Quality of life and adherence to antiretroviral therapy in Southern Brazil

The absence of or limited adherence to treatment is the main cause for the failure of Highly Active Antiretroviral Therapy (HAART). In Brazil, adherence to antiretroviral therapy has been lower than the recommended levels. Although HAART may produce adverse reactions, failure to comply with it may aggravate patients' health status and impair Quality of Life (QoL). The QoL of individuals living chronically with HIV and AIDS has been considered one of the main treatment outcomes. This study is part of a 225-day prospective trial in which participants were enrolled in two different modalities of follow-up: the usual model medical follow-up or an intervention based on the Medication Adherence Training Instrument (MATI). The WHOQOL-HIV BREF questionnaire was used to evaluate QoL of research participants in both groups on the 15th and 225th days of follow-up after the baseline assessment. The result of this study revealed no significant differences of WHOQOL-HIV BREF scores between participants allocated to MATI and non-MATI groups in the first assessment. However, there was a significant difference between the scores obtained on the 15th and 225th days in the domain related to spirituality and personal beliefs irrespective of the modality of follow-up. Other domains of the WHOQOL-HOV BREF remained unchanged. These results indicate that, in this sample, personal beliefs and spirituality may be relevant subjects to explain sustained levels of adherence to HAART.     

Enhancing adherence to antiretroviral therapy at the HIV clinic in resource constrained countries; the Tanzanian experience

Objective  To evaluate various strategies aimed at improving adherence to antiretroviral therapy (ART).
Methods  Patients initiated on ART at Muhimbili National Hospital HIV clinic were randomly assigned to either regular adherence counseling, regular counseling plus a calendar, or regular counseling and a treatment assistant. Patients were seen monthly; during these meetings self-reported adherence to treatment was recorded. Disease progression was monitored clinically and immunologically.
Results  Of the 621 patients randomized, 312 received regular counseling only, 242 regular counseling and calendars, while 67 had treatment assistants in addition to regular counseling. The mean (SD) follow-up time was 14.5 (4.6) months. During follow-up 20 (3.2%) patients died, and 102 (16.4%) were lost to follow-up; this was similar in all groups. In 94.8% of all visits, patients reported to have adhered to treatment. In only 39 (0.7%) visits did patients report a ≤95% adherence. There were no differences in adherence ( P  = 0.573) or differences in CD4 count and weight changes over time in the interventions.
Conclusions  Good adherence to ART is possible in resource constrained countries. Persistent adherence counseling in clinic settings by itself may be effective in improving adherence to ART.     

Adherence to antiretroviral therapy among HIV-positive children: examination of the role of caregiver health beliefs

This study examined the association between two components of the Health Belief Model (perceived vulnerability and barriers) and adherence to antiretroviral therapy (ART) among children who are HIV-infected. The parents/caregivers of 30 children (mean age = 5.21, SD = 3.18) who were HIV-infected and who were on active ART were surveyed to assess current methods of adherence assessment and educational efforts within the institution. All participants (except one) were African American and reported low monthly family incomes (M = $869.45, SD = $832.63). Assessment instruments included measures of perceived vulnerability, caregiver-reported adherence and perceived barriers, and objective measures of adherence (clinical pill count; electronic measurement). The results failed to demonstrate a significant relationship between parental perceived vulnerability, perceived barriers and adherence to antiretroviral medications. Methods of assessing adherence provided significantly discrepant estimates of adherence. Results are discussed in terms of implications for patient care and for future research in this area. The addition of behavioural and motivational components to traditional educational approaches may positively impact treatment results.     

Cognitive-behavioral intervention to enhance adherence to antiretroviral therapy: a randomized controlled trial (CCTG 578)

OBJECTIVE: We conducted a randomized, multi-site, controlled trial of a cognitive-behavioral adherence intervention for patients initiating or changing an antiretroviral (ART) regimen. DESIGN: A 3 x 2 factorial design was used with the primary randomization assigning patients (1: 1: 1) to one of two adherence interventions or usual care. METHODS: The five-session adherence interventions consisted of cognitive-behavioral and motivational components, with or without a 2-week pre-treatment placebo practice trial. Intent-to-treat analysis used probability weights and regression tree analysis to account for missing data. RESULTS: A total of 230 patients were randomized; 199 started ART, of whom 74% completed the 48-week study. Electronic monitored adherence outcomes between the two intervention groups did not differ significantly and were thus pooled in analyses. At week 4, 82% of intervention patients had taken at least 90% of their prescribed ART doses, compared with 65% of controls (P < 0.01); this group difference dropped to 12% at week 12 (72 versus 60%; P = 0.15) and 11% at week 24 (66 versus 55%; P = 0.28). Mean adherence in the intervention group was significantly higher than the control group at week 24 (89 versus 81%; P < 0.05) only. There were no group differences with respect to HIV-1 RNA throughout the study. CONCLUSIONS: The effects of the cognitive-behavioral intervention on adherence were modest and transient, and no effects were observed on viral load or CD4 cell count. More robust effects may require a more intense intervention that combines ongoing adherence monitoring and individualized intervention "dosage" that matches the need and performance of each patient.     

Food Insecurity,HIV Disease Progression and Access to Care Among HIV-Infected Russians not on ART

Food insecurity (FI) has been associated with HIV disease progression among people on antiretroviral therapy (ART), presumably a consequence of poor medication adherence. We assessed whether there is a longitudinal association between FI and two primary outcomes reflecting on HIV disease progression (i.e., CD4 count and time to ART initiation) among people not on ART. Analyses used linear mixed effects and Cox models controlling for confounders. In this cohort (n = 310) FI was common (53%). Most (71.3%) reported past month heavy alcohol use and 37.1% reported past month injection drug use. Only 50 participants initiated ART during the study and mean time to ART was 128 days (SD 120). There were no significant differences in CD4 cell count between the groups with mild/moderate FI or severe FI versus those with no FI [adjusted mean difference, mild/moderate insecurity versus no FI ?32.5 (95% CI ?94.3, 29.3); severe versus no FI ?45.5 (95% CI ?124.1, 33.0); global p = 0.42]. We found no significant association between FI and longer time to ART initiation (p = 0.36). Food security is a desirable goal for overall health and shown beneficial for those on ART, however it does not appear to be associated with HIV disease progression among those with high prevalence of substance use and not yet on ART.     

Counseling for improving adherence to antiretroviral treatment: a systematic review

One-on-one counseling can be an effective strategy to improve patient adherence to HIV treatment. The aim of this systematic review is to examine articles with one-on-one counseling-based interventions, review their components and effectiveness in improving ART adherence. A systematic review, using the following criteria was performed: (i) experimental studies; (ii) published in Spanish, English or Portuguese; (iii) with interventions consisting primarily of counseling; (iv) adherence as the main outcome; (v) published between 2005 and 2016; (vi) targeted 18 to 60 year old, independent of gender or sexual identity. The author reviewed bibliographic databases. Articles were analyzed according to the type of study, type of intervention, period of intervention, theoretical basis for intervention, time used in each counseling session and its outcomes. A total of 1790 records were identified. Nine studies were selected for the review, these applied different types of individual counseling interventions and were guided by different theoretical frameworks. Counseling was applied lasting between 4 to 18 months and these were supervised through three to six sessions over the study period. Individual counseling sessions lasted from 7.5 to 90 minutes (Me. 37.5). Six studies demonstrated significant improvement in treatment. Counseling is effective in improving adherence to ART, but methods vary. Face-to-face and computer counseling showed efficacy in improving the adherence, but not the telephone counseling. More evidence that can determine a basic counseling model without losing the individualized intervention for people with HIV is required.     

Simple adherence assessments to predict virologic failure among HIV-infected adults with discordant immunologic and clinical responses to antiretroviral therapy

We evaluated the association between two antiretroviral therapy (ART) adherence measurements--the medication possession ratio (MPR) and patient self-report--and detectable HIV viremia in the setting of rapid service scale-up in Lusaka, Zambia. Drug adherence and outcomes were assessed in a subset of patients suspected of treatment failure based on discordant clinical and immunologic responses to ART. A total of 913 patients were included in this analysis, with a median time of 744 days (Q1, Q3: 511, 919 days) from ART initiation to viral load (VL) measurement. On aggregate over the period of follow-up, 531 (58%) had optimal adherence (MPR > or =95%), 306 (34%) had suboptimal adherence (MPR 80-94%), and 76 (8%) had poor adherence (MPR <80%). Of the 913 patients, 238 (26%) had VL > or =400 copies/ml when tested. When compared to individuals with optimal adherence, there was increasing risk for virologic failure in those with suboptimal adherence [adjusted relative risk (ARR): 1.3; 95% confidence interval (CI): 1.0, 1.6] and those with poor adherence (ARR: 1.7; 95% CI: 1.3, 2.4) based on MPR. During the antiretroviral treatment course, 676 patients (74%) reported no missed doses. The proportion of patients with virologic failure did not differ significantly among those reporting any missed dose from those reporting perfect adherence (26% vs. 26%, p = 0.97). Among patients with suspected treatment failure, a lower MPR was associated with higher rates of detectable viremia. However, the suboptimal sensitivity and specificity of MPR limit its utility as a sole predictor of virologic failure.     

Effects of Counselling on Adherence to Antiretroviral Treatment Among People with HIV in Estonia: A Randomized Controlled Trial

To assess the efficacy of an education- and strengths-based counselling programme to promote antiretroviral therapy (ART) adherence in a cohort of HIV-infected individuals with high prevalence of injection drug use in Estonia. Parallel-group randomized (1:1) controlled trial (RCT). Adults receiving ART in two clinics were followed for 12 months. The trial compared: (i) an intervention (three sessions) incorporated into routine clinic visits, providing education about HIV, ART, the role of adherence, and tailoring regimen to daily routines using problem-solving skills to address adherence barriers versus (ii) usual care (control). Primary and secondary outcomes were self-reported ART adherence (3-day recall) and viral load (respectively). 519 patients were randomized and 82% completed the study. Recent optimal ART adherence (3-day recall ≥95%) was reported by 75.6% in the intervention group and 72.9% of controls at baseline and 76.7% and 67.5%, respectively, at 12 months (RR 1.14, 95% CI 1.00–1.28; adjusted RR 1.13, 95% CI 1.00–1.27). There was no difference in the proportion of patients with undetectable viral load. At 12 months the intervention group reported significantly higher perceptions of ART necessity versus ART concerns [mean ART necessity-concerns differential: intervention group 1.32 (SD 1.22) vs control group 1.08 (SD 1.12); p = 0.048]. All-cause mortality among study participants was 27.7 per 1000 person years (95% CI 15.6–44.8). A brief, clinic-based adherence intervention alone may assist with adherence but lacks impact on viral load at 12 months.     

Impact of antiretroviral dosing frequency and pill burden on adherence among newly diagnosed, antiretroviral-naive HIV patients

There are few data on the impact of antiretroviral therapy (ART) regimen factors on adherence in ART-na?ve HIV patients on contemporary once- or twice-daily regimens. Ninety-nine newly diagnosed patients in a prospective observational cohort study completed a visual analogue scale to assess their ART adherence. Adherence by type of ART and dosing frequency were compared by Brown-Mood median tests. Participants taking once-daily regimens had higher adherence (n = 70, 99.5%) compared with participants taking twice-daily regimens (n = 29, 94%; P = 0.01). Adherence of participants taking the fixed dose combination efavirenz-emtricitabine-tenofovir (n = 34, 100%) compared with those taking once-daily regimens of two or more pills was no different (n = 36, 99.3%; P = 0.34). Among a cohort of newly diagnosed ART-na?ve patients, once-daily dosing of ART resulted in higher adherence than twice-daily dosing. Pill burden among once-daily regimens did not predict adherence, suggesting that factors other than pill burden should drive regimen selection.     

Side effects,adherence self-efficacy,and adherence to antiretroviral treatment: a mediation analysis in a Chinese sample

Antiretroviral therapy (ART) is a lifelong treatment. To date, ART adherence is suboptimal for most patients in resource-poor settings. Previous research indicates that medication side effects are perceived to be a significant barrier of high ART adherence. Data regarding the role of adherence self-efficacy in mediating the relationship between side effects from ART and adherence to ART are limited; thus, this study examines this potential mediational role of self-efficacy. A cross-sectional survey of 2987 people living with HIV aged ≥18 years was conducted in 2012–2013 in Guangxi Autonomous Region (Guangxi) which has one of the fastest-growing HIV rates in China. Of the total sample, 2146 (72.1%) participants had initiated ART. Participants reported the number of days of completing the daily dose of ART in the past month; adherence was defined as completing the daily dose at least 28 days in the last month (≥90%). Side effects were significantly negatively related to adherence to ART. Mediation analyses indicated that adherence self-efficacy significantly mediated the side effects–adherence relationship. Future interventions to increase adherence self-efficacy and effective coping with side effects among HIV patients are needed in order to improve their ART adherence.     

Factors associated with lack of antiretroviral adherence among adolescents in a reference centre in Rio de Janeiro, Brazil

The objective of this study was to describe the adherence to antiretroviral therapy (ART) among adolescents followed-up in Rio de Janeiro. This cross-sectional study included all adolescents (aged 10-19 years) followed at Instituto de Puericultura e Pediatria Martag?o Gesteira and Hospital Universitário Clementino Fraga Filho. Adherence was determined by self-report (number of missed ART doses in three days prior to the interview). Adherence was categorized as taking > or = 95% of the ARTs (adherent), or < 95% (non-adherent). Variables related to demographics and treatment were evaluated and if P value < or = 0.15, they were selected for a logistic regression analysis. One hundred and one adolescents were interviewed. The mean time on ART was 91 months and the mean adherence was 94% of this, 21 were non-adherent, and 80 adherent. The risk factors associated with non-adherence were: if the patient was not concerned about ART, odds ratio (OR) = 3.47 (95% confidence interval [CI] = 1.13-10.68); if they do not carry an extra dose of ART, OR = 6.63 (95% CI = 1.73-25.47); if a health-care worker taught them how to take ART, OR = 0.27 (95% CI = 0.08-0.93). Adherence among adolescents was higher than expected. Factors associated with lack of adherence were: interviewees being unaware of ARTs and lack of commitment to the treatment. Interventions involving these factors must be evaluated.     

Randomized trial of an adherence programme for clients with HIV

Our aim was to determine if a comprehensive adherence package improved self reported adherence to antiretroviral therapy. The adherence package included an education programme, individualized planning of regimens, and the opportunity for a patient to choose from a number of adherence aids and reminder devices. A randomized step wedge design was used. Forty-three individuals were randomized to begin the intervention over a five-month period. There was a substantial fall in the number of missed doses reported for the last four days (0.76 to 0.38, P =0.03) and last seven days (1.5 to 0.74, P =0.005) but not for the last 28 days (2.5 to 2.5, P =0.63). There was no statistical difference in the viral load or CD4 lymphocyte count in the period before or after the intervention. The Morisky score during the pre and post intervention periods was significantly different (P =0.006), 2.9 (SD 0.9) and 3.3 (SD 0.8) respectively. This adherence package improved self reported adherence during the last four and seven days.     

Prediction of adherence to antiretroviral therapy: a one-year longitudinal study

The aim of this longitudinal study was to identify the determinants of adherence to antiretroviral therapy (ART) in HIV patients over a period of 12 months. A total of 376 individuals living with HIV treated with ART participated in the study. Data were collected at baseline and at three, six, nine and 12 months. Variables assessed were adherence, attitude, outcome expectancies, self-efficacy, patient satisfaction with the relationship with their physician, provision of social support, optimism, CD4 cell count, viral load and side effects. Predictors of adherence in the Generalized Estimated Equation (GEE) were: high perception of self-efficacy (OR=1.68; 95%CI 1.27-2.22), positive attitude towards taking medication (OR=1.56; 95%CI 1.18-2.06), not living alone (OR=1.47; 95%CI 1.04-2.08) and being a male (OR=2.81; 95%CI 1.47-5.34). Subsequent analysis showed that a positive attitude towards taking medication was associated with a high level of patient satisfaction with their physician, high perceived social support, being optimistic, living with HIV for five years or less and experiencing no side effects. Also, a strong sense of self-efficacy was associated with positive perception of social support, high level of patient satisfaction with their physician and not living alone. These results suggest that interventions aimed at improving adherence to ART should focus on reinforcing self-efficacy and developing a positive attitude towards taking medication.     

Predictors of antiretroviral treatment-associated tuberculosis in Ethiopia: a nested case-control study

Little is known about the predictors of antiretroviral treatment (ART)-associated tuberculosis (TB) in developing nations. The objective of this study was to determine predictors of ART-associated TB in adults with HIV infection at Jimma University Hospital, Ethiopia. A nested case-control study was conducted in October 2009. The study population consisted of adults with HIV infection (aged >14 years) who developed active TB in the first six months since ART initiation and controls that did not develop active TB. Data were collected using a structured and pretested questionnaire. Cox proportions hazards analysis was done to determine predictors of ART-associated TB. A total of 357 patients (119 cases and 238 controls) participated in the study. After six months of follow-up, cumulative incidence of ART-associated TB was 5.2% (123/2355). Forty (33.6%) cases were lost to follow-up after they developed ART-associated TB and 11 (9.2%) died. Fifty-one (21.4%) controls interrupted ART and 11 (4.6%) died. A CD4 lymphocyte count increase >0.5/μL/day (adjusted hazard ratio [AHR] = 19.80, 95% confidence interval [CI]: 9.52, 41.12, P < 0.001), a base-line CD4 lymphocyte count <200 cells/μL (AHR = 9.59, 95% CI: 2.36, 39.04, P = 0.002), World Health Organization (WHO) clinical stage 3 or 4 (AHR = 3.04, 95% CI: 1.62, 5.69, P < 0.001), night sweats during ART initiation (AHR = 1.53, 95% CI: 1.06, 2.21, P < 0.001) and high ART adherence (AHR = 1.30, 95% CI: 1.13, 1.50, P < 0.001) were independent predictors of ART-associated TB. HIV-infected adults with these risk factors should be followed cautiously for the development of ART-associated TB. Good ART adherence and a good immunological response during ART were associated with ART-associated TB, most likely because of an immune reconstitution inflammatory syndrome unmasking the TB.     

Safer sexual behaviors after 12 months of antiretroviral treatment in Mombasa, Kenya: a prospective cohort

Roll-out of antiretroviral treatment (ART) raises concerns about the potential for unprotected sex if sexual activity increases with well-being, resulting in continued HIV spread. Beliefs about reduced risk for HIV transmission with ART may also influence behavior. From September 2003 to November 2004, 234 adults enrolled in a trial assessing the efficacy of modified directly observed therapy in improving adherence to ART. Unsafe sexual behavior (unprotected sex with an HIV-negative or unknown status partner) before starting ART and 12 months thereafter was compared. Participants were a mean 37.2 years (standard deviation [SD] = 7.9 years) and 64% (149/234) were female. Nearly half (107/225) were sexually active in the 12 months prior to ART, the majority (96/107) reporting one sexual partner. Unsafe sex was reported by half of those sexually active in the 12 months before ART (54/107), while after 12 months ART, this reduced to 28% (30/107). Unsafe sex was associated with nondisclosure of HIV status to partner; recent HIV diagnosis; not being married or cohabiting; stigma; depression and body mass index <18.5 kg/m(2). ART beliefs, adherence, and viral suppression were not associated with unsafe sex. After adjusting for gender and stigma, unsafe sex was 0.59 times less likely after 12 months ART than before initiation (95% confidence interval [CI] = 0.37-0.94; p = 0.026). In conclusion, although risky sexual behaviors had decreased, a considerable portion do not practice safe sex. Beliefs about ART's effect on transmission, viral load, and adherence appear not to influence sexual behavior but require long-term surveillance. Positive prevention interventions for those receiving ART must reinforce safer sex practices and partner disclosure.     

Treatment adherence and subjective well-being in HIV/AIDS infection

The aim of this study was to analyze the relationship between treatment adherence and subjective well-being (positive and negative affects and satisfaction with life) in HIV/AIDS infection. The empirical study was conducted at two Portuguese hospitals (Porto and Lisbon) with a sample of 197 outpatients diagnosed with HIV/AIDS attending the Infectology service and on antiretroviral medication, during a 6-month period (February–July 2009). All patients were asked for voluntary fulfillment of the questionnaire which recorded information on different socio-demographic variables. Clinical records were inspected in order to collect additional clinical information from the patients. The “Questionnaire to Assess Adherence to Antiretroviral Treatment-HIV” was used in order to assess the adherence degree in Portuguese version of Reis et al. The Portuguese versions of “Positive and Negative Affect Schedule” (PANAS) and the “Satisfaction with Life Scale” were used to measure subjective well-being. The study collected evidence on the positive correlation between therapeutic adherence (assessed by CEAT-VIH) and positive affect, as well as between adherence and satisfaction with life. Differences in therapeutic adherence and positive affect according to some clinical variables were also found. The multiplicity and the interaction of several determinants are being considered in the adjustment process during treatment for HIV/AIDS. The results may have implications for the psychological intervention directed at improving adherence to antiretroviral therapy.     

Risk factors for treatment denial and loss to follow-up in an antiretroviral treatment cohort in Kenya

OBJECTIVES: To evaluate risk factors for treatment denial and loss to follow-up in an antiretroviral treatment (ART) cohort in a rural African setting in western Kenya. METHOD: Sociodemographic and clinical data of patients enrolled in an ART cohort were collected within 18 months of an observational longitudinal study and analysed by logistic and Cox regression models. RESULTS: Of 159 patients with treatment indication 35 (22%) never started ART. Pregnancy [adjusted odds ratio (AOR) 3.60, 95% confidence interval (CI) 1.10-11.8; P = 0.035] and lower level of education (AOR 3.80, 95% CI 1.14-12.7; P = 0.03) were independently associated with treatment denial. The incidence of total loss of patients under therapy was 43.2 per 100 person years (pys) (mortality rate 19.2 per 100 pys plus drop out rate 24 per 100 pys). Older age [adjusted hazard ratio (AHR) 1.06, 95% CI 1.01-1.12; P = 0.04], AIDS before starting treatment (AHR 5.83, 95% CI 1.15-29.5; P = 0.03) and incomplete adherence to treatment (AHR 1.05, 95% CI 1.03-1.07; P < 0.001) were independent risk factors for death. Incomplete adherence also independently predicted drop out because of other reasons (AHR 1.06, 95% CI 1.04-1.09; P < 0.001). CONCLUSION: Pregnancy and lower level of education, higher age, advanced AIDS stage and impaired compliance to ART were identified as risk factors for treatment denial and death, respectively. Adequate counselling strategies for patients with these characteristics could help to improve adherence and outcome of treatment programmes in resource-limited settings.     

Randomized controlled trial of a personalized cellular phone reminder system to enhance adherence to antiretroviral therapy

Adherence to antiretroviral therapy (ART) represents one of the strongest predictors of progression to AIDS, yet it is difficult for most patients to sustain high levels of adherence. This study compares the efficacy of a personalized cell phone reminder system (ARemind) in enhancing adherence to ART versus a beeper. Twenty-three HIV-infected subjects on ART with self-reported adherence less than 85% were randomized to a cellular phone (CP) or beeper (BP). CP subjects received personalized text messages daily; in contrast, BP subjects received a reminder beep at the time of dosing. Interviews were scheduled at weeks 3 and 6. Adherence to ART was measured by self-report (SR, 7-day recall), pill count (PC, past 30 days at baseline, then past 3 weeks), Medication Event Monitoring System (MEMS; cumulatively at 3 and 6 weeks), and via a composite adherence score constructed by combining MEMS, pill count, and self report. A mixed effects model adjusting for baseline adherence was used to compare adherence rates between the intervention groups at 3 and 6 weeks. Nineteen subjects completed all visits, 10 men and 9 females. The mean age was 42.7 ± 6.5 years, 37% of subjects were Caucasian and 89% acquired HIV heterosexually. The average adherence to ART was 79% by SR and 65% by PC at baseline in both arms; over 6 weeks adherence increased and remained significantly higher in the ARemind group using multiple measures of adherence. A larger and longer prospective study is needed to confirm these findings and to better understand optimal reminder messages and user fatigue.     

Beliefs about antiretroviral therapy, treatment adherence and quality of life in a 48-week randomised study of continuation of zidovudine/lamivudine or switch to tenofovir DF/emtricitabine, each with efavirenz

Adherence may be facilitated by reducing perceptual and practical barriers to antiretroviral therapy (ART). Practical barriers include the complexity of daily dosing, while perceptual barriers include perceptions of the need for treatment and concerns about adverse effects. The study aim was to assess the effect of switching zidovudine plus lamivudine twice-daily (Combivir, CBV) to once-daily tenofovir DF plus emtricitabine (Truvada, TVD), each plus efavirenz (EFZ), on adherence, beliefs about ART and quality of life (QoL). Subjects stable on CBV + EFV were randomised 1:1 to continue this regimen or switch to TVD + EFV. Adherence was measured using the Medication Adherence Self-Report Inventory at 4, 12, 24 and 48 weeks. Beliefs about ART (perceptions of necessity and concerns about adverse effects), treatment intrusiveness and QoL were measured by questionnaire at baseline 4, 12, 24 and 48 weeks. Viral load was assessed at each visit. Two hundred and thirty-four subjects initiated treatment. At week 48, the proportion of subjects reporting high adherence (≥95% taken as prescribed) was significantly greater in the TVD arm (p=0.049). Low adherence (reporting taking <95% as prescribed, discontinuing the study or having missing data) was associated with doubts about necessity (p=0.020), stronger concerns about adverse effects (p=0.010), greater treatment intrusiveness (p=0.010) and poorer mental health related QoL (p=0.008). At week 48, both concerns about ART (p=0.038) and treatment intrusiveness (p=0.004) were lower among those who switched to TVD. Furthermore, there was a decline in both concerns about ART (p=0.007) and treatment intrusiveness (p=0.057) over the 48 weeks among those who switched to TVD. There were no significant differences in necessity beliefs, QoL or viral load between randomised groups. Switching from CBV to TVD may improve patient reported outcomes including slightly better adherence, a greater reduction in concerns about adverse effects and less treatment intrusiveness.