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HIV self-testing kits available soon from pharmacy

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HIV self-testing kits available soon from pharmacy

Licensed HIV self-testing kits will soon be sold through pharmacies -- part of the Government’s drive to encourage more ‘at risk’ groups to be screened for the virus.

The first UK-licensed HIV self-testing kits are expected to become available at the end of 2014 or early 2015.

Previously, under the HIV Testing Kits and Services Regulations 1992, HIV test results had to be given by a healthcare professional. Private HIV screening has been available from online pharmacies and charities, as well as in-store, for some time, but patients have to return the sample for analysis before being given the result and appropriate counselling. With the new licensed HIV self-testing kits, people take the kit home, test themselves with a finger-prick blood sample and obtain their result immediately.

Unregulated self-testing kits are currently available over the internet, but their quality is not guaranteed. According to Public Health England, these kits may come with little or no instructions, and no advice on safer sexual practices or information on how to get HIV treatment and advice. There is also no guarantee that they will work reliably and they may even give a false result.

With the change in the law, the licensed self-testing HIV kits will be subject to regulation by the Medicines and Healthcare products Regulatory Agency (MHRA). Tests that meet the required standards will be given a CE mark to guarantee that they work properly and are safe. To comply with MHRA regulations, the self-testing kits will include clear information on how to interpret the results and advice on where to receive a follow-up test.

“Many people already buy unlicensed HIV testing kits from the internet, unaware that they may well be unreliable and give false results,” says Heather Leake Date, consultant pharmacist in HIV and sexual health at Brighton and Sussex University Hospitals NHS Trust and spokesperson for the Royal Pharmaceutical Society. “It is better for consumers to buy licensed kits from community pharmacies, who can signpost them to the right local services, than a faceless website where there is no support or information available.”

Diagnosis boost

Licensed HIV self-testing kits are not intended to replace a clinic- based diagnosis but they will increase the reliable screening options available, targeting in particular those at risk who are too scared or uncomfortable to visit a clinic. According to HIV and sexual health charity, the Terrence Higgins Trust, of the estimated 100,000 people living with HIV in the UK, around a fifth don’t know they are HIV positive. Yet if someone with HIV is diagnosed early enough and is able to access treatment, they can have a near-normal life expectancy.

The Terrence Higgins Trust HIV self-sampling scheme, which was launched in January 2013, has demonstrated a significant nationwide demand for the option to test for HIV at home. Following a marketing push in March 2014, the charity received more than 3,000 requests for postal HIV tests over one weekend. People at increased risk of infection were invited to place an order online and receive a free HIV test kit through the post.

Users were asked to provide a finger-prick of blood, which they then posted to a laboratory. The result was returned within 14 days, either by text message (if the result was negative), or with a telephone call to provide support and referral to a specialist HIV service (if the result was positive). Of those people who returned a test, 32 per cent had never tested for HIV before and 25 per cent had not tested in the past 12 months.

“Given the scale of public demand, and the positive feedback from those who have used the service, it is likely that HIV self-sampling will form a key strut of our prevention work in the UK from this point on,” says Dr Michael Brady, medical director at the Terrence Higgins Trust. “It also suggests there may be reasonable demand for HIV self-testing once an approved kit goes on sale.”

Case study

Ropharm Pharmacy in Plaistow, East London, was one of the first pharmacies in London to offer in-store HIV testing on the NHS, as part of a PCT-funded scheme. “During the 14 to 15 months of the scheme, we conducted 800 HIV screens, of which eight were positive,” says pharmacist Jignesh Patel. “We overcame the stigma of HIV, normalising the service as if it was diabetes or hypertension [testing], and many customers said they preferred a pharmacy-based service due to convenience and anonymity than a GP or clinic-based one.”

In 2013, funding was slashed and the service was directed back through GP surgeries. Ropharm Pharmacy now offers private HIV testing using the same protocols as the NHS service, promoting the service online and in-store. “We perform around five or six tests a month, targeting anyone concerned about sexually transmitted infections, in all age groups,” says Jignesh. “Before doing the test, I always provide background information on HIV, including treatments, and explain that the service is confidential and anonymous.”

The test involves taking a finger-prick sample from the customer, with results available within 10 minutes. “When I give the results (positive or negative), I explain them clearly and signpost to relevant local services,” says Jignesh. “My concern with HIV self-testing kits is whether people will seek advice after they have done the test at home. With HIV, many people worry about divulging information, especially in relation to patient records, and whether it could affect insurance. Instead of selling tests for people to do at home, pharmacists may be better off providing the testing kits as an additional service in-store, so that customers have ready access to professional advice and signposting.” 

Pharmacy screening

Some pharmacies already offer in-store HIV and hepatitis screening alongside other sexual health services. Jason Warriner, clinical director at the Terrence Higgins Trust, says that offering in-store services is a step forward in normalising HIV. “People already go to the pharmacy for a range of health needs, so offering in-store HIV testing and selling self-testing kits should be just as normal as offering pregnancy kits and medicines advice,” he says.

“People have been buying unregulated testing kits over the internet for years, so the recent change in regulation is a giant step forward, especially in high-prevalence areas. However, no one yet knows what size the UK market will be or how much the kits will cost, which will play a big part in determining demand for them.” 

If community pharmacists are selling licensed HIV self-testing kits, they need to provide information at point of sale to make sure customers understand how to do the test and interpret it. “Pharmacists have a responsibility in what they do and the advice they offer,” says RPS English Pharmacy Board vice-chair Ash Soni.

“Pharmacists and pharmacy staff must be fully trained, expanding on their current knowledge and skills base used for emergency contraception and other sexual health services. If the HIV test result is positive, it is important the customer seeks appropriate help. Even if it is negative, pharmacists need to discuss issues surrounding HIV testing and support people engaging in risky behaviour.”

Tim Morgan, pharmacy manager at Newport’s Superdrug branch, which already offers a private on-site HIV testing service, says community pharmacy is the ideal setting for the sale of home-testing kits. “This would undoubtedly make HIV testing easier to access and improve early diagnosis,” he says. “However it’s the advice given that is preventing the transmission of HIV, not the test itself. Community pharmacies should be adding value through the provision of excellent sexual health advice alongside the sale of these kits, otherwise the only benefit they would be offering over an internet sale would be improved accessibility.”

The ultimate aim for pharmacists offering in-store screening or home testing kits should be to refer customers to their GP or signpost to the local sexual health clinic. “All pharmacists have a basic knowledge of sexually transmitted infections and sexual health, so they are already able to convey this knowledge to the customer,” says Morgan. “If provided with the appropriate resources and a robust framework or standard operating procedure, it wouldn’t take a significant amount of time for pharmacists to prepare themselves for such a service. However, the manner in which this service is regulated for quality is paramount.”

 

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