Greater Acceptance of Routine HIV Testing (Opt-Out) by Patients Attending an Infectious Disease Unit in Spain

Background

Early HIV infection diagnosis is important for both individual and health system benefits. In Spain, according to a national HIV/AIDS hospital survey, 63% of patients are diagnosed at AIDS stage. ¹ In addition, a quarter of people living with HIV are unaware they have HIV. ² In 2010, a total of 27 116 newly diagnosed HIV infections were reported by 28 countries of the European Union (EU) and European Economic Area (EEA), with evidence of continuing transmission and no clear signs of decline. The predominant mode of transmission and increasing trend of HIV in the EU/EEA was due to sex between men. An increase in AIDS diagnoses in several countries and a high proportion of late presenters suggest delayed access to treatment and care. ³ Recently, Moreno et al reported a high prevalence of undiagnosed HIV infection (0.35%, 95% CI 0.13-0.57) in a representative sample of the population aged 16 to 80 years who visited primary care centers in Madrid, Spain. ⁴ In Spain, the epidemiology of HIV infection has changed since the mid-1990s. Currently, the most frequent transmission category is sexual transmission, particularly among men having sex with men, and immigrants are an important part of the epidemic. ⁵

Nevertheless, the Center for Disease Control and Prevention (CDC) has estimated that approximately 25% of persons unaware of their HIV infection account for 54% (upper bound of estimate, 70%) of new infection transmissions. ⁶ A higher proportion of people aware that they are infected with HIV can lead to a considerable reduction in new infections. Nowadays, highly active antiretroviral therapy (HAART) has dramatically changed treatment and survival of HIV-infected patients. So, AIDS has changed from a fatal disease to a highly treatable chronic condition. It is estimated that a 25-year-old HIV-infected person who is receiving care in the 21st century can expect to live another 38.9 years, only 12 years less than the estimated life expectancy of an uninfected counterpart. ⁷

In summary, late diagnosis of HIV has serious implications for survival, avoids early access to therapy, and facilitates transmission of unaware infections. ⁸ These facts underline that the current strategies used for diagnosis are inadequate. In Europe and particularly in Spain, the diagnosis strategy based on risk factors and/or clinical scenarios fails because more than one-third of patients are diagnosed at an advanced stage of disease (late presenters).

On September 22, 2006, the CDC published recommendations for a major change in the approach to testing for HIV infection in the United States: expanded screening in health care settings with streamlined procedures for consent and pretest information. This includes offering HIV tests to all adults and adolescents (13-64 years) in health care settings, including emergences. ² These recommendations favor the “opt-out” strategy. Then, routine HIV testing is offered when HIV seroprevalence rate is above 1% or if AIDS diagnosis rate is greater than 1 per 1000 hospital discharges.

However, there are different barriers to carry out these recommendations like direct cost of the program, logistic problems, confidentiality or cultural issues of concerns, referral to specialist difficulties, and waiting time to obtain outcome.

There are few studies analyzing patients’ attitudes about routine HIV testing in health care settings. The objective of our investigation was to determine the attitude and  opinion of patients attending an infectious diseases unit (SIU) about offering HIV testing universally.

Material and Methods

We conducted a prospective observational study at San Juan’s University Hospital, in Alicante, Spain. This survey was performed from October 2008 to January 2009. Patients between 18 and 65 years were requested to participate if they met the following inclusion criteria: (1) attended during hospitalization or outpatient ward in SIU and (2) verbal informed consent was obtained to participate in the screening program. Exclusion criteria were (1) refusing to give informed consent or to do the test, (2) pregnancy or lactation, and (3) previously HIV-infected patients. We collected some patients and test variables like rate of prior test performed, reasons for rejection, HIV risk factor, immigrant status, universal testing personal view, benefits and/or problems with performance strategy, test availability, delivery result, and HIV-screening-associated stigma.

Results

We surveyed 91 patients (54.9% males). Origin: Spain (83.5%) and South America (11%, mainly Argentine and Columbia). Chief complaint: fever (23%), urinary tract infection (22%), osteoarticular and soft tissue infections (14%), chronic hepatitis C (11%), and pneumonia (10%). HIV serology had been performed in the past in 42.9% of the surveyed patients (no previous rejection). Of these, in 69.2% the test was carried out in the past 2 years. Reasons for previous test requests were clinical status (33.3%), HIV risk factor (20.5%), pregnancy (17.9%), being a blood donor (15.4%), and self application (7.7%). Surprisingly, up to 18.7% of patients mistakenly believed that HIV test is routinely performed without consent request. A great majority (98.9%) felt that universal performance of the test would benefit mainly early diagnosing and/or preventing transmission. Patients younger than 42 years were significantly more prone to doing the test as a routine procedure. Only 4 (4.4%) patients did not participate because they believed they were “not infected.” A vast majority (80.5%) of respondents would prefer to have results within the first 24 hours. In addition, 20.7% would have a problem with confidentiality if HIV serology testing was done.

Discussion

Traditional screening based on guided classic risk factors “lost” a large proportion of HIV-infected patients. Several studies have shown that HIV prevalence was higher than 1% in hospitalized patients. Brady ⁹ assessed HIV seroprevalence in medical and surgical patients in 2 large US hospitals, detecting 2.3% of new infections. A higher prevalence rate was found in medical patients (3.7%) compared with surgical patients (1.4%). Otherwise, Mehta et al ¹⁰ found 1.4% prevalence among patients from outpatient ward and 1.2% in hospitalized patients.

In June 2004, the World Health Organization (WHO) introduced the opt-out screening initiative (universal offering of testing with willful rejection to increase the acknowledgment of serostatus of the “low-risk” population). ¹¹ HIV testing is offered routinely to all patients attending a medical center, as in the antennal diagnosis, even if they are asymptomatic or have no apparent risk of HIV. It is not based on individual risk, although testing should be repeated in “high-risk” collectives. It remains noncompulsory, since the patient has the option to refuse (opt out).

This kind of universal screening can reduce the stigma associated with having a negative test. These recommendations were endorsed by CDC and UK diagnostic guidelines for HIV infection in 2006, which recommend considering implementation of HIV testing in any patient presenting to the health sector irrespective of the signs or symptoms of disease or risk factors. This strategy of universal screening has been evaluated in several studies of cost-effectiveness. Walensky ¹² conducted a study evaluating the cost-effectiveness of screening in patients admitted to hospitals. The program increased by 78% the number of new HIV cases. It reduced the percentage of AIDS cases in 32%. Cost-effectiveness was $38 600/quality-adjusted life year (QALY) for a prevalence of HIV in the population of 1.0%. Sanders et al ¹³ showed that patients identified by opt-out in the HAART era were diagnosed of HIV in earlier stages with higher CD4 counts and increased survival. Cost-effectiveness was demonstrated even in low-prevalence populations. For 1% prevalence, the cost-effectiveness was $15.078/QALY. This opt-out strategy by the Public Health Department in San Francisco increased the diagnosis of new cases of HIV infection  from 20.6 to 30.6 each month. ¹⁴ Moreover, Paltiel et al ¹⁵ showed that this strategy is cost-effective (<$50 000/quality-adjusted life year (QALY) for a prevalence of 0.2%).

The opt-out strategy joins ethical principles and legal aspects of clinical practice and biomedical research. Values in medical ethics are respected (autonomy, beneficence, nonmaleficence, justice, dignity, and honesty). ¹⁶ In addition, HIV infection is consistent with all the generally accepted criteria that justify screening: (1) HIV infection is a serious health disorder that can be diagnosed before symptoms develop; (2) HIV can be detected by reliable, inexpensive, and noninvasive screening tests; (3) infected patients have years of life to gain if treatment is initiated early, before symptoms develop; and (4) the costs of screening are reasonable in relation to the anticipated benefits.

Another reason favoring universal screening is missed opportunities. A high proportion of the HIV-infected patients have multiple health care system contacts, either as hospitalized patients or as outpatients before they are finally diagnosed. ¹⁷

Few studies have been published about patients’ attitudes and opinions about routine HIV testing. Greenwald ¹⁸ compared the routine HIV testing to usual strategies regarding screening (risk factors or patient request). Patients' opinions about HIV routine testing (opt-out strategy) were requested. Only 11% of the respondents had an unfavorable opinion. Taking into account this result, hospital administration agreed to conduct routine HIV testing after obtaining informed consent. Wurcel et al ¹⁹ compared the acceptance of HIV testing by serological test against rapid methods. The overall acceptance rate was 60% (as 40% already had previous HIV tests). There were no significant differences in age and sex, but race (Hispanic preferred rapid testing) showed a significant difference. In 2006, Kayser Family Foundation survey ²⁰ showed that 65% of people accepted routine HIV testing in the general population. However, only 27% believed that written informed consent should be obtained before.

Hutchinson et al ²¹ showed high acceptance of HIV antibody testing among inpatients and outpatients at a public health hospital comparing rapid versus standard HIV testing. Survey participants supported use of rapid tests routinely for the convenience and ease of implementation. However, fear of reliability, cost, and confidentiality were the main drawbacks.

In our study, we realize that 42.9% of respondents had previously been tested for HIV infection. None had rejected HIV testing. Almost a fifth mistakenly believed that HIV test is routinely performed without obtaining informed consent.

Our most striking discovery was that the vast majority (98.9%) considered universal HIV testing would be of benefit. Mainly, it would favor early diagnosis and avoid occult transmission. They were also receptive to universal HIV testing. Also, great acceptance of routine testing was reported, especially in younger patients. These findings are consistent with the previous studies. ^{18 –22} Only 4 patients (4.4%) did not consent for HIV testing (because of low-risk perception).

Most of the respondents (80.5%) would prefer to have HIV testing results within 24 hours. Rapid HIV diagnostic testing can facilitate the implementation of these universal screening practices. The main drawback is that 20.7% of people would have problems with confidentiality, such as having an HIV-negative serology.

Study limitations include the small number of surveys; having an active infectious disease could have increased the number of patient’s positive perceptions about the routine HIV testing; having an external validity of survey; and almost 20% of patients having an HIV risk factor.

In summary, the vast majority (95.6%) of the surveyed patients had a fair opinion about universal HIV testing. Only 4 patients (4.4%) would not consent for HIV testing (because of low-risk perception). Availability of rapid HIV tests can facilitate fast result delivery, facilitating linkage to care. Considering favorable patients’ opinion, recent opt-out screening recommendations, highest HIV prevalence in admitted patients, and cost-effectiveness, studies favor universal HIV testing.