Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-02-20 @ 3:39 PM
Study NCT ID:
NCT02915367
Status:
COMPLETED
Last Update Posted:
2023-05-31
First Post:
2016-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Monitoring Pre-exposure Prophylaxis for Young Adult Women
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jhaberer@partners.org', 'phone': '617-643-9195', 'title': 'Jessica Haberer', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'We attempted to follow all participants for 24 months.', 'eventGroups': [{'id': 'EG000', 'title': 'SMS Reminders', 'description': 'Participants will receive regular SMS reminders regarding PrEP. All participants will receive adherence monitoring through a WisePill device.\n\nSMS Reminders: Participants will receive daily reminders, with content and timing of their choosing, regarding their PrEP use. Participants will have the choice to later receive SMS reminders only when they forget to take their dose (as indicated by real-time adherence monitoring via WisePill).', 'otherNumAtRisk': 173, 'deathsNumAtRisk': 173, 'otherNumAffected': 5, 'seriousNumAtRisk': 173, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'No Reminders', 'description': 'Participants will not receive SMS reminders. All participants will receive adherence monitoring through a WisePill device.', 'otherNumAtRisk': 174, 'deathsNumAtRisk': 175, 'otherNumAffected': 5, 'seriousNumAtRisk': 174, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Social harm', 'notes': 'There were five social harms per study arm that were probably or definitely related to study participation, and consisted of verbal or physical abuse with a sexual partner.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 5}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Enacted Adherence as Measured by Electronic Monitoring at 6 and 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SMS Reminders', 'description': 'Participants will receive regular SMS reminders regarding PrEP. All participants will receive adherence monitoring through a WisePill device.\n\nSMS Reminders: Participants will receive daily reminders, with content and timing of their choosing, regarding their PrEP use. Participants will have the choice to later receive SMS reminders only when they forget to take their dose (as indicated by real-time adherence monitoring via WisePill).'}, {'id': 'OG001', 'title': 'No Reminders', 'description': 'Participants will not receive SMS reminders. All participants will receive adherence monitoring through a WisePill device.'}], 'classes': [{'title': 'Month 6 adherence', 'categories': [{'measurements': [{'value': '40.2', 'groupId': 'OG000', 'lowerLimit': '36.1', 'upperLimit': '44.4'}, {'value': '36.8', 'groupId': 'OG001', 'lowerLimit': '32.7', 'upperLimit': '40.8'}]}]}, {'title': 'Month 24 adherence', 'categories': [{'measurements': [{'value': '27.0', 'groupId': 'OG000', 'lowerLimit': '23.6', 'upperLimit': '30.5'}, {'value': '26.6', 'groupId': 'OG001', 'lowerLimit': '23.1', 'upperLimit': '30.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 2 years follow-up', 'description': 'Comparison of average percent adherence (doses taken/doses prescribed) by study arm at each time point among participants choosing to pick up PrEP.', 'unitOfMeasure': 'percentage of adherence', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants choosing to take PrEP per arm'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting High Acceptability of Wisepill Devices for PrEP Adherence Monitoring', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SMS Reminders', 'description': 'Participants will receive regular SMS reminders regarding PrEP. All participants will receive adherence monitoring through a WisePill device.\n\nSMS Reminders: Participants will receive daily reminders, with content and timing of their choosing, regarding their PrEP use. Participants will have the choice to later receive SMS reminders only when they forget to take their dose (as indicated by real-time adherence monitoring via WisePill).'}, {'id': 'OG001', 'title': 'No Reminders', 'description': 'Participants will not receive SMS reminders. All participants will receive adherence monitoring through a WisePill device.'}], 'classes': [{'categories': [{'measurements': [{'value': '141', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.93', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Pearson chi-square'}], 'paramType': 'NUMBER', 'timeFrame': 'Month 1', 'description': 'Questionnaire indicating "very interested" in using the Wisepill monitor (a pill box that records the date and time of each opening as a proxy for pill ingestion)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants using the Wisepill adherence monitor'}, {'type': 'SECONDARY', 'title': 'USD Per Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SMS Reminders', 'description': 'Participants will receive regular SMS reminders regarding PrEP. All participants will receive adherence monitoring through a WisePill device.\n\nSMS Reminders: Participants will receive daily reminders, with content and timing of their choosing, regarding their PrEP use. Participants will have the choice to later receive SMS reminders only when they forget to take their dose (as indicated by real-time adherence monitoring via WisePill).'}, {'id': 'OG001', 'title': 'No Reminders', 'description': 'Participants will not receive SMS reminders. All participants will receive adherence monitoring through a WisePill device.'}], 'classes': [{'title': 'Incremental cost per month in USD (Wisepill + SMS)', 'categories': [{'measurements': [{'value': '12.64', 'groupId': 'OG000'}]}]}, {'title': 'Incremental cost per month in USD (Wisepill + SMS; at scale)', 'categories': [{'measurements': [{'value': '7.57', 'groupId': 'OG000'}]}]}, {'title': 'Incremental cost per month in USD (SMS only)', 'categories': [{'measurements': [{'value': '7.69', 'groupId': 'OG000'}]}]}, {'title': 'Incremental cost per month in USD (SMS only; at scale)', 'categories': [{'measurements': [{'value': '2.76', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'two years', 'description': 'Cost estimates (including time and motion studies) and mathematical modeling estimate the cost-effectiveness of Wisepill plus SMS reminders per HIV case averted', 'unitOfMeasure': 'USD per month', 'reportingStatus': 'POSTED', 'populationDescription': 'Costs for study participants in the "SMS reminders" arm (data were not collected from participants in the "No Reminders" arm)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Risk Perception', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SMS Reminders', 'description': 'Participants will receive regular SMS reminders regarding PrEP. All participants will receive adherence monitoring through a WisePill device.\n\nSMS Reminders: Participants will receive daily reminders, with content and timing of their choosing, regarding their PrEP use. Participants will have the choice to later receive SMS reminders only when they forget to take their dose (as indicated by real-time adherence monitoring via WisePill).'}, {'id': 'OG001', 'title': 'No Reminders', 'description': 'Participants will not receive SMS reminders. All participants will receive adherence monitoring through a WisePill device.'}], 'classes': [{'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.96', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Pearson chi-square'}], 'paramType': 'NUMBER', 'timeFrame': 'up to 2 years follow-up', 'description': 'Assess self-reported weekly HIV risk perception through an automated SMS survey', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants by arm who reported perceived HIV risk during at least 1 week (among a subset of the participants responding to the SMS surveys)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Adherence Measure Performance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SMS Reminders', 'description': 'Participants will receive regular SMS reminders regarding PrEP. All participants will receive adherence monitoring through a WisePill device.\n\nSMS Reminders: Participants will receive daily reminders, with content and timing of their choosing, regarding their PrEP use. Participants will have the choice to later receive SMS reminders only when they forget to take their dose (as indicated by real-time adherence monitoring via WisePill).'}, {'id': 'OG001', 'title': 'No Reminders', 'description': 'Participants will not receive SMS reminders. All participants will receive adherence monitoring through a WisePill device.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.56', 'groupId': 'OG000'}, {'value': '0.66', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 2 years follow-up', 'description': 'Tenofovir concentration in DBS compared to electronic adherence data from the prior 30 days for each participant.', 'unitOfMeasure': 'Correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'Data reflect a 15% random sample.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Pregnancy Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SMS Reminders', 'description': 'Participants will receive regular SMS reminders regarding PrEP. All participants will receive adherence monitoring through a WisePill device.\n\nSMS Reminders: Participants will receive daily reminders, with content and timing of their choosing, regarding their PrEP use. Participants will have the choice to later receive SMS reminders only when they forget to take their dose (as indicated by real-time adherence monitoring via WisePill).'}, {'id': 'OG001', 'title': 'No Reminders', 'description': 'Participants will not receive SMS reminders. All participants will receive adherence monitoring through a WisePill device.'}], 'classes': [{'categories': [{'title': 'live birth', 'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}, {'title': 'pregnancy loss', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}, {'title': 'ectopic', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months post-partum or end of the study', 'description': 'Descriptive measures of infants exposed to PrEP during gestation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of pregnancies by arm'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SMS Reminders', 'description': 'Participants will receive regular SMS reminders regarding PrEP. All participants will receive adherence monitoring through a WisePill device.\n\nSMS Reminders: Participants will receive daily reminders, with content and timing of their choosing, regarding their PrEP use. Participants will have the choice to later receive SMS reminders only when they forget to take their dose (as indicated by real-time adherence monitoring via WisePill).'}, {'id': 'FG001', 'title': 'No Reminders', 'description': 'Participants will not receive SMS reminders. All participants will receive adherence monitoring through a WisePill device.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '173'}, {'groupId': 'FG001', 'numSubjects': '175'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '136'}, {'groupId': 'FG001', 'numSubjects': '144'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '31'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'BG000'}, {'value': '175', 'groupId': 'BG001'}, {'value': '348', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'SMS Reminders', 'description': 'Participants will receive regular SMS reminders regarding PrEP. All participants will receive adherence monitoring through a WisePill device.\n\nSMS Reminders: Participants will receive daily reminders, with content and timing of their choosing, regarding their PrEP use. Participants will have the choice to later receive SMS reminders only when they forget to take their dose (as indicated by real-time adherence monitoring via WisePill).'}, {'id': 'BG001', 'title': 'No Reminders', 'description': 'Participants will not receive SMS reminders. All participants will receive adherence monitoring through a WisePill device.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '158', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '314', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '22'}, {'value': '21', 'groupId': 'BG001', 'lowerLimit': '19', 'upperLimit': '22'}, {'value': '21', 'groupId': 'BG002', 'lowerLimit': '19', 'upperLimit': '22'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '173', 'groupId': 'BG000'}, {'value': '175', 'groupId': 'BG001'}, {'value': '348', 'groupId': 'BG002'}]}, {'title': 'Male', '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': '173', 'groupId': 'BG000'}, {'value': '175', 'groupId': 'BG001'}, {'value': '348', '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': 'Kenya', 'categories': [{'measurements': [{'value': '173', 'groupId': 'BG000'}, {'value': '175', 'groupId': 'BG001'}, {'value': '348', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-25', 'size': 1130059, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-09-16T09:52', 'hasProtocol': True}, {'date': '2019-11-04', 'size': 203650, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-09-16T10:24', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 348}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-29', 'studyFirstSubmitDate': '2016-09-16', 'resultsFirstSubmitDate': '2021-11-09', 'studyFirstSubmitQcDate': '2016-09-22', 'lastUpdatePostDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-04-07', 'studyFirstPostDateStruct': {'date': '2016-09-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Risk Perception', 'timeFrame': 'up to 2 years follow-up', 'description': 'Assess self-reported weekly HIV risk perception through an automated SMS survey'}, {'measure': 'Adherence Measure Performance', 'timeFrame': 'up to 2 years follow-up', 'description': 'Tenofovir concentration in DBS compared to electronic adherence data from the prior 30 days for each participant.'}, {'measure': 'Pregnancy Outcomes', 'timeFrame': '6 months post-partum or end of the study', 'description': 'Descriptive measures of infants exposed to PrEP during gestation'}], 'primaryOutcomes': [{'measure': 'Enacted Adherence as Measured by Electronic Monitoring at 6 and 24 Months', 'timeFrame': 'up to 2 years follow-up', 'description': 'Comparison of average percent adherence (doses taken/doses prescribed) by study arm at each time point among participants choosing to pick up PrEP.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Reporting High Acceptability of Wisepill Devices for PrEP Adherence Monitoring', 'timeFrame': 'Month 1', 'description': 'Questionnaire indicating "very interested" in using the Wisepill monitor (a pill box that records the date and time of each opening as a proxy for pill ingestion)'}, {'measure': 'USD Per Month', 'timeFrame': 'two years', 'description': 'Cost estimates (including time and motion studies) and mathematical modeling estimate the cost-effectiveness of Wisepill plus SMS reminders per HIV case averted'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV/AIDS', 'adherence', 'women', 'real time monitoring', 'risk', 'SMS', 'mHealth'], 'conditions': ['HIV/AIDS', 'Adherence']}, 'referencesModule': {'references': [{'pmid': '35147580', 'type': 'DERIVED', 'citation': 'Haberer JE, Mugo N, Bukusi EA, Ngure K, Kiptinness C, Oware K, Garrison LE, Musinguzi N, Pyra M, Valenzuela S, Thomas KK, Anderson PL, Thirumurthy H, Baeten JM. Understanding Pre-Exposure Prophylaxis Adherence in Young Women in Kenya. J Acquir Immune Defic Syndr. 2022 Mar 1;89(3):251-260. doi: 10.1097/QAI.0000000000002876.'}, {'pmid': '33662265', 'type': 'DERIVED', 'citation': 'Haberer JE, Bukusi EA, Mugo NR, Pyra M, Kiptinness C, Oware K, Garrison LE, Thomas KK, Musinguzi N, Morrison S, Anderson PL, Ngure K, Baeten JM; MPYA Study Team. Effect of SMS reminders on PrEP adherence in young Kenyan women (MPYA study): a randomised controlled trial. Lancet HIV. 2021 Mar;8(3):e130-e137. doi: 10.1016/S2352-3018(20)30307-6.'}]}, 'descriptionModule': {'briefSummary': 'Next generation real-time monitoring for PrEP adherence in young Kenyan women', 'detailedDescription': 'This protocol describes a longitudinal study of young Kenyan women at high risk for HIV who will be offered HIV pre-exposure prophylaxis (PrEP) for up to two years. Adherence will be monitored in all women with the next generation Wisepill; half will be randomized to receive short message service (SMS) reminders. The technical function, acceptability, cost, and validity of the next generation Wisepill device coupled to SMS reminders will be determined among this cohort of young Kenyan women. Additionally, SMS will be used for longitudinal assessment of risk perception and its alignment with PrEP adherence.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '24 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-uninfected (as determined by Kenya national testing algorithms)\n* Wanting to start PrEP with an initial recommendation of 6 months of use\n* Clinically safe to receive PrEP, in accordance with Centers for Disease Control and Prevention (CDC) guidelines:\n\n * Creatinine clearance \\>60 mL/min\n * Not infected with hepatitis B\n * No other medical condition that in the discretion of the site investigator would make participation unsafe or complicate the goals of the study\n* Sexually active (defined as vaginal or anal sex) within the last 3 months\n* At high risk for HIV infection based on a validated risk score of \\>5 or being in an HIV serodiscordant relationship\n* Not pregnant\n* Owns a personal cell phone (not shared) compatible with study protocols and the ability to charge it\n* Ability to send a text message\n* Intending to stay in the area for at least the next year\n* Willing to use study criteria\n\nExclusion Criteria:\n\n* Unable to provide consent\n* Breast-feeding (PrEPis not currently approved for use during breast-feeding)\n* Concurrent participation in another research study that may influence adherence to PrEP and/or interfere with the procedures of this study.'}, 'identificationModule': {'nctId': 'NCT02915367', 'acronym': 'MPYA', 'briefTitle': 'Monitoring Pre-exposure Prophylaxis for Young Adult Women', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Next Generation Real-time Monitoring for PrEP Adherence in Young Kenyan Women', 'orgStudyIdInfo': {'id': 'R01MH109309', 'link': 'https://reporter.nih.gov/quickSearch/R01MH109309', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SMS Reminders', 'description': 'Participants will receive regular SMS reminders regarding PrEP. All participants will receive adherence monitoring through a WisePill device.', 'interventionNames': ['Behavioral: SMS Reminders']}, {'type': 'NO_INTERVENTION', 'label': 'No Reminders', 'description': 'Participants will not receive SMS reminders. All participants will receive adherence monitoring through a WisePill device.'}], 'interventions': [{'name': 'SMS Reminders', 'type': 'BEHAVIORAL', 'description': 'Participants will receive daily reminders, with content and timing of their choosing, regarding their PrEP use. Participants will have the choice to later receive SMS reminders only when they forget to take their dose (as indicated by real-time adherence monitoring via WisePill).', 'armGroupLabels': ['SMS Reminders']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kisumu', 'country': 'Kenya', 'facility': 'KEMRI', 'geoPoint': {'lat': -0.10221, 'lon': 34.76171}}, {'city': 'Thika', 'country': 'Kenya', 'facility': 'KEMRI', 'geoPoint': {'lat': -1.03326, 'lon': 37.06933}}], 'overallOfficials': [{'name': 'Jessica Haberer, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachussetts General Hospital'}, {'name': 'Jared Baeten, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}, {'name': 'Nelly Mugo', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kenya Medical Research Institute'}, {'name': 'Elizabeth Bukusi', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kenya Medical Research Institute'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Data will be available within 12 months of publishing primary results', 'ipdSharing': 'YES', 'description': 'De-identified data will be made available at the end of the study upon request.', 'accessCriteria': 'Data use agreement'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Washington', 'class': 'OTHER'}, {'name': 'Kenya Medical Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Scientist', 'investigatorFullName': 'Jessica Haberer, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}