Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-31 @ 11:27 AM
Study NCT ID:
NCT01058694
Status:
COMPLETED
Last Update Posted:
2010-01-29
First Post:
2010-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Short Message Services (SMS) on ARV Adherence in Western Kenya
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'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'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 720}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-28', 'studyFirstSubmitDate': '2010-01-27', 'studyFirstSubmitQcDate': '2010-01-28', 'lastUpdatePostDateStruct': {'date': '2010-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MEMS Adherence', 'timeFrame': '12 months follow up'}], 'secondaryOutcomes': [{'measure': 'Frequency/incidence of ARV treatment interruptions', 'timeFrame': '12 months follow up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mobile phones,', 'Medication Adherence', 'Micro-Electrical-Mechanical Systems', 'HIV Infections'], 'conditions': ['AIDS', 'Antiretroviral Therapy', 'Medication Adherence', 'HIV Infections']}, 'referencesModule': {'references': [{'pmid': '21252632', 'type': 'DERIVED', 'citation': 'Pop-Eleches C, Thirumurthy H, Habyarimana JP, Zivin JG, Goldstein MP, de Walque D, MacKeen L, Haberer J, Kimaiyo S, Sidle J, Ngare D, Bangsberg DR. Mobile phone technologies improve adherence to antiretroviral treatment in a resource-limited setting: a randomized controlled trial of text message reminders. AIDS. 2011 Mar 27;25(6):825-34. doi: 10.1097/QAD.0b013e32834380c1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of proposed research is to implement a randomized study that will allow us to understand and address a number of key barriers to patient adherence as well as study the effects of better adherence on health and socio-economic outcomes.', 'detailedDescription': 'Several studies have shown that proper adherence to treatment regimens is essential for the effectiveness of ARV therapy (e.g Wools-Kaloustian et al. 2006). There is also evidence in that in some treatment programs in Africa, adherence rates are not always high (Gill et al. 2005). Even in settings where adherence levels are found to be high, numerous factors have been identified as being relevant, although the causal effects are unknown (Castro, 2006). As ARV treatment programs are scaled up in Africa, it is essential to understand the socio-economic determinants of adherence to ARV treatment, as well as the impact of interventions to support high levels of adherence. A secondary objective of this study is to understand the socio-economic impacts of higher adherence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who had been on ARV therapy at the Chulaimbo Rural Health Center for a maximum of three months and providing consent to participate in the study.\n\nExclusion Criteria:\n\n* Patients who had been on ARV therapy for more than 3 months.'}, 'identificationModule': {'nctId': 'NCT01058694', 'acronym': 'CAPS', 'briefTitle': 'The Impact of Short Message Services (SMS) on ARV Adherence in Western Kenya', 'organization': {'class': 'OTHER', 'fullName': 'Georgetown University'}, 'officialTitle': 'Adherence to ARV Treatment and Its Effects on Medium Run Socio-Economic Outcomes: Evidence From Western Kenya', 'orgStudyIdInfo': {'id': '2008-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Weekly SMS, brief message', 'description': 'Weekly SMS received on Monday at 12 noon', 'interventionNames': ['Behavioral: Short Message Services to Support ARV therapy adherence']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Receives a phone, but no messages.', 'interventionNames': ['Behavioral: Short Message Services to Support ARV therapy adherence']}, {'type': 'EXPERIMENTAL', 'label': 'Daily SMS, Brief message', 'description': 'Receive daily brief message at 12 noon: "This is your reminder"', 'interventionNames': ['Behavioral: Short Message Services to Support ARV therapy adherence']}, {'type': 'EXPERIMENTAL', 'label': 'Daily SMS, Long Message', 'description': 'Receive a daily long message at 12 noon: "This is your reminder + encouragement"', 'interventionNames': ['Behavioral: Short Message Services to Support ARV therapy adherence']}, {'type': 'EXPERIMENTAL', 'label': 'Weekly SMS, Long Message', 'description': 'Weekly message sent at 12 noon on Mondays: "This is your reminder + encouragement"', 'interventionNames': ['Behavioral: Short Message Services to Support ARV therapy adherence']}], 'interventions': [{'name': 'Short Message Services to Support ARV therapy adherence', 'type': 'BEHAVIORAL', 'description': 'Short message services were sent to randomly selected consenting subjects on ARV therapy. The frequency and content of the message is varied in a factorial design.', 'armGroupLabels': ['Control Group', 'Daily SMS, Brief message', 'Daily SMS, Long Message', 'Weekly SMS, Long Message', 'Weekly SMS, brief message']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kisumu', 'state': 'Maseno District', 'country': 'Kenya', 'facility': 'Chulaimbo Rural Health Center', 'geoPoint': {'lat': -0.10221, 'lon': 34.76171}}], 'overallOfficials': [{'name': 'John Sidle, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}, {'name': 'Duncan Ngare, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Moi University'}, {'name': 'Harsha Thirumurthy, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina'}, {'name': 'Markus Goldstein, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'World Bank'}, {'name': 'Joshua Graff-Zivin, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego'}, {'name': 'Damien de Walque, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'World Bank'}, {'name': 'Cristian Pop-Eleches, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}, {'name': 'David Bangsberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harvard Medical School (HMS and HSDM)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Georgetown University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Moi Univeristy', 'class': 'OTHER'}, {'name': 'World Bank', 'class': 'OTHER'}, {'name': 'Indiana University', 'class': 'OTHER'}, {'name': 'Harvard University', 'class': 'OTHER'}, {'name': 'Columbia University', 'class': 'OTHER'}, {'name': 'University of California, San Diego', 'class': 'OTHER'}, {'name': 'University of North Carolina', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'James Habyarimana, PhD/Assistant Professor', 'oldOrganization': 'Georgetown Public Policy Institute'}}}}