Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT03512418
Status:
COMPLETED
Last Update Posted:
2025-09-17
First Post:
2018-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Development of Ingestible Biosensors to Enhance PrEP Adherence in Substance Users (PrEPSteps)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'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': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069480', 'term': 'Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination'}], 'ancestors': [{'id': 'D000068698', 'term': 'Tenofovir'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000068679', 'term': 'Emtricitabine'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pchai@bwh.harvard.edu', 'phone': '617-732-5640', 'title': 'Peter Chai', 'organization': "Brigham and Women's Hospital"}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Our study had several limitations. First, it was conducted at a single federally qualified community health center with expertise in HIV treatment and prevention, which may differ from settings with less familiarity in prescribing PrEP or infrastructure to support PrEPSteps deployment. Second, our study population was predominantly white; other demographic groups at higher HIV risk, such as Black and Latinx individuals with potential medical mistrust, might have different perspectives.'}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'PrEPsteps', 'description': 'Participants receive the digital pills with Truvada, plus the PrEPsteps intervention that is programmed at the randomization study visit (Study Visit 2). Participants will use PrEPsteps and the digital pill to measure Truvada adherence for months 1-3.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Participants receive digital pills with Truvada alone. Participants will use digital pills with Truvada for months 1-3.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Feasibility of the Adherence Intervention Qualitative and Quantitive Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PrEPsteps', 'description': 'Participants receive the digital pills with Truvada, plus the PrEPsteps intervention that is programmed at the randomization study visit (Study Visit 2). Participants will use PrEPsteps and the digital pill to measure Truvada adherence for months 1-3.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants receive digital pills with Truvada alone. Participants will use digital pills with Truvada for months 1-3.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'three month study visit', 'description': 'Number of participants who were able to complete the trial and record adherence events using the digital pill system in the intervention arm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Potential of PrEPsteps to Improve Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PrEPsteps', 'description': 'Participants receive the digital pills with Truvada, plus the PrEPsteps intervention that is programmed at the randomization study visit (Study Visit 2). Participants will use PrEPsteps and the digital pill to measure Truvada adherence for months 1-3.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants receive digital pills with Truvada alone. Participants will use digital pills with Truvada for months 1-3.'}], 'classes': [{'categories': [{'measurements': [{'value': '86', 'spread': '17.23', 'groupId': 'OG000'}, {'value': '72', 'spread': '33.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'three month study visit', 'description': 'Number of digital pill recorded ingestions at week 13 (end of intervention period) recorded as percent adherence', 'unitOfMeasure': 'percentage of pills taken appropriately', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of People Who Found the Digital Pill Acceptable to Use Within the Intervention Arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PrEPsteps', 'description': 'Participants receive the digital pills with Truvada, plus the PrEPsteps intervention that is programmed at the randomization study visit (Study Visit 2). Participants will use PrEPsteps and the digital pill to measure Truvada adherence for months 1-3.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'three month visit', 'description': 'Qualitative interviews asking participants if they found the use of the digital pill system acceptable and did not interfere with their daily PrEP use. This outcome was only assessed in the PrEPSteps (intervention arm) only.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only intervention arm (PrEPSteps) completed qualitative interviews at the 3 month study endpoint for this outcome.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Accuracy of Digital Pill Compared to Pill Counts and Dried Blood Spot for Adherence', 'timeFrame': 'one and three month study visits', 'description': 'Accuracy of digital pill in measuring PrEP adherence as compared to dried blood spot testing for tenofovir diphosphate', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-07'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PrEPSteps (Intervention)', 'description': 'A text-based cognitive behavioral adherence intervention delivered in response to adherence data obtained through a digital pill system (ingestible radio frequency system co-encapsulated with tenofovir disoproxil fumarate/emtricitabine). In response to nonadherence dates detected by the digital pill, PrEPSteps sends personalized adherence interventions presenting barriers to adherence and solutions to these barriers in real-time.'}, {'id': 'FG001', 'title': 'Control', 'description': 'Operation of the digital pill system to measure daily adherence to tenofovir disoproxil fumarate/emtricitabine. Participants were trained on the use of the digital pill system and asked to operate it daily to record adherence.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were recruited from a health clinic in Boston, MA. We also conducted community-based outreach in the greater Boston metropolitan area through flyers and postings. Interested participants contacted the study team and were prescreened for eligibility criteria.', 'preAssignmentDetails': 'Potentially eligible participants were consented and started on the digital pill system (DPS). Standardized training was completed and participants were asked to use the DPS for 2 weeks as a run-in period prior to randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PrEPSteps (Intervention)', 'description': 'A text-based cognitive behavioral adherence intervention delivered in response to adherence data obtained through a digital pill system (ingestible radio frequency system co-encapsulated with tenofovir disoproxil fumarate/emtricitabine). In response to nonadherence dates detected by the digital pill, PrEPSteps sends personalized adherence interventions presenting barriers to adherence and solutions to these barriers in real-time.'}, {'id': 'BG001', 'title': 'Control', 'description': 'Operation of the digital pill system to measure daily adherence to tenofovir disoproxil fumarate/emtricitabine. Participants were trained on the use of the digital pill system and asked to operate it daily to record adherence.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000', 'lowerLimit': '22', 'upperLimit': '54'}, {'value': '37.5', 'groupId': 'BG001', 'lowerLimit': '25', 'upperLimit': '59'}, {'value': '37.5', 'groupId': 'BG002', 'lowerLimit': '22', 'upperLimit': '59'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Male/female at birth', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', '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': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', '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': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Number of sexual partners', 'classes': [{'categories': [{'measurements': [{'value': '14.8', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '30'}, {'value': '3.36', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '30'}, {'value': '3.5', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '30'}]}]}], 'paramType': 'MEDIAN', 'description': 'number of sexual partners by self report in the past 3 months.', 'unitOfMeasure': 'partners', 'dispersionType': 'FULL_RANGE'}, {'title': 'Substance use during sex', 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '65'}, {'value': '2.5', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '50'}, {'value': '3', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '65'}]}]}], 'paramType': 'MEDIAN', 'description': 'Self reported instances of substance use before or during sex in the past 3 months. Participants self report the number of instances. The value does not indicate a better or worse outcome.', 'unitOfMeasure': 'events', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-09-08', 'size': 4087385, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-08-08T07:35', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Pilot randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-13', 'studyFirstSubmitDate': '2018-03-21', 'resultsFirstSubmitDate': '2025-07-24', 'studyFirstSubmitQcDate': '2018-04-19', 'lastUpdatePostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-13', 'studyFirstPostDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Accuracy of Digital Pill Compared to Pill Counts and Dried Blood Spot for Adherence', 'timeFrame': 'one and three month study visits', 'description': 'Accuracy of digital pill in measuring PrEP adherence as compared to dried blood spot testing for tenofovir diphosphate'}], 'primaryOutcomes': [{'measure': 'Feasibility of the Adherence Intervention Qualitative and Quantitive Questionnaire', 'timeFrame': 'three month study visit', 'description': 'Number of participants who were able to complete the trial and record adherence events using the digital pill system in the intervention arm.'}], 'secondaryOutcomes': [{'measure': 'Potential of PrEPsteps to Improve Adherence', 'timeFrame': 'three month study visit', 'description': 'Number of digital pill recorded ingestions at week 13 (end of intervention period) recorded as percent adherence'}, {'measure': 'Number of People Who Found the Digital Pill Acceptable to Use Within the Intervention Arm', 'timeFrame': 'three month visit', 'description': 'Qualitative interviews asking participants if they found the use of the digital pill system acceptable and did not interfere with their daily PrEP use. This outcome was only assessed in the PrEPSteps (intervention arm) only.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['HIV Prevention', 'Pre-exposure Prophylaxis', 'Digital Pill', 'Substance Use Disorder'], 'conditions': ['HIV Infections', 'Substance Use Disorders']}, 'descriptionModule': {'briefSummary': 'This study will deploy a novel, personalized, smartphone-based intervention (PrEPSteps) that responds to real-time PrEP adherence and nonadherence detected through the use of a digital pill. The PrEPSteps intervention will be developed and refined through a series of focus groups. Participants will be screened at the Screening Visit, and, if eligible, will then begin using the digital pill system at Study Visit 1 for 2 weeks. At Study Visit 2, participants will undergo randomization to using either PrEPSteps + the digital pill, or the digital pill alone to measure PrEP adherence, for 90 days. Participants will then complete 3 monthly study visits (Study Visits 3-5) where the investigators will assess digital pill adherence, conduct manual pill counts, obtain dried blood spots to confirm adherence, provide substance use disorder counseling, and obtain urine drug screens. At Study Visit 5, the investigators will conduct a semi-structured qualitative interview with participants in the PrEPsteps arm, which will be grounded in the Technology Acceptance Model, in order to understand the user response to PrEPSteps and the digital pill. All participants will complete the final follow-up assessment 3 months after Study Visit 5 (Study Visit 6).', 'detailedDescription': 'PrEPSteps is a novel, smartphone-based behavioral intervention that delivers PrEP adherence messages in response to detected PrEP ingestion via an innovative digital pill. PrEPSteps comprises 1) an adaptation of LifeSteps, an evidence-based medication adherence behavioral intervention, with smartphone-delivered booster sessions, 2) messages of contingent reinforcement and corrective feedback, and 3) stimulant use screening, brief assessment, and referral to treatment. In this K23, the investigators will first refine and inform the specification of PrEPSteps with a series of focus groups. The investigators will next test the feasibility, acceptability and potential for an effect of PrEPSteps to boost PrEP adherence in a pilot randomized controlled trial of men who have sex with men (MSM) with stimulant use. Finally, the investigators will conduct qualitative interviews among participants who used PrEPSteps to understand the participant response to living with the intervention.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'cisgender men who have sex with men (MSM)', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Cisgender MSM\n* Moderate to severe non-alcohol substance use disorder\n* Self-reported missed PrEP doses (\\> or equal to 2 doses in 1 week over past 3 months)\n* HIV negative\n* On PrEP or initiating PrEP\n* Has qualifying laboratory testing: Cr clearance, HBV, liver function tests\n* Owns a smartphone with Android or iOS\n* Age 18 or older\n\nExclusion Criteria:\n\n* Non-English speaker\n* HIV positive\n* History of Crohn's disease or ulcerative colitis\n* History of gastric bypass, bowel stricture\n* History of GI malignancy or radiation to abdomen\n* Unable/unwilling to ingest a digital pill\n* Allergy to gelatin, silver or zinc (components of the digital pill)\n* Does not qualify for PrEP (abnormal liver function, or Cr Clearance \\<60)"}, 'identificationModule': {'nctId': 'NCT03512418', 'acronym': 'PrEPSteps', 'briefTitle': 'Development of Ingestible Biosensors to Enhance PrEP Adherence in Substance Users (PrEPSteps)', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Development of Ingestible Biosensors to Enhance PrEP Adherence in Substance Users (PrEPSteps)', 'orgStudyIdInfo': {'id': '2019P000792'}, 'secondaryIdInfos': [{'id': 'K23DA044874', 'link': 'https://reporter.nih.gov/quickSearch/K23DA044874', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PrEPsteps', 'description': 'Participants receive the digital pills with Truvada, plus the PrEPsteps intervention that is programmed at the randomization study visit (Study Visit 2). Participants will use PrEPsteps and the digital pill to measure Truvada adherence for months 1-3.', 'interventionNames': ['Behavioral: PrEPsteps', 'Device: Digital pill', 'Drug: Truvada']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Participants receive digital pills with Truvada alone. Participants will use digital pills with Truvada for months 1-3.', 'interventionNames': ['Device: Digital pill', 'Drug: Truvada']}], 'interventions': [{'name': 'PrEPsteps', 'type': 'BEHAVIORAL', 'description': 'Smartphone-based adherence intervention based in 1) LifeSteps, 2) Contingent Reinforcement/Corrective Feedback, and 3) Screening Brief Intervention and Referral to Treatment (SBIRT).', 'armGroupLabels': ['PrEPsteps']}, {'name': 'Digital pill', 'type': 'DEVICE', 'description': "The digital pill comprises a standard gelatin capsule with an integrated radiofrequency emitter that overencapsulates the desired medication (Truvada). When participants ingest the digital pill, the chloride ion gradient in the stomach activates the radiofrequency emitter which transmits direct evidence of medication ingestion to a wearable reader which relays this data to the participant's smartphone and cloud server.", 'armGroupLabels': ['Control', 'PrEPsteps']}, {'name': 'Truvada', 'type': 'DRUG', 'description': 'Participants receive once daily Truvada as PrEP to prevent HIV.', 'armGroupLabels': ['Control', 'PrEPsteps']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boylston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Fenway Health', 'geoPoint': {'lat': 42.39176, 'lon': -71.70368}}], 'overallOfficials': [{'name': 'Peter R Chai, MD, MMS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, {'name': 'The Fenway Institute', 'class': 'OTHER'}, {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Emergency Medicine Physician', 'investigatorFullName': 'Peter R Chai MD', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}