NCT00119548

Brief Summary

Background: HIV testing is cost-effective in unselected general medical populations, yet testing rates among those at-risk remain low, even among those with regular primary care. HIV rapid testing is effective in many healthcare settings but scant research has been done within primary care settings, nor within the US Department of Veteran's Affairs Healthcare System. Objectives: We evaluated three methods proven effective in other diseases/settings: Nurse standing orders for testing, streamlined counseling, and HIV rapid testing. Design: Randomized, controlled trial with three intervention models: Model A (traditional counseling/testing); Model B (nurse-initiated screening, traditional counseling/testing); Model C (nurse-initiated screening, streamlined counseling/rapid testing). Participants: 251 patients with primary/urgent care appointments in two VA clinics in the same city (one large urban hospital, one freestanding outpatient clinic in a high HIV prevalence area) Measurements: Rates of HIV testing and receipt of results; sexual risk reduction; HIV knowledge improvement. Results: Testing rates were 40.2% (Model A), 84.5% (Model B), and 89.3% (Model C) (p=\<.01). Test receipt rates were 14.6% (Model A), 31.0% (Model B), 79.8% (Model C) (all p=\<.01). Sexual risk reduction and knowledge improvement did not differ significantly between counseling methods. Conclusions: Streamlined counseling with rapid testing significantly increased testing and receipt rates over current practice without changes in risk behavior or post-test knowledge. Increased testing and receipt of results could lead to earlier disease identification, increased treatment and reduced morbidity/mortality. Policymakers should consider streamlined counseling/rapid testing when implementing routine HIV testing into primary/urgent care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
251

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2005

Typical duration for not_applicable

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

March 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 13, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

April 7, 2015

Status Verified

April 1, 2009

Enrollment Period

1.8 years

First QC Date

July 5, 2005

Last Update Submit

April 6, 2015

Conditions

Keywords

HIV Rapid TestingCost-effectivenessHIV Seronegativity

Outcome Measures

Primary Outcomes (1)

  • To determine whether nurse-based referral for traditional HIV testing and counseling will improve screening rates compared to current testing procedures.To determine whether nurse-based rapid testing with streamlined counseling improves screening rates

    90 days

Secondary Outcomes (1)

  • To compare patient knowledge of HIV testing prevention practices and their views of the procedures' acceptability after traditional and rapid testing/streamlined counseling.

    4 weeks

Study Arms (3)

Arm 1

OTHER

Randomized, controlled trial with three intervention models: Model A (traditional counseling/testing);

Other: Rates of HIV testing and receipt of resultsOther: Sexual risk reduction; HIV knowledge improvement

Arm 2

OTHER

Model B (nurse-initiated screening, traditional counseling/testing);

Other: Rates of HIV testing and receipt of resultsOther: Sexual risk reduction; HIV knowledge improvement

Arm 3

OTHER

Model C (nurse-initiated screening, streamlined counseling/rapid testing).

Other: Rates of HIV testing and receipt of resultsOther: Sexual risk reduction; HIV knowledge improvement

Interventions

Rates of HIV testing and receipt of results

Arm 1

Sexual risk reduction; HIV knowledge improvement

Arm 1

Eligibility Criteria

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

You may qualify if:

  • Seeing a provider the day of recruitment Between 18-65 years of age Unaware of HIV status Has not had an HIV test in past year Able to communicate fluently in English Competent to consent to participation and HIV testing

You may not qualify if:

  • Not between 18-65 yrs. of age aware of HIV status has had HIV test within past year cannot communicate in English deemed incompetent to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073, United States

Location

Related Publications (2)

  • Pinkerton SD, Bogart LM, Howerton D, Snyder S, Becker K, Asch SM. Cost of OraQuick oral fluid rapid HIV testing at 35 community clinics and community-based organizations in the USA. AIDS Care. 2009 Sep;21(9):1157-62. doi: 10.1080/09540120902729940.

  • Anaya HD, Hoang T, Golden JF, Goetz MB, Gifford A, Bowman C, Osborn T, Owens DK, Sanders GD, Asch SM. Improving HIV screening and receipt of results by nurse-initiated streamlined counseling and rapid testing. J Gen Intern Med. 2008 Jun;23(6):800-7. doi: 10.1007/s11606-008-0617-x. Epub 2008 Apr 18.

MeSH Terms

Conditions

Immune System DiseasesHIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

  • Steven M. Asch, MD MPH

    VA Greater Los Angeles Healthcare System, West Los Angeles, CA

    PRINCIPAL INVESTIGATOR
  • Douglas K. Owens, MD MS

    VA Palo Alto Health Care System, Palo Alto, CA

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 5, 2005

First Posted

July 13, 2005

Study Start

March 1, 2005

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

April 7, 2015

Record last verified: 2009-04

Locations