Ten-year incidence and risk factors of bone fractures in a cohort of treated HIV1-infected adults.: Bone fractures in HIV1 infected patients.

International audienceIn the ANRS CO8 APROCO-COPILOTE cohort of patients treated with combination antiretroviral therapy since 1997-1999, the incidence density of bone fractures was 3.3 for 1000 patient-years [95% confidence interval (CI) = 2.0-4.6]. The rate was 2.9-fold (95% CI = 1.3-6.5) higher among patients with excessive alcohol consumption and 3.6-fold (95% CI = 1.6-8.1) higher in those with hepatitis C virus (HCV) coinfection. Specific monitoring of HCV/HIV-coinfected patients and active promotion of alcohol cessation should be recommended for the prevention of bone fractures

Adherence to and effectiveness of Highly Active Antiretroviral Treatment for HIV infection: assessing the bidirectional relationship

It is well-established that high adherence to HAART is a major determinant of virological and immunological success. Furthermore, psycho-social research has identified a wide range of adherence factors. Our objective was to assess the bi-directional relationship between adherence and response to treatment among patients enrolled in the ANRS CO8 APROCOCOPILOTE study. An econometric approach was implemented through a bivariate twoequation simultaneous system, studying the factors associated with both adherence and undetectability of HIV plasma viral load. Our results highlight that good biological results induced by adherence reinforce continued adherence. This strengthens the argument that patients who do not experience rapid improvements in their immunological and clinical statuses after HAART initiation should be prioritized when developing adherence support interventions. Furthermore, it rules out the hypothesis that HAART leads to "false reassurance" among HIV infected patients.Adherence ; HIV ; relationship between adherence and effectiveness ; simultaneous equations ; GEE

HIV-2 diversity displays two clades within group A with distinct geographical distribution and evolution

Genetic diversity of HIV-2 groups A and B has not yet been fully described, especially in a few Western Africa countries such as Ivory-Coast or Mali. We collected 444 pol, 152 vif, 129 env, and 74 LTR sequences from patients of the French ANRS CO5 HIV-2 cohort completed by 221 pol, 18 vif, 377 env, and 63 LTR unique sequences from public databases. We performed phylogenetic reconstructions and revealed two distinct lineages within HIV-2 group A, herein called A1 and A2, presenting non-negligible genetic distances and distinct geographic distributions as A1 is related to coastal Western African countries and A2 to inland Western countries. Estimated early diversification times for groups A and B in human populations were 1940 [95% higher probability densitiy: 1935-53] and 1961 [1952-70]. A1 experienced an early diversification in 1942 [1937-58] with two distinct early epidemics in Guinea-Bissau or Senegal, raising the possibility of group A emergence in those countries from an initial introduction from Ivory-Coast to Senegal, two former French colonies. Changes in effective population sizes over time revealed that A1 exponentially grew concomitantly to Guinea-Bissau independence war, but both A2 and B lineages experienced a latter growth, starting during the 80s economic crisis. This large HIV-2 genetic analysis provides the existence of two distinct subtypes within group A and new data about HIV-2 early spreading patterns and recent epidemiologic evolution for which data are scarce outside Guinea-Bissau

Trials

Background Optimising hearing and vision function may be important in improving a range of outcomes for people living with dementia (PwD) and their companions. The SENSE-Cog cross-national randomised controlled trial (RCT) is evaluating the effectiveness of a sensory intervention (SI) to improve quality of life for PwD with concurrent hearing and/or vision impairment, in five European countries. To ascertain how or why the intervention will, or will not, achieve its outcomes, we have designed a process evaluation to explore potential discrepancies between expected and observed outcomes. This will also help us to understand how context may influence the outcomes. Here we describe the protocol for this process evaluation, which is embedded within the RCT. Methods/design We will use a mixed methods approach with a theoretical framework derived from the UK Medical Research Council’s’ guidance on process evaluations. It will include the following: (1) evaluating how key aspects of the intervention will be delivered, which will be important to scale the intervention in real world populations; (2) characterising the contextual issues, which may shape the delivery and the impact of the intervention in different countries; and (3) investigating possible causal mechanisms through analyses of potential moderators and mediators. To avoid bias, we will analyse the process data before the analysis of the main effectiveness outcomes. Discussion This evaluation will provide insight into how the complex SENSE-Cog SI will be tailored, enacted and received across the different European contexts, all of which have unique health and social care economies. The findings will provide insight into the causal mechanisms effecting change, and will determine whether we should implement the intervention, if effective, on a wider scale for PwD and concurrent sensory impairment

Individualised sensory intervention to improve quality of life in people with dementia and their companions (SENSE-Cog trial): study protocol for a randomised controlled trial

Background: Hearing and vision impairments are highly prevalent in people with dementia and may have a negative impact on quality of life and other dementia-related outcomes. Intervening to optimise sensory impairment and support sensory function may be a means of improving dementia-related outcomes. The SENSE-Cog trial will test whether a home-based multi-part sensory intervention is effective in improving quality of life and other key outcomes in people with dementia and hearing or vision problems (or both) and their companions. Methods: This is an European, multi-centre, observer-blind, pragmatic, randomised controlled trial. Three hundred fifty four people with dementia and hearing or vision impairment (or both) and their companions will be randomly assigned to receive either "care as usual" or a multi-component sensory intervention including assessment and correction of hearing or vision impairments (or both), home-based (maximum 10 visits over 18 weeks), therapist-delivered sensory support (that is, adherence to devices; improving the sensory environment (that is, lighting), communication training, and sign-posting to other support agencies). Change from baseline to intervention end (18 weeks) and post-intervention (36 weeks) will be compared between the two arms in the following outcomes: quality of life (primary endpoint), sensory and cognitive functional ability, relationships, mental well-being, health resource utilisation and cost-effectiveness. Discussion: This is one of two articles outlining the SENSE-Cog trial. Here, we describe the protocol for the effectiveness of the SENSE-Cog intervention. A parallel and complementary process evaluation will be described elsewhere. If the SENSE-Cog trial demonstrates that the sensory intervention improves outcomes in dementia, we will make a toolkit of training materials, resources and information available to health and social care providers to implement the intervention in routine practice. This will be a significant contribution to the therapeutic management of people with dementia and sensory impairment. Trial registration: ISRCTN (Trial ID: ISRCTN17056211) on 19 February 2018

Structured self-management education maintained over two years in insufficiently controlled type 2 diabetes patients: the ERMIES randomised trial in Reunion Island.

International audienceABSTRACT: BACKGROUND: Self-management education programs can reduce the complications and mortality in type 2 diabetes. The need to structure these programs for outpatient and community care with a vision for long-term maintenance has been recognised. In Reunion Island, an area affected by epidemiological and nutritional transition, diabetes affects 18% of the adult population over 30 years, with major social disparities, poor glycaemic control and frequent cardiovascular complications. Methods/design ERMIES is a randomised controlled trial designed to test the efficacy of a long-term (2 years) structured group self management educational intervention in improving blood glucose in non-recent, insufficiently controlled diabetes. After an initial structured educational cycle carried out blind for the intervention arm, patients will be randomized in two parallel group arms of 120 subjects: structured on-going group with educational intervention maintained over two years, versus only initial education. Education sessions are organised through a regional diabetes management network, and performed by trained registered nurses at close quarters. The educational approach is theoretically based (socio-constructivism, social contextualisation, empowerment, action planning) and reproducible, thanks to curricula and handouts for educators and learners. The subjects will be recruited from five hospital outpatient settings all over Reunion Island. The main eligibility criteria include: age [greater than or equal to]18 years, type 2 diabetes treated for more than one year, HbA1c [greater than or equal to] 7.5% for [greater than or equal to]3 months, without any severe evolving complication (ischaemic or proliferative retinopathy, severe renal insufficiency, coronaropathy or evolving foot lesion), and absence of any major physical or cognitive handicap. The primary outcome measure is HbA1c evolution between inclusion and 2 years. The secondary outcome measures include anthropometric indicators, blood pressure, lipids, antidiabetic medications, level of physical activity, food ingestion, quality of life, social support, anxiety, depression levels and self-efficacy. An associated nested qualitative study will be conducted with 30 to 40 subjects in order to analyse the learning and adaptation processes during the education cycles, and throughout the study. CONCLUSION: This research will help to address the necessary but difficult issue of structuring therapeutic education in type 2 diabetes based on: efficacy and potential interest of organising on-going empowerment group sessions at close quarters over the long term, in a heterogeneous socioeconomic environment. Trial registration: ID_RCB number : 2011-A00046-35 Clinicaltrials.gov number: NCT01425866

La santé mentale des femmes séropositives en France à l'ère des thérapies antirétrovirales : quelles différences avec les hommes ? Quels enjeux ?

International audienceCe travail a pour objectif de présenter différents indicateurs relatifs à la santé mentale des femmes infectées par le VIH suivies en France. Dans un premier temps, nous utiliserons les données de l'enquête Vespa, afin de présenter une analyse des facteurs associés aux tentatives de suicide. Dans un second temps, nous présentons des résultats obtenus à partir des données de la cohorte Aproco de patients infectés par le VIH et sous thérapies antirétrovirales. Nous proposons une analyse des facteurs associés à une meilleure qualité de vie physique et mentale trois années après la mise sous traitementLes différents résultats mettent en évidence un impact important des symptômes lipodystrophiques, ainsi que des caractéristiques socio démographiques et psychosociales telles que les comportements de discrimination quant à la santé mentale des femmes infectées par le VIH.L'ensemble de ces résultats est discuté au regard de l'évolution de la prise en charge des femmes infectées par le VIH, dans une logique d'optimisation des pratiques des divers acteurs concernés par cette prise en charge

Adherence to and effectiveness of Highly Active Antiretroviral Treatment for HIV infection: assessing the bidirectional relationship

ESSEC Working paper. Document de Recherche ESSEC / Centre de recherche de l'ESSEC ISSN : 1291-9616 WP 1110It is well-established that high adherence to HAART is a major determinant of virological and immunological success. Furthermore, psycho-social research has identified a wide range of adherence factors. Our objective was to assess the bi-directional relationship between adherence and response to treatment among patients enrolled in the ANRS CO8 APROCOCOPILOTE study. An econometric approach was implemented through a bivariate twoequation simultaneous system, studying the factors associated with both adherence and undetectability of HIV plasma viral load. Our results highlight that good biological results induced by adherence reinforce continued adherence. This strengthens the argument that patients who do not experience rapid improvements in their immunological and clinical statuses after HAART initiation should be prioritized when developing adherence support interventions. Furthermore, it rules out the hypothesis that HAART leads to "false reassurance" among HIV infected patients

Prevalence and Predictors of Deterioration of a Trustful Patient-Provider Relationship Among HIV-Infected Persons Treated With Antiretroviral Therapy

International audiencethe ANRS CO-8 APROCO Study Group Objectives: We studied the evolution of the patient-provider relationship (PPR) in HIV-infected patients who reported trustful relationships at highly active antiretroviral therapy (HAART) treatment initiation. Methods: Psychosocial and clinical data were obtained from the French ANRS CO-8 cohort. Break of trust was defined using the question ''How much do you trust the provider who usually treats you at this clinic?'' Predictors of a possible break of trust during the 5 years after initiating treatment for those patients reporting a trustful PPR at month 0 were identified using a Cox model. Results: During a total follow-up of 3044 person-years, 68 (7%) patients reported having at least 1 break of trust in their PPR. Break of trust is independently associated with younger age, dissatisfaction with medical staff's explanations, cigarette smoking, and self-reported side effects and is independently inversely associated with severe HIV-related events and changes of treatment. Conclusions: A patient's break of trust in his provider is relatively infrequent. Accounting for the influence of immunologic status and psychosocial factors, self-reported side effects are shown to be detrimental to the PPR. Interestingly, clinical events and changes of treatment prevent a possible break of trust by reinforcing the pro-vider's role. These results underline the importance of recognizing a patient's perceived secondary effects and developing appropriate care