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Anopheles

Pan American Health Organization's Proposed Contribution to the
United States Agency for International Development (USAID) /
Latin America and Caribbean Bureau's
Amazon Malaria Initiative (AMI):

Project Proposal and Workplans for Years 2 & 3

Summaries: PAHO
PAHO: Progress Report
Proposal, Years 2–3
Monitoring & Evaluation
Project Management
Budget
Rational Pharmaceutical Management (RPM) Plus
Technical Objectives/Rationale
Planned Activities
US Pharmaceuticals, Drug Quality & Information Program (USP-DQI)
Long-Term Goal
Multi-Year Strategy for Monitoring Drug Quality
Proposal Year One
Workplans: Regional   |   RPM   |   USP-DQI   |   CDC
Bolivia   |   Brazil   |   Colombia   |   Ecuador
Guyana   |   Peru  |   Suriname   |   Venezuela
Full-Text Report (17 pp, PDF: above workplans excluded)
Practical Guide for in vivo Antimalarial Drug-Efficacy Studies

PAHO: Progress Report

Funds provided by USAID to date have greatly contributed to the development and strengthening of a regional network a regional network for surveillance of antimalarial drug resistance. National surveillance networks were established in each target country to assess the efficacy of antimalarial drugs. In addition, studies of efficacy of malarial drugs for P. falciparum were initiated and studies of P. vivax drug resistance were contemplated in few countries.

The AMI includes three intermediate results:

  1. First intermediate result (IR): "reliable and standardized malaria drug efficacy information available."
  2. Second IR: "Tools and approaches developed, adapted, tested, and/or disseminated."
  3. Third IR: "Partnerships to improve malaria control in the subregion enhanced", aims to facilitate dialogue and joint efforts among target countries and their institutions.

Proposal, Years 2– 3

This proposal describes the activities and related budget for the AMI project to be implemented over a two-year period and to be completed by 30 September 2004. The proposed budget for USAID funding is US $1,644,000 and US $1,065,000 for fiscal years 2002 and 2003 respectively, for a total of $2,709,000.

During AMI's second and third years, work initiated in the first year will continue with the aim of concluding drug resistance studies and providing an evidence base to support processes of ratification/reform of national malaria-treatment policies.

PAHO will continue to coordinate and monitor the implementation of the project as a whole, while providing technical cooperation to the target countries. During these two years the project will focus on completing malaria drug efficacy studies, assisting in data analysis and evaluation of alternative treatments, and on revising malaria-treatment policy (for non-complicated P. falciparum). As new treatment policies are adopted, PAHO will assist countries to plan and implement the new treatment policies, and to implement effectiveness studies to monitor the implementation of new treatment regimens. Operations research, training, and South-South activities will also be undertaken. Below are the proposed activities, by intermediate result.

IR1: Reliable and Standardized Malaria Drug-Resistance Information Available

  • Technical cooperation to establish and monitor surveillance sites.
  • Technical cooperation to develop/adapt protocols (at country level).
  • Technical cooperation to develop the capacity of human resources in surveillance sentinel sites.
  • Technical cooperation to establish/strengthen the National Coordinating Committees (NCC).
  • Technical cooperation to carry out regional quality controls (RQC) for in vivo studies (microscopic diagnosis and drug quality).
  • Technical cooperation on data analysis, and to reach consensus on evaluated treatment alternatives or new treatment guidelines.
  • Technical cooperation to implement efficacy studies.
  • Technical cooperation for dissemination of information through the PAHO website.

IR2: Tools or Approaches Developed and/or Adapted, Tested and Disseminated

  • Technical cooperation to carry out field tests of rapid diagnosis (RDT).
  • Technical cooperation to carry out a subregional training workshop on EPI Info.
  • Convene regional expert group to build consensus about revised in vivo efficacy protocol, including the WHO updated protocol (Geneva, December 2001).
  • Convene regional expert group to build consensus about effectiveness protocols.
  • Provide technical cooperation in developing revised treatment guidelines, including monitoring and evaluation.
  • Technical cooperation in the preparation and dissemination of new treatment guidelines.
  • Technical cooperation to implement operational researches areas defined in Santa Cruz meeting (review, select and provide funding for proposals.

IR3: Partnerships to Improve Malaria Control Enhanced

  • Plan and organize the AMI Annual Meeting (in order to strengthen the planning and coordination of FY02 and FY03 activities).
  • Convene the first Technical Advisory Group (TAG) Meeting. Outside experts will be convened to review the strategy and the process of the project, as well as the research findings with a view to examining the course in the project and issue recommendation.
  • Participation and technical cooperation in the subregional training on data analysis.
  • Participation and technical cooperation on a subregional training workshop on anti-malaria drug-policy reform processes.
  • Technical cooperation on South-South activities (assistance and training).
  • Technical cooperation to centers of excellence supporting the processes and promoting South-South cooperation.
  • Technical cooperation on a subregional training in management of malaria at the district level.

Monitoring and Evaluation

PAHO will continue to use the jointly agreed upon indicators and targets to measure progress and impact of the program. Initiative-level indicators will be collected and reported in the annual report.

  • SO-Level Indicator: Number of target countries that develop or revise and implement evidence-based malaria treatment.
  • IR 1: Target countries that complete anti-malarial drug resistance studies based on WHO/PAHO protocol.
  • IR 2: Tools or approaches developed and/or adapted, tested and disseminated: number of country target countries that use tools disseminated by the initiative.
  • IR 3: Number of South-South training or technical exchange activities: process indicators and milestones will be updated and revised as necessary, and reported on every six months.

Project Management

The coordination of AMI will be carried out through a Steering Committee with representatives of the financing agency (USAID), of PAHO, the CDC, and new partners RPM Plus (Rational Pharmaceutical Management Plus Program) and USPDQI (United States Pharmacopeia Convention Drug Quality and Information). The Committee aims to facilitate coordination and information sharing between AMI partners, and serves as a mechanism for discussion of technical issues.

The National Coordination Committees will coordinate, guide and support AMI activities at the country level, with inclusion of the focal points of PAHO, including the countries where the project is executed by USAID missions (Bolivia and Peru).

PAHO staff taking part in this project, under the direction of Dr. Renato Gusmão, Chief, Communicable Diseases Control Unit:

- Dr. Gustavo Bretas, Roll Back Malaria Advisor for Amazon Countries
- Dr. Keith Carter, Regional Advisor in Malaria, Project Coordinator
- Dr. Roberto Montoya, Project Technical Coordinator
- Ms. Raquel Requejo, Project Manager Consultant
- Ms. Roxane Salvatierra-González, Public Health Officer
- Dr. Zaida Yadón, Regional Advisor, TDR

At country level, PAHO staff from Regional Office in Brazil, Colombia, Ecuador, Guyana, Suriname, and Venezuela will provide technical cooperation supporting the national project coordinators and Coordination National Committee in executing project activities. In Bolivia and Peru coordination of efforts will be provided by the USAID offices, with collaboration of PAHO staff.

PAHO staff from the Regional Office involved in the project:

- Dr. José Pablo Escobar, Bolivia
- Dr. Carlos Catao Loiola Prates, Brazil
- Dr. Celsa Sampson, Colombia
- Dr. Angel Valencia, Ecuador
- Dr. Bernadette Theodore-Gandi, Guyana
- Dr. Rubén Figueroa, Peru
- Dr. Marthelise Eersel, Suriname
- Dr. Mario Valcárcel, Venezuela

Budget

The proposed second- and third-year budget for PAHO's proposal for USAID funding is US$ 1,644,000 and US$ 1,065,000 respectively for a total budget of $2,709,000.

PAHO will provide $390,000 total (FY 2002, $240,000 and FY 2003, $150,000) in direct contribution to malaria activities, in addition to approximately $531,000 in staff salary support ($265,500 for each year). The FY 2002 and FY 2003 budget provided by USAID and PAHO combined amounts to $2,149,500 and $1,480,500 respectively, for a total budget of $3,630,000.

Rational Pharmaceutical Management (RPM) Plus

Technical Objectives/Rationale

The long-term strategy of RPM Plus is to strengthen the ability of policy-makers, health-care providers and institutions in the region to improve drug management. At the same time, RPM Plus plans to work with its partners, international health care organizations, and national and local health officials to develop policies and strategies to improve the treatment of infectious diseases. Through the USAID-funded LAC Amazon Malaria Initiative (AMI), RPM Plus will be working with the Pan American Health Organization (PAHO), CDC, USP-DQI, USAID/Peru, USAID/Bolivia, and other local mission officers to effectively develop and implement strategies to improve malaria drug management in the region. These activities will also contribute to the accomplishment of the Regional Bureau for Latin America and Caribbean's Strategic Objective: "More Effective Delivery of Selected Health Services and Policy Interventions."

Technical Objective 1: Strengthen Health Systems for the Appropriate Drug Management of Malaria in the LAC Region.

The role of RPM Plus will be to ensure that drug management for malaria is properly addressed to enhance effectiveness of the initiative activities. RPM Plus will participate on the AMI Steering Committee meetings. The data collection instrument developed with USAID BGH funds to assess malaria drug use at the community level will be tailored to the needs of the initiative partners and translated into Spanish to be used in the region. The tool will be field tested through funds provided by other partners for country activities. RPM Plus will participate in the training of country personnel to use the tool as well as to analyze the data collected.

Depending on availability of funds, RPM Plus will also adapt and translate into Spanish a module on drug management for malaria. This module may be incorporated to other training tools that initiative partners' have already developed.

RPM Plus activities in this area will contribute to the SO-level statement of AMI: "Malaria control programs in the Amazon Basin sub-region substantially incorporate selected best practices". RPM Plus participation will contribute to the achievement of the following intermediate objectives:

  • IR-2: Tools and approaches developed, adapted, tested and/or disseminated.
  • IR-3: Partnerships to improve malaria control in the sub-region enhanced.

Planned Activities

IR-2: Tools and Approaches Developed, Adapted, Tested and/or Disseminated
1. Adaptation and Translation of the Community-Level Drug Management for Malaria Tool

RPM Plus with funds from BGH is preparing materials for a training course on drug management for malaria. With funds from LAC/RSD RPM Plus will adapt and translate this module to be used in the LAC region. The materials will be ready for individual countries to use during training activities, and for future AMI training workshops at the sub-regional level.

In collaboration with CDC and the local AMI team the data collection instrument developed with USAID BGH funds to assess malaria drug use at the community level will be tailored to the need of the initiative partners and translated to be used in the region.

RPM Plus will provide training to local personnel in the country where the activity will take place. Coordination has been established with the Peru AMI team to conduct this activity.

RPM Plus will work with country counterparts to analyze the data and modify the tool according to results of the field test.

2. Adaptation and Translation of a Module on Drug Management for Malaria

RPM Plus with funds from BGH will prepare a module addressing the main aspects of drug management for malaria programs. With funds from LAC/RSD RPM Plus will adapt and translate this module to be used in the LAC region.

IR-3 Partnerships to Improve Malaria Control in the Subregion Enhanced
3. Coordination of Activities with AMI Partners

This activity includes technical activity coordination, workplan development, budget monitoring, progress monitoring, reporting, meetings, and communications with partners and collaborators.

RPM Plus will participate on technical meetings with other members of the initiative. It is expected that the AMI Steering Committee will meet at least once during the current FY. Funds will also be allocated to attend a Technical Coordination Meeting with national managers from participant countries.

US Pharmaceuticals, Drug Quality & Information (USP-DQI)

Long-Term Goal

To strengthen antimalarial drug-quality assurance in the Amazon region in order to increase treatment efficacy, reduce antimalarial drug resistance, and maximize the use of health care resources for malaria.

Multi-Year Strategy for Monitoring Drug Quality

  1. Establish collection points at the final selected surveillance sites in the two countries based upon staffing and facilities.
  2. Train site staff to sample and analyze drug content using TLC for the drugs used as first line treatment in the site area following standard protocols and procedures.
  3. Collect a three-day regimen of any product suspected of clinical failure for submission to the designated reference laboratory for quality assessment. The reference lab may be a district, national or. Regional facility.
  4. Collect samples equivalent to a three-day regimen of any new products seen in the market place. Ship for formulation quality assessments to a reference laboratory.
  5. A three-day regimen of all products which appear by screening analysis (TLC) to be substandard or which contain a previously unobserved component should be sent for formulation assessment to one of the selected reference laboratories.

Proposal Year One

USP-DQI proposes to initially begin in two sites selected by the AMI partner organizations in each of the selected countries. USP-DQI will assess capacity at the site, i.e. human resources, lab equipment, communications equipment, etc., and work with the NMP to identify specific people to be trained. It is anticipated that staff at four sites will be trained this fiscal year. Training modules will be based upon working currently ongoing in Africa and Asia.

The country(s) must have the following:

  • Adequate human resources at the surveillance area who can be trained in drug sampling, TLC, and proper documentation of test results or other topical areas when identified as needed by the specific area.
  • Access to a reference laboratory that can do advanced drug-testing including HPLC, ultraviolet, infrared, and dissolution at minimum.
  • Availability in country of necessary supplies, e.g. reagents, glassware.
  • Reasonable access to the surveillance sites via air.
  • Willing collaboration by the local institution doing drug-resistance monitoring.
  • Approval of national malaria control program and drug regulatory authority.
  • An environment conducive to broad dissemination of drug-quality data.

About RAVREDA-AMI   |   Project Proposal Year One (2002)
Meetings: 2002   |   2001
Practical Guide for Practical Guide for in vivo Antimalarial Drug-Efficacy Studies in the Americas
Guía práctica para estudios in vivo de eficacia de los medicamentos antimaláricos en las Américas


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