Ignite Creation Date:
2025-12-24 @ 1:09 PM
Ignite Modification Date:
2026-01-09 @ 4:28 PM
Study NCT ID:
NCT04696861
Status:
COMPLETED
Last Update Posted:
2025-04-20
First Post:
2020-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Telehealth to Reduce Suicidality and Improve HIV Care Engagement in Tanzania
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013405', 'term': 'Suicide'}, {'id': 'D059020', 'term': 'Suicidal Ideation'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D057545', 'term': 'Social Stigma'}], 'ancestors': [{'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'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': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D012919', 'term': 'Social Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'brandon.knettel@duke.edu', 'phone': '1 919 660 1218', 'title': 'Brandon Knettel', 'organization': 'Duke University School of Nursing'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 months post enrollment', 'description': 'One adverse event, a serious adverse event involving the death of a study participant, was reported to the study IRBs and determined to be not related to the study.', 'eventGroups': [{'id': 'EG000', 'title': 'IDEAS for Hope Intervention', 'description': 'Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.\n\nIDEAS for Hope: Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Enhanced Standard of Care With Safety Planning', 'description': 'Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.\n\nEnhanced Standard of Care (Safety Planning): Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'AIDS-related complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Suicidal Ideation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IDEAS for Hope Intervention', 'description': 'Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.\n\nIDEAS for Hope: Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.'}, {'id': 'OG001', 'title': 'Enhanced Standard of Care With Safety Planning', 'description': 'Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.\n\nEnhanced Standard of Care (Safety Planning): Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.'}], 'classes': [{'title': 'Suicidal Thoughts', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Plan', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Intent', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.961', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.', 'groupDescription': 'Generalized linear mixed models were conducted and odds ratios (ORs) were reported', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months post enrollment', 'description': "Columbia-Suicide Severity Rating Scale (C-SSRS) items measuring suicidal thoughts (yes/no), intent (yes/no), and plan (yes/no). Reported here are the number of participants who responded 'yes' to each of the items.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '1 intervention participant died prior to 3-month follow-up and 1 intervention participant was lost to follow-up and did not complete the 3-month follow-up survey'}, {'type': 'PRIMARY', 'title': 'Number of Participants With a Gap in HIV Care Engagement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IDEAS for Hope Intervention', 'description': 'Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.\n\nIDEAS for Hope: Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.'}, {'id': 'OG001', 'title': 'Enhanced Standard of Care With Safety Planning', 'description': 'Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.\n\nEnhanced Standard of Care (Safety Planning): Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.961', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.', 'groupDescription': 'Generalized linear mixed models were conducted and odds ratios (ORs) were reported', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months post enrollment', 'description': 'Participant medical records were reviewed after the 3-month follow-up survey to identify whether they had a gap in care during the study period, defined as 6 or more days where they did not have enough prescribed medication on hand to maintain adherence between HIV clinic appointments.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '1 intervention participant died prior to 3-month follow-up'}, {'type': 'PRIMARY', 'title': 'HIV Medication Adherence, as Measured by Number of Participants Who Report Adherence Challenges', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IDEAS for Hope Intervention', 'description': 'Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.\n\nIDEAS for Hope: Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.'}, {'id': 'OG001', 'title': 'Enhanced Standard of Care With Safety Planning', 'description': 'Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.\n\nEnhanced Standard of Care (Safety Planning): Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.368', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.', 'groupDescription': 'Generalized linear mixed models were conducted and odds ratios (ORs) were reported', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months post enrollment', 'description': 'During the baseline and follow-up surveys, participants were asked two questions related to their adherence to antiretroviral medication: "Think about the last 14 days. On how many days did you miss taking your HIV pill(s)?" and the same question with a 90 day recall period. Adherence challenges were coded yes/no at each time point, defined as (1) missing 3 or more days of medication in the past 14 days or (2) missing 6 or more days in the past 90 days.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '1 intervention participant died prior to 3-month follow-up and 1 intervention participant was lost to follow-up and did not complete the 3-month follow-up survey'}, {'type': 'PRIMARY', 'title': 'Viral Load', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IDEAS for Hope Intervention', 'description': 'Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.\n\nIDEAS for Hope: Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.'}, {'id': 'OG001', 'title': 'Enhanced Standard of Care With Safety Planning', 'description': 'Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.\n\nEnhanced Standard of Care (Safety Planning): Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.'}], 'timeFrame': 'Baseline, 3 months Post Enrollment', 'description': 'Extraction of routine HIV viral load testing from the patient medical record at baseline and 3-months post study enrollment.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected.'}, {'type': 'SECONDARY', 'title': 'Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IDEAS for Hope Intervention', 'description': 'Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.\n\nIDEAS for Hope: Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.'}, {'id': 'OG001', 'title': 'Enhanced Standard of Care With Safety Planning', 'description': 'Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.\n\nEnhanced Standard of Care (Safety Planning): Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.71', 'spread': '2.43', 'groupId': 'OG000'}, {'value': '3.13', 'spread': '2.87', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.634', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.', 'groupDescription': 'General linear mixed models', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 months post enrollment', 'description': 'Patient Health Questionnaire (PHQ-9), 9 items, score 0-27 with higher indicating more depression', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 intervention participant died prior to 3-month follow-up and 1 intervention participant was lost to follow-up and did not complete the 3-month follow-up survey'}, {'type': 'SECONDARY', 'title': 'HIV Stigma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IDEAS for Hope Intervention', 'description': 'Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.\n\nIDEAS for Hope: Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.'}, {'id': 'OG001', 'title': 'Enhanced Standard of Care With Safety Planning', 'description': 'Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.\n\nEnhanced Standard of Care (Safety Planning): Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.35', 'spread': '3.49', 'groupId': 'OG000'}, {'value': '30.31', 'spread': '5.39', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.832', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.', 'groupDescription': 'General linear mixed models', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 months post enrollment', 'description': 'HIV Stigma Scale (HSS), 12 items, score 12-48 with higher indicating more stigma', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 intervention participant died prior to 3-month follow-up and 1 intervention participant was lost to follow-up and did not complete the 3-month follow-up survey'}, {'type': 'SECONDARY', 'title': 'Number of HIV Disclosures Made by Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IDEAS for Hope Intervention', 'description': 'Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.\n\nIDEAS for Hope: Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.'}, {'id': 'OG001', 'title': 'Enhanced Standard of Care With Safety Planning', 'description': 'Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.\n\nEnhanced Standard of Care (Safety Planning): Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.'}], 'classes': [{'title': 'Disclosed to partner', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Disclosed to family', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Disclosed to friends', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Disclosed to others', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months post enrollment', 'description': 'Self-reported disclosures to partner, family, friends, others (yes/no)', 'unitOfMeasure': 'Disclosures', 'reportingStatus': 'POSTED', 'populationDescription': '1 intervention participant died prior to 3-month follow-up and 1 intervention participant was lost to follow-up and did not complete the 3-month follow-up survey'}, {'type': 'SECONDARY', 'title': 'Total Number of HIV Disclosures Made by Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IDEAS for Hope Intervention', 'description': 'Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.\n\nIDEAS for Hope: Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.'}, {'id': 'OG001', 'title': 'Enhanced Standard of Care With Safety Planning', 'description': 'Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.\n\nEnhanced Standard of Care (Safety Planning): Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.624', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.', 'groupDescription': 'Generalized linear mixed models were conducted and odds ratios (ORs) were reported', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '3 months post enrollment', 'unitOfMeasure': 'Disclosures', 'reportingStatus': 'POSTED', 'populationDescription': '1 intervention participant died prior to 3-month follow-up and 1 intervention participant was lost to follow-up and did not complete the 3-month follow-up survey'}, {'type': 'SECONDARY', 'title': 'Social Support', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IDEAS for Hope Intervention', 'description': 'Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.\n\nIDEAS for Hope: Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.'}, {'id': 'OG001', 'title': 'Enhanced Standard of Care With Safety Planning', 'description': 'Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.\n\nEnhanced Standard of Care (Safety Planning): Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.21', 'spread': '7.15', 'groupId': 'OG000'}, {'value': '27.9', 'spread': '7.42', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.833', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.', 'groupDescription': 'General linear mixed models', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 months post enrollment', 'description': 'Perceived Availability of Support Scale (PASS), 7 items, score 7 to 35 with higher indicating more social support', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 intervention participant died prior to 3-month follow-up and 1 intervention participant was lost to follow-up and did not complete the 3-month follow-up survey'}, {'type': 'SECONDARY', 'title': 'Acceptability of Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IDEAS for Hope Intervention', 'description': 'Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.\n\nIDEAS for Hope: Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.'}, {'id': 'OG001', 'title': 'Enhanced Standard of Care With Safety Planning', 'description': 'Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.\n\nEnhanced Standard of Care (Safety Planning): Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.93', 'spread': '3.11', 'groupId': 'OG000'}, {'value': '33.5', 'spread': '2.78', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.', 'groupDescription': 'General linear mixed models', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 months post enrollment', 'description': '10 items adapted from the Client Satisfaction Questionnaire (CSQ), score 10 to 40 with higher indicating greater satisfaction with the intervention', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 intervention participant died prior to 3-month follow-up and 1 intervention participant was lost to follow-up and did not complete the 3-month follow-up survey'}, {'type': 'SECONDARY', 'title': 'Hopelessness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IDEAS for Hope Intervention', 'description': 'Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.\n\nIDEAS for Hope: Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.'}, {'id': 'OG001', 'title': 'Enhanced Standard of Care With Safety Planning', 'description': 'Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.\n\nEnhanced Standard of Care (Safety Planning): Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.75', 'spread': '2.12', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '2.33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.79', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.', 'groupDescription': 'General linear mixed models', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 months post enrollment', 'description': 'Beck Hopelessness Scale (Balsamo Short Form), 9 items, score 0 to 9 with higher indicating more hopelessness', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 intervention participant died prior to 3-month follow-up and 1 intervention participant was lost to follow-up and did not complete the 3-month follow-up survey'}, {'type': 'SECONDARY', 'title': 'Reasons for Living', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IDEAS for Hope Intervention', 'description': 'Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.\n\nIDEAS for Hope: Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.'}, {'id': 'OG001', 'title': 'Enhanced Standard of Care With Safety Planning', 'description': 'Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.\n\nEnhanced Standard of Care (Safety Planning): Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.'}], 'classes': [{'categories': [{'measurements': [{'value': '60.54', 'spread': '8.79', 'groupId': 'OG000'}, {'value': '62.3', 'spread': '5.49', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.55', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.', 'groupDescription': 'General linear mixed models', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 months post enrollment', 'description': 'Brief Reasons for Living Inventory, 12 items, score 12 to 72 with higher indicating more reasons to live', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 intervention participant died prior to 3-month follow-up and 1 intervention participant was lost to follow-up and did not complete the 3-month follow-up survey'}, {'type': 'SECONDARY', 'title': 'Quality of Life (Overall)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IDEAS for Hope Intervention', 'description': 'Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.\n\nIDEAS for Hope: Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.'}, {'id': 'OG001', 'title': 'Enhanced Standard of Care With Safety Planning', 'description': 'Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.\n\nEnhanced Standard of Care (Safety Planning): Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.54', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '3.60', 'spread': '0.62', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.823', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 months post enrollment', 'description': 'The World Health Organization Quality of Life Brief Version (WHOQOL-BREF), 2 items, score 2 to 10 with higher indicating better quality of life', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 intervention participant died prior to 3-month follow-up and 1 intervention participant was lost to follow-up and did not complete the 3-month follow-up survey'}, {'type': 'SECONDARY', 'title': 'Quality of Life (Health Satisfaction)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IDEAS for Hope Intervention', 'description': 'Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.\n\nIDEAS for Hope: Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.'}, {'id': 'OG001', 'title': 'Enhanced Standard of Care With Safety Planning', 'description': 'Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.\n\nEnhanced Standard of Care (Safety Planning): Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.79', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '3.73', 'spread': '0.91', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.942', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 months post enrollment', 'description': 'The World Health Organization Quality of Life Brief Version (WHOQOL-BREF), 2 items, score 2 to 10 with higher indicating better quality of life', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 intervention participant died prior to 3-month follow-up and 1 intervention participant was lost to follow-up and did not complete the 3-month follow-up survey'}, {'type': 'POST_HOC', 'title': 'Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IDEAS for Hope Intervention', 'description': 'Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.\n\nIDEAS for Hope: Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.'}, {'id': 'OG001', 'title': 'Enhanced Standard of Care With Safety Planning', 'description': 'Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.\n\nEnhanced Standard of Care (Safety Planning): Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'spread': '4.22', 'groupId': 'OG000'}, {'value': '7.43', 'spread': '5.71', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.207', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.', 'groupDescription': 'General linear mixed models', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 months post enrollment', 'description': 'Brief Symptom Inventory Anxiety Subscale, 6 items, score 0 to 24 with higher indicating more anxiety', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 intervention participant died prior to 3-month follow-up and 1 intervention participant was lost to follow-up and did not complete the 3-month follow-up survey'}, {'type': 'POST_HOC', 'title': 'Suicide Coping Self-Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IDEAS for Hope Intervention', 'description': 'Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.\n\nIDEAS for Hope: Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.'}, {'id': 'OG001', 'title': 'Enhanced Standard of Care With Safety Planning', 'description': 'Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.\n\nEnhanced Standard of Care (Safety Planning): Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.86', 'spread': '11.51', 'groupId': 'OG000'}, {'value': '43.53', 'spread': '11.99', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.594', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.', 'groupDescription': 'General linear mixed models', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 months post enrollment', 'description': 'Self-Efficacy to Avoid Suicidal Action (SEASA) Scale, 6 items, score 0 to 60 with higher indicating more coping self-efficacy', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 intervention participant died prior to 3-month follow-up and 1 intervention participant was lost to follow-up and did not complete the 3-month follow-up survey'}, {'type': 'POST_HOC', 'title': 'Attitudes About Antiretroviral Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IDEAS for Hope Intervention', 'description': 'Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.\n\nIDEAS for Hope: Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.'}, {'id': 'OG001', 'title': 'Enhanced Standard of Care With Safety Planning', 'description': 'Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.\n\nEnhanced Standard of Care (Safety Planning): Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.25', 'spread': '3.53', 'groupId': 'OG000'}, {'value': '42.73', 'spread': '4.59', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.738', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.', 'groupDescription': 'General linear mixed models', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 months post enrollment', 'description': 'Beliefs About Medicine Questionnaire (BMQ), 10 items, score 10 to 50 with higher indicating more positive attitudes about medication', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 intervention participant died prior to 3-month follow-up and 1 intervention participant was lost to follow-up and did not complete the 3-month follow-up survey'}, {'type': 'POST_HOC', 'title': 'HIV Acceptance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IDEAS for Hope Intervention', 'description': 'Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.\n\nIDEAS for Hope: Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.'}, {'id': 'OG001', 'title': 'Enhanced Standard of Care With Safety Planning', 'description': 'Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.\n\nEnhanced Standard of Care (Safety Planning): Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.75', 'spread': '2.77', 'groupId': 'OG000'}, {'value': '20.73', 'spread': '3.86', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.845', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.', 'groupDescription': 'General linear mixed models', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 months post enrollment', 'description': 'Illness Cognition Questionnaire (ICQ), 7 items, score 7-28 with higher indicating more acceptance', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 intervention participant died prior to 3-month follow-up and 1 intervention participant was lost to follow-up and did not complete the 3-month follow-up survey'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IDEAS for Hope Intervention', 'description': 'Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.\n\nIDEAS for Hope: Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.'}, {'id': 'FG001', 'title': 'Enhanced Standard of Care With Safety Planning', 'description': 'Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.\n\nEnhanced Standard of Care (Safety Planning): Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'IDEAS for Hope Intervention', 'description': 'Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.\n\nIDEAS for Hope: Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.'}, {'id': 'BG001', 'title': 'Enhanced Standard of Care With Safety Planning', 'description': 'Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.\n\nEnhanced Standard of Care (Safety Planning): Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.83', 'spread': '11.86', 'groupId': 'BG000'}, {'value': '42.67', 'spread': '10.99', 'groupId': 'BG001'}, {'value': '43.25', 'spread': '11.36', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Tanzania', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-05-13', 'size': 243079, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-07-24T13:44', 'hasProtocol': True}, {'date': '2023-08-07', 'size': 334298, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-12-06T17:34', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients who screen positive for suicidal ideation will be enrolled in the study, complete the baseline survey, and then randomly assigned to the intervention (3 sessions of counseling) or enhanced standard of care (brief safety planning).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-14', 'studyFirstSubmitDate': '2020-12-22', 'resultsFirstSubmitDate': '2024-07-30', 'studyFirstSubmitQcDate': '2021-01-04', 'lastUpdatePostDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-26', 'studyFirstPostDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Suicidal Ideation', 'timeFrame': '3 months post enrollment', 'description': "Columbia-Suicide Severity Rating Scale (C-SSRS) items measuring suicidal thoughts (yes/no), intent (yes/no), and plan (yes/no). Reported here are the number of participants who responded 'yes' to each of the items."}, {'measure': 'Number of Participants With a Gap in HIV Care Engagement', 'timeFrame': '3 months post enrollment', 'description': 'Participant medical records were reviewed after the 3-month follow-up survey to identify whether they had a gap in care during the study period, defined as 6 or more days where they did not have enough prescribed medication on hand to maintain adherence between HIV clinic appointments.'}, {'measure': 'HIV Medication Adherence, as Measured by Number of Participants Who Report Adherence Challenges', 'timeFrame': '3 months post enrollment', 'description': 'During the baseline and follow-up surveys, participants were asked two questions related to their adherence to antiretroviral medication: "Think about the last 14 days. On how many days did you miss taking your HIV pill(s)?" and the same question with a 90 day recall period. Adherence challenges were coded yes/no at each time point, defined as (1) missing 3 or more days of medication in the past 14 days or (2) missing 6 or more days in the past 90 days.'}, {'measure': 'Viral Load', 'timeFrame': 'Baseline, 3 months Post Enrollment', 'description': 'Extraction of routine HIV viral load testing from the patient medical record at baseline and 3-months post study enrollment.'}], 'secondaryOutcomes': [{'measure': 'Depression', 'timeFrame': '3 months post enrollment', 'description': 'Patient Health Questionnaire (PHQ-9), 9 items, score 0-27 with higher indicating more depression'}, {'measure': 'HIV Stigma', 'timeFrame': '3 months post enrollment', 'description': 'HIV Stigma Scale (HSS), 12 items, score 12-48 with higher indicating more stigma'}, {'measure': 'Number of HIV Disclosures Made by Participants', 'timeFrame': '3 months post enrollment', 'description': 'Self-reported disclosures to partner, family, friends, others (yes/no)'}, {'measure': 'Total Number of HIV Disclosures Made by Participants', 'timeFrame': '3 months post enrollment'}, {'measure': 'Social Support', 'timeFrame': '3 months post enrollment', 'description': 'Perceived Availability of Support Scale (PASS), 7 items, score 7 to 35 with higher indicating more social support'}, {'measure': 'Acceptability of Intervention', 'timeFrame': '3 months post enrollment', 'description': '10 items adapted from the Client Satisfaction Questionnaire (CSQ), score 10 to 40 with higher indicating greater satisfaction with the intervention'}, {'measure': 'Hopelessness', 'timeFrame': '3 months post enrollment', 'description': 'Beck Hopelessness Scale (Balsamo Short Form), 9 items, score 0 to 9 with higher indicating more hopelessness'}, {'measure': 'Reasons for Living', 'timeFrame': '3 months post enrollment', 'description': 'Brief Reasons for Living Inventory, 12 items, score 12 to 72 with higher indicating more reasons to live'}, {'measure': 'Quality of Life (Overall)', 'timeFrame': '3 months post enrollment', 'description': 'The World Health Organization Quality of Life Brief Version (WHOQOL-BREF), 2 items, score 2 to 10 with higher indicating better quality of life'}, {'measure': 'Quality of Life (Health Satisfaction)', 'timeFrame': '3 months post enrollment', 'description': 'The World Health Organization Quality of Life Brief Version (WHOQOL-BREF), 2 items, score 2 to 10 with higher indicating better quality of life'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Suicide', 'Suicidal Ideation', 'HIV Infections', 'Adherence, Medication', 'Treatment Adherence and Compliance', 'Stigma, Social', 'Disclosure', 'Quality of Life']}, 'referencesModule': {'references': [{'pmid': '40905305', 'type': 'DERIVED', 'citation': 'Knettel BA, Madundo K, Amiri I, Msoka EF, Pan W, Khofi T, Ngangula P, Turner EL, Joel L, Rwakilomba J, Tarimo CS, Katiti V, Knippler ET, Mmbaga BT, Relf MV, Goldston DB. Results of a Pilot Randomized Controlled Trial of IDEAS for Hope: A Brief Telehealth Intervention for Suicide Prevention and HIV Care Engagement in Tanzania. J Acquir Immune Defic Syndr. 2025 Dec 15;100(5):435-444. doi: 10.1097/QAI.0000000000003758.'}]}, 'descriptionModule': {'briefSummary': 'The overall objectives of the proposed research are to develop a brief telehealth counseling intervention to provide support for people living with HIV and experiencing suicidal ideation, and to support HIV care engagement. The investigators hypothesize that a brief telehealth counseling intervention will be safe (participants in the clinical trial will not have increased risk of suicidal behavior), acceptable (high patient retention and satisfaction, high fidelity), and will demonstrate preliminary efficacy (reduced suicidal ideation, improved care engagement, improved mental well-being).', 'detailedDescription': 'The objective of the proposed research is to assess the feasibility and acceptability of a 3-session, nurse-delivered telehealth intervention to reduce suicidality and improve HIV care engagement among adults living with HIV in the Kilimanjaro Region of Tanzania. Suicide is a leading cause of death among people living with HIV (PLWH) worldwide and mental health disorders are key contributors to poor HIV care engagement, lower quality of life, higher transmission risk, and increased mortality among PLWH. Conversely, connecting PLWH with targeted mental health support improves these critical health outcomes. Telehealth counseling represents a cost-effective, innovative approach to mental health treatment in low-resource settings such as Tanzania, with the potential to expediently extend services. The proposed study will include Aim 1: Identifying the desired characteristics of a telehealth intervention for suicidality and HIV care engagement in the Tanzanian clinical context, Aim 2: Refining intervention content with support from a local study advisory board in Tanzania, and Aim 3: Testing the telehealth model in a pilot randomized control trial. Given emerging evidence for telehealth approaches to improve access to treatment and reduce health disparities, the intervention has great potential to support NIMH strategic objectives to address mental health comorbidities and strengthen the HIV care continuum.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Attending HIV care at study clinic\n* Screen positive for suicidal ideation\n* Able to understand Kiswahili or English\n* Medically stable\n* Capable of providing informed consent to participate\n\nExclusion Criteria:\n\n* Under 18 years old\n* Unable to understand Kiswahili or English\n* Experiencing medical or psychiatric symptoms requiring immediate treatment\n* Incapable of providing informed consent to participate'}, 'identificationModule': {'nctId': 'NCT04696861', 'briefTitle': 'Telehealth to Reduce Suicidality and Improve HIV Care Engagement in Tanzania', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Telehealth to Reduce Suicidality and Improve HIV Care Engagement in Tanzania', 'orgStudyIdInfo': {'id': 'Pro00107424'}, 'secondaryIdInfos': [{'id': 'K08MH124459', 'link': 'https://reporter.nih.gov/quickSearch/K08MH124459', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IDEAS for Hope Intervention', 'description': 'Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.', 'interventionNames': ['Behavioral: IDEAS for Hope']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enhanced Standard of Care with Safety Planning', 'description': 'Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.', 'interventionNames': ['Behavioral: Enhanced Standard of Care (Safety Planning)']}], 'interventions': [{'name': 'IDEAS for Hope', 'type': 'BEHAVIORAL', 'description': 'Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.', 'armGroupLabels': ['IDEAS for Hope Intervention']}, {'name': 'Enhanced Standard of Care (Safety Planning)', 'type': 'BEHAVIORAL', 'description': 'Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.', 'armGroupLabels': ['Enhanced Standard of Care with Safety Planning']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Moshi', 'country': 'Tanzania', 'facility': 'Majengo Health Centre', 'geoPoint': {'lat': -3.35, 'lon': 37.33333}}, {'city': 'Moshi', 'country': 'Tanzania', 'facility': 'Mawenzi Hospital', 'geoPoint': {'lat': -3.35, 'lon': 37.33333}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, {'name': 'Kilimanjaro Christian Medical Centre, Tanzania', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}