Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
Study NCT ID:
NCT01118767
Status:
COMPLETED
Last Update Posted:
2021-11-22
First Post:
2010-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of a Computer-Based System Using Cell Phones for HIV People in Peru
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D047568', 'term': 'Unsafe Sex'}, {'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'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'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2011-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-12', 'studyFirstSubmitDate': '2010-05-06', 'studyFirstSubmitQcDate': '2010-05-06', 'lastUpdatePostDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-reported medication adherence', 'timeFrame': '12 months'}, {'measure': 'HIV-1 viral load', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'CD4', 'timeFrame': '12 months'}, {'measure': 'Self-reported HIV transmission risk behaviors', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Adherence', 'Appointment', 'Cell Phone', 'Cellular Phone', 'Clinic', 'Computers', 'Controlled Clinical Trials, Randomized', 'HIV/AIDS', 'Health Informatics', 'Health behavior', 'Information Technology', 'Internet', 'Intervention', 'Medication', 'Patient Satisfaction', 'Patient Self-Report', 'Patients', 'Peru', 'Phone', 'Public Health', 'Public Health Informatics', 'Randomized', 'Randomized Controlled Clinical Trials', 'Randomized Controlled Trials', 'Research', 'Secondary Prevention', 'Self-Report', 'Sex Behavior', 'Sexual Behavior', 'Sexually Transmitted Diseases', 'Sexually Transmitted Infection', 'Survey Instrument', 'Surveys', 'Telephone', 'Telephone, Cellular', 'Text', 'Unprotected Sex', 'Viral Load result', 'Vulnerable Populations', 'WWW', 'anti-retroviral therapy', 'consumer informatics', 'evidence base', 'follow-up', 'medication adherence', 'medication compliance', 'randomization', 'randomized controlled study', 'randomized trial', 'randomly assigned', 'safer sex', 'treatment adherence', 'user centered design', 'web', 'world wide web'], 'conditions': ['HIV', 'Adherence', 'Sexual Behavior', 'HIV Infections']}, 'descriptionModule': {'briefSummary': 'The investigators propose to develop and evaluate a computer-based intervention using cell phones to enhance adherence to antiretroviral treatment (ART) and support of HIV transmission risk-reduction among adult HIV-positive patients in Peru.', 'detailedDescription': 'Adherence to ART is critical for treatment success at the individual level and to avoid the onset of resistant strains of HIV. In Peru, where ART has recently been introduced, adherence to HIV treatment has not yet been addressed properly. Innovative approaches using information technologies such as cell phones are needed to increase adherence to ART for people with HIV/AIDS. The specific aims of the study are to: 1) Conduct formative research to assess culturally-specific behavioral messages to be included in the computer-based system; 2) Develop and test an interactive computer-based system using cell phones to enhance adherence to ART and to deliver HIV transmission risk reduction messages; 3) Evaluate the impact of the system on antiretroviral adherence and sexual risk behaviors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-positive healthy male or female aged greater than or equal to 18\n* Currently on ART\n* Patients with a mobile phone for their personal use (not shared)\n* Patients who know how to retrieve read text messages on their mobile phone\n* Signed and dated written informed consent prior to admission to the study\n\nExclusion Criteria:\n\n* Patients whose clinical condition might have interfered with the study (e.g., deafness, serious mental illness, mental retardation)\n* Patients unable to give their informed consent.'}, 'identificationModule': {'nctId': 'NCT01118767', 'acronym': 'Cell-POS', 'briefTitle': 'Evaluation of a Computer-Based System Using Cell Phones for HIV People in Peru', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Peruana Cayetano Heredia'}, 'officialTitle': 'Evaluation of a Computer-Based System Using Cell Phones for HIV People in Peru', 'orgStudyIdInfo': {'id': 'R01TW007896', 'link': 'https://reporter.nih.gov/quickSearch/R01TW007896', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01TW007896', 'link': 'https://reporter.nih.gov/quickSearch/R01TW007896', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cell phone intervention', 'description': 'Participant receives short text messages', 'interventionNames': ['Other: Cell phone intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of care', 'description': 'Participant receives standard of care support but not short text messages'}], 'interventions': [{'name': 'Cell phone intervention', 'type': 'OTHER', 'description': 'Participant receives short text messages, including: antiretroviral reminders, clinic appointment reminders, and preventive/educational messages', 'armGroupLabels': ['Cell phone intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lima', 'country': 'Peru', 'facility': 'Universidad Peruana Cayetano Heredia', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'city': 'Lima', 'country': 'Peru', 'facility': 'Via Libre', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}], 'overallOfficials': [{'name': 'Walter H Curioso, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Peruana Cayetano Heredia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Peruana Cayetano Heredia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fogarty International Center of the National Institute of Health', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Universidad Peruana Cayetano Heredia', 'investigatorFullName': 'Walter Curioso Vilchez', 'investigatorAffiliation': 'Universidad Peruana Cayetano Heredia'}}}}