Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-01-05 @ 12:01 AM
Study NCT ID:
NCT04372667
Status:
COMPLETED
Last Update Posted:
2020-05-04
First Post:
2020-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adaptation and Evaluation of the PMTCT CSC in Dedza and Ntcheu Districts, Malawi
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Community score card approach'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1233}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-30', 'studyFirstSubmitDate': '2020-04-29', 'studyFirstSubmitQcDate': '2020-04-30', 'lastUpdatePostDateStruct': {'date': '2020-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early diagnosis of HIV exposed infants (HEI)', 'timeFrame': '6 - 8 weeks after birth', 'description': 'Proportion of HEI receiving a DNA PCR test'}, {'measure': 'Early retention of pregnant and breastfeeding HIV positive women in PMTCT', 'timeFrame': '1 to 6 months', 'description': 'Proportions of HIV-positive pregnant and breastfeeding women (including women newly-identified and already-known to be HIV positive) retained in PMTCT services'}, {'measure': 'Early retention of newly diagnosed HIV-positive women in HIV care', 'timeFrame': '1 to 6 months', 'description': 'Proportions of HIV-positive women (pregnant and breastfeeding women as well as non-pregnant women) newly initiating ART services retained in HIV care'}, {'measure': 'Implementation cost of CSC', 'timeFrame': '12 months', 'description': 'Estimate the total cost of implementing of the CSC intervention at community and facility levels.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PMTCT', 'HIV', 'Quality improvement', 'Social accountability', 'Patient centered', 'Retention in care', 'Early infant diagnosis of HIV'], 'conditions': ['HIV/AIDS', 'Infant Morbidity']}, 'referencesModule': {'references': [{'pmid': '32698814', 'type': 'DERIVED', 'citation': "Laterra A, Callahan T, Msiska T, Woelk G, Chowdhary P, Gullo S, Mwale PM, Modi S, Chauwa F, Kayira D, Kalua T, Wako E. Bringing women's voices to PMTCT CARE: adapting CARE's Community Score Card(c) to engage women living with HIV to build quality health systems in Malawi. BMC Health Serv Res. 2020 Jul 22;20(1):679. doi: 10.1186/s12913-020-05538-2."}]}, 'descriptionModule': {'briefSummary': 'This CDC-funded study sought to evaluate the effect of an adapted Community Score Card Approach on maternal retention in ART, maternal retention across the PMTCT service cascade, and the uptake of early infant diagnosis services in Malawi. The study also estimated the cost of the implementation of the Community Score Card Approach.', 'detailedDescription': 'Prevention of Mother to Child HIV Transmission (PMTCT) services aim to identify HIV-infected pregnant and breastfeeding mothers and initiate them on antiretroviral treatment (ART) for improving the health of the mother as well as reducing HIV transmission to their infants. In 2011, Malawi was the first country to adopt lifelong ART for HIV- pregnant and breastfeeding women, known as \'Option B+\'. Despite leading the way on operationalization of this approach, Malawi has faced challenges retaining HIV-infected pregnant and breastfeeding women on lifelong ART as well as with improving uptake of early infant HIV testing for HIV-exposed infants. Innovative approaches are needed which engage health service users (i.e. patients) as part of quality improvement solutions within clinical settings to improve retention throughout the PMTCT cascade and ultimately improve PMTCT outcomes for mothers and infants.\n\nOne approach to broadly engage health service users in quality improvement activities is the Community Score Card (CSC). The CSC engages both service providers and users within a clinical setting in dialogues to identify solutions to the perceived barriers with health service delivery and utilization.\n\nCARE developed the CSC intervention in Malawi in 2002 as part of a project aimed at developing innovative and sustainable models to improve general maternal and child health services. The main goal of the CSC intervention is to positively influence the quality, efficiency, and accountability with which health services are provided at different levels. The original CSC consists of five core phases, repeated on a regular basis (called "rounds"), for the life of the project.\n\nThis project adapted the CSC to the PMTCT setting across 11 sites in two priority PEPFAR scale-up districts in Malawi. The adaptation of the CSC was evaluated through a pre-post design to measure change in maternal retention on ART, change in maternal retention across the PMTCT service cascade, and uptake of Early Infant Diagnosis (EID) services following CSC implementation. Additionally, the project estimated the cost of the adapted CSC implementation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* New born infants of HIV-positive women\n* Women 18 years and over newly initiating antiretroviral therapy (ART) at ART clinic\n* HIV-positive pregnant women \\>15 years of age newly receiving care at first ANC (ANC1)\n* Women who are HIV-positive at ANC1 (known positive, already on treatment)\n* Women who are newly identified HIV-positive and initiated on treatment at ANC (newly identified at ANC or labor and delivery)\n* Women known HIV-positive but not yet on treatment prior to enrollment at ANC and initiated on treatment at ANC\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04372667', 'briefTitle': 'Adaptation and Evaluation of the PMTCT CSC in Dedza and Ntcheu Districts, Malawi', 'organization': {'class': 'OTHER', 'fullName': 'Elizabeth Glaser Pediatric AIDS Foundation'}, 'officialTitle': 'Adaptation and Evaluation of the PMTCT Community Score Card Approach in Dedza and Ntcheu Districts, Malawi', 'orgStudyIdInfo': {'id': 'EG0163'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Post intervention', 'description': 'Community score card approach', 'interventionNames': ['Behavioral: Community score card approach']}], 'interventions': [{'name': 'Community score card approach', 'type': 'BEHAVIORAL', 'otherNames': ['social accountability', 'user involvement', 'patient engagement'], 'description': 'The CSC intervention is a participatory community approach. Health care workers (HCWs), PMTCT clients identified the issues that most impacted PMTCT service quality and uptake, and came together to implement actions for improvement. The core implementation strategy is using dialogue in a participatory forum that engages both service users and service providers. The CSC consists of five core phases, repeated on a regular basis (called "rounds"), for the life of the project. The five core phases include:\n\n1. Phase I: Planning and preparation\n2. Phase II: Conducting the Score Card with the community\n3. Phase III: Conducting the Score Card with service providers\n4. Phase IV: Interface meeting and action planning\n5. Phase V: Action plan implementation and follow-up', 'armGroupLabels': ['Post intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lilongwe', 'country': 'Malawi', 'facility': 'Elizabeth Glaser Pediatric AIDS Foundation', 'geoPoint': {'lat': -13.96692, 'lon': 33.78725}}], 'overallOfficials': [{'name': 'Godfrey Woelk, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'E. Glaser Pediatric AIDS Found'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elizabeth Glaser Pediatric AIDS Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cooperative for Assistance and Relief Everywhere, Inc. (CARE)', 'class': 'UNKNOWN'}, {'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}, {'name': 'Ministry of Health, Malawi', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}