Summary Background No high-quality trials have provided evidence of effectiveness and cost-effectiveness of HIV treatment adherence intervention strategies. We therefore examined the effectiveness ...and cost-effectiveness of the Adherence Improving self-Management Strategy (AIMS) compared with treatment as usual. Methods We did a pragmatic, multicentre, open-label, randomised controlled trial in seven HIV clinics at academic and non-academic hospitals in the Netherlands. Eligible participants were patients with HIV who were either treatment experienced (ie, with ≥9 months on combination antiretroviral therapy ART and at risk of viral rebound) or treatment-naive patients initiating their first combination ART regimen. We randomly assigned participants (1:1) to either AIMS or treatment as usual (ie, containing a range of common adherence intervention strategies) using a computer-generated randomisation table. Randomisation was stratified by treatment experience (experienced vs naive) and included block randomisation at nurse level with randomly ordered blocks of size four, six, and eight. 21 HIV nurses from the participating clinics received three training sessions of 6 h each (18 h in total) on AIMS and a 1·5 h booster training session at the clinic (two to three nurses per session) after each nurse had seen two to three patients. AIMS was delivered by nurses during routine clinic visits. We did mixed-effects, intent-to-treat analyses to examine treatment effects on the primary outcome of log10 viral load collected at months 5, 10, and 15. The viral load results were exponentiated (with base 10) for easier interpretation. Using cohort data from 7347 Dutch patients with HIV to calculate the natural course of illness, we developed a lifetime Markov model to estimate the primary economic outcome of lifetime societal costs per quality-adjusted life-years (QALYs) gained. This trial is registered at ClinicalTrials.gov (number NCT01429142 ). Findings We recruited participants between Sept 1, 2011, and April 2, 2013; the last patient completed the study on June 16, 2014. The intent-to-treat sample comprised 221 patients; 109 assigned to AIMS and 112 to treatment as usual. Across the three timepoints (months 5, 10, and 15), log viral load was 1·26 times higher (95% CI 1·04–1·52) in the treatment-as-usual group (estimated marginal mean 44·5 copies per mL 95% CI 35·5–55·9) than in the AIMS group (estimated marginal mean 35·4 copies per mL 29·9–42·0). Additionally, AIMS was cost-effective (ie, dominant: cheaper and more effective) since it reduced lifetime societal costs by €592 per patient and increased QALYs by 0·034 per patient. Interpretation Findings from preparatory studies have shown that AIMS is acceptable, feasible to deliver in routine care, and has reproducible effects on medication adherence. In this study, AIMS reduced viral load, increased QALYs, and saved resources. Implementation of AIMS in routine clinical HIV care is therefore recommended. Funding Netherlands Organisation for Health Research and Development.
Background Reduced estimated glomerular filtration rate (eGFR) and albuminuria have been associated with worse cognitive performance. However, few studies have examined whether these associations are ...confined to older individuals or may be extended to the middle-aged population. Study Design Cross-sectional analyses of a prospective population-based cohort study. Setting & Participants 2,987 individuals aged 40 to 75 years from the general population (The Maastricht Study). Predictor eGFR and urinary albumin excretion (UAE). Outcomes Memory function, information processing speed, and executive function. Measurements Analyses were adjusted for demographic variables (age, sex, and educational level), lifestyle factors (smoking behavior and alcohol consumption), depression, and cardiovascular disease risk factors (glucose metabolism status, waist circumference, total to high-density lipoprotein cholesterol ratio, triglyceride level, use of lipid-modifying medication, systolic blood pressure, use of antihypertensive medication, and prevalent cardiovascular disease). Results UAE was <15 mg/24 h in 2,439 (81.7%) participants, 15 to <30 mg/24 h in 309 (10.3%), and ≥30 mg/24 h in 239 (8.0%). In the entire study population, UAE ≥ 30 mg/24 h was associated with lower information processing speed as compared to UAE < 15 mg/24 h (β SD difference = −0.148; 95% CI, −0.263 to −0.033) after full adjustment, whereas continuous albuminuria was not. However, significant interaction terms ( P for interaction < 0.05) suggested that albuminuria was most strongly and extensively associated with cognitive performance in older individuals. Mean (±SD) eGFR, estimated by the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) creatinine–cystatin C equation (eGFRcr-cys ), was 88.4 ± 14.6 mL/min/1.73 m2 . eGFRcr-cys was not associated with any of the domains of cognitive performance after full adjustment. However, significant interaction terms ( P for interaction < 0.05) suggested that eGFRcr-cys was associated with cognitive performance in older individuals. Limitations Cross-sectional design, which limited causal inferences. Conclusions In the entire study population, albuminuria was independently associated with lower information processing speed, whereas eGFRcr-cys was not associated with cognitive performance. However, both were more strongly and extensively associated with cognitive performance in older individuals.
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