Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2025-12-28 @ 3:10 AM
Study NCT ID:
NCT01196468
Status:
UNKNOWN
Last Update Posted:
2012-04-12
First Post:
2010-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HIV Indicator Diseases Survey Across Europe - UK Arm
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D004194', 'term': 'Disease'}, {'id': 'D002578', 'term': 'Uterine Cervical Dysplasia'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D012628', 'term': 'Dermatitis, Seborrheic'}, {'id': 'D005076', 'term': 'Exanthema'}, {'id': 'D006942', 'term': 'Hypergammaglobulinemia'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012625', 'term': 'Sebaceous Gland Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082922', 'term': 'HIV Testing'}, {'id': 'D007407', 'term': 'Interviews as Topic'}], 'ancestors': [{'id': 'D008828', 'term': 'Microbiological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'Salivary or serological HIV test'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-04-11', 'studyFirstSubmitDate': '2010-08-10', 'studyFirstSubmitQcDate': '2010-09-07', 'lastUpdatePostDateStruct': {'date': '2012-04-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of HIV infection in patients presenting to specific services with specific HIV indicator diseases'}], 'secondaryOutcomes': [{'measure': 'Previous HIV testing behaviour of individuals presenting with an indicator disease or condition (sub-study only)', 'description': 'Any previous history of HIV tests taken: total number, dates, and results'}, {'measure': 'Demographic data of individuals presenting for care with specified indicator diseases', 'description': 'Data comprise: age group, sex, ethnicity (plus sexuality and injecting drug use history for sub-study participants only)'}, {'measure': 'Time to transfer to care for those individuals testing HIV positive'}, {'measure': 'Immune status of newly-diagnosed HIV positive individuals as determined by CD4 cell count'}, {'measure': 'HIV risk factors (sub-study only)'}, {'measure': 'Previous medical history and health-seeking behaviour (sub-study only)', 'description': 'Past medical history will be recorded, with particular attention paid to previous illnesses that constitute AIDS-defining illnesses, or other severe, non-AIDS infections and cancers. Number of visits to primary care and any inpatient admissions over preceding five years will be recorded.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV', 'Testing', 'Targeted', 'Indicator', 'Diseases', 'Anal dysplasia', 'Cervical dysplasia', 'STI', 'Lymphoma', 'Seborrhoeic dermatitis', 'Exanthema', 'Thrombocytpaenia', 'Lymphopaenia', 'Hypergammaglobulinaemia'], 'conditions': ['HIV', 'AIDS', 'Indicator Diseases/Indicator Conditions']}, 'descriptionModule': {'briefSummary': 'In Europe many patients infected with HIV remain undiagnosed, although this percentage varies between 15-80% across the continent. In the UK it is estimated to be 27%. Undiagnosed HIV results in increased morbidity and mortality and reduced treatment response, as appropriate health interventions are delayed. It also has adverse public health implications, with those individuals unaware of their HIV status being more likely to transmit the virus.\n\nAn important public health issue is how to diagnose more individuals with HIV earlier in the course of their infection. In the US, the Centre for Disease Control and Prevention (CDC) has introduced testing guidelines whereby all individuals are tested, unless they object, at any point of contact with the healthcare system - the "opt-out" testing guidelines.\n\nAt the "HIV in Europe" Conference held in November 2007, the consensus, which included patient and public involvement, was that such an approach would not be suitable for Europe. The Conference recommended further development of focused HIV testing in patients presenting with certain clinical conditions and diseases - the "indicator disease\'\' testing guidelines.\n\nCost effectiveness analyses suggests cost savings if a screened population has an HIV prevalence of at least 1%, although this rate may be as low as 0.1%. However, there is very little - if any - evidence regarding HIV prevalence for certain conditions and diseases in specific and easy to identify sections of society. The focus of attention is on those conditions and diseases which occur more frequently in individuals known to be infected with HIV.\n\nThe aim of this study is to assess HIV prevalence for several diseases and conditions, within a specific segment of the population not yet diagnosed with HIV, who present for care with that specific disease or condition. These conditions have been selected as they occur frequently in individuals already diagnosed with HIV infection. This is a pilot study to inform phase two, which will involve more diseases and conditions with a wider participation of centres across Europe.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults (16 years and over), not known already to be HIV-positive, presenting for care in designated healthcare settings with one of five "indicator diseases." Sequential patients will be offered HIV tests, and if they accept, asked to provide additional information via focussed interview (sub-study).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Aged 16 years and over\n* Presenting for care with one of the indicator diseases or conditions:\n\n * A sexually transmitted disease\n * Malignant lymphoma\n * Cervical or anal dysplasia or cancer\n * Unexplained leukocytopenia or thrombocytopenia lasting at least 4 weeks, or hypergammaglobulinaemia\n * Seborrheic dermatitis or exanthema\n* sub-study - consents to providing additional information\n\nExclusion criteria\n\n* Known HIV positive\n* sub-study - declines to consent for additional information to be collected'}, 'identificationModule': {'nctId': 'NCT01196468', 'briefTitle': 'HIV Indicator Diseases Survey Across Europe - UK Arm', 'organization': {'class': 'OTHER', 'fullName': 'Chelsea and Westminster NHS Foundation Trust'}, 'officialTitle': 'HIV Indicator Diseases Survey Across Europe', 'orgStudyIdInfo': {'id': 'Indicator Diseases Survey'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Anal/cervical dyplasia', 'description': 'Any patient presenting for care with any degree of anal or cervical dysplasia', 'interventionNames': ['Other: HIV test (serological or salivary)', 'Other: Interview']}, {'label': 'STI', 'description': 'Any patient presenting for care with any non-HIV sexually transmitted infection', 'interventionNames': ['Other: HIV test (serological or salivary)', 'Other: Interview']}, {'label': 'Lymphoma', 'description': 'Any patient presenting for care with malignant lymphoma of any histological type', 'interventionNames': ['Other: HIV test (serological or salivary)', 'Other: Interview']}, {'label': 'Seborrhoeic dermatitis/exanthema', 'description': 'Any patient presenting for care with seborrhoeic dermatitis/exanthema', 'interventionNames': ['Other: HIV test (serological or salivary)', 'Other: Interview']}, {'label': 'Thromobocytopaenia/Leucopaenia, or hypergammaglobulinaemia', 'description': 'Any patient presenting for care with unexplained thromobocytopaenia/leucopaenia of more than four weeks duration, or with hypergammaglobulinaemia', 'interventionNames': ['Other: HIV test (serological or salivary)', 'Other: Interview']}], 'interventions': [{'name': 'HIV test (serological or salivary)', 'type': 'OTHER', 'description': 'An HIV test will be offered to all patients accessing the healthcare setting for care of the "indicator" condition', 'armGroupLabels': ['Anal/cervical dyplasia', 'Lymphoma', 'STI', 'Seborrhoeic dermatitis/exanthema', 'Thromobocytopaenia/Leucopaenia, or hypergammaglobulinaemia']}, {'name': 'Interview', 'type': 'OTHER', 'description': 'Demographic data will be collected for each patient consenting to an HIV test. With informed written consent, additional data will be collected from patients via focussed interview. Data comprises: previous medical history, previous health seeking behaviours, previous HIV testing history, previous viral hepatitis testing/diagnosis history, and assessment of HIV acquisition risk factors', 'armGroupLabels': ['Anal/cervical dyplasia', 'Lymphoma', 'STI', 'Seborrhoeic dermatitis/exanthema', 'Thromobocytopaenia/Leucopaenia, or hypergammaglobulinaemia']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SW10 9NH', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Ann K Sullivan, MBBS FRCP', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Nick Wales, MBBS FRCOG', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Helen Yarranton, MRCP MRCPath', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Chris Bunker, MBBS FRCP', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Chelsea and Westminster NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW3 6JJ', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'David Cunningham, PhD FRCP', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Royal Marsden NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Ann K Sullivan, MBBS FRCP', 'role': 'CONTACT', 'email': 'ann.sullivan@chelwest.nhs.uk', 'phone': '+44 (0)208 746 8000', 'phoneExt': '56199'}, {'name': 'Michael Rayment, MBBS MA MRCP', 'role': 'CONTACT', 'email': 'michaelrayment@nhs.net', 'phone': '+44 (0)208 746 8000', 'phoneExt': '56529'}], 'overallOfficials': [{'name': 'Ann K Sullivan, MBBS FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chelsea and Westminster NHS Foundation Trust'}, {'name': 'Jens Lundgren, MBBS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Copenhagen and Righospitalet'}, {'name': 'David Cunningham, PhD FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Marsden NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chelsea and Westminster NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'HIV in Europe (Co-Sponsor)', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Dr Ann Sullivan', 'oldOrganization': 'Chelsea and Westminster NHS Foundation Trust, London, UK'}}}}