Inactive

NAVAL MEDICAL RESEARCH UNIT SOUTH PERFORMANCE WORK STATEMENT: “Tropical parasitic disease surveillance in endemic regions of Brazil” Introduction: The Performance Work Statement (PWS) defines the requ... NAVAL MEDICAL RESEARCH UNIT SOUTH PERFORMANCE WORK STATEMENT: “Tropical parasitic disease surveillance in endemic regions of Brazil” Introduction: The Performance Work Statement (PWS) defines the requirements for conducting the study entitled “Tropical parasitic disease surveillance in endemic regions of Brazil”. The study is funded by the Global Emerging Infections Surveillance and Response Branch (GEIS) of the Armed Forces Health Surveillance Division (AFHSD) Intramural Funding. The country where the activities will be carried out is Brazil. Background: Malaria remains as the most important vector-borne disease worldwide with more than 240 million cases worldwide having significant impact on deployed military forces and civilian population. Success of Malaria control strategies has created a shift in predominant species with a major role of P. vivax as the leading cause of malaria in the US military. In malaria regions, the genetic variability of the circulating population has an important effect on the rates and spread of mutations. In this regard, increased genetic variability can provide means for the parasite to evade vaccine-induced immune responses or to the rapid development of resistance against antimalarials representing a barrier for malaria elimination programs. Leishmaniasis is another major problem to current and future U.S military as is currently sweeping across the Middle East. While there are no armed conflicts between the US and countries in South America, more than 50,000 US military personnel rotate through this region each year. With such a significant number of personnel at risk, the execution of surveillance activities and the development of more effective and sensitive means to correctly identify the causative agent becomes a research priority. A key mission of the Department of Parasitology is the execution of surveillance activities in the Americas. Accomplishing this activity requires in-depth knowledge an on-site expertise in the endemic sites to ensure that the Department gets the most accurate information of emerging disease threats. Brazil is the biggest country in South America and has a strategic location in the SOUTHCOM region sharing borders with 10 other countries. This country is an endemic region for tropical infectious diseases such as leishmaniasis and malaria accounting for thousands of cases each year. Establishing the surveillance capacity for NAMRU SOUTH in Brazil requires the services of an on/site research institution that can collect the samples and conduct laboratory experiments for pathogen characterization. In this regard, this project will define allow the execution of surveillance activities in Brazil and to explore means to provide actionable data that can be used for the benefit of the war fighter. General Requirements: This PWS is for a one-year period of performance with optional extension period for two additional years. The study sites will be located in: Brazil: Acre Minas Gerais Other sites as requested by NAMRU SOUTH. The contractor will provide general classes of services including (but not limited to) project management, provision of clinical samples, laboratory testing, shipment of samples and reporting. Laboratory molecular testing will be performed by the contractor in response to NAMRU SOUTH requirements. In addition, the contractor shall provide demographic, clinical and laboratory test results in a de-identified manner to NAMRU SOUTH. Monitoring activities will be conducted by NAMRU SOUTH and periodical monitoring visits and reports will be coordinated. Frequent communications such as monthly teleconferences are expected during the conduction of the study. Performance Requirements: The Offeror is encouraged to propose a labor mix and level of effort based on their technical approach. The contractor shall provide general classes of services including (but not limited to) project management, provision of clinical samples, laboratory testing, shipment of samples, data analysis and reporting. Laboratory molecular testing shall be performed by the contractor in response to NAMRU SOUTH requirements. In addition, the contractor shall provide demographic, clinical and laboratory test results to NAMRU SOUTH. Monitoring activities will be conducted by NAMRU SOUTH and periodical monitoring visits and reports will be coordinated. Frequent communications such as monthly teleconferences are expected during the conduction of the study. Duties, education, experience, & training: Field work activities Obtain institutional review board approvals and regulatory permits required for enrolling human subjects and collecting human and animal specimens in the study sites and shipping them to NAMRU SOUTH Parasitology. Coordinate execution of activities in the form of passive or active surveillance with local point of contacts. Provide feedback on site performance, identify underperforming sites, and provide remedies which may include alternate sites. Identify and open other field sites at the request of the NAMRU SOUTH. Enroll, collect, and test a minimum of 250 samples from human subjects and animals on each performance period meeting the inclusion criteria as defined by the governing human or animal use protocol. Collect clinical and epidemiological data from enrolled participants and animals. Packaging and local shipment of samples from field sites to a central laboratory in Brazil for testing. Perform one shipment of samples on each performance period if requested by NAMRU SOUTH (Shipment costs covered by the contractor). Laboratory activities Standardize molecular biology procedures for malaria, leishmania and chagas detection as requested by NAMRU SOUTH Parasitology including but not limited to nucleic acid material extraction, loop mediated isothermal amplification assays, conventional PCR, real time PCR and sequencing methods. Perform specific testing on clinical samples to detect the infecting pathogen and provide results back to NAMRU SOUTH Parasitology. Process a minimum of 250 specimens per performance period. Receive samples from NAMRU SOUTH for specific testing if required. Data sharing The contractor shall provide data collection information on enrollment site up to the district level and, if possible up to the household level, clinical symptoms and other relevant epidemiological data as requested by NAMRU SOUTH Parasitology. At the completion of a study or when requested, the contractor shall provide all data to NAMRU SOUTH. The contractor shall provide laboratory testing data as requested by NAMRU SOUTH Parasitology. Provide input for report, scientific manuscripts and thesis preparation and participate on authorship of resulting products. Equipment, supplies and materials The contractor will cover the cost of supplies and materials necessary for sample collection, transport, storage and molecular tsting for pathogen identification. Depending on funding availability, NAMRU SOUTH may provide DNA extraction kits, PCR primers and master mix for up to 250 subjects per performance period. The contractor shall provide all required equipment. No Government Furnished equipment will be provided. Shipments The contractor shall cover the cost of one shipment of samples per year to NAMRU SOUTH Lima facilities per year upon coordination with the Department of Parasitology. The delivery address is: Parasitology – NAMRU SOUTH Av. Venezuela cd 36 S/N – Bellavista – Callao The Contractor shall include the following into the shipments of samples: Biological specimens collected as part of the study. Nucleic acid material (if applicable) obtained from collected samples covered under this contract. Spreadsheet with study codes, type of sample and volume. Deliverables: The materials specifically listed and requested must be delivered in a timely manner and in good condition. Once fieldwork starts, the contractor shall provide reports indicating the number of participants enrolled, age, gender and screening results on a monthly basis or as requested by NAMRU SOUTH A minimum of 250 clinical samples collected in Brazil. Nucleic acid material obtained from collected samples for PCR analysis. Demographic, clinical and laboratory test results of collected samples in Brazil. Period of performance: The project is scheduled to be conducted in 12 months with optional extension period for two additional years.