title: Addressing social issues in a universal HIV test and treat intervention trial (ANRS 12249 TasP) in South Africa: methods for appraisal.
abstract: BACKGROUND
  The Universal HIV Test and Treat (UTT) strategy represents a challenge for science, but is also a challenge for individuals and societies. Are repeated offers of provider-initiated HIV testing and immediate antiretroviral therapy (ART) socially-acceptable and can these become normalized over time? Can UTT be implemented without potentially adding to individual and community stigma, or threatening individual rights? What are the social, cultural and economic implications of UTT for households and communities? And can UTT be implemented within capacity constraints and other threats to the overall provision of HIV services? The answers to these research questions will be critical for routine implementation of UTT strategies.
  
  
  METHODS
  A social science research programme is nested within the ANRS 12249 Treatment-as-Prevention (TasP) cluster-randomised trial in rural South Africa. The programme aims to inform understanding of the (i) social, economic and environmental factors affecting uptake of services at each step of the continuum of HIV prevention, treatment and care and (ii) the causal impacts of the TasP intervention package on social and economic factors at the individual, household, community and health system level. We describe a multidisciplinary, multi-level, mixed-method research protocol that includes individual, household, community and clinic surveys, and combines quantitative and qualitative methods.
  
  
  CONCLUSIONS
  The UTT strategy is changing the overall approach to HIV prevention, treatment and care, and substantial social consequences may be anticipated, such as changes in social representations of HIV transmission, prevention, HIV testing and ART use, as well as changes in individual perceptions and behaviours in terms of uptake and frequency of HIV testing and ART initiation at high CD4. Triangulation of social science studies within the ANRS 12249 TasP trial will provide comprehensive insights into the acceptability and feasibility of the TasP intervention package at individual, community, patient and health system level, to complement the trial's clinical and epidemiological outcomes. It will also increase understanding of the causal impacts of UTT on social and economic outcomes, which will be critical for the long-term sustainability and routine UTT implementation.
  
  
  BACKGROUND
  Clinicaltrials.gov: NCT01509508; South African Trial Register: DOH-27-0512-3974.
authors.affiliation: INSERM/University of Bordeaux, ISPED, Centre Inserm U897- Épidemiologie-Biostatistique, Bordeaux, France. Joanna.Orne-Gliemann@isped.u-bordeaux2.fr.
authors.forename: Joanna
authors.initials: J
authors.lastname: Orne-Gliemann
authors.affiliation: Centre Population et Développement (CEPED UMR 196 Université Paris Descartes Ined IRD), Paris, France. joseph.larmarange@ird.fr.|Africa Centre for Health and Population Studies, University of KwaZulu-Natal, Durban, South Africa. joseph.larmarange@ird.fr.
authors.forename: Joseph
authors.initials: J
authors.lastname: Larmarange
authors.affiliation: INSERM-IRD-Aix-Marseille University, Faculty of Medicine, Aix-Marseille School of Economics (AMSE), SESSTIM-UMR 912, 13006, Marseille, France. sylvie.boyer@inserm.fr.
authors.forename: Sylvie
authors.initials: S
authors.lastname: Boyer
authors.affiliation: Africa Centre for Health and Population Studies, University of KwaZulu-Natal, Durban, South Africa. ciwuji@AfricaCentre.ac.za.
authors.forename: Collins
authors.initials: C
authors.lastname: Iwuji
authors.affiliation: Africa Centre for Health and Population Studies, University of KwaZulu-Natal, Durban, South Africa. N.McGrath@soton.ac.uk.|Academic Unit of Primary Care and Population Sciences, and Department of Social statistics and Demography, University of Southampton, Southampton, UK. N.McGrath@soton.ac.uk.
authors.forename: Nuala
authors.initials: N
authors.lastname: McGrath
authors.affiliation: Africa Centre for Health and Population Studies, University of KwaZulu-Natal, Durban, South Africa. tbarnighausen@africacentre.ac.za.|Department of Global Health and Population, Harvard School of Public Health, Boston, Massachusetts, USA. tbarnighausen@africacentre.ac.za.
authors.forename: Till
authors.initials: T
authors.lastname: Bärnighausen
authors.affiliation: Africa Centre for Health and Population Studies, University of KwaZulu-Natal, Durban, South Africa. tzuma@africacentre.ac.za.
authors.forename: Thembelile
authors.initials: T
authors.lastname: Zuma
authors.affiliation: INSERM, UMR_S1136, Pierre Louis Institute of Epidemiology and Public Health, Research Team in social epidemiology, F-75013, Paris, France. rosemary.dray-spira@inserm.fr.|Sorbonne Universités, UPMC Univ Paris 06, UMR_S1136, Pierre Louis Institute of Epidemiology and Public Health, Team Research in social epidemiology, F-75013, Paris, France. rosemary.dray-spira@inserm.fr.
authors.forename: Rosemary
authors.initials: R
authors.lastname: Dray-Spira
authors.affiliation: INSERM-IRD-Aix-Marseille University, Faculty of Medicine, Aix-Marseille School of Economics (AMSE), SESSTIM-UMR 912, 13006, Marseille, France. bruno.spire@inserm.fr.
authors.forename: Bruno
authors.initials: B
authors.lastname: Spire
authors.affiliation: Africa Centre for Health and Population Studies, University of KwaZulu-Natal, Durban, South Africa. trochat@AfricaCentre.ac.za.
authors.forename: Tamsen
authors.initials: T
authors.lastname: Rochat
authors.affiliation: Centre de recherche en Épidémiologie et Santé des Populations (CESP, Inserm Unité 1018), Villejuif, France. France.Lert@inserm.fr.
authors.forename: France
authors.initials: F
authors.lastname: Lert
authors.affiliation: Africa Centre for Health and Population Studies, University of KwaZulu-Natal, Durban, South Africa. JImrie@futuresgroup.com.|Centre for Sexual Health and HIV Research, Research Department of Infection and Population Health, Faculty of Population Health Sciences, University College London, London, UK. JImrie@futuresgroup.com.
authors.forename: John
authors.initials: J
authors.lastname: Imrie
mesh_terms: D005260:Female; D017144:Focus Groups; D015658:HIV Infections / Q000175:diagnosis* / Q000188:drug therapy; D006801:Humans; D007407:Interviews as Topic; D008297:Male; D008403:Mass Screening; D036301:Qualitative Research; D057545:Social Stigma; D013019:South Africa; D011795:Surveys and Questionnaires