In March of this year, UNAIDS launched the In Your Hands HIV self-testing campaign in the Caribbean, aiming to increase the proportion of HIV-positive individuals who know their status. In January, Senegal's government approved its new HIV self-testing strategy, working with a donor-funded program to promote and distribute the HIV self-tests in West Africa. These efforts join others around the world, with a push from the World Health Organization for countries to fast-track HIV self-testing.

These HIV self-testing efforts are not just well-intentioned – they're backed by solid evidence of effectiveness. 3ie oversaw the production of a good chunk of that impact evaluation research.

The way HIV self-testing moved from pilot programs to worldwide adoption in less than a decade shows how rigorous impact evaluations can make a difference. It also shows how evidence-informed decision-making can work in the real world.

This story has been driven in large part by two key actors: the World Health Organization (WHO) and the Bill & Melinda Gates Foundation (BMGF). While WHO has developed strong internal policies for how evidence should shape its decisions, the Foundation has invested substantial funding to develop evidence within its focus areas, including HIV prevention and management. As a result, we have learned that HIV self-testing is an effective strategy to make sure people know their HIV status, and countries around the world are changing policies and offering the self-tests.

WHO's guidelines for developing guidelines

Although issuing global public health guidelines has been part of WHO's mission since its inception, the process by which those guidelines were drafted was not always as evidence-based as it is now.

For decades, the organization's policy was that guidelines should be based on expert opinions. This practice allowed biases to affect guidelines, since not all experts always share the same views. In 2003, the organization recognized a need to consider evidence more systematically in the creation of its guidelines. New policies approved that year by WHO's cabinet said WHO guidelines should be based on transparent and systematic reviews of available evidence.

Changing the policy did not immediately change the practice, however.

"The guidelines for developing WHO guidelines do not seem to be closely followed when WHO develops recommendations for member states," according to a 2007 research paper about the organization's processes. "Processes for developing recommendations typically rely heavily on experts in a particular content area and not on representatives of those who will have to live with the recommendations or on experts in particular methodological area… no mechanisms have been put in place to support and monitor adherence to the guidelines, and our study suggests that they are not being followed."

In response, the organization released its first WHO Handbook for Guideline Development in 2012, followed by a second edition in 2014 (The second edition notes that its development was funded by the BMGF). The handbook lays out practical processes for developing guidelines and recommendations based on systematic review evidence. This process is the one that would subsequently be used to issue guidelines recommending the use of HIV self-testing.

Piloting and studying HIV self-testing

With as many as one quarter of HIV-positive people worldwide unaware of their status – and therefore more likely to unknowingly transmit the virus – testing has been seen as a critical step to reducing the number of new infections. Self-testing was seen as one option to close the gap, but evidence on its effectiveness was lacking.

In 2012, the BMGF awarded $7.2 million to 3ie for two HIV-related evidence programs: one on voluntary male circumcision, and one on HIV self-testing. The HIV self-testing evidence program, which ended in 2019, funded design and evaluation of seven small-scale interventions to provide HIV self-tests to targeted populations.

The interventions studied in the 3ie HIV self-testing evidence program, which took place in Kenya, Uganda, and Zambia, targeted different at-risk groups: sex workers, truck drivers, and male partners of new mothers. The program first funded formative evaluation in Kenya and Zambia to answer questions about targeting, acceptance, feasibility, accuracy of messaging, packaging, labelling, linkage to services and care, as well as potential social harms and their mitigation. Research teams came from Harvard, the London School of Hygiene and Tropical Medicine, the University of KwaZulu-Natal, the Medical University of South Carolina, and others.

In general, the studies found that providing HIV self-testing options increased the likelihood that people would get tested, although the finding was not statistically significant in every study. Synthesizing the results from multiple studies on a single question requires a systematic review – which is exactly what the WHO did next.

Arriving at a WHO recommendation

The first recommendation from the WHO for the use of HIV self-testing came in a 2016 supplemental guidance document which recommended that self-testing be offered as "an additional approach" to HIV testing services. At that point, the WHO's systematic review only identified five rigorous studies on HIV self-testing.

By 2019, the evidence picture had changed, leading to an updated recommendation. At that point, the WHO's systematic review turned up 32 randomized control trials evaluating the effectiveness of HIV self-testing.

In addition to the 3ie-supported evaluations, the WHO cited a range of other research: a study in Malawi which was also supported by the BMGF; a study by researchers from the Chinese University of Hong Kong on people who use chat rooms for men who have sex with men; a study by Brown University researchers about members of minority groups in the United States; and many others.

With that new evidence, self-testing was no longer to be considered an "additional approach". Now, the WHO simply recommends that "HIV self-testing should be offered".

Country-level action

As the WHO recommendations came in, countries, donors, and health organizations around the world began to take action. According to a 2019 WHO report, "the number of countries with supportive HIV self-testing policies has grown nearly thirteen-fold, increasing from six countries to 77 between 2015 and 2019."

In Kenya and Uganda, where some of the 3ie-supported research took place, authorities took action based on the studies in their countries and the WHO's initial recommendation. Kenya began distributing tests to men at antenatal care centers, and Uganda opted to distribute tests to sex workers and make them available at antenatal care centers.

Elsewhere, like in this project in Côte d'Ivoire, Mali, and Senegal, donor-funded initiatives are bringing self-tests to populations that need it. Jamaica is making tests available in pharmacies.

In addition, in a huge swath of the world – 135 countries – HIV self-tests will soon be available for less than $2, thanks to a Unitaid-supported initiative announced in April. Unitaid notes that "access to self-tests has been recognized as a key factor in meeting the global goal of 90% of people knowing their HIV status." That recognition, and all this global action, stems in large part from the rigorous impact evaluation research showing that the tests are, in fact, effective.

More information about 3ie's HIV Self-Testing Evidence Program is available here. For many more stories about the real-world impacts of our evaluations on a whole range of development and health topics beyond HIV Self-Testing, check out our Evidence Impact Summaries.