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

April 6, 2015 updated by: US Department of Veterans Affairs

Improving HIV Screening by Nurse Rapid Testing, Streamlined Counseling

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND/RATIONALE:

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.

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 incorporated rapid HIV testing into the proposed screening trial.

OBJECTIVE(S):

The specific aims of this project were:

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 were to 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 proposed a robust three-arm randomized controlled trial.

METHODS:

We planned 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 underwent 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 were 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 focused on differences between the three models in rates of screening, receipt of results, knowledge, acceptability and cost-effectiveness.

FINDINGS/RESULTS:

Testing rates were 40.2% (Model A), 84.5% (Model B), and 89.3% (Model C) (p=<.01). Rates of receipt of test results were 14.6% (Model A), 31.0% (Model B), 79.8% (Model C) (all p=<.01). Reduction in sexual risk and HIV knowledge improvement did not differ significantly between traditional versus streamlined counseling.

IMPACT:

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.

Widespread implementation would lead to critically important health benefits for veterans: 1) Increased rates of testing, which would lead to earlier identification of disease, increased treatment and decreased HIV transmission, morbidity and mortality; 2) Lower screening costs without decrements in either patient knowledge or acceptability.

The CDC has made identification of people with HIV a national priority. The VA has an opportunity to provide national leadership in elucidating how best to identify people living with HIV and ensure access to state-of-the-art care.

Study Type

Interventional

Enrollment (Actual)

251

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • West Los Angeles, California, United States, 90073
        • VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Arm 1
Randomized, controlled trial with three intervention models: Model A (traditional counseling/testing);
Other: Rates of HIV testing and receipt of results
Rates of HIV testing and receipt of results
Other: Sexual risk reduction; HIV knowledge improvement
Sexual risk reduction; HIV knowledge improvement
Other: Arm 2
Model B (nurse-initiated screening, traditional counseling/testing);
Other: Rates of HIV testing and receipt of results
Rates of HIV testing and receipt of results
Other: Sexual risk reduction; HIV knowledge improvement
Sexual risk reduction; HIV knowledge improvement
Other: Arm 3
Model C (nurse-initiated screening, streamlined counseling/rapid testing).
Other: Rates of HIV testing and receipt of results
Rates of HIV testing and receipt of results
Other: Sexual risk reduction; HIV knowledge improvement
Sexual risk reduction; HIV knowledge improvement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
To compare patient knowledge of HIV testing prevention practices and their views of the procedures' acceptability after traditional and rapid testing/streamlined counseling.
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Investigators

  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

July 5, 2005

First Submitted That Met QC Criteria

July 5, 2005

First Posted (Estimate)

July 13, 2005

Study Record Updates

Last Update Posted (Estimate)

April 7, 2015

Last Update Submitted That Met QC Criteria

April 6, 2015

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIR 04-023
  • PCC 2004-081171

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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