Bringing HIV Self-Testing Policy to the Forefront

Cheryl Johnson, World Health Organization

Rachel Baggaley, World Health Organization

This blog post is the third in a series of four on the HIV Self-Test AfRica (STAR) project, which works in Zimbabwe, Zambia and Malawi. The STAR team will be in Blantyre, Malawi, from June 27 to July 1, 2016 with PSI Global Ambassador Debra Messing to learn more about how HIV Self-Testing can contribute to achieving the UN’s 90-90- 90 targets. Follow @psiimpact to see what the team is doing during this week.

The United Nations has set targets to diagnose 90% of all people with HIV by 2020. Currently it is estimated that only 54% of people with HIV are aware of their infection. To close the gap, countries are seeking ways to rapidly increase access to and uptake of HIV testing services; particularly among populations with lowest coverage and highest risk who may not otherwise test.

The World Health Organization (WHO) first explored the potential of HIV self-testing in April 2013 by convening the first global consultation. At this meeting, HIV self-testing was defined as a process in which people can collect their own specimen (saliva or blood), perform a test and interpret the result, often in private or with someone they trust. Experts also highlighted the importance of HIV self-testing as it showed potential to reach people at high risk for HIV who may not otherwise test, such as health workers, young people and men in high prevalence settings and serodiscordant couples and key populations (men who have sex with men, sex workers, transgender people and people who use or inject drugs) in all settings. Despite this potential, however, by 2013, only two country policies (Kenya and the United States of America) explicitly supported HIV self-testing. The lack of normative guidance on HIV self-testing and the lack of low-cost quality assured products and the systems to assess and regulate them, particularly for resource-limited settings, was also identified as a key barrier to further implementation.

As a result of this consultation, the WHO HIV Department took up a pivotal role reviewing and synthesizing available evidence; and thus, provided global guidance encouraging countries to implement HIV self-testing in the context of operational research as of 2014[1]. Since the development of this guidance, more countries have begun to introduce or develop national HIV self-testing policies and regulatory frameworks (Table). These advances in policy development have been critical, however, WHO has yet to issue full normative guidance due to evidence gaps on how to implement HIV self-testing in the most ethical, acceptable and effective manner.

Note: All policies reported as 2016 are based on country reporting to the Global AIDS Response Progress Reporting (WHO, UNAIDS, UNICEF) as of 23 June 2016. Other reports are based on market landscaping and reports from www.hivst.org. *In Brazil it is planned to introduce a product for HIV self-testing in pharmacies later this year in 2016. +In Australia, Malawi, Rwanda, Spain and the United Republic of Tanzania report that while there is a policy in place, implementation has not yet begun. °While the South African Pharmaceutical Council has lifted the ban on the sale of HIVST in May 2015, however the Ministry of Health has not provided official policy, criteria or standards

To address the remaining gaps, the WHO HIV Department, as part of the UNITAID/PSI Self-Testing Africa (STAR) Project consortium, has embarked on the largest evaluation of HIV self-testing to date. While there are many goals, WHO’s primary aim is to fill the remaining knowledge gaps so that normative guidance on HIV self-testing can be issued and to thereby catalyse both the development of evidence-based national policy and increased access to low-cost and quality assured technologies for HIV self-testing in resource- limited settings.

PSI New Start Center Harare, Zimbabwe April 2016 HIV testing and counseling. Source: UNITAID / PSI STAR Project

Early into project implementation there has been substantial progress. In accordance with WHO’s existing guidance the Global Fund’s Expedited Review Panel for Diagnostics issued the first expression of interest for HIV self-tests in February 2016, as well as an information note indicating that countries applying or receiving funds can utilize Global Fund resources to implement HIV self-testing in the context of operational research. WHO has begun to develop full normative guidance on HIV self-testing which will be released in December 2016. Additionally, the WHO Prequalification of in vitro diagnostics (IVDs) Programme released the first sample dossier for HIV self-testing technologies to guide manufacturers for public comment, and in close collaboration with the HIV Department, is finalizing the standards and pathway for prequalification of HIV rapid diagnostic tests for self-testing to be released later this year.

Countries will have to see how best to deliver HIV self-testing and how to make HIV self-testing accessible to those at risk for HIV infection who may not otherwise test. To guide them, WHO recommendations and the availability of low-cost WHO prequalified rapid diagnostic tests for HIV self-testing will be essential to realize the potential of HIV self-testing.

Byambaa Khyishigbayar, WHO. Carmen Figueroa, WHO. Jeannette de Putter, WHO. Rachel Baggaley, WHO. Cheryl Johnson, WHO. Anita Sands, WHO. Nadia Hilal, WHO. Shona Dalal, WHO. Valerie Amiel, WHO.