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

Primary Purpose

Health Care Quality, Access, and Evaluation, Delivery of Health Care, Immune System Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rates of HIV testing and receipt of results
Sexual risk reduction; HIV knowledge improvement
Rates of HIV testing and receipt of results
Sexual risk reduction; HIV knowledge improvement
Rates of HIV testing and receipt of results
Sexual risk reduction; HIV knowledge improvement
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Health Care Quality, Access, and Evaluation focused on measuring HIV Rapid Testing, Cost-effectiveness, HIV Seronegativity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

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).

Outcomes

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

Secondary Outcome Measures

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

Full Information

First Posted
July 5, 2005
Last Updated
April 6, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00119548
Brief Title
Improving HIV Screening With Nurse-Based Rapid Testing/Streamlined Counseling
Official Title
Improving HIV Screening by Nurse Rapid Testing, Streamlined Counseling
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Health Care Quality, Access, and Evaluation, Delivery of Health Care, Immune System Diseases, HIV Infections
Keywords
HIV Rapid Testing, Cost-effectiveness, HIV Seronegativity

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
251 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Other
Arm Description
Randomized, controlled trial with three intervention models: Model A (traditional counseling/testing);
Arm Title
Arm 2
Arm Type
Other
Arm Description
Model B (nurse-initiated screening, traditional counseling/testing);
Arm Title
Arm 3
Arm Type
Other
Arm Description
Model C (nurse-initiated screening, streamlined counseling/rapid testing).
Intervention Type
Other
Intervention Name(s)
Rates of HIV testing and receipt of results
Intervention Description
Rates of HIV testing and receipt of results
Intervention Type
Other
Intervention Name(s)
Sexual risk reduction; HIV knowledge improvement
Intervention Description
Sexual risk reduction; HIV knowledge improvement
Intervention Type
Other
Intervention Name(s)
Rates of HIV testing and receipt of results
Intervention Description
Rates of HIV testing and receipt of results
Intervention Type
Other
Intervention Name(s)
Sexual risk reduction; HIV knowledge improvement
Intervention Description
Sexual risk reduction; HIV knowledge improvement
Intervention Type
Other
Intervention Name(s)
Rates of HIV testing and receipt of results
Intervention Description
Rates of HIV testing and receipt of results
Intervention Type
Other
Intervention Name(s)
Sexual risk reduction; HIV knowledge improvement
Intervention Description
Sexual risk reduction; HIV knowledge improvement
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven M. Asch, MD MPH
Organizational Affiliation
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Douglas K. Owens, MD MS
Organizational Affiliation
VA Palo Alto Health Care System, Palo Alto, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
City
West Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20024775
Citation
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.
Results Reference
result
PubMed Identifier
18421508
Citation
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.
Results Reference
result

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

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