NCT01258582

Brief Summary

This study was initially designed to compare the effectiveness of two different approaches to providing routine HIV counseling, testing, and referral services in an urban hospital emergency department setting. The initial phase was closed in July 2008. The second phase of this trial consists of establishing the differences in acceptability of HIV testing based on the method of testing offered (rapid oral fluid vs. fingerstick).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,651

participants targeted

Target at P75+ for not_applicable hiv-infections

Timeline
Completed

Started May 2009

Shorter than P25 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

May 1, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 13, 2010

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

June 5, 2012

Completed
Last Updated

June 13, 2012

Status Verified

May 1, 2012

Enrollment Period

8 months

First QC Date

December 10, 2010

Results QC Date

May 3, 2012

Last Update Submit

June 10, 2012

Conditions

HIV Infections

Keywords

HIVTestingHIV Seronegativity

Outcome Measures

Primary Outcomes (1)

  • Acceptability of the HIV Test

    The primary outcome measure was HIV test acceptance rate defined by the proportion of participants whom accepted HIV testing among those randomized within each trial arm (fingerstick or oral fluid).

    Assess on day subject enrolled into the study

Study Arms (2)

Oral HIV testing

EXPERIMENTAL
Procedure: Oral HIV screening

Fingerstick HIV testing

ACTIVE COMPARATOR
Procedure: Fingerstick HIV screening

Interventions

Oral HIV screeningPROCEDURE

Participants will undergo oral HIV screening and, if positive, further study visits for up to 6 months

Oral HIV testing
Fingerstick HIV screeningPROCEDURE

Participants will undergo fingerstick HIV screening and, if positive, further study visits for up to 6 months

Fingerstick HIV testing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Waiting to receive care in the Brigham and Women's Hospital emergency room
  • English- or Spanish-speaking
  • Enters the emergency room when an HIV counselor is available

You may not qualify if:

  • An estimated severity index score of 1 or 2 who have mechanical ventilation or are not deemed alert, awake, and oriented to person, place and time by the triage nurse
  • HIV infected

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Ganguli I, Collins JE, Reichmann WM, Losina E, Katz JN, Arbelaez C, Donnell-Fink LA, Walensky RP. Missed opportunities: refusal to confirm reactive rapid HIV tests in the emergency department. PLoS One. 2013;8(1):e53408. doi: 10.1371/journal.pone.0053408. Epub 2013 Jan 8.

    PMID: 23308216DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

HIV Testing

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Microbiological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Results Point of Contact

Title
Rochelle P. Walensky, MD, MPH
Organization
Massachusetts General Hospital
rwalensky@partners.org
(617) 724-8445

Study Officials

  • Rochelle P Walensky, MD, MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 10, 2010

First Posted

December 13, 2010

Study Start

May 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

June 13, 2012

Results First Posted

June 5, 2012

Record last verified: 2012-05

Locations

US(1)