Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-02-23 @ 2:21 AM
Study NCT ID:
NCT02180750
Status:
UNKNOWN
Last Update Posted:
2014-07-03
First Post:
2014-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Randomised Controlled Trial of Memory Work Therapy at PASADA, Tanzania
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-07-01', 'studyFirstSubmitDate': '2014-06-24', 'studyFirstSubmitQcDate': '2014-07-01', 'lastUpdatePostDateStruct': {'date': '2014-07-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change: Brief Symptom Inventory', 'timeFrame': 'T0( study entry), T1 (2 weeks), T2 (6 weeks)', 'description': 'The BSI measures psychological symptom patterns'}], 'secondaryOutcomes': [{'measure': 'Change: Rosenberg Self-Esteem Scale', 'timeFrame': 'T0 (study entry), T1 (2 weeks), T2 (6 weeks)', 'description': 'A measure of self esteem'}, {'measure': "Change: Goodman's strengths and difficulties questionnaire", 'timeFrame': 'T0 (study entry), T1 (2 weeks) T2 (6 weeks)', 'description': 'Measures mental health in children and young people'}, {'measure': 'Change: Self-efficacy questionnaire for children', 'timeFrame': 'T0 (study entry), T1 (2 weeks), T2 (6 weeks)', 'description': 'measure emotional and social self-efficacy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Children', 'HIV', 'orphans'], 'conditions': ['HIV']}, 'referencesModule': {'references': [{'pmid': '30332895', 'type': 'DERIVED', 'citation': 'Harding R, Wei G, Gwyther L, Miti E. Improving psychological outcomes for orphans living with HIV in Tanzania through a novel intervention to improve resilience: findings from a pilot RCT. AIDS Care. 2019 Mar;31(3):340-348. doi: 10.1080/09540121.2018.1533630. Epub 2018 Oct 17.'}]}, 'descriptionModule': {'briefSummary': 'Memory Work Therapy (MWT) has been developed to improve psycho-social outcomes for children living with HIV who are orphaned. This phase 2 trial aims to determine whether attending the intervention improves outcomes compared to standard care. We aim to test the hypothesis that attendance at MWT improves psychological symptoms, self-esteem, emotional and behavioural difficulties, and self-efficacy compared to standard care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 14-18 years\n* HIV positive\n* Orphaned\n* Naïve to the intervention\n\nExclusion Criteria:\n\n* Adults\n* Children under 14\n* HIV negative\n* Parent(s) living\n* Previously attended the intervention'}, 'identificationModule': {'nctId': 'NCT02180750', 'acronym': 'MWT', 'briefTitle': 'Phase II Randomised Controlled Trial of Memory Work Therapy at PASADA, Tanzania', 'organization': {'class': 'OTHER', 'fullName': 'Pastoral Activities and Service for AIDS Dar-Es-Salaam Archdiocese'}, 'officialTitle': 'An Evaluation of a Psychosocial Intervention for Orphans With HIV Infection: a Phase II Randomised Controlled Trial of Memory Work Therapy at PASADA, Tanzania', 'orgStudyIdInfo': {'id': 'MWT01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention: Memory Work Therapy', 'description': 'Residential week intervention consisting of memory box, memory book, tree of life, Active Citizen book, all activities facilitated.', 'interventionNames': ['Other: Memory Work Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control: standard care', 'description': 'Usual care services.', 'interventionNames': ['Other: Standard care']}], 'interventions': [{'name': 'Memory Work Therapy', 'type': 'OTHER', 'armGroupLabels': ['Intervention: Memory Work Therapy']}, {'name': 'Standard care', 'type': 'OTHER', 'description': 'Pediatric clinic, ART', 'armGroupLabels': ['Control: standard care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Temeke', 'country': 'Tanzania', 'facility': 'PASADA', 'geoPoint': {'lat': -6.85, 'lon': 39.25}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pastoral Activities and Service for AIDS Dar-Es-Salaam Archdiocese', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Cape Town', 'class': 'OTHER'}, {'name': "King's College London", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Social Worker', 'investigatorFullName': 'Elvis Joseph Miti', 'investigatorAffiliation': 'Pastoral Activities and Service for AIDS Dar-Es-Salaam Archdiocese'}}}}