Yes. A generic protocol template for HIV recent infection surveillance is available for countries to adapt to guide implementation and to use for required review and approval by the host country government, CDC, DOD, and other partner institutions. Protocols may be deemed non-research public health surveillance, depending on scope, objectives, design and procedures. Host country…
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No. Given that the test has been evaluated and validated in ILB/CDC and other independent laboratories (e.g., NICD, South Africa), in-country validation of the RTRI is not necessary prior to implementation of recent infection surveillance. Validation of this test may not be feasible in every country since it requires a well-characterized bank of specimens with…
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Possibly. Some country regulating bodies may require registration of the RTRI prior to routine use, and registration requirements may differ based on the intended use (e.g., research vs. surveillance). We recommend that programs review their country’s registration requirements well ahead of planned implementation (including timeline for registration, costs of registration, and technical requirements) to ensure…
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Many factors need to be carefully considered in use of routine recent infection surveillance to estimate population HIV incidence, including recency assay-specific performance characteristics, timing and coverage of HIV testing among persons at-risk within the population, and coverage and quality of recency testing among those newly diagnosed with HIV. Approaches that adequately measure or adjust…
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Recent surveillance data can be used to characterize new HIV diagnoses in a population by recent infection status and other characteristics of interest routinely captured such as demographics or risk information. Additionally, these data can be used to estimate the proportion recently infected among a proxy population of persons at-risk (those who test HIV-negative within…
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Yes. PrEP may slow maturation of antibodies, which can delay identification as HIV-positive on routine diagnostic tests and result in infection classified as recent for a longer time than the mean duration of recent infection (about 6 months). These events (breakthrough infection while on PrEP) are likely to be rare. Persons using PrEP who are…
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