Clinical trial NCT00676481: Rapid HIV Testing for Emergency Department Patients
Official title: Rapid HIV Testing for Emergency Department Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Patient Education
Emergency Medicine
HIV Prevention
HIV Seronegativity
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2008-05-13
Enrollment: 570
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The purpose of this study is to test data collection options in emergency departments (EDs) and to enhance ED patient awareness of the risk of HIV infection.

Detailed description: Rapid HIV testing is a new technology that speeds receipt of HIV test results. Its use in EDs has been demonstrated, but patient acceptance of rapid testing in the ED has not been optimal. It is likely that the low acceptance is partially due to ED patients not realizing the risk of acquiring an HIV infection or the importance of knowing their HIV status. The purpose of this study is to test data collection options in EDs and to enhance ED patient awareness of the risk for HIV infection.

This three phase study will take place at the Rhode Island Hospital Emergency Department. Each participant will be followed for the duration of their ED visit.

In Phase I, the proportion of participants who are willing to undergo rapid HIV testing in the ED will be measured. Additionally, the HIV testing history of these participants, their reasons for undergoing testing or for never having been tested for HIV, and factors associated with acceptance or decline of testing and history of HIV testing will be determined. An educational video will be developed and used to investigate its effectiveness in convincing participants to have the rapid HIV test. All participants agreeing to undergo a rapid HIV test will receive a survey to complete.

In Phase II, a questionnaire and feedback tool to make participants aware of their risk for an HIV infection through injection drug use and sex will be developed and investigated.

In Phase III, the questionnaire and feedback tool developed in Phase II will be used to determine whether or not making participants aware of their risk for an HIV infection increases their acceptance of being tested for HIV in the ED. Participants in Arm 1 will receive the questionnaire and feedback tool while participants in Arm 2 will not.

Eligibility criteria: Inclusion Criteria:

* English-speaking
* Subcritical illness or injury

Exclusion Criteria:

* Critical illness or injury
* Mental or physical disability
* Known HIV infection
* Participation in an HIV vaccine study
* Prison inmate
* Acute psychiatric illness that, in the opinion of the investigator, would prevent the participant from completing the study

Primary outcomes:
measure: Willingness of participant to have HIV testing
timeFrame: Throughout study
Secondary outcomes:
measure: Participant comprehension of rapid HIV pre-test information
timeFrame: Throughout study
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital Emergency Department
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital/Warren Alpert Medical School
name: Roland C Merchant, MD, MPH, ScD
role: PRINCIPAL_INVESTIGATOR
References: