Russia’s healthcare watchdog faces backlash from NGOs over new restrictions on at-home HIV tests

On September 8, reports emerged that Russia’s healthcare watchdog, Roszdravnadzor, had issued a warning to the medical supply company UNIDENT, which imports the OraQuick rapid HIV test. According to the AIDS Center, the Roszdravnadzor document says that the test is registered for professional use in Russia and although the instructions say it can be used at home, this violates the law. At the same time, OraQuick is registered abroad as a test available for at-home use. UNIDENT said that now the tests are being “practically seized” from pharmacies.

Due to high demand, express HIV tests were not easy to get at pharmacies in Russia to begin with (they cost anywhere from 300–1,000 rubles or about $4–$13) and non-profit organizations often distribute them for free.

According to Roszdravnadzor, first the department established that the Novosibirsk-based NGO the Humanitarian Project would be responsible for distributing express tests among vulnerable groups, and then it issued the warning to UNIDENT. Interestingly, the Humanitarian Project was involved in a project with HIV-activist Sergey Ulyanov, who starred in YouTuber Yury Dud’s extremely popular documentary HIV in Russia. In the film, which was released in February 2020, Dud is tested for HIV on camera using an OraQuick express test.

According to the Russian instructions for Retrochek, another HIV express test available in Russia, it is only available for professional use, as well.

The World Health Organization recommends rapid tests

Express tests allow for a person to find out whether or not they have HIV within 15 to 40 minutes. For this, you need to collect the person’s saliva using an oral swab or dispense a few drops of blood into the ports on a plastic test device.

As Roszdravnadzor rightly points out, these types of tests aren’t the most accurate and require additional laboratory testing. However, the World Health Organization (WHO) notes that “self-tests have greatly facilitated diagnosis and the linkage with treatment and care” and that they “increase access for people who are not reached for HIV testing through facility-based services.” At-home tests also increase access for people who are too shy or ashamed to seek laboratory tests through a medical institution.

However, bear in mind that rapid tests require not only subsequent laboratory testing, but also consultations with a specialist like a doctor, psychologist, or NGO worker, who can explain what to do next.

NGOs oppose Roszdravnadzor’s decision

Russia has the highest prevalence of HIV in Europe. If a person doesn’t know that he or she is infected with HIV and goes untreated, they can pass the virus to other people. This has been the main basis of the criticism non-profit organizations have aimed at Roszdravnadzor’s decision. According to them, these types of restrictions will lead to a decrease in the number of people who know whether or not they are HIV positive. Moreover, in an interview with the St.Petersburg-based health site Doctor Piter, the director of development at the charitable organization Humanitarian Action (Gumanitarnoe Deystvie), Alexey Lakhov, explained that these tests are especially useful during the coronavirus pandemic:

“The majority of HIV tests that we use are capillary blood tests. We have a license to carry out medical activities and have a staff of nurses. But during the COVID pandemic our mobile points weren’t working for several months, so we launched a self-testing program with these OraQuick tests — we sent them to the homes of about 100 St. Petersburg [residents] from at-risk groups with mandatory counselling before and after. Our colleagues from Novosibirsk did the same. We’ve never encountered any problems with the use of these tests. What could be simpler? Take it, run a special [swab] along [your] gums, and then put it in a container with a solution and get a result.”

Denis Kamaldinov, the head of the Humanitarian Project (the organization mentioned in Roszdravnadzor’s statement), offered suggestions to the news outlet Taiga.Info on how government bodies could remedy the situation:

“The success of prevention programs shouldn’t be held hostage by outdated documents, as rapid tests for self-testing and work with vulnerable groups are approved in many countries [and] recommended by the WHO and SanPiN [Russia’s Sanitary Rules and Norms] for HIV prevention. What comes with the suspension of NGO-based testing throughout the country? The loss of millions of rubles and increased mortality due to the fact that people will be late to find out about their HIV positive status. Here’s what I would like to hear: in addition to prohibitive measures, necessary recommendations on what tests can be used by citizens for self-testing and by NGOs in their work with vulnerable groups. Now it’s important that an initiative appears from Roszdravnadzor, the Health Ministry and [Russia’s public health watchdog] Rospotrebnadzor, with an invitation to manufacturers, distributors, and NGOs, to solve the problem quickly and to overcome this barrier to the implementation of the government’s strategy to combat HIV.”

Story by Daria Sarkisyan

Translation by Eilish Hart