HIV Health Literacy Clinical Trial
Official title:
Facilitating HIV/AIDS and HIV Testing Literacy for Emergency Department Patients
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.
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.
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