NCT00676481

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
570

participants targeted

Target at P75+ for not_applicable hiv-infections

Timeline
Completed

Started Jul 2004

Longer than P75 for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 13, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

March 9, 2015

Status Verified

May 1, 2008

Enrollment Period

4.7 years

First QC Date

May 9, 2008

Last Update Submit

March 5, 2015

Conditions

HIV Infections

Keywords

Patient EducationEmergency MedicineHIV PreventionHIV Seronegativity

Outcome Measures

Primary Outcomes (1)

  • Willingness of participant to have HIV testing

    Throughout study

Secondary Outcomes (1)

  • Participant comprehension of rapid HIV pre-test information

    Throughout study

Study Arms (2)

1

ACTIVE COMPARATOR

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

Behavioral: HIV risk education

2

NO INTERVENTION

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

Interventions

HIV risk educationBEHAVIORAL

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

1

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • English-speaking
  • Subcritical illness or injury

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Hospital Emergency Department

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Roland C Merchant, MD, MPH, ScD

    Rhode Island Hospital/Warren Alpert Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2008

First Posted

May 13, 2008

Study Start

July 1, 2004

Primary Completion

March 1, 2009

Study Completion

June 1, 2009

Last Updated

March 9, 2015

Record last verified: 2008-05

Locations

US(1)