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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00119548
First received: July 5, 2005
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Health Care Quality, Access, and Evaluation
Delivery of Health Care
Immune System Diseases
HIV Infections
Other: Rates of HIV testing and receipt of results
Other: Sexual risk reduction; HIV knowledge improvement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Improving HIV Screening by Nurse Rapid Testing, Streamlined Counseling

Resource links provided by NLM:


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 [ Time Frame: 90 days ] [ Designated as safety issue: No ]

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. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 251
Study Start Date: March 2005
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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

  Show Detailed Description

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States, 90073
Sponsors and Collaborators
Investigators
Principal Investigator: Steven M. Asch, MD MPH VA Palo Alto Health Care System
Principal Investigator: Douglas K. Owens, MD MS VA Palo Alto Health Care System
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00119548     History of Changes
Obsolete Identifiers: NCT00186160
Other Study ID Numbers: IIR 04-023, PCC 2004-081171
Study First Received: July 5, 2005
Last Updated: April 15, 2014
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Slow Virus Diseases
HIV Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014