Common use of Linkage Clause in Contracts

Linkage. Have tools available that support testers’ links to confirmative testing, counseling, treatment, and/ or prevention after a self-test. Tools should allow the tester to opt-in, use the highest level of technology available to the target population (e.g., phone, Internet, smartphone), offer the option of speaking to a human and direct community follow-up, and protect the privacy and confidentiality of the self-testing experience. Tools should not pressure self-testing clients to disclose their test results nor compromise the privacy of the testing experience. People who use a self-test kit at a facility or community event should be offered confirmatory testing and linkage services on site. Linking self-testers who test off site is more challenging, so innovative follow-up approaches, such as calls, SMS, WhatsApp contact, or community outreach, might be required. The STAR Initiative has developed a range of tools to support linkage, available at: ▇▇▇.▇▇▇.▇▇▇/▇▇▇▇▇▇▇/▇▇▇▇. Also see, USAID resources, available at: ▇▇▇▇▇▇▇▇.▇▇▇▇▇.▇▇▇/ resources/hts-kb/hiv-self-testing/all. HIVST KITS Where can HIVST kits be procured? There are currently four WHO prequalified HIVST products: • OraQuick HIV Self-Test (OraSure Technologies, USA); oral fluid • INSTI HIV Self-Test (Bioanalytical, Canada); blood-based • Mylan HIV Self-Test (Mylan, Atomo Diagnostics, Australia); blood-based • SURE CHECK HIV 1/2 Assay (Chembio, USA), blood-based All four kits can be procured with U.S. Government or Global Fund funds. To order, contact the Global Health Supply Chain- 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. c Rapid Test Kits (GHSC-RTK) via ▇▇▇▇▇▇ ▇▇▇▇▇ (▇▇▇▇▇▇@▇▇▇▇▇.▇▇▇). Selecting HIVST products for procurement from WHO’s lists of prequalified HIVST kits will enable countries to forgo in-country performance evaluations. HIVST products for procurement can be identified by reviewing those listed at the following links: WHO prequalification and GF Quality Assurance Policy for Diagnostic Products. HOW? There are many effective HIVST delivery mechanisms, in which individuals either test by themselves in private or in the presence of a sexual partner or peer, or distribute tests to partners and social contacts.

Linkage. Have tools available that support testers’ links to confirmative testing, counseling, treatment, and/ or and/or prevention after a self-self- test. Tools should allow the tester to opt-opt- in, use the highest level of technology available to the target population (e.g., phone, Internet, smartphone), offer the option of speaking to a human and direct community follow-up, and protect the privacy and confidentiality of the self-testing experience. Tools should not pressure self-testing clients to disclose their test results nor compromise the privacy of the testing experience. People who use a self-test kit at a facility or community event should be offered confirmatory testing and linkage services on site. Linking self-testers who test off site is more challenging, so innovative follow-up approaches, such as calls, SMS, WhatsApp contact, or community outreach, might be required. The STAR Initiative has developed a range of tools to support linkage, available at: ▇▇▇.▇▇▇.▇▇▇/▇▇▇▇▇▇▇/▇▇▇▇. Also see, USAID resources, available at: ▇▇▇▇▇▇▇▇.▇▇▇▇▇.▇▇▇/ resources/hts-kb/hiv-self-testing/all. HIVST KITS Where can HIVST kits be procured? There are currently four WHO prequalified HIVST products: • OraQuick HIV Self-Test (OraSure Technologies, USA); oral fluid • INSTI HIV Self-Test (Bioanalytical, Canada); blood-based • Mylan HIV Self-Test (Mylan, Atomo Diagnostics, Australia); blood-based • SURE CHECK HIV 1/2 Assay (Chembio, USA), blood-based All four kits can be procured with U.S. Government or Global Fund funds. To order, contact the Global Health Supply Chain- 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. c Rapid Test Kits (GHSC-RTK) via ▇▇▇▇▇▇ ▇▇▇▇▇ (▇▇▇▇▇▇@▇▇▇▇▇.▇▇▇). Selecting HIVST products for procurement from WHO’s lists of prequalified HIVST kits will enable countries to forgo in-country performance evaluationscountry Table 1. HIVST products for procurement can be identified by reviewing those listed at the following links: with WHO prequalification and GF Quality Assurance Policy for Diagnostic Products. HOW? There are many effective HIVST delivery mechanismsPQ, in which individuals either test by themselves in private EPRD or in the presence approval from founding member of a sexual partner or peer, or distribute tests to partners and social contacts.IMDRF*