Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-01-16 @ 8:27 AM
Study NCT ID:
NCT02646605
Status:
COMPLETED
Last Update Posted:
2016-01-05
First Post:
2016-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Depression Amongst HIV Positive Patients in Lilongwe
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D003863', 'term': 'Depression'}], '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'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 206}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-04', 'studyFirstSubmitDate': '2016-01-04', 'studyFirstSubmitQcDate': '2016-01-04', 'lastUpdatePostDateStruct': {'date': '2016-01-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of depression amongst HIV positive patients attending ART clinic at Lighthouse Lilongwe, Malawi', 'timeFrame': 'enrollment', 'description': 'the survey will be administered one time'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Depression', 'AIDS', 'HIV'], 'conditions': ['HIV', 'AIDS']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Malawi Demographic Profile 2012'}, {'type': 'BACKGROUND', 'citation': 'Mwale M.C. et al (2006) The Prevalence Of Psychological Distress And Associated Factors Among People Living With Aids Attending Antiretroviral Therapy Clinics In Mzuzu, Malawi: A Cross Sectional Descriptive study. Accessed on 09 June 2012 from www.medcol.mw/mph/.../Charles%20M%20%20Mwale.pdf'}, {'pmid': '14741909', 'type': 'BACKGROUND', 'citation': 'Guilbert JJ. The world health report 2002 - reducing risks, promoting healthy life. Educ Health (Abingdon). 2003 Jul;16(2):230. doi: 10.1080/1357628031000116808. No abstract available.'}, {'pmid': '15159365', 'type': 'BACKGROUND', 'citation': 'Rochon PA, Mashari A, Cohen A, Misra A, Laxer D, Streiner DL, Dergal JM, Clark JP, Gold J, Binns MA. Relation between randomized controlled trials published in leading general medical journals and the global burden of disease. CMAJ. 2004 May 25;170(11):1673-7. doi: 10.1503/cmaj.1031006.'}, {'type': 'BACKGROUND', 'citation': 'World Health Organisation. (2005). Promoting Mental Health: concepts, emerging evidence, practice: report of the world health organisation, Dept of Mental Health and Substance Abuse in collaboration with the Victorian Health Promotion Foundation & the University of Melbourne. Geneva: World Health Organisation.'}]}, 'descriptionModule': {'briefSummary': 'Quantitative, validated tools of depression screening will be used to collect data to determine the prevalence of depression and its association with antiretroviral (ARV) adherence amongst HIV positive patients attending ART clinic at Lighthouse Lilongwe, Malawi.', 'detailedDescription': 'Preliminary data on prevalence and associations will be collected from 200 HIV positive adult men and women attending ART clinic at the Lighthouse in Lilongwe, Malawi. Quantitative, validated tools of depression screening will be used. A short structured demographic questionnaire will be used to collect demographic data. For depression, a Patient Health Questionnaire (PHQ) will be used while alcohol use will be assessed by Alcohol Use Disorders Identification Test (AUDIT) screening tool. The data collected will provide baseline data planning, program development and evaluation, and to promote comprehensive care provision for the people living with AIDS attending ART clinics in Malawi.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Men and women accessing HIV care at Lighthouse clinic, Lilongwe, Malawi will be invited to participate.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years and above\n* HIV positive men and women accessing care at LH\n* Both ART naïve and on ART\n* Registered with LH\n* Receiving primary care and/ or ART from LH\n\nExclusion Criteria:\n\n* Too sick to comprehend consent or requiring admission\n* Known mentally ill patient on psychiatric drugs\n* Less than 18 years old'}, 'identificationModule': {'nctId': 'NCT02646605', 'briefTitle': 'Depression Amongst HIV Positive Patients in Lilongwe', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Prevalence of Depression Amongst HIV Positive Patients Attending ART Clinic at Lighthouse Clinic, Lilongwe', 'orgStudyIdInfo': {'id': '12-2158'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients initiating ART', 'description': 'HIV positive men and women initiating ART', 'interventionNames': ['Other: depression screening']}, {'label': 'patients on established ART', 'description': 'HIV positive men and women on established ART', 'interventionNames': ['Other: depression screening']}], 'interventions': [{'name': 'depression screening', 'type': 'OTHER', 'description': 'Patient Health Questionnaire', 'armGroupLabels': ['patients initiating ART', 'patients on established ART']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'P/Bag A-104', 'city': 'Lilongwe', 'country': 'Malawi', 'facility': 'Lighthouse Clinic', 'geoPoint': {'lat': -13.96692, 'lon': 33.78725}}], 'overallOfficials': [{'name': 'Mina Hosseinipour, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fogarty AIDS international training research program', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Director', 'investigatorFullName': 'Mina Hosseinipour, MD, MPH', 'investigatorAffiliation': 'University of North Carolina, Chapel Hill'}}}}