Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-25 @ 5:14 PM
Study NCT ID:
NCT05606003
Status:
UNKNOWN
Last Update Posted:
2022-11-04
First Post:
2022-09-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Using a Community-level Just-in-Time Adaptive Intervention to Address COVID-19 Testing Disparities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1280}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-03', 'studyFirstSubmitDate': '2022-09-19', 'studyFirstSubmitQcDate': '2022-11-03', 'lastUpdatePostDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Testing Uptake', 'timeFrame': 'Baseline through study completion (26 months)', 'description': 'Examine the short and long-term change in testing proportion from baseline in the CBGs adjusted for testing capacity (testing proportion in the county during the same time period)'}], 'secondaryOutcomes': [{'measure': 'Disparities in Testing', 'timeFrame': 'Baseline through study completion (26 months)', 'description': 'Explore impact on testing disparities by race/ethnicity and SES'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19 testing', 'decision making', 'testing behaviors', 'vulnerable populations'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'In collaboration with community partners, this study will identify disparities and dynamics of COVID-19 testing and infections in three Texas regions; and implement a multilevel intervention that increases access to testing and referrals to follow-up care among vulnerable populations. Using a three-arm group-randomized controlled trial, this study will assess the impact of multi-level interventions influencing motivation and access to testing.\n\nThe outcomes of this study are measured at the population level and no individual data will be gathered. Analyses of de-identified PHI data from local and regional health departments on COVID testing and infection rates will be used to assess intervention outcomes.', 'detailedDescription': 'In the U.S. vulnerable populations experience significant disparities in terms of both COVID-19 infection and mortality rates, especially in Texas, where Hispanic, African Americans, and other groups have experienced substantial disparities in both incidence and mortality. Building on the partnerships and resources of the Center for Clinical and Translational Science (CCTS), the goal of the proposed project is to identify dynamic COVID-19 disease hotspots and testing deserts in racially diverse regions of South Texas, Houston/Harris County, Texas, and Northeast Texas to inform the rapid adaptation and deployment of multilevel level just-in-time adaptive intervention strategies to reduce testing disparities among vulnerable populations.\n\nA group-randomized controlled trial (RCT) will be conducted to evaluate the reach, effectiveness, and implementation of a community-level Just-In-Time-Adaptive-Intervention (JITAI) to increase COVID-19 testing in identified high-risk priority neighborhoods. To conduct the RCT, 120 priority census blocks groups will be identified and randomized to each condition using a community risk index score that balances distribution in the three study arms with respect to important characteristics including population density, demographics, and baseline testing rates.\n\nIn Intervention Condition 1 - Multi-Level Multi-Component Intervention (MLI), individuals will receive a multilevel, multi-component intervention comprising of 1) Building testing access for vulnerable populations, 2) Community Health Worker (CHW)-delivered navigation to COVID-19 testing and access and reinforcing risk mitigation recommendations; 3) 2-1-1 helpline-referrals and navigation to testing and 4) social marketing and small media campaign to provide geo-targeted messages promoting testing and COVID-19 risk mitigation behaviors. In Intervention Condition 2 - Community JITAI individuals will receive the same MLI intervention components but with an added JITAI approach informed by real-time data related to testing and other relevant information based on community and stakeholder experience and tacit knowledge about factors influencing testing determinants. The Comparison Condition will receive standard exposure to ongoing city and county communication and access to testing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* residing in identified COVID-19 hotspots and testing deserts within study regions\n* aged 18 years or older\n\nExclusion Criteria:\n\n* aged under 18 years'}, 'identificationModule': {'nctId': 'NCT05606003', 'briefTitle': 'Using a Community-level Just-in-Time Adaptive Intervention to Address COVID-19 Testing Disparities', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Using a Community-level Just-in-Time Adaptive Intervention to Address COVID-19 Testing Disparities: A Population-based Study', 'orgStudyIdInfo': {'id': 'HSC-SPH-20-1372 Main Study'}, 'secondaryIdInfos': [{'id': '3UL1TR003167', 'link': 'https://reporter.nih.gov/quickSearch/3UL1TR003167', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multi-level Multi-Component Intervention (MLI)', 'description': 'Individuals receive COVID-19 CHW-delivered education and navigation, 2-1-1 helpline referrals, and social marketing messaging.', 'interventionNames': ['Behavioral: Multi-Level Multi-Component Intervention (MLI)']}, {'type': 'EXPERIMENTAL', 'label': 'Community Just-in-Time-Adaptive Intervention (JITAI)', 'description': 'Individuals receive MLI intervention components that are informed by real-time data and community stakeholder feedback.', 'interventionNames': ['Behavioral: Community Just-In-Time Adaptive Intervention (Community JITAI)']}, {'type': 'NO_INTERVENTION', 'label': 'Comparison Condition', 'description': 'Individuals receive standard exposure to ongoing city and county COVID-19 communication and testing.'}], 'interventions': [{'name': 'Multi-Level Multi-Component Intervention (MLI)', 'type': 'BEHAVIORAL', 'description': 'The strategic components of our multi-level, multi-component intervention (MLI) include: 1. Building testing access for vulnerable populations, 2) Community Health Worker (CHW)-delivered navigation to SARSCoV- 2 testing and access and reinforce risk mitigation recommendations, 3) 2-1-1 helpline-referrals and navigation to FDA approved SARSCoV- 2 testing (and self sampling once approved) and risk mitigation education, and 4) social marketing and small media campaign to provide geo-targeted messages promoting testing and COVID risk mitigation behaviors. We selected these components because of their evidence base, their current use by partners in response to COVID 19, and confidence that they can be adapted through a community engaged process as described.', 'armGroupLabels': ['Multi-level Multi-Component Intervention (MLI)']}, {'name': 'Community Just-In-Time Adaptive Intervention (Community JITAI)', 'type': 'BEHAVIORAL', 'description': 'This intervention includes the same MLI components described above, with an added JITAI approach. Community and stakeholder partners will use real-time data related to testing and other relevant information generated by the Epidemiologic Surveillance and Analysis team (ESA) in Aim 1, as well as other information based on their community and stakeholder experience and tacit knowledge about factors influencing testing determinants, to adapt intervention activities as needed to optimize access to testing.', 'armGroupLabels': ['Community Just-in-Time-Adaptive Intervention (JITAI)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78520', 'city': 'Brownsville', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center, Brownsville', 'geoPoint': {'lat': 25.90175, 'lon': -97.49748}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75708', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center at Tyler', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}], 'overallOfficials': [{'name': 'Maria Fernandez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}, {'name': 'Belinda E Reininger, DrPh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Brownsville'}, {'name': 'David D McPherson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}, {'name': 'Paul McGaha, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Tyler'}, {'name': 'Marcia C de Oliveira Otto, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}, {'name': 'Kayo Fujimoto, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Advancing Translational Sciences (NCATS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lorne Bain Distinguished Professorship in Public Health and Director, Center for Health Promotion and Prevention Research', 'investigatorFullName': 'Maria E Fernandez', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}