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

6 kwietnia 2015 zaktualizowane przez: 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.

Przegląd badań

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

251

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

    • California
      • West Los Angeles, California, Stany Zjednoczone, 90073
        • VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 65 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Diagnostyczny
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Ramy czasowe
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
Ramy czasowe: 90 days
90 days

Miary wyników drugorzędnych

Miara wyniku
Ramy czasowe
To compare patient knowledge of HIV testing prevention practices and their views of the procedures' acceptability after traditional and rapid testing/streamlined counseling.
Ramy czasowe: 4 weeks
4 weeks

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

  • Główny śledczy: Steven M. Asch, MD MPH, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
  • Główny śledczy: Douglas K. Owens, MD MS, VA Palo Alto Health Care System, Palo Alto, CA

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 marca 2005

Zakończenie podstawowe (Rzeczywisty)

1 stycznia 2007

Ukończenie studiów (Rzeczywisty)

1 stycznia 2007

Daty rejestracji na studia

Pierwszy przesłany

5 lipca 2005

Pierwszy przesłany, który spełnia kryteria kontroli jakości

5 lipca 2005

Pierwszy wysłany (Oszacować)

13 lipca 2005

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

7 kwietnia 2015

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

6 kwietnia 2015

Ostatnia weryfikacja

1 kwietnia 2009

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • IIR 04-023
  • PCC 2004-081171

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