02-26535. Support for the National Laboratory for HIV/AIDS Reference & Quality Assurance in the Republic of Uganda; Notice of Award of Funds

A. Purpose

The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2002 funds for a cooperative agreement program to develop and support the National HIV/AIDS Reference Laboratory (HRL) in Uganda.

The overall aim of this program is to strengthen laboratory capacity across the country by assuring the accuracy of HIV testing at blood banks and at laboratories carrying out national sentinel surveillance, HIV-related research and those supporting Voluntary Counseling and Testing (VCT) and Prevention of Mother-To-Child Transmission (PMTCT) services.

The United States Government seeks to reduce the impact of HIV/AIDS in specific countries within sub-Saharan Africa, Asia and the Americas. CDC has initiated its Global AIDS Program (GAP) to strengthen capacity and expand activities in the areas of (1) HIV primary prevention, (2) HIV care, support and treatment and (3) capacity and infrastructure development, including surveillance. Targeted countries represent those with the most severe epidemics and the highest number of new infections. They also represent countries where the potential impact is greatest and where United States government agencies are already active. Uganda is one of these countries.

CDC is working in a collaborative manner with national governments and other agencies to develop programs of assistance to address the HIV/AIDS epidemic in many countries and it currently has an existing GAP Program in Uganda. CDC's mission in Uganda is to work with Ugandan and international partners in discovering and applying effective interventions to prevent HIV infection and associated illness and death from AIDS.

One of the functions of an HRL is to provide quality assurance of HIV testing nationwide. In Uganda, HIV testing is carried out to ensure the safety of the blood supply, to support national sentinel surveillance and specific research projects and in support of voluntary counseling and testing (VCT) and prevention of mother-to-child transmission (PMTCT) services.

The purpose of this program is to provide assistance to the National HRL in establishing a quality assurance (QA) program for all laboratories providing HIV testing services in both the governmental and non-governmental sectors.

VCT services are available at a large number of private and government clinics across the country and PMTCT services are expected to increase dramatically in the next few years as drugs to prevent mother-to-child transmission become more widely available. Serum-based HIV rapid testing is likely to be replaced by finger-stick rapid HIV testing at many of the sites providing VCT and PMTCT services presenting a new challenge for QA. There is no laboratory accreditation scheme in Uganda and the proficiency of many of the laboratories providing HIV testing services has not been established. As a consequence, users of these services, including policy makers and the general public are often not confident of the quality of laboratory test results. Currently there is no national QA scheme for rapid HIV testing and this program is intended to address this situation. It is expected that the scheme will become a model for other African countries as they develop their own HIV testing services in support of safe blood, surveillance and VCT and PMTCT programs.

This program will support both the development of the HRL and the implementation of a QA scheme for HIV testing. The development of the HRL will likely require; improvements in the physical infrastructure of the laboratory including power backup, computers, furnishings and fittings; additional equipment to ensure safe-practice and to support an expanded range of laboratory assays; recruitment and training of staff; development of a laboratory management plan; design and implementation of HIV testing algorithms; design of a specimen repository policy and the development of a financial management plan. The implementation of the QA scheme will require; a census to be carried out to identify the potential scope of the scheme; evaluation of the performance characteristics of HIV assays and testing algorithms; development of QA activities in consultation with participating laboratories including training needs assessments and implementation of appropriate training programs, tools to evaluate laboratory performance, proficiency testing panels, schedule of QA site visits and reporting mechanisms.

B. Eligible Applicants

Assistance will be provided only to the National HRL of the Ministry of Health (MOH) of Uganda. No other applications are solicited.

The National HIV Reference Laboratory, being the mandated MOH laboratory for HIV reference activities, is the only appropriate and qualified laboratory to conduct the specific activities which will support the CDC Global AIDS Program's technical assistance to Uganda for the following reasons:

The HRL is uniquely positioned in terms of legal authority, ability and credibility with the Ugandan public to provide such services in support of communicable disease control and the maintenance of public health.

The HRL has provided limited HIV reference services for many years to most of the laboratories carrying out HIV testing in the country. As a result, HRL has established excellent working relations with the National Blood Bank, the AIDS Information Centre who are the main provider of VCT services in the country, the MOH-AIDS Control Program which has worked with the HRL in support of sentinel surveillance since it's inception in 1987 and with numerous governmental and non-governmental laboratories in the country.

This proposal will help strengthen capacity within the existing framework of laboratories which are supported by the HRL to perform existing and newly-defined functions more effectively.

C. Availability of Funds

Approximately U.S. $280,000 is available in FY 2002 to fund two specific activities within this award as follows:

1. U.S. $160,000—non-recurrent expenditure for infrastructure development including furniture and fittings, equipment and vehicles.

2. U.S. $120,000—recurrent expenditure for QA activities.

It is expected that the award will begin on or about August 30, 2002 and will be made for a 12-month budget period within a project period of three (3) years. Annual funding estimates may change.

Continuation awards within an approved project period will be made on the basis of satisfactory progress as evidenced by required reports and the availability of funds.

All requests for funds, including the budget contained in the application, shall be stated in U.S. dollars. Once an award is made, the Department of Health and Human Services (DHHS) will not compensate foreign grantees for currency exchange fluctuations through the issuance of supplemental awards.

Use of Funds

Funds may only be utilized at the National HIV Reference Laboratory for QA of HIV testing as described in the goals, objectives, and activities of the submitted and funded plan.

Applicants may contract with other organizations under these cooperative agreements, however, applicants must perform a substantial portion of the activities (including program management and operations and delivery of prevention services for which funds are requested).

The costs that are generally allowable in grants to domestic organizations are likewise allowable to foreign institutions and international organizations, with the following exceptions:

Indirect Costs: With the exception of the American University, Beirut, the Gorgas Memorial Institute, and the World Health Organization, indirect costs will not be paid (either directly or through a sub-award) to organizations located outside the territorial limits of the United States or to international organizations regardless of their location.

The purchase of antiretrovirals, reagents, and laboratory equipment for antiretroviral treatment projects requires pre-approval from the Global AIDS Program headquarters.

No funds appropriated under this Act shall be used to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug.

D. Where To Obtain Additional Information

This and other CDC announcements can be found on the CDC home page Internet address—http://www.cdc.gov. Click on “Funding” then “Grants and Cooperative Agreements.”

To obtain business management technical assistance, contact: Cynthia Collins, Grants Management Specialist, Grants Management Branch, Procurement and Grants Office, Centers for Disease Control and Prevention, 2920 Brandywine Road, Room 3000, Atlanta, GA 30341-4146. Telephone: [phone]. E-mail: [e-mail].

For program technical assistance, contact: Jonathan Mermin, MD, MPH, Global Aids Program [GAP], Uganda Country Team, National Center for HIV, STD and TB Prevention, Centers for Disease Control and Prevention [CDC], PO Box 49, Entebbe, Uganda. Telephone: [phone]. E-mail: [e-mail].

Dated: October 9, 2002.

Edward J. Schultz,

Deputy Director, Procurement and Grants Office, Centers for Disease Control and Prevention.