Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-28 @ 12:14 AM
Study NCT ID:
NCT04517760
Status:
COMPLETED
Last Update Posted:
2020-08-18
First Post:
2020-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating an HIV Risk Screening Tool for Orphans and Vulnerable Children in Tanzania
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': 21080}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-17', 'studyFirstSubmitDate': '2020-08-12', 'studyFirstSubmitQcDate': '2020-08-17', 'lastUpdatePostDateStruct': {'date': '2020-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity of HIV risk screening tool', 'timeFrame': 'Within four weeks', 'description': 'Children/adolescents testing HIV positive on the tool who are truly HIV positive'}, {'measure': 'Specificity of HIV risk screening tool', 'timeFrame': 'Within four weeks', 'description': 'Children/adolescents testing HIV negative on the tool who are truly HIV negative'}, {'measure': 'Positive predictive value', 'timeFrame': 'Within four weeks', 'description': 'Proportion of children/adolescents testing positive on the tool who actually have HIV'}, {'measure': 'Negative predictive value', 'timeFrame': 'Within four weeks', 'description': 'Proportion of children/adolescents testing negative on the tool who do not actually have HIV'}, {'measure': 'Acceptability of HIV risk screening tool', 'timeFrame': 'Within six weeks', 'description': 'Examining the extent of reception of the screening tool by the OVC caregivers and the community case workers using a semi-structured questionnaire'}, {'measure': 'Feasibility of HIV risk screening tool', 'timeFrame': 'Within six weeks', 'description': 'Exploring the practicality of use of HIV risk screening tool through focus group discussions with community case workers'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV Screen tool', 'orphans and vulnerable children', 'Tanzania'], 'conditions': ['Pediatric HIV Infection']}, 'descriptionModule': {'briefSummary': 'The goal of the research was to evaluate the performance of items within the Kizazi Kipya (K2) Orphan and Vulnerable Children (OVC) HIV risk screening tool in identifying HIV-positive children, to optimize an HIV screening tool for OVC and children and adolescents in facility settings and to assess the feasibility and acceptability of home-based HIV risk screening and testing.', 'detailedDescription': "Under the ongoing community-based Kizazi Kipya (K2) OVC project, program staff currently administer a 13-item HIV risk screening tool to all K2 program beneficiaries, and refers those who screen positive to facility-based HIV testing. A subset of this 13-item tool is a module of four items that had previously been used as a standalone four-question screening tool in facilities in Zimbabwe.\n\nThe primary objectives of this study are as follows.\n\n1. To evaluate the performance of a lay cadre-administered four-item subset of the K2 HIV risk screening tool that matches the Zimbabwe evidence-based tool in predicting the HIV status of vulnerable children/adolescents represented by two populations: (a) K2 OVC beneficiaries and (b) children/adolescents attending health facilities.\n2. To identify additional items in the K2 HIV risk screening tool that could be added to the four-question subset to improve the tool's performance.\n3. To assess fidelity to the administration of the OVC HIV screening tool items through structured observations of community case workers in the K2 program.\n4. To assess the acceptability of OVC HIV risk screening and testing implemented in the community among OVC beneficiaries in the K2 program.\n5. To assess the acceptability and feasibility of integrating the OVC HIV screening tool with HIV testing among OVC community case workers in the K2 program."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children and adolescents (and their caregivers as applicable) participating in an orphans and vulnerable children (OVC) program or presenting for services at a study facility. Community care workers (CCWs) who have been conducting HIV risk screening in OVC households as part of their role in the OVC program.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Children and adolescents and their caregivers:\n\nInclusion Criteria:\n\n* Living in a household deemed to be at elevated HIV risk based on previously identified risk criteria\n* Attending a study health facility in two regions of Tanzania\n* Age 2-19 years\n\nExclusion Criteria:\n\n* Previously tested HIV-positive\n* History of antiretroviral treatment (ART)\n* Unable or unwilling to be consented\n* Age 5-19 years old, tested negative in past 6 months, and having no reported exposure to HIV through sexual contact (consensual, abuse) or through blood transfusion/needle injury.\n\nCommunity care workers:\n\nInclusion criteria:\n\n* conducting HIV risk screening in OVC households as part of their role in the Kizazi Kipya project in the subset of study districts where structured observations and focus group discussions were conducted\n\nExclusion criteria:\n\n* unwilling to consent to the study'}, 'identificationModule': {'nctId': 'NCT04517760', 'briefTitle': 'Evaluating an HIV Risk Screening Tool for Orphans and Vulnerable Children in Tanzania', 'organization': {'class': 'OTHER', 'fullName': 'Elizabeth Glaser Pediatric AIDS Foundation'}, 'officialTitle': 'Evaluating an HIV Risk Screening Tool for Use in a Population of Orphans and Other Vulnerable Children in Tanzania', 'orgStudyIdInfo': {'id': 'EG0216'}}, 'contactsLocationsModule': {'locations': [{'city': 'Dar es Salaam', 'country': 'Tanzania', 'facility': 'Elizabeth Glaser Pediatric AIDS Foundation', 'geoPoint': {'lat': -6.82349, 'lon': 39.26951}}], 'overallOfficials': [{'name': 'Gretchen Antelman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'E. Glaser Pediatric AIDS Found'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'End 2020', 'ipdSharing': 'YES', 'description': 'The IPD sharing plan will include the final quantitative datasets, tools, data dictionaries and analytic code will be made publicly available through a Dataverse repository.', 'accessCriteria': 'Dataverse repository'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elizabeth Glaser Pediatric AIDS Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tanzania Ministry of Health, Community Development, Gender, Elderly and Children', 'class': 'UNKNOWN'}, {'name': 'PACT International', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}