Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-03-09 @ 2:45 AM
Study NCT ID:
NCT02938533
Status:
COMPLETED
Last Update Posted:
2017-10-30
First Post:
2016-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Social Norms and Priming to Improve Adherence to Antiretroviral Therapy and Retention in Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 438}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-26', 'studyFirstSubmitDate': '2016-10-11', 'studyFirstSubmitQcDate': '2016-10-17', 'lastUpdatePostDateStruct': {'date': '2017-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retention in care, defined as an attended visit between 150-210 days after the baseline visit', 'timeFrame': '6 months', 'description': 'This measure of retention in care accounts for variability in visit scheduling by individual providers and therefore uses a window period of 150-210 days to determine whether the patient was in care at 6 months'}, {'measure': '>=95% medication possession ratio (MPR)', 'timeFrame': '6 months', 'description': 'MPR is a measure of ART adherence that is correlated with viral suppression'}], 'secondaryOutcomes': [{'measure': 'The proportion of scheduled visits that were completed during the 6-month observation period', 'timeFrame': '6 months'}, {'measure': 'Medication possession ratio (MPR), continuous scale', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['HIV Infection', 'Adherence']}, 'referencesModule': {'references': [{'pmid': '28486553', 'type': 'DERIVED', 'citation': 'McCoy SI, Fahey C, Rao A, Kapologwe N, Njau PF, Bautista-Arredondo S. Pilot study of a multi-pronged intervention using social norms and priming to improve adherence to antiretroviral therapy and retention in care among adults living with HIV in Tanzania. PLoS One. 2017 May 9;12(5):e0177394. doi: 10.1371/journal.pone.0177394. eCollection 2017.'}]}, 'descriptionModule': {'briefSummary': "Interventions incorporating constructs from behavioral economics and psychology have the potential to enhance HIV 'treatment as prevention' (TasP) strategies. To test this hypothesis, the investigators evaluated a combination intervention to improve antiretroviral therapy (ART) adherence based on the concepts of social norms and priming.", 'detailedDescription': 'The investigators conducted a quasi-experimental pilot study of a combination behavioral intervention based on the concepts of social norms and priming. The intervention included visual feedback about clinic-level retention in care, a self-relevant prime, and useful take-home items with the priming image. The intervention was developed using tools from marketing research and patient-centered design. The hypothesis was that the intervention would improve retention in care and adherence to ART among patients living with HIV infection (PLHIV). The intervention was implemented at two HIV primary clinics in Shinyanga, Tanzania in 2-week intervals for six months. The investigators reviewed medical records of a random sample of exposed and unexposed adult PLHIV to compare retention and the proportion of patients with medication possession ratio (MPR) ≥95% after six months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. At least 18 years of age\n2. Living with HIV infection\n3. Receiving HIV primary care at one of the two study clinics'}, 'identificationModule': {'nctId': 'NCT02938533', 'briefTitle': 'Social Norms and Priming to Improve Adherence to Antiretroviral Therapy and Retention in Care', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Berkeley'}, 'officialTitle': 'Pilot Study of a Multi-Pronged Intervention Using Social Norms and Priming to Improve Adherence to Antiretroviral Therapy and Retention in Care Among Adults Living With HIV in Tanzania', 'orgStudyIdInfo': {'id': 'OPP1118511'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'Standard HIV primary care services available at HIV care and treatment clinics in Tanzania.'}, {'type': 'EXPERIMENTAL', 'label': 'Behavioral Intervention Using Social Norms and Priming', 'description': 'Patients in this arm may have been exposed to the behavioral intervention, which included the following components: 1) visual feedback about clinic-level retention in care through an interactive poster; 2) a self-relevant priming image that appeared on all components; and 3) a take-home item (i.e., pillbox or calendar) with the priming image.', 'interventionNames': ['Behavioral: Intervention']}], 'interventions': [{'name': 'Intervention', 'type': 'BEHAVIORAL', 'description': 'The intervention includes a clinic-based component and a take-home component. All components include the priming image of a Baobab tree. The clinic-based component is an interactive poster that rewarded appointment attendance. Patients who attend three consecutive on-time visits are congratulated and given a colored sticker to place on a poster that is publicly displayed at the clinic. In one clinic, the take-home component is a 2015 calendar in Kiswahili that contained the priming Baobab image. In the other clinic, the take-home component is a small plastic pillbox featuring the Baobab logo.', 'armGroupLabels': ['Behavioral Intervention Using Social Norms and Priming']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kahama', 'state': 'Shinyanga', 'country': 'Tanzania', 'facility': 'Bugsi Dispensary', 'geoPoint': {'lat': -3.83333, 'lon': 32.6}}, {'city': 'Shinyanga', 'country': 'Tanzania', 'facility': 'Tinde Health Center', 'geoPoint': {'lat': -3.66393, 'lon': 33.42118}}], 'overallOfficials': [{'name': 'Sandra I McCoy, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Berkeley'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Berkeley', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Tanzania', 'class': 'OTHER_GOV'}, {'name': 'Mexican National Institute of Public Health', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}