The current initiative is to expand HIV testing to achieve UNAIDS 95-95-95 targets. There has been significant progress meeting these targets and many countries are reaching epidemic control. It is both a programmatic and ethical imperative and priority for Ministries of Health (MOH) and National AIDS Control (NAC) programs to implement robust quality management systems that deliver reliable and accurate HIV test results. The HIV Rapid Test Continuous Quality Improvement initiative (RTCQI), launched in 2014 as a practical and comprehensive approach to ensure the quality of HIV test results.
RTCQI is based on five main pillars which include
RTCQI emphasizes the quality assurance cycle (QAC) which is a foundation for increasing uptake, coverage and impact of quality assurance for HIV testing. The QAC is comprised of three major phases including: Planning, Implementation, and Evaluation. Conceptualized in a cycle, the emphasis on the QAC is to ensure all activities of the various phases are completed and RTCQI is guided by the implementation of innovative strategies to ensure the QAC is accomplished.
The people who make RTCQI implementations happen across the world.
Dr. Parekh obtained his B.S. and M.S. from University of Bombay, India before moving to the United States where he earned his doctorate in Biochemistry/Virology from Louisiana State University working on lentiviruses. He did his post-doctoral research at Scripps Research Institute in La Jolla, California working on hemorrhagic fever viruses. He worked as a Senior Scientist/Project Leader at Bio-Rad Laboratories in California where he was engaged in research and development of HIV and HTLV diagnostic assays, including Western blot assays.
Since 1990, his work focused on improving accuracy of HIV diagnosis, understanding HIV-1 and HIV-2 cross-reactivity and type-specific diagnosis, SIV surveillance in humans, early infant diagnosis, factors affecting perinatal transmission, evaluation/improvement of viral load assays, and development of HIV-1 incidence assays. As a Section Chief of HIV Serology, he ran HIV reference laboratory for several years helping to resolve difficult diagnosis. As a Team Lead of HIV Serology/Incidence Team in ILB and now as Associate Chief for Research and Innovation, Dr. Parekh provides critical laboratory support to global HIV work for PEPFAR in more than 40+ countries, assuring high quality of HIV testing in our programs and in surveys, including in PHIA surveys. Innovative quality assurance tools and HIV-1 incidence assays he developed in his laboratory have become the standards in many countries to ensure accuracy of HIV testing, estimate HIV-1 incidence, measure the impact of HIV programs, and identify hot-spots of new infections in near real-time. He has earned several awards including DHHS Secretary’s Award (twice), several nominations for Shepard Award for best publications (winning it twice) and Federal Laboratory Consortium’s Award for Excellence in Technology Transfer, among others. He has authored/co-authored more than 160 papers, review articles, or book chapters.
Mireille B. Kalou is a medical doctor with a master’s degree in public health – Infectious Disease. Mireille has over 20 years of experience in laboratory science, capacity building, program design and management. Mireille had spearheaded and laid cornerstones to the PEPFAR centrally funded HIV Rapid Test Quality Improvement Initiative while supporting its adoption by ministries of health in multiple countries in African, Asia and the Caribbean Region. Since 2018 she has been serving as senior Laboratory Advisor to oversee the PEPFAR lab portfolio of Haiti (2018-2021) and Eswatini (2022 to present). In that capacity, she has collaborated with laboratory stakeholders in countries to strengthen laboratory services and systems, develop national strategic plans, provide technical guidance for the establishment of the national public health laboratory. In addition, she is supporting the MoH Port Health team in their efforts to strengthen border health capacity for screening travelers in and out of Eswatini. As the new activity manager for the Ministry of Health Cooperative Agreement, she chaired an PEPFAR interagency task team to align two government-to-government funding mechanisms. She has been recognized several times for her outstanding contributions. She has received the American Embassy Mission Honor Award in Cameroon, the Mission National Meritorious Honor Award in Haiti and in Eswatini, and the Center for Global Health Excellence in Laboratory Quality Award. She has authored and co-authored more than 20 articles in peer-reviewed journals and book chapter. In her free time, Mireille spends quality time with her daughter, enjoys baking, walking, relaxing with a nice book and whenever possible, discovering new places.
Trudy Dobbs is currently a Biologist within the Serology & Incidence Team within the International Laboratory Branch (ILB) at the Division of Global HIV and TB, Global Health Center, US Centers for Disease Control and Prevention.
Mrs. Dobbs joined the Newborn Screening Quality Assurance (QA) Program, in 1990, where she supported QA measures for the HIV surveillance in childbearing women, and then moved to the Division of HIV/AIDS in 1996, where she specialized in research for HIV drug resistance and incidence surveillance. She continued with HIV incidence research upon transferring to ILB in 2008.
She is a member of the HIV Rapid Test Continuous Quality Improvement (RTCQI) core team which seeks to enhance RTCQI practices in PEPFAR countries. Moreover, as team general supervisor, she co-leads Quality Management System (QMS) activities for CAP, CLIA and ISO certification.
In addition, she provides technical assistance with protocol development, laboratory training and survey implementation for HIV recency surveillance, Population-based HIV Impact Assessment (PHIA) surveys and HIV Rapid Test Continuous Quality Improvement (RTCQI) in PEPFAR countries.
Kelsie Decker-Pulice is currently a microbiologist on the HIV Serology and Incidence Team. She focuses on international HIV recency implementation, serology testing, and various research projects. She has supported several PEPFAR Population-based HIV Impact Assessments (PHIAs) in: Eswatini, Lesotho, Uganda, Malawi, Zambia, Botswana, and Tanzania by conducting lab trainings in country which focused on quality assurance in HIV rapid testing, waste management, blood collection, and sustaining the in- country laboratories well after the PHIA. Kelsie also has five years of experience in CLIA testing, ISO and CAP accreditation audits.
She is currently the recency and serology ISME for Brazil, Ukraine and Lesotho and works with these countries to ensure quality testing and data usage.
Kelsie looks forward to providing technical assistance and guidance to strengthen quality management systems at the national, regional, and district levels.
Kemba is a Public Health Scientist with background in pharmacology and molecular genetics, more than 20 years of research experience and several years (since 2016) experience in Laboratory Quality Management Systems (QMS). She is a Subject Matter Expert (SME) for HIV Recency and HIV Rapid Test Continuous Quality Improvement (RTCQI) program development and implementation. Her service as an RTCQI SME has assisted several countries build laboratory capacity and strengthen programs, particularly Proficiency testing and National (Site and Tester) Certification programs. She has helped to establish RTCQI programs in Malawi, Botswana, and South Africa, develop the RTCQI website, e-Tools, other program tools and training materials during the early days of RTCQI and continues to provide consultation and technical assistance to maintain and promote sustainability of quality programs in multiple countries.
She possesses extensive experience in laboratory quality assurance and improvement in context of public health, through her over 15-year service in CAP, ISO accredited HIV serology laboratory for applied research as well as WHO-accredited regional reference laboratory of the WHO’s Western Pacific Region for polio virologic surveillance. She provided technical supports under PEPFAR program to ensure the testing quality of HIV rapid diagnostic assay and HIV recent infection surveillance using a rapid test e.g., in Zimbabwe, Namibia, South Africa, DRC, Caribbean region, and Ghana. She also supported the continuous quality improvement of laboratory network for virologic surveillance in China, as part of WHO’s global laboratory network for polio eradication.
Floris is a laboratory quality management expert and certified assessor for ISO 15189, and ISO/IEC 17025 standards; Certified Strengthening of Laboratory Management Towards Accreditation (SLMTA) trainer; and Quality Management System (QMS) trainer for (ISO/IEC 17025, ISO 15189, ISO 15190 and CAP) laboratory standards. She is a Subject Matter Expert (SME) for Population Based HIV Impact Assessment (PHIA) Surveys, HIV Recency, and HIV Rapid Test Continuous Quality Improvement (RTCQI) program development and implementation.
Among her accomplishments are a successful track record of assisting laboratories in multiple countries acquire international accreditation; Proficiency testing program development and implementation in compliance with ISO/IEC 17043 standard; Design, development and validation of laboratory testing algorithms (HIV, Syphilis, Hepatitis, COVID-19); and Program management.
Keisha received a Bachelor of Science degree in Microbiology and Cell Science at the University of Florida, Gainesville. Her early career as a microbiologist involved collaborating with Saint Louis University on studies involving the cellular and humoral immune responses of HIV infected patients in HIV-1 vaccine and treatment clinical trials. Keisha continued her work in HIV in 2009 where she managed a global portfolio of capacity building efforts in PEPFAR-supported countries to strengthen quality assurance measures for HIV diagnostics and surveillance programs at national and sub-national levels. She has fostered collaborations with different organizations and partners including, the World Health Organization (WHO), U.S. Agency for International Development (USAID), Institut de Recherche en Santé de Surveillance Epidémiologique et de Formation (IRESSEF), the African Field Epidemiology Network (AFENET), the African Society for Laboratory Medicine (ASLM) and the Foundation for Innovative New Diagnostics (FNID) in order to implement robust quality management systems in PEPFAR-support countries.
From 2018 to 2022, Keisha served as the program coordinator for the HIV Rapid Test Continuous Quality Improvement Initiative (RTCQI) where she provided technical assistance and training to laboratorians and Ministries of Health, in PEPFAR-supported countries to help implement innovative and comprehensive approaches to ensure the accuracy and reliability of HIV diagnostic testing. She has provided technical assistance with protocol development, laboratory and field training and survey implementation for the Population-based HIV Impact Assessment (PHIA) and HIV-1 Recent Infection Surveillance in PEPFAR countries.
Keisha has over 20 years’ experience working in College of American Pathology (CAP), International Organization for Standardization (ISO) and Clinical Laboratory Improvement Amendment (CLIA) certified laboratories for public health and clinical research. As she forges ahead in a new career path, Keisha continues to support quality management systems and innovative strategies for diagnostics and surveillance both domestically and internationally.
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