Rapid HIV Testing for Emergency Department Patients

HIV Infections Clinical Trial

Official title:

Rapid HIV Testing for Emergency Department Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00676481
• Other study ID #: K23 A1060363
• Secondary ID: K23 A1060363U65/
• Status: Completed
• Phase: N/A
• First received: May 9, 2008
• Last updated: March 5, 2015
• Start date: July 2004
• Est. completion date: June 2009

Study information

• Verified date: May 2008
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 570
• Est. completion date: June 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Screening

Related Conditions & MeSH terms

• Emergencies
• HIV Infections

Intervention

Behavioral:
• HIV risk education
Education for Phase III participants about potential risk of HIV infection before being asked to take a rapid HIV test in the ED

Locations

Country	Name	City	State
United States	Rhode Island Hospital Emergency Department	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Willingness of participant to have HIV testing		Throughout study	No
Secondary	Participant comprehension of rapid HIV pre-test information		Throughout study	No