4 count and quality of life measures in a Ugandan cohort of people living with HIV.MethodsWe prospectively assessed quality of life among 1274 HIV patients attending an HIV clinic within a national referral hospital over a period of 6 months. Quality of life was measured using an objective measure, the Medical Outcomes Study HIV health survey summarized as Physical Health Score and Mental Health Score and a subjective measure, the Global Person Generated Index. Generalized estimating equations were used to analyze the data. The primary predictor variable was change in CD4 count, and the outcome was quality of life scores. We controlled for sociodemographic characteristics, clinical factors and behavioral factors. Twenty in-depth interviews were conducted to assess patient perception of quality of life and factors influencing quality of life.ResultsOf the 1274 patients enrolled 1159 had CD4 count at baseline and six months and 586 (51 %) received antiretroviral therapy. There was no association found between change in CD4 count and quality of life scores at univariate and multivariate analysis among the study participants whether on or not on antiretroviral therapy. Participants perceived quality of life as happiness and well-being, influenced by economic status, psychosocial factors, and health status.ConclusionsClinicians and policy makers cannot rely on change in immunological markers to predict quality of life in this era of initiating antiretroviral therapy among relatively healthy patients. In addition to monitoring immunological markers, socioeconomic and psychosocial factors should be underscored in management of HIV patients.

Lower Self-Reported Quality of Life in HIV-Infected Patients on cART and With Low Comorbidity Compared With Healthy Controls.

Self-reported quality of life (QoL) has previously been found to be impaired in patients living with HIV and associated with viral replication, degree of immunodeficiency, and comorbidity. We aimed at investigating QoL in a group of HIV-infected patients with suppressed viral replication and with low comorbidity, compared with healthy controls. We furthermore aimed to identify factors associated with QoL. Cross-sectional study of 52 HIV-infected patients and 23 healthy controls matched on age, gender, education, and comorbidity. HIV-infected patients and healthy controls had previously been examined regarding cognitive, physical, metabolic, and immunological parameters. QoL was investigated using the Medical Outcomes Study HIV Health Survey (MOS-HIV). Linear multiple regression models were created to find factors associated with mental health summary score (MHS) and physical health summary score (PHS). HIV-infected patients reported lower QoL compared with controls. In HIV-infected patients, female gender and depression score were associated with lower MHS. In controls, years of education, depression score, and cognitive test performance were associated with lower MHS. In HIV-infected patients, years of education, depression score, and body mass index were associated with lower PHS, whereas in controls, years of education and fitness level were associated with PHS. Even well-treated HIV-infected patients with low level of comorbidity reported lower QoL compared with healthy controls. Especially, depression score and body mass index were associated with QoL in HIV-infected patients.

Quality of life and self-reported lower extremity function in adults with HIV-related distal sensory polyneuropathy.

Distal sensory polyneuropathy (DSP) is a common complication of HIV disease. Its effects on quality of life (QOL) and function have not been well described. The study objectives were: (1) to compare QOL and lower extremity function in people with HIV-related DSP and people with HIV disease who do not have DSP, (2) to determine the extent to which function predicts QOL, (3) to evaluate the agreement of 2 function scales, and (4) to describe the use of pain management resources. This was a cross-sectional survey study with predictive modeling and measurement tool concordant validation. A demographic questionnaire, the Medical Outcomes Study HIV Health Survey, the Lower Extremity Functional Scale (LEFS), the Lower Limb Functional Index (LLFI), and a review of medical records were used. General linear modeling was used to assess group differences in QOL and the relationship between function and QOL. Bland-Altman procedures were used to assess the agreement of the LEFS and the LLFI. Usable data for analyses were available for 82 of the 94 participants enrolled. The 67% of participants who reported DSP symptoms tended to be older, had HIV disease longer, and were more likely to receive disability benefits. Participants without DSP had better LLFI, LEFS, and physical health summary scores. In multivariate models, lower limb function predicted physical and mental health summary scores. The LLFI identified participants with a lower level of function more often than the LEFS. Participants with DSP were more likely to use medical treatment, physical therapy, and complementary or alternative treatments. A sample of convenience was used; the sample size resulted in a low power for the mental health summary score of the Medical Outcomes Study HIV Health Survey. Quality of life and function were more impaired in participants with HIV disease and DSP. The LLFI was more likely to capture limitations in function than the LEFS. Participants with DSP reported more frequent use of pain management resources.

Usefulness of Patient-Generated Index for HIV to Measure Individual Quality of Life: A Study from Thailand

ObjectivesTo measure health-related quality of life (HRQOL) in Thai HIV patients using the patient-generated index for HIV (PGI-HIV) and to compare the psychometric properties of the PGI-HIV with those of the EuroQol five-dimensional (EQ-5D) questionnaire and the Medical Outcome Study HIV Health Survey in terms of practicality, reliability, validity, and responsiveness. MethodsIn this study, two rounds of interviews were carried out in HIV outpatients who met the eligibility criteria and attended the HIV Clinic of Warinchamrap Hospital between January and March 2010. The patients were interviewed using a data collection form and three HRQOL measures (the PGI-HIV, the EQ-5D questionnaire, and the Medical Outcome Study HIV Health Survey) to assess the practicality and validity. The second interview was performed to check the test-retest reliability and responsiveness. ResultsA total of 210 patients completed the study. They were mostly women (69.5%), with a mean age of 39.2 ± 11.1 years. The majority with the US Centers for Disease Control and Prevention clinical stage C took the current antiretroviral drugs within 1 year. The average PGI score was about 0.60, implying HIV/AIDS and antiretroviral drug therapy decreased the patients’ quality of life by 40% from their healthy life. Three mostly cited impact domains were hyperlipidemia, lipid maldistribution and lipodystrophy, and hepatitis. The PGI-HIV was considered as practical, with a mean difficulty score of 3.7 ± 0.8, highly reliable (intraclass correlation coefficient = 0.75; P < 0.001), and responsive to HRQOL changes (effect size = 0.81; standardized response mean = 0.99), but not valid when compared with CD4 levels and viral loads (all Pearson’ r < 0.2; P > 0.05). ConclusionsThe PGI-HIV was used to measure the individual HRQOL in a Thai sample of HIV-positive patients. It proves to be practical, highly reliable, and very responsive to changes in patients’ HRQOL.

DI-027 Quality of life in older HIV-infected patients with antiretroviral therapy

BackgroundAdvances in antiretroviral therapy have resulted in more potent and safe drugs, with higher success rates due to improved adherence and better control of the HIV infection. Efforts to improve...

The Role of Depression in Work-Related Outcomes of HIV Treatment in Uganda

The primary goal of this analysis was to examine the influence of depression above and beyond the effects of HIV treatment on work activity and function. We combined data from three longitudinal studies of patients starting antiretroviral therapy (ART) and/or entering HIV care in Uganda. Assessments were conducted at baseline and months 6 and 12. The nine-item Patient Health Questionnaire (PHQ-9) was used to assess depressive symptoms, as well as Major (scores >9) and Minor (scores 5-9) Depression status; work functioning was assessed using a subscale of the Medical Outcomes Study HIV Health Survey (MOS-HIV). Multivariate random-effects logistic regression models for longitudinal data were used to examine the impact of treatment on work status and optimal work functioning, with measures of both baseline and change in physical health functioning, cognitive functioning and depression in the models, controlling for baseline demographics, and CD4 cell count. The sample of 1,731 participants consisted of 1,204 starting ART and 527 not yet eligible for ART. At baseline, 35% were not working, and 37% had sub-optimal work functioning. Intention-to-treat analyses revealed that those on ART experienced greater improvement in both work outcomes over 12months relative to non-ART patients, and that baseline and change in physical health functioning, continuous and categorical depression were all independently associated with improvement in both work outcomes, even after accounting for the direct effect of ART. Improvement in physical and mental health plays a key role in the positive impact of HIV treatment on work activity and function, suggesting potential economic benefits of integrating depression treatment into HIV care.

Loss and growth: Identity processes with distinct and complementary impacts on well-being among those living with chronic illness

The diagnosis and treatment of any chronic illness are a major source of stress for most individuals. Although many individuals living with chronic illness report experiencing growth that arises from this experience, studies have revealed mixed results regarding the association between reported growth and other aspects of psychological well-being. This pilot study examines the complementary and buffering influences of self-growth on self-loss in perceptions of physical and mental health among individuals living with HIV (N = 60). The sample was comprised of a racially/ethnically diverse sample of men and women ranging in age from 27 to 62. Measures included impact of illness on Self-Concept Scale, the Medical Outcomes Study HIV Health Survey, the HIV Symptom Index, and the Center for Epidemiological Studies Depression Scale. Regression analyses were conducted to examine the impact of self-growth and self-loss on self-reported bothersome symptoms and depression, controlling for demographic covariates and physical health. Self-loss accounted for a significant proportion of variance in both bothersome symptom reports and depression, after controlling for physical health. In multivariate analysis, self-growth appeared to buffer the negative impact of self-loss on bothersome symptoms, but not on depression. These data suggest that self-loss is a critical construct in understanding adaptation to chronic illness, and that identity processes may influence symptom perception and mental health outcomes above and beyond the impact of traditional measures of health status.

Patient reported outcome instruments used in clinical trials of HIV-infected adults on NNRTI-based therapy: a 10-year review.

BackgroundPatient-reported outcomes (PROs) may provide valuable information to clinicians and patients when choosing initial antiretroviral therapy.ObjectiveTo identify and classify PRO instruments used to measure treatment effects in clinical trials evaluating NNRTIs.MethodsWe conducted a structured literature review using PubMed to identify NNRTI trials published from March 2003 to February 2013. Studies identified--based on disease, instrument, PRO, and NNRTI medication terms were reviewed--to identify PRO instruments. Domains measured within each instrument were recorded to understand key areas of interest in NNRTIs.ResultsOf 189 articles reviewed, 27 validated instruments were administered in 26 unique trials, with a mean of 1.9 instruments (median: 1; range: 1–7) per trial. The Medical Outcomes Study HIV Health Survey (MOS-HIV) was the most commonly used instrument (n = 8 trials). Seventeen trials (65%) included at least one multidimensional health-related quality of life (HRQL) instrument (HIV-targeted, n = 11; general, n = 8). Other validated instruments measured sleep (n = 5), depression (n = 5), anxiety (n = 4), psychiatric symptoms (n = 2), beliefs about HIV medications (n = 2), HIV symptoms (n = 1), and stress (n = 1).ConclusionsAlthough review of recent NNRTI trials suggests a lack of consensus on the optimal PRO instruments, a typical battery is comprised of a multidimensional HRQL measure coupled with one or more symptom measures. Further work is needed to clarify advantages and disadvantages of using specific PRO instruments to measure relevant constructs and to identify the most useful batteries of instruments for NNRTI trials.

Responsiveness of the MOS-HIV and EQ-5D in HIV-infected adults receiving antiretroviral therapies

BackgroundSelection of an appropriate patient-reported outcome (PRO) instrument for a clinical trial requires knowledge of the instrument’s responsiveness to detecting treatment effects. The purpose of this study was to examine the responsiveness of two health-related quality of life (HRQL) instruments used in clinical trials involving HIV-infected adults: the HIV-targeted Medical Outcomes Study HIV Health Survey (MOS-HIV), and a generic measure, the EuroQol-5D (EQ-5D).MethodsA systematic review identified clinical trials using the MOS-HIV or EQ-5D to assess outcomes for HIV-infected adults. Data abstracted from each study included study type, treatment regimen(s), PRO results, and effect size (either reported or calculated). Effect size was calculated as the difference between baseline and follow-up mean scores divided by the baseline standard deviation. Magnitude was categorized as small (d=0.20), medium (d=0.50), and large (d=0.80).ResultsBetween 2005 and 2010, the MOS-HIV was administered in 12 trials. Significant differences were observed between groups and over time in physical health summary (PHS) and mental health summary (MHS) scores (P<0.05) in subjects switching therapy after experiencing Grade-2 adverse events. Effect sizes were medium (0.55 and 0.49 for PHS and MHS, respectively) among treatment-naïve adults beginning therapy (two studies), but negligible among treatment-experienced adults (0.04 and 0.13 for PHS and MHS, respectively; three studies). The EQ-5D was used in five trials between 2001 and 2010. It was responsive to occurrences of adverse events and opportunistic infections, with small-to-medium effect sizes (range 0.30–0.50) in each of its five dimensions.ConclusionsA systematic review of PRO study results showed both the MOS-HIV and EQ-5D were responsive to changes between groups and/or over time in treatment-naïve HIV-infected patients. These instruments may be used either individually or together in clinical trials to measure changes in HRQL.

Gender differences in health related quality of life of people living with HIV/AIDS in the era of highly active antiretroviral therapy

Background:Data about the health-related quality of life (HR-QOL) of people living with HIV/AIDS (PLHA) after the implementation of free antiretroviral treatment in India are scarce.Aim:The study was to describe the HR-QOL and gender differences of PLHA in rural India.Materials and Methods:Cross sectional study of 120 PLHA who came to the outpatient department in a rural district hospital. Assessment of the HR-QOL was performed through interviews using a validated structured questionnaire from the Medical Outcome Study HIV Health Survey. Linear regression with robust standard errors was used for multivariable analysis.Results:Domains related to social and daily activities such as cognitive, role and social functioning had lower HR-QOL scores than domains related to physical health. Men had higher scores of HR-QOL in health transition, perceived HR-QOL, health distress, social functioning and role functioning. In multivariable analysis, factors associated with poorer HR-QOL were female sex, lower levels of education and being widowed or separated in women.Conclusions:HR-QOL of PLHA in rural India is poor, especially in widowed or separated women and people with lower levels of education. There is an urgent need of implementing programmes for improving the HR-QOL of HIV infected women in rural India.

Effectiveness of Cognitive Behavioral and Spiritual Trainings on Improving Mental Health of HIV Positive Drug Addicts

Background: HIV positive drug addict are in need of extensive social support to be able to fight against the destructive effects of this disease including the resulting mental and physical problems. Objectives: The present research has been designed to study the effectiveness of cognitive-behavioral trainings with an emphasis on spirituality to improve the mental health of this group of individuals in the society. Patients and Methods: This research was semi-experimental with pre-test and post-test design and control group. The statistical population included all 300 HIV positive drug addicted males who had referred to the health center, located west of Tehran, during 2009. 30 out of 300 individuals were randomly selected as a sample group. They were divided into two groups: 15 in the experimental and 15 in the control. The experimental group participated in a cognitive-behavioral and spiritual training program (8 sessions each 90 minutes, per week). In order to study the effect of the treatment; a questionnaire of life quality measurement from the Medical Outcomes Study HIV Health Survey (MOS-HIV) was used. This questionnaire was validated (with one-month time interval) through a retesting method (Cronbach's Alpha 0.70). The sample group completed the questionnaire at two stages, pre-education and post-education programs. The data was analyzed by the t-test to compare the mean differences of mental and physical health in experimental and control groups. Results: The result of the present research showed that cognitive-behavioral trainings with an emphasis on spirituality were effective for improving quality of life, regarding general aspects of mental and physical health, sub-scales of general health, physical performance, the performance of role, physical pain, social performance, energy, stress and, cognitive performance of HIV positive drug addicts (P < 0.01). Conclusions: It can be concluded that cognitive-behavioral and spiritual training was effective for the improvement of mental health of HIV positive drug addicts.

A clinical trial to compare the quality of life of HIV+ patients who start monotherapy with LPV/r versus continuing triple therapy with a boosted PI

Purpose of the studyEfficacy, toxicity and complexity of antiretroviral (ARV) regimens may impact the quality of life (QoL). Since over the past years the simplification approach of lopinavir/ritonavir (LPV/r) as monotherapy (MT) has been shown to be non‐inferior to triple therapy (TT) in virological and immunological efficacy, the objective of this study was to compare several health‐ and treatment‐related outcomes between both ARV strategies with LPV/r.MethodsA phase IV national, multicenter, controlled, randomized (2:1), open label, parallel‐group clinical trial to compare the QoL in patients on ARV TT containing any boosted protease inhibitor (PI), undetectable viral load (VL&lt; 50 cop/mL) in the past 6 months and a CD4 nadir &gt; 100 cells/µL, versus those who were simplified to LPV/r MT, for 24 weeks. QoL and health outcomes were evaluated by the Medical Outcomes Study HIV Health Survey (MOS‐HIV) and the five‐dimensional EuroQol questionnaire (EQ‐5D). Treatment satisfaction was assessed by the Spanish Questionnaire of Satisfaction with ARV Treatment (CESTA). Treatment adherence was assessed by the Spanish Multifactorial Adherence questionnaire (GEEMA) and a visual analog scale (VAS). Tolerability, safety and virological and immunological efficacy at week 24 were also analyzed.Summary of results225 patients from 29 sites were enrolled (MT: 146, 64.5%; TT: 79, 35.1%). Mean age (years) was 44.5 in MT and 45.2 in TT (p=0.745); mean duration (years) from HIV infection was 13.4 in MT and 12.8 in TT (p=0.587) and 71% were male in both arms. 87.6% of patients completed correctly the study (MT: 88.4%; TT: 86.1%; p=0.674). Health and treatment outcomes evaluated at final study visit are shown in figure 1 1. At study end, 84.1% in MT and 89.6% in TT had undetectable VL (p=0.313) and mean CD4 count were 742.8 cells/µL in MT and 646.5 cells/µL in TT (p=0.060). There were no significant differences in the percentage of patients with virological failure at week 24 as VL &gt;50 cop/mL (MT: 8.2%; TT: 3.9%; p=0.271) and as VL &gt;200 cop/mL (MT: 3.4%; TT: 0%; p=0.167).‘Quality of life’ impact: monotherapy vs triple therapy.imageConclusionsThe MT simplification strategy with LPV/r maintains comparable virological and immunological efficacy, as well as the tolerability profile, than the TT. The saving resulting from NRTIs withdrawal from the ARV regimen and the good results on QoL and patients treatment satisfaction make MT strategy with LPV/r be taken into account in clinical practice.

Health-Related Quality of Life ‘Well-Being' in HIV Distal Neuropathic Pain is More Strongly Associated with Depression Severity than with Pain Intensity

Despite modern antiretroviral treatment, HIV-associated distal neuropathic pain (DNP) remains one of the most prevalent and debilitating complications of HIV disease. Neuropathic pain is often accompanied by depressed mood, and both pain and depression have been associated with decreased health-related quality of life (HRQOL) well-being. The relative contribution of depression and pain to worse life quality has not been addressed, however, even though a better understanding might sharpen intervention strategies. We used the Medical Outcomes Study HIV (MOS-HIV) Health Survey and the Beck depression inventory-II and linear regression models to investigate HRQOL well-being in HIV-infected patients with DNP (n = 397) participating in an observational cohort study at six U.S. sites (CNS HIV Antiretroviral Treatment Effects Research Study, CHARTER). For this sample of patients with HIV DNP, severity of depressed mood was more highly correlated with HRQOL well-being than was pain intensity. These results suggest that interventions to improve HRQOL well-being in individuals with HIV-associated DNP may need to address not only pain intensity but mood state as well.

Reliability and construct validity of three health-related self-report scales in HIV-positive adults in rural Rwanda

Depression, low health-related quality of life, and low perceived social support have been shown to predict poor health outcomes, including HIV-related outcomes. Mental health morbidity and HIV are important public health concerns in Rwanda, where approximately half of the current population is estimated to have survived the genocide and 3% is living with HIV. We examined the reliability and construct validity of the Hopkins Symptom Checklist-15 (HSCL-15), the Medical Outcomes Study HIV Health Survey (MOS-HIV), and the Duke/UNC Functional Social Support Questionnaire (DUFSSQ), which were used to assess depression, health-related quality of life, and perceived social support, respectively, among HIV-infected adults in rural Rwanda. We also studied whether scale reliability differed by gender, literacy status, or antiretroviral therapy (ART) delivery strategy. The Kinyarwanda versions of the HSCL-15, MOS-HIV, and DUFSSQ performed well in the study population. Reliability was favorable (Cronbach's alpha coefficients ≥0.75 or above) for the scales overall and across subgroups of gender, literacy, and mode of ART delivery. The scales also demonstrated good convergent, discriminant, and known-group validity.

Quality of Life of People With HIV/AIDS Receiving Antiretroviral Therapy in Cuba: A Cross-Sectional Study of the National Population

We studied the effect of antiretroviral therapy (ART) on the quality of life (QOL) of Cubans with HIV/AIDS. We conducted a cross-sectional study including administration of the Medical Outcomes Study-HIV Health Survey Questionnaire to a representative sample of the 1592 Cubans receiving ART in 2004. For univariate analyses, we compared mean HIV scale scores. We used logistic regression models to estimate the association between role function and year of diagnosis, between pain and sex, and between health transition and region of diagnosis, with adjustment for demographics, ART regimen, and clinical status. There were 354 participants (73 women, 281 men). Scores for all functional activities showed means higher than 80 out of 100. Pain interfered more in women than in men (73.2 vs 81.9; P = .01). When HIV diagnosis occurred after 2001, the probability of experiencing difficulties performing work (odds ratio [OR] = 4.42; 95% CI = 1.83, 10.73) and pain (OR = 1.70; 95% CI = 1.01, 2.88) increased compared with earlier diagnosis. People treated with indinavir showed a greater perception of general health (58.9 vs 52.4; P = .045) and greater health improvement (78.6 vs 67.8; P = .002). Although Cubans receiving ART are maintaining a high QOL, we observed significant differences by sex and time of diagnosis. QOL assessment can serve as a health outcome and may allow identification of QOL reductions potentially related to ART side effects.