Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02284451
Recruitment Status : Unknown
Verified October 2014 by Rhode Island Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : November 6, 2014
Last Update Posted : May 2, 2017
Sponsor:
Collaborators:
Brown University
Northeastern University
Olive View-UCLA Education & Research Institute
University of Alabama at Birmingham
University of Cincinnati
Information provided by (Responsible Party):
Rhode Island Hospital

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.


Condition or disease Intervention/treatment Phase
HIV Health Literacy Other: Video or Pictorial Brochure Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Facilitating HIV/AIDS and HIV Testing Literacy for Emergency Department Patients
Study Start Date : February 2015
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: English HIGH Health Literacy
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.
Other: Video or Pictorial Brochure
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).

Active Comparator: English LOW Health Literacy
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.
Other: Video or Pictorial Brochure
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).

Active Comparator: Spanish HIGH Health Literacy
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.
Other: Video or Pictorial Brochure
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).

Active Comparator: Spanish LOW Health Literacy
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.
Other: Video or Pictorial Brochure
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 Measures :
  1. Change from Baseline in HIV/AIDS and HIV testing knowledge questionnaire [ Time Frame: Day 1 ]

    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:

    1. Greatest in the video arm who primarily speak English and have higher health literacy
    2. Greatest in the video arm among English speakers or higher health literacy patients
    3. Greater in the video arm than the pictorial brochure regardless of language and health literacy level
    4. The same despite information delivery mode, language, and health literacy level


Secondary Outcome Measures :
  1. Change from Baseline in HIV/AIDS and HIV testing knowledge questionnaire at 12 months [ Time Frame: 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:

    1. Greatest in the video arm who primarily speak English and have higher health literacy
    2. Greatest in the video arm among English speakers or higher health literacy patients
    3. Greater in the video arm than the pictorial brochure regardless of language and health literacy level
    4. The same despite information delivery mode, language, and health literacy level



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02284451


Sponsors and Collaborators
Rhode Island Hospital
Brown University
Northeastern University
Olive View-UCLA Education & Research Institute
University of Alabama at Birmingham
University of Cincinnati
Investigators
Layout table for investigator information
Principal Investigator: Roland C Merchant, MD Rhode Island Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT02284451     History of Changes
Other Study ID Numbers: 1R01NR014782-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 6, 2014    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: October 2014
Keywords provided by Rhode Island Hospital:
HIV/AIDS and HIV Testing Knowledge
Additional relevant MeSH terms:
Layout table for MeSH terms
Emergencies
Disease Attributes
Pathologic Processes