Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT04692467
Status:
COMPLETED
Last Update Posted:
2024-04-09
First Post:
2020-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Treatment of Early Hypertension Among Persons Living With HIV in Haiti
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D058246', 'term': 'Prehypertension'}, {'id': 'D006973', 'term': 'Hypertension'}], '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': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017311', 'term': 'Amlodipine'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mam9365@med.cornell.edu', 'phone': '646-962-8140', 'title': 'Dr. Margaret McNairy', 'organization': 'Weill Cornell Medicine'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'All participants were asked at each community and clinic visit whether they had adverse events. Clinic visits occurred at 1, 3, 6, 9, and 12 months after enrolment. Community visits occurred at 2, 5, and 8 months after enrolment. Participants were followed up for up to 12 months after enrollment.', 'description': 'Signs and symptoms of hypotension and peripheral edema, or any other reported side effects were graded using the existing Division of AIDS (DAIDS) criteria.', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention (Early Hypertension)', 'description': "Participants randomized to the early HTN treatment arm will initiate 5mg daily of amlodipine immediately, increasing to 10 mg if SBP \\>130 mmHg after 1 month.\n\nAmlodipine 5mg: Amlodipine, Haiti's first-line antihypertensive medication, will be administered to the intervention group.", 'otherNumAtRisk': 124, 'deathsNumAtRisk': 124, 'otherNumAffected': 22, 'seriousNumAtRisk': 124, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Standard of Care', 'description': 'Participants randomized to the SOC arm will not be initiated on any medications initially. They may be initiated on amlodipine only if they develop HTN (SBP ≥140 or DBP ≥90 mm Hg).', 'otherNumAtRisk': 126, 'deathsNumAtRisk': 126, 'otherNumAffected': 0, 'seriousNumAtRisk': 126, 'deathsNumAffected': 2, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Edema', 'notes': 'Grade 1: mild', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2017'}, {'term': 'Edema', 'notes': 'Grade 2: moderate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2017'}, {'term': 'Fatigue', 'notes': 'Grade 2: moderate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2017'}, {'term': 'Headache', 'notes': 'Grade 2: moderate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2017'}, {'term': 'Dizziness', 'notes': 'Grade 1: mild', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2017'}, {'term': 'Dizziness', 'notes': 'Grade 2: moderate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2017'}, {'term': 'Urine Flow Increase', 'notes': 'Grade 1: mild', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2017'}, {'term': 'Neck Stiffness', 'notes': 'Grade 2: moderate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2017'}], 'seriousEvents': [{'term': 'Marked weakness', 'notes': 'Grade 3: severe', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2017'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Mean Systolic Blood Pressure (SBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (Early Hypertension)', 'description': "Participants randomized to the early HTN treatment arm will initiate 5mg daily of amlodipine immediately, increasing to 10 mg if SBP \\>130 mmHg after 1 month.\n\nAmlodipine 5mg: Amlodipine, Haiti's first-line antihypertensive medication, will be administered to the intervention group."}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Participants randomized to the SOC arm will not be initiated on any medications initially. They may be initiated on amlodipine only if they develop HTN (SBP ≥140 or DBP ≥90 mm Hg).'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.58', 'spread': '11.01', 'groupId': 'OG000'}, {'value': '-4.65', 'spread': '11.41', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.88', 'ciLowerLimit': '-8.77', 'ciUpperLimit': '-3.01', 'estimateComment': 'The mean difference reflects the difference in mean change (i.e., mean change = 12 months minus baseline for each arm) between the intervention arm and SOC arm (direction = intervention arm minus SOC arm).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 months', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For participants receiving Standard of Care, 120 of the 126 (95.2%) had a 12-month visit. For the participants receiving the intervention, 122 of the 124 (98.4%) had a 12-month visit.'}, {'type': 'SECONDARY', 'title': 'Change in Number of Participants With HIV Viral Suppression as Measured by HIV-1 RNA Viral Loads < 1,000 Copies/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (Early Hypertension)', 'description': "Participants randomized to the early HTN treatment arm will initiate 5mg daily of amlodipine immediately, increasing to 10 mg if SBP \\>130 mmHg after 1 month.\n\nAmlodipine 5mg: Amlodipine, Haiti's first-line antihypertensive medication, will be administered to the intervention group."}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Participants randomized to the SOC arm will not be initiated on any medications initially. They may be initiated on amlodipine only if they develop HTN (SBP ≥140 or DBP ≥90 mm Hg).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 12 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'At the 12-month visit, 8 participants in the Standard of Care arm and 5 participants in the intervention arm were missing viral load data.'}, {'type': 'SECONDARY', 'title': 'Change in HIV Medication Adherence as Measured by Number of Participants With > 90% Adherence Using 4-day Pill Recalls', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (Early Hypertension)', 'description': "Participants randomized to the early HTN treatment arm will initiate 5mg daily of amlodipine immediately, increasing to 10 mg if SBP \\>130 mmHg after 1 month.\n\nAmlodipine 5mg: Amlodipine, Haiti's first-line antihypertensive medication, will be administered to the intervention group."}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Participants randomized to the SOC arm will not be initiated on any medications initially. They may be initiated on amlodipine only if they develop HTN (SBP ≥140 or DBP ≥90 mm Hg).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 6 months and 12 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Who Have Adverse Events Related to Amlodipine, Including Dizziness, Fainting, Lower Extremity Edema, and Any Other Symptoms Which May be Related.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (Early Hypertension)', 'description': "Participants randomized to the early HTN treatment arm will initiate 5mg daily of amlodipine immediately, increasing to 10 mg if SBP \\>130 mmHg after 1 month.\n\nAmlodipine 5mg: Amlodipine, Haiti's first-line antihypertensive medication, will be administered to the intervention group."}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Participants randomized to the SOC arm will not be initiated on any medications initially. They may be initiated on amlodipine only if they develop HTN (SBP ≥140 or DBP ≥90 mm Hg).'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Followup month 1', 'description': 'Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Who Have Adverse Events Related to Amlodipine, Including Dizziness, Fainting, Lower Extremity Edema, and Any Other Symptoms Which May be Related.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (Early Hypertension)', 'description': "Participants randomized to the early HTN treatment arm will initiate 5mg daily of amlodipine immediately, increasing to 10 mg if SBP \\>130 mmHg after 1 month.\n\nAmlodipine 5mg: Amlodipine, Haiti's first-line antihypertensive medication, will be administered to the intervention group."}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Participants randomized to the SOC arm will not be initiated on any medications initially. They may be initiated on amlodipine only if they develop HTN (SBP ≥140 or DBP ≥90 mm Hg).'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Followup month 2', 'description': 'Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Who Have Adverse Events Related to Amlodipine, Including Dizziness, Fainting, Lower Extremity Edema, and Any Other Symptoms Which May be Related.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (Early Hypertension)', 'description': "Participants randomized to the early HTN treatment arm will initiate 5mg daily of amlodipine immediately, increasing to 10 mg if SBP \\>130 mmHg after 1 month.\n\nAmlodipine 5mg: Amlodipine, Haiti's first-line antihypertensive medication, will be administered to the intervention group."}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Participants randomized to the SOC arm will not be initiated on any medications initially. They may be initiated on amlodipine only if they develop HTN (SBP ≥140 or DBP ≥90 mm Hg).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Followup month 3', 'description': 'Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (Early Hypertension)', 'description': "Participants randomized to the early HTN treatment arm will initiate 5mg daily of amlodipine immediately, increasing to 10 mg if SBP \\>130 mmHg after 1 month.\n\nAmlodipine 5mg: Amlodipine, Haiti's first-line antihypertensive medication, will be administered to the intervention group."}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Participants randomized to the SOC arm will not be initiated on any medications initially. They may be initiated on amlodipine only if they develop HTN (SBP ≥140 or DBP ≥90 mm Hg).'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Followup month 5', 'description': 'Number of subjects who have adverse events related to amlodipine, including dizziness, fainting, lower extremity edema, and any other symptoms which may be related. Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Who Have Adverse Events Related to Amlodipine, Including Dizziness, Fainting, Lower Extremity Edema, and Any Other Symptoms Which May be Related.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (Early Hypertension)', 'description': "Participants randomized to the early HTN treatment arm will initiate 5mg daily of amlodipine immediately, increasing to 10 mg if SBP \\>130 mmHg after 1 month.\n\nAmlodipine 5mg: Amlodipine, Haiti's first-line antihypertensive medication, will be administered to the intervention group."}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Participants randomized to the SOC arm will not be initiated on any medications initially. They may be initiated on amlodipine only if they develop HTN (SBP ≥140 or DBP ≥90 mm Hg).'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Followup month 6', 'description': 'Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Who Have Adverse Events Related to Amlodipine, Including Dizziness, Fainting, Lower Extremity Edema, and Any Other Symptoms Which May be Related.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (Early Hypertension)', 'description': "Participants randomized to the early HTN treatment arm will initiate 5mg daily of amlodipine immediately, increasing to 10 mg if SBP \\>130 mmHg after 1 month.\n\nAmlodipine 5mg: Amlodipine, Haiti's first-line antihypertensive medication, will be administered to the intervention group."}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Participants randomized to the SOC arm will not be initiated on any medications initially. They may be initiated on amlodipine only if they develop HTN (SBP ≥140 or DBP ≥90 mm Hg).'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Followup month 8', 'description': 'Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Who Have Adverse Events Related to Amlodipine, Including Dizziness, Fainting, Lower Extremity Edema, and Any Other Symptoms Which May be Related.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (Early Hypertension)', 'description': "Participants randomized to the early HTN treatment arm will initiate 5mg daily of amlodipine immediately, increasing to 10 mg if SBP \\>130 mmHg after 1 month.\n\nAmlodipine 5mg: Amlodipine, Haiti's first-line antihypertensive medication, will be administered to the intervention group."}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Participants randomized to the SOC arm will not be initiated on any medications initially. They may be initiated on amlodipine only if they develop HTN (SBP ≥140 or DBP ≥90 mm Hg).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Followup month 9', 'description': 'Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '1 participant in the standard of care arm was excluded from analysis because the participant died of causes unrelated to the research prior to follow-up month 9.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Who Have Adverse Events Related to Amlodipine, Including Dizziness, Fainting, Lower Extremity Edema, and Any Other Symptoms Which May be Related.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (Early Hypertension)', 'description': "Participants randomized to the early HTN treatment arm will initiate 5mg daily of amlodipine immediately, increasing to 10 mg if SBP \\>130 mmHg after 1 month.\n\nAmlodipine 5mg: Amlodipine, Haiti's first-line antihypertensive medication, will be administered to the intervention group."}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Participants randomized to the SOC arm will not be initiated on any medications initially. They may be initiated on amlodipine only if they develop HTN (SBP ≥140 or DBP ≥90 mm Hg).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Followup month 12', 'description': 'Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '2 participants in the standard of care arm were excluded from analysis because these participants died of causes unrelated to the research prior to follow-up month 12.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Are Enrolled at Baseline and Remain in the Study by 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (Early Hypertension)', 'description': "Participants randomized to the early HTN treatment arm will initiate 5mg daily of amlodipine immediately, increasing to 10 mg if SBP \\>130 mmHg after 1 month.\n\nAmlodipine 5mg: Amlodipine, Haiti's first-line antihypertensive medication, will be administered to the intervention group."}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Participants randomized to the SOC arm will not be initiated on any medications initially. They may be initiated on amlodipine only if they develop HTN (SBP ≥140 or DBP ≥90 mm Hg).'}], 'classes': [{'categories': [{'measurements': [{'value': '122', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, 12 months', 'description': 'All participants were included in enrolment. Remaining in the study was defined as having a clinic visit at month 12 (final study visit).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '2 participants in the standard of care arm were excluded from analysis because these participants died of causes unrelated to the research prior to follow-up month 12.'}, {'type': 'SECONDARY', 'title': 'Acceptability of Study Intervention Assessed by Qualitative Interviews Among Participants and Providers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (Early Hypertension)', 'description': 'Patients who participated in the study who were given the intervention were invited to a focus-group discussion. In each session there were 6-8 participants.'}, {'id': 'OG001', 'title': 'Providers', 'description': 'Providers who were part of the study and also consented to being interviewed'}], 'classes': [{'title': 'Satisfaction', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Positive Effects', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Negative Effects', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Intent to continue', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Amlodipine Initiation', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'CVD Risk', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Unintended consequences', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Implementation Challenges', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Using semi-structured interview guides exploring topics including acceptability, side effects, perceived benefit, and perceived cost, in depth interviews will be conducted with 15-20 study participants in the intervention arm, and all healthcare providers involved in the study (nurses, doctors, social workers).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Focus-group discussions were conducted with participants who received the intervention. A subset of 16 participants were randomly selected and called to conduct FGD. Individual interviews were conducted with providers. All physicians (two) who were involved in the study were interviewed. One nurse was excluded as they could not be contacted as they had left the clinic.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention (Early Hypertension)', 'description': "Participants randomized to the early HTN treatment arm will initiate 5mg daily of amlodipine immediately, increasing to 10 mg if SBP \\>130 mmHg after 1 month.\n\nAmlodipine 5mg: Amlodipine, Haiti's first-line antihypertensive medication, will be administered to the intervention group."}, {'id': 'FG001', 'title': 'Standard of Care', 'description': 'Participants randomized to the SOC arm will not be initiated on any medications initially. They may be initiated on amlodipine only if they develop HTN (SBP ≥140 or DBP ≥90 mm Hg).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '124'}, {'groupId': 'FG001', 'numSubjects': '126'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '124'}, {'groupId': 'FG001', 'numSubjects': '126'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention (Early Hypertension)', 'description': "Participants randomized to the early HTN treatment arm will initiate 5mg daily of amlodipine immediately, increasing to 10 mg if SBP \\>130 mmHg after 1 month.\n\nAmlodipine 5mg: Amlodipine, Haiti's first-line antihypertensive medication, will be administered to the intervention group."}, {'id': 'BG001', 'title': 'Standard of Care', 'description': 'Participants randomized to the SOC arm will not be initiated on any medications initially. They may be initiated on amlodipine only if they develop HTN (SBP ≥140 or DBP ≥90 mm Hg).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.0', 'groupId': 'BG000', 'lowerLimit': '48.3', 'upperLimit': '55.3'}, {'value': '47.5', 'groupId': 'BG001', 'lowerLimit': '41.3', 'upperLimit': '55.0'}, {'value': '49.0', 'groupId': 'BG002', 'lowerLimit': '42.0', 'upperLimit': '55.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '148', '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': '124', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '250', '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': '124', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '250', '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': 'Haiti', 'categories': [{'measurements': [{'value': '124', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Systolic Blood Pressure', 'classes': [{'categories': [{'measurements': [{'value': '129', 'groupId': 'BG000', 'lowerLimit': '126', 'upperLimit': '132'}, {'value': '128', 'groupId': 'BG001', 'lowerLimit': '126', 'upperLimit': '133'}, {'value': '129', 'groupId': 'BG002', 'lowerLimit': '126', 'upperLimit': '132'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'INTER_QUARTILE_RANGE'}], 'populationDescription': 'In intention-to-treat analysis, the analysis population is the same as the assignment under randomization.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-29', 'size': 706516, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-11-21T10:22', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-11', 'studyFirstSubmitDate': '2020-12-15', 'resultsFirstSubmitDate': '2024-03-11', 'studyFirstSubmitQcDate': '2020-12-29', 'lastUpdatePostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-11', 'studyFirstPostDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Mean Systolic Blood Pressure (SBP)', 'timeFrame': 'Baseline, 12 months'}], 'secondaryOutcomes': [{'measure': 'Change in Number of Participants With HIV Viral Suppression as Measured by HIV-1 RNA Viral Loads < 1,000 Copies/mL', 'timeFrame': 'Baseline, 12 months'}, {'measure': 'Change in HIV Medication Adherence as Measured by Number of Participants With > 90% Adherence Using 4-day Pill Recalls', 'timeFrame': 'Baseline, 6 months and 12 months'}, {'measure': 'Number of Subjects Who Have Adverse Events Related to Amlodipine, Including Dizziness, Fainting, Lower Extremity Edema, and Any Other Symptoms Which May be Related.', 'timeFrame': 'Followup month 1', 'description': 'Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events.'}, {'measure': 'Number of Subjects Who Have Adverse Events Related to Amlodipine, Including Dizziness, Fainting, Lower Extremity Edema, and Any Other Symptoms Which May be Related.', 'timeFrame': 'Followup month 2', 'description': 'Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events.'}, {'measure': 'Number of Subjects Who Have Adverse Events Related to Amlodipine, Including Dizziness, Fainting, Lower Extremity Edema, and Any Other Symptoms Which May be Related.', 'timeFrame': 'Followup month 3', 'description': 'Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events.'}, {'measure': 'Adverse Events', 'timeFrame': 'Followup month 5', 'description': 'Number of subjects who have adverse events related to amlodipine, including dizziness, fainting, lower extremity edema, and any other symptoms which may be related. Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events.'}, {'measure': 'Number of Subjects Who Have Adverse Events Related to Amlodipine, Including Dizziness, Fainting, Lower Extremity Edema, and Any Other Symptoms Which May be Related.', 'timeFrame': 'Followup month 6', 'description': 'Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events.'}, {'measure': 'Number of Subjects Who Have Adverse Events Related to Amlodipine, Including Dizziness, Fainting, Lower Extremity Edema, and Any Other Symptoms Which May be Related.', 'timeFrame': 'Followup month 8', 'description': 'Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events.'}, {'measure': 'Number of Subjects Who Have Adverse Events Related to Amlodipine, Including Dizziness, Fainting, Lower Extremity Edema, and Any Other Symptoms Which May be Related.', 'timeFrame': 'Followup month 9', 'description': 'Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events.'}, {'measure': 'Number of Subjects Who Have Adverse Events Related to Amlodipine, Including Dizziness, Fainting, Lower Extremity Edema, and Any Other Symptoms Which May be Related.', 'timeFrame': 'Followup month 12', 'description': 'Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events.'}, {'measure': 'Number of Participants Who Are Enrolled at Baseline and Remain in the Study by 12 Months', 'timeFrame': 'Baseline, 12 months', 'description': 'All participants were included in enrolment. Remaining in the study was defined as having a clinic visit at month 12 (final study visit).'}, {'measure': 'Acceptability of Study Intervention Assessed by Qualitative Interviews Among Participants and Providers', 'timeFrame': '12 months', 'description': 'Using semi-structured interview guides exploring topics including acceptability, side effects, perceived benefit, and perceived cost, in depth interviews will be conducted with 15-20 study participants in the intervention arm, and all healthcare providers involved in the study (nurses, doctors, social workers).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypertension', 'HIV'], 'conditions': ['HIV/AIDS', 'Pre Hypertension']}, 'referencesModule': {'references': [{'pmid': '39761592', 'type': 'DERIVED', 'citation': 'Yan LD, Rouzier V, Sufra R, Sauveur RS, Guiteau C, Lee MH, Ogyu A, Mourra N, Oparil S, Theard M, Brisma JP, Alfred JP, Deschamps MD, Pape JW, McNairy ML. Treatment of prehypertension among adults with HIV. AIDS. 2025 Mar 1;39(3):261-269. doi: 10.1097/QAD.0000000000004065. Epub 2024 Nov 13.'}, {'pmid': '34351939', 'type': 'DERIVED', 'citation': 'Yan LD, Rouzier V, Dade E, Guiteau C, Pierre JL, St-Preux S, Metz M, Oparil S, Pape JW, McNairy M. Treatment of early hypertension among persons living with HIV in Haiti: Protocol for a randomized controlled trial. PLoS One. 2021 Aug 5;16(8):e0254740. doi: 10.1371/journal.pone.0254740. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': "The investigators are conducting an unblinded pilot randomized control trial of 250 persons living with HIV (PLWH), aged 18-65 years, who receive antiretroviral therapy care at Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic Infections (GHESKIO), are virally suppressed, and have pre-hypertension (systolic blood pressure (SBP) 120-139 or diastolic blood pressure (DBP) 80-89 mmHg) to be randomized to early hypertension (HTN) treatment versus standard of care (SOC). Participants will be recruited from GHESKIO's HIV clinic. Eligible individuals will complete informed consent and be randomized to early HTN treatment vs. SOC. Participants in early HTN treatment will initiate amlodipine immediately versus those in SOC will initiate amlodipine only if they meet the HTN threshold (SBP ≥140 or DBP ≥90 mmHg) during the study period. All participants will be followed for 12 months.", 'detailedDescription': 'The investigators propose a pilot randomized controlled trial to evaluate antihypertensive treatment among people living with HIV (PLWH) with pre-hypertension (pre-HTN) at GHESKIO. This study will provide critical data on the feasibility, benefits and risks of antihypertensive treatment for cardiovascular disease (CVD) prevention among PLWH with pre-HTN that will inform a future definitive trial powered for incident CVD events.\n\nFor the pilot study, the investigators will enroll 250 PLWH (18-65 years of age) who have been on antiretroviral therapy (ART) for ≥ 1 years with viral suppression within past 12 months and SBP 120-139 or DBP 80-89 mm Hg and no current antihypertensive treatment; randomize them to "early HTN treatment" or the current standard of care (SOC); and follow them for 12 months. Amlodipine is the recommended first-line anti-hypertensive medication according to Haiti\'s new primary care HTN guidelines. Participants in the early HTN treatment arm will initiate amlodipine 5 mg immediately, increasing to 10 mg if SBP \\>130 mm Hg after 1 month. Participants in the SOC arm will initiate amlodipine only if they develop HTN (SBP ≥140 or DBP ≥90 mm Hg).\n\nParticipants that meet study eligibility criteria will proceed to study enrollment visit (\\~90 min). Participants will be randomized to early HTN treatment vs. SOC in a 1:1 ratio using a computer-generated random assignment. The research nurse will collect demographic and clinical data, administer a baseline questionnaire, measure unobserved BP, and perform an ECG. The questionnaire includes a CVD medical history, family history, medications, CVD health behaviors (smoking, alcohol, physical activity, and diet) using validated questions that have been used at GHESKIO and are comparable to those used in US cohorts. Enrollment labs (\\~15ml of venous blood) including HgbA1c, total cholesterol, high density cholesterol, CD4 (cluster of differentiation 4) cell count, and HIV viral load (unless available from electronic medical record in the past 6 months) will be collected. Samples of serum and plasma will be stored for future studies, with documented consent from participants. The study physician will interpret the ECG and perform an echocardiogram and vascular ultrasound.\n\nStudy drug will be dispensed to participants randomized to the early treatment arm with appropriate education and counseling on adherence and potential side effects. Amlodipine will be started at 5mg at enrollment and increased to 10mg if SBP \\>130 mm Hg after 1 month for participants in the early treatment arm. Locator and contact information will be verified and follow up appointment given.\n\nAfter enrollment and randomization assignment (including amlodipine initiation), participants will have follow-up visits either at GHESKIO (months 0.5-1, 3, 6, 9, 12) or in the community / home with community health workers (months 2, 5, 8). All visits will include BP measurement, lifestyle counseling, adherence encouragement, and assessment of adverse events. The GHESKIO visits will also include a physical exam. Participants in the early intervention arm will receive monthly amlodipine refills. Participants in the SOC arm will initiate amlodipine only if they develop hypertension (SBP \\>140 or DBP \\>90 mm Hg).\n\nAt the 12-month study visit, participants will also complete a brief questionnaire about changes in health behaviors and have viral load measured. Participants may return to the HIV clinic at any time for symptoms, questions, or other concerns, and a BP measurement will be taken at each of these encounters. Adverse events will be assessed at each visit. Medical record abstraction will be done by research staff for any hospitalization or death among a participant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PLWH 18-65 years of age\n* ART duration ≥ 1 year, stable regimen ≥ 6 months\n* HIV 1-RNA \\< 1,000 copies/mL within past 12 months\n* Pre-HTN (SBP 120-139 or DBP 80-89 mm Hg)\n* No current antihypertensive treatment\n* Receives HIV care at GHESKIO\n* Willing to provide consent\n\nExclusion Criteria:\n\n* Pregnancy\n* Kidney disease or diabetes\n* On protease inhibitor/ritonavir\n* Advanced illness with limited life expectancy\n* Plans to move out of the area within the next year\n* Clinician determination that patient is unstable on ART'}, 'identificationModule': {'nctId': 'NCT04692467', 'briefTitle': 'Treatment of Early Hypertension Among Persons Living With HIV in Haiti', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'Treatment of Early Hypertension Among Persons Living With HIV in Haiti', 'orgStudyIdInfo': {'id': '20-03021735'}, 'secondaryIdInfos': [{'id': 'R21TW011693', 'link': 'https://reporter.nih.gov/quickSearch/R21TW011693', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention (Early hypertension)', 'description': 'Participants randomized to the early HTN treatment arm will initiate 5mg daily of amlodipine immediately, increasing to 10 mg if SBP \\>130 mmHg after 1 month.', 'interventionNames': ['Drug: Amlodipine 5mg']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'Participants randomized to the SOC arm will not be initiated on any medications initially. They may be initiated on amlodipine only if they develop HTN (SBP ≥140 or DBP ≥90 mm Hg).'}], 'interventions': [{'name': 'Amlodipine 5mg', 'type': 'DRUG', 'otherNames': ['Norvasc'], 'description': "Amlodipine, Haiti's first-line antihypertensive medication, will be administered to the intervention group.", 'armGroupLabels': ['Intervention (Early hypertension)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Port-au-Prince', 'country': 'Haiti', 'facility': 'GHESKIO', 'geoPoint': {'lat': 18.54349, 'lon': -72.33881}}], 'overallOfficials': [{'name': 'Margaret McNairy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}, {'name': 'Jean Pape', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic"}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Study protocol and statistical analysis plan available after publication and ending 3 years following publication.', 'ipdSharing': 'YES', 'description': 'All the individual participant data collected during the trial, after deidentification will be shared.', 'accessCriteria': 'Researchers who provide a methodologically sound proposal may have access. Proposals should be directed to the PI at mam9365@med.cornell.edu. To gain access, data requestors will need to sign a data access agreement. Data are available following publications through 3 years after publication and will be provided directly from the PI.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'collaborators': [{'name': "Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic", 'class': 'OTHER'}, {'name': 'Fogarty International Center of the National Institute of Health', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}