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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

251 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2007-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Qualitative Assessment of Implementing Routine Rapid HIV Testing

NCT00680862

HIV Infections

COMPLETED

A Theory Based HIV Prevention Video For Rapid HIV Testing: A Randomized Trial

NCT00250549

HIV

COMPLETED NA

Effectiveness and Implementation of Text Messaging to Improve HIV Testing in Adolescents

NCT06096519

HIV

RECRUITING NA

Peer-driven Intervention to Seek, Test & Treat Heterosexuals at High Risk for HIV

NCT01607541

HIV/AIDS

COMPLETED PHASE2/PHASE3

Improving HIV Prevention Among Heterosexual Men Seeking STI Services in Malawi

NCT06200545

HIV Infection Sexually Transmitted Infections Pre-exposure Prophylaxis +1 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1

Randomized, controlled trial with three intervention models: Model A (traditional counseling/testing);

Group Type OTHER

Rates of HIV testing and receipt of results

Intervention Type OTHER

Rates of HIV testing and receipt of results

Sexual risk reduction; HIV knowledge improvement

Intervention Type OTHER

Sexual risk reduction; HIV knowledge improvement

Arm 2

Model B (nurse-initiated screening, traditional counseling/testing);

Group Type OTHER

Rates of HIV testing and receipt of results

Intervention Type OTHER

Rates of HIV testing and receipt of results

Sexual risk reduction; HIV knowledge improvement

Intervention Type OTHER

Sexual risk reduction; HIV knowledge improvement

Arm 3

Model C (nurse-initiated screening, streamlined counseling/rapid testing).

Group Type OTHER

Rates of HIV testing and receipt of results

Intervention Type OTHER

Rates of HIV testing and receipt of results

Sexual risk reduction; HIV knowledge improvement

Intervention Type OTHER

Sexual risk reduction; HIV knowledge improvement

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rates of HIV testing and receipt of results

Intervention Type OTHER

Sexual risk reduction; HIV knowledge improvement

Intervention Type OTHER

Rates of HIV testing and receipt of results

Intervention Type OTHER

Sexual risk reduction; HIV knowledge improvement

Intervention Type OTHER

Rates of HIV testing and receipt of results

Intervention Type OTHER

Sexual risk reduction; HIV knowledge improvement

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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