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Health Care Quality, Access, and EvaluationNCT00119548

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

A study testing Rates of HIV testing and receipt of results and Sexual risk reduction; HIV knowledge improvement in people with Health Care Quality, Access, and Evaluation and Delivery of Health Care, run by US Department of Veterans Affairs at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
Rates of HIV testing and receipt of results and Sexual risk reduction; HIV knowledge improvement
Could I receive a placebo?
No, everyone receives an active treatment
How many people
251 participants
Where
1 siteUnited States
Study dates
Mar 2005to Jan 2007
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA

    West Los Angeles, California, 90073

Other trials in United States

About this study

Official title: 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.

Read more

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.

Read the 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.

Being tested
Rates of HIV testing and receipt of results, Sexual risk reduction; HIV knowledge improvement
Keywords
HIV Rapid Testing, Cost-effectiveness, HIV Seronegativity
Medical subject headings
Immune System Diseases, HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rates of HIV testing and receipt of resultsOther

    Rates of HIV testing and receipt of results

  • Sexual risk reduction; HIV knowledge improvementOther

    Sexual risk reduction; HIV knowledge improvement

  • Rates of HIV testing and receipt of resultsOther

    Rates of HIV testing and receipt of results

  • Sexual risk reduction; HIV knowledge improvementOther

    Sexual risk reduction; HIV knowledge improvement

  • Rates of HIV testing and receipt of resultsOther

    Rates of HIV testing and receipt of results

  • Sexual risk reduction; HIV knowledge improvementOther

    Sexual risk reduction; HIV knowledge improvement

Study groups in NCT00119548
Study groupRoleWhat they receive
Arm 1OtherRandomized, controlled trial with three intervention models: Model A (traditional counseling/testing);
Receives: Other: Rates of HIV testing and receipt of results; Other: Sexual risk reduction; HIV knowledge improvement
Arm 2OtherModel B (nurse-initiated screening, traditional counseling/testing);
Receives: Other: Rates of HIV testing and receipt of results; Other: Sexual risk reduction; HIV knowledge improvement
Arm 3OtherModel C (nurse-initiated screening, streamlined counseling/rapid testing).
Receives: Other: Rates of HIV testing and receipt of results; Other: Sexual risk reduction; HIV knowledge improvement

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 90 days

Secondary outcomes (1)
  1. To compare patient knowledge of HIV testing prevention practices and their views of the procedures' acceptability after traditional and rapid testing/streamlined counseling.

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2005 (estimated)
  2. Study startMar 2005
  3. Primary completionJan 2007
  4. Study completionJan 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
251 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00119548
Sponsor's protocol ID
IIR 04-023
Other IDs
PCC 2004-081171
Status last verified
Apr 2009
First submitted
5 Jul 2005
Last updated
7 Apr 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 20024775
  • 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.

    PubMed 18421508

Questions about this trial

What is this clinical trial studying?

A study testing Rates of HIV testing and receipt of results and Sexual risk reduction; HIV knowledge improvement in people with Health Care Quality, Access, and Evaluation and Delivery of Health Care, run by US Department of Veterans Affairs at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00119548, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015.

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