{"doc_desc":{"title":"Treatment as Prevention ANRS 12249, phase 1","idno":"DDI.ANRS12249-P1","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 Ined IRD) / Africa Centre for Health and Population Studies","role":"Data documentation"}],"prod_date":"2015-01-19","version_statement":{"version":"3.5.0","version_date":"2015-01-19","version_notes":"1.0.0 Intitial version (2 May 2014)\n1.0.1 Labels and missing values added to IQs dataset (7 May 2014)\n1.0.2 Labels and missing values added to CBCs, HIV Drug Treatments, ARTemis patients and ARTemis Lab results dataset (8 May 2014)\n1.0.3 Value labels of ShouldTestWhenRegHowOften in IQs dataset fixed (12 May 2014)\n1.1.0 IndividualId in IQs dataset fixed (12 May 2014)\n1.1.1 Typo fixed in trial statuses value labels in Individuals dataset (14 May 2014)\n2.0.0 Initial release of version 2 (15 July 2014)\n--- Generated from a new snapshot of the database, dated 22 May 2014\n--- New datasets: HHIs, CHE Adverse events, CHE Action Plans, SCBs SCCs, SCIs, Specimens, Individual Consents, iDART\n--- Individuals dataset: AgeGroupAtRegistration has been fixed\n--- IQs dataset:\n------ Health Care expenditure section has been added\n------ Variables CurrentCluster, CurrentClusterType, ClusterAtRegistration, ClusterTypeAtRegistration, FormType added\n------ Deprecated value fixed for variables ShouldTestWhenFeelSick to ShouldTestWhenRefused , KnowsPosMyself to KnowsPosCommunity\n------ Not applicable value fixed for variables WhyNotHIVTestTodayPos to WhyNotHIVTestTodayRefused\n------ Some duplicates removed\n--- CBCs dataset: variables CurrentCluster, CurrentClusterType, ClusterAtRegistration, ClusterTypeAtRegistration added\n--- CHEs dataset:\n------ Variables CurrentCluster, CurrentClusterType, ClusterAtRegistration, ClusterTypeAtRegistration added\n------ PrevTB1DateStarted, PrevTB2DateStarted and CurrTBDateStarted  variables fixed\n--- Lab Test Results dataset: VisitId added\n--- ARTemis Patients dataset: \n------ DateOfViralLoadNear6m DateOfViralLoadNear24m and DateOfViralLoadNear36m added\n------ AreaOfResidenceCode recoded\n3.0.0 Initial release of version 3 (25 September 2014)\n--- Generated from a new snapshot of the database, dated 19 September 2014\n--- End of data collection for phase 1 is now fixed to 31st May 2014 (included)\n--- Locations dataset: ConstructionState and MappedOnDevice variables have been removed\n--- Individuals dataset:\n------ Trial statuses have been removed from that file and are now provided in a separate Trial Statuses dataset\n------ 85 new pre-calculated variables have been added, following the TasP definitions document\n--- IQs dataset: Issue of missing IQs fixed\n--- Lab Tests Reults dataset: Some PIMA CD4 count documented initialy only in CHEs have been added to the dataset\n3.1.0 Distance variables added to Locations dataset (30 Sep 2014)\n3.2.0 Locations datatset: duplicates bug introduced in version 3.1.0 of the dataset is now fixed (7 Oct 2014)\n3.3.0 All datasets have been regenerated (9 Oct 2014)\n--- A bug with LocationId and HouseholdId has been fixed\n--- Cluster dataset has been added\n--- Individuals dataset:\n------ BaselineClinicVisitDate and LastClinicVisitDate definition has been updated (see TasP definitions do)\n------ 100 new pre-calculated variables added on retention in TasP clinics\n--- Trial Statuses dataset: details of Exits have been added\n--- Visits dataset: CBCcomputed, CHEcomputed, BaselineClinicVisitDate, onART, NextAppointmentDateComputed and PreviousClinicVisitDate added\n--- HHIs dataset: ClusterId, CalendarRound, AssetsScore and AssetsScoreCat added\n--- CBCs dataset: EarliestHIVDrugRegStartDate updated (new definition) and ARTInitiationDate removed\n3.4.0 (23 Oct 2014)\n--- Lab Test Results: duplicates (PIMA CD4 count) removed (23 Oct 2014)\n--- 2 new datasets: CFUs and CFU Pill Tests\n--- Shapefiles added on the repository\n--- Individuals dataset\n------ minor fix of variable TasPBaselineARTUse\n------ 3 variables added: FirstReferralTS, EverEnteredCareAR and NewlyDiagnosedAtReferral\n3.5.0 (19 Jan 2015)\n--- New datasets: \n------ SAE Initial Notifications, SAE Initial Notifications - Events details, SAE Initial Notifications - Medications, SAE Complementary Notifications & SAE Complementary Notifications - Medications\n--- Individuals dataset:\n------ AgeAtRegistration has been updated (now exact age and missig if year of birth is unknown)\n------ New variables about age: \n            AgeAtReferral, AgeAtBaselineClinicVisit\n------ New variables derived from IQs: \n            BaselineHighestEducationLevel, BaselineMaritalStatus, BaselineProfessionalStatus, BaselineEmployed & BaselineActiveStatus\n------ New variables derived from iDART: \n            LinkedToIDART, iDARTLastEpisodeStartDateBR, iDARTLastPackageCollectionDateBR, iDARTFirstEpisodeStartDateAR, \n            iDARTFirstPackageCollectionDateAR, iDARTLastEpisodeStartDateBHSBT, iDARTLastPackageCollectionDateBH, iDARTFirstEpisodeStartDate, \n            iDARTLastEpisodeStartDate, iDARTFirstPackageCollectionDate, iDARTLastPackageCollectionDate\n------ Other new variables: \n            NbTasPClinicVisits, InCareAtBeginning, TasPLCVDate, TasPLCVAppointmentDate, EverInCare, EverDiagnosedHIVPositive,\n            InCareAtEndPhase1, InTasPCareAtEndPhase1, ARTemisLastVL, ARTemisLastVLDate, TasPLastVL, TasPLastVLDate,\n            LastVL, LastVLDate, UndetectableVLAtEndPhase1\n------ Variable updated due to changes in TasP definitions document: \n            SeenInTasPClinic, TasPInitiatedART, CareAtReferral, InCareAtEndPhase1, OnARTAtBeginning, OnARTAtReferral & OnARTAtEndPhase1\n--- IQs dataset\n------ New variables:\n            AgeAtIQ, NonEmploymentTypeRecoded, HighestEducationLevel2, CurrentMaritalStatus2, Employed, ProfessionalStatus, ActiveStatus\n--- Visits dataset\n------ Variable PreviousClinicVisitDate fixed"}},"study_desc":{"title_statement":{"idno":"ANRS12249","title":"Treatment as Prevention ANRS 12249, phase 1","alt_title":"TasP Phase 1","translated_title":"Ukuphila kwami, ukuphila kwethu (my health for our health)"},"authoring_entity":[{"name":"Dabis, Fran\u00e7ois","affiliation":"Inserm Unit\u00e9 897, ISPED"},{"name":"Newell, Marie-Louise","affiliation":"Faculty of Medicine, Faculty of Social and Human Sciences, University of Southampton"}],"production_statement":{"producers":[{"name":"Africa Centre for Health and Population Studies","affiliation":"UKZN","role":""}],"prod_date":"2014-09-25","prod_place":"Mtubatuba, 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"}],"grant_no":"ANRS 12249 2010.2048.6-003.00"},"distribution_statement":{"distributors":[{"name":"Africa Centre for Health and Population Studies","abbreviation":"AC","affiliation":"UKZN","uri":"http://data.africacentre.ac.za/"}]},"version_statement":{"version":"3.5","version_date":"2015-01-19","version_notes":"1.0 Initial version  (2 May 2014)\n1.1 IndividualId in IQs dataset fixed (12 May 2014)\n2.0 Initial release of version 2 (15 July 2014)\n--- Generated from a new snapshot of the database, dated 22 May 2014\n--- New datasets: HHIs, CHE Adverse events, CHE Action Plans, SCBs SCCs, SCIs, Specimens, Individual Consents, iDART\n--- Individuals dataset: AgeGroupAtRegistration has been fixed\n--- IQs dataset:\n------ Health Care expenditure section has been added\n------ Variables CurrentCluster, CurrentClusterType, ClusterAtRegistration, ClusterTypeAtRegistration, FormType added\n------ Deprecated value fixed for variables ShouldTestWhenFeelSick to ShouldTestWhenRefused , KnowsPosMyself to KnowsPosCommunity\n------ Not applicable value fixed for variables WhyNotHIVTestTodayPos to WhyNotHIVTestTodayRefused\n------ Some duplicates removed\n--- CBCs dataset: variables CurrentCluster, CurrentClusterType, ClusterAtRegistration, ClusterTypeAtRegistration added\n--- CHEs dataset:\n------ Variables CurrentCluster, CurrentClusterType, ClusterAtRegistration, ClusterTypeAtRegistration added\n------ PrevTB1DateStarted, PrevTB2DateStarted and CurrTBDateStarted  variables fixed\n--- Lab Test Results dataset: VisitId added\n--- ARTemis Patients dataset: \n------ DateOfViralLoadNear6m DateOfViralLoadNear24m and DateOfViralLoadNear36m added\n------ AreaOfResidenceCode recoded\n3.0 Initial release of version 3 (25 September 2014)\n--- Generated from a new snapshot of the database, dated 19 September 2014\n--- End of data collection for phase 1 is now fixed to 31st May 2014 (included)\n--- Locations dataset: ConstructionState and MappedOnDevice variables have been removed\n--- Individuals dataset:\n------ Trial statuses have been removed from that file and are now provided in a separate Trial Statuses dataset\n------ 85 new pre-calculated variables have been added, following the TasP definitions document\n--- IQs dataset: Issue of missing IQs fixed\n--- Lab Tests Reults dataset: Some PIMA CD4 count documented initialy only in CHEs have been added to the dataset\n3.1 Distance variables added to Locations dataset (30 Sep 2014)\n3.2 Locations datatset: duplicates bug introduced in version 3.1.0 of the dataset is now fixed (7 Oct 2014)\n3.3 All datasets have been regenerated (9 Oct 2014)\n--- A bug with LocationId and HouseholdId has been fixed\n--- Cluster dataset has been added\n--- Individuals dataset:\n------ BaselineClinicVisitDate and LastClinicVisitDate definition has been updated (see TasP definitions do)\n------ 100 new pre-calculated variables added on retention in TasP clinics\n--- Trial Statuses dataset: details of Exits have been added\n--- Visits dataset: CBCcomputed, CHEcomputed, BaselineClinicVisitDate, onART, NextAppointmentDateComputed and PreviousClinicVisitDate added\n--- HHIs dataset: ClusterId, CalendarRound, AssetsScore and AssetsScoreCat added\n--- CBCs dataset: EarliestHIVDrugRegStartDate updated (new definition) and ARTInitiationDate removed\n3.4 (23 Oct 2014)\n--- Lab Test Results: duplicates (PIMA CD4 count) removed (23 Oct 2014)\n--- 2 new datasets: CFUs and CFU Pill Tests\n--- Shapefiles added on the repository\n--- Individuals dataset\n------ minor fix of variable TasPBaselineARTUse\n------ 3 variables added: FirstReferralTS, EverEnteredCareAR and NewlyDiagnosedAtReferral\n3.5 (19 Jan 2015)\n--- New datasets: \n------ SAE Initial Notifications, SAE Initial Notifications - Events details, SAE Initial Notifications - Medications, SAE Complementary Notifications & SAE Complementary Notifications - Medications\n--- Individuals dataset:\n------ AgeAtRegistration has been updated (now exact age and missig if year of birth is unknown)\n------ New variables about age: \n            AgeAtReferral, AgeAtBaselineClinicVisit\n------ New variables derived from IQs: \n            BaselineHighestEducationLevel, BaselineMaritalStatus, BaselineProfessionalStatus, BaselineEmployed & BaselineActiveStatus\n------ New variables derived from iDART: \n            LinkedToIDART, iDARTLastEpisodeStartDateBR, iDARTLastPackageCollectionDateBR, iDARTFirstEpisodeStartDateAR, \n            iDARTFirstPackageCollectionDateAR, iDARTLastEpisodeStartDateBHSBT, iDARTLastPackageCollectionDateBH, iDARTFirstEpisodeStartDate, \n            iDARTLastEpisodeStartDate, iDARTFirstPackageCollectionDate, iDARTLastPackageCollectionDate\n------ Other new variables: \n            NbTasPClinicVisits, InCareAtBeginning, TasPLCVDate, TasPLCVAppointmentDate, EverInCare, EverDiagnosedHIVPositive,\n            InCareAtEndPhase1, InTasPCareAtEndPhase1, ARTemisLastVL, ARTemisLastVLDate, TasPLastVL, TasPLastVLDate,\n            LastVL, LastVLDate, UndetectableVLAtEndPhase1\n------ Variable updated due to changes in TasP definitions document: \n            SeenInTasPClinic, TasPInitiatedART, CareAtReferral, InCareAtEndPhase1, OnARTAtBeginning, OnARTAtReferral & OnARTAtEndPhase1\n--- IQs dataset\n------ New variables:\n            AgeAtIQ, NonEmploymentTypeRecoded, HighestEducationLevel2, CurrentMaritalStatus2, Employed, ProfessionalStatus, ActiveStatus\n--- Visits dataset\n------ Variable PreviousClinicVisitDate fixed"},"study_notes":"A dataset containing GPS coordinates of homesteads has been released on the internal data repository of Africa Centre. Access conditions for this dataset are specific (cf. internal AC data repository).","study_info":{"abstract":"Background: Thirty years after the discovery of the human immunodeficiency virus (HIV), prevention is difficult to achieve and the pandemic does not show any sign of abating. Antiretroviral therapy (ART) is now rolled out at a large scale in lower-income countries. ART with fully suppressive antiretroviral (ARV) drugs combinations lowers HIV viral load (VL) in all body compartments and decreases the risk of transmission to a low level. It is thus legitimate to raise the following question: Could ART contribute to reducing transmission at individual and population level? Not only may earlier treatment reduce HIV incidence (acquisition of new cases of HIV infection through sexual or mother-to-child transmission), it may also benefit the individual. The long-term benefits of starting ART earlier would likely be of particular importance in settings where the incidence of life-threatening HIV-related diseases occurring at relatively high CD4 levels (tuberculosis, invasive bacterial diseases, and possibly malaria) is substantial, a typical situation in most sub-Saharan Africa including South Africa.\n\nResearch hypothesis: HIV testing of all adult members of a community, followed by immediate ART initiation of all, or nearly all, HIV-infected participants regardless of immunological or clinical staging will prevent onward transmission and reduce HIV incidence in this population.\n\nObjectives: To estimate the effect of ART initiated immediately after HIV diagnosis, irrespective of CD4 count criteria, on the reduction in incidence of new HIV infections in the general population in the same setting. \nSetting: The trial will be conducted in Hlabisa sub-district, Umkhanyakude district, Northern KwaZulu-Natal, South Africa. This rural setting of 1430 km2 in size has a population of approximately 220 000 Zulu-speaking people. In this sub-district, the Africa Centre for Health and Population studies, a research institute at the University of KwaZulu-Natal (<http://www.africacentre.com>) carries out socio-demographic and HIV surveillance and clinical research. The KwaZulu-Natal Department of Health and the Africa Centre established in 2004 the Hlabisa HIV Treatment and Care Programme, devolved to all 17 primary health care clinics in the sub-district. By mid-2013, over 28 000 HIV-infected people eligible for treatment had been initiated on ART; patients' treatment eligibility is determined by South African guidelines. \n\nDesign: A cluster-randomised trial with 22 (2\u00d711) clusters will be conducted within the Hlabisa sub-district, covering a total population of approximately 22 000 inhabitants aged 16 years and above, of whom an estimated 17 600 will be HIV-negative. A full prevention and HIV testing strategy will be provided in both the intervention and control arms, consisting of the current range of community and clinic testing options plus the implementation of 6-monthly rounds of home-based HIV testing. The adult HIV-infected population residing in the intervention clusters will be offered immediate ART initiation upon HIV diagnosis whereas the HIV-infected population in the control clusters will be offered ART according to national guidelines (CD4 less than 350 cells/ml, WHO stage 3 or 4 disease or MDR/XDR TB). The protocol outlines the overall trial design, which has HIV incidence as primary outcome. The first phase of the trial (24 months) will take place in ten (2\u00d75) clusters, with two to three rounds of home-based HIV testing and surveillance according to the trial protocol, and has as main outcome acceptability and feasibility rather than HIV incidence. If results from the first phase indicate acceptability and feasibility, the trial will be rolled-out to the other 12 clusters during the second phase. Possible amendments to the trial for phase 2 will be based on the advice from the Data Safety Monitoring Board and the Scientific Advisory Board.\n\nTrial eligibility criteria: To be aged 16 years and above and a member of a household in the designated cluster (head of household defines membership status in KwaZulu culture).\n\nTreatment eligibility criteria: Those already on ART from the Hlabisa HIV Treatment and Care Programme may opt to transfer their care to the trial; the few (if any) people already on ART from private/other HIV treatment providers will be encouraged to take part in the trial monitoring procedures, and be given the opportunity to change ART provider to the Hlabisa HIV Treatment and Care Programme trial. \n\nTrial treatment: The standard first-line drug regimen will be the combination of tenofovir (TDF) + emtricitabine (FTC) + efavirenz (EFV) once daily, i.e. Atripla\u00ae. This will also be applicable to pregnant women irrespective of the trimester of pregnancy.","time_periods":[{"start":"2012-03-09","end":"2014-05-31","cycle":"Phase 1"}],"coll_dates":[{"start":"2012-03-09","end":"2012-11-03","cycle":"Calendar Round 1 - First group of clusters"},{"start":"2012-11-13","end":"2013-04-19","cycle":"Calendar Round 2 - First group of clusters"},{"start":"2013-05-02","end":"2013-08-31","cycle":"Calendar Round 3 - First group of clusters"},{"start":"2013-01-22","end":"2013-07-26","cycle":"Calendar Round 1 - Second group of clusters"},{"start":"2013-08-14","end":"2013-03-01","cycle":"Calendar Round 2 - Second group of clusters"},{"start":"2013-03-10","end":"2014-05-31","cycle":"TasP clinics follow-up"}],"nation":[{"name":"South Africa","abbreviation":"ZA"}],"geog_coverage":"Ten survey clusters located in Hlabisa sub-district, Umkhanyakude district, of northern KwaZulu-Natal, South Africa.\n\nThe Hlabisa health sub-district is a rural setting of 1 430 km2 in size, with a population of approximately 220 000 Zulu-speaking people of whom 3.3% are located in a formal urban township (KwaMsane), 19.9% in peri-urban areas and the remainder (76.8%) classified as living in a rural area. The rural population lives in scattered homesteads that are not concentrated 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 and six contiguous neighbourhoods, each cluster comprising an average of 1 000 individuals >15 years of age. Clusters were designed to encompass social networks based on earlier studies. TasP phase 1 has been implemented in 10 geographic clusters (5 control and 5 intervention).\n\nLocations: corresponds to physical locations. There are two types of locations: homesteads and TasP clinics.\n\nHomesteads: the population lives in scattered homesteads that are not concentrated into villages or compounds. All usable and occupied homesteads were eligible for trial participation.\n\nHouseholds: each homestead coul be composed of one or several households. An household remains always attached to the same homestead.\n\nEligible individuals : all 16 years or older and resident household members. Each individuals is attached to an household. In case of internal migration, an individual could move to another household.\n\nTasP clinics: dedicated trial clinics implemented in each survey cluster."},"method":{"data_collection":{"data_collectors":[{"name":"Africa Centre for Health and Population Studies","abbreviation":"AC","affiliation":"UKZN"}],"frequency":"A calendar round refers to the time period it took to implement one home-based HIV testing round in all the clusters. During the first phase of the trial, three calendar rounds were conducted in four clusters (first group, 8 months, 4 months, 4 months duration) and two calendar rounds in six clusters (second group, 6 months and 6 months). \n\nClinical data of HIV-infected patients followed in TasP clinics has been collected on a day-to-day basis.","sampling_procedure":"Randomisation (control clusters vs intervention clusters) was performed by the trial statisticians at the start of the trial for all clusters. \n\nAll individuals 16 years or older and resident member of a local household are eligible.","coll_mode":"Face to face interviews"}},"data_access":{"dataset_use":{"conditions":"To access these datasets, an analysis proposal needs to be discussed with one of the TasP working groups and approved by TasP's principal investigators.\n\nPlease contact Collins Iwuj <ciwuji@africacentre.ac.za> and/or Joanna Orne-Gliemann <Joanna.Orne-Gliemann@isped.u-bordeaux2.fr> for further details and the model of form for submitting an analysis proposal.\n\nThis form must be filled and submitted by the Lead Researcher. Lead Researcher refers to the person who serves as the main point of contact for all communications involving this agreement. Access to licensed datasets will only be granted when the Lead Researcher is an employee of a legally registered receiving agency (university, company, research centre, national or international organization, etc.) on behalf of which access to the data is requested. The Lead Researcher assumes all responsibility for compliance with all terms of this Data Access Agreement by employees of the receiving organization."}}},"schematype":"survey","type":"survey","data_files":[{"file_id":"F11","file_name":"DBS Results","description":"This file contains the results of HIV tests performed on Dried Blood Spots (DBS) collected during the home-based survey. This file contains one row per test.","case_count":"15791","var_count":"5","producer":null,"data_checks":null,"missing_data":null,"version":null,"notes":null,"metadata":null},{"file_id":"F22","file_name":"HIV Drug Treatments","description":"HIV drug treatment for TasP patients in care in TasP clinics. One row per regimen and per patient.\nEach time a patient switched from one regimen to another regimen, a new record was stored in that dataset.","case_count":"11003","var_count":"9","producer":null,"data_checks":null,"missing_data":null,"version":null,"notes":null,"metadata":null},{"file_id":"F24","file_name":"Households","description":"This dataset contains one row per registered households.","case_count":"3546","var_count":"7","producer":null,"data_checks":null,"missing_data":null,"version":null,"notes":null,"metadata":null},{"file_id":"F28","file_name":"CBCs","description":"This dataset corresponds to Clinic Baseline Visit (CBC) forms completed by ART counsellors in TasP clinics.","case_count":"1310","var_count":"30","producer":null,"data_checks":null,"missing_data":null,"version":null,"notes":null,"metadata":null},{"file_id":"F29","file_name":"CHEs","description":"This dataset corresponds to Clinical History and Examination forms (CHE) completed by nurses in tasP clinics. The following sections of the questionnaire are provided in separate datasets:\n- 11. Concomitant medication not recorded in ART or TB regimen -> HIV Drug Treatments dataset\n- 12. Adverse Events -> Adverse Events dataset\n- 24. Drug Prescriptions -> HIV Drug Treatments dataset\n- 25. Action Plan -> Action Plans dataset","case_count":"12158","var_count":"151","producer":null,"data_checks":null,"missing_data":null,"version":null,"notes":null,"metadata":null},{"file_id":"F30","file_name":"Lab Test Results","description":"This dataset contains the resuts of the clinical tests done for patients in care in TasP clinics. It contains one row per test date and per individual.","case_count":"15128","var_count":"33","producer":null,"data_checks":null,"missing_data":null,"version":null,"notes":null,"metadata":null},{"file_id":"F31","file_name":"ARTemis Lab Results","description":"This dataset contains all ARTemis Lab test results (in particular CD4 counts and viral loads) for TasP registered individuals linked to ARTemis.","case_count":"10367","var_count":"16","producer":null,"data_checks":null,"missing_data":null,"version":null,"notes":null,"metadata":null},{"file_id":"F32","file_name":"ARTemis Patients","description":"This file contains data from ARTemis database for each registered TasP individual linked to ARTemis. One row per individual.\n\nThe data collated here is obtained from patients' records completed during routine HIV clinical care within the Hlabisa Treatment and Care Programme. The HIV treatment and Care programme was implemented as a joint initiative by the Department of Health (DoH) and the Africa Centre for Health and Population Studies (http://www.africacentre.ac.za) in response to the Comprehensive HIV and AIDS Care Management and Treatment Plan in 2004. HIV treatment and care is offered in 17 nurse-led primary health-care (PHC) clinics and 1 district hospital. The data comprises HIV positive patients pre- and post- ART initiation. However for patients pre-ART only the personal identifiers (name, sex and South African ID number) and the CD4 counts measured for assessment of ART eligibility are recorded. All patients within ARTemis are HIV positive and all patients are aware of their HIV status. This database was initially set up for monitoring and evaluating (M&E) patients and programme performance and outcomes. Over time in addition to M&E, these data are used to answer research questions to better understand issues related to HIV and ART in HIV positive patients. \n\nRoutine data collection schedule is summarized below:\n\nBasic details \n\nAge, sex, address, ID number, contact details, treatment clinic (collected at ART initiation only or when need arises during follow-up)\n\nSocio-demographic details \n\nGrants received, employment, school attendance, number of dependents (collected at ART initiation only)\n\nTuberculosis (TB) record\n\nTuberculosis (TB) record\n\nPrevious history of TB, TB treatment at initiation, new episodes of TB (collected only in those receiving ART)\n\nART record \n\nWHO clinical stage, Previous ART and/or PMTCT, ART regimen at initiation, changes in ART regimen during treatment\n\nLaboratory data \n\nFor patients on ART\n\nBaseline and 6-monthly CD4 and HIV viral load, baseline haematology and biochemistry\n\nFor patients pre-ART\n\nAll pre-ART CD4 cell counts routinely done in accordance with the South African ART guidelines are recorded","case_count":"1989","var_count":"121","producer":null,"data_checks":null,"missing_data":null,"version":null,"notes":null,"metadata":null},{"file_id":"F34","file_name":"CHE Adverse Events","description":"This dataset corresponds to the Adverse Events section of the CHE (clinical history examination) forms. It contains one row per recorded adverse event.","case_count":"422","var_count":"7","producer":null,"data_checks":null,"missing_data":null,"version":null,"notes":null,"metadata":null},{"file_id":"F36","file_name":"Specimens","description":"This dataset indicates specimens collected within TasP (at home or in TasP clinics), one row per specimen.","case_count":"19356","var_count":"5","producer":null,"data_checks":null,"missing_data":null,"version":null,"notes":null,"metadata":null},{"file_id":"F38","file_name":"Individual Consents","description":"This dataset contains individual consents. One row per individual.","case_count":"14216","var_count":"13","producer":null,"data_checks":null,"missing_data":null,"version":null,"notes":null,"metadata":null},{"file_id":"F39","file_name":"SCBs SCCs","description":"This dataset contains SCBs and SCCs forms (clinic-based survey, ART consellor administered), one row per form.","case_count":"2502","var_count":"97","producer":null,"data_checks":null,"missing_data":null,"version":null,"notes":null,"metadata":null},{"file_id":"F41","file_name":"iDART","description":"iDART dataset","case_count":"422","var_count":"6","producer":null,"data_checks":null,"missing_data":null,"version":null,"notes":null,"metadata":null},{"file_id":"F44","file_name":"CHE Action Plans","description":"This dataset corresponds to the Action Plans section of the CHE (clinical history examination) forms. It contains one row per recordedaction plan.","case_count":"38382","var_count":"6","producer":null,"data_checks":null,"missing_data":null,"version":null,"notes":null,"metadata":null},{"file_id":"F45","file_name":"Locations","description":"Locations, i.e Homesteads and TasP clinics","case_count":"7738","var_count":"15","producer":null,"data_checks":null,"missing_data":null,"version":null,"notes":null,"metadata":null},{"file_id":"F46","file_name":"Clusters","description":"Trial clusters","case_count":"10","var_count":"5","producer":null,"data_checks":null,"missing_data":null,"version":null,"notes":null,"metadata":null},{"file_id":"F48","file_name":"Trial Statuses","description":"These file contains individual trial statuses, one row per trial status.","case_count":"24373","var_count":"42","producer":null,"data_checks":null,"missing_data":null,"version":null,"notes":null,"metadata":null},{"file_id":"F49","file_name":"Visits","description":"This table contains one row per visit. There are two sorts of visits: homestead visits and TasP clinic visits, that can be identified through the variable LocationType.\n\nLocationId refers to a homestead or to a TasP visit, according to the sort of visit.\n\nSeveral individuals could be surveyed for a same homestead visit while a TasP clinic visit always concerns only one individual.","case_count":"33388","var_count":"18","producer":null,"data_checks":null,"missing_data":null,"version":null,"notes":null,"metadata":null},{"file_id":"F50","file_name":"HHIs","description":"This dataset contains Household Information / Assets forms. One row per form.","case_count":"7246","var_count":"49","producer":null,"data_checks":null,"missing_data":null,"version":null,"notes":null,"metadata":null},{"file_id":"F51","file_name":"SCIs","description":"This dataset contains SCI forms (clinic-based survey, independent interwiever administered), one row per form.","case_count":"1256","var_count":"268","producer":null,"data_checks":null,"missing_data":null,"version":null,"notes":null,"metadata":null},{"file_id":"F52","file_name":"CFUs","description":"This file contains one row per Clinic Follow-Up form (CFU) completed by Trial Counsellor. Data from question 3.5 (Adherence Pill Identification Test) are provided in a seperate dataset (CFU Pill tests).","case_count":"10805","var_count":"21","producer":null,"data_checks":null,"missing_data":null,"version":null,"notes":null,"metadata":null},{"file_id":"F53","file_name":"CFU Pill Tests","description":"This file contains data from question 3.5 (Adherence Pill Identification Test), one row per pill. You can link data with CFUs dataset using CVIntId.","case_count":"13720","var_count":"11","producer":null,"data_checks":null,"missing_data":null,"version":null,"notes":null,"metadata":null},{"file_id":"F55","file_name":"SAEs Initial Notifications","description":"Serious Adverse Events - Initial Notifications. 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