Number of Countries Adopting HIV Self-Testing Policies Rises Sharply

Posted juillet 25, 2017

Geneva – Unitaid and the World Health Organization (WHO) announced today the publication of the 2017 HIV Rapid Diagnostic Tests for Self-Testing Landscape report. Released during the 9^th IAS Conference on HIV Science in Paris, the third edition of the landscape report provides an updated analysis of the latest technologies and market trends in HIV self-testing (HIVST) in low- and-middle income countries (LMICs).

In comparison to the previous edition, this year’s report identifies a growing number of HIVST products entering the market along with an increase in the number of countries adopting HIV self-testing. A total of 40 countries have incorporated HIVST in their national policies, following the WHO’s recommendation in 2016 that HIV self-testing be offered as a complementary approach to existing HIV testing approaches. An additional 48 countries are currently developing national HIV self-testing policies. This is more than double the number reported a year ago, when only 16 countries had policies supporting self-testing.

“WHO applauds countries taking up innovative approaches, including HIV self-testing, as additional ways to reach people who are currently not accessing testing services and are at higher risk of HIV infection, such as key populations, young people, and men in many settings,” says Dr Gottfried Hirnschall, WHO’s Director of HIV Department and Global Hepatitis Programme. “WHO will continue working with countries and partners to further support the rapid scale-up of HIV testing, including self-testing.”

To date, four HIV rapid diagnostic tests have been approved for use by a founding member of the Global Harmonization Task Force, while only one HIV self-test has obtained the approval of the WHO Expert Review Panel for Diagnostics. All of these products are now included in the list of eligible products approved for procurement using Global Fund and Unitaid funds. In addition, several other HIVST products are nationally registered in Brazil, China, Kenya, and Nigeria.

According to the report, pricing of HIV self-test kits continues to vary widely both across and within countries. In high income countries, prices range from US$ 22-48 in the private sector to US$ 7.50-15 per test kit in the public sector. While in emerging countries, prices vary from US$ 3-6 per test in the public sector to US$ 8-16 in the private sector. However, HIVST pricing in LMICs may begin to decrease, in part due to the Bill & Melinda Gates Foundation’s recent agreement to support the affordable sale of OraSure Technologies’ OraQuick^® Self-Tests, in an effort to accelerate scale-up. As a result, public and non-profit buyers in 50 LMICs and high HIV burden countries will be able to purchase OraSure tests at the price of US$ 2 per kit.

At least four million HIV self-test kits are expected to be procured by donor-funded programmes between July 2017 and end of 2018, mainly the Unitaid-funded HIV Self-Testing Africa (STAR) Initiative, followed by programmes funded respectively by the Global Fund and the US President’s Emergency Plan for AIDS Relief (PEPFAR).

“Unitaid is at the forefront of global efforts to expand access to HIV self-testing in lower- and middle-income countries,” said Unitaid Executive Director Lelio Marmora. “The findings of this report show that our investments, and those of our partners, are helping countries to move forward in pursuit of the global goal of having 90 per cent of people living with HIV aware of their status by 2020.”

The STAR initiative and other efforts also provided the global community with a range of HIVST distribution models and systems to support linkage to care, promote products, and educate end users, all of which can inform HIVST programming in other regions.

“We’ve seen the effectiveness of HIV self-testing first hand through STAR,” states Dr. Karin Hatzold, Project Director STAR. “The successful scale-up of HIVST in initial STAR countries and its rapid introduction in new countries under the Initiative will provide a model for adoption in other regions.”

Despite these positive developments, successful implementation of HIV self-testing faces several challenges, including the level of government and donor support, uncertain and non-transparent regulatory pathways at the country-level, the need for product innovation, and low and unpredictable demand. Country governments, manufacturers, and partners, must continue to work together to address these challenges and support the development of an HIV self-test market. Doing so could expand HIV testing coverage and help countries meet key global targets, namely diagnosing 90 per cent of all people with HIV by 2020.

Read the full report: “Landscape for HIV rapid diagnostic tests for HIV self-testing – 3rd edition” – July 2016.

The report was prepared by Population Services International (PSI) and the World Health Organization (WHO) with funding from Unitaid and the Bill & Melinda Gates Foundation.

For more information, please contact:

Andrew Hurst, Unitaid, +41795616807, [email protected]

Tunga Namjilsuren, WHO, +41 79 203 31 76, [email protected]

Sandy Garçon, Population Services International (PSI), +1- 202.790.3162, [email protected]

About Unitaid

Unitaid invests in new ways to prevent, diagnose and treat HIV/AIDS, hepatitis C, tuberculosis and malaria more quickly, affordably and effectively. It brings the power of new medical discoveries to the people who most need them. And it helps sets the stage for the large-scale introduction of new health products by collaborating with Governments and funding partners such as PEPFAR and the Global Fund. Learn more at www.unitaid.org.

About the World Health Organization

The World Health Organization (WHO) is the United Nations specialized agency for global health. WHO’s Department of HIV works to provide leading normative and technical guidance and support to the Member States to accelerate their responses to HIV towards achieving the universal coverage of prevention, treatment, care and support of services for every person in need.

About Population Services International

PSI is a leading global health organization working in HIV, reproductive health, child survival, non-communicable diseases and sanitation. Partnering with the public sector and harnessing the power of markets, PSI provides lifesaving products, services and communications that empower vulnerable populations to lead healthier lives. Learn more at staging.psi-2017.flywheelsites.com.

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Digitalizing contraceptive counseling to reach rural women and girls in Ethiopia

By: Fana Abay, Marketing and Communications Director, PSI Ethiopia

In rural Ethiopia, women and girls often face significant barriers in accessing healthcare facilities, which can be located hours away. Moreover, there is a prevailing stigma surrounding the use of contraception, with concerns about potential infertility or the perception of promiscuity. To address these challenges, the Smart Start initiative has emerged, linking financial well-being with family planning through clear and relatable messaging that addresses the immediate needs of young couples—planning for the lives and families they envision. Smart Start takes a community-based approach, utilizing a network of dedicated Navigators who engage with women in their localities. These Navigators provide counseling and refer interested clients to Health Extension Workers or healthcare providers within Marie Stopes International-operated clinics for comprehensive contraceptive counseling and services.

In a significant development, PSI Ethiopia has digitized the proven counseling messaging of Smart Start, expanding its reach to more adolescent girls, young women, and couples. This approach aligns with the priorities set by the Ethiopian Ministry of Health (MOH) and is made possible through funding from Global Affairs Canada. The interactive and engaging digital messaging has revolutionized counseling services, enabling clients to make informed and confident decisions regarding both their finances and contraceptive choices.

Clients who received counseling with the digital Smart Start tool reported a higher understanding of their options and were more likely to choose contraception (74 percent) compared to those counseled with the manual version of Smart Start (64 percent). Navigators also found the digital tool more effective in connecting with clients, leading to higher ratings for the quality of their counseling.

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In 2022, 328 thousand malaria cases were recorded by CHWs); 6.5 thousand severe malaria cases were referred to health centers, according to the national health information system.

During that time, the PMI Impact Malaria project (IM) designed and supported two rounds of supportive supervision of 123 CHWs in their workplaces in the IM-supported regions of Kayes and Koulikoro. This included developing and digitizing a standardized supervision checklist; and developing a methodology for selecting which CHWs to visit. Once a long list of CHW sites had been determined as accessible to supervisors for a day trip (including security reasons), the supervisors telephoned the CHWs to check when they would be available to receive a visit [as being a CHW is not a full-time job, and certain times of the year they are busy with agricultural work (planting, harvesting) or supporting health campaigns like mosquito net distribution].

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In IM-supported areas of Mali, 36% of CHWs in the first round were competent in performing the RDT, which rose to 53% in the second. 24% of CHWs in the first round compared to 38% in the second were competent in the treatment of fever cases and pre-referral counseling. Between both rounds, availability of ACT increased from 80 percent to 90 percent.

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“Rather than relying on traditional aid models that often distribute free or heavily subsidized sanitation products, market-based sanitation creates sustainable and affordable solutions, integrating market forces and supporting businesses to grow.”

— Michael Negash, Deputy Chief Party of T/WASH

Promoting self-managed care like Self-testing and Self-Sampling

By: Dr Karin Hatzold, Associate Director HIV/TB/Hepatitis

Building upon the success and insights gained from our work with HIV self-testing (HIVST), PSI is actively applying this approach to better integrate self-care, more broadly, in the health system beginning with Hepatitis C and COVID-19. Self-testing has emerged as a powerful tool to increase access to integrated, differentiated, and decentralized health services, accelerating prevention, care, and treatment for various diseases, while also increasing health system resilience against COVID-19.

Here’s how we got there.

Seven years ago, the landscape of HIV self-testing lacked global guidelines, and only the U.S., the UK and France had policies in place that allowed for HIV self-testing. High disease burdened countries in low-and-middle-income-countries (LMICs) lacked evidence and guidance for HIVST despite major gaps in HIV diagnosis.

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Here’s what it looks like in practice.

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Kassai’s analytics system to follow learners’ success rate and to adjust the course content to learners’ performance and needs. Kassai analytics are integrated with DHIS2 – the Health Management Information System (HMIS) of Angolan MOH, to be able to link learners’ knowledge and performance with the health outcomes in the health facilities. The analytics track learners’ performance by course and gives visibility by health provider, health facility, municipality, and province. Each course has pre-and post-evaluation tests to track progress of learning, too.

By the end of 2022, there were 6,600 unique users on the Kassai platform and 31,000 course enrollments. PSI Angola’s partnership with UNITEL, the largest telecommunication provider in Angola, allows for free internet access to learn on the Kassai for all public health providers in Angola. Building on its success for malaria training, Kassai now also provides courses in family planning, COVID-19, and maternal and child health. This reduces training silos and provides cross-cutting benefits beyond a single disease.

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Number of Countries Adopting HIV Self-Testing Policies Rises Sharply

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Digitalizing contraceptive counseling to reach rural women and girls in Ethiopia

Building community health worker capacity to deliver malaria care

Taking a market-based approach to scale sanitation in Ethiopia

Promoting self-managed care like Self-testing and Self-Sampling

Using peer coaches to counter HIV stigma in South Africa

simplifying consumers’ journey to care in Vietnam

Engaging the private sector for disease surveillance in Myanmar

Training health workers in Angola

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