Prepare to play a bigger part in HIV awareness, testing and advice
It is estimated that there are approximately 100,000 people living with HIV in the UK, and that up to a quarter may not know that they have the virus. Stigma still exists, and fear and ignorance about HIV infection continue to affect uptake of HIV testing.
This article outlines the tests that are available for HIV and describes the new self-testing option, which will be available from April 2014. It also explains the relationship between time from exposure and testing, and gives examples of local HIV testing initiatives.
To read the full article download the attached PDF.
With an increasing focus on public health and the advent of home HIV tests, community pharmacists will need to be more aware of HIV and be better equipped to answer queries
Source: CHRIS GALLAGHER/SCIENCE PHOTO LIBRARY
WORLD AIDS day, on 1 December, aims to increase awareness of progress in HIV/AIDS prevention, treatment and care. Specifically one aim is “Zero AIDS-related deaths” — such deaths are mostly avoidable if those at risk are tested and treated early.
It is estimated that there are approximately 100,000 people living with HIV in the UK, and that up to a quarter may not know that they have the virus.1 Stigma still exists, and fear and ignorance about HIV infection continue to affect uptake of HIV testing. There is a drive in the Public Health Outcomes Framework (2013–16)2 to reduce undiagnosed HIV in the population, enabling access to treatment and care, and resulting in improved health outcomes. Not only that, testing and treatment also reduce onward transmission.
One of the great success stories in reducing HIV transmission has been the introduction of “optout” testing in antenatal screening. This means that all pregnant women in the UK are now tested for HIV (among other routine tests, such as for anaemia and rubella status) unless they specifically object. As a result, 98 per cent of pregnant women were tested for HIV in 2012.3
Diagnosis early in pregnancy allows the woman to be treated so the chance of having a healthy, HIV-negative baby is greater than 99 per cent. Combination antiretroviral therapy (cART) suppresses the HIV viral load in blood during pregnancy and at delivery, and is responsible for the large decrease in vertical transmission.
A similar principle drives “treatment as prevention” (TasP) initiatives. Untreated patients contribute disproportionately to horizontal (sexual) transmission of HIV, therefore getting those infected onto treatment and decreasing their viral load will lower the risk of transmission and contribute to a global reduction in new HIV infections. For this reason, wider access to HIV testing is not just beneficial to the individual, but to the local community.
These days an HIV diagnosis may mean taking as little as one tablet a day and a near normal lifespan. It is, therefore, essential that we normalise HIV testing, making it seem as routine as having a cholesterol or blood pressure check.
Targeted testing initiatives are often viewed as the best approach. It is recommended that all new GP registrants in high prevalence areas (ie, >0.2 per cent) and aged 15 to 59 years are tested for HIV.
Public Health England has estimates of prevalence for every local authority area in England.4 In Wandsworth, for example, the prevalence is 0.49 per cent and a number of initiatives have taken place, including a team from the
St George’s Hospital Sexual Health Service visiting primary care practices and promoting testing of existing patients already diagnosed with HIV indicator conditions associated with immunosuppression (see later). This has resulted in an increase in GP referrals into HIV treatment and care at St George’s Hospital. However, reducing undiagnosed HIV infection in the community requires a number of different strategies in order to be effective.
A number of initiatives offering HIV testing in community pharmacies have been established. Moreover, several pilots supported by Public Health England have produced some promising results,5 but current recommendations for wider testing in community based healthcare settings are only for areas where the prevalence of HIV infection in the local population is >0.2 per cent (ie, more than two in 1,000). Nevertheless, because HIV is primarily a sexually transmitted infection (STI), offering HIV testing works well with testing for other STIs in community settings.
What tests are there?
Most HIV tests detect antibodies, or antibodies and antigens, but they can differ in sensitivity. Moreover, it takes time before antibodies (seroconversion) or antigens are detectable. This depends on both the person and the test. For example, although most people who are exposed to HIV will have produced antibodies by one month, in a few it can take up to three months for detectable antibodies to be produced. In other words, there is a “window period” — the time from exposure until a test will be reliable. If a test works by detecting HIV antibodies, the window period can be up to three months.
Tests that detect the p24 antigen decrease the window period to one month because this antigen can be detected earlier in HIV infection than antibodies, and such tests may be useful for indicating more recent exposure.
Some examples of point-of-care tests are given in Panel 1. These are appropriate for a number of testing settings, including pharmacies. Third generation tests (eg, INSTI HIV and Orasure Oraquick) are less sensitive than fourth generation tests (eg, Determine) when used where exposure has occurred less than a month ago.
It is important to understand the limitations of specificity. For example, if a test is 99.7 per cent specific, in 1,000 tests there will be three false positives, and if the prevalence of HIV infection in that local community is 0.1 per cent (one in 1,000) then one test would be truly positive. This means the positive predictive value of this test locally is only 25 per cent (ie, one in four reactive tests). For this reason, a positive result from a point-of-care test result is best described as “reactive” and onward referral for a confirmatory test via a genito-urinary medicine (GUM) clinic or GP surgery is necessary before a diagnosis can be made.
Samples are sent to a laboratory and tests for p24 antigens and HIV antibodies are more sensitive. Results tend to take longer than point-of-care tests — often one or two days. Diagnostic tests may involve a number of different methods, and may also include testing for viral RNA proteins.
Since 1992, under The HIV Testing Kits and Service Regulations, the sale, supply and advertising of HIV test kits has been illegal in the UK unless under the direction of a medical practitioner or in providing a testing service (eg, on donated blood). Currently, therefore, individuals are purchasing tests online that are not regulated, that may produce a high rate of false results, that may be misinterpreted and that offer no access to support and counselling. This is about to change: from April 2014 self-test kits will be legalised. These over-the-counter home-testing kits will be regulated by the Medicines and Healthcare products Regulatory Agency. Crucially, this will ensure that tests are accurate and that there is appropriate follow-up available for anyone with a positive result.
There is evidence from the US that when self-test kits were approved by the Food and Drug Administration, a large number of people who used them had not tested before. It is thought that there will be a similar group in the UK who may believe they have a risk of HIV but are unwilling to go to a clinic or their GP to test and these people will benefit from having a test at home. Part of the approval of these tests is that there is access to post-test support and counselling, and onward referral to HIV services if necessary, and pharmacists will need to be prepared to deal with queries appropriately.
Not all patients will want to pay for a test to use at home and access to HIV testing and treatment through sexual health services remains free at the point of care.
Time from exposure
The time from exposure and its relation to testing is important. As already explained, there is a window period before a test can be reliably used and this may need to be explained to patients. Although fourth generation tests that detect a combination of p24 antigen and antibodies can find infection as early as 11 days, false negatives can occur and a repeat test should be done, ideally two weeks later. The sensitivity of laboratory-based fourth generation tests is about 95 per cent at four weeks in detecting infection.
Patients who believe they have been exposed to HIV infection within the past three months should, therefore, be encouraged to seek advice from a GUM clinic or their GP. The Family Planning Association website (www.fpa.org.uk) can search services using a postcode to find the nearest clinic.
Anyone who has been at risk of exposure to HIV within the past 72 hours should be encouraged to seek immediate support from a GUM clinic or an accident and emergency department because they may require post-exposure prophylaxis for HIV after sexual exposure, known as PEPSE.
Panel 2 describes the current regimen and advice on side effects that pharmacists should be aware of.
There is no known benefit of PEPSE if given more than 72 hours from exposure to HIV but anyone concerned about exposure should be referred to a sexual health adviser. He or she will provide support around behavior change to reduce risk of exposure and confidential counselling on issues around sexually transmitted infections, including HIV, in a non judgemental way.
If 72 hours has passed it is still important to recommend that the person consults a GUM clinic doctor because he or she will need to be tested at an appropriate time (at four weeks or earlier if they have symptoms such as fever or swollen glands).
So, any test result must be viewed in relation to the most recent risk of exposure to HIV and this is best done in a GUM clinic or GP practice setting where appropriate follow-up can be planned if a more recent risk exposure cannot yet be detected by available tests.
Regardless of time of exposure, absence of a test result and referral, one of the most important pieces of advice a pharmacist can give is not to have unprotected sex because people can be infectious from the point of exposure.
In order to reduce undiagnosed HIV in our communities, a targeted approach to testing in primary care is recommended. You may have knowledge about your patients that might enable a discussion around the benefits of testing. Groups at increased risk of HIV are:
• Men who have had sex with men (MSM)
• Those who have had unprotected sex with someone from a region where HIV is more prevalent (eg, sub-Saharan Africa, the Caribbean, and South-east Asia)
• Injecting drug users who share injecting equipment
• Those who have had unprotected sex with a sex worker
•Those who have had unprotected sex with anyone in the above categories
However, we are not suggesting that these risk factors should necessarily prompt questions which may seem inappropriate.
Pharmacists should also be aware of conditions that are HIV indicators. Although HIV infection is symptomless in many patients, some may present in primary care with the conditions listed in Panel 3. It is possible that some of these conditions may occur in isolation or in patients who do not have HIV infection, but consider offering a test if a patient has:
• Identified risk factors (see above)
• Indicator symptoms that are recurrent, recalcitrant or unexplained
• More than one indicator condition
Candida and oral hairy leukoplakia are probably the most common conditions affecting people with advanced HIV infection and are a sign of immunosuppression. Oral hairy leukoplakia is a white, ribbed lesion along the edge of the tongue caused by the Epstein-Barr virus. Lesions typically disappear once a patient is diagnosed and treated for HIV. In the Image above, candida is also present as a white coating on the tongue or the inside of the mouth. Candida can occasionally appear as red patches. Candida responds to antifungal therapy but if the patient is diagnosed and treated for HIV it usually will disappear as the immune system gets stronger.
Using a private area for consultation is always best to ask further questions about a condition that may be embarrassing for a patient. If, for example, a patient with oral thrush asks for advice, you would want to determine if this was a new condition, whether he or she is taking any medicines, such as corticosteroids, broadspectrum antibiotics or immunosuppressants, and if he or she has any underlying medical condition that could cause this, such as dry mouth, poorly controlled diabetes, immunosuppression or cancer. Smokers more commonly have oral candida. It is very much a situation where you need to develop a rapport with patients in order to initiate a discussion where you believe it is appropriate. You may want to encourage patients to seek advice from their GP or you may be able to gain their consent to discuss this with their GP on their behalf. Alternatively, if you have links with a GUM or sexual health service then you could put them in touch with that clinic.
Suggesting that someone has an HIV test is not easy but it may also help to outline the benefits of knowing that you are HIV positive. These include the following points:
• You can achieve a near normal life expectancy on antiretrovirals
• If you have symptoms antiretrovirals can restore you to good health
• If you have a sexual partner, you will know to protect them by using a barrier method of contraception
• If you wish to have children it is possible to have healthy babies if you know your HIV status early in pregnancy
Having leaflets widely available on testing may be helpful and could avoid an awkward conversation. Leaflets are also a useful resource for pharmacy staff to read and enable fluent conversations with patients. The FPA offers excellent leaflets on sexually transmitted infections, including HIV.
Making a difference
There have been a number of local initiatives in HIV testing with mixed success. One that has been effective was supported by NHS Newham and identified eight reactive tests out of a total of 800 in three pharmacies over 15 months. These were all new diagnoses and uptake was probably good because the tests were free.
Jignesh Patel, pharmacist at Rohpharm Ltd in Plaistow, said of the study: “We referred patients to the Greenway Centre at Newham General Hospital using referral forms via a secure fax machine. Patients were contacted within 48 hours by the clinic.” It is this prompt follow up and link into specialist care that is so important in any of the community-based testing schemes. Commitment is crucial too. Mr Patel continued: “Pharmacists trained and linked up to HIV diagnostic and care pathways can provide HIV screening and counselling within community pharmacies. Pharmacists must have a confidential consultation room where conversation cannot be heard from outside. Frontline staff need to be knowledgeable about the service so that clients are dealt with sensitively and confidentially.”
Dr Thom, the online GP service allied to Lloyds Pharmacy, is working with an NHS provider to target MSM users of a dating website after a successful targeted campaign that had four reactive tests out of 73 tests. Tom Brett, medical director of Dr Thom, says: “We are accessing a group of people that do not want to go their GP or a sexual health clinic to test. We are meeting a demand for online access to healthcare.”
Clearly with the advent of self test kits next year, there are opportunities to support patients before and after testing. They will need advice about local sexual health services, for example.
It remains to be seen how local authorities discharge their responsibilities towards public health and in particular contribute to reducing undiagnosed HIV in the population. Community-based healthcare settings such as community pharmacies offer another way of normalising HIV testing and engaging patients in diagnosing conditions that can be managed well with early intervention.
Reducing undiagnosed HIV infection in the community requires collaboration and innovation to decrease stigma and normalise HIV testing to achieve our goals.
References available online.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2013.11130589
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