HIV self-testing (HIVST) is being introduced as a new way for more undiagnosed people to know their HIV status. As countries start to implement HIVST, assuring the quality and regulating in vitrodiagnostics, including HIVST, are essential. We aimed to document the emerging regulatory landscape and perceptions of key stakeholders involved in HIVST policy and regulation prior to implementation in three low- and middle-income countries.
AUTHORS: Russell J Dacombe, Victoria Watson, Lot Nyirenda, Claudius Madanhire, Musonda Simwinga, Lignet Chepuka, Cheryl C Johnson, Elizabeth L Corbett, Karin Hatzold and Miriam Taegtmeyer