Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2026-02-24 @ 3:14 PM
Study NCT ID:
NCT01910493
Status:
COMPLETED
Last Update Posted:
2013-07-29
First Post:
2013-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Impact of Mobile Phone Messages on ART and PMTCT Adherence in Mozambique
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006679', 'term': 'HIV Seropositivity'}], 'ancestors': [{'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': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1352}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-25', 'studyFirstSubmitDate': '2013-07-25', 'studyFirstSubmitQcDate': '2013-07-25', 'lastUpdatePostDateStruct': {'date': '2013-07-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retention in ART care', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Retention in PMTCT care', 'timeFrame': 'until 8 weeks post partum'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['mhealth', 'mobile health', 'SMS', 'SMS reminders', 'ART retention in care', 'PMTCT', 'PMTCT cascade', 'retention in care'], 'conditions': ['HIV-positive']}, 'descriptionModule': {'briefSummary': 'Mobile phone SMS are increasingly used to promote positive health behaviour with an aim to improve health outcomes. However, robust data on the efficacy of SMS on health seeking behaviour and patient outcomes in resource-limited settings is sparse. The SMSaude study aims to assess whether regular SMS-reminders improve retention on antiretroviral therapy (ART) and prevention of mother to child transmission of HIV (PMTCT) programmes in Mozambique.', 'detailedDescription': "SMSaúde is a multisite randomised clinical trial of HIV-infected adults on ART and HIV-infected pregnant women in six clinics in Maputo Province, Mozambique. Eligibility criteria include: currently residing in the province; no plans to move for 12+ months; have own cell-phone; literate; 8-28 weeks pregnant (PMTCT cohort); on first line ART and on ART for \\>15 days (ART cohort). Patients were interviewed for eligibility, and then randomized (1:1). SMS reminders are sent to the intervention group using software that picks up the patient's next appointment from the electronic patient database. Primary outcomes tested were improved retention in ART care and uptake of all PMTCT services."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* On ART for \\>15 days (for ART only)\n* Live in province and plan to stay for 12+ months\n* Have cell phone\n* Literate\n\nFor PMTCT (in addition to above criteria):\n\n\\- pregnant between 8-28 weeks\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01910493', 'acronym': 'SMSaude', 'briefTitle': 'Evaluation of the Impact of Mobile Phone Messages on ART and PMTCT Adherence in Mozambique', 'organization': {'class': 'OTHER', 'fullName': 'Absolute Return for Kids'}, 'officialTitle': 'Evaluation of the Impact of Mobile Phone Messages on ART and PMTCT Adherence in Mozambique: A Randomized Control Trial', 'orgStudyIdInfo': {'id': 'SMSaude01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ART no SMS reminders', 'description': 'control group', 'interventionNames': ['Behavioral: SMS reminders']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PMTCT no SMS reminders', 'description': 'control group', 'interventionNames': ['Behavioral: SMS reminders']}, {'type': 'EXPERIMENTAL', 'label': 'SMS reminders to PMTCT cohort', 'description': 'experimental group', 'interventionNames': ['Behavioral: SMS reminders']}, {'type': 'EXPERIMENTAL', 'label': 'SMS reminders to ART cohort', 'description': 'experimental group', 'interventionNames': ['Behavioral: SMS reminders']}], 'interventions': [{'name': 'SMS reminders', 'type': 'BEHAVIORAL', 'description': 'Intervention participants only will be sent text messages to their phones. The content of text messages will have a maximum of 160 characters and not mention HIV and will state the dates for the forthcoming consultations, visits to the pharmacy, lab results, time to take medication and reminders for patients who miss appointments.', 'armGroupLabels': ['ART no SMS reminders', 'PMTCT no SMS reminders', 'SMS reminders to ART cohort', 'SMS reminders to PMTCT cohort']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Matola, Xinavane, Machava and Namaacha', 'state': 'Maputo', 'country': 'Mozambique', 'facility': '6 Health Facilities'}], 'overallOfficials': [{'name': 'Cesar de Palha, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Eduardo Mondlane'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Absolute Return for Kids', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vodacom', 'class': 'UNKNOWN'}, {'name': 'United States Agency for International Development (USAID)', 'class': 'FED'}, {'name': 'Department for International Development, United Kingdom', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}