JHU-Clin Trans Valid

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Summary Point of care (POC) diagnosis of sexually transmitted infections (STIs) can positively impact public health, the healthcare system and patient-related outcomes. Laboratory-based STI diagnostic tests with long turn-around times remain the standard of care in high-resource settings; the diagnosis often returns after the patient has left the clinic compromising the provider's ability to ensure treatment and interrupt transmission. Syndromic management continues to be the standard of care for STI treatment in low-resource settings and in emergency departments and urgent care settings which leads to high rates of over and under treatment for those with symptoms. Despite a number of new POC STI tests with functional prototypes, developers face significant barriers to commercialization, which include limited access to patient samples for testing and appropriate clinical care settings for performance testing. Getting feedback from end-users on prototypes and early designs is also critical for evaluating tests in practice to accelerate adoption. Understanding how POC STI tests can be integrated into clinical work flow to provide timely diagnosis without disrupting care could transform care for STIs by allowing same-visit diagnostic certainty and targeted treatment. Specific barriers to implementation include lack of data regarding performance characteristics of new tests in diverse settings and lack of provider awareness of POC STI tests. We have developed methods and tools to evaluate POCT for STDs performance, acceptability and usability of POC tests among end-users in diverse settings. The work of the Clinical Translation and Validation Core will be guided by three Core aims: 1) To evaluate diagnostic accuracy, usability and acceptability of prototype POC devices for STI diagnosis, 2) To describe and evaluate implementation of POCT for STDs including end-users' assessment of preference, acceptability, usability, and test experience. We will also assess the impact on patient and partners' health, behaviors and well-being as well as the impact on healthcare delivery and/or public health outcomes, and 3) Develop a sustainable, searchable STI Diagnostic Watch database for developers and end-users. Our Center allows developers at all stages of the development pipeline to have one-stop shopping; from early iterative testing with samples from our well-curated biorepository, to clinical testing in diverse settings including an urban emergency department, an adolescent ambulatory clinic, a low-resource setting in Uganda, and by internet access with self-sampling. We will address site-specific aims based on end-user needs particular to each site. This Clinical Translation and Validation Core will accelerate development of new POC STI tests that will be accurate and rapidly adopted.