Opt-out/provider-initiated testing

In order to increase the provision of HIV testing, it is generally agreed that tests would have to be offered on a ‘provider-initiated’ and ‘opt-out’ basis.

These terms are separate concepts, or two parts of a single process.

‘Provider-initiated’ implies that physicians or other healthcare providers take the initiative to offer the patient a test for a disease or condition, rather than waiting till the patient requests a test.

‘Opt-out’ implies that instead of requiring the patient to provide explicit evidence of consent to a test, the patient’s consent to the offered test is assumed unless they specifically refuse it.

BHIVA’s one-sentence definition of provider-initiated, opt-out testing is that “all individuals attending specified settings are offered and recommended an HIV test as part of routine care but an individual has the option to refuse a test.”¹

It is not ethical to conduct any medical procedure if the patient does not consent to it, except in cases where the patient lacks capacity to consent (e.g. is unconscious, mentally incompetent or a child). In the UK, a body of common law has developed to define exactly what ‘capacity’ consists of.

Most standard blood tests are done as opt-out tests; your doctor does not ask for your consent for every measurement of haemoglobin or cholesterol, for instance. The General Medical Council states that: “Patients can give consent orally or in writing, or they may imply consent by complying with the proposed examination or treatment, for example, by rolling up their sleeve to have their blood pressure taken.”² New patients often sign a generalised consent form at their first appointment which authorises standard medical treatment, including tests.

The World Health Organization (WHO) provides a much more detailed explanation of provider-initiated testing in its 2007 guidance on the subject.³ It says that: “Provider-initiated HIV testing and counselling refers to HIV testing and counselling which is recommended by health care providers to persons attending health care facilities as a standard component of medical care”, and points out that lack of provider-initiated testing may be unethical. It says: “In the case of persons presenting to health facilities with symptoms or signs of illness that could be attributable to HIV, [emphasis in original], it is a basic responsibility of heath care providers to recommend HIV testing and counselling as part of the patient’s routine clinical management.”

In all cases, the WHO says, three ‘Cs’ - informed consent, counselling and confidentiality – must be observed. The WHO emphasises that: “Provider-initiated HIV testing and counselling is neither mandatory nor compulsory. WHO and UNAIDS do not support mandatory or compulsory testing of individuals on public health grounds.”

In terms of ‘opt-in’ and ‘opt-out’, WHO defines these as follows:

• “With ‘opt-in’ approaches, patients must affirmatively agree to the test being performed after pretest information has been received. Informed consent is analogous to that required for special investigations or interventions in clinical settings such as liver biopsy or surgical interventions.
• “With ‘opt-out’ approaches, individuals must specifically decline the HIV test after receiving pretest information if they do not want the test to be performed. This approach to informed consent is analogous to that required for common clinical investigations.”

WHO points out that provider-initiated testing could be combined with an opt-in approach (explicitly expressing consent). This may occur, for example, in “health facilities that serve highly vulnerable populations”, such as prisons, where it may continue to be important to establish explicitly that the patient understands the meaning and possible consequences of testing.

“Whether patients ‘opt-in’ or ‘opt-out’, the end result should be the same,” says the WHO: “an informed decision by the patient to accept or decline the health care provider’s recommendation of an HIV test”.

Provider-initiated testing still leaves it open for the provider to decide to whom to offer the test. Surveys of late diagnosis and missed opportunities for diagnosis in a number of healthcare settings show that diagnoses are missed because physicians use targeted testing which may be based on incorrect, prejudiced or outdated assumptions about who is likely to have HIV.

Recently, some testing guidelines have moved to the position that there should be outright screening of certain populations in certain settings. Screening implies that testing is done as a matter of course on a whole population and differs from provider-initiated testing in that the decision to test is taken away from the physicians – though it should not involve the removal of the patient’s right to refuse.