| Protocol No: | ECCT/25/05/10 | Date of Protocol: | 17-02-2025 |
| Study Title: | Evaluation of a Point-of-Care (PoC) diagnostic device to improve sexually Transmitted Infections Management and outcomes in Kenya: SERU PROTOCOL NO. NON KEMRI 5074
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| Study Objectives: |
General Objective
The main objective of this study is to generate evidence on the feasibility, acceptability, and operational considerations for implementing point-of-care (POC) diagnostic-led STI management in public facilities, drop-in centers and private pharmacies in Kenya. For this study, we are defining POC as “testing conducted in a clinical setting that can produce a test result rapidly enough to allow same day result communication”.
Specific objectives
Objective 1: Evaluate the clinical performance of Aptitude MetrixTM POC diagnostics for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV) in a clinical setting.
Objective 2: Evaluate the feasibility, acceptability, and potential scalability of a POC diagnostic approach for STIs in Kenya
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| Laymans Summary: | The World Health Organization (WHO) recently released new guidelines to improve the way sexually transmitted infections (STIs) are identified and treated. Besides treating patients based on the symptoms they are experiencing; they encouraged the use of laboratory or other tests that can be done on the spot (point of care) to ensure patients are treated immediately and accurately. This new approach aims to improve the quality of STI testing and treatment services by adopting new developments in the field, and ensuring antibiotics used for treating STI’s are used responsibly. The Bill & Melinda Gates Foundation is supporting the development of cheaper tests that can be conducted on the spot to identify three common STI’s [Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV)], and has funded a research project by Jhpiego and the International Centre for Reproductive Health Kenya (ICRHK) to test these new testing approaches in health facilities in Kenya. The research will show if these tests can be used in treating patients seeking STI services in public health facilities, if they are accepted by patients and health workers, and what needs to be done to use these tests. The findings from this research can also be used to guide if and how these tests can be used in other low- and middle-income countries.
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| Abstract of Study: | The World Health Organization (WHO) recently released new guidance promoting a diagnostic-led approach for Sexually Transmitted Infections (STIs), encouraging integration of laboratory or Point of Care (POC) testing to enhance syndromic management, increasing the accuracy of STI diagnosis and quality of management. The guidance recognizes the need for new models of STI services to keep up with scientific advances in STI treatment and testing, and for antibiotic use and stewardship. The Bill & Melinda Gates Foundation is investing in the development of lower-cost, true POC diagnostics that will identify Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) infections, and has funded Jhpiego and sub-partner International Centre for Reproductive Health Kenya to conduct a field evaluation of the Aptitude MetrixTM research-use-only diagnostic test for CT, NG and TV in health facilities in Kenya to inform strategies for further scale-up of diagnostic-led STI management approaches for low and middle income countries (LMICs). The aim of this study is to generate evidence on the feasibility, acceptability, and operational considerations for implementing point-of-care (POC) diagnostic-led STI management in the public health sector in Kenya. For this study, we are defining POC as “testing conducted in clinical settings that can produce a test result rapidly enough to allow same day result communication”.
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