Ignite Creation Date:
2025-12-24 @ 12:55 PM
Ignite Modification Date:
2025-12-27 @ 9:29 PM
Study NCT ID:
NCT03755661
Status:
COMPLETED
Last Update Posted:
2021-05-06
First Post:
2018-11-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
MI With Text Messaging to Reduce Sexual Risk and Hazardous Drinking Among MSM
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047568', 'term': 'Unsafe Sex'}], 'ancestors': [{'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'laneia@bu.edu', 'phone': '617-358-6346', 'title': 'LaNeia Thomas', 'organization': 'Boston University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected up to the 6 month outcome following enrollment. This corresponds to the time period from initial enrollment to study completion', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': 'This intervention arm is a combined in-person text messaging intervention\n\nMI\\&TXT4MSM: brief in-person intervention followed by text messaging\n\nNo adverse events', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Assessment Only Control', 'description': 'The is the assessment only comparison condition\n\nNo adverse events', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Heavy Drinking Episodes NIAAA Criteria (5 or More Drinks on a Single Occasion)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'This intervention arm is a combined in-person text messaging intervention\n\nMI\\&TXT4MSM: brief in-person intervention followed by text messaging'}, {'id': 'OG001', 'title': 'Assessment Only Control', 'description': 'The is the assessment only comparison condition'}], 'classes': [{'categories': [{'measurements': [{'value': '3.09', 'spread': '3.62', 'groupId': 'OG000'}, {'value': '5.33', 'spread': '3.42', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.048', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'provide inferential statistics for data completion. Study is not designed to detect significant differences between groups', 'groupDescription': 'pilot study to calculate effect size, study is not powered to detect significant group differences', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'R-square change = .12; F-change (1, 20) = 4.44', 'nonInferiorityComment': 'pilot data to estimate effect size f-squared as the parameter as primary outcome', 'otherAnalysisDescription': 'Computed f-squared as effect size estimate where baseline value of heavy drinking episodes entered in step 1 and condition in step 2\n\nf- squared = .22'}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'Number of heavy drinking episodes in the past 30 days. This question is an open ended question that asks the participant to report the number of times in the past 30 days that he has consumed 5 or more drinks on a single occasion \\[no scale\\]. Higher score is a worse outcome, range 0-30', 'unitOfMeasure': 'heavy drinking episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Condomless Anal Intercourse Episodes (CAI) From the Sexual Behaviors Survey (Gordon et al., 2007) is Used to Measure Sexual Risk [Main Time Point at 3 Month Follow-up]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'This intervention arm is a combined in-person text messaging intervention\n\nMI\\&TXT4MSM: brief in-person intervention followed by text messaging'}, {'id': 'OG001', 'title': 'Assessment Only Control', 'description': 'The is the assessment only comparison condition'}], 'classes': [{'categories': [{'measurements': [{'value': '1.54', 'spread': '2.46', 'groupId': 'OG000'}, {'value': '4.33', 'spread': '6.12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.34', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'F-change (1, 20) = 0.97', 'groupDescription': 'pilot trial to compute effect size estimate', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The main outcome variable is f-squared as an estimate of differences between conditions controlling for baseline value.\n\nA statistical test is provided only for completeness as this study is not powered to detect significant effects', 'otherAnalysisDescription': 'Computed f-squared as effect size estimate where baseline value of CAI entered in step 1 and condition in step 2 f- squared = .05, r-squared change = .04'}], 'paramType': 'MEAN', 'timeFrame': '90 days', 'description': 'Frequency of CAI in past 90 days. This is an open ended question where the Participant report the frequency of condomless anal intercourse episodes over a period of 90 days \\[no scale\\] Range from 0-90', 'unitOfMeasure': 'condomless anal intercourse episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Modified Daily Drinking Questionnaire- Typical Number of Standard Drinks Per Week Over the Past Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'This intervention arm is a combined in-person text messaging intervention\n\nMI\\&TXT4MSM: brief in-person intervention followed by text messaging'}, {'id': 'OG001', 'title': 'Assessment Only Control', 'description': 'The is the assessment only comparison condition'}], 'classes': [{'categories': [{'measurements': [{'value': '9.45', 'spread': '6.57', 'groupId': 'OG000'}, {'value': '11.58', 'spread': '6.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.20', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'data provided for completeness, not powered to test differences', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'F-change (1, 20) = 1.80', 'nonInferiorityComment': 'This is a pilot trial to estimate effect sizes and not powered to detect significant differences', 'otherAnalysisDescription': 'Computed f-squared as effect size estimate where baseline value of CAI entered in step 1 and condition in step 2 f- squared = .09, r-squared change = .058'}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'Average quantity of alcohol use per week in the past 30 days. Participants complete a seven day calendar which reflects the typical number of standard drinks that they have consumed for each day of the week over the past 30 days. The number of drinks can range from 0 to an unlimited high number. A higher number of drinks listed in the week is reflective of a worse outcome', 'unitOfMeasure': 'Average number of drinks per week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Young Adult Alcohol Consequences Questionnaire [Alcohol]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'This intervention arm is a combined in-person text messaging intervention\n\nMI\\&TXT4MSM: brief in-person intervention followed by text messaging'}, {'id': 'OG001', 'title': 'Assessment Only Control', 'description': 'The is the assessment only comparison condition'}], 'classes': [{'categories': [{'measurements': [{'value': '6.45', 'spread': '6.62', 'groupId': 'OG000'}, {'value': '9.41', 'spread': '7.41', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.19', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Pilot trial not powered to detect significant group differences', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'F-change (1, 20) = 1.83', 'nonInferiorityComment': 'Pilot trial not powered to detect significant group differences. Data from analyses presented for completeness. Primary outcome is effect size estimates', 'otherAnalysisDescription': 'Computed f-squared as effect size estimate where baseline value of CAI entered in step 1 and condition in step 2 f- squared = .09, r-squared change = .048'}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'Number of alcohol-related consequences in the past month. This is the 48-item Yes/No version of the YAACQ. The range for the score is 0-48. Higher score is a worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of CAI Past 6 Weeks From the Sexual Behaviors Survey Item Described Above.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'This intervention arm is a combined in-person text messaging intervention\n\nMI\\&TXT4MSM: brief in-person intervention followed by text messaging'}, {'id': 'OG001', 'title': 'Assessment Only Control', 'description': 'The is the assessment only comparison condition'}], 'classes': [{'categories': [{'measurements': [{'value': '0.91', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '1.63', 'spread': '1.56', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.26', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'F-change (1, 19) = 1.34', 'groupDescription': 'Not powered to test significant differences. provide data on effect size estimate below', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'Computed f-squared as effect size estimate where baseline value of CAI entered in step 1 and condition in step 2 f- squared = .05, r-squared change = .04'}], 'paramType': 'MEAN', 'timeFrame': '6 -weeks', 'description': 'The number of condomless anal intercourse episodes (CAI) in the 6 weeks following the baseline as an additional outcome', 'unitOfMeasure': 'condomless anal intercourse episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': 'This intervention arm is a combined in-person text messaging intervention\n\nMI\\&TXT4MSM: brief in-person intervention followed by text messaging'}, {'id': 'FG001', 'title': 'Assessment Only Control', 'description': 'This condition includes only assessment measures. It is used as the comparison condition to the intervention under study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited through social media ads and the study was conducted at a university laboratory that is affiliated with a psychological services clinic', 'preAssignmentDetails': 'Eligibility was confirmed at the in-person session. Randomization occurred following baseline assessment'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': 'This intervention arm is a combined in-person text messaging intervention\n\nMI\\&TXT4MSM: brief in-person intervention followed by text messaging'}, {'id': 'BG001', 'title': 'Assessment Only Control', 'description': 'The is the assessment only comparison condition'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.18', 'spread': '7.26', 'groupId': 'BG000'}, {'value': '30.75', 'spread': '7.79', 'groupId': 'BG001'}, {'value': '30.48', 'spread': '7.36', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'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': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', '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': '2', 'groupId': 'BG001'}, {'value': '2', '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': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', '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': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-04-17', 'size': 230508, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-04-08T10:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The outcomes assessor is not provided with randomization information for the subjects'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are randomly assigned to one of two groups'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-03-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-08', 'studyFirstSubmitDate': '2018-11-26', 'resultsFirstSubmitDate': '2021-03-07', 'studyFirstSubmitQcDate': '2018-11-26', 'lastUpdatePostDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-08', 'studyFirstPostDateStruct': {'date': '2018-11-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of CAI Past 6 Weeks From the Sexual Behaviors Survey Item Described Above.', 'timeFrame': '6 -weeks', 'description': 'The number of condomless anal intercourse episodes (CAI) in the 6 weeks following the baseline as an additional outcome'}], 'primaryOutcomes': [{'measure': 'Number of Heavy Drinking Episodes NIAAA Criteria (5 or More Drinks on a Single Occasion)', 'timeFrame': '30 days', 'description': 'Number of heavy drinking episodes in the past 30 days. This question is an open ended question that asks the participant to report the number of times in the past 30 days that he has consumed 5 or more drinks on a single occasion \\[no scale\\]. Higher score is a worse outcome, range 0-30'}, {'measure': 'Number of Condomless Anal Intercourse Episodes (CAI) From the Sexual Behaviors Survey (Gordon et al., 2007) is Used to Measure Sexual Risk [Main Time Point at 3 Month Follow-up]', 'timeFrame': '90 days', 'description': 'Frequency of CAI in past 90 days. This is an open ended question where the Participant report the frequency of condomless anal intercourse episodes over a period of 90 days \\[no scale\\] Range from 0-90'}, {'measure': 'Modified Daily Drinking Questionnaire- Typical Number of Standard Drinks Per Week Over the Past Month', 'timeFrame': '30 days', 'description': 'Average quantity of alcohol use per week in the past 30 days. Participants complete a seven day calendar which reflects the typical number of standard drinks that they have consumed for each day of the week over the past 30 days. The number of drinks can range from 0 to an unlimited high number. A higher number of drinks listed in the week is reflective of a worse outcome'}], 'secondaryOutcomes': [{'measure': 'Young Adult Alcohol Consequences Questionnaire [Alcohol]', 'timeFrame': '30 days', 'description': 'Number of alcohol-related consequences in the past month. This is the 48-item Yes/No version of the YAACQ. The range for the score is 0-48. Higher score is a worse outcome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol; Harmful Use', 'Sex, Unsafe']}, 'descriptionModule': {'briefSummary': 'This is a small pilot study to provide effect size estimates for a brief intervention designed to reduce hazardous drinking and sexual risk behavior among men who have sex with men. The intervention consists of an "in-person" brief motivational intervention followed by a series of text messages related to alcohol and sexual risk reduction. The primary outcome is heavy drinking episodes and frequency of condomless anal intercourse at 3 months.', 'detailedDescription': 'This is a pilot study designed to provide initial effect size estimates for an intervention addressing hazardous drinking and sexual risk behavior among men who have sex with men. In this study, 24 participants initially recruited through advertisements in the community will be randomly assigned to either Assessment Only or Intervention Condition. Those in the Assessment Only condition will complete baseline, 6-week, 3-month and 6-month assessments. Those in the intervention condition will receive a 50-min brief intervention in person followed by 6 weeks of tailored app-based messaging to support the intervention content, then another 6-weeks of goal setting text-based messages. Data will be analyzed to determine effect sizes of the intervention on key alcohol use and sex risk outcomes. The primary outcome will be 3-month outcomes, controlling for corresponding baseline outcomes.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'genderBased': True, 'genderDescription': 'identify as male', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 1 heavy drinking episode or consumption of more than 14 drinks per week over the past month\n* At least 1 condomless anal sex episode in past 3 months\n* Score of 3 or greater on the Kinsey Scale (Kinsey et al., 1948) indicating at least "equally heterosexual and homosexual". Scale ranges from 0 (exclusively heterosexual) to 6 (exclusively homosexual)\n\nExclusion Criteria:\n\n* Alcohol treatment currently or in past 3 years\n* Bipolar disorder or schizophrenia treatment\n* Exclusive monogamous relationship'}, 'identificationModule': {'nctId': 'NCT03755661', 'acronym': 'MI&TXT4MSM', 'briefTitle': 'MI With Text Messaging to Reduce Sexual Risk and Hazardous Drinking Among MSM', 'organization': {'class': 'OTHER', 'fullName': 'Boston University Charles River Campus'}, 'officialTitle': 'Alcohol and Implicit Process in Sexual Risk Behavior in MSM Supplement', 'orgStudyIdInfo': {'id': '3468a'}, 'secondaryIdInfos': [{'id': '3R01AA022301-02S1', 'link': 'https://reporter.nih.gov/quickSearch/3R01AA022301-02S1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'This intervention arm is a combined in-person text messaging intervention', 'interventionNames': ['Behavioral: MI&TXT4MSM']}, {'type': 'NO_INTERVENTION', 'label': 'Assessment Only Control', 'description': 'The is the assessment only comparison condition'}], 'interventions': [{'name': 'MI&TXT4MSM', 'type': 'BEHAVIORAL', 'description': 'brief in-person intervention followed by text messaging', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston University Department of Psychological and Brain Science', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'ipdSharingStatementModule': {'timeFrame': 'Data will be available one year after the trial end. They will be available for investigators to request up to 5 years following their release', 'ipdSharing': 'YES', 'description': 'Data will be shared following release within one year of the trial end to investigators who make specific requests in writing regarding analysis plans. Plans will be reviewed with co-investigators to ensure that there is no overlap with planned analyses. Specific de-identified data set will be provided to other researchers after this review', 'accessCriteria': 'Researcher with specified analytic request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston University Charles River Campus', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Tibor Palfai', 'investigatorAffiliation': 'Boston University Charles River Campus'}}}}