Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2026-04-11 @ 6:47 AM
Study NCT ID:
NCT02690818
Status:
COMPLETED
Last Update Posted:
2019-04-23
First Post:
2016-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Promoting Adherence to Treatment for Latent TB Infection Through Text Messaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055985', 'term': 'Latent Tuberculosis'}, {'id': 'D014376', 'term': 'Tuberculosis'}], 'ancestors': [{'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000085343', 'term': 'Latent Infection'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-22', 'studyFirstSubmitDate': '2016-01-05', 'studyFirstSubmitQcDate': '2016-02-19', 'lastUpdatePostDateStruct': {'date': '2019-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment', 'timeFrame': 'Ongoing', 'description': 'How many approached by clinic, how many referred, how many study eligible, how many consented; why ineligible or refused; how long to recruit each patient'}], 'secondaryOutcomes': [{'measure': 'Retention', 'timeFrame': 'Ongoing', 'description': 'How many drop out at each monthly time point, who and why'}, {'measure': 'Perceptions of Intervention through a questionnaire', 'timeFrame': 'Once, up to 12 months post-treatment', 'description': "Perceptions and opinions (if the intervention was helpful, non-helpful, effectiveness) in the intervention arm will be assessed after the study follow-up through a questionnaire of a subset of enrolled individuals at the completion of the participant's treatment (up to 12 months post-treatment initiation)."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Tuberculosis', 'Latent Tuberculosis', 'Texting', 'Adherence', 'Medication'], 'conditions': ['Latent Tuberculosis']}, 'referencesModule': {'references': [{'pmid': '28293431', 'type': 'BACKGROUND', 'citation': 'Oren E, Bell ML, Garcia F, Perez-Velez C, Gerald LB. Promoting adherence to treatment for latent TB infection through mobile phone text messaging: study protocol for a pilot randomized controlled trial. Pilot Feasibility Stud. 2017 Mar 13;3:15. doi: 10.1186/s40814-017-0128-9. eCollection 2017.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this pilot study is to determine whether regularly scheduled medication reminder text messages (SMS) are effective in increasing latent tuberculosis infection (LTBI) treatment completion.', 'detailedDescription': 'We aim to determine the feasibility and acceptability of text reminders for improving adherence in latent TB patients. Specific objectives of the current study are to: 1) Assess the feasibility of the intervention as indicated by participant recruitment and retention and; 2) Evaluate the acceptability of the intervention, as indicated by intervention adherence, outcome measurement rates, and feedback from participants.\n\nData will be used to design a definitive trial which will test the hypothesis that the intervention will improve medication adherence, as measured through an increase in treatment completion rates, and result in higher self-reported medication adherence, fewer missed appointments and doses, and a shorter course of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consent to the study\n* Own a mobile phone which operates on a telecom provider supported by our SMS platform\n* Initiating or actively receiving treatment for LTBI at the Pima County TB Clinic in Tucson, AZ\n* Prescribed self-administered therapy\n* Report not having prior or current active TB disease\n* Know how to and are able to receive SMS messages\n* At least 18 years of age\n\nExclusion Criteria:\n\n* Do not meet inclusion criteria\n* Do not consent to study'}, 'identificationModule': {'nctId': 'NCT02690818', 'acronym': 'TXT4MED', 'briefTitle': 'Promoting Adherence to Treatment for Latent TB Infection Through Text Messaging', 'organization': {'class': 'OTHER', 'fullName': 'University of Arizona'}, 'officialTitle': 'Promoting Adherence to Treatment for Latent TB Infection Through Mobile Phone Text Messaging', 'orgStudyIdInfo': {'id': 'TXT4MED'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Behavioral intervention arm', 'description': 'Regularly scheduled medication reminder text messages\n\nDaily LTBI text messages without the option to text back. The messages will read, "This is a reminder to take your medication."\n\nStandard of care: Monthly reminder call and clinic visit', 'interventionNames': ['Behavioral: Regularly scheduled LTBI medication reminder text messages']}, {'type': 'NO_INTERVENTION', 'label': 'Control group receiving standard care', 'description': 'Standard of care: Monthly reminder call and clinic visit'}], 'interventions': [{'name': 'Regularly scheduled LTBI medication reminder text messages', 'type': 'BEHAVIORAL', 'description': 'Regularly scheduled medication reminder text messages Daily LTBI text messages without the option to text back. The messages will read, "This is a reminder to take your medication."', 'armGroupLabels': ['Behavioral intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85714', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Pima County Health Department', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}], 'overallOfficials': [{'name': 'Eyal Oren, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arizona'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arizona', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pima County Health Department', 'class': 'UNKNOWN'}, {'name': 'American Lung Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}