Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-29 @ 1:56 PM
Study NCT ID:
NCT04413708
Status:
COMPLETED
Last Update Posted:
2025-03-12
First Post:
2020-05-29
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
mHealth Technologies to Enhance PrEP Adherence Among Thai MSM
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'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': 'sara.legrand@duke.edu', 'phone': '919-438-0448', 'title': 'Sara LeGrand', 'organization': 'Duke University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Approximately 6 months', 'eventGroups': [{'id': 'EG000', 'title': 'P3-T PrEP Adherence App', 'description': 'P3-T provided daily PrEP reminders, a medication tracker and calendar, personalized medication adherence strategies, refill reminders, and tailored adherence support messages; social support via a social wall that included daily discussion prompts; daily quests to build knowledge and skills; a multimedia knowledge center; interactive narrative collections; personalized adherence counseling provided by an adherence counselor via in-app messaging; in-app rewards; a "bank account" that rewards daily app use by adding or subtracting a small financial reward based on daily app use; and, a user profile that included a user-selected avatar. Intended app use included, at a minimum, participant completion of selected app activities (medication tracking, daily quest, social wall post) each day for the 3-month intervention period.\n\nParticipant completion of Standard of Care PrEP adherence and sexual risk behavior counseling at the 1-month post-prescription visit and the 4-month post-prescription visit.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard of Care', 'description': 'Participant completion of Standard of Care PrEP adherence and sexual risk behavior counseling at the 1-month post-prescription visit and the 4-month post-prescription visit.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intervention Feasibility: Average Number of Days of Any App Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'P3-T PrEP Adherence App', 'description': 'P3-T provided daily PrEP reminders, a medication tracker and calendar, personalized medication adherence strategies, refill reminders, and tailored adherence support messages; social support via a social wall that included daily discussion prompts; daily quests to build knowledge and skills; a multimedia knowledge center; interactive narrative collections; personalized adherence counseling provided by an adherence counselor via in-app messaging; in-app rewards; a "bank account" that rewards daily app use by adding or subtracting a small financial reward based on daily app use; and, a user profile that included a user-selected avatar.\n\nIntended app use includes, at a minimum, participant completion of selected app activities (medication tracking, daily quest, social wall post) each day for the 3-month intervention period.\n\nParticipant completion of Standard of Care PrEP adherence and sexual risk behavior counseling at the 1-month post-prescription visit and the 4-month post-prescription visit.\n\nOther Name: P3-T'}], 'classes': [{'categories': [{'measurements': [{'value': '68', 'spread': '29', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3', 'description': 'The number of days of any app use among those assigned to the P3-T adherence arm during the 3-month intervention period as recorded by backend app metrics. Higher number of days indicates higher intervention feasibility.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only applies to P3-T PrEP Adherence App group'}, {'type': 'PRIMARY', 'title': 'Intervention Feasibility: Average Number of Days of PrEP Medication Tracked Through App', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'P3-T PrEP Adherence App', 'description': 'Intended app use includes, at a minimum, participant completion of selected app activities (medication tracking, daily quest, social wall post) each day for the 3-month intervention period. Participant completion of Standard of Care PrEP adherence and sexual risk behavior counseling at the 1-month post-prescription visit and the 4-month post-prescription visit.\n\nP3-T PrEP Adherence App: P3-T provides daily PrEP reminders, a medication tracker and calendar, personalized medication adherence strategies, refill reminders, and tailored adherence support messages; social support via a social wall that includes daily discussion prompts; daily quests to build knowledge and skills; a multimedia knowledge center; interactive narrative collections; personalized adherence counseling provided by an adherence counselor via in-app messaging; in-app rewards; a "bank account" that rewards daily app use by adding or subtracting a small financial reward based on daily app use; and, a user profile that includes a user-selected avatar.'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'spread': '28', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3', 'description': 'The number of days of PrEP medication tracked through app during the 3-month intervention period among participants assigned to the P3-T adherence arm as recorded by backend app metrics. Higher number indicates higher intervention feasibility.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only applies to P3-T PrEP Adherence App group'}, {'type': 'PRIMARY', 'title': 'Intervention Acceptability: Mean Intervention Acceptability, Composite Score CSQ-8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'P3-T PrEP Adherence App', 'description': 'P3-T provided daily PrEP reminders, a medication tracker and calendar, personalized medication adherence strategies, refill reminders, and tailored adherence support messages; social support via a social wall that included daily discussion prompts; daily quests to build knowledge and skills; a multimedia knowledge center; interactive narrative collections; personalized adherence counseling provided by an adherence counselor via in-app messaging; in-app rewards; a "bank account" that rewards daily app use by adding or subtracting a small financial reward based on daily app use; and, a user profile that included a user-selected avatar.Intended app use includes, at a minimum, participant completion of selected app activities (medication tracking, daily quest, social wall post) each day for the 3-month intervention period.\n\nParticipant completion of Standard of Care PrEP adherence and sexual risk behavior counseling at the 1-month post-prescription visit and the 4-month post-prescription visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.18', 'spread': '4.11', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3', 'description': 'Intervention acceptability was assessed using the Client Satisfaction Questionnaire (CSQ-8), an 8-item validated scale measuring the construct of global intervention satisfaction, collected in the 3-month follow-up survey (intervention group only). The eight items (quality of app, kind of service received from app, app met needs, recommend app to a friend, amount of help received from app, the effectiveness of app for dealing with health issue (PrEP adherence), overall satisfaction, and willingness to use the app again) were assessed using a 4-point response scale with individually specified anchors. The mean composite score of the CSQ-8 was calculated with a total possible range of 8 (lowest acceptability, worst outcome) to 32 (highest acceptability, best outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only applies to P3-T PrEP Adherence App group. Data not collected on 2 participants.'}, {'type': 'SECONDARY', 'title': 'Difference in PrEP Medication Adherence Between Study Arms at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'P3-T PrEP Adherence App', 'description': 'P3-T provided daily PrEP reminders, a medication tracker and calendar, personalized medication adherence strategies, refill reminders, and tailored adherence support messages; social support via a social wall that included daily discussion prompts; daily quests to build knowledge and skills; a multimedia knowledge center; interactive narrative collections; personalized adherence counseling provided by an adherence counselor via in-app messaging; in-app rewards; a "bank account" that rewards daily app use by adding or subtracting a small financial reward based on daily app use; and, a user profile that included a user-selected avatar.\n\nIntended app use includes, at a minimum, participant completion of selected app activities (medication tracking, daily quest, social wall post) each day for the 3-month intervention period.\n\nParticipant completion of Standard of Care PrEP adherence and sexual risk behavior counseling at the 1-month post-prescription visit and the 4-month post-prescription visit.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Participant completion of Standard of Care PrEP adherence and sexual risk behavior counseling at the 1-month post-prescription visit and the 4-month post-prescription visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.41', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.62', 'ciLowerLimit': '0.50', 'ciUpperLimit': '5.17', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3', 'description': 'The number of participants with protective levels of tenofovir-diphosphate (TFV-DP) at month 3 between the study arms.', 'unitOfMeasure': 'count of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected on 4 participants.'}, {'type': 'SECONDARY', 'title': 'Difference in PrEP Medication Adherence Between Study Arms at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'P3-T PrEP Adherence App', 'description': 'P3-T provided daily PrEP reminders, a medication tracker and calendar, personalized medication adherence strategies, refill reminders, and tailored adherence support messages; social support via a social wall that included daily discussion prompts; daily quests to build knowledge and skills; a multimedia knowledge center; interactive narrative collections; personalized adherence counseling provided by an adherence counselor via in-app messaging; in-app rewards; a "bank account" that rewards daily app use by adding or subtracting a small financial reward based on daily app use; and, a user profile that included a user-selected avatar. Intended app use includes, at a minimum, participant completion of selected app activities (medication tracking, daily quest, social wall post) each day for the 3-month intervention period.\n\nParticipant completion of Standard of Care PrEP adherence and sexual risk behavior counseling at the 1-month post-prescription visit and the 4-month post-prescription visit.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Participant completion of Standard of Care PrEP adherence and sexual risk behavior counseling at the 1-month post-prescription visit and the 4-month post-prescription visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.0', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.61', 'ciUpperLimit': '1.90', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 6', 'description': 'The number of participants with protective levels of TFV-DP at month 6 between the study arms.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected on 5 participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'P3-T PrEP Adherence App', 'description': 'P3-T provided daily PrEP reminders, a medication tracker and calendar, personalized medication adherence strategies, refill reminders, and tailored adherence support messages; social support via a social wall that included daily discussion prompts; daily quests to build knowledge and skills; a multimedia knowledge center; interactive narrative collections; personalized adherence counseling provided by an adherence counselor via in-app messaging; in-app rewards; a "bank account" that rewards daily app use by adding or subtracting a small financial reward based on daily app use; and, a user profile that included a user-selected avatar.\n\nIntended app use includes, at a minimum, participant completion of selected app activities (medication tracking, daily quest, social wall post) each day for the 3-month intervention period.\n\nParticipant completion of Standard of Care PrEP adherence and sexual risk behavior counseling at the 1-month post-prescription visit and the 4-month post-prescription visit.\n\nOther Name: P3-T'}, {'id': 'FG001', 'title': 'Standard of Care', 'description': 'Participant completion of Standard of Care PrEP adherence and sexual risk behavior counseling at the 1-month post-prescription visit and the 4-month post-prescription visit.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Individuals were recruited by study staff based on physician referral to the Chulalongkorn pre-exposure prophylaxis (PrEP) clinic in Bangkok, Thailand between June 12, 2020 and January 15, 2021.', 'preAssignmentDetails': '60 individuals met the study inclusion criteria and were enrolled and randomized into the P3T arm or the Standard of Care arm.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'P3-T PrEP Adherence App', 'description': 'Intended app use includes, at a minimum, participant completion of selected app activities (medication tracking, daily quest, social wall post) each day for the 3 month intervention period.\n\nParticipant completion of Standard of Care PrEP adherence and sexual risk behavior counseling at the 1-month post-prescription visit and the 4-month post-prescription visit.\n\nP3-T PrEP Adherence App: P3-T provides daily PrEP reminders, a medication tracker and calendar, personalized medication adherence strategies, refill reminders, and tailored adherence support messages; social support via a social wall that includes daily discussion prompts; daily quests to build knowledge and skills; a multimedia knowledge center; interactive narrative collections; personalized adherence counseling provided by an adherence counselor via in-app messaging; in-app rewards; a "bank account" that rewards daily app use by adding or subtracting a small financial reward based on daily app use; and, a user profile that includes a user-selected avatar.'}, {'id': 'BG001', 'title': 'Standard of Care', 'description': 'Participant completion of Standard of Care PrEP adherence and sexual risk behavior counseling at the 1-month post-prescription visit and the 4-month post-prescription visit.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000', 'lowerLimit': '20', 'upperLimit': '21'}, {'value': '22', 'groupId': 'BG001', 'lowerLimit': '20', 'upperLimit': '23'}, {'value': '21', 'groupId': 'BG002', 'lowerLimit': '20', 'upperLimit': '22'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Assigned male sex at birth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Thailand', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Current sexual identity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Gay, homosexual, same gender loving', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Bisexual', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Queer', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The primary analysis population included young, gay, bisexual, and other men who have sex with men, ages 16-24, who were initiating preexposure prophylaxis (PrEP). Individuals were randomized 1:1 into either the P3-T app intervention + standard of care or the standard of care arm. Study participants completed a Qualtrics survey at baseline, M3, and M6. At M3 and M6 dried blood spots were collected for tenofovir diphosphate (TFV-DP) to quantify PrEP adherence levels.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-16', 'size': 4969028, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-04-07T19:41', 'hasProtocol': True}, {'date': '2020-04-29', 'size': 269813, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-04-07T19:43', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'Model Description Model Description Definition: Provide details about the Interventional Study Model. Limit: 1000 characters.Model Description Definition: Provide details about the Interventional Study Model. Limit: 1000 characters.Model Description Definition: Provide details about the Interventional Study Model. Limit: 1000 characters.Model Description Definition: Provide details about the Interventional Study Model. Limit: 1000 characters.Model Description Definition: Provide details about the Interventional Study Model. Limit: 1000 characters.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Model Description Definition: Provide details about the Interventional Study Model. Limit: 1000 characters.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2021-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-06', 'studyFirstSubmitDate': '2020-05-29', 'resultsFirstSubmitDate': '2023-04-11', 'studyFirstSubmitQcDate': '2020-05-29', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-06', 'studyFirstPostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intervention Feasibility: Average Number of Days of Any App Use', 'timeFrame': 'Month 3', 'description': 'The number of days of any app use among those assigned to the P3-T adherence arm during the 3-month intervention period as recorded by backend app metrics. Higher number of days indicates higher intervention feasibility.'}, {'measure': 'Intervention Feasibility: Average Number of Days of PrEP Medication Tracked Through App', 'timeFrame': 'Month 3', 'description': 'The number of days of PrEP medication tracked through app during the 3-month intervention period among participants assigned to the P3-T adherence arm as recorded by backend app metrics. Higher number indicates higher intervention feasibility.'}, {'measure': 'Intervention Acceptability: Mean Intervention Acceptability, Composite Score CSQ-8', 'timeFrame': 'Month 3', 'description': 'Intervention acceptability was assessed using the Client Satisfaction Questionnaire (CSQ-8), an 8-item validated scale measuring the construct of global intervention satisfaction, collected in the 3-month follow-up survey (intervention group only). The eight items (quality of app, kind of service received from app, app met needs, recommend app to a friend, amount of help received from app, the effectiveness of app for dealing with health issue (PrEP adherence), overall satisfaction, and willingness to use the app again) were assessed using a 4-point response scale with individually specified anchors. The mean composite score of the CSQ-8 was calculated with a total possible range of 8 (lowest acceptability, worst outcome) to 32 (highest acceptability, best outcome).'}], 'secondaryOutcomes': [{'measure': 'Difference in PrEP Medication Adherence Between Study Arms at Month 3', 'timeFrame': 'Month 3', 'description': 'The number of participants with protective levels of tenofovir-diphosphate (TFV-DP) at month 3 between the study arms.'}, {'measure': 'Difference in PrEP Medication Adherence Between Study Arms at Month 6', 'timeFrame': 'Month 6', 'description': 'The number of participants with protective levels of TFV-DP at month 6 between the study arms.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PrEP adherence', 'HIV', 'Young men who have sex with men', 'YMSM', 'Thailand', 'Mobile app', 'mHealth'], 'conditions': ['Adherence, Patient', 'Pre-Exposure Prophylaxis', 'HIV/AIDS']}, 'referencesModule': {'references': [{'pmid': '34734828', 'type': 'DERIVED', 'citation': 'Songtaweesin WN, LeGrand S, Bandara S, Piccone C, Wongharn P, Moonwong J, Jupimai T, Saisaengjan C, Theerawit T, Muessig K, Hightow-Weidman L, Puthanakit T, Phanuphak N, Tangmunkongvorakul A. Adaptation of a Theory-Based Social Networking and Gamified App-Based Intervention to Improve Pre-Exposure Prophylaxis Adherence Among Young Men Who Have Sex With Men in Bangkok, Thailand: Qualitative Study. J Med Internet Res. 2021 Nov 4;23(11):e23852. doi: 10.2196/23852.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to: 1) adapt the theory-based P3 (Prepared, Protected, emPowered) app designed to improve pre-exposure prophylaxis (PrEP) adherence, retention in PrEP clinical care, and PrEP persistence among young gay, bisexual, and other men who have sex with men (YMSM) in the United States for YMSM in Thailand, and 2) conduct a pilot randomized controlled trial (RCT) to assess the feasibility, acceptability, and potential impact of the adapted P3-Thailand (P3-T) app.', 'detailedDescription': 'This R21 study, titled "Novel mHealth Technologies to Enhance PrEP Adherence among Thai MSM: Collaborative Adaptation and Evaluation" was designed to adapt and test a theory-based, PrEP adherence smartphone app, P3, to 1) improve PrEP adherence and thus protective PrEP drug levels, 2) to increase retention in PrEP clinical care, 3) support PrEP persistence among YMSM in the United States for YMSM in Thailand, and 4) conduct a pilot RCT to assess the feasibility and acceptability of the adapted P3-T app and to examine the potential impact of the app on PrEP adherence.\n\nThe study was a partnership between Duke University, Chulalongkorn University, Thai Red Cross AIDS Research Centre (TRC-ARC), and the University of North Carolina-Chapel Hill, and includes a robust plan to increase mHealth capacity at Chulalongkorn University and TRC-ARC.\n\nP3 is a theory-based, comprehensive smartphone app platform for YMSM that utilizes social networking and game-based mechanics as well as evidenced-based features to improve PrEP medication adherence. P3 is a product born from the collaborative effort of researchers and health game developers working closely with members of the target population in the United States. Built on a successful, evidence-based platform designed by our collaborating technology partner, Ayogo, and tested by our study team, P3 is flexible, allowing for customization and adaptations for different cultural and linguistic contexts, and responsive to changes in technology.\n\nThe social networking features of P3 are designed to capitalize on social involvement as a means through which YMSM can receive information and social support, experience social norms and reflective appraisals, and feel a sense of connectedness to peers. Peers have been recognized as a highly important source of sexual health and HIV prevention information and support among Thai YMSM. The gaming features of P3 were goal-oriented and immersive and provided a challenging and motivating environment for behavior change. As a result, P3 is ideal for engaging YMSM in behavior change, by maintaining attention and avoiding boredom and attrition.\n\nThe pilot RCT of the adapted P3-T app was conducted with 60 YMSM newly starting PrEP in Bangkok, Thailand to 1) assess app feasibility and acceptability, and 2) explore the potential impact of the app on PrEP adherence.\n\nIn-depth interviews were conducted with 10 P3-T arm participants after the 3-month intervention period. The interview will ask participants about their experience and impressions of the app, how they used it, and how it may have impacted their behaviors during the 3-month intervention period.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '24 Years', 'minimumAge': '16 Years', 'genderBased': True, 'genderDescription': 'Self-identify as male', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Male sex at birth\n* Gender identity is male\n* Identify as a man who has sex with men\n* Ages 16-24\n* Plan to start PrEP in next 14 days\n* Able to speak and read Thai\n* Own an Android or iOS smartphone\n\nExclusion Criteria:\n\n* Currently participating in another experimental PrEP adherence intervention\n* Plan to move out of Bangkok in the next 6 months\n* Unable to be consented due to an active substance use or psychological condition'}, 'identificationModule': {'nctId': 'NCT04413708', 'acronym': 'P3-T', 'briefTitle': 'mHealth Technologies to Enhance PrEP Adherence Among Thai MSM', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Novel mHealth Technologies to Enhance PrEP Adherence Among Thai MSM: Collaborative Adaptation and Evaluation', 'orgStudyIdInfo': {'id': '2020-0099'}, 'secondaryIdInfos': [{'id': '1R21TW010965', 'link': 'https://reporter.nih.gov/quickSearch/1R21TW010965', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'P3-T PrEP adherence app', 'description': 'Intended app use includes, at a minimum, participant completion of selected app activities (medication tracking, daily quest, social wall post) each day for the 3 month intervention period.\n\nParticipant completion of Standard of Care PrEP adherence and sexual risk behavior counseling at the 1-month post-prescription visit and the 4-month post-prescription visit.', 'interventionNames': ['Behavioral: P3-T PrEP Adherence App']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'Participant completion of Standard of Care PrEP adherence and sexual risk behavior counseling at the 1-month post-prescription visit and the 4-month post-prescription visit.'}], 'interventions': [{'name': 'P3-T PrEP Adherence App', 'type': 'BEHAVIORAL', 'otherNames': ['P3-T'], 'description': 'P3-T provides daily PrEP reminders, a medication tracker and calendar, personalized medication adherence strategies, refill reminders, and tailored adherence support messages; social support via a social wall that includes daily discussion prompts; daily quests to build knowledge and skills; a multimedia knowledge center; interactive narrative collections; personalized adherence counseling provided by an adherence counselor via in-app messaging; in-app rewards; a "bank account" that rewards daily app use by adding or subtracting a small financial reward based on daily app use; and, a user profile that includes a user-selected avatar.', 'armGroupLabels': ['P3-T PrEP adherence app']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10330', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Chulalongkorn University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Sara LeGrand, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, {'name': 'Chulalongkorn University', 'class': 'OTHER'}, {'name': 'Thai Red Cross AIDS Research Centre', 'class': 'OTHER'}, {'name': 'Fogarty International Center of the National Institute of Health', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}