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HIV Testing in the U.S.A.

In any epidemic, the identification of individual cases of disease is essential, not only to gain a greater understanding of the scale of the problem, but also to better provide treatment, care and advice for those infected. With HIV, this necessity is particularly great, as people can remain unaware they are infected for many years, creating huge potential for onward transmission.

In recent years, the USA has begun to place particular emphasis on the benefits of testing through a major campaign to get as many of its citizens tested for HIV as possible. Testing centres have appeared in a wide variety of clinics, hospitals and other non-medical settings all over the country. So how did this drive for testing come about? Where is it taking place? How is it being implemented and monitored? And is it proving effective?

Screening the blood supply

The urgent need for a test

AIDS was first recognised as a distinct condition in the early 1980s, but it wasn’t until 1984 that scientists discovered the cause: the Human Immunodeficiency Virus. Once HIV had been identified, the race was on to find a method of detecting it. In the US, the push to develop a test was particularly urgent, as by 1982, it had become clear that the country’s blood supply was contaminated, and that people were developing AIDS following blood transfusions.

After initial controversy over the ethics of asking donors about their sexuality, guidelines that banned homosexuals from donating were introduced in many blood banks in 1983 ¹. Homosexual rights groups initially protested, but eventually accepted the rule under the belief that it would only be a temporary measure that could be changed once a reliable screening method was introduced.

Creating a test was not as easy as initially hoped. It was quickly recognised that a test for the virus itself would be very difficult to develop, as well as being extremely costly and inefficient. It was therefore decided that the best way to detect it would be to look for the antibodies produced by the body following exposure to HIV.

Five pharmaceutical companies were given licences by the US government to develop a test, and after many months of research, the very first ELISA (Enzyme-Linked Immuno-Sorbent Assay) was produced by Abbott Laboratories. For the first time, doctors had a way to detect a virus that had previously remained invisible in most infected individuals, and a way to screen both the blood supply used for transfusions and the supply of the blood factor VIII given to haemophiliacs.

Concerns over consequences

A test that could screen the blood supply for HIV was a huge advancement, but with screening came a great number of practical and ethical dilemmas.

Firstly, there were issues over the accuracy of the tests, which had been found to give both false positive and false negative results. As well as being unable to detect HIV antibodies during the so-called ‘window period’ following initial infection (antibodies to HIV can take up to 3 months to develop and become detectable), the tests were also prone to incorrectly isolating non-HIV antibodies from the blood, giving a false positive result. The Western Blot test (a complex ‘back-up’ test) largely solved this problem later, but initially there was much uncertainty. What would be the implications of a false negative diagnosis for someone receiving contaminated blood? What would they be for the individual who had donated the blood in the first place?

Some countries, including the UK, were so concerned about the inaccuracy of the US developed test kits, they chose to delay screening, and instead awarded contracts to home-based companies to develop alternatives.

Doctors quickly realised that there could now be a duty on them to inform donors if their blood tested positive. At the time, being HIV positive was synonymous with AIDS and death. There were no drugs to help suppress the virus, and people diagnosed with AIDS faced considerable stigma and often rejection from friends, family and employers. It was soon recognised that if donors were to be informed therefore, confidential counselling would be required to help them come to terms with the result. After much debate, the US health department issued a recommendation to all blood banks that they should appoint a trained counsellor to discuss positive results with clients.

“In all cases,” it said, “it will be extremely important to protect the confidentiality of donor identity in relation to test results… The misuse of such information could have serious consequences for both donors and blood establishments because positive test results could result in loss of employment or insurability.” ²

At this early stage, there were also concerns (which were later discovered to be unfounded) that people could receive a false HIV positive result because they had anti-HIV antibodies in their blood but no actual HIV infection.

Ultimately however, it was decided that these fears were insignificant when compared to the desperate need to clear the blood supply of HIV. In March 1985, the first ELISA test was made commercially available in the US, and screening of the national blood supply began shortly afterwards.

Advances in screening

Since 1985, a number of improvements have been made to the blood screening process in the US. In 1992, the HIV 1 / 2 antibody test was brought in to detect the presence of HIV-2 as well as HIV-1. In 1996, a test to detect the p24 protein found in HIV was also introduced, allowing it to be detected as soon as a week after infection. Then in 1999, blood services began using a highly sensitive Nucleic Acid Testing (NAT) to detect the presence of the virus’ genetic material, which helped to cut the number of undetected HIV+ blood donations further still.

Despite the improved range of sophisticated tests however, people believed to be at increased risk of HIV are still banned from donating blood. This includes homosexuals, injecting drug users, haemophiliacs and people from areas in Africa where the rare and potentially undetectable HIV group O is endemic. ³

HIV testing of individuals

While HIV screening of the blood supply was implemented in the US in 1985, it took another two years before the ELISA blood tests were officially authorised for clinical diagnostic use and thus the testing of individuals who wished to know their HIV status. ⁴

While we now take it for granted that it’s beneficial to find out if you have HIV, in the 1980s, many people, including some AIDS groups, saw little point in HIV testing being made more accessible. No drugs were available, so the theory was that there was not a lot you could even if you were aware of your HIV status. Condoms were an option, but it was expected that everyone should use them regardless of whether they knew they had HIV or not.

This attitude later changed for several reasons.

Firstly, the US government realised that not providing HIV testing in a clinical setting was pushing people to donate blood in the hope of finding out their status. Given the problem of the 3-month ‘window period’ delay, and the occasional inaccuracy of tests, this effectively meant that the risk of HIV+ blood slipping past the screening process was increased, as people were tempted to lie about possible risky behaviour just to get tested.

Secondly, 1987 saw the introduction of the antiretroviral drug AZT, and for the first time people had some way of fighting the virus itself, not just the symptoms. This gave hope to many with AIDS, and gave a point to HIV testing.

Thirdly, an increasing number of heterosexuals were becoming infected. For those wishing to have children, using a condom simply wasn’t a practical solution, so testing for the virus was seen as an important way to ensure women did not become pregnant if they were HIV+, and thus risk passing on the virus to their child.

By the start of the 1990s, testing had become an acceptable and necessary part of HIV prevention and control. Counselling began to be seen not only as a necessary step to ensuring the mental wellbeing of those undergoing testing, but also as a vital tool to help educate people about the virus with which they were infected, and the ways in which it could be passed on. There was a growing realisation that anyone could be infected with HIV, and that the virus was already proliferating outside of the gay community.

For much of the 1990s, condoms remained the focus of many anti-AIDS campaigns, but as America moved into the new millennium, it became obvious that new strategies would be needed if the epidemic was to be contained. The promotion of sexual abstinence was one solution to this dilemma; the other was the expansion of HIV testing.

HIV testing in the US today

A survey carried out by the Kaiser Family Foundation in 2006 found that just over half (55%) of all adults aged 18-64 in the US had been tested for HIV at least once in their lifetimes. Of these, 21% reported being tested in the previous 12 months. ⁵ This compares favourably to figures from a decade earlier - in 1997, just 43% of Americans aged 18-64 said they had been tested. Much of the increase in testing uptake can be attributed to improved levels of routine antenatal testing, but a certain degree is probably also due to a greater focus on testing in the country as a whole. However, it is thought that approximately 25% of Americans living with HIV are still unaware of their infections.

In September 2006 the US Centers for Disease Control and Prevention published a new set of guidelines on HIV testing which aimed to reduce the high numbers of people who do not know their HIV status⁶. The guidelines call for automatic, routine HIV testing of all adults and adolescents attending a healthcare setting. The policy allows patients to opt out if they do not wish to take a test, but removes the need for written consent and lengthy pre-test prevention counselling, which were viewed as barriers to HIV testing.

The strategy expands upon an idea first established by the CDC in its 2003 Advancing HIV Prevention (AHP) programme. AHP called for HIV testing to be routinely offered to everyone attending clinics and other participating health care outlets (including many dental surgeries and emergency rooms) in areas where HIV prevalence was high. For low prevalence areas, they recommended that testing be offered to all those at high risk of acquiring HIV. The CDC however recognised that establishing whether an area was 'high prevalence' and which patients were at 'high risk' was a very difficult and time consuming process for many physicians, prompting a change to a universal screening approach.

In those states that fully adopt the new testing guidelines, all adults aged 13-64 attending a health-care facility will be offered HIV screening, with those at higher risk offered repeat testing every year. In line with previous recommendations, all pregnant women will be routinely offered an HIV test in early pregnancy. The guidelines state that testing must always be informed and voluntary, but that pre-test counselling need only consist of simple information about what HIV infection is, and what a positive and negative result mean. They also state that patients should always be given the chance to refuse testing, but a separate form indicating consent for an HIV test need not be signed.

After diagnosis, all patients will receive counselling, particularly if the result is positive. If a person is found to be HIV positive, their healthcare provider will also normally offer to help them track down previous partners who may either have given them HIV, or may have been infected by the individual concerned. These partners will then be informed they have been put at risk of HIV, and advised to go for testing. This process is known as Partner Counselling and Referral Services (PCRS), and is strongly encouraged by the CDC. More about PCRS can be found on our HIV Prevention in America page.

The new testing strategy has been largely accepted as beneficial to patients and overall public health, though some have warned that in busy clinics and hospitals, patients may not be properly informed that they are being tested for HIV, or that they have to right to refuse the test.⁷ In addition, no new federal funding has ever been provided to implement the scheme, meaning by September 2007 (a year after the guidelines were introduced) very few healthcare centres were actually providing universal testing.⁸ In places where money is available, some are claiming the strategy will not be cost effective and could result in fewer diagnoses than a more targeted approach ⁹. This is however denied by those who have actually implemented the programme in their clinics and hospitals.¹⁰

Type of HIV testing

At some places offering VCT, people are still offered a standard antibody ELISA test, which is then confirmed by further tests if the first result is positive. However, an increasing number of testing centres in the US are now introducing rapid tests, which provide results far more quickly.

Free testing is available in most publicly funded clinics, although certain tests (for example the oral fluid test) are more expensive than standard blood tests and may have to be paid for. If a person is unable to access free testing, their health insurance policy may cover it, although many will only cover testing in an emergency, and would not pay out for a routine test.

Rapid testing

In a country as large as the US, offering universal access to HIV testing is not a straightforward task. Many people are reluctant to be tested because of the stigma surrounding the virus. Many others avoid it simply because they do not think they are at risk, or they fear a positive result. One of the main obstacles faced by people testing for HIV however is the length of time (anything between one and four weeks) it takes for the results to be obtained.

The CDC has estimated that 31% of people fail to go back to public testing sites to obtain their results¹¹, either because they forget, or because at some point during the period they have to wait, they lose the courage to return. Many more individuals are thought to be discouraged from taking the test in the first place, because of the distress they think the wait will cause them.

In an effort to overcome this problem, the US government has invested large sums in the distribution of ‘rapid tests’. Rapid tests pick up antibodies to HIV in the blood, much as standard ELISA tests do. However, with a rapid test, the individual can be given their results on the same day, sometimes in as little as twenty minutes, which vastly reduces the risk that they will remain ignorant of their HIV status. This makes them particularly well suited for use in busy hospitals, or non-healthcare settings.

Rapid tests are easy to perform (some require a single drop of blood obtained through a simple finger prick, others only need a sample of oral fluid) but they are slightly less accurate than standard antibody tests, and will sometimes give false positive results (i.e. read positive when in fact the person is negative). This means that all positive rapid test results must be confirmed by a standard ELISA or Western Blot antibody test.

Rapid tests are proving so popular in the US, the Food and Drug Administration is now considering licensing them for use at home.

Home Testing

The idea of introducing a ‘home test’ for HIV that could be used in a similar way to a home pregnancy test has been around for many years, but has always been considered too complicated and too risky to formally implement. The fear has been that without the counselling and support offered in testing centres, people would suffer severe psychological stress and may even attempt suicide following a positive result.

Recently however, there has been a reassessment of the risks of home HIV tests in the US. With the introduction of HAART (Highly Active Antiretroviral Therapy), people with HIV are now able to stay healthy and live for many years without developing AIDS. The association between HIV and death has therefore lessened, and with it, the risk of suicide.

In October 2005, the first ever rapid test for home use (OraQuick Advance) was submitted to the FDA for approval ¹². The outcome should be known in 2007. If approved, it is expected that a detailed leaflet will accompany the test, explaining the implications of a positive result and offering a telephone support service for those who need to talk through their results.

FDA approved kits for collecting a blood sample at home are currently available in the US, but all samples have to be sent to a central laboratory for testing, and results are given over the telephone by a professional counsellor.

National HIV Testing Day

Rapid HIV testing now plays a major role in the USA’s annual HIV testing day.

National HIV Testing Day takes place on 27th June every year, and is sponsored by the National Association of People with AIDS (NAPWA). It aims to spread awareness about the importance of VCT, and in recent years, free rapid testing at centres all over the country has been offered on this day. More about National HIV Testing Day can be found at on NAPWA's website, and a comprehensive list of HIV sites can be found at hivtest.org.

State variation

CDC guidelines are designed to be universally adopted across the country. However, the structure of the USA gives each state the autonomy to create their own laws on areas of public health. This means that standard practice is rarely the same in every state, and this is particularly true of testing policy.

While many states have adjusted their screening policies to be in line with the principals of the 2006 guidelines and the AHP initiative, the ways in which this has been done vary. In some cases, written consent for an HIV testing is required across the state for example, making routine testing a difficult option without significant changes to testing regulations.

Other main areas of difference include:

• The HIV testing of mothers and newborns
• Anonymous versus confidential HIV testing policies
• Case reporting following a positive result
• Mandatory testing of certain populations

More about the state differences in the testing of mothers and newborns can be found in our HIV testing in pregnancy page. The other three issues are explained below.

Anonymous versus confidential HIV testing

Some people fear that their confidentiality will be breached when they go for an HIV test, and that somehow their status will be leaked to someone they know. Others do not like the idea of their name being passed on to the authorities, or fear giving their details in case they are recognised by a member of staff.

While US testing policy strictly prohibits names from being given to anyone other than medical staff or the local health department, many states still offer an ‘anonymous’ service by which clients do not give their name or address when they go for testing. The results will still be reported as part of state and national HIV surveillance if they are positive, but no name will be linked to them.

This contrasts to confidential testing, whereby a name and contact details must be given, and medical personnel and state health departments can have access to the results and the patient’s records. In some clinics, the test result may go into a patient’s medical records, which can then be viewed by health and life insurance companies if a patient tries to make a claim. ¹³ However, the test is still considered 'confidential' as no one else will be told about or given access to the results without the individual’s express permission.

In total, 40 states offer anonymous testing as well as confidential testing, and 10 offer only confidential tests ¹⁴. Whether the availability of anonymous testing significantly impacts on HIV testing rates is difficult to assess.

However, in the early years of the epidemic ¹⁵, where anonymous testing was made available in the state of Oregon, 50% more people went for testing, leading to twice as many seropositive cases being identified. It is possible that in the 20 years since this survey was performed, attitudes towards anonymous testing may have changed as the virus has become less stigmatised, but such results still create a clear case for the provision of anonymous services.

The CDC currently recommends that anonymous testing is provided as an option wherever possible, to maximise the number and range of people agreeing to take a test. However, a report by PACHA ¹⁶ (The Presidential Advisory Council on HIV/AIDS) has recommended the opposite approach, and has called for it to be eliminated. According to the report, “We must be able to inform people who are HIV-positive that they carry HIV. Anonymous testing makes appropriate follow-up needlessly difficult, and frequently impossible.” The report does not present any evidence to back up this assertion, and with rapid testing, it is becoming less and less likely that people will not return for anonymous test results. However, a lack of contact details does make partner ‘tracing’ impossible, and if an individual still refuses to give their name and address after receiving a positive result, it can make it virtually impossible for them to access treatment and care as they will not be added to the registered list of people living with HIV in the area.

Case reporting following a positive result

Closely linked to the issue of anonymous versus confidential testing is the problem of case reporting.

AIDS cases have long been tracked in the US, but surveillance of actual HIV diagnosis (before a person becomes sick with AIDS) is a relatively new requirement.

The CDC currently recommends that all states use a system of HIV surveillance known as name-based reporting ¹⁷. This means that every person who tests positive for HIV (excluding those who test anonymously) must give their name and address so that they can be contacted and easily tracked throughout the progression of their illness. Their name becomes their identifier and means care, treatment and other HIV services can easily be accessed.

This practice has however led to some concerns over confidentiality. In February 2005 for example, a report detailing the names of many HIV+ people living in the state of Florida was accidentally e-mailed to 800 members of the Florida Health Department, after a statistician unintentionally attached the list to a standard update on HIV surveillance.

Worries about confidentiality and the the negative effects that name disclosure can have on testing uptake, led some states to opt for a confidential code-based system (whereby names are replaced by anonymous codes to identify individuals). The CDC has however put increased pressure on ‘code-based’ states to convert their reporting structures to a more accurate name-based system by threating to restrict federal AIDS funds to those states that do not comply. As of May 2007, just two states still operated a code-based system, with the remaining 48 using name-based reporting ¹⁸.

Sceptics and some AIDS organisations have suggested that the insistence on name-based reporting is linked to a governmental focus on HIV+ people as the ‘perpetrators’ of the HIV epidemic and that records of names are being kept more as a specific identification and surveillance measure than as a general epidemiological guide. However, the US government insists that name based reporting is simply much more precise. So strong is their belief in the inaccuracy of code-based reporting, they refuse to include any data reported by code-based states in their annual countrywide HIV surveillance reports (see our US statistics pages).

Mandatory testing

One of the concerns about an increasing focus on identifying people with HIV, is that it will eventually lead to a policy of mandatory testing, whereby individuals have no choice over whether they are tested or not. As already mentioned, screening of people who give blood is already mandatory, but at present, the general population of the USA cannot be forced to take an HIV test if they don’t want one, and consent must always be obtained.

There are however certain sectors of society who, for public health reasons, are required by law to take an HIV test.

Prison Inmates

There is no specific CDC recommendation on how prison inmates should be tested, but the agency does identify them as a high-risk group that should be targeted under the AHP scheme.

The most recent US department of Justice survey of HIV in prisons ¹⁹, found that by the end of 2004, 1.9% of State prison inmates and 1.1% of Federal prison inmates were infected with HIV in the USA. The figure for individual states varies massively however. In areas of low prevalence, such as Montana, just 0.2% of the total prison population are HIV+. This contrasts to 7% in New York.

Many states have reacted to these high levels of HIV prevalence by imposing strict testing policies. As of 1999 ²⁰, 19 states had laws in place that required all prison inmates to receive an HIV test upon entry into jail (for most this is mandatory). 39 states test inmates after they’d been in an incident that caused bleeding, and three states (and all prisons run by the Federal Bureau of Prisons) impose mandatory testing of inmates upon release. Local and city prisons generally do not enforce mandatory testing however.

Both the World Health Organisation and the US Department of Justice oppose mandatory testing in prisons, and AIDS organisations have long campaigned for it to be banned. They argue that mandatory testing removes the basic human right of choice, and can lead to discrimination and segregation within the prison. It also results in lower levels of counselling being given to the prisoner at the time of the test. If an inmate can make a personal decision about whether to get tested, they will require far more knowledge about the causes and dangers of HIV before they can make an informed choice. With a compulsory test, there often seems little point in counselling a prisoner, as they will receive a test whether the individual concerned deems it necessary or not. ²¹

There is currently very little evidence showing that mandatory testing in prisons is effective as a public health measure, so most AIDS organisations advocate a voluntary opt-out policy similar to that offered to pregnant women.

Immigrants

Any person wishing to live in the United States for work or study purposes, or because they are joining a family member, must undergo a compulsory HIV test as part of their medical. Anyone found positive who has not obtained a special ‘medical waiver’ from US Immigration Services, will be refused entry to the country.²²

In theory, people visiting the USA on holiday could also be refused entry. If immigration officials at customs points have any reason to suspect an individual of being HIV+ (perhaps because they are carrying antiretroviral drugs, or because they look sick), they can either be forced to take an HIV test, or will be deported back to their country of origin. Many governments and HIV organisations object to this policy, which is why major international HIV conferences are very rarely held in the United States.

Military Personnel

All personnel are required to take an HIV test before they join the military. They are also required to test every two years throughout their time in service. A positive test result for an existing serviceman will not automatically result in discharge (unless the individual is severely ill) although new recruits may be rejected if they are discovered to be HIV+. ²³

HIV testing: the future

The US approach of prevention through testing is a new, and previously untried way of controlling the epidemic, and only time will tell if it can achieve the results the government is hoping for. Some early signs suggest that it may well be having a positive impact in some areas - the huge reduction in the number of HIV+ children being born in the US today is mainly thanks to the expansion routine testing and identification in pregnant mothers.

However, while widespread testing may lead to the US population being one of the most ‘status aware’ nations in the world, a careful balance needs to be struck between case identification and an individual’s right to privacy, choice and confidentiality. The importance of promoting other forms of prevention also needs to be carefully considered. Intervention strategies that focus on the “positive person” may help to prevent further spread of the virus, but if that individual had been targeted by an effective prevention campaign before they decided to engage in risky behaviour, it is possible that their infection could have been avoided altogether.

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