Why Wait? The Ethics of Disclosing HIV Screening Results

Abstract

Counseling patients on their HIV test results is an important part of undergraduate and graduate medical education. However, many trainees and physicians feel ill prepared to counsel patients on potentially distressing results. We present a case involving early disclosure of a false-positive HIV screening test result to a patient and the downstream effects of this premature disclosure. This case highlights the importance of understanding the various HIV testing options available and the importance of education on effectively counseling patients on screening versus confirmatory HIV test results.

Introduction

Proper training on disclosing screening and diagnostic test results is paramount in ensuring therapeutic patient-doctor relationships. In this article, we present a case of a patient at low risk of HIV with alcoholic cirrhosis, previously undiagnosed autoimmune hepatitis, and hypergammaglobulinemia with a false-positive HIV electrochemiluminescence immunoassay (ECLIA) screening test. We present an overview of HIV testing options and discuss methods for effectively counseling patients on screening versus confirmatory HIV test results.

Case Presentation

A 68-year-old male presented to a Veterans Affairs Hospital (VAH) with progressively worsening abdominal distention and discomfort over 6 months. His past medical history was notable for remote alcohol dependence, previously drinking a quart of whiskey daily for 3 decades. He denied any past intravenous drug use, blood transfusions, and international travel in 20 years. He was monogamous with 1 female sexual partner for the past 3 decades, and he had chlamydia once in his 30s, which was treated. He was a retired mechanic.

The patient was admitted for abdominal distention workup, initially attributed to alcoholic cirrhosis. Abdominal ultrasound showed free abdominal fluid and a cirrhotic liver. On hospital day 1, he was screened for HIV and hepatitis B/C per universal screening recommendations by the Center for Disease Control and Prevention (CDC) but was not explicitly counseled on these tests. ¹ Hepatitis serologies were nonreactive; HIV ECLIA screen was reactive. On hospital day 2, the inpatient team’s attending informed the patient of his positive HIV screening test and he responded with confusion and anger. The patient was told he would need further labs to determine next steps; counseling on confirmatory testing was not performed. On hospital day 6, further hepatic workup showed alpha-1-antitrypsin and antinuclear and anti-mitochondrial antibodies within reference ranges. However, anti-smooth muscle antibody results were 14 units above the upper limit and IgA, IgM, and IgG were over twice the upper limits. On hospital day 7, send-out confirmatory HIV-1/HIV-2 antibody testing (Geenius assay) along with HIV-1 qualitative ribonucleic acid transcription-mediated amplification showed no evidence of infection. The patient was reassured he was HIV-negative and the screening test was falsely reactive. He remained upset and expressed distrust of his health care team throughout his hospital admission until discharged 3 weeks later.

Discussion

This case highlights the importance of educating physicians and trainees on HIV screening and diagnostic testing, including counseling patients on results based on individual risk factors. At the VAH in this case, the average turnaround time for receiving confirmatory HIV-1 and HIV-2 antibody test result ranges from 4 to 7 days as it is a send-out test, highlighting the need for proper counseling in this patient population.

Since the first HIV antibody test was developed in 1985, more accurate tests are available (Table 1). ² HIV tests have gone from measuring HIV IgG using indirect ELISA to now measuring both HIV IgM and HIV-1 p24 antigen, using sandwich ELISA or ECLIA. ² The ELISA and ECLIA tests both use a combination of antigens and antibodies to detect target molecules (eg, HIV IgG, IgM, and p24 antigen). However, a positive test with an ELISA requires confirmatory testing to distinguish between antigen and antibody, or use of a signal to cutoff ratio, whereas the ECLIA distinguishes in the initial readout.^2,3 In addition to the increased sensitivity and specificity in each subsequent test, the window period for false negative results decreases; combined HIV antibody-antigen tests have a negative window of approximately 2 weeks compared with 10 weeks for the HIV IgG test. ²

Table 1.

HIV Diagnostic Assays (Year Created).

	Indirect ELISA for anti-HIV-1 IgG (1985)	Indirect ELISA for anti-HIV-1 and HIV-2 IgG (1987)	Sandwich ELISA for anti-HIV-1 and HIV-2 IgG, and IgM (1991)	Sandwich ELISA for anti-HIV-1 and HIV-2 IgG, IgM, and p24 Ag (1997)	ECLIA for anti-HIV-1 and HIV-2 IgG, IgM, and p24 Ag (2015)
Specificity	95%-98%	>99%	>99.5%	99.5%	99.5%
Sensitivity	99%	>99.5%	>99.5%	>99.8%	100%
Negative window	8-10 wk	4-6 wk	2-3 wk	2 wk	2 weeks
Results	Single result	Single result	Single result	Single result; does not differentiate Ab and Ag positivity	Separate HIV-1 and HIV-2 Ab and Ag results
Confirmatory tests	HIV-1 Western blot or IFA	HIV-1 Western blot or IFA; HIV-2 ELISA and Western blot if HIV-1 confirmatory test is negative	HIV-1 Western blot or IFA; HIV-2 ELISA and Western blot if HIV-1 confirmatory test is negative	HIV-1,2 differentiation assay followed by qualitative HIV-1 RNA PCR if differentiation assay is negative	HIV-1,2 differentiation assay followed by qualitative HIV-1 RNA PCR if differentiation assay is negative

Table adapted from Alexander. ²

Abbreviations:

ECLIA, electrochemiluminescence immunoassay; Ab, antibody; Ag, antigen; IFA, immunofluorescence assay; RNA, ribonucleic acid; PCR, polymerase chain reaction.

Initial screening tests are advantageous because they usually provide results within an hour, reducing the chance a patient is released and potentially lost to follow-up prior to results disclosure, compared with confirmatory tests, which can take days. ² However, proper counseling on screening results is important to minimize patient distress. Unfortunately, our patient remained distressed due to his positive screening results for several days until confirmatory testing revealed no infection. Just as false-negative screening results can lead to detrimental health implications, the same is true for false-positives; these may lead to unwarranted emotional distress, unnecessary treatment, and misdiagnosis. ⁴ Although an alternative explanation for the false-positive HIV screening test result was ultimately identified (ie, undiagnosed autoimmune hepatitis), at the time of the HIV screen no comorbidity contributing to a false-positive HIV screen was known.

Our case raises the question of how best to counsel patients on screening test results, especially for trainees who may be delivering this news for the first time. In these instances, an attending-led modeling discussion on how to inform patients of potentially life-changing screening test results, and next steps necessary to verify these test results, may lower patient distress. In this case, there was limited counseling on the role of confirmatory testing and interpretation of the patient’s screening test result in the context of being low risk for HIV.

With appropriate education on delivering difficult news and HIV tests, our team could have provided the patient with a better understanding of what the positive screening test result meant in relation to his risk factors known at the time. Importantly, on hospital day 6, it was discovered that the patient had elevated anti–smooth muscle antibody and multiple elevated immunoglobulins, supporting a diagnosis of autoimmune hepatitis and hypergammaglobulinemia. Both conditions, and his elevated gamma gap (4.1 g/dL), are well-established associations with false-positive HIV results. ⁵ Our patient’s sample was falsely reactive on an ECLIA test, and although it has some advantages over ELISA, cross-reactive antibodies are limitations with both. ³ This knowledge could have informed counseling discussions early on and continued with the subsequent negative HIV confirmatory test result.

Thorough discussion and case-based education at both undergraduate and graduate medical education levels is imperative to ensuring all trainees know the available resources and receive training on disclosing positive screening test results prior to their first real encounter. Common teaching methods on this topic include didactics, simulations, and case-based learning.^6-9 However, as many as 60% to 70% of medical students and trainees feel ill prepared for delivering difficult news.^7,10,11 This educational disparity continues into practice, where many practicing physicians feel like they have had insufficient training in this area.^11-14 Limited education on delivering difficult news leads to patient dissatisfaction and physician/trainee burnout.^12,15,16 Streamlined processes for educating trainees early in their careers on how to deliver difficult news, providing easily accessible resources, and ensuring trainees feel comfortable asking for help when they find out their patient has a positive screening or diagnostic test is important.

There are few publications on the most effective teaching methods for medical professionals.^6,8,9 A combination of didactics, group discussion, and hands-on practice led by attending physicians seems to be preferred and is effective in increasing confidence in delivering bad news and increasing patient satisfaction (Table 2).^6-10

Table 2.

Advantages and Disadvantages of Strategies for Teaching Medical Students and Residents How to Deliver Difficult News.

Strategy	Advantages	Disadvantages
Didactic approaches	− Able to efficiently present key concepts to large groups – Minimal faculty time and resources – Can incorporate skills demonstrations	− Little opportunity for discussion between learners and faculty – No opportunity for individual practice and feedback
Small-group discussion	− Opportunity to discuss techniques and concerns with fellow learners and faculty	− No opportunity for individual practice and feedback – Faculty time intensive
Small-group, peer role-play	− Opportunity to discuss techniques and concerns with fellow learners and faculty – Learners can practice skills and receive feedback from faculty and peers – Insight into patient perspective	− Variability in patient portrayal between students – Less realistic than standardized patient encounter – Faculty time intensive
Small-group standardized patient role-play	− Can incorporate different scenarios to cover a variety of patient responses – Ability to observe other learners’ approaches – Ability to practice and receive feedback from faculty, peers, and standardized patients – More realistic than peer role-play	− Peer performance anxiety – Standardized patients and faculty time intensive – Less realistic than one-to-one standardized patient encounter
One-to-one standardized patient encounters	− Ability to practice and receive feedback from standardized patients and/or faculty – More realistic than group encounters – Reduced performance anxiety	− No group discussion – No exposure to other learners’ approaches or patient interactions – Faculty and/or standardized patient intensive
Teachable moments in clinical settings	− Ability to observe real patient encounters – Ability for learners to practice skills under supervision and receive feedback	− Clinical time restraints – Patient privacy – Faculty time intensive

Table adapted from the Alelwani and Ahmed ⁶ and Rosenbaum et al. ⁸

There are advantages and drawbacks to each teaching style, so finding the most effective balance between an institution’s resources and knowledge gained is important. For example, although didactics are easy to standardize, are not a large resource pull, and can increase trainee confidence, their effectiveness depends on when the lecture occurred in relationship to their training stage and if it was followed by a skills assessment or chance to practice. In contrast, hands-on practice and group discussions are more time intensive and require more resources but are preferred by most trainees.^6,8,9 More research needs to be conducted to determine detailed guidance for building curricula around this topic and how to standardize assessments on curriculum effectiveness.

In our academic institution, universal HIV and HCV testing are performed in the emergency department (ED), using point of care screening and confirmatory tests to allow rapid diagnosis. To address the needs of learners, a simulation exercise is completed by all ED residents with specific training on giving a positive HIV test result and understanding discordant test results (ie, positive HIV screen with negative or indeterminate confirmatory test). Furthermore, an ED and infectious disease physician are notified of all positive test results in the ED and confer with the ED resident prior to the patient being informed. In contrast, our VAH is not staffed by our ED residents and the testing algorithm requires send-out testing, resulting in delays for confirmation. This case is a reminder that training in settings where staff ED physicians and internal medicine residents are giving HIV results is warranted to provide the best patient care.

In conclusion, false-positive HIV tests are uncommon (0.5%), given the high specificity of current screening technology. Patients with diseases causing hypergammaglobulinemia may have a higher rate of false-positive screening tests due to an increased likelihood of cross-reactivity with HIV diagnostics. Therefore, providers must holistically assess patients while interpreting these tests and properly counsel patients on screening results until confirmatory results are acquired as lack of proper counseling can lead to patient distress and an impaired patient-doctor relationship. Proper training at the undergraduate and graduate medical education levels ensures patients receive compassionate, empathetic care when being delivered difficult news. Educational methodologies, such as combined didactics, group discussion, and hands-on practice, are preferred and effective for adult learners in health care.