Summary

This activity has split funding and is the same activity as HTXS ID # 21082

Background

Malawi is striving to increase the number of children who access life-saving ART services from the current

8% of all who ever started ART to 10-15% by 2010. The Early Infant Diagnosis (EID) Program is a

demonstration project aimed at decreasing mortality and morbidity of HIV-infected infants by early

identification and referral for care and treatment. Previously in Malawi, HIV-exposed children born to HIV-

infected mothers could not be reliably diagnosed as HIV infected until the age of 18 months. Without proper

care and treatment, greater than 50% of infants who are HIV infected through MTCT would die before the

age of two.

Under the leadership of the Head of the HIV Unit of the MoH, a consortium comprising the USG, Baylor

College of Medicine, Taiwan Mission, Clinton Foundation, University of North Carolina (UNC), UNICEF, and

WHO was established. The consortium was tasked with developing a one-year demonstration project that

will provide the foundation for the Malawi national scale-up plan for pediatric ART care and treatment. The

USG's specific role in the consortium was to provide leadership and direction, recruit critical staff, provide

training on DBS collection, storage and shipment, provide start-up equipment, train laboratory staff, and

establish a quality assurance program. Other partners provide complementary support such as clinical care,

reagents and supplies, and support for a courier system to collect samples and return results.

To date, the EID Program has established diagnostic capability for children and referral networks for care

and treatment services in the Central and Northern regions which are now operational. Two major sites at

Lilongwe (central) and Mzuzu (north) have become the diagnostic hubs that each supports 7 satellite clinics.

In December 2005, 1,999 children aged 12 years and below were on ART, representing less than 5% of all

patients on ART in Malawi. However, it is estimated that children represent up to 14% of HIV-infected

individuals requiring ART. Ten Laboratory Technicians from Lilongwe and Mzuzu were trained on

Laboratory diagnosis of HIV infection in infants from Dried Blood Spots (DBS) using DNA PCR. Following

the training, 7 lab techs have performed tests successfully using proficiency panels and been certified to

perform DNA PCR testing. As of July 31, 2007, 577 children had been enrolled in the pilot program from 13

health facilities. Among them, 346 test results had been entered into the database and are available to be

entered into the quarterly reporting system. Among the 346 infants that DNA PCR results were available, 64

(18%) were HIV-positive and some have been referred to ART clinics for further evaluation and possible

inclusion in ART. As of August 31st, 2007 809 infant DBS specimens had been tested and children referred

to treatment.

The DBS samples have been tested on infants from 6 weeks to 18 months of age at the two major testing

hubs Mzuzu and Kamuzu Central Hospital Laboratories. With assistance from the EID M&E officer, a

comprehensive quality assurance program has been put in place to manage quality control, proficiency

testing, inventory, specimen management, standard operating procedures, and documentation of lab

results. In the first 2 months of the reporting period a total of 146 infants received single dose NVP within

72 hours and 8% had a positive DNA PCR result. At the same time, 31 children did not receive single dose

NVP and 23% had a positive DNA PCR result.

In FY 2008, HUTAP will use Emergency Plan (EP) funds to continue supporting the expansion and

sustainability of the Ministry of Health (MoH) EID program in the following areas: 1. Laboratory capacity

building; 2. Human capacity building and training; 3. Uninterrupted flow of laboratory supplies and reagents;

4. QA/QC systems and 5. Service contracts for essential laboratory equipment.

Activities under this program area are linked to the laboratory infrastructure program area.

Activity 1: In-Service Training

In-service trainings will be conducted at all the laboratories providing EID. This will not only be restricted to

DNA PCR, but technicians will also be trained in CD4 and CD4% enumeration, chemistries, hematology,

and the diagnosis of common infections including opportunistic infections. The training will be aimed at

building the capacity of lab staff to provide support for other HIV services such as PMTCT and ART

treatment while maintaining quality standards. This activity will build on HUTAP's existing training activities

for strengthening the capacity of laboratory personnel.

During FY 2008, Emergency Plan (EP) funds will be allocated for the expansion of EID services to the

Southern Region of Malawi. Queen Elizabeth Hospital is proposed to become the third major testing hub

for HIV Infant Diagnosis. HUTAP will provide the training support and assist with the establishment of a

Quality Assurance Program for this region.

Activity 2: Procurement of Reagents and Supplies, and Provision of Service Contracts for Equipment

HUTAP, in collaboration with CDC, UNICEF, and the Clinton Foundation will continue to support the MoH in

building the capacity of laboratories to provide testing services for HIV diagnosis and disease monitoring.

Reagents and other consumables will be procured through HUTAP and the Clinton Foundation to

supplement orders currently procured by the MoH through the Global fund and SWAp common fund.

Activity 3: Coordination of Diagnostic Testing and Referral Networks

This activity will focus on strengthening the laboratory infrastructure at EID sites as entry points for quality

laboratory testing that would support all HIV/AIDS-related treatment and care. Currently, several of the

sites are linked to PMTCT and ARV programs at district hospitals and rural health centers in the central and

northern regions. Currently the program is relying completely on a local courier service to transport

specimens for PCR, CD4, and Hematology and Chemistry testing due to the limited capacity for these

referral sites to provide routine, consistent testing services. HUTAP will assist the MoH in building the

capacity of the district hospital laboratories/EMLS to carry out routine hematological, chemistry and CD4

testing; develop SOPs; implement quality assurance programs; and improve the laboratory infrastructure

Activity Narrative: where appropriate. HUTAP will assist the MoH in strengthening the referral system for sites that may not

have the full complement of laboratory capabilities.

Activity 4: Human Resources Support

During FY 2008, HUTAP will continue to build laboratory capacity for EID services through hiring technical

and management staff. Through existing funding, HUTAP hired a Program Manager for the EID program, a

Laboratory Coordinator and three Laboratory Technicians. New funds will be used to retain the current

staffing and fill human resource gaps at other sites where required.

HUTAP will accelerate the implementation of its activity plan to support the rapid scale-up of the ARV

program. In doing so, HUTAP will increase the number of testing sites with diagnostic capability for early

infant diagnosis, PMTCT and disease monitoring; increase the capacity of tests performed at major testing

sites through the placement of trained lab technicians, functioning equipment with backup service and a

consistent supply of reagents; and solid performance in quality assurance programs for HIV, CD4, and PCR

testing.

Summary

This activity has split funding with activity ID#20183 and share identical narratives.

Beginning in 2008, HUTAP will request Emergency Plan (EP) funding to retain employees that oversee

activities at the HIV Reference Laboratory and for the Pediatric HIV Diagnosis program. In addition, HUTAP

is proposing a five-year laboratory infrastructure support plan with EP funding to: (1) update pre-service

training curricula that target HIV diagnosis, disease monitoring and opportunistic infections diagnosis; (2)

train trainers and clinical instructors on new HIV curriculum content, educational methodology and

curriculum implementation; (3) conduct in-service-training in management, HIV diagnosis, and disease

monitoring for lab technicians at service delivery sites; (4) support or create Laboratory Centers of

Excellence at key high throughput service-delivery sites for HIV testing and patient monitoring; (5) bridge

human resource gaps through recruitment and hiring of senior level laboratory personnel, and (6) continue

to support the HIV epidemiologist that is implementing the HIV Surveillance activities, including ARV Drug

Resistance and Monitoring, and HIV Behavioral Surveillance studies.

Background

For the previous four years, Howard University has provided technical assistance (TA) to Malawi with a

focus on strengthening laboratory testing capacity for HIV/AIDS services. Until March 2007, the program

received its funding through a cooperative agreement with USG through the CDC-GAP University Technical

Assistance Program (UTAP). Through this program Howard University Technical Assistance Program

(HUTAP) provided support to two pre-service laboratory training institutions which together now graduate as

many as 80 laboratory technicians a year.

In FY 2007, HUTAP expanded its assistance to Malawi through a subcontract with the MoH. An

epidemiologist, a laboratory manager, and a laboratory supervisor were hired and placed at the

Epidemiology Unit and the National HIV Reference laboratory, CHSU. Also, through an existing funding

mechanism, a project manager, laboratory coordinator, and three laboratory technicians were hired for the

scale-up of the pediatric HIV diagnosis and referral network under the MoH.

HUTAP will continue its strategy to improve laboratory services in Malawi through the following activities:

Activity 1: Conduct In-Service-Trainings

HUTAP will build the capacity of laboratory staff in HIV diagnosis and disease monitoring, lab safety, and

management through in-service training. HIV testing workshops will be conducted to cover topics such as

HIV Rapid Testing, ELISA, Flow Cytometry and CD4 enumeration, PCR, and OI diagnosis. This activity will

target laboratory technicians who are working at HUTAP supported laboratories and from other laboratories

linked to HIV service delivery sites. The new funding will allow HUTAP to build on its achievements in FY

2007 where 82 lab technicians received knowledge and skills updates in Infection Prevention/Lab Safety,

HIV testing including CD4 and PCR, Lab Management, and Effective Teaching Skills.

Activity 2: Strengthen and update laboratory pre-service curriculum in HIV diagnosis, disease monitoring,

and opportunistic infections (OI)

In 2005, HUTAP along with a core team of laboratory tutors, technicians, and curriculum development

experts, developed an HIV testing pre-service learning package. The competency-based curriculum was

designed to address gaps that were identified in the HIV content in the pre-service curriculum. The core

competencies (HIV testing, Lab Management, Safety and Ethics) were integrated into existing courses in

which the content was taught.

With new funding, the learning package will be expanded to include theoretical and hands-on applications

along with reference materials and assessment tools for CD4, PCR, and OIs . HUTAP will continue to

procure the necessary equipment and supplies to support the practical training component. Prior to the

implementation of the updated curriculum, HUTAP will conduct a training of trainers and clinical instructors

on new HIV curriculum content, educational methodology and curricular implementation.

Activity 3: Employ High-level Managerial and Lab Technical Staff

An HIV epidemiologist, HIV reference laboratory manager, and supervisor were hired through a MoH/CDC

subcontract in an effort to strengthen the National HIV/AIDS Reference Laboratory at CHSU under the

MoH. Through the existing contract, they will continue to provide adequate management and supervision of

the HIV reference lab and HIV surveillance activities, and assist in the development and implementation of

the national quality assurance programs for HIV testing.

Through the previous CDC-UTAP COAG, HUTAP has hired two laboratory tutors at the Malawi College of

Health Sciences to assist with the implementation of the HIV pre-service curriculum and to provide

supervision and training of students at designated clinical training sites. Through this funding mechanism,

HUTAP also recruited three lab technicians, one laboratory coordinator, and one Project Manager to assist

the MoH with the scale-up of the pediatric treatment and care program. This one year demonstration project

will advise the Malawi national scale-up plan for pediatric ART care and treatment.

HUTAP will request EP funds to extend these positions through FY 2009 based on results from program

assessments and staffing needs. Where vacancies exist, HUTAP in collaboration with the MoH and USG,

will recruit personnel from sub-Saharan region, including Malawi, to fill the positions.

Activity 4: Implement and Monitor QA programs for HIV-related Testing

Using FY 2008 Emergency Plan (EP) funds, HUTAP will increase the capacity at government and mission

hospital laboratories to carry out quality HIV diagnosis and disease monitoring by establishing national

quality assurance programs for HIV, CD4, and PCR testing.

Activity 5: Provide Mentoring and Training for Laboratory Supervisors

Activity Narrative:

HUTAP will provide training and mentorship to laboratory supervisors and managers from central and

district hospitals. Through this training and mentorship, supervisors will be able to manage the laboratory

more efficiently and to assure accuracy and quality in testing results. Supervisors will be trained to oversee

quality assurance programs instituted for HIV testing. This will be a collaborative effort between HUTAP and

the EMLS-MoH since the EMLS is mandated to provide management/supervision and training to laboratory

staff in the district hospitals.

Activity 6: Refurbish Laboratories at Central and District Hospitals

During FY 2008, HUTAP will complete the refurbishment of the Malamulo Hospital laboratories with EP

funding. All laboratories will be supplied with high quality laboratory furnishing, equipment, supplies, and

reagents. Service contracts will be provided for all major equipment. HUTAP will provide support to

laboratories that presently have the greatest capacity to carry out quality testing including trained staff,

supervisory structure, and those that will participate in the national quality assurance program. These

laboratories are closely linked to ARV and PMTCT service delivery.

Activity 7: Support or build laboratory Centers of Excellence (COE)

HUTAP will target the following sites as COEs: Kamuzu Central Hospital - KCH, Mzuzu Central Hospital,

Thyolo District Hospital, Queen Elizabeth Central Hospital (QECH), Malamulo Mission Hospital, and

Mzimba District Hospital. These sites will provide HIV testing services and will be linked to ARV and PMTCT

referral sites. All laboratories will be refurbished by HUTAP in partnership with the MoH through the Sector

Wide Approach (SWAp). Though USG funds are not pooled in Malawi, USG partakes in the Program of

Work for the MoH by supporting earmarked activities in the SWAp plan. Critical equipment will be

upgraded, training provided, and systems for ensuring consistent stock of reagents and supplies will be

established. They will be enrolled in national and international QA programs.

Summary

The USG Malawi team in partnership with a consortium that includes Baylor College of Medicine, UNC,

UNICEF, Taiwan Medical Mission, Clinton Foundation, and the Ministry of Health (MoH) supports the early

infant diagnosis (using DNA PCR) and referral program. The USG Malawi team has an active presence in

two of the four referral hospitals in the country and plans to expand to a third hospital in FY 2008. As part of

the staging process for positive infants, the GoM requires CD4% enumeration where this is possible. A high

throughput Beckman Coulter Epics CD4 enumeration machine already exists at Mzuzu hospital in the

northern region. The USG Malawi team will procure two additional high throughput CD4 enumeration

machines for the central and northern regional hospitals.

Background

In Malawi only 1% of individuals currently on ART treatment are referred from the PMTCT services. This is

primarily because the national guidance was based on clinical staging and a reduced emphasis on CD4

enumeration. In a study conducted by UNC and other partners in Malawi it was demonstrated that as much

as 25% of pregnant women who are eligible for ART treatment were missed because they did not have

access to CD4 enumeration. Enrolling these women into treatment programs would not only save their lives

but would also reduce greatly transmission of HIV from mothers to their infants. The GoM through funds

from UNITAID has agreed to the procurement and installation of CD4 enumeration capability in each of the

28 district hospitals in the country. This does not however include the four referral hospitals in the country.

Activity 1: Procurement of CD4 Machines

In FY 2007 the USG-Malawi team used end-of-year funds to procure two Beckman Coulter Epics equipment

for CD4 enumeration. Each of the new machines has a two year service contract. The contract covers

preventive maintenance, equipment, and call-out service visits. The equipment will be installed and

commissioned in FY 2008 at the Kamuzu Central Hospital in Lilongwe and the Queen Elizabeth Hospital in

Blantyre. All necessary reagents and supplies for the four referral hospitals are provided by the Clinton

Foundation.

Activity 2: Conducting Training and Tests

Key laboratory staff to provide the testing services have been recruited and trained by the USG partner

Howard University (see Howard ID#10749). Reagents for performing 10,000 tests a year have been

provided by the Clinton Foundation. The new staff will mentor and train their MoH counterparts.

This activity has split funding and is the same activity narartive as HVSI#21084.

Summary

Activities under this program area include planning, designing, and coordinating all HIV activities within the

Ministry of Health's (MoH) Epidemiology unit, including HIV Drug Resistance surveillance, and Integrated

Disease Surveillance. Other activities involve the development of lab protocols and coordination of data

collection and data entry; the analysis and interpretation of data; and the dissemination of findings.

Background

Howard University was funded by USG to strengthen the HIV testing capacity in Malawi through pre-service

and in-service training. The funds were used to strengthen the knowledge and skills of laboratory tutors and

clinical instructors in HIV testing through workshops and practical training. In FY 2007, Howard University

updated and strengthened the laboratory science curriculum in HIV testing, Laboratory Management,

Quality Assurance, Ethics, and Laboratory Safety. Laboratories were refurbished, supplies and equipment

were purchased, and HIV testing standards to improve the quality of testing and training at the clinical

training site were implemented. The project utilized regional and local contractors to assist with project

implementation. All of this work was done in collaboration with the MoH, USG and other donor partners. It

was based on a needs assessment that identified the training needs and resources required to build the

capacity for HIV testing training at Malamulo and Malawi College of Health Sciences, and to prepare

laboratory technicians working in government and private laboratories for expanded roles in HIV/AIDS

testing.

Our efforts strengthened the laboratory infrastructure to support HIV diagnosis, monitoring of treatment

effectiveness and surveillance. Since much of the equipment was outdated or malfunctioning, supplies and

reagents were in short supply, and there was a great need to upgrade the knowledge and skills of

laboratory personnel, HUTAP addressed critical needs for building the laboratory infrastructure in Malawi.

HUTAP supported the MoH in addressing the shortage of laboratory personnel through recruiting and hiring

laboratory technicians, lab supervisors a laboratory manager, and lecturers for the laboratory training

schools. These efforts have assisted in building the capacity of Malawians to conduct laboratory testing in

support of the scale-up of the antiretroviral therapy program.

In FY 2007, through a sub-contractual agreement with the MoH, HUTAP employed a Senior HIV

Epidemiologist to assist in the implementation and management of HIV/AIDS surveillance activities within

the Epidemiology Unit at the Community Health Sciences Unit (CHSU) in the MoH. The hiring of an HIV

epidemiologist has contributed greatly to the commencement of activities for the national HIV

epidemiological surveillance system in the MoH. Through the guidance and supervision of the HIV

epidemiologist, several achievements have been made in this program area. For example, in only 19

antenatal clinics was surveillance conducted since 1994. During FY 2007, the number of sites increased to

53 and now covers 26 districts through USG funding. Over 50 individuals including lab technicians and

nurses have received training in surveillance procedures, documentation, and in the collection and

processing of blood samples.

With FY 2008 funds, HUTAP will continue to support the Epidemiologist within CHSU's Epidemiology Unit,

thus the following activity narratives are directly related to CHSU's SI narrative.

Activity 1: HIV Drug Resistance Surveillance

With FY 2008 EP funding, HUTAP will support the HIV Epidemiologist position in the MoH. More

specifically, the epidemiologist will play a critical role in HIV Drug Resistance (HIVDR) Monitoring, including

in FY 2007 the HIVDR Threshold Survey to look at the transmission of HIVDR; generation of early warning

indicator reports to monitor programmatic factors that have been linked to the development of HIVDR; and

the HIVDR Retrospective Monitoring Survey to look at the development of drug resistance in patients that

have been on treatment for one year.

With FY 2008 funds, HUTAP will support the Epidemiologist within the CHSU Epidemiology Unit to

implement the prospective HIVDR monitoring survey with the support of PEPFAR funds Funding from the

USG will support the site training, site preparation and supervision. The activity develops local capacity

through training site members in surveillance methodology and specifically the implementation of the

monitoring survey. Four sites are selected to serve as sentinel sites for Malawi in Mzuzu, Lilongwe,

Blantyre and Thyolo. CHSU will mobilize other funding to support the generation of the Early Warning

Indicator (EWI) report, and the next threshold survey will occur in FY 2009.

Activity 2: Techncial Assistance for Data Analysis, Interpretation, and Use

The Epidemiologist will help develop protocols; coordinate data collection, data entry and data analysis; will

disseminate findings and respond to the MoH and other key stakeholders. The epidemiologist will take part

in HIV surveillance activities, including an inpatient survey for HIV cases, and interpret findings for program

planning. The epidemiologist will actively participate in data triangulation activities that are coordinated by

NAC.