Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-02-20 @ 6:20 PM
Study NCT ID:
NCT03397420
Status:
COMPLETED
Last Update Posted:
2020-01-28
First Post:
2018-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Family-centered HIV Care, Viral Suppression and Retention in HIV-positive Children, Swaziland
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 742}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-27', 'studyFirstSubmitDate': '2018-01-02', 'studyFirstSubmitQcDate': '2018-01-05', 'lastUpdatePostDateStruct': {'date': '2020-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of HIV-positive children on ART virally suppressed', 'timeFrame': '18 months after study enrollment.', 'description': 'Proportion of HIV-positive children on ART with viral suppression (defined as HIV RNA copies/mL below the level of assay detection) and the proportion with HIV RNA \\<1,000 copies/mL at 18 months after enrollment'}, {'measure': 'Proportion of HIV-positive on ART virally unsuppressed', 'timeFrame': '18 months after study enrollment.', 'description': 'Proportion of HIV-positive children on ART with HIV RNA \\>1000 copies/mL 18 months after enrollment into the study.'}], 'secondaryOutcomes': [{'measure': 'Proportion HIV-positive children on ART virally suppressed (<1,000 copies/mL of HIV RNA) at 6 and 12 months after study enrollment', 'timeFrame': '6 and 12 months after study enrollment', 'description': 'Proportion of HIV-positive children on ART with viral suppression (defined as HIV RNA copies/mL below the level of assay detection) and HIV RNA \\>1000 copies/mL'}, {'measure': 'Factors associated with HIV viral suppression', 'timeFrame': '18 months after study enrollment', 'description': 'Individual and family factors associated with viral suppression.'}, {'measure': 'Loss to follow-up', 'timeFrame': '18 months after study enrollment', 'description': 'Loss to follow-up (not seen in clinical care \\>3 months)'}, {'measure': 'ART initiation', 'timeFrame': '18 months after study enrollment', 'description': 'ART initiation in HIV-positive children not on ART at study entry'}, {'measure': 'Acceptability of the FAM-CARE program based on individual interview responses', 'timeFrame': '18 months after study enrollment', 'description': 'Acceptability of the FAM-CARE program to caregivers and health care provider as measured from responses on individual interviews using a structured questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '34428241', 'type': 'DERIVED', 'citation': 'Ashburn K, Chouraya C, Khumalo P, Mpango L, Mthethwa N, Machekano R, Guay L, Mofenson LM. A randomized controlled trial evaluating the effects of a family-centered HIV care model on viral suppression and retention in care of HIV-positive children in Eswatini. PLoS One. 2021 Aug 24;16(8):e0256256. doi: 10.1371/journal.pone.0256256. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'The study will evaluate the effect of implementing a family-centered care (FAM-CARE) program (where all HIV-positive family members are seen together as a unit and receive care together) on viral suppression and retention in HIV-positive children \\<15 years through enrollment of a prospective cohort of 660 HIV-positive children and their caregivers at sites that were randomized to either implement the family-care program (intervention sites) or continue the current standard of care (control sites).', 'detailedDescription': 'The proposed study will evaluate the effect of implementing a FAM-CARE program on viral suppression and retention in children through enrollment of a prospective cohort of HIV-positive children and their caregivers at sites implementing the FAM-CARE program and control sites continuing the current standard of care. The study will be conducted in four "clusters" of facilities (2 hospitals and 2 health centers and their filter clinics) in the Hhohho region of Swaziland. Two facility "clusters" (one hospital and one health center, with their filter clinics) will be randomized to initiate the FAM-CARE program with viral load monitoring and two "clusters" (one hospital and one health center, with their filter clinics) will be control standard-of care sites. A prospective cohort of HIV-positive children and their caregivers will be followed in the FAM-CARE program sites and control sites. Each child will be followed for 18 months following enrollment. The primary objective is to evaluate the effect of the FAM-CARE program on the rates of viral suppression and retention in care, comparing rates of viral suppression and retention in children enrolled in FAM-CARE versus control sites. The study will also evaluate factors associated with viral suppression and retention (including family demographic characteristics), and conduct qualitative interviews to assess the acceptability of the FAM-CARE program by caregivers and health care providers in the intervention sites.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-positive child aged \\<15 years receiving HIV care at the study facility.\n\nExclusion Criteria:\n\n* At least one family member residing in the household is also HIV-positive and is receiving services at the study facility'}, 'identificationModule': {'nctId': 'NCT03397420', 'acronym': 'FAM-CARE', 'briefTitle': 'Family-centered HIV Care, Viral Suppression and Retention in HIV-positive Children, Swaziland', 'organization': {'class': 'OTHER', 'fullName': 'Elizabeth Glaser Pediatric AIDS Foundation'}, 'officialTitle': 'Effect of Family-centered Model of HIV Care (FAM-CARE) on Viral Suppression and Retention in Care of HIV-positive Children in Swaziland', 'orgStudyIdInfo': {'id': 'EG0168'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FAM-CARE', 'description': 'Two facility "clusters" (one hospital and one health center, with their filter clinics) will be randomized to initiate the FAM-CARE program (where all HIV-positive family members are seen together as a unit and receive care together) with viral load monitoring', 'interventionNames': ['Other: FAM-CARE']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Standard of Care', 'description': 'Two "clusters" (one hospital and one health center, with their filter clinics) will be control standard-of care (usual practice) sites. Standard HIV care and treatment services, (drug resupply, clinical assessments etc.), including viral load monitoring, will be provided to adults and children in separate adult and pediatric clinics, even though they many be from the same family.', 'interventionNames': ['Other: FAM-CARE']}], 'interventions': [{'name': 'FAM-CARE', 'type': 'OTHER', 'description': 'Family-centered care, where all HIV-positive family members are seen together as a unit and receive HIV care and treatment services together, for HIV-positive children and their caregivers', 'armGroupLabels': ['Control Standard of Care', 'FAM-CARE']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mbabane', 'country': 'Eswatini', 'facility': 'Mbabane', 'geoPoint': {'lat': -26.31667, 'lon': 31.13333}}], 'overallOfficials': [{'name': 'Caspian Chouraya, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Elizabeth Glaser Pediatric AIDS Foundation'}, {'name': 'Nobuble Mthethwa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ministry of Health, Swaziland'}, {'name': 'Lynne Mofenson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Elizabeth Glaser Pediatric AIDS Foundation'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Six months after study publication', 'ipdSharing': 'YES', 'description': 'All collected IPDs', 'accessCriteria': 'Datasets will be available for download upon request from Population Council/USAID website'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elizabeth Glaser Pediatric AIDS Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Agency for International Development (USAID)', 'class': 'FED'}, {'name': 'Ministry of Health, Swaziland', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}