Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-02-28 @ 3:31 AM
Study NCT ID:
NCT03343158
Status:
TERMINATED
Last Update Posted:
2021-02-05
First Post:
2017-11-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Orphans and Vulnerable Children Risk Screening Tool Research Study (Zimbabwe)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2260}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Significantly more resources would have been necessary to complete the study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-10-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2018-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-03', 'studyFirstSubmitDate': '2017-11-10', 'studyFirstSubmitQcDate': '2017-11-14', 'lastUpdatePostDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1: Validity of various questions in predicting the probability of HIV among OVC (Screening tool)', 'timeFrame': 'Four weeks', 'description': 'Sensitivity and specificity of eleven questions in predicting HIV among OVC'}, {'measure': 'Phase 2: Validation of combined questions in predicting HIV among OVC (Validating Screen tool)', 'timeFrame': 'Six weeks', 'description': 'Validation of combined questions assessed from Phase 1 in predicting HIV among OVC'}], 'secondaryOutcomes': [{'measure': 'Usability of screening tool', 'timeFrame': 'Two weeks', 'description': 'CHWs who participate in the screening will be invited to participate in a short survey, offered in either Shona or English (depending on participant choice), on the ease, simplicity, and usability of the screening tool, as well as perceptions of the process'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Orphans, Children, Adolescents', 'Vulnerable Children, Adolescents', 'Community-based']}, 'descriptionModule': {'briefSummary': 'Investigators propose to assess the sensitivity, specificity, positive and negative predictive value of an HIV Risk Screening Tool in identifying the risk of being HIV-infected among Orphans and Vulnerable Children (OVC) aged 2-18 years in a community setting.', 'detailedDescription': 'In the first phase of the study, investigators will identify an optimal set of screening questions with acceptable sensitivity and false positive rate, based on the draft 11-question pilot tool. Using the identified questions, investigators will develop a composite screening tool and determine criteria that should be used for identifying children for testing with minimally acceptable sensitivity and false positive rates. In the second phase of the study, investigators will select optimal questions to create a composite screening tool and validate it in a similar study population. Investigators anticipate the accuracy of the tool will be much improved compared to the individual questions. Investigators will also assess the usability of the HIV Risk Screening Tool as measured by the time taken to administer the tool, and perceptions of its ease and simplicity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'OVC aged 2-18 years, living in households which are registered on a database developed by World Education Institute, a Non-Government Organization which provides services for orphans and vulnerable children in the community', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children/adolescents ages 2 up to 18 years living in a household and enrolled in WEI/Zimbabwe and/or partners program;\n* Children/adolescents ages 2 up to 18 years with HIV status unknown, or who tested negative three or more months ago;\n* Children/adolescents ages 2 up to 18 years who are healthy or ill (unless they are ill enough to require immediate hospitalization).\n\nExclusion Criteria:\n\n* Children/adolescents aged 2 up to 18 years tested HIV positive\n* Children/adolescents ages 2 up to 18 years who require immediate hospitalization;\n* Children/adolescents ages 2 up to 18 years who refuse/are refused participation.'}, 'identificationModule': {'nctId': 'NCT03343158', 'briefTitle': 'Orphans and Vulnerable Children Risk Screening Tool Research Study (Zimbabwe)', 'organization': {'class': 'OTHER', 'fullName': 'Elizabeth Glaser Pediatric AIDS Foundation'}, 'officialTitle': 'Orphans and Vulnerable Children Risk Screening Tool Research Study (Zimbabwe)', 'orgStudyIdInfo': {'id': 'EG0174'}}, 'contactsLocationsModule': {'locations': [{'city': 'Harare', 'country': 'Zimbabwe', 'facility': 'EGPAF Zimbabwe', 'geoPoint': {'lat': -17.82772, 'lon': 31.05337}}], 'overallOfficials': [{'name': 'Agnes Mahomva, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Elizabeth Glaser Pediatric AIDS Foundation'}, {'name': 'Godfrey Woelk, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Elizabeth Glaser Pediatric AIDS Foundation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elizabeth Glaser Pediatric AIDS Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'JSI Research & Training Institute, Inc.', 'class': 'OTHER'}, {'name': 'Biomedical Research and Training Institute, Zimbabwe', 'class': 'OTHER'}, {'name': 'United States Agency for International Development (USAID)', 'class': 'FED'}, {'name': 'World Education, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}