HIV self-testing (HIVST) was first proposed in the mid 1980s. At that time, however, there were concerns about the availability of treatment and how people would respond to receiving a reactive (positive) result. Despite these former concerns, in the past decade there has been renewed and growing interest with the possibilities of HIV self-testing. 

In April 2013, the World Health Organization and Liverpool School of Tropical Medicine hosted the First International symposium on self-testing for HIV: the legal, ethical, gender, human rights and public health implications of self-testing scale-up. At the meeting, experts reached consensus that HIVST has a unique potential to reach underserved populations who are not accessing existing services. In particular, HIVST could greatly benefit key populations and other groups at high risk for HIV infection that re-test frequently, e.g. serodiscordant couples, health workers and general populations in high prevalence settings, men who have sex with men, transgender people, sex workers, people who inject drugs.

Currently evidence around HIV self-testing is limited. There are, however, several on-going trials to evaluate HIV self-testing. See Evidence Map for more details.

At this time, although efforts to develop quality HIV self-test kits are underway, there is only one kit that is currently approved by the United States Food and Drug Administration (FDA) for HIVST. For details on this approval process, see the US FDA Summary of Safety and Effectiveness Report.

Many countries are adapting and developing policies to include HIV self-testing, e.g. USA, Kenya, Zimbabwe Australia, the UK, France. However, there are still many settings where there are few or no policies and regulations in place. Based on recent reports it appears that rapid diagnostic tests (RDTs) for self-testing may be increasingly available in several countries.