Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2025-12-25 @ 8:43 PM
Study NCT ID:
NCT03555669
Status:
COMPLETED
Last Update Posted:
2023-05-31
First Post:
2018-06-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Project SOAR-Mental Health Malawi: Depression and HIV Integration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'The investigators will employ a multiple baseline evaluation design in two clinics to evaluate the impact of depression treatment on HIV outcomes. Patients who screen positive for depression using PHQ-9 during the "pre" period will comprise the comparison group, while patients who screen positive during the "post" period will comprise the active group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2082}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-30', 'studyFirstSubmitDate': '2018-06-01', 'studyFirstSubmitQcDate': '2018-06-01', 'lastUpdatePostDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of participants who are retained in care', 'timeFrame': '6 months after ART initiation', 'description': 'Retention in care is defined as attending sufficient HIV appointments to maintain ART supply through the first 6 months on ART.'}, {'measure': 'Proportion of participants who are virally suppressed', 'timeFrame': '6 months after ART initiation', 'description': 'Viral suppression is defined as HIV RNA viral load of \\<1,000 copies/mL. Viral loads are measured approximately 6 months after ART initiation.'}], 'secondaryOutcomes': [{'measure': 'Proportion of participants who achieve depression remission (PHQ-9 score less than 5)', 'timeFrame': '6 months after ART initiation', 'description': 'Depression remission is defined as scoring less than 5 on the PHQ-9 approximately 6 months after ART initiation. The PHQ-9 is a self-report questionnaire designed to assess depression through nine questions that come directly from the DSM-IV signs and symptoms of major depression. The 9 items describe problems associated with depression, and participants must rate how often the patient has been bothered by the problems in the last 2 weeks on a 0-3 scale. The scores are summed for a total depression score, ranging from 0-27, with 0-4 being minimum and indicating no depressive symptoms, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, and 20-27 severe depression. Depressive symptoms will be measured with the PHQ-9 at baseline through approximately 6 months after ART initiation.'}, {'measure': 'Proportion of scheduled ART visits attended', 'timeFrame': '6 months after ART initiation', 'description': 'ART visit attendance is defined as attending scheduled ART appointments over the first 6 months on ART.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Implementation Science', 'Malawi'], 'conditions': ['Depression', 'HIV/AIDS']}, 'referencesModule': {'references': [{'pmid': '37088107', 'type': 'DERIVED', 'citation': 'Kulisewa K, Minnick CE, Stockton MA, Gaynes BN, Hosseinipour MC, Mphonda S, Sansbury G, Udedi MM, Pence BW. The acceptability of antidepressant treatment in people living with HIV in Malawi: A patient perspective. Glob Public Health. 2023 Jan;18(1):2201327. doi: 10.1080/17441692.2023.2201327.'}, {'pmid': '31242877', 'type': 'DERIVED', 'citation': 'Udedi M, Stockton MA, Kulisewa K, Hosseinipour MC, Gaynes BN, Mphonda SM, Pence BW. The effectiveness of depression management for improving HIV care outcomes in Malawi: protocol for a quasi-experimental study. BMC Public Health. 2019 Jun 26;19(1):827. doi: 10.1186/s12889-019-7132-3.'}, {'pmid': '30064418', 'type': 'DERIVED', 'citation': 'Udedi M, Stockton MA, Kulisewa K, Hosseinipour MC, Gaynes BN, Mphonda SM, Mwagomba BM, Mazenga AC, Pence BW. Integrating depression management into HIV primary care in central Malawi: the implementation of a pilot capacity building program. BMC Health Serv Res. 2018 Jul 31;18(1):593. doi: 10.1186/s12913-018-3388-z.'}]}, 'descriptionModule': {'briefSummary': 'Depression is highly prevalent among people living with HIV (PLHIV) in Malawi and elsewhere in sub-Saharan Africa (SSA). Besides its high prevalence, depression likely represents an important barrier to consistent HIV care engagement and long-term viral suppression. However, the potential for depression treatment to improve HIV care outcomes has received little attention in the region, in part because of limited mental health infrastructure. In this study, the investigators will evaluate the impact of a depression treatment program integrated within existing HIV clinics on depression response, retention in HIV care, and viral suppression. It is expected that this evaluation will yield important evidence on the impact of depression treatment integrated with HIV care for improving HIV care and mental health outcomes in Malawi.', 'detailedDescription': 'Study population:\n\nThe evaluation will abstract screening data for adult (≥18 years old) patients newly initiating antiretroviral therapy (ART) who are screened for depression at the two clinics before and after the integration of the depression treatment program, and additional treatment and outcome data for those patients who screen positive for depression.\n\nStudy Size:\n\nAcross the two clinics, the investigators expect to abstract depression screening data for approximately 2,300 patients. The investigators expect to abstract further treatment and outcome data for approximately 640 patients who screen positive for mild, moderate, or severe depression.\n\nStudy Duration:\n\nEvaluation and dissemination activities will last two years.\n\nStudy Evaluation:\n\nTo evaluate the impact of the mental health treatment program on HIV care outcomes, the investigators will collect data on HIV appointment adherence and viral load at 6 months following ART initiation.\n\nTo evaluate the impact of the mental health treatment program on mental health outcomes the investigators will collect data on depression symptoms at baseline through 6 months following ART initiation.\n\nStudy Design Overview:\n\nThe study will employ a pre-post design in two HIV clinics in Lilongwe to evaluate the impact of integrating the depression treatment program within existing clinic operations on HIV and mental health outcomes. The investigators will use existing medical records and the depression patient registry maintained by the Ministry of Health-run clinics to abstract routinely collected clinical data. Using these data, the investigators will compare mental health and HIV outcomes before and after the integration of the depression treatment program. Depressive symptoms will be measured with the Patient Health Questionnaire 9 (PHQ-9). The PHQ-9 is a self-report questionnaire designed to assess depression through nine questions that come directly from the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) signs and symptoms of major depression. Additionally, the investigators will conduct short qualitative interviews with clinic and Ministry of Health staff about the integration of the depression screening and treatment program and with patients on their understanding of depression and satisfaction with depression screening and treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (≥18 years)\n* HIV-infected\n* Newly initiating antiretroviral treatment at one of the program sites\n* Screened for depression\n\nExclusion Criteria:\n\n• None'}, 'identificationModule': {'nctId': 'NCT03555669', 'briefTitle': 'Project SOAR-Mental Health Malawi: Depression and HIV Integration', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'UNCPM 21609 Project SOAR Mental Health: Evaluation of the Impact of a Depression Treatment Program on Mental Health and HIV Care Outcomes in Malawi', 'orgStudyIdInfo': {'id': '16-2834'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Screening Phase (Pre) Group', 'description': 'Patients who screen positive on the PHQ-9 for depression during the "pre" period will comprise the comparison group. Participants will receive "standard of care" depression treatment at the providers discretion.'}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Phase (Post) Group', 'description': 'Patients who screen positive during on the PHQ-9 for depression during the "post" period will comprise the active group. Participants will receive the depression treatment intervention in the form of anti-depressants and/or problem solving therapy (PST) based on their PHQ-9 score.', 'interventionNames': ['Other: Depression Treatment']}], 'interventions': [{'name': 'Depression Treatment', 'type': 'OTHER', 'description': "The depression treatment program combines measurement-based antidepressant treatment with PST with clinical response appropriate to the level of depressive severity. Patients scoring 0-4 on the PHQ-9, indicating no depression, receive no treatment. Patients scoring 5-9 on the PHQ-9, indicating mild depressive symptoms that likely are not a full major depressive episode, are offered PST. Patients scoring 10 or above on the PHQ-9, indicating moderate-to-severe depressive symptoms, are first offered anti-depressants. For this group, PST will be an alternative or augmentation option for those who do not tolerate or respond to antidepressant treatment. All patients' depressive severity is monitored with the option of modifying their treatment plan if their symptoms worsen or do not improve.", 'armGroupLabels': ['Treatment Phase (Post) Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lilongwe', 'country': 'Malawi', 'facility': 'Area 18 Clinic', 'geoPoint': {'lat': -13.96692, 'lon': 33.78725}}, {'city': 'Lilongwe', 'country': 'Malawi', 'facility': 'Area 25 Clinic', 'geoPoint': {'lat': -13.96692, 'lon': 33.78725}}], 'overallOfficials': [{'name': 'Brian Pence, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UNC Gillings School of Global Public Health'}, {'name': 'Michael Udedi, MBA MPhil', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Malawi Ministry of Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Agency for International Development (USAID)', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}