Study entitled “Chagas disease and leishmaniasis surveillance in Antioquia”.

The requirement is for a 12-month base period of performance with an additional 12 month extension.

The contractor shall provide services including (but not limited to) project management, ethical and regulatory approval, collection and identification of samples and screening.

The contractor shall provide all supplies for sample collection and laboratory testing. NAMRU SOUTH will provide some reagents and supplies for collection and testing depending on funding availability.

In addition, the contractor shall provide disease incidence data available from direct sources such as active human subject studies or indirectly from local health authorities.

The study sites will be located in:

Colombia:

Antioquia state

Other sites as requested by NAMRU SOUTH

Monitoring activities will be conducted by NAMRU SOUTH via monthly conference calls and visits to selected field sites during the contract period. Monthly, short reports are expected during the conduction of the study.

1. 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 and biological specimens, 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.

1. FIELD AND LAB ACTIVITIES
   1. Entomological component
2. 1. 1. Approvals: Secure all ethical and regulatory approvals required for collecting entomological specimens in Colombia.
      2. Sand fly collection: Perform field collections in two different regions of Antioquia: San Luis municipality and Turbo municipality using standard methods (CDC light traps). Secure the collection of approximately 200 sand flies and store them in ethanol. Record field collection data and prepare a database.
      3. Triatomine collection: Perform field collections of Triatomine bugs in two different regions of Antioquia: San Luis municipality and Turbo municipality using standard methods (Angulo tramps). Secure the collection of 40-50 triatomine bugs and store them at room temperature in ethanol.
      4. Entomological specimen identification: Perform taxonomic identification of at least 50% of specimens collected and preserve specimens for molecular testing.
      5. Lab testing: Determine the status of infection with Leishmania and Trypanosoma cruzi in 80 entomological specimens using molecular methods. Provide DNA aliquots of positive specimens to NAMRU SOUTH if requested.
      6. Data sharing: Provide information on field site, entomological specimen numbers recorded, sand fly and triatomine species identified per collection period per site, specimen inventory, and relevant epidemiological data as requested by NAMRU SOUTH Entomology.
3. 1. Animal component
4. 1. 1. Approvals: Secure all ethical and regulatory permits approvals for conducting work with animals and collecting specimens in Colombia.
      2. Fieldwork: Perform animal trapping of potential Leishmania spp. reservoirs in Province (El Barcino) located in Campamento municipality and (El Alto del Pollo) Puerto Triunfo municipality.
      3. Specimens: Collect a minimum of 20 specimens from potential animal reservoirs, process and preserve them for molecular testing.
      4. Lab testing: Determine the status of infection with Leishmania and Trypanosoma spp in twenty specimens of wild mammals using serological or molecular methods.
      5. Data sharing: Provide information on collection site up to the district level, clinical and other relevant epidemiological data and laboratory testing results as requested by NAMRU SOUTH Parasitology.
   2. Human component
5. 1. 1. Approvals: Secure all ethical and regulatory permits approvals for conducting human subject research in Colombia.
      2. Fieldwork: Enroll human subjects from Campamento and Puerto Triunfo (Antioquia) and Puerto Boyac (Boyac ) in Colombia. Enrolment and specimen collection should follow the criteria as defined by the governing human use protocol.
      3. Specimens: Collect a minimum of 100 specimens from human participants, process and preserve them for molecular testing.
      4. Lab testing: Determine the status of infection with Leishmania and Trypanosoma spp in 100 human specimens using serological or molecular methods.
      5. Data sharing: Provide information on collection sites up to the district level, clinical and other relevant epidemiological data and laboratory testing results as requested by NAMRU SOUTH Parasitology.
6. DATA SHARING
   1. The contractor shall provide data collection information on field sites, entomological specimen numbers recorded, sand flies and triatomines species identified per collection period per site, specimen inventory, and relevant epidemiological data as requested by NAMRU SOUTH Entomology.
   2. The contractor shall provide 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.
   3. At the completion of a study or when requested, the contractor shall provide all data to NAMRU SOUTH.
   4. The contractor shall provide laboratory testing data as requested by NAMRU SOUTH Parasitology and Entomology.
   5. Provide input for report, scientific manuscripts and thesis preparation and participate on authorship of resulting products.
7. EQUIPMENT, SUPPLIES AND MATERIALS
   1. The contractor will cover the cost of supplies and materials necessary for sample collection, transport, storage and screening.
   2. Depending on funding availability, NAMRU SOUTH may provide DNA extraction kits, PCR primers and master mix for up to 200 subjects per performance period.
   3. The contractor shall provide all required equipment. No Government Furnished equipment will be provided.
8. 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:

1. Clinical samples collected as part of the study.
2. Nucleic acid material (if applicable) obtained from collected samples covered under this contract.
3. Spreadsheet with study codes, type of sample and volume.
4. DELIVERABLES
   1. Once fieldwork starts, the contractor shall provide reports indicating the number of participants enrolled, age, gender and malaria screening results on a monthly basis or as requested by NAMRU SOUTH.
   2. A minimum of 200 sand flies and 40 triatomine bugs collected and identified morphologically. A minimum of 80 entomological specimens tested for Leishmania and Trypanosoma cruzi.
   3. At the completion of the study or when requested, the contractor shall provide the study database to NAMRU SOUTH. Information collected should include geographical data up to the household level, clinical symptoms, relevant epidemiological data and laboratory results.
5. SPECIAL REQUIREMENTS: N/A
6. TASK ORDERS: N/A
7. ANNUAL SCHEDULE

Quarter 1 and 2:

• Organizational meetings, identify VBD transmission sites focusing on Chagas and leishmania infections through meetings with key contacts and MoH personnel.
• Obtain project and IRB permits and coordinate collection activities with local authorities.
• Purchase supplies and materials for field work and laboratory activities.
• Participate in bimonthly teleconferences with NAMRU SOUTH.
• Conduct human sample collection activities in Chagas and Leishmaniasis endemic areas in Antioquia, Colombia. Database preparation and submission to NAMRU SOUTH.
• Send demography, clinical data and laboratory results to NAMRU SOUTH.

Quarter 3 and 4:

• Continue human, reservoir, and entomological collection activities in leishmaniasis and Chagas disease endemic areas in Colombia . Database preparation and submission to NAMRU SOUTH.
• Perform molecular testing of entomological specimens for Leishmania spp. and T. cruzi infection.
• Send demography, clinical data and laboratory results to NAMRU SOUTH.
• Database quality control and data analysis.
• Participate in bimonthly teleconference with NAMRU SOUTH.
• Perform one shipment of human samples to NAMRU SOUTH Lima.
• Assist NAMRU SOUTH with data analysis, revision of study results and reporting, and manuscript preparation.

Period of performance:

The project is scheduled to be conducted in 12 months.

TASK/

DELIVERABLE

PERFORMANCE STANDARD

PERFORMANCE INDICATOR/

ACCEPTABLE LEVEL OF PERFORMANCE (ALP)

METHOD OF SURVEILLANCE

AND RISK RELATED SCHEDULE

PERFORMANCE RATING

Compliance of products, services, documents, related deliverables, and overall quality of work performance.

Contract requirements met with few minor and no significant problems encountered.

Performance meets all technical and functional requirements in the PWS, and contains pertinent, useful, and informative data and information.

Contractor's technical performance meets all contract requirements.

Problems that are encountered are minor in nature, and are as follows:

• does not cause a delay in schedule;
• does not cause costs to increase;
• involves minimal effort to fix; and
• does not affect overall contractor performance

All matters shall be resolved in a satisfactory and timely manner.

100% Inspection

Are study reports complete and are they compliant with various Government regulations?

Assignment of performance rating and criteria:

Excellent: Performance meets and exceeds contract requirements. Performance delivered with no required re-performance /rework; problems encountered were minor and resolved in a highly effective manner, having no impact on schedule, costs, and overall contractor performance.

Acceptable: Performance meets most contract requirements. Performance delivered with minimal re-performance/rework; problems encountered were minor and resolved in a satisfactory manner.

Unacceptable: Performance fails to meet many contract requirements. Substantial problems were encountered and were resolved in a less than satisfactory manner causing significant impact to schedule, cost, and/or overall contractor performance. Significant re-performance or rework required.

Timeliness of

Performance and

Services and Product

Deliverables, including

Administrative aspects

of Performance.

Contract requirements

met with few minor and

no significant problems

encountered.

Performance meets all

technical and functional

requirements in the PWS, and provides on time pertinent, useful, and informative data and information.

Contractor's technical

performance meets all

contract requirements.

Problems that are

encountered are minor

in nature, and are as follows:

• does not cause a delay in schedule;
• does not cause costs to increase;
• involves minimal effort to fix; and
• does not affect overall contractor performance

All matters shall be resolved in a satisfactory and timely manner.

100% Inspection

Is the contractor meeting established timeframes?

Assignment of performance rating and criteria:

Excellent: Performance meets all contract

timeliness requirements. Problems that

are encountered are minor and resolved in

a highly effective manner, having no

impact on schedule, cost, and overall

contractor performance.

Acceptable: Performance meets most

timeliness requirements. Performance

delivered with minimal reperformance/

rework; problems encountered were minor and resolved in a satisfactory manner. Minimal impact on schedule, cost, and overall contractor performance

Unacceptable: Performance fails to meet

many timeliness requirements. Substantial

problems were encountered and were resolved in a less than satisfactory manner causing significant impact to schedule,cost, and/or overall contractor performance.

Commitment to Customer Satisfaction and Business-like concern for its Customers' interest including responsiveness to internal and external Governments.

Contract requirements met with few minor and no significant problems encountered.

Performance meets all technical and functional requirements in the PWS, and contains pertinent, useful, and informative data and information.

Contractor's technical performance meets all contract requirements. Problems that are encountered are minor in nature, and are as follows:

• does not cause a delay in schedule;
• does not cause costs to increase;
• involves minimal effort to fix; and
• does not affect overall contractor performance

All matters shall be resolved in a satisfactory and timely manner.

100% Inspection

Is the contractor committed to high customer satisfaction? How proactive is the contractor? Is the contractor providing positive value to the Government?

Has the contractor communicated in a timely manner unexpected delays or issues and proposed alternative solutions to meet governments contract requirements?

Assignment of performance rating and criteria:

Excellent: Performance meets and exceeds contract requirements. Performance delivered with no required re-performance /rework; problems encountered were minor and resolved in a highly effective manner, having no impact on schedule, costs, and overall contractor performance.

Acceptable: Performance meets most contract requirements. Performance delivered with minimal re-performance/rework; problems encountered were minor and resolved in a satisfactory manner. Minimal impact on schedule, cost, and overall contractor performance.

Unacceptable: Performance fails to meet many contract requirements. Substantial problems were encountered and were resolved in a less than satisfactory manner causing significant impact to schedule, cost, and/or overall contractor performance. Significant re-performance or rework required.

Overall Satisfaction

Contract requirements met with few minor and no significant problems encountered.

Performance meets all technical and functional requirements in the PWS, and contains pertinent, useful, and informative data and information.

Contractor's technical performance meets all contract requirements. Problems that are encountered are minor in nature, and are as follows:

• does not cause a delay in schedule;
• does not cause costs to increase;
• involves minimal effort to fix; and
• does not affect overall contractor performance

All matters shall be resolved in a satisfactory and timely manner.

Periodic Inspection

What is the Governments overall satisfaction with the contractor?

Assignment of performance rating and criteria:

Excellent: Performance meets and exceeds contract requirements. Performance delivered with no required re-performance /rework; problems encountered were minor and resolved in a highly effective manner, having no impact on schedule, costs, and overall contractor performance.

Acceptable: Performance meets most contract requirements. Performance delivered with minimal re-performance/rework; problems encountered were minor and resolved in a satisfactory manner. Minimal impact on schedule, cost, and overall contractor performance.

Unacceptable: Performance fails to meet many contract requirements. Substantial problems were encountered and were resolved in a less than satisfactory manner causing significant impact to schedule, cost, and/or overall contractor performance. Significant re-performance or rework required.