Rapid HIV Testing for Emergency Department Patients

NCT ID: NCT00676481

Last Updated: 2015-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 570 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2009-06-30

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.

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

1

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

Group Type: ACTIVE_COMPARATOR

HIV risk education

Intervention Type: BEHAVIORAL

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

2

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roland C Merchant, MD, MPH, ScD

Role: PRINCIPAL_INVESTIGATOR

Rhode Island Hospital/Warren Alpert Medical School

Locations

Rhode Island Hospital Emergency Department

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

K23 A1060363

Identifier Type: -

Identifier Source: secondary_id

U65/CCU124504

Identifier Type: -

Identifier Source: secondary_id

K23 A1060363

Identifier Type: -

Identifier Source: org_study_id