At-home HIV test poses dilemmas and opportunities

Abstract

The first HIV test for home use to be approved in the USA will be available to buy in the country's major pharmacies next month. Carrie Arnold reviews its pros and cons.Tom Donohue's life changed at a routine doctor's appointment 9 years ago. As part of his annual physical, the then 22-year-old university student was tested for HIV. Donohue initially thought nothing of it, sure that the test would come back negative. It didn't.Learning about his HIV status sparked a crusade in the young man to reduce HIV/AIDS stigma and encourage everyone to get tested for HIV. In rural Pennsylvania, Donohue founded the national AIDS charity Who's Positive as a means of reaching other young people at risk for HIV. His work has also led him to support the new OraQuick At-Home HIV test. The test, formally approved by the US Food and Drug Administration (FDA) on July 3, is the first over-the-counter HIV test licensed for home use. It is expected to be on sale at major pharmacies from October.“Knowing your status is an important factor in the effort to prevent the spread of HIV”, said Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research, in a statement announcing the approval of OraQuick. “The availability of an over-the-counter home-use rapid HIV test kit provides another option for individuals to get tested so that they can seek medical care, if appropriate.”Much of the drive to develop an over-the-counter, home HIV test came from concern about data gathered by the Centers for Disease Control and Prevention (CDC) that many people who were HIV-positive did not know it. The CDC estimates that 1·2 million Americans have HIV, and almost one in five HIV-positive individuals do not know that they have the virus. 1 week before the FDA announced the approval of OraQuick, the US Preventive Services Task Force recommended that all Americans be tested for HIV at least once in their lives as part of general preventive care. The OraQuick home HIV test, says Ron Ticho, senior vice president of communications at OraSure, the makers of the test, is a way to expand access to HIV testing to people who might not otherwise choose to get tested and to those who want to test their HIV status more frequently.The test involves a simple mouth swab that detects HIV antibodies in saliva. After swabbing their upper and lower gums, the tester places the swab in a vial of developer solution and waits for 20–40 minutes. The test has a 92% sensitivity and a 99·98% specificity, which means that one out of every 12 test results in HIV-infected individuals will be a false negative. Similarly, one out of every 5000 test results in uninfected individuals will be a false positive. These results are comparable to other at-home tests, Ticho said.The false-negative rate is quite high, concedes David Dowdy epidemiologist Johns Hopkins University, Baltimore, MI. “You need to make sure that the test is foolproof because you need to assume that the level of skill of someone taking the test is low”, he said.The OraQuick test is easy to use, but not exactly foolproof, which explains the high false-negative rate. However, OraSure, the FDA, and public health experts all indicate that any OraQuick test needs to be verified in a clinic, just as the results of a home pregnancy test are frequently confirmed by a physician.Ticho says that the at-home test will cost around US$40, roughly twice as much as a similar test available to physicians. Part of the difference in price, the company says, will help fund a group of professionally trained, bilingual counsellors who can be contacted 24 hours a day, 7 days a week. These counsellors are just as well-qualified as any professionals available in HIV testing centres and clinics around the country, he noted.In the USA, mandatory psychological counselling has been a huge part of the HIV testing process, according to Jose Bauermeister, an assistant professor of Health Behaviour and Health Education at the University of Michigan, Ann Arbor, MI. In the 1980s and early 1990s, when AIDS was essentially a death sentence, counselling was crucial to helping patients understand their terminal diagnosis, what to expect, and how to inform sexual or drug-using partners that they may have been exposed.The development of new antiretroviral drugs has allowed many HIV-positive patients to live relatively normal lives, but many in the HIV treatment community still believe that counselling is key. Providing psychological and practical support for someone receiving a life-altering and devastating diagnosis is essential, but counselling those who test negative remains a crucial part of HIV prevention. “Counsellors provide health education about how to reduce your risk of getting HIV, as well as reinforcing messages about repeat testing and consistent condom use”, Bauermeister said.Ironically, the lack of mandatory counselling with OraQuick may help decrease the stigma around testing. Advocates initially worried that the psychological distress of someone who just found out they were HIV positive might drive them to suicide—hence the mandatory counselling. To some, however, this required counselling only further emphasised the death knell surrounding a positive HIV test. After all, Bauermeister pointed out, a pregnancy test can be similarly life-altering and, depending on whether one wanted to be pregnant, devastating. Yet it is easily available over the counter at any neighbourhood pharmacy with no requirement that the person be counselled about antenatal care or safer sexual behaviours.Donohue says that counselling will still be available for those who want it, even if it is no longer mandatory. Part of the FDA approval process was balancing the benefits of mandatory counselling against the benefits of allowing more people to know their HIV status. In the end, Donohue said, the benefit of knowing your HIV status won out, both in the FDA and in the larger AIDS community.This hunch has been borne out in some of the studies on the test. When researchers at Columbia University in New York City asked a group of 27 ethnically diverse men who have sex with men to try the OraQuick test with friends and potential sexual partners, they identified ten HIV-positive individuals using 100 tests. Six of these ten men did not know they were positive, as the scientists reported earlier this year in the journal AIDS and Behavior. What is more, the men who tried the test reported wanting to use this test themselves and on prospective sexual partners before having sex. None of the ten men who tested positive had sex immediately after the test.Having telephone support available at all hours of the day or night may actually be preferable to face-to-face counselling in a physician's office, Donohue pointed out. People can take their time to formulate their questions and do not have to confine the counselling to a short session. They can call back if they think of something in the middle of the night. It is a rather 21st century approach to HIV counselling, Donohue says.Quite a few barriers exist towards many people getting tested for HIV. People who engage in risky sexual or drug-taking behaviours do not always disclose these to a physician who could recommend a test. Many rural communities lack proper HIV testing facilities. For those rural areas that do have facilities, people may be reluctant to request a test in case they are recognised and subsequently stigmatised.Of course, a person could be recognised at a local pharmacy, but a testing kit can be easily concealed by placing it with other items being purchased, by utilising automated checkout lanes, and by visiting a more distant pharmacy with less familiar personnel. “An at-home test will allow people to test when they want to and how they want to, in the privacy of their own home. This will allow a whole new population of people to learn their HIV status without having to go to a local testing centre”, Donohue said.Bauermeister agrees. The group of people who purchase the OraQuick home HIV test may be completely different from the people who seek out HIV testing at a clinic. The important thing is for people to learn their status, he says, not exactly how or where they do it. Despite the imperfections of the test, Dowdy believes it will ultimately be useful from a public health perspective.Having an HIV test openly and easily available might also reduce the stigma surrounding both the illness and getting tested for it. “Just having a product that is available alongside condoms and other items will help to routinise testing”, Ticho said. “An HIV test will hopefully be seen as just another part of your normal health routine.”The increased convenience and anonymity at neighbourhood pharmacies has spurred the CDC to launch a new pilot programme to train pharmacists at 24 pharmacies to undertake HIV tests and counsel people before and after the tests. Pharmacies will be selected in locations with high rates of HIV and/or low availability of HIV services. Half of the sites will be in rural areas, and half in urban ones. “This initiative is a pilot, so CDC will need to evaluate what works best. Based on lessons learned, we will develop a comprehensive toolkit that pharmacists and retail clinic staff from around the country can use to implement HIV testing”, said Jonathan Mermin, director for the Division of HIV/AIDS Prevention at the CDC. “Knowing your HIV status is key to protecting your health and that of your loved ones.”The normalisation of HIV testing combined with improved treatments and the relatively normal lives led by HIV-positive individuals should encourage people to learn their HIV status. “I truly believe that we will identify a significant number of HIV-positive people who are walking around and don't know that they are positive”, Donohue said.For the podcast see http://www.thelancet.com/lancet-news-audio-2012This online publication has been corrected. The corrected version first appeared at thelancet.com on April 26, 2012 The first HIV test for home use to be approved in the USA will be available to buy in the country's major pharmacies next month. Carrie Arnold reviews its pros and cons. Tom Donohue's life changed at a routine doctor's appointment 9 years ago. As part of his annual physical, the then 22-year-old university student was tested for HIV. Donohue initially thought nothing of it, sure that the test would come back negative. It didn't. Learning about his HIV status sparked a crusade in the young man to reduce HIV/AIDS stigma and encourage everyone to get tested for HIV. In rural Pennsylvania, Donohue founded the national AIDS charity Who's Positive as a means of reaching other young people at risk for HIV. His work has also led him to support the new OraQuick At-Home HIV test. The test, formally approved by the US Food and Drug Administration (FDA) on July 3, is the first over-the-counter HIV test licensed for home use. It is expected to be on sale at major pharmacies from October. “Knowing your status is an important factor in the effort to prevent the spread of HIV”, said Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research, in a statement announcing the approval of OraQuick. “The availability of an over-the-counter home-use rapid HIV test kit provides another option for individuals to get tested so that they can seek medical care, if appropriate.” Much of the drive to develop an over-the-counter, home HIV test came from concern about data gathered by the Centers for Disease Control and Prevention (CDC) that many people who were HIV-positive did not know it. The CDC estimates that 1·2 million Americans have HIV, and almost one in five HIV-positive individuals do not know that they have the virus. 1 week before the FDA announced the approval of OraQuick, the US Preventive Services Task Force recommended that all Americans be tested for HIV at least once in their lives as part of general preventive care. The OraQuick home HIV test, says Ron Ticho, senior vice president of communications at OraSure, the makers of the test, is a way to expand access to HIV testing to people who might not otherwise choose to get tested and to those who want to test their HIV status more frequently. The test involves a simple mouth swab that detects HIV antibodies in saliva. After swabbing their upper and lower gums, the tester places the swab in a vial of developer solution and waits for 20–40 minutes. The test has a 92% sensitivity and a 99·98% specificity, which means that one out of every 12 test results in HIV-infected individuals will be a false negative. Similarly, one out of every 5000 test results in uninfected individuals will be a false positive. These results are comparable to other at-home tests, Ticho said. The false-negative rate is quite high, concedes David Dowdy epidemiologist Johns Hopkins University, Baltimore, MI. “You need to make sure that the test is foolproof because you need to assume that the level of skill of someone taking the test is low”, he said. The OraQuick test is easy to use, but not exactly foolproof, which explains the high false-negative rate. However, OraSure, the FDA, and public health experts all indicate that any OraQuick test needs to be verified in a clinic, just as the results of a home pregnancy test are frequently confirmed by a physician. Ticho says that the at-home test will cost around US$40, roughly twice as much as a similar test available to physicians. Part of the difference in price, the company says, will help fund a group of professionally trained, bilingual counsellors who can be contacted 24 hours a day, 7 days a week. These counsellors are just as well-qualified as any professionals available in HIV testing centres and clinics around the country, he noted. In the USA, mandatory psychological counselling has been a huge part of the HIV testing process, according to Jose Bauermeister, an assistant professor of Health Behaviour and Health Education at the University of Michigan, Ann Arbor, MI. In the 1980s and early 1990s, when AIDS was essentially a death sentence, counselling was crucial to helping patients understand their terminal diagnosis, what to expect, and how to inform sexual or drug-using partners that they may have been exposed. The development of new antiretroviral drugs has allowed many HIV-positive patients to live relatively normal lives, but many in the HIV treatment community still believe that counselling is key. Providing psychological and practical support for someone receiving a life-altering and devastating diagnosis is essential, but counselling those who test negative remains a crucial part of HIV prevention. “Counsellors provide health education about how to reduce your risk of getting HIV, as well as reinforcing messages about repeat testing and consistent condom use”, Bauermeister said. Ironically, the lack of mandatory counselling with OraQuick may help decrease the stigma around testing. Advocates initially worried that the psychological distress of someone who just found out they were HIV positive might drive them to suicide—hence the mandatory counselling. To some, however, this required counselling only further emphasised the death knell surrounding a positive HIV test. After all, Bauermeister pointed out, a pregnancy test can be similarly life-altering and, depending on whether one wanted to be pregnant, devastating. Yet it is easily available over the counter at any neighbourhood pharmacy with no requirement that the person be counselled about antenatal care or safer sexual behaviours. Donohue says that counselling will still be available for those who want it, even if it is no longer mandatory. Part of the FDA approval process was balancing the benefits of mandatory counselling against the benefits of allowing more people to know their HIV status. In the end, Donohue said, the benefit of knowing your HIV status won out, both in the FDA and in the larger AIDS community. This hunch has been borne out in some of the studies on the test. When researchers at Columbia University in New York City asked a group of 27 ethnically diverse men who have sex with men to try the OraQuick test with friends and potential sexual partners, they identified ten HIV-positive individuals using 100 tests. Six of these ten men did not know they were positive, as the scientists reported earlier this year in the journal AIDS and Behavior. What is more, the men who tried the test reported wanting to use this test themselves and on prospective sexual partners before having sex. None of the ten men who tested positive had sex immediately after the test. Having telephone support available at all hours of the day or night may actually be preferable to face-to-face counselling in a physician's office, Donohue pointed out. People can take their time to formulate their questions and do not have to confine the counselling to a short session. They can call back if they think of something in the middle of the night. It is a rather 21st century approach to HIV counselling, Donohue says. Quite a few barriers exist towards many people getting tested for HIV. People who engage in risky sexual or drug-taking behaviours do not always disclose these to a physician who could recommend a test. Many rural communities lack proper HIV testing facilities. For those rural areas that do have facilities, people may be reluctant to request a test in case they are recognised and subsequently stigmatised. Of course, a person could be recognised at a local pharmacy, but a testing kit can be easily concealed by placing it with other items being purchased, by utilising automated checkout lanes, and by visiting a more distant pharmacy with less familiar personnel. “An at-home test will allow people to test when they want to and how they want to, in the privacy of their own home. This will allow a whole new population of people to learn their HIV status without having to go to a local testing centre”, Donohue said. Bauermeister agrees. The group of people who purchase the OraQuick home HIV test may be completely different from the people who seek out HIV testing at a clinic. The important thing is for people to learn their status, he says, not exactly how or where they do it. Despite the imperfections of the test, Dowdy believes it will ultimately be useful from a public health perspective. Having an HIV test openly and easily available might also reduce the stigma surrounding both the illness and getting tested for it. “Just having a product that is available alongside condoms and other items will help to routinise testing”, Ticho said. “An HIV test will hopefully be seen as just another part of your normal health routine.” The increased convenience and anonymity at neighbourhood pharmacies has spurred the CDC to launch a new pilot programme to train pharmacists at 24 pharmacies to undertake HIV tests and counsel people before and after the tests. Pharmacies will be selected in locations with high rates of HIV and/or low availability of HIV services. Half of the sites will be in rural areas, and half in urban ones. “This initiative is a pilot, so CDC will need to evaluate what works best. Based on lessons learned, we will develop a comprehensive toolkit that pharmacists and retail clinic staff from around the country can use to implement HIV testing”, said Jonathan Mermin, director for the Division of HIV/AIDS Prevention at the CDC. “Knowing your HIV status is key to protecting your health and that of your loved ones.” The normalisation of HIV testing combined with improved treatments and the relatively normal lives led by HIV-positive individuals should encourage people to learn their HIV status. “I truly believe that we will identify a significant number of HIV-positive people who are walking around and don't know that they are positive”, Donohue said. For the podcast see http://www.thelancet.com/lancet-news-audio-2012This online publication has been corrected. The corrected version first appeared at thelancet.com on April 26, 2012 For the podcast see http://www.thelancet.com/lancet-news-audio-2012This online publication has been corrected. The corrected version first appeared at thelancet.com on April 26, 2012 For the podcast see http://www.thelancet.com/lancet-news-audio-2012 This online publication has been corrected. The corrected version first appeared at thelancet.com on April 26, 2012 Department of ErrorArnold C. At-home HIV test poses dilemmas and opportunities. Lancet 2012; 380: 1045–46—In this World Report (Sept 22), the third sentence of the fifth paragraph should have read: “The test has a 92% sensitivity and a 99·98% specificity, which means that one out of every 12 test results in HIV-infected individuals will be a false negative. Similarly, one out of every 5000 test results in uninfected individuals will be a false positive.” This correction has been made to the online version as of April 26, 2013. Full-Text PDF Report fails to acknowledge problems with at-home HIV testIn your World Report on the OraQuick home HIV test (Sept 22, p 1045),1 the potential implications of the new test on health insurance applications and lawsuits were not discussed. Insurance companies will often charge higher premiums or even refuse insurance for medical conditions such as HIV, and, if undeclared, such disorders will often invalidate claims against existing policies. This is one of the reasons why people choose not to take an HIV test, especially if they believe themselves likely to be positive. Full-Text PDF