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Facilitating HIV/AIDS and HIV Testing Literacy for Emergency Department Patients

Primary Purpose

HIV Health Literacy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Video or Pictorial Brochure
Sponsored by
Rhode Island Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for HIV Health Literacy focused on measuring HIV/AIDS and HIV Testing Knowledge

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18-64 years old; English or Spanish speaking

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    English HIGH Health Literacy

    English LOW Health Literacy

    Spanish HIGH Health Literacy

    Spanish LOW Health Literacy

    Arm 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.

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Change from Baseline in HIV/AIDS and HIV testing knowledge questionnaire
    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. Improvement of knowledge is: Greatest in the video arm who primarily speak English and have higher health literacy Greatest in the video arm among English speakers or higher health literacy patients Greater in the video arm than the pictorial brochure regardless of language and health literacy level The same despite information delivery mode, language, and health literacy level

    Secondary Outcome Measures

    Change from Baseline in HIV/AIDS and HIV testing knowledge questionnaire at 12 months
    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. Retention of knowledge is: Greatest in the video arm who primarily speak English and have higher health literacy Greatest in the video arm among English speakers or higher health literacy patients Greater in the video arm than the pictorial brochure regardless of language and health literacy level The same despite information delivery mode, language, and health literacy level

    Full Information

    First Posted
    October 17, 2014
    Last Updated
    May 1, 2017
    Sponsor
    Rhode Island Hospital
    Collaborators
    Brown University, Northeastern University, Olive View-UCLA Education & Research Institute, University of Alabama at Birmingham, University of Cincinnati
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02284451
    Brief Title
    Facilitating HIV/AIDS and HIV Testing Literacy for Emergency Department Patients
    Official Title
    Facilitating HIV/AIDS and HIV Testing Literacy for Emergency Department Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2015 (undefined)
    Primary Completion Date
    January 2019 (Anticipated)
    Study Completion Date
    June 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Rhode Island Hospital
    Collaborators
    Brown University, Northeastern University, Olive View-UCLA Education & Research Institute, University of Alabama at Birmingham, University of Cincinnati

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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. The 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.
    Detailed Description
    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. The 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. At 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. As 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). As 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. Study 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV Health Literacy
    Keywords
    HIV/AIDS and HIV Testing Knowledge

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    English HIGH Health Literacy
    Arm Type
    Active Comparator
    Arm 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.
    Arm Title
    English LOW Health Literacy
    Arm Type
    Active Comparator
    Arm 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.
    Arm Title
    Spanish HIGH Health Literacy
    Arm Type
    Active Comparator
    Arm 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.
    Arm Title
    Spanish LOW Health Literacy
    Arm Type
    Active Comparator
    Arm 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.
    Intervention Type
    Other
    Intervention Name(s)
    Video or Pictorial Brochure
    Intervention 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).
    Primary Outcome Measure Information:
    Title
    Change from Baseline in HIV/AIDS and HIV testing knowledge questionnaire
    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. Improvement of knowledge is: Greatest in the video arm who primarily speak English and have higher health literacy Greatest in the video arm among English speakers or higher health literacy patients Greater in the video arm than the pictorial brochure regardless of language and health literacy level The same despite information delivery mode, language, and health literacy level
    Time Frame
    Day 1
    Secondary Outcome Measure Information:
    Title
    Change from Baseline in HIV/AIDS and HIV testing knowledge questionnaire at 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. Retention of knowledge is: Greatest in the video arm who primarily speak English and have higher health literacy Greatest in the video arm among English speakers or higher health literacy patients Greater in the video arm than the pictorial brochure regardless of language and health literacy level The same despite information delivery mode, language, and health literacy level
    Time Frame
    12 Months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 18-64 years old; English or Spanish speaking Exclusion Criteria: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Roland C Merchant, MD
    Organizational Affiliation
    Rhode Island Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    32200999
    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.
    Results Reference
    derived
    PubMed Identifier
    29986662
    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.
    Results Reference
    derived

    Learn more about this trial

    Facilitating HIV/AIDS and HIV Testing Literacy for Emergency Department Patients

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