Integrated Support for Malaria/HIV Diagnostics

THIS IS A NEW ACTIVITY FOR COP 09

The Ethiopia Health and Nutrition Research Institute (EHNRI) has been given the mandate to oversee

infectious disease diagnostic quality assurance / quality control (QA/QC) in the country. The institute has

regional satellite centers, so-called Regional Reference Laboratories, of which there are 12 throughout the

country. Currently no national, systematic evaluation of the quality of malaria diagnosis is fully operational.

Thus, although three Regional Reference Laboratories exist in Oromia (Adama, Jimma, Nekemte), only one

(in Adama) is currently fully operational and has been empowered with performing infectious disease

diagnostic QA/QC for the districts within the region. Most of these activities in the Regional Reference

Center in Adama have focused on HIV/AIDS and tuberculosis, and have been supported by the U.S.

Centers for Disease Control (CDC) through PEPFAR support; the principal PEPFAR partner in this area has

been Columbia University's ICAP. Thus, with CDC/PEPFAR and ICAP support EHNRI and Regional

References Laboratories have strengthened hospital laboratory HIV/AIDS diagnosis, patient management

and follow-up; laboratory curriculum and SOP development; training of clinical and laboratory health

personnel; QA/QC and supervision of laboratory strengthening activities. At health center level, activities

strengthening laboratory diagnosis of HIV/AIDS and tuberculosis are implemented by Management

Sciences for Health (MSH) through their USAID/E-supported HIV Care and Support Project.

The FMOH's objective is to ensure, by 2010, universal access for malaria diagnosis and treatment within 24

hours of the onset of fever. Laboratory-based diagnostic services are currently available to approximately

34% of the population served at health centers and hospitals. The service is expected to increase with

expanding health services (e.g. with the scale-up of the Health Extension Program). Although from 2001-

2005 the annual average number of malaria cases reported was 9.4 million, only approximately 500,000 of

these are confirmed parasitologically, primarily by microscopic examination of blood slides. Thus, laboratory

confirmed malaria currently comprises less than 6% of all cases. An added complexity is the requirement to

differentiate between the parasite species causing malaria (i.e. Plasmodium falciparum and P. vivax) as

these require different treatment regimens. Similarly, the unstable nature of malaria transmission in the

country (i.e. malaria is mostly seasonal with peak transmission occurring after the main rainy period) means

that throughout the year the proportion of fever cases that are actually malaria may vary significantly, again

demanding a special emphasis, and significant investment on improved diagnostics in the context of malaria

patient case management. Thus, for malaria, health centers and hospitals should, in theory, be able to have

microscopy diagnostic services available for diagnosis of malaria. In contrast, malaria diagnosis at the

health post level is based on clinical assessment and/or results of rapid diagnostic tests (RDTs).

Since 2005, largely through Global Fund To Fight AIDS, Tuberculosis and Malaria (GFATM) support, the

Government of Ethiopia (GOE) has significantly scaled-up malaria interventions in the country, including

malaria diagnosis (e.g. millions of RDTs have been distributed to health facilities to support case

management at peripheral level). However, with regards to diagnosis, the following knowledge, information

and programmatic gaps following this scale-up have emerged:

•No data is available on health facility laboratory capacity, either in terms of the human resources or

infrastructure needed to successfully implement quality laboratory diagnosis for malaria;

•National guidelines and training manuals for malaria (laboratory) diagnosis are outdated;

•A QA/QC system to comprehensively monitor malaria laboratory diagnosis at health facility level does not

exist;

Additionally, no data exists on the importance or burden of co-infections of malaria (e.g. HIV) in the

populations at risk. Thus, whilst not as important as the association between TB and HIV, there is now

increasing evidence for an interaction between malaria and HIV, including increased susceptibility to either

infection, greater parasitological load when co-infected, and reduced treatment response when co-infected.

Whilst these interactions are at the biological level, other interactions at programmatic levels exist, including

rational drug management in collaboration with Management Sciences for Health/Strengthening

Pharmaceutical Systems (MSH/SPS) and integrated laboratory diagnosis and laboratory and drug QA/QC

with the United States Pharmacopeia.

The Presidential Malaria Initiative (PMI) is supporting Columbia University's ICAP to strengthen laboratory

diagnosis of malaria at health facilities in Oromia, in collaboration with EHNRI, Regional Reference

Laboratories and other in-country partners. Activities include training laboratory and clinical health facility

personnel; carrying out a laboratory baseline survey assessing health facility laboratory capacity;

developing, piloting and establishing a malaria diagnosis QA/QC system as well as monitoring anti-malarial

drug efficacy in selected sites. Inasmuch as possible activities under PMI support will be building onto

systems developed by PEPFAR support for HIV and to a lesser extent TB; note, because of different at risk

populations, most PEPFAR laboratory support has focused on hospitals, whereas the malaria activities will

focus on health centers and health posts, extending quality laboratory support to those levels. The currently

proposed PMI support will, however, not be sufficient to address the biological interactions between HIV

and malaria or maximize the integration of malaria laboratory diagnosis activities into existing laboratory

activities for HIV and TB.

In COP09, PMI funds will be leveraged to strengthen integrated laboratory diagnostic activities especially at

health center levels. For that reason, PEPFAR and PMI will work together to integrate efforts on supporting

laboratory diagnostics. This activity will help link these resources (e.g. laboratory curriculum and SOPs;

QA/QC systems and supervision) to malaria laboratory diagnosis activities, thereby maximizing the U.S

government investment under both Presidential initiatives.

Expected results

•Increased proportion of government health center facilities capable of laboratory diagnosis of malaria and

Malaria diagnosis in HIV patients

•Health workers trained in laboratory diagnostics (RDTs and microscopy and Malaria/HIV diagnosis);

Activity Narrative: •Increased proportion of malaria cases confirmed with laboratory diagnostics in HIV positive patients.

New/Continuing Activity: New Activity

Continuing Activity:

Table 3.3.16: