HIVST PEPFAR COP GUIDANCE. XXXXXX started to integrate HIVST into their future financing plans for countries, including by incorporating HIVST into its Country Operational Plans (COP) since 2017. The COP guidance recommends the use of HIVST strategies to complement and enhance conventional HIV testing. Importantly, HIVST should be part of the HTS portfolio especially in high-burden settings and should be strategically deployed to screen adolescent girls and young women (AGYW) and their partners, male partners of ANC clients, KPs and their partners, and other priority populations (e.g., refugees, prisoners, young at-risk men) that face high levels of stigma and discrimination. Where feasible, messages and materials should be tailored to the barriers and drivers of particular groups and it is vital to Table 1. HIVST products with WHO PQ, EPRD or approval from founding member of IMDRF* TEST (MANUFACTURER) SPECIMEN APPROVAL PEPFAR UNIT PRICE EX WORKS Mylan HIV Self Test (Atomo Diagnostics, Australia) Blood WHO PQ $1.99 autotest VIH®** (AAZ Labs, France) Blood CE mark BioSURE HIV Self Test** (BioSURE , United Kingdom Ltd) Blood CE mark ERPD-3 Exacto® Test HIV (Biosynex, France) Blood CE mark INSTI® HIV Self Test** (bioLytical Lab., Canada) Blood WHO PQ $3.09 OraQuick® In-Home HIV Test (OraSure Technologies, USA) Oral fluid FDA CE Mark OraQuick® HIV Self Test (OraSure Technologies, USA) Oral fluid WHO PQ $2.00 SURE CHECK® HIV Self Test (Chembio Diagnostic Systems Inc., USA) Blood WHO PQ $2.99 HIC: high-income countries; FDA: Food and Drug Administration; ERPD: Expert Review Panel for Diagnostics; Gen: test generation; LMIC: low- and middle-income countries, MRSP: maximum suggested retail price; NA: not available. * Includes products prequalified by WHO, approved by a regulatory authority in one of founding-member countries of the International Medical Device Regulators Forum or eligible for procurement on recommendation of Unitaid/GF Expert Review Panel for Diagnostics. ** These products sold in more than one packaging format. Note: Product details based on information provided by the manufacturers at the time of report preparation. Source: Unitaid/WHO, 2019. engage community groups to advocate for, design, implement, and analyze the success of HIVST. Programs should anticipate the internal and external barriers and challenges that clients may face in deciding whether to link to care and aim to address those barriers. Based on positive outcomes (e.g., linkage and initiation on ART), HIVST...
HIVST PEPFAR COP GUIDANCE. XXXXXX started to integrate HIVST into their future financing plans for countries, including by incorporating HIVST into its Country Operational Plans (COP) since 2017. The COP guidance recommends the use of HIVST strategies to complement and enhance conventional HIV testing. Importantly, HIVST should be part of the HTS portfolio especially in high-burden settings and should be strategically deployed to screen adolescent girls and young women (AGYW) and their partners, male partners of ANC clients, sex workers and their clients, KPs and their partners, and other priority populations (e.g., refugees, prisoners, young at-risk men) that face high levels of stigma and discrimination. In addition, self-testing can be incorporated into education campaigns to increase targeted testing of men.
