Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-30 @ 4:42 AM
Study NCT ID:
NCT03978793
Status:
COMPLETED
Last Update Posted:
2025-08-03
First Post:
2019-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MyTPill: A Novel Strategy to Monitor Antiretroviral Adherence Among HIV+ Prescription Opioid Users
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-31', 'studyFirstSubmitDate': '2019-06-04', 'studyFirstSubmitQcDate': '2019-06-05', 'lastUpdatePostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dried blood spots', 'timeFrame': 'six months', 'description': 'Measurement of dried blood spots for TDF/FTC concentrations'}, {'measure': 'Adherence per two different electronic adherence measures', 'timeFrame': 'Six months', 'description': 'Secondary outcomes are the identification of multi-level factors that are prevalent in the target population most closely linked to ART non-adherence and EAM non-adherence.'}], 'secondaryOutcomes': [{'measure': 'Pill counts', 'timeFrame': 'Six months', 'description': 'Count numbers of antiretroviral pills at followup sessions'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV-positive Individuals']}, 'referencesModule': {'references': [{'pmid': '36627157', 'type': 'BACKGROUND', 'citation': 'Bischof JJ, Chai P, Mohamed Y, Padappayil R, Merchant RC, Boyer EW, Rosen R, Reyes-Gibby CC, Viamonte M, W Carrico A. MyTPill: study protocol for a cross-over randomised controlled trial comparing novel strategies to monitor antiretroviral adherence among HIV+ prescription opioid users. BMJ Open. 2023 Jan 10;13(1):e062805. doi: 10.1136/bmjopen-2022-062805.'}]}, 'descriptionModule': {'briefSummary': 'This study compares several different antiretroviral adherence measures, including digital pills, in HIV+ individuals who are maintained on opioid analgesics.', 'detailedDescription': 'This study compares digital pills, electronic pill bottles, self-report, and dried blood spots, in measuring adherence to antiretroviral medications containing emtricitabine and tenofovir.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'HIV+', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* HIV+, Viral load \\>200copies/mL, on single pill containing TDF/FTC, receiving prescription for opioid analgesics\n\nExclusion Criteria:\n\n* Severe renal or hepatic disease\n* Hypersensitivity to silver, magnesium, or zinc following oral use\n* Pregnancy\n* non-English speaking\n* History of Crohn's disease or Ulcerative Colitis\n* History of bowel surgery, gastric bypass, or bowel stricture\n* History of gastrointestinal malignancy or radiation to the abdomen."}, 'identificationModule': {'nctId': 'NCT03978793', 'acronym': 'MyTPill', 'briefTitle': 'MyTPill: A Novel Strategy to Monitor Antiretroviral Adherence Among HIV+ Prescription Opioid Users', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'MyTPill: A Novel Strategy to Monitor Antiretroviral Adherence Among HIV+ Prescription Opioid Users', 'orgStudyIdInfo': {'id': '2021X0070'}, 'secondaryIdInfos': [{'id': 'R01DA047236', 'link': 'https://reporter.nih.gov/quickSearch/R01DA047236', 'type': 'NIH'}, {'id': 'K24DA037109', 'link': 'https://reporter.nih.gov/quickSearch/K24DA037109', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'MyTPill', 'description': 'Participants receive digital pills for three months, have a 2-week washout, then switch to Wisepill.', 'interventionNames': ['Device: MyTPill, a digital pill']}], 'interventions': [{'name': 'MyTPill, a digital pill', 'type': 'DEVICE', 'otherNames': ['Wisepill, a digital pillbox'], 'description': 'MyTPill is a digital pill containing an approved medication', 'armGroupLabels': ['MyTPill']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Edward W Boyer, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Miami', 'class': 'OTHER'}, {'name': 'The Miriam Hospital', 'class': 'OTHER'}, {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, {'name': 'Florida International University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Edward Boyer', 'investigatorAffiliation': 'Ohio State University'}}}}