Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 11:06 AM
Study NCT ID:
NCT07459218
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-12
First Post:
2026-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IDEAS for Hope to Reduce Suicide Risk and Improve HIV Care Engagement in Tanzania
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D000092864', 'term': 'Suicide Prevention'}, {'id': 'D015438', 'term': 'Health Behavior'}], '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': 'D013405', 'term': 'Suicide'}, {'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2031-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-10', 'studyFirstSubmitDate': '2026-03-04', 'studyFirstSubmitQcDate': '2026-03-04', 'lastUpdatePostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with Suicidal thinking', 'timeFrame': '6 months', 'description': 'Self-report of actual thoughts of suicide in the last 30 days'}, {'measure': 'Number of participants with a Suicidal plan', 'timeFrame': '6 months', 'description': 'Self-report of plan to attempt suicide'}, {'measure': 'Number of participants with Suicidal intent', 'timeFrame': '6 months', 'description': 'Self-report of intent to attempt suicide'}, {'measure': 'Number of participants with Suicide preparatory behavior', 'timeFrame': '6 months', 'description': 'Self-report of preparatory behavior such as writing a suicide note or preparing materials to attempt suicide'}, {'measure': 'Number of participants with Suicide attempt', 'timeFrame': '6 months', 'description': "Self-report of harming oneself with the intention of ending one's life"}, {'measure': 'Number of participants with HIV care engagement', 'timeFrame': '6 months', 'description': 'Single triangulated variable (yes/no) integrating self-reported antiretroviral medication adherence, HIV clinic attendance, and HIV viral load'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['task-shifting', 'task-sharing', 'stigma reduction', 'suicide prevention', 'health behavior', 'care engagement', 'HIV', 'telehealth', 'nurse-led intervention'], 'conditions': ['HIV - Human Immunodeficiency Virus', 'Suicide Prevention']}, 'descriptionModule': {'briefSummary': 'In this project, the investigators will conduct a clinical trial to test the effectiveness and implementation of IDEAS for Hope, a 3-session telehealth counseling intervention delivered by nurses, to reduce suicidality and improve HIV care engagement among PLWH in Tanzania. The investigators will also examine mechanisms of change and implementation outcomes of the intervention, including cost-effectiveness, to disseminate a feasible, scalable, and sustainable intervention and implementation package to address a critical mental health comorbidity in HIV care.', 'detailedDescription': 'Suicide is a leading cause of death among people living with HIV (PLWH) worldwide and PLWH in Tanzania are two to three times as likely to die by suicide compared to people without HIV. Mental health challenges are also closely linked to poor HIV outcomes, including lapses in clinic attendance, poor medication adherence, risk of HIV transmission, and AIDS-related death. Yet when PLWH receive mental health treatment that addresses barriers to HIV treatment adherence, both mental health and HIV outcomes improve. The investigators are developing innovative approaches to bridge the mental health treatment gap in Tanzania, including telehealth and nurse-led counseling interventions. The investigators previously developed and conducted a pilot feasibility randomized controlled trial of IDEAS for Hope, a 3-session telehealth counseling intervention, led by nurses, to reduce suicide risk and improve HIV care engagement in Tanzania. The IDEAS for Hope intervention, grounded in Motivational Interviewing, CBT, and Problem-Solving Therapy frameworks, facilitates HIV education, stigma reduction, and social support to address social determinants of suicide risk. The pilot trial with 60 PLWH who were experiencing suicidal ideation demonstrated clear feasibility and acceptability of IDEAS for Hope, as well as strong trends toward intervention efficacy to reduce suicide risk. The long-term objective of this research is to develop a scalable implementation package to expand care, reduce suicide risk, and improve HIV care engagement in Tanzania. In Aim 1, the investigators will determine the effectiveness of IDEAS for Hope to reduce suicide risk and improve HIV care engagement in an individually randomized controlled trial. Based on the pilot trial, the investigators hypothesize that IDEAS for Hope will reduce suicidal plan and intent to near zero and will improve HIV care engagement by 17% at 6-month follow-up, which will be statistically superior to brief safety planning. In Aim 2, the investigators will explore mechanisms of change to identify how and for whom IDEAS for Hope is most effective. The investigators will analyze the effect of hypothesized mediators of suicide risk and HIV care engagement, including self-efficacy, depression, anxiety, and stigma; potential moderators include sex, age, and severity of baseline symptoms. These data will inform future refinement for at-risk groups and adaptation to other settings. In Aim 3, the investigators will evaluate implementation outcomes, including cost-effectiveness, guided by the Consolidated Framework for Implementation Research (CFIR). The investigators hypothesize that IDEAS for Hope will be effectively expanded to 12 clinic sites, with a favorable Incremental Cost-Effectiveness Ratio. Structured surveys and qualitative interviews with patients and providers will assess fidelity and sustainability outcomes for implementation. Given the emerging evidence for telehealth and nurse-led approaches, IDEAS for Hope has great potential to reduce the mental health treatment gap in Tanzania. The research is innovative, yet fundamentally essential, and supports NIH Strategic Objectives to prevent suicide across the lifespan in low- and middle-income countries, address mental health comorbidities of HIV, and strengthen the HIV care continuum.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult\n* Living with HIV\n* Attending HIV care appointments\n* Self-report experiencing thoughts of suicide in the last 30 days\n\nExclusion Criteria:\n\n* Physically or cognitively unable to provide informed consent or complete study procedures'}, 'identificationModule': {'nctId': 'NCT07459218', 'briefTitle': 'IDEAS for Hope to Reduce Suicide Risk and Improve HIV Care Engagement in Tanzania', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'IDEAS for Hope: A Brief Telehealth Intervention to Reduce Suicide Risk and Improve HIV Care Engagement in Tanzania', 'orgStudyIdInfo': {'id': 'Pro00119742'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IDEAS for Hope', 'description': '3-session, nurse-delivered, telehealth counseling intervention developmed by Knettel and colleagues', 'interventionNames': ['Behavioral: IDEAS for Hope']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Brief Safety Planning', 'description': 'Single session brief safety planning intervention (BSI) developed by Stanely \\& Brown', 'interventionNames': ['Behavioral: Safety Planning Intervention']}], 'interventions': [{'name': 'IDEAS for Hope', 'type': 'BEHAVIORAL', 'description': "The IDEAS for Hope framework integrates Joiner's Interpersonal Theory to address stigma, burdensomeness, and other drivers of suicide risk and improve HIV care engagement. This includes theoretical grounding in Motivational Interviewing-enhanced safety planning (MI-SafeCope), stigma reduction, cognitive-behavioral therapy with adherence counseling (CBT-AD), and problem-solving therapy. MI-SafeCope improves coping for suicide risk by developing an individualized safety plan and facilitating social support. The integration of MI into standard safety planning goes beyond identifying coping strategies to facilitate values-driven improvement in health behavior and address the unique drivers of suicide risk among PLWH in Tanzania.", 'armGroupLabels': ['IDEAS for Hope']}, {'name': 'Safety Planning Intervention', 'type': 'BEHAVIORAL', 'description': 'The single-session safety planning intervention (SPI) will be provided according to protocols developed by Stanley \\& Brown. The SPI involves collaboratively creating a personalized, step-by-step plan to help individuals recognize warning signs, use coping strategies, seek support, and reduce access to means during a suicidal crisis.', 'armGroupLabels': ['Brief Safety Planning']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Moshi', 'country': 'Tanzania', 'contacts': [{'name': 'Blandina Mmbaga, MD, MMED, PhD', 'role': 'CONTACT', 'email': 'b.mmbaga@kcri.ac.tz', 'phone': '+255 27 275 4201'}], 'facility': 'Kilimanjaro Clinical Research Institute', 'geoPoint': {'lat': -3.35, 'lon': 37.33333}}], 'centralContacts': [{'name': 'Brandon A Knettel, Ph.D.', 'role': 'CONTACT', 'email': 'brandon.knettel@duke.edu', 'phone': '(919) 660-1218'}], 'overallOfficials': [{'name': 'Brandon A Knettel, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'ipdSharing': 'YES', 'description': 'Age, sex, ethnicity, socioeconomic status, depression symptoms, distress, suicide risk, suicide coping self-efficacy, hopelessness, reasons for living, anxiety symptoms, traumatic stress symptoms, impairment, resilience, social support, quality of life, study feedback, method and date of HIV diagnosis, antiretroviral therapy (ART) use and date of initiation, ART adherence, persistence, and retention, beliefs about ART, stigma, HIV knowledge, HIV acceptance.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'RTI International', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}