Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2026-01-13 @ 1:11 AM
Study NCT ID:
NCT01951092
Status:
COMPLETED
Last Update Posted:
2016-04-22
First Post:
2013-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
mHealth Intervention Supporting HIV Treatment Adherence and Retention
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'arana@lifespan.org', 'phone': '401-793-4680', 'title': 'Aadia Rana, MD', 'organization': 'Alpert Medical School of Brown University/The Miriam Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months (during participation in the study)', 'description': 'Primary adverse events evaluated for would be loss of confidentiality due to text messaging. None were reported in this study.', 'eventGroups': [{'id': 'EG000', 'title': 'Single Arm Intervention Study', 'description': 'All subjects receive text messages for: 1) medication reminders; 2) appointment reminders; 3) a text message addressing barriers (e.g., reminders to attend AA meetings). Each subject will undergo baseline assessments, choose personalized messages at that time. Subsequently monthly phone calls with study coordinator regarding frequency/changing messages, and then month 3 assessment, and month 6 (final assessment) with option for qualitative interview.', 'otherNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Particpatns Who Considered the Intervention Feasible and Acceptable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Intervention Study', 'description': 'All subjects receive text messages for: 1) medication reminders; 2) appointment reminders; 3) a text message addressing barriers (e.g., reminders to attend AA meetings). Each subject will undergo baseline assessments, choose personalized messages at that time. Subsequently monthly phone calls with study coordinator regarding frequency/changing messages, and then month 3 assessment, and month 6 (final assessment) with option for qualitative interview.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'A qualitative interview is completed at the end of the 6 month intervention where participants are queried on aspects of the texting intervention including: frequency of messaging, content of messaging, comfort with confidentiality with messaging, interactions between clinic staff as a result of messaging, and ideas on how to incorporate messaging clinic-wide.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All 20 participants who completed the study at 6 months participated in interviews and reported that the texting intervention was feasible and acceptable.'}, {'type': 'SECONDARY', 'title': 'Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Intervention Study', 'description': 'All subjects receive text messages for: 1) medication reminders; 2) appointment reminders; 3) a text message addressing barriers (e.g., reminders to attend AA meetings). Each subject will undergo baseline assessments, choose personalized messages at that time. Subsequently monthly phone calls with study coordinator regarding frequency/changing messages, and then month 3 assessment, and month 6 (final assessment) with option for qualitative interview.'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Exploratory end point of PVL \\<200 copies at the end of the study', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Single Arm Intervention Study', 'description': 'All subjects receive text messages for: 1) medication reminders; 2) appointment reminders; 3) a text message addressing barriers (e.g., reminders to attend AA meetings). Each subject will undergo baseline assessments, choose personalized messages at that time. Subsequently monthly phone calls with study coordinator regarding frequency/changing messages, and then month 3 assessment, and month 6 (final assessment) with option for qualitative interview.\n\nText messaging'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Incarceration', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Transfer of Care', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Patients at the Immunology Center in Providence RI who were either 1) newly diagnosed, 2) returning to care after a gap, 3) or with difficulties with adherence to care were eligible for enrollment in this pilot study.\n\nParticipants were recruited from January 2013 through July 2013 and followed for 6 months.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Single Arm Intervention Study', 'description': 'All subjects receive text messages for: 1) medication reminders; 2) appointment reminders; 3) a text message addressing barriers (e.g., reminders to attend AA meetings). Each subject will undergo baseline assessments, choose personalized messages at that time. Subsequently monthly phone calls with study coordinator regarding frequency/changing messages, and then month 3 assessment, and month 6 (final assessment) with option for qualitative interview.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '64'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Participants with HIV PVL <200 copies/mL', 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of patients with baseline HIV PVL \\<200 copies/mL', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-11', 'studyFirstSubmitDate': '2013-09-18', 'resultsFirstSubmitDate': '2014-10-08', 'studyFirstSubmitQcDate': '2013-09-23', 'lastUpdatePostDateStruct': {'date': '2016-04-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-04-11', 'studyFirstPostDateStruct': {'date': '2013-09-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Particpatns Who Considered the Intervention Feasible and Acceptable', 'timeFrame': '6 months', 'description': 'A qualitative interview is completed at the end of the 6 month intervention where participants are queried on aspects of the texting intervention including: frequency of messaging, content of messaging, comfort with confidentiality with messaging, interactions between clinic staff as a result of messaging, and ideas on how to incorporate messaging clinic-wide.'}], 'secondaryOutcomes': [{'measure': 'Efficacy', 'timeFrame': '6 months', 'description': 'Exploratory end point of PVL \\<200 copies at the end of the study'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV', 'adherence', 'retention', 'texting'], 'conditions': ['HIV', 'Adherence', 'Retention']}, 'descriptionModule': {'briefSummary': 'Despite advances in antiretroviral treatment (ART) over the past 10 years, the incidence of HIV in the United States remains stagnant with over 50,000 new cases annually. HIV-infected individuals inconsistently engaged with care are less likely to receive ART which is associated with correspondingly adverse clinical outcomes in the long term and increased risk of transmission. Mobile health (mHealth) strategies including cell phone and text messaging have shown success in the developing world for medication adherence, yet mHealth interventions have not been developed to improve retention in HIV care. This strategy needs to be tested to demonstrate feasibility, acceptability and preliminary effectiveness in supporting HIV treatment adherence in Rhode Island.\n\nThe Miriam Hospital Immunology Center is an urban HIV-clinic that provides comprehensive primary and specialty care for over 1400 HIV-infected patients. It is the largest HIV clinic in Rhode Island with patients also referred from eastern Connecticut and southern Massachusetts. In 2010, there were 165 new patients in clinic, 70 of whom were diagnosed within 1 year of entering care. In this environment, we propose a pilot study with the following specific aims:\n\nSpecific Aim 1: To pilot a bidirectional mHealth intervention among individuals at high risk of loss to follow-up, including those with a recent HIV diagnosis or those re-engaging in HIV care. HIV-infected persons (n=30) with a recent diagnosis or re-engaging in care at the Immunology Center at TMH will be recruited to participate in a bidirectional mHealth intervention that delivers automated, regularly scheduled appointment and medication adherence reminders in an individualized format, and also allows individuals to request motivational enhancement and problem-solving support to address barriers to care.\n\nSpecific Aim 2: To assess the impact and acceptability of the pilot intervention through qualitative interviews. All participants will also be invited to complete individual in-depth interviews which will assess acceptability and effectiveness of the pilot mHealth intervention, such as content and frequency of automatic messages, for retention and medication adherence for HIV-infected individuals in RI.\n\nThe results of this study will provide preliminary data to inform an R21 or R34 application to determine efficacy of an mHealth intervention among HIV-infected persons at high-risk for loss to follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV infected\n* age \\>/= 18\n* patient at The Miriam Hospital Immunology Center\n* has cell phone that can send and receive text messages\n* English speaking only\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01951092', 'briefTitle': 'mHealth Intervention Supporting HIV Treatment Adherence and Retention', 'organization': {'class': 'OTHER', 'fullName': 'The Miriam Hospital'}, 'officialTitle': 'mHealth Intervention Supporting HIV Treatment Adherence and Retention', 'orgStudyIdInfo': {'id': 'Lifespan Dev Grant Rana-2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Arm intervention study', 'description': 'All subjects receive text messages for: 1) medication reminders; 2) appointment reminders; 3) a text message addressing barriers (e.g., reminders to attend AA meetings). Each subject will undergo baseline assessments, choose personalized messages at that time. Subsequently monthly phone calls with study coordinator regarding frequency/changing messages, and then month 3 assessment, and month 6 (final assessment) with option for qualitative interview.', 'interventionNames': ['Other: Text messaging']}], 'interventions': [{'name': 'Text messaging', 'type': 'OTHER', 'armGroupLabels': ['Single Arm intervention study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02906', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'The Miriam Hospital Immunology Center', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Miriam Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Aadia Rana', 'investigatorAffiliation': 'The Miriam Hospital'}}}}