Despite the near-ubiquity of free, rapid HIV tests in the U.S., approximately one in seven HIV-positive people does not know their status.
In 2012, the U.S. Food and Drug Administration approved a simple, saliva-based testing kit that can be used in the privacy of one's home. The product, OraQuick, works like a pregnancy test, with one line representing a negative result and two lines representing a positive result. Results must be confirmed by a blood-based HIV test, and studies in the U.S. have shown that populations using the test are willing to visit a clinic for follow-up care after a positive OraQuick result.
OraQuick is seen as a way to increase access to care for people with HIV who are unwilling or unable to visit a clinic. Now, use of the test is being scaled up across the globe, especially in regions with a high burden of HIV where traditional testing approaches are not identifying all HIV-positive people.
Globally, about half of HIV-positive people are aware of their status. OraQuick is poised to take off in low-income markets thanks to the World Health Organization (WHO)'s recent stamp of approval, given at the behest of the Bill and Melinda Gates Foundation, which negotiated for a lowered price with the company, OraSure.
But, as with any new technology, some experts are worried about possible implications of a rollout in Africa, Asia and other less-wealthy regions where HIV is a major public health crisis. One of the biggest questions hovers over linkage to care: Although there are a few studies about linkage to care that is based in the U.S., in the rest of the world, it's relatively unclear whether an at-home positive HIV test result would encourage people to come into a clinic to start treatment.
Although the test is relatively unstudied in developing countries, many experts agree that OraQuick is generally safe and should therefore be deployed without delay as yet another tool that might boost the number of people aware of their status.
"In these African settings, most people who know their status are on treatment, most who are on treatment are virally suppressed," Kelly Curran, the senior director of HIV, malaria and infectious diseases at Jhpiego, a nonprofit organization affiliated with Johns Hopkins University, told TheBodyPRO.com. "Where we need to focus is finding those folks who are undiagnosed. The HIV self-test will be an additional tool to find [people] for whom traditional approaches are not successful."
"I think it's a great idea," said Guillermo Martínez Pérez, a project manager at ISGlobal. "I think it's a great move to start [making] the self-tests as affordable as possible, or even distributing them freely, for the individuals who have challenges accessing HIV testing services."
OraQuick's use across the globe "is something that is just now starting to pick up some steam and gain traction," said Paul K. Drain, M.D., M.P.H., an assistant professor in the division of allergy and infectious diseases at the University of Washington School of Medicine. "For several years there was a big push on doing the community-based testing with mobile vans going to rural areas -- that got us pretty far, but it didn't get us the whole way. This is a logical next step," Drain told TheBodyPRO.com.
"I've heard it referred to as a 'demand creation strategy,'" said Curran. "As the HIV community is trying to find these remaining number of people who still don't know their status, it's going to be harder and harder to find them. There are more and more hidden people."
OraQuick: A Product for Marginalized Groups
According to experts, OraQuick could be a perfect tool for people who are reluctant or unable to visit a formal clinical setting. This category includes many of the marginalized communities who are at risk of HIV, including sex workers and men who have sex with men (MSM).
However, in many African settings, the category of "missing people" could be broadened to include cisgender men as well, many of whom generally do not visit health clinics unless grievously injured. "We're missing out on people are positive that do not use health care services, and that includes adult men," said Curran.
In many settings in Africa, men face pressure to "market themselves as strong men who only demand health care when they only have a true and real health problem," Martínez Pérez said. "Many men see clinics as women's spaces," he added. "I think that men could benefit from accessing OraQuick in chemists' shops or taverns, or any space that men frequently go."
However, Martínez Pérez noted that many other groups might benefit from a private HIV self-test. These include adolescents who are sexually active and fear judgment by nurses and health workers, as well as MSM, who may face prison in some countries if they disclose their identity or sexual behavior.
"We've done some studies to try to understand this group better," said Drain. "We're coming out with a paper suggesting that people facing mental health issues and people who had depression or anxiety [are] less likely to be testing or seeking engagement in care. This group also includes people who have lower incomes and women in more remote areas. Generally, people who live more than 5 km from the clinic often present very late for care."
To Drain, his research highlights the need for a thoughtful distribution plan for the OraQuick test. "It's very easy to see that if you just keep the test at the clinic, you're only accessing the group that's coming into the clinic," he said.
He cautioned that "the actual implementation is going to be quite challenging" and "there are still a lot of questions," but feels that public health officials should being using this new tool as soon as possible.
Putting Rapid HIV Testing in the Right Hands
It's likely that each country will create a different distribution strategy for OraQuick. For example, in a country such as South Africa, it would be feasible to sell the product online and in retail stores, whereas in a country such as Botswana, community-based health approaches might be more effective at getting OraQuick into the right hands.
For several years, Médecins Sans Frontières (MSF) has advocated for the use of HIV self-testing, said Martínez Pérez, who has worked with MSF in South Africa. However, the South African government has been reluctant to start formal distribution because authorities fear that people won't link to care and that the test might spur intimate partner violence.
Although a recent study based in Malawi demonstrated that self-testing did not appear to increase gender-based violence, South African authorities are likely to want data from their own country, Martínez Pérez noted.
The recent WHO stamp of approval -- called prequalification -- will go a long way toward encouraging local governments to purchase the product and create a distribution plan, experts said. Yet there is no one-size-fits-all approach for getting OraQuick into the hands of people who may benefit.
It is clear, however, that OraQuick does not really have a role in the clinic itself, said Drain. Current blood-based tests seem to work slightly better than OraQuick and are relatively non-invasive. By the time people are already in the clinic, they are likely to submit to a blood-based rapid HIV test, he said.
"Historically an HIV-positive test result has been given by a counselor or clinician," so some argue that information about HIV status should continue to be conveyed by a professional, said Curran. However, she noted that similar arguments were made when home pregnancy tests first hit the market, and now that concept "seems ridiculous."
A better distribution model, and one that's currently being tested, is to give several OraQuick tests to women who visit clinics and ask them to go home and distribute them to male partners, Curran said.
"I think the remaining questions are about, 'How do you distribute this type of test to ensure it's getting to people who need the testing?'" said Drain. "The second remaining question is, 'What type of impact is it having once it's distributed widely to the communities?'"
Will Self-Testers Follow Up for HIV Care?
OraQuick is considered safe and effective, and research has demonstrated that people are generally able to use it properly. OraSure, the company that makes OraQuick, has said that it will manufacture a slightly different version of the device for use outside the U.S.
Martínez Pérez, who has self-tested with OraQuick, said that using the device is "pretty straightforward," although it's possible that people could make mistakes, especially if they are illiterate.
"I think there's relatively good data to suggest that patients who are doing the OraQuick get reliable results," said Drain. "There's always going to be some false positives and false negatives, but that's why there's a follow-up test."
With the device generally regarded as safe, effective and easy to use, experts are now clamoring for data that will demonstrate metrics around linkage to care after a positive OraQuick test.
"There are some preliminary studies that suggest that giving people an HIV self-test is safe and is a reasonable thing to do, but it's a leap to know whether these people will present to a clinic to receive care," said Drain. "People feel like it's ready for prime time, but the degree of impact that it will have is a little bit unknown."
"Self-testing is still fairly new in most of the places we're working," said Curran. However, she pointed to forthcoming data from the HIV Self-Testing Africa (STAR) Project, a four-year effort to study and encourage adoption of HIV self-testing. The initiative is sponsored by UNITAID/PSI in collaboration with the London School of Tropical Hygiene and Tropical Medicine.
Phase 1 of the STAR project is ongoing and will evaluate the recent distribution of 750,000 self-testing kits in different populations. This research will provide powerful data on linkage to care.
In addition, Curran pointed to a study conducted by her organization, Jhpiego, which gave OraQuick tests to women visiting clinics in Kenya and encouraged them to distribute the tests to male partners. "We found that this was highly effective at increasing the percent of men who were tested," she said.
When it comes to linkage to care, "there is still a lot we need to learn," said Drain, "but that shouldn't hold up the rollout." The research and the rollout of OraQuick should happen simultaneously, he said.
"I think that people have the right to learn their HIV status at a time and place of their choosing," said Curran. "There are no magic bullets in dealing with this epidemic. This is an additional tool which is promising, and I believe has the potential to increase access."