Around the world, 34 million people are infected with human immunodeficiency virus, or HIV. Women, young adults, and at-risk populations, such as injectable drug users and commercial sex workers, are most heavily affected. Though a number of treatment regimens are now available to help bring the disease under control, about 60 percent of the infected population worldwide remains unaware of their status. This problem is not limited to developing countries, as one might expect. Statistics in North America show that many individuals (about 40 percent) show up late for care, often exhibiting symptoms of advanced late-stage HIV or AIDS. This increases hospitalization costs and overall costs to the health care system.
This is especially problematic given the strong and growing evidence on the effectiveness of early and well-managed HIV treatment at the individual level, which controls infection for a lifetime. The benefits of treatment also extend beyond the individual to society—treating HIV infected individuals early reduces the chances of transmission to partners, and thus brings about control of infection at the community level.
If all goes well in treatment, then an acute and highly infectious disease like HIV can be downshifted to a manageable and chronic infection. But this story of effective control can only begin when people who are infected know that they are infected.
One simple and seemingly obvious solution is to establish medical test centers that offer inexpensive screening in areas with high infection rates. This kind of facility-based testing for HIV has existed for about two decades, and yet people in endemic regions generally remain unscreened. The unfortunate fact is that testing, even when available and affordable, is regularly hindered by long wait times at busy clinics, social visibility associated with testing for HIV, and resultant stigma and discrimination. This is especially true in many developing countries, and is reflected in the anecdotal statistics that one in three individuals in India, and one in two individuals in South Africa, do not know their infection status, contributing to the spread to partners and children.
Social stigma against those infected with HIV has been particularly (and historically) rampant across much of Asia and Africa. The issues run from overt forms of discrimination to more subtle impacts of social exclusion or ostracism. Given this, the intentionally public and visible nature of many testing facilities can backfire, impairing screening efforts, since many people forgo screening, miss follow up meetings, and, most importantly, avoid continued treatment, in order to avoid social backlash. A host of other problems sink the rate of HIV screening in many developing countries. For instance, poor quality of care in public health clinics along with insufficient infrastructure predisposes patients to miss follow-up appointments. (A fair amount of money has recently improved treatment for HIV, reducing the problem of poor quality care. Poor quality screening and monitoring for treatment are now the main issues.)
There are also significant levels of malpractice and lack of accountability in the private sector, further pushing patients to avoid screening centers.
To address these problems, Nitika Pant Pai, assistant professor in the department of medicine at McGill University, has centered her research on increasing the rate and success of HIV screening with innovative, inexpensive, point-of-care tests for HIV (and co-infections, like Hepatitis B and Syphilis). Most importantly, these are private self-testing kits, approved by the U.S. Food and Drug Administration in 2012. The application of this technology is beginning in India, where a number of recent programs focused on improving access to screening and getting people onto HIV treatment have proven very successful.
Because of the success of these programs, it is believed that the rate of HIV infection nationwide has actually plateaued. Estimates of the national prevalence of HIV in India stand at less than 1 percent. (In the United States, the figure is estimated at about 0.3 percent). But given a population of 1.2 billion, the number of individuals actually infected is quite high.
It’s important to now turn attention to early and timely HIV testing, as India is at a critical juncture and capable of turning the tide of the epidemic. Programs now in place to help get people tested, often at hospitals or through outreach work, could be supplemented with widespread distribution and availability of self-testing kits.
Self testing will be useful for several middle-income and low-income groups. Additionally, high-risk groups that do not wish to show up at health care clinics may be interested if a convenient option is made available to them. In many of these groups, HIV transmission has actually continued unabated. These “hidden” populations are doubly stigmatized—not just for infection with HIV, but often for the nature of their lifestyles—and they therefore harbor a particularly keen desire for discreet screening and care options.
That said, because of the complexity associated with a stigmatized disease, it will always be difficult to reach the hidden populations—often also the hardest hit—in a way that is both private and effective. Self-test kits are a first step: they can be used in the comfort of one’s own home with nothing more than a saliva sample. This generally works better than finger stick options, as the procedure is painless, non-invasive, and relatively straightforward. The process empowers patients to take health care into their own hands, but requires a few main considerations:
• reaching populations with low literacy rates
• making sure that kits are affordable
• getting regulatory approval by making sure self-testing efficacy compares favorably with clinical screening.
• and seeking timely linkages with care and counseling.
On the first point, a supervised strategy that allows HIV self-testing in populations with low literacy rates should use health facilities with on-call assistance. This option could be supplemented with phone counseling.
The question of cost is important, as a reasonable price range for developed countries is about $10-20, while it’s closer to $7-10 for developing countries. Currently, home tests are priced at $40. But the price ties into the third challenge, which is overcoming regulatory hurdles.
Only a few countries—the United States, Singapore, and Kenya—have so far approved HIV saliva home tests for over-the-counter sales. Anecdotally, countries like Britain, France, and The Netherlands, are likely to follow suit. Globally the World Health Organization has called for studies to prove the feasibility of using this testing on a large scale, and to generate evidence for the most effective testing strategies. This is the key step right now: with approval of self-tests by the U.S. Food and Drug Administration, several international agencies like the Bill and Melinda Gates Foundation, the Wellcome Trust, and Grand Challenges Canada have pooled resources to evaluate the diffusion and use of HIV self-tests as an alternative to facility-based testing. With evidence and support, we expect prices to drop close to, or within, the ranges described above.
Of course, with the establishment of over-the-counter tests comes the risk of a market that deals in cheap, fake, and generally poor quality tests. This is a particular risk in developing countries with weak regulatory oversight. Additionally, self-tests are not intended as a panacea for the problem of undiagnosed HIV. Self-tests also ought to be followed-up with clinical testing. In that respect, they do not entirely erase the concern over stigmatization associated with a diagnosis of HIV.
But they certainly facilitate the initial process of knowing, like a pregnancy test. They empower the patient with that knowledge, and they could readily facilitate the next step of bringing patients in for treatment.
Efforts in Dr. Pai’s lab, and around the world, are now focused on proving the effectiveness of saliva-based self-test kits, satisfying regulatory requirements, and creating models to help roll out testing in countries, both poor and rich.
In the case of India, approval may not be far away, and, therefore, neither is the prospect of permanently curtailing the spread of HIV.