Common use of Practical considerations Clause in Contracts

Practical considerations. It is important to start the planning process from an informed perspective, both in terms of the country in which the program will be implemented and the lessons learnt from other countries. The core practical considerations for establishing a new HIVST program include understanding the regulatory framework (or lack of one) with respect to medical devices, understanding the processes and impediments for getting the selected products into the country, and confidence that it will be possible to provide a safe, effective and reliable delivery system. For any country where HIVST has not previously been available, it may be necessary to undertake program evaluations to study the prospective acceptability of the testing approach, preferences of potential clients, language and cultural issues that could affect the success of the program, and studies to ascertain whether an HIVST program could achieve the intended health goals. Much work has been done to answer some core programmatic implementation questions and understand the factors that determine its overall impact. For example, modelling and investment scenarios developed as part of STAR demonstrated that the impact and cost-effectiveness of HIVST is sensitive to the prevalence of undiagnosed HIV in the sub-population and the overall costs of service delivery. Studies of data from Malawi, Zambia and Zimbabwe showed that the greatest epidemiological impact can be achieved with the most cost-effective use of scarce resources when HIVST focuses on adult men and when targeted at women having transactional sex. Providers of HIVST testing should put in place quality assurance (QA) mechanisms to ensure that individuals who self-test get a correct diagnosis. Those who self-test HIV positive (reactive) must undergo confirmatory testing using approved algorithm. Distributors of HIVST should ensure that users are provided with information and tools to support effective linkage and referrals to confirmatory testing, treatment and prevention. Recommended models for linkages can be found in the “Implementation” section of this guide. Other key findings from experience to date with HIVST led to the recommendations that in all programs: • Those who receive a reactive (potentially positive) result should be referred to confirmatory testing and, if confirmed, linkage to ART; and, • Those who test negative (non-reactive) should still receive referrals and linkage to HIV prevention, as well as other health information on tuberculosis, other sexually transmitted diseases (STIs) and hepatitis. This can be done using user guides, frequently asked questions brochures and materials delivered in addition to the HIVST kits (and IFU included in the HIVST kits). When distributing HIVST kits, users should be provided with appropriate and high-quality pre-test information and demonstrations. Key messaging should include: • How to collect the specimen and how to conduct the test • How to interpret the result of the HIVST (reactive, non-reactive, or invalid) • Where to get confirmatory testing if the result is reactive • How to link to prevention, treatment and other HIV-related services In the STAR HIVST pilot studies it was found that most errors arose from users’ inability to comprehend the IFU and correctly interpret results. While these issues were discovered during studies of oral fluid HIVST kits, it is likely that they would also occur during sample collection and transfer for blood based HIVST kits. Some important caveats should be borne in mind before HIVST programs are scaled up: 1. HIVST is not for people living with HIV and receiving ART. Self-testing, as well as retesting in general, should be discouraged in this population as false negative self-test results may occur. 2. Retesting following a negative self- test result is only necessary for those at ongoing risk, such as people from key populations and those reporting potential HIV exposure in the preceding 12 weeks. 3. HIVST cannot replace facility-based visits for people starting PrEP. A negative (non-reactive) self-test result, unless followed by a negative test

Practical considerations. It is important to start the planning process from an informed perspective, both in terms of the country in which the program will be implemented and the lessons learnt from other countries. The core practical considerations for establishing a new HIVST program include understanding the regulatory framework (or lack of one) with respect to medical devices, understanding the processes and impediments for getting the selected products into the country, and confidence that it will be possible to provide a safe, effective and reliable delivery system. For any country where HIVST has not previously been available, it may be necessary to undertake program evaluations to study the prospective acceptability of the testing approach, preferences of potential clients, language and cultural issues that could affect the success of the program, and studies to ascertain whether an HIVST program could achieve the intended health goals. Much work has been done to answer some core programmatic implementation questions and understand the factors that determine its overall impact. For example, modelling and investment scenarios developed as part of STAR demonstrated that the impact and cost-effectiveness of HIVST is sensitive to the prevalence of undiagnosed HIV in the sub-population and the overall costs of service delivery. Studies of data from Malawi, Zambia and Zimbabwe showed that the greatest epidemiological impact can be achieved with the most cost-effective use of scarce resources when HIVST focuses on adult men and when targeted at women having transactional sex. Providers of HIVST testing should put in place quality assurance (QA) mechanisms to ensure that individuals who self-test get a correct diagnosis. Those who self-test HIV positive (reactive) must undergo confirmatory testing using approved algorithm. Distributors of HIVST should ensure that users are provided with information and tools to support effective linkage and referrals to confirmatory testing, treatment and prevention. Recommended models for linkages can be found in the “Implementation” section of this guide. Other key findings from experience to date with HIVST led to the recommendations that in all programs: • Those who receive a reactive (potentially positive) result should be referred to confirmatory testing and, if confirmed, linkage to ART; and, • Those who test negative (non-reactive) should still receive referrals and linkage to HIV prevention, as well as other health information on tuberculosis, other sexually transmitted diseases (STIs) and hepatitis. This can be done using user guides, frequently asked questions brochures and materials delivered in addition to the HIVST kits (and IFU included in the HIVST kits). When distributing HIVST kits, users should be provided with appropriate and high-quality pre-test information and demonstrations. Key messaging should include: • How to collect the specimen and how to conduct the test test‌ • How to interpret the result of the HIVST (reactive, non-reactive, or invalid) • Where to get confirmatory testing if the result is reactive • How to link to prevention, treatment and other HIV-related services In the STAR HIVST pilot studies it was found that most errors arose from users’ inability to comprehend the IFU and correctly interpret results. While these issues were discovered during studies of oral fluid HIVST kits, it is likely that they would also occur during sample collection and transfer for blood based HIVST kits. Some important caveats should be borne in mind before HIVST programs are scaled up: 1. HIVST is not for people living with HIV and receiving ART. Self-testing, as well as retesting in general, should be discouraged in this population as false negative self-test results may occur. 2. Retesting following a negative self- test result is only necessary for those at ongoing risk, such as people from key populations and those reporting potential HIV exposure in the preceding 12 weeks. 3. HIVST cannot replace facility-based visits for people starting PrEP. A negative (non-reactive) self-test result, unless followed by a negative test