Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-02-26 @ 12:43 AM
Study NCT ID:
NCT02284451
Status:
UNKNOWN
Last Update Posted:
2017-05-02
First Post:
2014-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Facilitating HIV/AIDS and HIV Testing Literacy for Emergency Department Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], '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': 'D012897', 'term': 'Slow 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': 'D014743', 'term': 'Videotape Recording'}], 'ancestors': [{'id': 'D013637', 'term': 'Tape Recording'}, {'id': 'D001296', 'term': 'Audiovisual Aids'}, {'id': 'D018961', 'term': 'Educational Technology'}, {'id': 'D013672', 'term': 'Technology'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D013690', 'term': 'Television'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-01', 'studyFirstSubmitDate': '2014-10-17', 'studyFirstSubmitQcDate': '2014-11-03', 'lastUpdatePostDateStruct': {'date': '2017-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in HIV/AIDS and HIV testing knowledge questionnaire', 'timeFrame': 'Day 1', 'description': 'The investigators will determine how short-term improvement of HIV/AIDS and HIV testing knowledge varies by information delivery mode (pictorial brochure or video), language (English or Spanish) and health literacy level (lower or higher) per four alternative hypotheses.\n\nImprovement of knowledge is:\n\n1. Greatest in the video arm who primarily speak English and have higher health literacy\n2. Greatest in the video arm among English speakers or higher health literacy patients\n3. Greater in the video arm than the pictorial brochure regardless of language and health literacy level\n4. The same despite information delivery mode, language, and health literacy level'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in HIV/AIDS and HIV testing knowledge questionnaire at 12 months', 'timeFrame': '12 Months', 'description': 'The investigators will determine how longer-term retention of HIV/AIDS and HIV testing knowledge varies by information delivery mode (pictorial brochure or video), language (English or Spanish) and health literacy level (lower or higher) per four alternative hypotheses.\n\nRetention of knowledge is:\n\n1. Greatest in the video arm who primarily speak English and have higher health literacy\n2. Greatest in the video arm among English speakers or higher health literacy patients\n3. Greater in the video arm than the pictorial brochure regardless of language and health literacy level\n4. The same despite information delivery mode, language, and health literacy level'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV/AIDS and HIV Testing Knowledge'], 'conditions': ['HIV Health Literacy']}, 'referencesModule': {'references': [{'pmid': '32200999', 'type': 'DERIVED', 'citation': 'Merchant RC, Marks SJ, Clark MA, Carey MP, Liu T. Limited Ability of Three Health Literacy Screening Items to Identify Adult English- and Spanish-Speaking Emergency Department Patients With Lower Health Literacy. Ann Emerg Med. 2020 Jun;75(6):691-703. doi: 10.1016/j.annemergmed.2020.01.019. Epub 2020 Mar 20.'}, {'pmid': '29986662', 'type': 'DERIVED', 'citation': 'Merchant RC, Liu T, Clark MA, Carey MP. Facilitating HIV/AIDS and HIV testing literacy for emergency department patients: a randomized, controlled, trial. BMC Emerg Med. 2018 Jul 9;18(1):21. doi: 10.1186/s12873-018-0172-7.'}]}, 'descriptionModule': {'briefSummary': 'The Centers for Disease Control and Prevention (CDC) recommends that all patients should receive information about HIV/AIDS and HIV testing orally or in writing at every HIV testing encounter. However, for busy emergency departments (EDs), delivering information orally is a barrier to HIV testing, and written brochures likely are not useful for those with lower health or general literacy. Videos might be as or more efficacious than orally-delivered information in improving HIV/AIDS and HIV testing knowledge, particularly for those with lower health literacy skills. However, the resources required to show videos might limit their use in EDs. Pictorial brochures are a promising alternative, but are of unknown efficacy.\n\nThe objectives of this study are to: (1) determine if HIV/AIDS and HIV testing information should be delivered by a video or pictorial brochure to emergency department (ED) patients to improve short-term (in the ED) knowledge about HIV/AIDS and HIV testing; (2) determine if longer-term retention (over 12 months) of HIV/AIDS and HIV testing knowledge is greater for those who watch a video or review a pictorial brochure; (3) determine if short-term improvement and longer-term retention in HIV/AIDS and HIV testing knowledge is better after watching a video or reviewing a pictorial brochure for those with lower health literacy, and if improvement and retention also varies by language spoken (English or Spanish); and (4) if willingness to be tested again in one year is greater for those who watch the video or review the pictorial brochure, and if this willingness also varies by health literacy level and language spoken.', 'detailedDescription': 'Regardless of how patients are informed, the investigators do not know how well or for how long HIV/AIDS and HIV testing knowledge is retained, if this information should be delivered according to patient needs and abilities, and if retention of this knowledge impacts future HIV testing behavior.\n\nThe investigators will conduct a multi-site, randomized, controlled, longitudinal trial among 600 English- and 600 Spanish-speaking 18-64-year-old ED patients to investigate these questions. Using a valid measure of health literacy, the investigators will stratify our sample within language by health literacy level (lower vs. higher). The investigators will randomly assign patients to receive HIV/AIDS and HIV testing information by video or pictorial brochure. At one year post-enrollment, the investigators will offer participants an opportunity to be tested again for HIV.\n\nAt each study site (Birmingham,Cincinnati, Los Angeles, and Providence), the investigators will recruit 300 patients for a total of 1200 patients. Participants will be randomly assigned to receive HIV/AIDS and HIV testing information from a comparable pictorial brochure or a video. Randomization will be stratified by health literacy level (lower vs. higher) and language (English or Spanish). Those who are study eligible will undergo verbal consent to conduct the pre- and post-information questionnaires and information delivery portions of the study (video or pictorial brochure). No patient identifiers will be collected during the screening process, pre- or post-information questionnaires, or the information delivery phase of the study. For those who agree to be in the next portion of the study, written consent to participate will be obtained. Written consent will be obtained at this juncture because HIV testing and follow-up is performed, and because patient identifiers are needed for the remainder of the study. Participants will complete the study instruments at enrollment and at 3, 6, 9, and 12 months follow-up. At the end of one year, they will be offered the opportunity to be retested for HIV.\n\nAs primary aims, the investigators will compare the efficacy of pictorial brochures and videos in improving short-term (in ED) HIV/AIDS and HIV testing knowledge and retaining this knowledge over 12 months. More specifically, the investigators will determine if and how short-term improvement and longer-term retention of knowledge interacts with information delivery mode (pictorial brochure or video), patient health literacy level (lower or higher) and language (English or Spanish).\n\nAs secondary aims, using the Information-Motivation-Behavioral Skills (IMB model as a heuristic framework, the investigators will examine components of the IMB model relevant to our study and their interrelationships, their impact on HIV re-testing behavior, and the moderating influence of information delivery mode, language and health literacy level through the model. In regards to HIV re-testing behaviors, the investigators will assess: (1) testing uptake at one year post-enrollment when offered as part of the study, (2) testing utilization during the study period but not as part of the study, and (3) change in testing utilization one year pre vs. post study enrollment.\n\nStudy findings will guide ED-based delivery of HIV/AIDS and HIV testing information; that is, whether delivery modes (video or pictorial brochure) should be selected for patients by language and/or health literacy level, or whether either mode could be used. The results also will inform EDs when, how, and for whom information needs to be provided for those testing again for HIV within one year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-64 years old; English or Spanish speaking\n\nExclusion Criteria:\n\n* HIV positive; In an HIV vaccine trial; On HIV pre-exposure prophylaxis medication; In an HIV testing study; No personal telephone; Outside of the United States over next year'}, 'identificationModule': {'nctId': 'NCT02284451', 'briefTitle': 'Facilitating HIV/AIDS and HIV Testing Literacy for Emergency Department Patients', 'organization': {'class': 'OTHER', 'fullName': 'Rhode Island Hospital'}, 'officialTitle': 'Facilitating HIV/AIDS and HIV Testing Literacy for Emergency Department Patients', 'orgStudyIdInfo': {'id': '1R01NR014782-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01NR014782-01A1', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'English HIGH Health Literacy', 'description': 'Using a valid measure of health literacy, 300 participants will be randomized into this group. These participants will receive HIV/AIDS and HIV testing information either by video or pictorial brochure in two equal groups.', 'interventionNames': ['Other: Video or Pictorial Brochure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'English LOW Health Literacy', 'description': 'Using a valid measure of health literacy, 300 participants will be randomized into this group. These participants will receive HIV/AIDS and HIV testing information either by video or pictorial brochure in two equal groups.', 'interventionNames': ['Other: Video or Pictorial Brochure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Spanish HIGH Health Literacy', 'description': 'Using a valid measure of health literacy, 300 participants will be randomized into this group. These participants will receive HIV/AIDS and HIV testing information either by video or pictorial brochure in two equal groups.', 'interventionNames': ['Other: Video or Pictorial Brochure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Spanish LOW Health Literacy', 'description': 'Using a valid measure of health literacy, 300 participants will be randomized into this group. These participants will receive HIV/AIDS and HIV testing information either by video or pictorial brochure in two equal groups.', 'interventionNames': ['Other: Video or Pictorial Brochure']}], 'interventions': [{'name': 'Video or Pictorial Brochure', 'type': 'OTHER', 'description': 'Participants will receive HIV/AIDS and HIV testing information by video or by pictorial brochure according to patient health literacy level (lower or higher) and language (English or Spanish).', 'armGroupLabels': ['English HIGH Health Literacy', 'English LOW Health Literacy', 'Spanish HIGH Health Literacy', 'Spanish LOW Health Literacy']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Roland C Merchant, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rhode Island Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rhode Island Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Brown University', 'class': 'OTHER'}, {'name': 'Northeastern University', 'class': 'OTHER'}, {'name': 'Olive View-UCLA Education & Research Institute', 'class': 'OTHER'}, {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, {'name': 'University of Cincinnati', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}