Ignite Creation Date:
2025-12-24 @ 6:25 PM
Ignite Modification Date:
2026-02-21 @ 1:34 AM
Study NCT ID:
NCT02536768
Status:
COMPLETED
Last Update Posted:
2019-07-30
First Post:
2015-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of South Africa's National Adherence Strategy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014376', 'term': 'Tuberculosis'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D055118', 'term': 'Medication Adherence'}], 'ancestors': [{'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8020}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-29', 'studyFirstSubmitDate': '2015-08-26', 'studyFirstSubmitQcDate': '2015-08-29', 'lastUpdatePostDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alive and in care using clinical records', 'timeFrame': '3-12 months', 'description': 'Patient has attended the clinic between 3 and 12 months after being eligible for an intervention'}, {'measure': 'HIV viral supression using lab data', 'timeFrame': '4-12 months', 'description': 'HIV viral load measure below 400 copies per ml between 4 and 12 months after eligibility for an intervention'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Medication adherence', 'ART', 'Counseling', 'Adherence Guidelines for Chronic Diseases (HIV, TB and NCDs)'], 'conditions': ['HIV', 'Tuberculosis', 'Diabetes', 'Hypertension']}, 'referencesModule': {'references': [{'pmid': '33735206', 'type': 'DERIVED', 'citation': 'Larson BA, Pascoe SJS, Huber A, Long LC, Murphy J, Miot J, Fraser-Hurt N, Fox MP, Rosen S. Fast-track treatment initiation counselling in South Africa: A cost-outcomes analysis. PLoS One. 2021 Mar 18;16(3):e0248551. doi: 10.1371/journal.pone.0248551. eCollection 2021.'}, {'pmid': '32585077', 'type': 'DERIVED', 'citation': 'Pascoe SJS, Scott NA, Fong RM, Murphy J, Huber AN, Moolla A, Phokojoe M, Gorgens M, Rosen S, Wilson D, Pillay Y, Fox MP, Fraser-Hurt N. "Patients are not the same, so we cannot treat them the same" - A qualitative content analysis of provider, patient and implementer perspectives on differentiated service delivery models for HIV treatment in South Africa. J Int AIDS Soc. 2020 Jun;23(6):e25544. doi: 10.1002/jia2.25544.'}, {'pmid': '31335865', 'type': 'DERIVED', 'citation': 'Fox MP, Pascoe S, Huber AN, Murphy J, Phokojoe M, Gorgens M, Rosen S, Wilson D, Pillay Y, Fraser-Hurt N. Adherence clubs and decentralized medication delivery to support patient retention and sustained viral suppression in care: Results from a cluster-randomized evaluation of differentiated ART delivery models in South Africa. PLoS Med. 2019 Jul 23;16(7):e1002874. doi: 10.1371/journal.pmed.1002874. eCollection 2019 Jul.'}, {'pmid': '29358446', 'type': 'DERIVED', 'citation': "Fox MP, Pascoe SJ, Huber AN, Murphy J, Phokojoe M, Gorgens M, Rosen S, Wilson D, Pillay Y, Fraser-Hurt N. Assessing the impact of the National Department of Health's National Adherence Guidelines for Chronic Diseases in South Africa using routinely collected data: a cluster-randomised evaluation. BMJ Open. 2018 Jan 21;8(1):e019680. doi: 10.1136/bmjopen-2017-019680."}]}, 'descriptionModule': {'briefSummary': 'NOTE THAT THE STUDY IS LED BY SOUTH AFRICA NATIONAL DEPARTMENT OF HEALTH AND WORLD BANK WITH SUPPORT FROM BOSTON UNIVERSITY. The South Africa National Department of Health (NDOH) intends to launch its newly developed National Adherence Guidelines for Chronic Diseases (HIV, TB and NCDs) throughout South Africa in the coming year. Early implementation of the "minimum package" of interventions described in the Adherence Guidelines for HIV patients will take place at 12 primary health clinics and community health centres in four provinces starting in July 2015. To maximize the learning potential of this early implementation stage, NDOH will match the intervention clinics with 12 comparison clinics and randomly allocate intervention or comparison status within the pairs of clinics. This will allow the outcomes of the interventions to be evaluated using a cluster-randomized design and generate data on the costs of implementation and the potential need for adherence support for the other diseases addressed in the guidelines (tuberculosis, hypertension, and diabetes). This protocol is for the evaluation, which will generate information on the effectiveness of minimum package interventions and help improve the design, implementation, and budgeting of the guidelines.', 'detailedDescription': 'The study will assess the effectiveness of five interventions in the minimum package: 1) Fast track initiation counseling for patients eligible for antiretroviral therapy; 2) Enhanced adherence counseling for unstable patients on HIV treatment; 3) adherence clubs for stable patients on HIV treatment; 4) decentralized medication delivery for stable patients on HIV treatment; and 5) early tracing of all patients who miss an appointment by two weeks. This study will also estimate for each study site an overall "adherence guideline impact" to provide an indication of the effectiveness of the package as a whole.\n\nIn addition, the study will estimate the cost of each of the interventions listed above compared to standard of care. Finally, the study will describe the cascade of care for tuberculosis, hypertension, and diabetes, three other chronic diseases for which little information currently exists. To evaluate these interventions the study team will work with the National Department of Health (which will implement the interventions) to randomize 24 clinics in 4 provinces 1:1 to receive the interventions or continue standard of care. All evaluations will use data routinely collected by the clinics, with no study interaction with subjects. A total of 8,256 patients will be enrolled and followed for up to 20 months to estimate short- and long-term outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ≥ 18 years old\n* Meet the inclusion criteria for one or more intervention\n* Not resident in the facility's catchment area\n* Recorded intention to transfer care to a different facility within 12 months\n\nExclusion Criteria:\n\n* Pregnant and eligible for PMTCT"}, 'identificationModule': {'nctId': 'NCT02536768', 'acronym': 'ENHANCE', 'briefTitle': "Evaluation of South Africa's National Adherence Strategy", 'organization': {'class': 'OTHER', 'fullName': 'Boston University'}, 'officialTitle': "Evaluation of the National Department of Health's National Adherence Guidelines for Chronic Diseases in South Africa Using Routinely Collected Data", 'orgStudyIdInfo': {'id': 'H-34074'}, 'secondaryIdInfos': [{'id': '7173709', 'type': 'OTHER_GRANT', 'domain': 'World Bank'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Minimum package of interventions to improve ART adherence including fast track initiation counselling, decentralized drug delivery, adherence clubs, fast patient tracing and spaced visits', 'interventionNames': ['Behavioral: Minimum package of interventions to improve ART adherence']}, {'type': 'NO_INTERVENTION', 'label': 'Comparison', 'description': 'Standard of care HIV treatment'}], 'interventions': [{'name': 'Minimum package of interventions to improve ART adherence', 'type': 'BEHAVIORAL', 'description': 'Package of 5 interventions to antiretroviral therapy adherence including fast track initiation counselling, decentralized drug delivery, adherence clubs, fast patient tracing and spaced visits', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Johannesburg', 'country': 'South Africa', 'facility': 'Johannesburg Site', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}], 'overallOfficials': [{'name': 'Matthew Fox, DSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston University', 'class': 'OTHER'}, 'collaborators': [{'name': 'World Bank (Lead institution)', 'class': 'UNKNOWN'}, {'name': 'Republic of South Africa National Department of Health (Lead institution)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor (Note: Not the PI, but one Co-PI)', 'investigatorFullName': 'Matthew Fox', 'investigatorAffiliation': 'Boston University'}}}}