{"doc_desc":{"title":"Concept sheet - Second line treatment","idno":"DDI.SecondLine-TasP","producers":[{"name":"Kobus Herbst","abbreviation":"","affiliation":"Africa Centre for Health and Population Studies","role":"Dataset production"},{"name":"Joseph Larmarange","abbreviation":"","affiliation":"Ceped (UMR 196 Paris Descartes IRD) \/ Africa Centre for Health and Population Studies","role":"Dataset production"},{"name":"Jaco Dreyer","abbreviation":"","affiliation":"Africa Centre for Health and Population Studies","role":"Dataset production\/documentation"}],"prod_date":"2015-11-13","version_statement":{"version":"1.0.0","version_date":"2015-11-13","version_notes":"1.0.0 Intitial version (13 Nov 2015)"}},"study_desc":{"title_statement":{"idno":"SecondlineTasP","title":"Concept sheet - Second line treatment","sub_title":"TasP","alt_title":"Concept Sheet Second line Treatment - TasP"},"production_statement":{"producers":[{"name":"Africa Centre for Health and Population Studies","affiliation":"UKZN","role":""}],"prod_date":"2015-11-13","prod_place":"Somkele, South Africa","funding_agencies":[{"name":"Agence Nationale de Recherche sur le Sida et les h\u00e9patites virales","abbreviation":"ANRS","role":"Sponsor and funder"},{"name":"Deutsche Gesellschaft f\u00fcr Internationale Zusammenarbeit","abbreviation":"GIZ","role":"Funder"},{"name":"MERCK & Co. Inc and Gilead Sciences","abbreviation":"","role":"Drugs supply"},{"name":"Wellcome Trust","abbreviation":"","role":"Core funding of Africa Centre"},{"name":"International Initiative for Impact Evaluation","abbreviation":"3ie","role":"Funder"}]},"distribution_statement":{"contact":[{"name":"Dami Collier","affiliation":"Africa Centre for Health and Population Studies","email":"Dami.Collier@lshtm.ac.uk","uri":""}]},"version_statement":{"version":"1.0.0","version_date":"2015-11-13","version_notes":"1.0.0 Initial Release"},"study_info":{"abstract":"An estimated quarter of all HIV infected individuals treated with antiretroviral therapy (ART) are failing treatment on first line non-nucleoside reverse transcriptase inhibitor (NNRTI) based treatment and qualify for protease inhibitor based (bPI) second line treatment.  It has been observed that up to 32% of those on second line bPI treatment do not suppress the virus, , .  This has implications for third line therapy in resource limited settings.\n\nAlthough the published studies are limited, there is a suggestion that the prevalence of PI drug resistance mutation at second line failure in South Africa is very low, up to 7% whereas drug resistance in other drug classes remain high, up to 78% i, v, , .  All but one of these studies measured the contribution of non-adherence to second line failure. The contribution of non-adherence, drug toxicity, pharmacokinetics eg concomitant rifampicin use and pharmacodynamics eg lack of refrigerator for soft gel lopinavir tablets to second line failure have been insufficiently studied. \n\nThis study aims to estimate the incidence rate of second line failure, the prevalence of antiretroviral drug resistance and to investigate factors associated with second line failure including but not limited to non-adherence, the duration on failing first line regimen, retention in care, drug tolerance, concomitant rifampicin use and lack of refrigeration of lopinavir amongst the TasP second line failing HIV-1 patients.","time_periods":[{"start":"2012-03-09","end":"2014-05-31","cycle":"Phase 1"},{"start":"2014-06-01","end":"2015-07-15","cycle":"Phase 2"}],"coll_dates":[{"start":"2012-03-10","end":"2015-07-15","cycle":"Data Collection"}],"nation":[{"name":"South Africa","abbreviation":"ZAR"}],"geog_coverage":"Twenty Two survey clusters located in Hlabisa sub-district, Umkhanyakude district, of northern KwaZulu-Natal, South\nAfrica.\nThe Hlabisa health sub-district is a rural setting of 1 430 km2 in size, with a population of approximately 220 000 Zuluspeaking\npeople of whom 3.3% are located in a formal urban township (KwaMsane), 19.9% in peri-urban areas and the\nTreatment as Prevention ANRS 12249 - Overview\n- 8 -\nremainder (76.8%) classified as living in a rural area. The rural population lives in scattered homesteads that are not\nconcentrated into villages or compounds (as would be the case in many other parts of Africa).","analysis_unit":"Clusters, Households, Individuals","universe":"Clusters: the trial area consists of 150 local areas (neighbourhoods). These were aggregated into 34 clusters of between one\nand six contiguous neighbourhoods, each cluster comprising an average of 1 000 individuals >15 years of age. Clusters\nwere designed to encompass social networks based on earlier studies. TasP phase 1 has been implemented in 10 geographic\nclusters (5 control and 5 intervention). Twelve additional clusters have been opened in June 2014.\nLocations: corresponds to physical locations. There are two types of locations: homesteads and TasP clinics.\nHomesteads: the population lives in scattered homesteads that are not concentrated into villages or compounds. All usable\nand occupied homesteads were eligible for trial participation.\nHouseholds: each homestead coul be composed of one or several households. An household remains always attached to the\nsame homestead.\nEligible individuals : all 16 years or older and resident household members. Each individuals is attached to an household. In\ncase of internal migration, an individual could move to another household.\nTasP clinics: dedicated trial clinics implemented in each survey cluster."}},"schematype":"survey"}