Temporal trends of population viral suppression in the context of Universal Test and Treat: the ANRS 12249 TasP trial in rural South Africa

Introduction: The universal test-and-treat (UTT) strategy aims to maximize population viral suppression (PVS), that is, the proportion of all people living with HIV (PLHIV) on antiretroviral treatment (ART) and virally suppressed, with the goal of reducing HIV transmission at the population level. This article explores the extent to which temporal changes in PVS explain the observed lack of association between universal treatment and cumulative HIV incidence seen in the ANRS 12249 TasP trial conducted in rural South Africa. Methods: The TasP cluster-randomized trial (2012 to 2016) implemented six-monthly repeat home-based HIV counselling and testing (RHBCT) and referral of PLHIV to local HIV clinics in 2 9 11 clusters opened sequentially. ART was initiated according to national guidelines in control clusters and regardless of CD4 count in intervention clusters. We measured residency status, HIV status, and HIV care status for each participant on a daily basis. PVS was computed per cluster among all resident PLHIV (≥16, including those not in care) at cluster opening and daily thereafter. We used a mixed linear model to explore time patterns in PVS, adjusting for sociodemographic changes at the cluster level. Results: 8563 PLHIV were followed. During the course of the trial, PVS increased significantly in both arms (23.5% to 46.2% in intervention, +22.8, p < 0.001; 26.0% to 44.6% in control, +18.6, p < 0.001). That increase was similar in both arms (p = 0.514). In the final adjusted model, PVS increase was most associated with increased RHBCT and the implementation of local trial clinics (measured by time since cluster opening). Contextual changes (measured by calendar time) also contributed slightly. The effect of universal ART (trial arm) was positive but limited. Conclusions: PVS was improved significantly but similarly in both trial arms, explaining partly the null effect observed in terms of cumulative HIV incidence between arms. The PVS gains due to changes in ART-initiation guidelines alone are relatively small compared to gains obtained by strategies to maximize testing and linkage to care. The achievement of the 90-90-90 targets will not be met if the operational and implementational challenges limiting access to care and treatment, often context-specific, are not properly addressed. Clinical trial number: NCT01509508 (clinicalTrials.gov)/DOH-27-0512-3974 (South African National Clinical Trials Register)

Denis Philippe, Becker Charles, L'épidémie du sida en Afrique subsaharienne. Regards historiens

Bazin Brigitte. Denis Philippe, Becker Charles, L'épidémie du sida en Afrique subsaharienne. Regards historiens. In: Outre-mers, tome 95, n°358-359, 1er semestre 2008. 1958 et l'outre-mer français. pp. 324-325

Denis Philippe, Becker Charles, L'épidémie du sida en Afrique subsaharienne. Regards historiens

Bazin Brigitte. Denis Philippe, Becker Charles, L'épidémie du sida en Afrique subsaharienne. Regards historiens. In: Outre-mers, tome 95, n°358-359, 1er semestre 2008. 1958 et l'outre-mer français. pp. 324-325

Contraintes éthiques des essais cliniques dans les pays en développement : expérience de l'Agence Nationale de Recherches sur le Sida (ANRS) française

La mise en application des grands principes d'éthique de la recherche clinique dans les pays en développement (PED), énoncés dans de nombreux textes internationaux récemment révisés, pose sur le terrain un certain nombre de problèmes concrets. L'Agence Nationale de Recherches sur le Sida (ANRS), en tant que promoteur institutionnel responsable de la recherche sur le sida et les hépatites en France et dans les PED, s'est dotée d'une Charte définissant ses engagements vis-à-vis de ses partenaires du Nord et du Sud. Les grands principes en sont : l'articulation de la recherche avec les programmes de santé publique des pays du Sud, la construction d'un partenariat Nord/Sud à toutes les étapes de la recherche, la mise en place de règles pour l'expertise des projets, la définition, la surveillance éthique de leur déroulement, l'inclusion et la prise en charge médicale des patients et la gestion du post-essai

Comité d’éthique et recherche de terrain : vers une entrave bureaucratique ?

International audienceProtection des personnes, des données personnelles, de l’intégrité de la recherche et du secret des affaires... On assiste depuis quelques années à une multiplication de règlementations dont le but serait d’assurer la dimension éthique de nos investigations. Comment éviter qu’elles n’entravent nos approches du terrain sans interroger en profondeur nos pratiques

Pore-scale to core-scale aspects of capillary desaturation curves using CT-scan imaging

International audienceno abstrac

French legal approach to clinical research

Since 1988, France has been committed to drafting laws regulating clinical research. These laws must both reflect general legal standards relating to personal data protection and patient information and comply with EU regulations, which are supra-national norms. The 2012 legislation known as “Jardé law” came into force in 2016 and distinguishes between 3 different types of research involving human subjects: category 1:interventional research implying an intervention on the patient which is not justified by their usual treatment. Category 2: interventional research, which does not focus on medicinal products and only entails minimal risks and constraints. Category 3: non-interventional research implying one or multiple acts or proceedings devoid of listed risks. These studies require preliminary favourable opinions from the French Ethical Research Committees (CPP), who are appointed by the State, and must ensure the protection of personal data. For the other types of studies (retrospective data, practice surveys), French legislation only requires that the protection of personal data is ensured. However, it is highly recommended to submit these studies to an Institutional Review Board (IRB) in order to confirm that human subjects are not involved and to obtain an ethical opinion in the event of a scientific journal submission. These laws are constantly evolving in order to comply with the various international recommendations and European regulations, which are binding in France