Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2026-03-02 @ 4:05 PM
Study NCT ID:
NCT03023033
Status:
COMPLETED
Last Update Posted:
2021-02-08
First Post:
2015-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Supporting Attendance for Facility Delivery and Infant Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], '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': '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': '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1505}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-03', 'studyFirstSubmitDate': '2015-02-27', 'studyFirstSubmitQcDate': '2017-01-13', 'lastUpdatePostDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Attendance for Early infant diagnosis (EID) of HIV', 'timeFrame': '1 year', 'description': 'Proportion of HIV-exposed infants (HEI) attending for early infant diagnosis of HIV (DBS collected) by 8 weeks'}, {'measure': 'Early identification of HEI at Reproductive and Child Health (RCH) Clinic', 'timeFrame': '1 year', 'description': 'Proportion of HEI identified early (48 hours,3 and 7 days) at RCH clinic'}, {'measure': 'Antenatal care (ANC) visits', 'timeFrame': '1 year', 'description': 'Proportion of pregnant women attending at least 4 ANC visits'}, {'measure': 'Facility delivery', 'timeFrame': '1 year', 'description': 'Proportion of pregnant women delivering in a health facility'}, {'measure': 'Post natal care (PNC) visits', 'timeFrame': '1 year', 'description': 'Proportion of post partum women attending PNC 48 hours, 3 and 7 days post delivery'}, {'measure': 'Nevirapine (NVP) at delivery', 'timeFrame': '1 year', 'description': 'Proportion of HEI given NVP at delivery'}], 'secondaryOutcomes': [{'measure': 'Receipt of EID results', 'timeFrame': '1 year', 'description': 'Proportion of HEI who received EID results by 12 weeks'}, {'measure': 'HIV infected infants initiated on antiretroviral therapy (ART)', 'timeFrame': '1 year', 'description': 'Proportion of HIV infected infants initiated on ART by 12 weeks of age'}, {'measure': 'Time to EID', 'timeFrame': '1 year', 'description': 'Time (days/weeks) from date of birth to attendance for EID'}, {'measure': 'Time to receipt of EID results', 'timeFrame': '1 year', 'description': 'Time (days/weeks) from date of birth to receipt of EID results'}, {'measure': 'Time to treatment', 'timeFrame': '! year', 'description': 'Time (days/weeks) from date of birth to initiation of ART'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PMTCT', 'MNCH'], 'conditions': ['HIV', 'AIDS']}, 'referencesModule': {'references': [{'pmid': '32813276', 'type': 'DERIVED', 'citation': 'Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this proposed intervention study is to increase the proportion of HIV positive and HIV negative pregnant women who deliver in a facility, the proportion of HIV exposed infants (HEI) who receive nevirapine (NVP) within 48 hours of delivery, and the proportion of HEI who are bled for HIV polymerase chain reaction (PCR) deoxyribonucleic acid (DNA) testing within 8 weeks of age.', 'detailedDescription': 'Following a formative phase I, we propose in phase II to implement a three-group cluster-randomized study to test the effectiveness of short message service (SMS) reminders and notifications, \\[mobile health or mhealth\\] (group 1) and the combined effectiveness of SMS reminders/notifications and cash transfers (group 2) compared to the standard prevention of mother-to-child transmission (of HIV)/maternal, neonatal and child health, (PMTCT/MNCH) practices (group 3).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Known or recently diagnosed HIV-positive in ANC or; Tested HIV-negative at ANC\n* Plans to deliver in facility catchment area\n* 18 years or older\n* Able and willing to provide consent\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03023033', 'acronym': 'SAFI', 'briefTitle': 'Supporting Attendance for Facility Delivery and Infant Health', 'organization': {'class': 'OTHER', 'fullName': 'Elizabeth Glaser Pediatric AIDS Foundation'}, 'officialTitle': 'Enhancing Retention in PMTCT/MNCH Services and Facility Delivery in Tabora, Tanzania', 'orgStudyIdInfo': {'id': 'EG0130'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clinic group 1', 'description': 'Clinics using SMS health promotion and reminder messages (mhealth messaging)', 'interventionNames': ['Behavioral: mHealth messaging']}, {'type': 'EXPERIMENTAL', 'label': 'Clinic group 2', 'description': 'Clinics using SMS health promotion and reminder messages + Clinics providing payment scaled to reflect typical transport costs to facility (transport payments)', 'interventionNames': ['Behavioral: Transport Payments']}, {'type': 'NO_INTERVENTION', 'label': 'Clinic group 3', 'description': 'Services provided under the Ministry of Health standard care'}], 'interventions': [{'name': 'mHealth messaging', 'type': 'BEHAVIORAL', 'description': 'SMS appointment reminders and health messaging via mobile phones', 'armGroupLabels': ['Clinic group 1']}, {'name': 'Transport Payments', 'type': 'BEHAVIORAL', 'description': 'A payment scaled to reflect the cost of typical return transport fare for residents of the clinic catchment area', 'armGroupLabels': ['Clinic group 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dar es Salaam', 'country': 'Tanzania', 'facility': 'Elizabeth Glaser Pediatric AIDS Foundation', 'geoPoint': {'lat': -6.82349, 'lon': 39.26951}}], 'overallOfficials': [{'name': 'Godfrey Woelk, MCOMMH, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Elizabeth Glaser Pediatric AIDS Foundation'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'timeFrame': 'The plan is for the data to become available in 2018', 'ipdSharing': 'YES', 'description': 'The dataset has been given to the USAID, the study sponsor. There is a plan to made these data publically available from 2018', 'accessCriteria': 'Access criteria will be defined by USAID'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elizabeth Glaser Pediatric AIDS Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Population Council', 'class': 'OTHER'}, {'name': 'Ministry of Health, Tanzania', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}