Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-01-06 @ 11:46 PM
Study NCT ID:
NCT05225493
Status:
UNKNOWN
Last Update Posted:
2022-02-04
First Post:
2022-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HIV Indicator Diseases in Hospital and Primary Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D006562', 'term': 'Herpes Zoster'}, {'id': 'D012628', 'term': 'Dermatitis, Seborrheic'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D007244', 'term': 'Infectious Mononucleosis'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D002177', 'term': 'Candidiasis'}, {'id': 'D000072281', 'term': 'Lymphadenopathy'}, {'id': 'D002578', 'term': 'Uterine Cervical Dysplasia'}, {'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D007970', 'term': 'Leukopenia'}, {'id': 'D013921', 'term': 'Thrombocytopenia'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': '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': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000073618', 'term': 'Varicella Zoster Virus Infection'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'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': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'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': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-26', 'studyFirstSubmitDate': '2022-01-17', 'studyFirstSubmitQcDate': '2022-01-26', 'lastUpdatePostDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The number of HIV tests in relation to the total number of HIV tests done by gender, ethnical background, age, previous HIV test and HIV indicator conditions of the patient, primary care setting and hospital setting.', 'timeFrame': '3 year'}, {'measure': 'Center for Disease Control and Prevention (CDC) HIV classification of the patients with an HIV positive test.', 'timeFrame': '3 year'}], 'primaryOutcomes': [{'measure': 'The number of adequately performed HIV tests of identified HIV indicator conditions in relation to the total number of identified HIV indicator conditions by physicians in hospital settings during the project.', 'timeFrame': '3 year'}, {'measure': 'The number of adequately performed HIV tests of identified HIV indicator conditions in relation to the total number of identified HIV indicator conditions by general practitioners in primary care during the project.', 'timeFrame': '3 year'}], 'secondaryOutcomes': [{'measure': 'The number of positive HIV tests in relation to the total number of HIV tests for identified HIV indicator conditions.', 'timeFrame': '3 year'}, {'measure': 'The percentage of adequately HIV tested patients per HIV indicator condition and per medical specialism.', 'timeFrame': '31 year'}, {'measure': 'The prevalence of HIV indicator conditions in primary care and hospitals.', 'timeFrame': '3 year'}, {'measure': 'The incidence of HIV indicator conditions in primary care and hospitals.', 'timeFrame': '3 year'}, {'measure': 'A sensitive and specific supervised artificial Intelligence tool that recognizes risk factors for HIV and HIV indicator conditions through natural language processing (NLP) and supports the hospital and primary care in proactive HIV testing policies.', 'timeFrame': '3 year'}, {'measure': 'Acceptance of HIV testing in by patients, medical specialist and in primary care.', 'timeFrame': '3 year', 'description': 'Assessed by questionnaire'}, {'measure': "The costs of pro-active HIV indicator case finding and relation to the savings and QALY's gained", 'timeFrame': '3 year', 'description': "Costs of the program in relation to the savings in costs and QALY's lost as a consequence of earlier HIV diagnosis with subsequent prevented HIV transmission, AIDS comorbidity and hospital admissions."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['General Practitioner, Medical Specialist, HIV indicator condition, HIV risk group, AIDS'], 'conditions': ['HIV Infections', 'Primary Health Care', 'Acquired Immunodeficiency Syndrome', 'Sexually Transmitted Diseases, Viral', 'Herpes Zoster', 'Dermatitis, Seborrheic', 'Pneumonia', 'Infectious Mononucleosis', 'Psoriasis', 'Candida Infection', 'Lymphadenopathy', 'Uterine Cervical Dysplasia', 'Weight Loss', 'Diarrhea Chronic', 'Leukopenia', 'Thrombocytopenia', 'AIDS Defining Illness', 'HIV Indicator Condition']}, 'referencesModule': {'references': [{'pmid': '39731054', 'type': 'DERIVED', 'citation': 'Jordans CCE, Niemantsverdriet-Rokx L, Struik JL, van der Waal EC, van der Voorn PVJM, Bakker N, Verbon A, Bindels PJE, Rokx C. Implementing HIV teams to improve HIV indicator condition-guided testing in general practitioner centers in the Netherlands. BMC Prim Care. 2024 Dec 27;25(1):440. doi: 10.1186/s12875-024-02666-0.'}]}, 'descriptionModule': {'briefSummary': 'Patients are frequently evaluated by physicians for medical work-up of HIV indicator conditions in hospital and in primary care at the general practitioner. Testing for HIV is indicated with HIV indicator disorder but often omitted in clinical work-up. Besides the fact that HIV testing is forgotten, there are other reasons such as an underestimation of the risk of HIV in the event of indicator disorders, stigma and difficulties in discussing the test with a patient. Also and more relevant for primary care than for the hospital, practical challenges can exist for a patient to go to a laboratory, or costs are a hurdle.\n\nThis project focuses on improving HIV indicator condition driven testing in different settings of the HIV epidemic, initially in the Netherlands as low HIV prevalence setting followed by an assessment of its benefit in different international settings. A specific focus will also be on the Rotterdam area in the Netherlands which has a high prevalence of undiagnosed HIV in the Netherlands. The ultimate aim is to decrease the number of undiagnosed HIV in populations, improve the 90-90-90 HIV cascade of care goals particularly its first pillar, and to help supporting the UNAIDS goal to end HIV/AIDS'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Medical specialists, general practitioners and their patients aged 18 years and older in the participating hospitals and primary care who present there with an HIV indicator condition.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of an HIV indicator conditions.\n\nExclusion Criteria:\n\n* Below 18 years of age\n* Recent HIV test (\\< 12 months, except for mononucleosis-like disease and STDs)'}, 'identificationModule': {'nctId': 'NCT05225493', 'acronym': '#AwareHIV', 'briefTitle': 'HIV Indicator Diseases in Hospital and Primary Care', 'organization': {'class': 'OTHER', 'fullName': 'Erasmus Medical Center'}, 'officialTitle': 'Supporting Health Care Professionals in Hospital and Primary Care to Promote Adequate HIV Risk and Indicator Condition Driven Testing in Routine Care.', 'orgStudyIdInfo': {'id': 'MEC-2021-0277'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hospital', 'description': 'Medical specialists in hospitals and their patients aged 18 years and older in the participating hospitals who are diagnosed there with an HIV indicator condition.', 'interventionNames': ['Behavioral: Peer to peer feedback']}, {'label': 'Primary care', 'description': 'General practitioners and their patients aged 18 years and older in the participating general practices who are diagnosed there with an HIV indicator condition.', 'interventionNames': ['Behavioral: Peer to peer feedback', 'Diagnostic Test: HIV rapid test']}], 'interventions': [{'name': 'Peer to peer feedback', 'type': 'BEHAVIORAL', 'description': 'HIV experts contact non-HIV specialised treating physicians on individual patient care to recommend HIV testing', 'armGroupLabels': ['Hospital', 'Primary care']}, {'name': 'HIV rapid test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Free HIV rapid tests are provided to non-HIV specialised treating physicians to use in individual patient care in patients at risk of HIV', 'armGroupLabels': ['Primary care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3015GD', 'city': 'Rotterdam', 'state': 'South Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Carlijn C Jordans, PhD', 'role': 'CONTACT', 'email': 'c.jordans@erasmusmc.nl', 'phone': '+31634304279'}, {'name': 'Maartje M Wagemaker, RN', 'role': 'CONTACT', 'email': 'm.wagemaker@erasmusmc.nl', 'phone': '+31631145074'}, {'name': 'Casper C Rokx, PhD MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Bart B Rijnders, PhD MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Carlijn C Jordans, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Adam A Anas, PhD MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jeroen J van Kampen, PhD MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Robert Jan Sips, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jet Gisolf, MD PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Annelies Verbon, Prof', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Femke Mollema, MD PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Rachida El Moussaoudi, MD PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Zoltan Szlavik, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'David vd Vijver, PharmD PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Renee Finkenflugel, Msc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Anna Roukens, MD PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Carlijn CCE Jordans', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'centralContacts': [{'name': 'Casper Rokx, MD PhD', 'role': 'CONTACT', 'email': 'c.rokx@erasmusmc.nl', 'phone': '+31681336328'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Available upon reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasmus Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Huisartspraktijk Gezondheidscentrum Mathenesserlaan', 'class': 'UNKNOWN'}, {'name': 'TU Delft department of Artificial Intelligence and MyTomorrows', 'class': 'UNKNOWN'}, {'name': 'Huisartsen Groep Rotterdam', 'class': 'UNKNOWN'}, {'name': 'AwareHIV Project Group', 'class': 'UNKNOWN'}, {'name': 'Huisartspraktijk Handellaan', 'class': 'UNKNOWN'}, {'name': 'Huisartspraktijk Leerdam', 'class': 'UNKNOWN'}, {'name': 'Huisartspraktijk Capelle ad IJssel', 'class': 'UNKNOWN'}, {'name': 'Leiden University Medical Center', 'class': 'OTHER'}, {'name': 'Maasstadziekenhuis', 'class': 'UNKNOWN'}, {'name': 'Rijnstate Hospital', 'class': 'OTHER'}, {'name': 'Medical Center Haaglanden', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Casper Rokx', 'investigatorAffiliation': 'Erasmus Medical Center'}}}}