Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-03-05 @ 9:50 AM
Study NCT ID:
NCT01917994
Status:
COMPLETED
Last Update Posted:
2017-02-08
First Post:
2013-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Text Messaging Intervention to Improve Retention in Care and Virologic Suppression in an Urban HIV-Infected Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010349', 'term': 'Patient Compliance'}], 'ancestors': [{'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': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 230}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-06', 'studyFirstSubmitDate': '2013-08-01', 'studyFirstSubmitQcDate': '2013-08-05', 'lastUpdatePostDateStruct': {'date': '2017-02-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Time to Virologic Suppression', 'timeFrame': '12 month'}, {'measure': 'Sustained virologic suppression', 'timeFrame': '12 month'}], 'primaryOutcomes': [{'measure': 'Viral Load', 'timeFrame': '12 month'}], 'secondaryOutcomes': [{'measure': 'Missed Visit Proportion', 'timeFrame': '12 month', 'description': 'Number of missed or "no show" visits divided by number of scheduled appointments'}, {'measure': 'Appointment Adherence', 'timeFrame': '12 month', 'description': "Each participant's proportion of kept appts divided by scheduled appts (mean of the proportions)"}, {'measure': 'Visit Constancy', 'timeFrame': '12 month', 'description': 'At least one kept visit in each six-month period'}, {'measure': 'Attended All Scheduled Visits', 'timeFrame': '12 month', 'description': 'Attended all scheduled visits'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['HIV', 'Patient Adherence', 'Mobile Technology']}, 'referencesModule': {'references': [{'pmid': '25551175', 'type': 'BACKGROUND', 'citation': 'Christopoulos KA, Riley ED, Tulsky J, Carrico AW, Moskowitz JT, Wilson L, Coffin LS, Falahati V, Akerley J, Hilton JF. A text messaging intervention to improve retention in care and virologic suppression in a U.S. urban safety-net HIV clinic: study protocol for the Connect4Care (C4C) randomized controlled trial. BMC Infect Dis. 2014 Dec 31;14:718. doi: 10.1186/s12879-014-0718-6.'}, {'pmid': '29474546', 'type': 'DERIVED', 'citation': 'Christopoulos KA, Riley ED, Carrico AW, Tulsky J, Moskowitz JT, Dilworth S, Coffin LS, Wilson L, Johnson-Peretz J, Hilton JF. A Randomized Controlled Trial of a Text Messaging Intervention to Promote Virologic Suppression and Retention in Care in an Urban Safety-Net Human Immunodeficiency Virus Clinic: The Connect4Care Trial. Clin Infect Dis. 2018 Aug 16;67(5):751-759. doi: 10.1093/cid/ciy156.'}]}, 'descriptionModule': {'briefSummary': 'Retention in care and virologic suppression are the key final steps of the HIV treatment cascade. Poor or intermittent retention has been associated with later initiation of antiretroviral therapy, virologic failure, and death. Regular HIV care has also been associated with a decrease in HIV transmission risk behavior. Despite the proven health and prevention benefits of consistent HIV care, only 40-50% of those infected with HIV in the United States are estimated to meet current retention in care standards and even fewer - only about 25% - are estimated to be virologically suppressed.\n\nThe Behavioral Model for Vulnerable Populations provides a useful framework for understanding broad areas that may impact adherence to care and treatment. Individual-level domains include vulnerable (e.g., depression, stigma), enabling (e.g., social support, positive affect), and need (e.g., co-morbidities) factors, and structural domains include, for example, features or the clinic and the provider-patient relationship.\n\nShort message service (SMS) technology represents a new and exciting tool to help retain HIV-infected patients in care and treatment. SMS interventions have been deployed successfully in support of antiretroviral adherence and virologic suppression in sub-Saharan Africa, where two randomized trials have showed clear benefits. A pilot study conducted in our clinic suggests that use of SMS messages to promote adherence to care and treatment in the urban HIV-infected poor is both feasible and acceptable.\n\nThe investigators believe that combining SMS technology with content-specific messages designed to impact factors highlighted in the Behavioral Model for Vulnerable Populations can improve retention in care and virologic suppression for an urban public hospital population living with HIV, thus the investigators propose the following specific aims.\n\nSpecific Aim 1: Determine whether a behavioral theory-based SMS intervention improves virologic suppression \\[primary outcome\\] and retention in care \\[secondary outcome\\] for a vulnerable urban HIV-infected population through a randomized trial of this technology compared to SMS appointment reminders alone. Retention in care will also be analyzed as a mediator of virologic suppression. Exploratory outcomes include time to virologic suppression, sustained virologic suppression, emergency department utilization and antiretroviral adherence, as well as levels of depression, positive affect, social support and empowerment.\n\nSpecific Aim 2: Examine patient experiences with the SMS intervention, focusing specifically on: 1) satisfaction with this technology; 2) identifying barriers to and facilitators of patient use of this technology, and; 3) the preferred frequency and content of intervention messages.\n\nSpecific Aim 3: Conduct cost and cost-effectiveness analyses of the SMS intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-infected\n* Age 18 or over\n* English-speaking\n* Able to give informed consent\n* Have a cell phone and willing to send/receive up to 25 text messages/month\n* Detectable viral load plus either 1) new to clinic (no more than 2 primary care visits) or 2) history of poor retention (one missed visit or lack of six-month visit constancy in the past year)\n\nExclusion Criteria:\n\n* HIV-uninfected\n* Under age 18\n* Monolingual speaker of a language other than English\n* Unable to give informed consent\n* Undetectable viral load\n* Perfect appointment adherence'}, 'identificationModule': {'nctId': 'NCT01917994', 'acronym': 'Connect4Care', 'briefTitle': 'Text Messaging Intervention to Improve Retention in Care and Virologic Suppression in an Urban HIV-Infected Population', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Seek Test Treat Retain Strategies Leveraging Mobile Health Technologies', 'orgStudyIdInfo': {'id': 'R01DA032057', 'link': 'https://reporter.nih.gov/quickSearch/R01DA032057', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Text Messages + Appointment Reminders', 'description': 'Participants in the intervention arm will receive supportive, informational, or motivational text messages three times a week for one year in addition to text message reminders about HIV primary care appointments.', 'interventionNames': ['Behavioral: Text Messages', 'Behavioral: Appointment Reminders']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Appointment Reminders', 'description': 'Participants in the control arm will receive text messages reminding them of HIV primary care appointments 48 hours before the scheduled appointment.', 'interventionNames': ['Behavioral: Appointment Reminders']}], 'interventions': [{'name': 'Text Messages', 'type': 'BEHAVIORAL', 'description': 'The intervention consists of supportive, informational, and motivational text messages three times a week targeting the following domains: promoting a sense of connectedness to the clinic, fostering social support, building empowerment, ameliorating negative affect, cultivating positive affect, and promoting healthy behaviors and adherence to antiretroviral medication.', 'armGroupLabels': ['Text Messages + Appointment Reminders']}, {'name': 'Appointment Reminders', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Appointment Reminders', 'Text Messages + Appointment Reminders']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco General Hospital Positive Health Program', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Katerina Christopoulos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}