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Improving HIV Screening With Nurse-Based Rapid Testing/Streamlined Counseling

This study has been completed.

Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00119548
  Purpose

The cumbersome nature and complexity of current counseling and testing procedures have been suggested as reasons that rates of receipt of HIV test results are so low. Because the standard screening test results are unavailable on the same day, many persons do not return for the results. Up to 30% of persons who tested HIV-positive during 2000 and 39% of persons who tested HIV-negative did not return (1). The CDC has recommended that alternate streamlined counseling and testing methods may increase the receipt rates of HIV tests. To address the problems of failing to return for screening results, we plan to incorporate rapid HIV testing into the proposed screening trial.


Condition Intervention
Health Care Quality, Access, and Evaluation
Delivery of Health Care
Immune System Diseases
HIV Infections
Procedure: HIV test order; doctor vs. nurse vs. rapid test
Procedure: Evaluation of receipt of HIV test results between 3 modes

MedlinePlus related topics:   AIDS   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Diagnostic, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Improving HIV Screening by Nurse Rapid Testing, Streamlined Counseling

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary aims are to compare patient knowledge of HIV testing prevention practices and their views of the procedures� acceptability after traditional and rapid testing/streamlined counseling. [ Designated as safety issue: No ]

Estimated Enrollment:   251
Study Start Date:   March 2005
Study Completion Date:   January 2007

Arms Assigned Interventions
1 Procedure: HIV test order; doctor vs. nurse vs. rapid test Procedure: Evaluation of receipt of HIV test results between 3 modes

Detailed Description:

Background:

The cumbersome nature and complexity of current counseling and testing procedures have been suggested as reasons that rates of receipt of HIV test results are so low. Because the standard screening test results are unavailable on the same day, many persons do not return for the results. Up to 30% of persons who tested HIV-positive during 2000 and 39% of persons who tested HIV-negative did not return (1). The CDC has recommended that alternate streamlined counseling and testing methods may increase the receipt rates of HIV tests. To address the problems of failing to return for screening results, we plan to incorporate rapid HIV testing into the proposed screening trial.

Objectives:

The specific aims of this project are:

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 more than nurse-based referral for traditional testing and counseling alone.

To assess the cost-effectiveness of these alternative strategies for HIV testing and counseling.

Secondary aims will compare patient knowledge of HIV testing prevention practices and their views of the procedures� acceptability after traditional and rapid testing/streamlined counseling. To achieve these aims, we propose a robust three-arm randomized controlled trial.

Methods:

We plan a parallel-group randomized controlled trial set in the general medicine and urgent care clinics of the West Los Angeles VA Medical Center (VAMC). All participants will undergo an interview collecting information about HIV risk factors and other predictors of HIV screening, as well as knowledge of HIV test characteristics and prevention. All patients will be randomized to one of three models of screening: Model A: Traditional counseling/testing; Model B: Nurse-based screening + traditional counseling/testing; Model C: Nurse-based screening + streamlined counseling/ rapid testing

The analysis will focus on differences between the three models in rates of screening, receipt of results, knowledge, acceptability and cost-effectiveness

Status:

Analysis completed. Manuscript submitted for review on April 1, 2007. Manuscript returned by editor for revision and resubmission; resubmission due 12-07.

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00119548

Locations
United States, California
VA Greater Los Angeles Health Care System    
      Los Angeles, California, United States, 90073
VA Greater Los Angeles Health Care System    
      Sepulveda, California, United States, 91343

Sponsors and Collaborators

Investigators
Principal Investigator:     Steven M. Asch, MD MPH     VA Greater Los Angeles Healthcare System    
  More Information


Publications of Results:

Responsible Party:   Department of Veterans Affairs ( Asch, Steven - Principal Investigator )
Study ID Numbers:   IIR 04-023, PCC 2004-081171
First Received:   July 5, 2005
Last Updated:   August 14, 2008
ClinicalTrials.gov Identifier:   NCT00119548
Health Authority:   United States: Federal Government

Keywords provided by Department of Veterans Affairs:
HIV Rapid Testing  
Cost-effectiveness  
HIV Seronegativity  

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Antibodies
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on October 17, 2008




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