Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-02-28 @ 2:11 PM
Study NCT ID:
NCT01962220
Status:
COMPLETED
Last Update Posted:
2015-12-22
First Post:
2013-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mother Infant Retention for Health: MIR4Health
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': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 680}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-19', 'studyFirstSubmitDate': '2013-10-10', 'studyFirstSubmitQcDate': '2013-10-10', 'lastUpdatePostDateStruct': {'date': '2015-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of mothers and infants non-retained in care at 6 months', 'timeFrame': '6 months', 'description': 'Mother/infant attrition at 6 months postpartum'}], 'secondaryOutcomes': [{'measure': 'Proportion of women completing the 2nd ANC visit and all ANC and PN visits', 'timeFrame': '6 months', 'description': 'Completion ANC and PN visits'}, {'measure': 'Proportion of women who had a hospital delivery', 'timeFrame': '6 months', 'description': 'Hospital delivery'}, {'measure': 'Proportion of infants receiving PCR testing at 6 weeks of age and 6 months', 'timeFrame': '6 months', 'description': 'Infant PCR testing'}, {'measure': 'Proportion of male partners receiving HIV testing', 'timeFrame': '12 months', 'description': 'Male Partner HIV tests'}, {'measure': 'Proportion of infants exclusively breastfeeding at 6 months and number of months infant spent breastfeeding', 'timeFrame': '6 months', 'description': 'Exclusive Breastfeeding'}, {'measure': 'Change in CD4+ cell count from study enrollment to 6 month postpartum for women', 'timeFrame': '12 months', 'description': 'CD4+ Cell Count'}, {'measure': 'Proportion of women with undetectable HIV RNA at delivery and 6 months postpartum', 'timeFrame': '12 months', 'description': 'Undetectable Viral RNA'}, {'measure': 'Proportion of women adherent to ARV regimen during pregnancy and postpartum period', 'timeFrame': '12 months', 'description': 'Mother ARV Adherence'}, {'measure': 'Proportion of infants adherent to postnatal ARV regimen during first six weeks of life', 'timeFrame': '1.5 months', 'description': 'Infant ARV Adherence'}, {'measure': 'Proportion of women & staff reporting APFU highly acceptable', 'timeFrame': '12 months', 'description': 'Intervention Acceptability'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV/AIDS', 'PMTCT', 'Pregnant Women', 'Kenya', 'Maternal Health'], 'conditions': ['HIV/AIDS']}, 'referencesModule': {'references': [{'pmid': '30399035', 'type': 'DERIVED', 'citation': 'Fayorsey RN, Wang C, Chege D, Reidy W, Syengo M, Owino SO, Koech E, Sirengo M, Hawken MP, Abrams EJ. Effectiveness of a Lay Counselor-Led Combination Intervention for Retention of Mothers and Infants in HIV Care: A Randomized Trial in Kenya. J Acquir Immune Defic Syndr. 2019 Jan 1;80(1):56-63. doi: 10.1097/QAI.0000000000001882.'}, {'pmid': '29321026', 'type': 'DERIVED', 'citation': 'DiCarlo A, Fayorsey R, Syengo M, Chege D, Sirengo M, Reidy W, Otieno J, Omoto J, Hawken MP, Abrams EJ. Lay health worker experiences administering a multi-level combination intervention to improve PMTCT retention. BMC Health Serv Res. 2018 Jan 10;18(1):17. doi: 10.1186/s12913-017-2825-8.'}, {'pmid': '27355501', 'type': 'DERIVED', 'citation': 'Fayorsey RN, Chege D, Wang C, Reidy W, Peters Z, Syengo M, Barasa C, Owino SO, Sirengo M, Hawken MP, Abrams EJ. Mother Infant Retention for Health (MIR4Health): Study Design, Adaptations, and Challenges With PMTCT Implementation Science Research. J Acquir Immune Defic Syndr. 2016 Aug 1;72 Suppl 2(Suppl 2):S137-44. doi: 10.1097/QAI.0000000000001060.'}]}, 'descriptionModule': {'briefSummary': 'Linking HIV-infected pregnant women into prevention of mother to child transmission (PMTCT) services and keeping them in care is important in ensuring that both mother and infant beneļ¬t from interventions that improve maternal health and decrease HIV transmission to infants. We propose an evaluation of strategies to link newly diagnosed HIV-infected women to care and keep them in care during pregnancy and after delivery in our study called MIR4HEALTH. The study will be conducted in Nyanza Province, Kenya. All participants will provide informed consent and will be randomized to receive the intervention, including individualized patient education, adherence support and phone call/Short Message Service (SMS) reminders for clinic appointments, or the standard of care (no additional intervention services).', 'detailedDescription': 'Mother Infant Retention for Health (MIR4HEALTH) is an innovative implementation science study focused on testing an effective multicomponent strategy to improve linkage and retention of newly identified HIV-infected pregnant women accessing maternal child health (MCH) services in Nyanza Province, Kenya. MIR4HEALTH is distinguished by several innovations including the recognition that newly identified HIV-infected pregnant woman are especially vulnerable to poor retention within PMTCT services and that both mother and child must be retained in care to ensure optimal health outcomes.\n\nThe study is a randomized trial to compare the effectiveness of a novel strategy using Active Patient Follow-Up (APFU) to the current standard of care (SOC) routinely provided for the retention of women and their exposed infants postpartum. The proposed APFU includes a package of evidence-based interventions including health education, provision of phone and short message service (SMS) appointment reminders, active tracking of patients for linkage and retention, and individualized retention and adherence support. Patients enrolled in the APFU intervention arm will complete three antenatal study visits after enrollment as well as two postnatal study visits with their infants at 6 weeks and 6 months postpartum. Laboratory blood specimens will be collected from mothers and infants at two separate visits to assess viral load and and drug levels. Additionally, all staff will be offered a chance to participate in an interview assessing the feasibility and acceptability of APFU.\n\nStudy participants will be recruited from various clinics in the Nyanza Province in Kenya. This study will enroll pregnant women who test positive for HIV during their first antenatal visit and have no prior HIV diagnosis. Upon live birth, the infants of participating women will also be included in the study. The study will enroll 214 newly-infected pregnant women, with 107 participants in the APFU arm (intervention) and 107 participants in the SOC arm. Infants born to women enrolled in the study will also be included so there will be a total of 214 mother-infant pairs, totaling 428 participants.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented HIV-infection according to two finger-prick rapid tests (both previously diagnosed and newly detected)\n* Confirmed pregnancy by urine pregnancy test or clinical assessment\n* Age 16 years or older\n* Able to provide informed consent for research\n* Fluent in Luo or English\n* Own a cell phone or have access to one in their households\n* Live born infants of women enrolled in the study\n\nExclusion Criteria:\n\n* Patients who fail to meet any of the inclusion criteria will be excluded\n* Significant obstetric condition documented at the first antenatal visit requiring urgent referral to another facility for specialized obstetric care (e.g., significant hypertension or active bleeding per vagina).\n* Denial of HIV status or refusal to initiate ART/ARV prophylaxis.\n* Stated intention to move from study site area during the pregnancy or within six months postpartum.'}, 'identificationModule': {'nctId': 'NCT01962220', 'acronym': 'MIR4HEALTH', 'briefTitle': 'Mother Infant Retention for Health: MIR4Health', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Mother Infant Retention for Health: Evaluation of a Multicomponent Strategy to Link and Retain Newly Identified HIV-infected Pregnant Women and Their Infants Throughout the Antenatal and Post-partum Period', 'orgStudyIdInfo': {'id': 'AAAL5557'}, 'secondaryIdInfos': [{'id': '1R01HD075163-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01HD075163-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'Routine ANC, Delivery and Postpartum Care: All consenting women will receive routine ANC/Delivery and Postpartum care offered to pregnant women in Kenya as per national guidelines at the MCH of the respective facility.\n\nRoutine PMTCT and HIV Care: All newly diagnosed HIV-infected pregnant women are enrolled into HIV care in the MCH and receive PMTCT/HIV care per Kenya national guidelines (Revised 2012 PMTCT Guidelines).'}, {'type': 'EXPERIMENTAL', 'label': 'Study Intervention for Retention (APFU)', 'description': 'Participants randomized to the experimental arm of the study will receive routine antenatal and HIV services as described above per Kenya national guidelines. In addition each newly identified HIV-infected pregnant woman randomized to the experimental arm will be assigned an outreach worker/counselor (Mama Mshauri), who will perform numerous tasks described in the intervention. In addition to the Mama Mshauri, this arm will receive phone/SMS appointment reminders, and default patient tracking if participants miss an appointment.', 'interventionNames': ['Behavioral: Study Intervention for Retention (APFU)']}], 'interventions': [{'name': 'Study Intervention for Retention (APFU)', 'type': 'BEHAVIORAL', 'description': 'Each newly identified HIV-infected pregnant woman randomized to the experimental arm will be assigned an outreach worker/counselor (Mama Mshauri).\n\nMama Mshauri tasks will include:\n\n* Immediately engaging the newly identified pregnant woman, providing individualized adherence and disclosure support, management of ART side effects, and helping the client navigate the health system.\n* Providing tailored individualized health education during home visits.\n\nAdditional intervention components include:\n\n* Appointments and Reminders: SMS or telephone reminders 1 week and 3 days before appointments. Reinforcement of importance of follow-up during home visits and every contact.\n* Patient Tracking and Defaulter Tracing: Monthly visits and immediate calls/home visit if she misses an appointment.', 'armGroupLabels': ['Study Intervention for Retention (APFU)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ahero', 'state': 'Nyanza', 'country': 'Kenya', 'facility': 'Ahero Sub-district Hospital', 'geoPoint': {'lat': -0.17359, 'lon': 34.9189}}, {'city': 'Ambira', 'state': 'Nyanza', 'country': 'Kenya', 'facility': 'Ambira Sub-District Hospital', 'geoPoint': {'lat': 0.1772, 'lon': 34.27022}}, {'city': 'Bondo', 'state': 'Nyanza', 'country': 'Kenya', 'facility': 'Bondo District Hospital', 'geoPoint': {'lat': -0.0962, 'lon': 34.27322}}, {'city': 'Got Agulu', 'state': 'Nyanza', 'country': 'Kenya', 'facility': 'Got Agulu Sub-district Hospital', 'geoPoint': {'lat': -0.03692, 'lon': 34.03009}}, {'city': 'Kisumu', 'state': 'Nyanza', 'country': 'Kenya', 'facility': 'Jaramoji Oginga Oginga Referral Hospital', 'geoPoint': {'lat': -0.10221, 'lon': 34.76171}}, {'city': 'Madiany', 'state': 'Nyanza', 'country': 'Kenya', 'facility': 'Madiany District Hospital', 'geoPoint': {'lat': -0.28863, 'lon': 34.35431}}, {'city': 'Masogo', 'state': 'Nyanza', 'country': 'Kenya', 'facility': 'Masogo Sub-district Hospital', 'geoPoint': {'lat': -0.17122, 'lon': 34.84953}}, {'city': 'Nyakatch', 'state': 'Nyanza', 'country': 'Kenya', 'facility': 'Nyakatch District Hospital'}, {'city': 'Siaya', 'state': 'Nyanza', 'country': 'Kenya', 'facility': 'Siaya District Hospital', 'geoPoint': {'lat': 0.0607, 'lon': 34.28806}}, {'city': 'Ukwala', 'state': 'Nyanza', 'country': 'Kenya', 'facility': 'Ukwala Health Center', 'geoPoint': {'lat': 0.1926, 'lon': 34.18723}}], 'overallOfficials': [{'name': 'Ruby Fayorsey, MD/MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ICAP Columbia University'}, {'name': 'William Reidy, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ICAP Columbia University'}, {'name': 'Eluid Mwangi, MD/MPH/MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ICAP - Kenya'}, {'name': 'Duncan Chege, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ICAP - Kenya'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, {'name': 'Kenya Ministry of Health', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director Research Unit, ICAP', 'investigatorFullName': 'Elaine J. Abrams, MD', 'investigatorAffiliation': 'Columbia University'}}}}