Summary

In FY 2008 CHSU will focus on a expanding a refresher supervisory training course for Quality Assurance

and Referral Laboratories (QARL), provide national quality assurance including external quality assurance

for all diagnostics and patient monitoring associated with HIV/AIDS, conduct additional quality assessments

at HIV/AIDS service provision sites, support the ART drug resistance surveillance, and provide

infrastructure improvements at the national reference laboratory.

Background

The Ministry of Health (MoH) has the sole responsibility to provide centralized HIV reference-laboratory

services through the National HIV Reference Laboratory (NHRL). The NHRL, a component of the

Community Health Sciences Unit (CHSU) has been responsible for comprehensive reference functions

including quality assurance for all testing including HIV diagnosis and monitoring, the evaluation of new

testing materials, the development of standard operating procedures, training and certification of HIV test

providers, as well as the national field supervision of laboratory service providers. Also CHSU is responsible

for providing refresher supervision training for QARL technicians.

The MoH financially supports CHSU with all of its day to day administrative costs. PEPFAR funds in the

past have supported laboratory infrastructure improvements, HIV surveillance including ARV drug

resistance, training, and quality assurance for HIV testing. Through the Howard University Technical

Assistance Program (HUTAP), PEPFAR funds have been used to recruit, place, and support critical staff at

the NHRL.

Limitations of the physical infrastructure at CHSU, lack of the appropriate complement of equipment,

shortage of staff, and inadequate transportation were a major impediment to the full utilization of the NHRL

at CHSU. In spite of those constraints, in FY 2007 all laboratory staff involved in HIV and STI surveillance,

including ARV drug monitoring and threshold surveys were trained as part of implementation of specific

surveillance programs or activities using FY 2006 Emergency Plan (EP) funds. CHSU provided quality

assurance support to more than 300 VCT coordinators, counselors, and other health staff in 27 districts.

CHSU evaluated several HIV rapid tests and was able to use the data to advise the MoH on the transition

from parallel testing to serial testing with tremendous savings to the GoM.

Activity 1: Conduct Refresher Supervision Training for QARL Technicians

Three consecutive EQA program supervision reports between Nov 2006 and May 2007 have detailed the

fragility of the EQA program in absence of orientation of all VCT coordinators and other health staff in 27

districts to ensure standardization and consistency in the implementation of the national EQA program. In

addition, the arrival of new technicians and rotation of existing ones in most Quality Assurance Referral

Laboratories (QARLs) necessitates refresher training to enhance supervision skills for the HIV EQA

activities in general. The refresher training provides an opportunity to introduce changes in national HIV

testing algorithms and to train the staff for biosafety and specimen management (collection, storage,

packaging, and transportation) for existing technicians and other relevant support staff at the QARLs.

Technicians are medical technicians working in medical hospitals (both Government and private), district

hospitals, and three Christian Health Association of Malawi (CHAM) hospitals.

Since it is difficult for a government institution (MoH) to supervise CHAM and vise versa, CHSU provides

oversight to supervisors who manage their own sites. Refresher training for QARL technicians is an on-

going activity supported with EP funds. In order to ensure sustainability, DHOs are contributing to and

incorporating these activities into their budgets.

Activity 2: Provide National Quality Assurance for all Surveillance and Laboratory-based Activities in

Support of the Diagnosis, Treatment, and Care of HIV/AIDS

The national external quality assurance (EQA) program is in its infancy and thus fragile. Many districts have

started including key activities in their district implementation plans. However, it is still necessary for CHSU

to provide strong leadership, through provision of technical advice, supervision, and logistics, on a quarterly

basis until a significant number of districts truly can continue without this intensive probing by CHSU.

Intensity of involvement will vary according to supervision/surveillance activity.

This quality assurance activity feeds back into the QARL. In activity one, the target population were the

medical technicians. This target population includes everyone involved in HIV/AIDS testing, including

district HIV/AIDS coordinators, counselors, health surveillance assistants, and national supervisors. Special

populations such as those in the prison service, defense forces, police, etc. are being targeted. Quality

assurance programs need to be in place in order to ensure that these disparate populations are receiving

quality HTC services.

This is an on-going activity supported by the EP. These national quality assurance activities also are

supported by MACRO international, MSF, NAC, and wrap around Child Survival funds to USAID.

Activity 3: Conducting Additional Quality Standards Evaluations

Since technology is constantly changing, it is important to remain knowledgeable of revised test kits and

new laboratory methodologies, HIV testing algorithms, and procedures. As technology changes, CHSU will

conduct additional quality standard evaluations to ensure that new procedures adhere to best practices.

This is an on-going PEPFAR activity. New funding will be used to support the multiple stages of evaluations

including field use of test kits.

Activity 4: Support the ART Drug Resistance Survey

In FY 2007 with EP funding, the NHRL conducted a successful ART drug resistance threshold survey. Data

from that survey indicated a <5% resistance in drug naive populations. A similar retrospective survey of

drug resistance was conducted in populations who have been on treatment for 1 year. This also showed a

<5% prevalence. With FY 2008 funding, the NHRL will continue to conduct threshold surveys as well as

Activity Narrative: prospective surveys.

Activity 5: Physical modifications to Existing Laboratory Facilities at CHSU to Meet Appropriate Technical

and Security Requirements for the Proper Functioning of a National HIV Reference Laboratory in Malawi.

Renovating HIV laboratories is essential in order to keep up with the demand for and complexity of

HIV/AIDS testing services. In FY 2006, benches and shelves were installed but more work needs to be

done. Floor tiles will be fixed, hoods will be replaced, safety cabinets installed, ceilings repaired, and an air

conditioning system installed. Also there is a need to maintain communication infrastructures, including the

installation of telephone lines, internet services, and new computers that can be hooked to modern

equipment (e.g. CD4 testing machines). Finally, issues of lab security including restricted access will be

addressed.

Summary

This activity will provide support for 1) HIV Drug Resistance (HIVDR) monitoring; 2) Inpatient AIDS Case

Surveillance; and 3) Information Dissemination on surveillance and reference activities. The emphasis

areas for this activity are: Human Capacity Development, Local Organization Capacity Building and

Strategic Information. The primary target populations are adults.

Background

The Government of Malawi (GoM), through the MoH, mandates that the Community Health Sciences Unit

(CHSU) develop local capacity for HIV reference laboratory functions, HIV surveillance, HIV information

management, and quality assured HIV counseling and testing to support diagnosis, care and treatment of

those infected with HIV and related illnesses. CHSU will continue to implement these functions in FY 2008

with USG support, through the Epidemiology Unit and the Public Health Reference Laboratory (PHL),

specifically the national HIV Reference Laboratory (NHRL).

Since 2001, the Epidemiology Unit has conducted semi-annual antenatal HIV sentinel surveillance at 19

sentinel sites, increasing to 52 sites in 26 districts in 2007. The unit will continue to coordinate the national

ARV drug resistance monitoring program every year. In FY 2008, the unit plans to conduct HIV prevalence

survey amongst in-patients and a HIV threshold survey. These functions are part of ongoing, routine

disease-surveillance and will continue in alternate years from 2008. The unit, through the Computer Lab will

continue to provide training in data analysis for all MoH staff.

With previous USG support, CHSU has led the implementation of the HIVDR Threshold Survey, generation

of the HIVDR early warning indicator report, and supported site preparations for HIVDR prospective

monitoring survey

Because of the cost of implementing HIVDR activities, many USG partners are supporting various aspects

of the FY2008 HIVDR prospective monitoring survey, including shipping and testing of samples. Also,

these surveillance activities benefit from the USG investment in the HIV national reference lab infrastructure

through USG expertise and resources. Finally, information from these HIV surveillance activities provides

important information for program planning in the areas of HIV treatment, care, and support.

Activity 1: HIV Drug Resistance Monitoring

In FY 2007, the HIV drug resistance (HIVDR) task force (TF) began implementing a three prong approach

for HIVDR monitoring in Malawi, 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. The first two of

these activities received direct technical and financial support from PEPFAR. Under the guidance of the

HIVDR Task Force, the CHSU Epidemiology Unit has been the primary implementer of these activities.

In FY 2008, the CHSU Epidemiology Unit plans 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 by 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 leverage non-USG funding to support the

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

Activity 2: In-patient HIV Case Monitoring

Currently, the CHSU Epidemiology Unit passively collects information on new AIDS cases observed in a

sample of hospitals and clinics. Many patients are never tested for HIV, rendering this method deeply

flawed in terms of understanding the burden that HIV/AIDS places on these facilities. Both CHSU and the

MoH HIV Unit value information on the impact of AIDS on health facilities, and how this burden fluctuates as

a function of the overall national response. Therefore, beginning in FY 2008, CHSU will implement a week

long opt-out HIV testing at general (non-disease specific) inpatient wards at select sentinel sites annually in

order to monitor trends in HIV infection and potential AIDS case burden at health facilities. In order to

ensure this event's success and sustainability, CHSU will implement this activity the week after the national

HIV testing week, during which there are many mass media campaigns on the importance of HIV testing.

USG FY 2008 funding will support continued HIVDR surveillance activities at sentinel sites to inform the

national ART program on patient sensitivities to the current treatment regimen. The STI and inpatient HIV

surveillance activities will inform the ART program and MoH of the general burden of disease which will

facilitate improved planning and forecasting.

Activity 3: Dissemination of Results

CHSU will use the three day workshop to get summary reports from HIV reference and HIV surveillance

activities so that all participants from both arms of the program have a clear understanding of the program,

and can produce one comprehensive report suitable for publication and dissemination. This activity has

been done informally in the past, but CHSU, under the leadership of the Deputy Director of Preventive

Health Services, will formalize this process and repeat it annually beginning in FY 2008. This first workshop

will be attended by members of the CHSU HIV reference lab and Epidemiology Unit, as well as

representatives of various partner organizations that provide external technical support.

Insufficient direct funding to CHSU will not allow translation of the report into ChiChewa. Therefore CHSU

will work with other partners, most especially NAC, to translate and disseminate these results. CHSU will

also take advantage of the existing bulletins and newsletter and annual conferences organized by NAC and

internationally to disseminate the results.