Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2026-01-08 @ 5:27 AM
Study NCT ID:
NCT01760759
Status:
COMPLETED
Last Update Posted:
2019-09-13
First Post:
2012-08-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antiretroviral Therapy Adherence and Secondary Prevention of Human Immunodeficiency Virus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-11', 'studyFirstSubmitDate': '2012-08-21', 'studyFirstSubmitQcDate': '2013-01-02', 'lastUpdatePostDateStruct': {'date': '2019-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in copies of human immunodeficiency virus per milliliter', 'timeFrame': 'Week 48'}, {'measure': 'self-report of medication adherence', 'timeFrame': 'baseline'}, {'measure': 'self-report of medication adherence', 'timeFrame': 'Week 8'}, {'measure': 'self-report of medication adherence', 'timeFrame': 'Week 16'}, {'measure': 'self-report of medication adherence', 'timeFrame': 'Week 24'}, {'measure': 'self-report of medication adherence', 'timeFrame': 'Week 36'}, {'measure': 'self-report of medication adherence', 'timeFrame': 'Week 48'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV', 'Antiretroviral therapy adherence'], 'conditions': ['HIV']}, 'descriptionModule': {'briefSummary': 'In this study, investigators propose to randomize 165 human immunodeficiency virus positive patients to one of three 16-week treatment conditions: (1) standard care; (2) standard care + cell phone-based adherence reminders; or (3) standard care + cell phone-based adherence reminders and contingency management. In this latter condition, patients will earn reinforcement for sending in time- and date-stamped self videos of antiretroviral therapy medication ingestion. Primary outcomes will include viral loads and self-report measures of adherence, and effects will be evaluated both during the treatment period and throughout a one-year follow-up. Investigators hypothesize that the cell phone reminder condition will improve adherence relative to standard care, and the cell phone reminder plus contingency management condition will have the best outcomes. Results from this study may have widespread implications for the use of cell phones as a novel technology to improve initial adherence to antiretroviral therapy, thereby reducing the spread of drug resistant human immunodeficiency virus strains to the community.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 18 years\n* initiating or on an antiretroviral therapy regimen and have a viral load \\>200 copies/mL in the past 6 months\n* one or more risk factors for poor adherence\n* English speaking\n* willing to use a cell phone to receive reminders and record medication ingestion for up to 16 weeks\n* able to read at 5th grade level and pass a brief quiz related to understanding the informed consent form\n\nExclusion Criteria:\n\n* living in an environment or has a visiting nurse that dispenses antiretroviral therapy medication\n* participating in another antiretroviral therapy adherence study\n* uncontrolled psychiatric disorders\n* significant cognitive impairment'}, 'identificationModule': {'nctId': 'NCT01760759', 'briefTitle': 'Antiretroviral Therapy Adherence and Secondary Prevention of Human Immunodeficiency Virus', 'organization': {'class': 'OTHER', 'fullName': 'UConn Health'}, 'officialTitle': 'Antiretroviral Therapy Adherence and Secondary Prevention of Human Immunodeficiency Virus', 'orgStudyIdInfo': {'id': '12-205O-2'}, 'secondaryIdInfos': [{'id': 'R01HD075630', 'link': 'https://reporter.nih.gov/quickSearch/R01HD075630', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Patients receive usual care from their medical providers.'}, {'type': 'EXPERIMENTAL', 'label': 'Usual care plus cell phone reminders', 'description': 'Patients receive reminders, scheduled to occur daily at time(s) of scheduled antiretroviral therapy dosing.', 'interventionNames': ['Behavioral: cell phone reminders']}, {'type': 'EXPERIMENTAL', 'label': 'Usual care, reminders & contingency management for adherence', 'description': 'Patients receive reminders and reinforcement in the form of vouchers for each video that they send in indicating adherence at the appropriate time.', 'interventionNames': ['Behavioral: cell phone reminders', 'Behavioral: contingency management for adherence']}], 'interventions': [{'name': 'cell phone reminders', 'type': 'BEHAVIORAL', 'description': 'Patients receive reminders, scheduled to occur daily at time(s) of scheduled antiretroviral therapy dosing.', 'armGroupLabels': ['Usual care plus cell phone reminders', 'Usual care, reminders & contingency management for adherence']}, {'name': 'contingency management for adherence', 'type': 'BEHAVIORAL', 'description': 'Patients will receive reinforcement in the form of vouchers for each video that they send in indicating adherence at the appropriate time.', 'armGroupLabels': ['Usual care, reminders & contingency management for adherence']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06030-3944', 'city': 'Farmington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'University of Connecticut Health Center', 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}, {'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Nathan Smith Clinic, Yale-New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Carla Rash, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UConn Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UConn Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Carla Rash', 'investigatorAffiliation': 'UConn Health'}}}}