Rapid HIV Testing for Emergency Department Patients

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Overall Status
Completed
CT.gov ID
NCT00676481
Collaborator
Centers for Disease Control and Prevention (U.S. Fed)
570
1
2
59
9.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: HIV risk education
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
570 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Screening
Official Title:
Rapid HIV Testing for Emergency Department Patients
Study Start Date :
Jul 1, 2004
Actual Primary Completion Date :
Mar 1, 2009
Actual Study Completion Date :
Jun 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

Phase III participants who are educated about risk of HIV infection before receiving a rapid HIV test

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

No Intervention: 2

Phase III participants who are not educated about risk of HIV infection before receiving a rapid HIV test

Outcome Measures

Primary Outcome Measures

  1. Willingness of participant to have HIV testing [Throughout study]

Secondary Outcome Measures

  1. Participant comprehension of rapid HIV pre-test information [Throughout study]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rhode Island Hospital Emergency Department Providence Rhode Island United States 02903

Sponsors and Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)
  • Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Roland C Merchant, MD, MPH, ScD, Rhode Island Hospital/Warren Alpert Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00676481
Other Study ID Numbers:
  • K23 A1060363
  • K23 A1060363
  • U65/CCU124504
First Posted:
May 13, 2008
Last Update Posted:
Mar 9, 2015
Last Verified:
May 1, 2008
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID)
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 9, 2015