Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 11:39 PM
Study NCT ID:
NCT03437694
Status:
TERMINATED
Last Update Posted:
2025-07-18
First Post:
2018-02-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Impact of Providing Medical Records in a Patient-Centered, Community Pharmacy Based, HIV Care Model (HIV-MOI)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'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': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054539', 'term': 'Medication Therapy Management'}], 'ancestors': [{'id': 'D010593', 'term': 'Pharmaceutical Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D054524', 'term': 'Medicare Part D'}, {'id': 'D007356', 'term': 'Insurance, Pharmaceutical Services'}, {'id': 'D007348', 'term': 'Insurance, Health'}, {'id': 'D007341', 'term': 'Insurance'}, {'id': 'D005381', 'term': 'Financing, Organized'}, {'id': 'D004467', 'term': 'Economics'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'id': 'D006278', 'term': 'Medicare'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'crystal.hodge@unthsc.edu', 'phone': '8177350131', 'title': 'Crystal Hodge', 'organization': 'University of North Texas Health Science Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Challenges with recruitment during the COVID-19 pandemic limited study participant enrollment within the grant period. Due to funding and enrollment constraints, the study was terminated before all study participants were able to complete all expected study visits.'}}, 'adverseEventsModule': {'timeFrame': 'Through study completion, up to 3 years', 'description': 'Serious adverse events included any hospitalization for any cause including scheduled procedures or unrelated hospitalizations. Other adverse events were not monitored or assessed', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention Arm', 'description': 'The study coordinator would request medical records for study participants in the intervention arm in compliance with Texas state laws and aggregate pertinent information (ex: labs) into a prespecified case report form. The case report form was provided to the study pharmacist conducting MTM during study visits with study participants.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 64, 'otherNumAffected': 0, 'seriousNumAtRisk': 64, 'deathsNumAffected': 1, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Control Arm', 'description': 'The study pharmacist conducted MTM with the study participants per standard of care (i.e. additional medical records information was not provided).', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 65, 'otherNumAffected': 0, 'seriousNumAtRisk': 65, 'deathsNumAffected': 1, 'seriousNumAffected': 9}], 'seriousEvents': [{'term': 'Hospitalization due to procedure or surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization unscheduled', 'notes': 'Causes varied from infection to fall or unknown. None were deemed to be associated with the study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ED visit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Average A1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm', 'description': 'The study coordinator would request medical records for study participants in the intervention arm in compliance with Texas state laws and aggregate pertinent information (ex: labs) into a prespecified case report form. The case report form was provided to the study pharmacist conducting MTM during study visits with study participants.'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'The study pharmacist conducted MTM with the study participants per standard of care (i.e. additional medical records information was not provided).'}], 'classes': [{'categories': [{'measurements': [{'value': '7.45', 'spread': '1.84', 'groupId': 'OG000'}, {'value': '6.66', 'spread': '2.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through study completion, up to 3 years', 'description': 'The average A1c in study participants with Diabetes mellitus at the end of their study participation', 'unitOfMeasure': 'Average A1c (% glyosylated hemoglobin)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only study participants with Diabetes mellitus'}, {'type': 'PRIMARY', 'title': 'Average Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm', 'description': 'The study coordinator would request medical records for study participants in the intervention arm in compliance with Texas state laws and aggregate pertinent information (ex: labs) into a prespecified case report form. The case report form was provided to the study pharmacist conducting MTM during study visits with study participants.'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'The study pharmacist conducted MTM with the study participants per standard of care (i.e. additional medical records information was not provided).'}], 'classes': [{'categories': [{'measurements': [{'value': '134.6', 'spread': '13.1', 'groupId': 'OG000'}, {'value': '129.2', 'spread': '14.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through study completion, up to 3 years', 'description': 'The average SBP in study participants with hypertension at the end of their study participation', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only study participants with hypertension'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention Arm', 'description': 'The study coordinator would request medical records for study participants in the intervention arm in compliance with Texas state laws and aggregate pertinent information (ex: labs) into a prespecified case report form. The case report form was provided to the study pharmacist conducting MTM during study visits with study participants.'}, {'id': 'FG001', 'title': 'Control Arm', 'description': 'The study pharmacist conducted MTM with the study participants per standard of care (i.e. additional medical records information was not provided).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '65'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed all 9 study visits', 'groupId': 'FG000', 'numSubjects': '25'}, {'comment': 'Completed all 9 study visits', 'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '39'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Arm', 'description': 'The study coordinator would request medical records for study participants in the intervention arm in compliance with Texas state laws and aggregate pertinent information (ex: labs) into a prespecified case report form. The case report form was provided to the study pharmacist conducting MTM during study visits with study participants.'}, {'id': 'BG001', 'title': 'Control Arm', 'description': 'The study pharmacist conducted MTM with the study participants per standard of care (i.e. additional medical records information was not provided).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.01', 'spread': '10.6', 'groupId': 'BG000'}, {'value': '52.38', 'spread': '10.96', 'groupId': 'BG001'}, {'value': '53.19', 'spread': '10.76', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Age at time of study enrollment expressed as years', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '78', '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': '64', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '129', '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', 'description': 'Self-identification as African American or Black was an inclusion criteria for this study. Other race and ethnicity data was not collected.', 'unitOfMeasure': 'Participants'}, {'title': 'HIV Viral Load', 'classes': [{'title': 'VL < LLOQ', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}, {'title': 'Detectable VL', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Comorbidities', 'classes': [{'title': 'Hypertension', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}, {'title': 'Diabetes mellitus', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-10-17', 'size': 887988, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-03-20T22:16', 'hasProtocol': True}, {'date': '2023-04-04', 'size': 341494, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-03-20T22:16', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized in a 1:1 ratio to either the intervention or control group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 129}}, 'statusModule': {'whyStopped': 'Recruitment and funding challenges', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-16', 'studyFirstSubmitDate': '2018-02-12', 'resultsFirstSubmitDate': '2025-03-21', 'studyFirstSubmitQcDate': '2018-02-12', 'lastUpdatePostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-16', 'studyFirstPostDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average A1c', 'timeFrame': 'Through study completion, up to 3 years', 'description': 'The average A1c in study participants with Diabetes mellitus at the end of their study participation'}, {'measure': 'Average Systolic Blood Pressure', 'timeFrame': 'Through study completion, up to 3 years', 'description': 'The average SBP in study participants with hypertension at the end of their study participation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV', 'AIDS', 'Diabetes Melllitus, Type 2', 'Hypertension', 'Pharmacist', 'Medication optimization', 'Medication Therapy Management', 'MTM'], 'conditions': ['HIV/AIDS', 'Diabetes Mellitus, Type 2', 'Hypertension']}, 'descriptionModule': {'briefSummary': "This is a clinical trial. The purpose of this clinical trial is to see if study participants have better health outcomes if their pharmacist has access to their medical records. The study will take place primarily in Fort Worth and Dallas, Texas. The trial will enroll adult, African-Americans with HIV. Study participants must also have either diabetes, high blood pressure or they may have both. Study participants will agree to have their medical records from all of their health providers released to UNTHSC. UNTHSC will provide the study pharmacist the medical records for half of the participants. Using the medical records, the study pharmacist will provide 'enhanced' patient counseling services to half of the participants. This enhanced service is called 'medication optimization'. For half of the participants that the study pharmacist does not see the medical records, they will receive usual and customary patient counseling. Not seeing the medical records is considered standard of care. In both groups, the counseling frequency will be based on the participant's needs but the study pharmacist will contact every participant to check on them at least every 90 days. These visits will happen for 2 years. The two groups will be compared to see if those participants having medical information supported medication optimization have better health than those getting routine, the standard of care medication optimization.", 'detailedDescription': "This study examines HIV medication optimization (HIV-MOI) in a prospective, randomized (1:1 HIV-MOI: standard of care), clinical trial, comparing disease-specific clinical and humanistic outcomes in up to 200 adult African-Americans with HIV (1:1 men: women) and either diabetes mellitus type 2 (DM) and/or hypertension (HTN). Data will be collected from individual participants for a 2 year period. Once properly screened, consented and enrolled, medical records from participant's medical provider(s) will be obtained. Upon receipt of the medical records, research team personnel (working closely with the project biostatistician) will provide medical information only for those participants randomized to receive HIV-MOI to the study pharmacist. The study pharmacist then assesses the information to determine the clinical effectiveness and appropriateness of the current medical plan's medications. Upon completion, the study pharmacist will develop a prioritized medication problem list, create a plan, discuss/collaborate with the medical provider/healthcare team member as needed and then conduct the initial HIV-MOI visit with the patient. At the initial visit, an individualized care plan would be finalized with study participant input. Also at the initial HIV-MOI visit, the patient should receive an accurate (and reconciled with medical providers) personal medication record (PMR). Participants should also receive an individualized care plan called a medication action plan (MAP). The MAP can include non-pharmacological instructions and education. This may be guided in part by qualitative survey data obtained as part of the study visit. Follow-up visits will occur (ideally) not less than quarterly. Follow-up visits may occur face-to-face or using telecommunication methods.\n\nThe study pharmacist will only be provided the medical information for the intervention group. Standard of care for pharmacists is not having access to medical information when providing HIV-MOI. Extracted data and study obtained data will be entered into the study database for analyses."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* African-American\n* HIV positive\n* At least one of the following: hypertension or diabetes type 2\n\nExclusion Criteria:\n\n* Pregnant (at screening, may enroll 6 months post-delivery)\n* Have a life expectancy \\< 2 years\n* Refusal to provide medical record release'}, 'identificationModule': {'nctId': 'NCT03437694', 'acronym': 'HIV-MOI', 'briefTitle': 'Impact of Providing Medical Records in a Patient-Centered, Community Pharmacy Based, HIV Care Model (HIV-MOI)', 'organization': {'class': 'OTHER', 'fullName': 'University of North Texas Health Science Center'}, 'officialTitle': 'Assessing the Impact of Providing Pharmacists With Medical Records in a Patient-Centered, Community Pharmacy-Based, HIV Care Model', 'orgStudyIdInfo': {'id': 'U54Proj2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Medication Optimization Intervention', 'description': 'This group will represent those participants whose medical records have been provided to the pharmacist.', 'interventionNames': ['Other: Medication optimization intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Medication Optimization Control', 'description': 'This group will represent those participants whose medical records have not been provided to the pharmacist.', 'interventionNames': ['Other: Medication optimization intervention']}], 'interventions': [{'name': 'Medication optimization intervention', 'type': 'OTHER', 'otherNames': ['medication therapy management'], 'description': 'Pharmacists will engage participants in medication therapy management either with access to the medical records (intervention) or without access (control).', 'armGroupLabels': ['Medication Optimization Control', 'Medication Optimization Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76107', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Crystal Hodge', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '76107', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'University of North Texas Health Science Center', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}], 'overallOfficials': [{'name': 'Crystal K Hodge, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UNTHSC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Texas Health Science Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of California, San Francisco', 'class': 'OTHER'}, {'name': 'University of Minnesota', 'class': 'OTHER'}, {'name': 'Walgreens Boots Alliance', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}