Cost comparison of three HIV counseling and testing technologies

doi:10.1016/S0749-3797(03)00115-6

American Journal of Preventive Medicine

Volume 25, Issue 2, August 2003, Pages 112-121

https://doi.org/10.1016/S0749-3797(03)00115-6 Get rights and content

Abstract

Background

In the United States, more than 2 million human immunodeficiency virus (HIV) antibody tests are performed annually at publicly funded HIV counseling and testing (CT) clinics. Clients do not receive results from one third of these tests because of low return rates. New rapid-testing technologies may improve receipt of results, but no study has systematically analyzed the costs of these newer technologies compared with the standard protocol.

Objective

To estimate and compare the economic costs associated with three HIV CT protocols: the standard protocol and the one-step and two-step rapid protocols.

Methods

A cost analysis model was developed in 2002 to calculate the intervention costs for HIV CT services with the standard CT protocol and the one-step and two-step rapid-test protocols for a hypothetical client in a publicly funded HIV clinic. Sensitivity analyses were performed to ascertain the effects of uncertainty in the model parameters.

Results

The one-step rapid protocol was generally the least expensive of the three protocols. The standard protocol cost less than the two-step protocol per HIV-positive client notified of his or her HIV status, but cost more per HIV-negative client. The sensitivity analysis indicated overlap in the cost estimates for HIV-negative clients, reflecting the generally similar costs of the three testing protocols. Taking into account HIV seroprevalence, the two-step rapid protocol would be less expensive than the standard protocol for most publicly funded testing programs in the United States.

Conclusions

Rapid test protocols offer economic advantages as well as convenience, compared to the standard testing protocol. The cost estimates presented here should prove helpful to HIV program managers and other public health decision makers who need information on these counseling and testing technologies.

Introduction

A pproximately 2.3 million human immunodeficiency virus (HIV) antibody tests were conducted each year at publicly funded HIV counseling and testing (CT) sites in the United States in 1997 and 1998.1 With the standard enzyme immunoassay (EIA) and Western blot (WB) tests, clients do not receive their test results until they return 2 weeks later.2 On average, 35% of clients who test HIV-positive and 42% who test HIV-negative do not return for their test results.1, 2, 3, 4, 5 Low return rates impede one of the main goals of HIV CT: to make individuals aware of their serostatus so that they can make informed choices about future behaviors and, if infected, about treatment options.6, 7, 8

Several simple-to-use HIV antibody–testing protocols have been developed that can produce same-day results.6, 9, 10, 11 Unlike the standard EIA tests, these rapid tests require little or no laboratory equipment12 and can be performed in ≤30 minutes.6, 13, 14, 15 Empirical studies have shown that the sensitivity and specificity of the rapid tests are similar to those of the standard EIA.9, 10, 13, 15, 16, 17, 18, 19, 20

Rapid HIV antibody tests have an indispensable role to play in the national effort to increase the number of clients who learn their HIV serostatus as early as possible and receive appropriate post-testing CT. These tests have been recognized as an important component of an overall strategy to achieve the national HIV strategic objective of reducing the annual number of new HIV infections to 20,000 by the year 2005 and have been highlighted by U.S. agencies such as the Centers for Disease Control and Prevention (CDC).7

The algorithm for standard antibody testing consists of two steps. First, the client’s blood sample is sent to a lab and subjected to a highly sensitive EIA screening test. If the EIA is repeatedly reactive for HIV antibody, then a confirmatory WB is performed. Depending on how frequently these tests are done in the lab and the time it takes for test results to get back to the clinic, all clients must return several days to 2 weeks after their initial clinic visit to obtain their test results. With the rapid-testing protocols, an on-site rapid test is used as the initial screening test and test results are available within minutes or hours. Thus, clients can receive preliminary HIV test results on the same day. For clients whose screening test is negative, no further testing is required and HIV testing is completed during one visit. If the screening test is reactive, supplemental testing must be done to confirm the result. In the two-step rapid-testing protocol commonly used in the United States, blood specimens repeatedly reactive on the rapid screening test are sent to a laboratory for confirmatory WB testing. Clients with a reactive rapid test must thus return for a second visit to receive their confirmed test result.2 In the one-step rapid-testing protocol recommended by the World Health Organization, a combination of two or three additional rapid assays is used to confirm an initial reactive result, and the client receives results of all tests on the same day.16, 17

Although both one- and two-step rapid protocols are widely used in different HIV CT settings around the world, at present only two rapid tests—both requiring a two-step protocol—are currently licensed by the U.S. Food and Drug Administration (FDA): the Single Use Diagnostic System (SUDS) for HIV-1 (manufactured by Abbott/Murex)6 and the OraQuick rapid HIV antibody test (manufactured by OraSure Technologies Inc.).21 The SUDS test is used with serum or plasma specimens, and the OraQuick test is used with whole-blood specimens. Recently, the U.S. Department of Health and Human Services (DHHS) announced the expanded availability of the OraQuick test, from 38,000 laboratories to more than 100,000 sites nationwide, including private medical offices and public HIV counseling and testing centers.22 Several additional rapid tests are currently awaiting FDA approval. Details on issues related to rapid HIV antibody tests along with additional resources are available at the CDC’s website (www.cdc.gov/hiv/pubs/rt.htm).

Several reports have indicated that rapid tests can substantially improve the overall effectiveness of CT services by increasing the acceptability of HIV testing to both providers and consumers6 and by increasing the number of persons who learn their HIV serostatus.6, 23 However, relatively little information is available about the economic costs associated with implementing rapid HIV antibody testing.

As rapid HIV testing gains wider acceptance, it becomes crucial to examine the resource costs associated with using these technologies in publicly funded HIV CT programs. This study estimates the economic costs associated with the standard CT protocol and the two rapid protocols. The intervention costs of these testing technologies were compared separately for clients who test positive and those who test negative. To take into account the greater proportion of clients who receive their test results with rapid test protocols, the cost per client notified for each protocol was also calculated. The effectiveness of these testing protocols was not estimated.

Section snippets

Methods

A cost-analysis model was developed to calculate the intervention costs associated with providing HIV CT services using the standard CT protocol and the two-step and one-step rapid-test protocols. The three CT protocols are outlined in Figure 1. For the standard CT protocol, each client was registered and then received pre-test counseling from a trained counselor, including an assessment of the client’s risk of HIV infection, discussion of testing procedures, and risk reduction. If the client

Results

The results of the base-case cost analysis are presented in Table 2. The results were essentially consistent from the societal and provider perspectives, but differed depending on the HIV status of the client. Costs for HIV-positive clients were substantially different for the three protocols. Both the cost per person tested and the cost per person notified were greatest for the two-step rapid protocol and smallest for the one-step rapid protocol. For HIV-negative clients, the standard protocol

Discussion

The one-step rapid protocol—where combinations of rapid tests are used to provide a definitive HIV test result—was consistently the least expensive of the three protocols. In particular, the one-step rapid protocol was substantially less costly per HIV-positive person tested because it required neither follow-up clinic visits nor use of the expensive Western blot confirmatory assay.

The comparison between the standard protocol and the two-step rapid protocol indicated that the standard protocol

Acknowledgements

SDP was supported, in part, by a grant from the National Institute of Mental Health (K02-MH01919 and P30-MH52776). We gratefully acknowledge the comments and suggestions of Hazel Dean and the graphics support of Janet Brzuskiewicz. We thank Ruby Hardy, Michelle Allen, and Reginald Brown of the Fulton County Department of Health and Wellness for sharing their experiences in HIV counseling and testing at the local level.

Use of trade names is for identification purposes only and does not imply

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Cited by (70)

Human Immunodeficiency Virus Infection
2012, Hunter's Tropical Medicine and Emerging Infectious Disease: Ninth Edition
Cost effectiveness analysis of the New Jersey rapid testing algorithm for HIV testing in publicly funded testing sites
2011, Journal of Clinical Virology
Before 2009, New Jersey (NJ) publicly funded counseling and testing sites (CTS) tested for HIV using a single rapid test followed, when positive, by a Western Blot (WB) for confirmation. With this strategy, 74.8% of confirmed positive clients returned to receive test results. To improve the client notification rate at these centers, the New Jersey (NJ) Division of HIV, STD and TB Services (DHSTS) implemented a rapid testing algorithm (RTA) which utilizes a second, different, rapid test to verify a preliminary positive.
To compare the cost-effectiveness of the two testing algorithms.
This was a retrospective cost-effectiveness analysis.
New Jersey HIV Rapid Testing Support Program (NJHIV) records, DHSTS grant documents, counseling time estimates from an online survey of site supervisors. Costs included test kits and personnel costs from month of RTA implementation through 11/30 in 2008 and 2009. The incremental cost of the RTA was calculated per additional percent of positive clients who were notified and per day earlier notification.
In 2008, 215 of 247 clients with a positive rapid HIV test were confirmed positive by WB. 90.9% of clients were notified a mean of 11.4 days after their initial test. 12 refused confirmatory WB. In 2009, 152 of 170 clients with one positive rapid test had a confirmatory second positive rapid test and were notified on the same day. The incremental cost of the RTA was $20.31 per additional positive person notified and $24.31 per day earlier notification or $3.23 per additional positive person and $3.87 per day earlier notification if the WB were eliminated.
The RTA is a cost-effective strategy achieving 100% notification of newly HIV positive clients a mean of 11.4 days earlier compared to standard testing.
Using nonrapid HIV technology for routine, opt-out HIV screening in a high-volume urban emergency department
2011, Annals of Emergency Medicine
We implement an opt-out routine screening program in a high-volume, urban emergency department (ED), using conventional (nonrapid) technology as an alternative to rapid HIV tests.
We performed a retrospective cohort study. Since October 2008, all patients who visited Ben Taub General Hospital ED and had blood drawn were considered eligible for routine opt-out HIV screening. The hospital is a large, publicly funded, urban, academic hospital in Houston, TX. The ED treats approximately 8,000 patients monthly. Screening was performed with standard chemiluminescence technology, batched hourly. Patients with positive screening test results were informed of their likely status, counseled by a service linkage worker, and offered follow-up care at an HIV primary care clinic. Confirmatory Western blot assays were automatically performed on all new HIV-positive samples.
Between October 1, 2008, and April 30, 2009, 14,093 HIV tests were performed and 39 patients (0.3%) opted out. Two hundred sixty-two (1.9%) HIV test results were positive and 80 new diagnoses were made, for an incidence of new diagnoses of 0.6%. There were 22 false-positive chemiluminescence results and 7 indeterminate Western blot results. Nearly half the patients who received a new diagnosis were not successfully linked to HIV care in our system.
Opt-out screening using standard nonrapid technology, rather than rapid testing, is feasible in a busy urban ED. This method of HIV screening has cost benefits and a low false-positivity rate, but aggressive follow-up and referral of patients with new diagnoses for linkage to care is required.
Outcomes and cost analysis of 3 operational models for rapid HIV testing services in an academic inner-city emergency department
2011, Annals of Emergency Medicine
Citation Excerpt :
Of the 3 staffing models we evaluated, the model that relied on exogenous staff exhibited the lowest cost per patient tested, but the models that used indigenous staff (indigenous medical staff only and hybrid) yielded lower cost per patient with confirmed positive results detected and linked to care. Our cost analysis provides a comparison of relative costs between staffing models and not incremental cost-effectiveness indicators that directly compare advantages of one staffing model over another.33 EDs that intend to initiate an HIV screening program must consider, in addition to costs, site-specific factors such as degree of support from the medical staff, operational flow, funding sources, coverage hours, and laboratory capability when designing a program most appropriate for their ED.
We compare the outcomes and costs of alternative staffing models for an emergency department (ED) rapid HIV testing program.
A rapid oral-fluid HIV testing program was instituted in an inner-city ED in 2005. Three staffing models were compared during 24.5 months: indigenous medical staff only, exogenous staff only, or exogenous staff plus medical staff (hybrid). Personnel obtained written consent and provided brief pretest counseling, obtained kits, collected specimens, returned specimens to the ED satellite laboratory, and performed posttest counseling and referral to care. Cost analysis was performed to estimate cost per patient tested and cost per patient linked to care.
Overall, 44 of 2,958 (1.5%) patients tested received confirmed positive results and 30 (68%) were linked to care. The exogenous staff only model yielded the highest number tested per month (587), and indigenous medical staff only yielded the lowest (57). Significantly higher positivity rates were found in both indigenous medical staff only (2.2%) and hybrid (2.0%) models versus the exogenous staff only model (0.6%) (prevalence rate ratio: 3.7 [95% confidence interval {CI}1.5 to 9.3] versus 3.4 [95% CI 1.5 to 7.8], respectively). All patients with confirmed positive results were linked to care in the indigenous medical staff only model but only approximately 60% were linked to care in the 2 other models (linked to care rate ratio versus exogenous staff only: 1.8 [95% CI 1.1 to 4.4]; versus hybrid: 1.7 [95% CI 1.2 to 2.5]). The indigenous medical staff only model had the highest cost ($109) per patient tested, followed by the hybrid ($87) and the exogenous staff only ($39). However, the indigenous medical staff only model had the lowest cost ($4,937) per patient linked to care, followed by the hybrid ($7,213) and exogenous staff only ($11,454).
The exogenous staff only model tested the most patients at the least cost per patient tested. The indigenous medical staff only model identified the fewest patients with unrecognized HIV infection and had the highest cost per patient tested but the lowest cost per patient linked to care.
Preliminary program evaluation of emergency department HIV prevention counseling
2011, Annals of Emergency Medicine
Citation Excerpt :
The recent focus on screening and reduction of barriers to screening in health care settings has outpaced emphasis on behavioral prevention efforts. Screening without counseling may be a missed opportunity to provide prevention services.6,15,17,18 However, requirements for counseling may create prohibitive barriers that prevent screening altogether, particularly in EDs in which resources are scarce.3
Controversy surrounds the linkage of prevention counseling with emergency department (ED)–based HIV testing. Further, the effectiveness and feasibility of prevention counseling in the ED setting is unknown. We investigate these issues by conducting a preliminarily exploration of several related aspects of our ED's HIV prevention counseling and testing program.
Our urban, academic ED provides formal client-centered prevention counseling in conjunction with HIV testing. Five descriptive, exploratory observations were conducted, involving surveys and analysis of electronic medical records and programmatic data focused on (1) patient perception and feasibility of prevention counseling in the ED, (2) patient perceptions of the need to link prevention counseling with testing, and (3) potential effectiveness of providing prevention counseling in conjunction with ED-based HIV testing.
Of 110 ED patients surveyed after prevention counseling and testing, 98% believed privacy was adequate, and 97% reported that their questions were answered. Patients stated that counseling would lead to improved health (80%), behavioral changes (72%), follow-up testing (77%), and discussion with partners (74%). However, 89% would accept testing without counseling, 32% were willing to seek counseling elsewhere, and 26% preferred not to receive the counseling. Correct responses to a 16-question knowledge quiz increased by 1.6 after counseling (95% confidence interval 1.3 to 12.0). The program completed counseling for 97% of patients tested; however, 6% of patients had difficulty recalling the encounter and 13% denied received testing. Among patients undergoing repeated testing, there was no consistent change in self-reported risk behaviors.
Participants in the ED prevention counseling and testing program considered counseling acceptable and useful, though not required. Given adequate resources, prevention counseling can be provided in the ED, but it is unlikely that all patients benefit.
Assessing the population-level prevention effect of emergency department-based HIV testing in the United States: A research framework and commentary
2011, Annals of Emergency Medicine

View all citing articles on Scopus

^☆: Dr. Ekwueme is currently affiliated with the National Center for Chronic Disease Prevention and Health Promotion, Division of Cancer Prevention and Control, Centers for Disease Control and Prevention, Atlanta, Georgia.

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Research articleCost comparison of three HIV counseling and testing technologies☆

Abstract

Background

Objective

Methods

Results

Conclusions

Introduction

Section snippets

Methods

Results

Discussion

Acknowledgements

Ann Emerg Med

Lancet

Prev Med

CDC updateHIV counseling and testing using rapid tests—United States 1995

MMWR Morb Mortal Wkly Rep

Effective detection of HIV

J Acquir Immune Defic Syndr

Rates of receiving HIV test resultsdata from the U.S. National Health Interview Survey for 1994 and 1995

J Acquir Immune Defic Syndr

HIV testing among the general US population and persons at increased riskinformation from national surveys, 1987–1996

Am J Public Health

Antiretroviral therapy for HIV infection in 1997. Updated recommendations of the International AIDS Society—USA panel

JAMA

Rapid tests for HIV antibody

AIDS Rev

Field evaluation of rapid HIV serologic tests for screening and confirming HIV-1 infection in Honduras

AIDS

Advances in HIV testing technology and their potential impact on prevention

AIDS Educ Prev

New tests for detecting HIV infection

West J Med

Rapid HIV testing with same-day resultsa field trial in Uganda

Int J STD AIDS

On-site testing in resource-poor settingsis one rapid test enough?

AIDS

Performance of a rapid, on-site human immunodeficiency virus antibody assay in a public health setting

J Clin Microbiol

Sensitivity of HIV-antibody assays determined by seroconversion panels

AIDS

Notice to readersapproval of a new rapid test for HIV antibody

MMWR Morb Mortal Wkly Rep

On-site rapid HIV testing with same-day results and counseling

AIDS

Interpretation and use of the Western Blot Assay for serodiagnosis of human immunodeficiency virus type 1 infections

MMWR Morb Mortal Wkly Rep

Research article
Cost comparison of three HIV counseling and testing technologies☆