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Expression of Interest to Hireindividual Consultant Services: Local REPUBLIC OF LIBERIA MINISTRY OF HEALTH Expression of Interest to HireIndividual Consultant Services: Local Consultant-To ConductEfficacy Study and safety of Artesunate +Amodiaquine and Artemether+Lumefatrine for the treatment of uncomplicated Plasmodium falciparum malaria in Saclepea-Mah Comprehensive Health Center (Saclepea-Mah District, Nimba County), Rennie Hospital (Kakata District, Margibi County) and Sinje Health Center (Garwula District, Cape Mount County) in Liberia. Reference #: “Ref: MOH/IC/NMCP/REOI/002/16/17 Released: April 11, 2017 REQUEST FOR EXPRESSION OF INTEREST SYNOPSIS Title: Efficacy and safety of Artesunate +Amodiaquine and Artemether+Lumefatrine for the treatment of uncomplicated Plasmodium falciparum malaria in Saclepea-Mah Comprehensive Health Center (Saclepea-Mah District, Nimba County), Rennie Hospital (Kakata District, Margibi County) and Sinje Health Center (Garwula District, Cape Mount County) in Liberia. Purpose:To assess the efficacy of the current first and/or second line treatment policy. Objective: To assess the efficacy and safety of Artesunate +Amodiaquine andArtemether+Lumefatrine for the treatment of uncomplicated P. falciparum malariainfections. Study Sites:Saclepea-Mah District in Nimba County, Kakata District in Margibi County and Garwula District, Cape Mount County.and Bensonville Hospital, Montserrado County Study Period: May to July 2017 Study Design:Two cohorts’ prospective study in sequential enrolments. Patient population: Febrile patients aged 6 to 59 months with confirmed uncomplicated P. falciparum infection. Sample Size: 88 patients per site for each drug. Treatment(s) and follow-up: Artesunate +Amodiaquine andArtemether+Lumefatrine (AL) the treatment is Artemether+Lumefatrine (AL) twice daily dose for three days. Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy. Primary endpoints: The proportion of patients with early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response as indicators of efficacy. Recrudescence will be distinguished from re-infection by polymerase chain reaction (PCR) analysis. Secondary endpoints: The frequency and nature of adverse events Exploratory endpoint: to determine the polymorphism of molecular markers for name of the antimalarial drug(s) resistance. Monitoring the efficacy of antimalarial medicines is a key component of malaria control as resistance of the parasites to such medicines can have devastating consequences. Resistance to Chloroquine in Africa in the 80s, for example, led to a dramatic increase in malaria-related deaths in many sub-Saharan African countries. As a result many countries adopted artemisinin- based combination therapies (ACTs) as the first line treatment for uncomplicated malaria. Liberia adopted artesunate and amodiaquine (ASAQ) in 2003 as first line treatment and later Artemether-lumefantrine (AL) in 2015 to be used as an alternative drug.Since the introduction of the ASAQ, it has been over five years since the study was done to determine its efficacy. however, for the AL no studies have been done to determine its effectiveness and safety in Liberia. Objectives The general objective of this study is to assess the therapeutic efficacy and safety of the two ACTs (Artesunate - Amodiaquine and Artemether – Lumefatrine) for the treatment of uncomplicated P. falciparum malaria in Liberia. The primary objectives are: To measure the clinical and parasitological efficacy of ASAQ and AL respectively in patients aged 6-59 months, suffering from uncomplicated falciparum malaria The secondary objectives are: (i) to evaluate the incidence of adverse events; and (ii) to determine the polymorphism of molecular markers for name of the antimalarial drug(s) resistance. Summary of the position The Principal Investigator (PI) is responsible for assuring compliance with the protocol and procedures as approved by the National Research Ethics Board. Although the PI may delegate tasks to members of his/her research team, s/he retains the ultimate responsibility for the quality and conduct of the study. In collaboration with National Malaria Control Program the incumbent will be responsible to ensure that: risks to research subjects are minimized by using procedures which are consistent with sound research design and which do not unnecessarily expose the subjects to risk diagnostic or treatment purposes individuals are adequately informed of the risks and benefits of research participation and the procedures that will be involved in the research, and that informed consent are obtained from each prospective research subject, or his/her legally authorized representative, in accordance with, and to the extent required, by NREB informed consent are obtained in advance of research participation and appropriately documented in accordance with stipulations of the NREB there is routine monitoring of the data collected to ensure the safety of research participants the privacy of study participants is protected and the confidentiality of data is maintained supervise co-investigators and other researchers Write the final report of the research and submit to the NMCP Qualification and Requirements: Medical Doctor or a Public Health Practitioner. Have at least three years in clinical management with experience in clinical research Demonstrated experience in managing a research of this nature Proven ability to work effectively in limited structure settings Strong project planning, implementation, and monitoring and evaluation skills Have basic understanding of financial management and accountability principals Proficiency in MS Office Suite applications Fluent English speaker with excellent written and oral communications skills Duration of Assignment The assignment is for a period of three months and the National Malaria Control Program will provide a working space and tools for the consultant. The Consultant shall however be responsible for his/her transportation except when he/she is going in the field at which time transportation and DSA will be provided at the Government of Liberia DSA rate. Interested individual may obtain further information from the address below and deliver their Expression of Interest (EOI) written in English, enclosed in an envelope clearly marked: “Expression of Interest:Individual Consulting Services: Local Consultant-TO CONDUCT MALARIA EFFICACY STUDY“Ref: MOH/IC/NMCP/REOI/002/16/17and drop in the tender box situated on the ground floor or electronically transmitted by the deadline specified below to: [email protected] no later than Tuesday, 25thApril2017 @ 2:00 PM/ 14: 00 GMT. Expression of Interest must be clearly marked “Consulting Services: “Local Consultant-TO CONDUCT MALARIA EFFICACY STUDY “Ref: MOH/IC/NMCP/REOI/002/16/17”. Only Shortlisted Consultants will be interviewed. The address is stated below: Jacob L.N Wapoe Director of Procurement Ministry of Health Congo Town, Room#140 or via email: [email protected] This Expression of Interest can also be found on: i. www.emansion.gov.lr ii. www.moh.gov.lr. Signed by: ____________________ Approved by: ___________________ Director of Procurement Deputy Minister for Admin. .
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