Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2026-01-04 @ 5:08 PM
Study NCT ID:
NCT03027258
Status:
UNKNOWN
Last Update Posted:
2017-10-17
First Post:
2017-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Point-of-Delivery Prenatal Test Results Through mHealth to Improve Birth Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}, {'id': 'D006509', 'term': 'Hepatitis B'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017216', 'term': 'Telemedicine'}], 'ancestors': [{'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-10-13', 'studyFirstSubmitDate': '2017-01-06', 'studyFirstSubmitQcDate': '2017-01-17', 'lastUpdatePostDateStruct': {'date': '2017-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reach', 'timeFrame': '6 months', 'description': 'Reach will be calculated as: the proportion of enrolled pregnant women relative to eligible pregnant women in the study catchment area.'}, {'measure': 'Effectiveness', 'timeFrame': '6 months', 'description': 'Effectiveness will be determined by assessing the impact of the mHealth platform on key outcomes such as screening for HIV, HBV, and sickle cell genotype, and health care utilizations for follow up visits. This will be measured by calculating the percentage of pregnant women that used the "smart card" at the point-of-delivery.'}, {'measure': 'Adoption', 'timeFrame': '6 months', 'description': 'Adoption rates will be calculated using the proportion of interested health care settings to the total number eligible for participation.'}, {'measure': 'Acceptability', 'timeFrame': '6 months', 'description': 'The proportion of enrolled pregnant women who accept to use the smart card for their health care services'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Mobile health technology'], 'conditions': ['HIV', 'Sickle Cell Disease', 'Hepatitis B']}, 'referencesModule': {'references': [{'pmid': '23758933', 'type': 'BACKGROUND', 'citation': 'Ezeanolue EE, Obiefune MC, Yang W, Obaro SK, Ezeanolue CO, Ogedegbe GG. Comparative effectiveness of congregation- versus clinic-based approach to prevention of mother-to-child HIV transmission: study protocol for a cluster randomized controlled trial. Implement Sci. 2013 Jun 8;8:62. doi: 10.1186/1748-5908-8-62.'}, {'pmid': '29335234', 'type': 'DERIVED', 'citation': 'Gbadamosi SO, Eze C, Olawepo JO, Iwelunmor J, Sarpong DF, Ogidi AG, Patel D, Oko JO, Onoka C, Ezeanolue EE. A Patient-Held Smartcard With a Unique Identifier and an mHealth Platform to Improve the Availability of Prenatal Test Results in Rural Nigeria: Demonstration Study. J Med Internet Res. 2018 Jan 15;20(1):e18. doi: 10.2196/jmir.8716.'}, {'pmid': '28550003', 'type': 'DERIVED', 'citation': 'Ezeanolue EE, Gbadamosi SO, Olawepo JO, Iwelunmor J, Sarpong D, Eze C, Ogidi A, Patel D, Onoka C. An mHealth Framework to Improve Birth Outcomes in Benue State, Nigeria: A Study Protocol. JMIR Res Protoc. 2017 May 26;6(5):e100. doi: 10.2196/resprot.7743.'}]}, 'descriptionModule': {'briefSummary': 'The investigators propose to adopt sustainable community networks (in this case churches) to implement an integrated community-based screening that incorporates mobile health technology (mHealth) to make prenatal test results available at the point-of-delivery to guide medical management.', 'detailedDescription': 'The investigators will develop and test the feasibility, acceptability, and usability of a mobile health platform that captures results for HIV, Hepatitis B virus (HBV) and sickle cell genotype obtained from participants during the Healthy Beginning Initiative (HBI) program; store data in a secure, web-based database; encrypt data on a "smart card" which is given to participants, and make these data available at the point-of-delivery using a cell-phone application to read the "smart card". Data on the web-based database can also be accessed directly using the cell phone application. Evidence exists that when clinician have maternal records available at the point of delivery, they are more likely to initiate antiretroviral prophylaxis for HIV-exposed infants, administer the first dose of hepatitis B vaccine with 24 hours for infants born to women who have positive hepatitis B surface antigen and screen infants born to mothers with sickle cell trait to allow early identification and initiation of penicillin prophylaxis for infants who have sickle cell disease.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women; 18 years or older enrolled in the Healthy Beginning Initiative\n* One of the three conditions - HIV, Hepatitis B, and Sickle cell trait/disease\n\nExclusion Criteria:\n\n* Those who do not accept to have their information uploaded on the secure database'}, 'identificationModule': {'nctId': 'NCT03027258', 'acronym': 'mHealth', 'briefTitle': 'Point-of-Delivery Prenatal Test Results Through mHealth to Improve Birth Outcome', 'organization': {'class': 'OTHER', 'fullName': 'University of Nevada, Las Vegas'}, 'officialTitle': 'Point-of-Delivery Prenatal Test Results Through mHealth to Improve Birth Outcome', 'orgStudyIdInfo': {'id': '820085-3'}, 'secondaryIdInfos': [{'id': 'R21TW010252-01', 'link': 'https://reporter.nih.gov/quickSearch/R21TW010252-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'mHealth intervention', 'interventionNames': ['Other: mHealth']}], 'interventions': [{'name': 'mHealth', 'type': 'OTHER', 'description': 'HBI participants who consent will be enrolled in this study and will have data collected from their community screening stored in a secure, web-based database. The stored data will be encrypted into a Quick Response code embedded in a "smart card." A unique identification number and participant\'s blood group type will be on the outside of the card. There will be no names or any other identifiers. Each participating center will identify a dedicated delivery room staff that will be trained to read the contents of the card using the cell phone application as well as enter new data in the participant\'s profile. When a participant presents at delivery without the card, information can still be obtained from the secure, web-based database and confirmed using the participant\'s name, date of birth and cell phone number. This information is provided to the clinician to guide management of the infant.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Makurdi', 'state': 'Benue State', 'status': 'RECRUITING', 'country': 'Nigeria', 'contacts': [{'name': 'John Olawepo, MD, MSc', 'role': 'CONTACT', 'email': 'jolawepo@ccfng.org', 'phone': '+234-805 564 8788'}, {'name': 'Echezona Ezeanolue, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Catholic Caritas Foundation', 'geoPoint': {'lat': 7.73375, 'lon': 8.52139}}], 'centralContacts': [{'name': 'Echezona Ezeanolue, MD, MPH', 'role': 'CONTACT', 'email': 'echezona.ezeanolue@unlv.edu', 'phone': '7028952687'}, {'name': 'Semiu O Gbadamosi, MD, MPH', 'role': 'CONTACT', 'email': 'semiu.gbadamosi@unlv.edu', 'phone': '7028351946'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nevada, Las Vegas', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fogarty International Center of the National Institute of Health', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Public Health and Pediatrics', 'investigatorFullName': 'Echezona Ezeanolue', 'investigatorAffiliation': 'University of Nevada, Las Vegas'}}}}