Treatment of Aids

TREATMENT OF AIDS

THE 2 YEAR PLAN TO SCALE UP

ANTIRETROVIRAL THERAPY

IN MALAWI

2004 – 2005

February 2004

Ministry of Health and Population, Malawi

ACKNOWLEDGEMENTS

The Ministry of Health gratefully acknowledge the help and assistance of the following people, who under the chairmanship of Dr. Edwin Libamba, were responsible for the ARV Scale Up Plan. Their names in alphabetical order are:-

Dr. William Aldis Dr. A Chitsa Banda Mr. Matt Boxhall Mr. Rhehab Chimzizi Mr. Henry Damisoni Prof Anthony Harries Dr. Vachagan Harutyunyan Ms. Jannie Herrington Dr. Mina Hosseinipour Dr. Perry Jansen Dr. Arno Jeannin Dr. Athanase Kiromera Dr. Edwin Libamba Mr. Simon Makombe Dr. Rex Mpazanje Dr. Andrina Mwansambo Dr. Henry Neufville Dr. Florian Neuhann Dr. Didakus Odhiambo Oda Dr. Erik Schouten Dr. Eliab Some Dr. Roger Teck Dr. Ralph Weigel Prof Ed Zijlstra

CONTENTS Page

Executive Summary 5

Introduction 7

Section 1: General Strategy:

1.1. Framework for antiretroviral therapy 8 1.1. 1. Goal 8 1.1.2. Objectives and targets 8 1.1.3. Strategy 8 1.1.4. ARV Policy package 9 1.1.5. Key Operations 9 1.1.6. Indicators to measure progress with ARV delivery 10

1.2. The Rationale for rapid scale-up of ARV therapy 11 1.1.1. Phase 1 rapid scale up of ARV therapy 11 1.1.2. Rationale for Phase 1 rapid scale up 11

1.3. Scaling up ARV therapy: 12 1.3.1. Current Goal 12 1.3.2. Policy 12 1.3.3. Institutions to deliver HAART 15 1.3.4. Current progress up to January 1st 2004 15

Section 2: Operational Plan: The First Year 2004

2.1. National Level 16 2.1.1. First three months (Jan – Mar) 16 2.1.1.1.Country-wide rapid situational assessment 16 2.1.1.2.Assessment of number of patients treated with HAART 17 2.1.1.3.Assessment of ARV drug quantification, costs and specification 17 2.1.1.4.ARV Monitoring tools 19 2.1.1.5.Training modules and Preparedness criteria 19 2.1.1.6.Strengthened HIV/AIDS Unit 20 2.1.1.7.Improved HIV/AIDS care management and coordination 20 2.1.1.8.Meetings of preparedness for ARV delivery 21 2.1.1.9.Campaign to inform the general public 21 2.1.1.10. Patient education 21 2.1.1.11. Procurement, distribution and security of ARV drugs 21 2.1.1.12. Budget development and financing mechanisms 22 2.1.1.13. Summary: activities to be completed by end March 22 4

CONTENTS (continued)

2.1.2. Next three months (Apr – Jun) 23 2.1.2.1.Training 23 2.1.2.2.VCT site and ARV clinic preparedness 23 2.1.2.3.Supervision and mentorship 24 2.1.2.4.Monitoring and Evaluation 24 2.1.2.5.Operational Research 24 2.1.2.6.Summary: Activities to be completed by end June 25 2.1.3. Next three months (Jul – Sep) 25 2.1.3.1.Hospitals assessed as being ready for ARV delivery 25 2.1.3.2.Hospital implementation of ARV delivery 25 2.1.3.3.Hospital site visitation 25 2.1.4. Next three months (Oct – Dec) 26 2.1.4.1.Implementation of ARV delivery 26 2.1.4.2.Monitoring and evaluation 26 2.1.4.3.Supervision 26 2.1.5. The first year 2004 (summary) 26

2.2. Central, district and mission hospital level 27 2.2.1. First three months (Jan – Mar) 27 2.2.1.1. Hospital HIV/AIDS care team 27 2.2.1.2. VCT systems in place 27 2.2.1.3. Systems in place for providing ARV treatment 27 2.2.1.4. Staff identified who will provide the ARV service 27 2.2.2. Next three months (Apr – Jun) 28 2.2.3. Next six months (Jul – Dec ) 28

Section 3: Operational Plan: The Second Year 2005

3.1. National level 29 3.2. Central, district and mission hospital level 29

Section 4: Appendices (1 – 9) 30 5

EXECUTIVE SUMMARY

The AIDS epidemic in Malawi is of such a magnitude and such a threat to economic and social stability that the country is proposing a bold and ambitious scale up plan. Malawi’s current “aspirational” goal is to deliver HAART to 80,000 eligible patients by the end of 2005.

The Policy: Phase 1 rapid scale up of ARV therapy

Malawi will from January 2004 start the process of delivering HAART to all eligible HIV-positive patients in the country. Between July and December 2004, 50 central, district, mission and Defence Force hospitals in the public health sector will start to deliver ARV therapy provided they are assessed as ready for implementation. There may be another 28 hospitals in the public health sector and in the private sector that can also deliver ARV therapy during this time. This is called the Phase 1 rapid scale up of ARV therapy. Once hospitals have satisfactorily demonstrated capacity to deliver Phase 1 ARV therapy, they will be encouraged to move to Phase 2 ARV scale up (ie, full adoption of Malawi ARV Treatment Guidelines using first line, alternative first line and second line therapy)

There are three essential pre-requisites for the Phase 1 rapid scale up: • Simplification of the ARV delivery system using first line ARV regimen only • Hospitals demonstrating and assessed as being ready to start ARV therapy • Adequate supplies of HIV test kits and ARV drugs

There are three possible constraints to such rapid scale up: • Capacity of the health sector to deliver ARV therapy • Capacity of CMS and UNICEF to procure and distribute ARV drugs • Patient demand for HIV testing and ARV therapy

The risks to Phase 1 rapid scale up of ARV therapy include a) drug security issues, b) drug adherence and risk of ARV drug resistance, c) impact on the health sector, d) equitable access to ARV therapy, e) overdue attention to care at the expense of prevention.

The estimated number of patients treated by HAART and the costs:

If the scale up involves just the 50 public health sector hospitals, there will be an estimated 34,500 patients on HAART by the end of June 2005

If the scale up involves all the other 28 delivery sites, there will be an estimated 44,100 patients on HAART by the end of June 2005.

If all 78 hospitals delivered HAART from July 2004, the cumulative number of patient-months on therapy (excluding deaths and withdrawels) is 319,650. The estimated cost of first line therapy is USD$21.3 per patient month (this includes CIF and procurement fee). The total cost for the first year – July 2004 to June 2005 – is estimated at USD$8,032,330, which includes a buffer stock. Global Fund allocations during this time for ARV drugs are USD$9,555,000. 6

The Operational Plan

The plan is detailed for the first year, and is divided into three-month sections.

In the first three months between January to March, there will be:

• A country-wide situational assessment in the public and private sector • An estimate of the number of patients who will access HAART in the first year • An assessment of the number of ARV drugs required, costs, and specification • ARV monitoring tools in use in hospitals providing ARV therapy • Development of Training modules, in-service training modalities and preparedness criteria for delivery of ARV therapy • A strengthened HIV/AIDS Unit in MOHP • Improved HIV/AIDS care management and coordination • Meetings to inform the health sector and development agencies about ARV scale up and preparedness for ARV delivery • Start of a campaign to inform the general public about ARV scale up • Development and production of materials for patient education about ARV delivery • A procurement, distribution and security plan for ARV drugs • Development of a budget for the 2 year plan and mechanisms for funding

In the second three month between April to June, there will be:

• Training of staff in the 50 hospitals in the country. Other hospitals including the private sector may also have had their staff trained. • Implementation of preparedness for VCT and ARV in the 50 hospitals in the country with support and supervision from supervisory teams • Preparations made with the TB programme to develop the systems and modalities for monitoring and evaluating ARV delivery. In addition, HMIS will have additional ARV indicators and the HIV/AIDS unit will have worked out how to collate, analyse and disseminate the country-wide data • Development of systems for managing operational research

In the six month period from July to December, the following activities will occur:

• Assessment of hospitals as being ready to implement ARV delivery • Hospital implementation of ARV therapy to eligible patients • Hospitals visits from monitoring and supervisory teams • Regular monitoring and evaluation and reporting of ARV treatment

The second year is an extension of the ARV delivery plan, started in the first year.

INTRODUCTION

Malawi has one of the highest HIV/AIDS prevalence rates in the world, with 14% of those aged 15 – 49 years infected. The National AIDS Commission estimated that in 2003 there were about 900,000 adults and children living with HIV/AIDS in the country. HIV/AIDS is now the leading cause of death in the most productive age group, resulting in an estimated 86,000 adult and child deaths annually. The cumulative number of orphans and vulnerable children, directly related to the AIDS epidemic, is approximately 700,000.

AIDS currently kills young adults in their most productive years, depriving the country of the skills and knowledge base so essential to human and economic development. AIDS leaves countless numbers of grandparents to bring up children. Many orphans cannot attend school, they suffer from poverty and malnutrition and become sucked into a spiral of crime, violence and commercial sex. AIDS retards development and creates the foundations for political instability.

Highly active antiretroviral therapy (HAART) has dramatically improved the survival of patients living with HIV and AIDS in industrialised countries of the world. AIDS has been transformed from a fatal disease into a potentially treatable and chronic condition. In Malawi, it is estimated that 170,000 people may be in need of HAART. However, by January 2004, it was estimated in the five public health facility sites in the country already delivering HAART that under 4,000 eligible persons are currently on this medication. The need for a fast track approach to scaling up treatment is urgently needed.

Access to HAART is an important component of a strategy to support people living with HIV/AIDS as well as preventing transmission of infection. People may be more willing to undergo voluntary counselling and testing and disclose their HIV status if there is the possibility of getting effective treatment. By reducing viral load ARV drugs may from a biological view-point reduce the risk of sexual transmission. Sick people will be able to return to work. Parents will stay alive longer, thus delaying the time when children become orphans. The rate of mother-to-child-transmission will be reduced.

ARV drugs must be provided within a structured framework, “a public health approach”, if the full benefits to the individual are to be realised and drug resistance is to be minimised. Widespread, unregulated access to ARV drugs in Malawi could lead to the rapid emergence of resistant viral strains, spelling doom for the individual, curtailing future treatment options and leading to transmission of resistant virus. A structured framework is therefore essential. There has to be a system to ensure regular procurement and distribution, good patient management, monitoring and evaluation. The Malawi ARV Treatment Guidelines provide for such an approach. The time is now right to put the principles of ARV therapy into practice. 8

SECTION 1: GENERAL STRATEGY

1.1. FRAMEWORK FOR ANTIRETROVIRAL DRUG DELIVERY

This framework lays out the public health approach for the wide scale delivery of antiretroviral (ARV) drugs. The framework consists of the following:-

• Goal • Objectives and targets of ARV therapy • Strategy for ARV therapy • ARV Policy Package • Key operations involving ARV therapy • Indicators to measure progress with ARV therapy

1.1.1. Goal

The goal is to reduce morbidity and mortality of HIV in adults and children.

1.1.2. Objectives and Targets

The objectives and targets of antiretroviral drug delivery are:

• To provide long term ARV therapy to eligible patients

• To monitor and report treatment outcomes on a quarterly basis

• To attain individual drug adherence rates of 95% for patients on ARV therapy

• To increase life span so that 50% of patients on ARV therapy are alive and ambulatory after three years of ARV therapy

• To ensure that 50% of patients on ARV therapy are engaged in their previous employment or any other productive activity within 6 months of starting ARV therapy

• To reduce the number of new orphans registered each year

1.1.3. Strategy

The strategy is to mobilise all existing ARV delivery sites and identify new ARV delivery sites to provide standardised combination ARV therapy to HIV-positive persons who present to health facilities and who fulfil the eligibility criteria (see Chapter on Patients Eligible for ARV Therapy), using guardian supported treatment.

1.1.4. ARV Policy Package

The success of the ARV delivery framework depends on the implementation of a 5- point policy package:

• government commitment to ARV delivery • detection of eligible cases who should have undergone voluntary counselling and HIV testing and have a confirmed HIV-seropositive result and who fulfil eligibility criteria • standardised combination ARV therapy to HIV-seropositive eligible patients under proper case management conditions with high levels of drug adherence • regular, secure and uninterrupted supply of ARV drugs to units which are administering ARV treatment • monitoring system for supervision of ARV therapy, effective patient tracing and follow-up and regular evaluation

1.1.5. Key Operations

• There is an HIV/AIDS Unit in Ministry of Health and Population, which has overall responsibility for the management of ARV therapy in the country • The ARV treatment guidelines are available in every treatment unit which administers ARV therapy • There is a standardised registration, recording and reporting system • There is a combined training and examination programme covering all aspects of ARV delivery, which all staff involved in ARV delivery must have attended and must have passed • There is a voluntary counselling and HIV testing service (VCT) linked to every unit providing ARV therapy, which is subject to regular quality assurance and quality control • ARV treatment units are provided within the general health services, at hospital and also at health centre level • There is a regular supply of ARV drugs and HIV testing materials • There is a plan of supervision • There is a plan of regular reporting and evaluation • HIV / AIDS research is fully regulated to support patient care and implementation of the ARV treatment guidelines • There is a development plan with budget details, funding sources and responsibilities

Other important key operations essential to strengthen and sustain ARV delivery include information, education, communication and social mobilisation, involving private and voluntary health care providers, and operational research.

1.1.6. Indicators to measure progress with ARV delivery

Input indicators:

• An ARV treatment guideline manual (reflects government commitment)

• Number of HIV Clinics administering ARV therapy

• Number of staff trained and accredited in the use of ARV drugs

• No stock-outs of ARV drugs and HIV test kits, and uninterrupted supplies of ARV drugs to patients

Output indicators:

• The number of patients who start on standardised ARV therapy

• The percentage of patients who show 95% adherence to ARV therapy

• The percentage of patients on ARV therapy alive at a given time

• The percentage of patients alive on ARV therapy who are ambulatory (or in the case of children are engaged in age-related day time activities)

• The percentage of patients alive on ARV therapy who are engaged in previous work or employment

• The number of new orphans registered each year in a district in which ARV therapy is being administered

In a sample of specimens assessed, the percentage of patients with undetectable viral load 6 months after the introduction of HAART 11

1.2. THE RATIONALE FOR PHASE 1 RAPID SCALE UP OF ANTIRETROVIRAL THERAPY

In response to the devastating AIDS epidemic in Malawi, the Ministry of Health intends to scale up highly active antiretroviral therapy (HAART) more rapidly than was presented two years previously in the Global Fund Proposal.

1.2.1. Phase 1 rapid scale up of ARV therapy:

Malawi will start the process of delivering HAART to all eligible patients in the country from the first quarter of 2004. All major central, district and mission hospitals in the country, which have demonstrated their preparedness to implement HAART, will start delivering the treatment between July to December 2004. In addition, hospitals that are ready to start before this date will be encouraged to do so. A few designated health centres and health facilities in the private sector will also be encouraged to start HAART delivery during this time.

1.2.2. Rationale for Phase 1 rapid scale up:

• The moral imperative. About 86,000 people in Malawi die from AIDS each year, and currently under 4,000 people only are receiving the drugs in the public health sector. HAART saves lives. If scale up takes pace at the rate described in the Global Fund Proposal, then thousands of Malawians will die unnecessarily. The time to act is now, and with a responsible approach scale up can proceed much more rapidly.

• The equity principle. Scale up in a phased manner from 5 current hospitals to 4 districts to another 5 or 10 districts in a year’s time has in built inequity. By scaling up at all major facilities from Chitipa to Nsanje at least potentially allows the whole population to access this life saving treatment.

• Economic and political stability. AIDS is currently killing economically productive members of society and is undermining political and economic stability. The wide-scale introduction of HAART will reduce viral load and will get sick people back to good health, and thus start to gradually reduce the huge burden of illness currently faced by the Malawi economy. Rapid country- wide scale up will cost money, but in the end this money spent within the country will save more money in the future. By getting sick people back to work and back to looking after their children will also benefit the country in economic and socio- demographic terms.

• Provision of better health care from health care providers. Nearly half of all staff positions in MOHP are vacant, and one of the important causes of staff shortages country-wide is attrition from HIV/AIDS. Rapid, country-wide scale up allows all HIV-infected health care workers to access HAART. The transformation of a sick staff force to a healthy staff force could be one important step in improving health care delivery in the country.

1.3. SCALING UP ANTIRETROVIRAL THERAPY

1.3.1. Current Goal:

Malawi’s current “aspirational” goal is to deliver HAART to 80,000 eligible patients in the country by the end of 2005. This is in line with discussions held by the World Health Organization, and contributes to WHO’s stated goal of “3 by 5”: ie getting 3 million people in the developing world on ARV therapy by the end of 2005.

As a pro-poor initiative, this plan embraces the concept of free ARV drugs to as many HIV-infected eligible persons as possible. There will also be consideration of having a revolving fund in place in the private sector, and a paying system for those who choose to use the private sector or OPD-1 at public hospitals.

The scale up 2-year plan estimates the number of people who might start on HAART between July 2004 - June 2005. From June 2005 onwards, the numbers on HAART are more accurately predicted from quarterly reports on case finding from ARV sites.

1.3.2. Policy:

1.3.2.1. Phase I: Rapid Scale-up country-wide: (the simplified approach):

Malawi will start the process of delivering HAART to all eligible patients in the country from the first quarter of 2004.

In the public sector, 50 central, district and mission hospitals, including those of the Malawi Defence Forces and Police, will start to prepare for ARV delivery during January to June 2004. Hospitals that are assessed as prepared and ready to deliver ARV therapy will start between July and December 2004. There may also be hospitals that are ready to deliver ARV therapy before July, and they will be encouraged to do so. These 50 hospitals are shown in Appendix 1.

There are 28 other public health facilities and private hospitals, which may also be considered for starting between July -December, and these are shown by district in Appendix 2.

In order to get prepared for ARV delivery, hospitals and health facilities will need to work closely with their partners in order to maximise logistic support. Teams from hospitals already delivering HAART will provide technical support and act as mentors for hospitals preparing to start ARV delivery.

Civic society needs to be informed about these developments and about the fact that HAART will soon be available in hospitals throughout the country.

In order to expedite the rapid expansion of HAART, considerable effort will be required from the central level, with strong determination needed from districts to implement the services. Nevertheless, it is a goal of the MOHP that HAART should become a fully integrated part of the district health care provision, and this medium term goal will inform the planning and implementation of scale up. 13

1.3.2.2. Phase II: Advanced Scale up of ARV therapy: (full implementation of ARV Treatment Guidelines)

Once ARV treatment units are delivering first line ARV therapy, the hospitals and districts will continue to work with their partners to deliver ARV treatment fully according to the ARV Guidelines [ ie, first line, alternative first line and second line regimens]. Other units attached to district hospitals, NGOs (eg Banja La Motsogolo), private companies, private clinics etc will also prepare and start to deliver ARV therapy using first the simplified approach and then moving to the more advanced approach.

1.3.2.3. The pre-requisites for Phase 1 rapid scale up:

• Simplification of the ARV delivery system: use of first line regimen only. The level of excellence provided by Lighthouse, Thyolo and Chiradzulu will not be possible through the normal government and mission hospitals. It is therefore recommended that the first line regimen only be used in this first rapid scale up of ARV therapy. This will simplify the management of patients, the recording and reporting as well as drug procurement. Patients who develop side effects or who fail the first line regimen will be referred to centres of excellence for appropriate treatment. These centres of excellence will need to be provided with drugs for alternative and second line treatment.

• Hospitals assessed as ready to start ARV therapy between July- December 2004. Each hospital will be assessed from July onwards about readiness to start ARV therapy. Readiness criteria are being developed and will be finished by end of February. The criteria currently include:- a) commitment from Hospital Management Teams to go forward with ARV delivery; b) a functioning VCT service; c) a dedicated room for delivery of ARV therapy which is suitably equipped and has the appropriate monitoring forms and copies of the national ARV Treatment Guidelines; d) good supply of HIV test kits in stock and a system to ensure regular procurement of HIV test kits from CMS; e) allocation of the appropriate number of clinical and nursing staff, and other such staff as are needed, to work full-time in the ARV clinic and the team members having undergone a certified MOHP training course.

• Adequate supplies of HIV test kits and ARV drugs. In the first instance, CMS will have ensured procurement and distribution of HIV test kits and UNICEF will have ensured procurement and distribution of ARV drugs. These must be in sufficient quantities in the country by June, ready for starting from July 2004 onwards. As estimates may initially be inaccurate it is important that the procurement agencies specify as long a shelf life as possible so that HIV test kits and drugs do not exceed their expiry dates. 14

1.3.2.4. Possible constraints to achieving Phase I rapid scale up:

• Capacity of the health sector to deliver ARV drugs to people in need. The health sector (public and CHAM, but also including the Defence Forces and Private Sector) needs to be committed to the goal of rapid scale up and the work required for preparedness. Individual Hospital Management Teams will need to make difficult decisions about which clinical and nursing staff should be released to train for, and deliver, HAART.

• Capacity of Central Medical Stores and UNICEF to provide ARV drugs. There have to be enough drugs to meet demand, and patient interruptions are unacceptable. There also has to be capacity in the provider units to account for ARV drugs and promptly order new stock.

• Patient demand for HIV testing and ARV therapy. This is an unknown variable, and initially the MOH and its partners have provided estimates based on operational targets or ceilings, so that the health sector is not swamped and overwhelmed by large patient numbers (see Appendices).

1.3.2.5. Risks associated with Phase 1 rapid scale up:

• Drug security issues: rapid scale up may involve loss of control of ARV drugs. However, this risk will be minimised by:- a) UNICEF initially procuring and distributing the drugs to all end user units; b) a system of checks during monitoring and evaluation to compare drug consumption with drug usage as described in the Malawi ARV treatment Guidelines. Hospitals showing excess drug usage will be investigated and stopped from putting any new patients on ARV therapy until security is sorted out.

• Drug adherence and risks of promoting ARV drug resistance. The ARV Treatment Guidelines suggest how to maximise drug adherence and how to monitor for drug resistance.

• Impact on the health sector. Rapid scale up may involve a shift of health care staff from general duties to ARV duties, and there may therefore be an even greater deficit of staff to deal with other medical problems. However, over 50% of hospital in-patients have HIV/AIDS, and it is expected that the provision of ARV therapy to such patients will ultimately reduce the burden on hospitals. This might then free up staff to attend to general duties.

• Equitable access to ARV therapy: access to ARV therapy will be based on clinical eligibility criteria. It is possible that privileged persons, eg health care workers, teachers, influential people and their families, may gain better access to ARV than the poor. Attempts to promote equity and monitor fair access to treatment will be undertaken. Initially, with ARV clinics in hospitals only for the initial phase scale up, patients with HIV/AIDS in remote areas will have difficulty getting access. This will ultimately change as more sites in a district become involved in Phase 1 rapid scale up after the first year.

• Attention to care of HIV at the expense of prevention. The provision of ARV therapy involves counselling and HIV testing. Explicit in the Malawi ARV Treatment Guidelines are risk reduction strategies and HIV prevention messages.

1.3.3. Institutions to deliver HAART:

Institutions to deliver HAART include:- a) the government health sector; ie central and district hospitals, including their outlying health centres b) CHAM institutions; ie mission hospitals c) The Malawi Defence forces, the police and prison service d) Non-governmental organizations (eg, Banja La Motsogolo) e) the private sector: ie the private hospitals and the private companies

Wherever feasible, these institutions will work with partners in getting prepared and set up to deliver ARV therapy to eligible patients. The HIV/AIDS Unit of the MOHP will also proactively try and identify supporting partners.

1.3.4. Current progress up to January 1st 2004:

Malawi has made good progress in its quest to deliver HAART to eligible persons in Malawi.

1. An HIV/AIDS Unit has been formed in the Ministry of Health and Population (MOHP). Currently this unit has a director and an assistant, with a person responsible for VCT. A technical assistant has been appointed to work as a counterpart to the director. Furthermore, another technical assistant has been appointed to co-ordinate the MOHP response to the HIV/AIDS epidemic. Despite this progress, the unit is weak in terms of staff numbers, and new staff will urgently need to be appointed in order to bring the unit up to full effectiveness. Suggestions about how to do this are described below.

2. VCT and ARV Treatment Guidelines have been produced and approved by the MOHP. They are currently waiting for printing and distribution. The Treatment of HIV-related diseases Guidelines are almost finalised.

3. The concept of standardised registration, recording and reporting systems have been developed and are part of the ARV treatment Guidelines. A standard ARV register has been approved by the MOHP, and this is currently being printed and will be distributed to units already providing ARV therapy

SECTION 2: OPERATIONAL PLAN: THE FIRST YEAR 2004

2.1. NATIONAL LEVEL

2.1.1. First three months (January to March 2003): Activities

2.1.1.1.Country-wide rapid situational assessment

Public sector. The first assessment will be carried out in the MOH, CHAM and Malawi Defence Forces and Police, using a monitoring tool developed by the MOHP. This assessment will focus on:- a) the hospital VCT service, particularly the number of full-time and part-time counsellors, aspects of quality assurance, and operational aspects of the VCT site b) data for 2003 on VCT uptakes and HIV-positivity on clients/ patients/ blood donors and TB patients c) the hospital laboratory service, particularly HIV testing protocols, quality control, and HIV test kits in stock d) Antiretroviral therapy, particularly data from those sites already providing ART and information on preparedness for those sites not yet providing ART e) PMTCT service, and where instituted information on the number of pregnant mothers HIV tested, those HIV-positive and those offered nevirapine f) Other sites (integrated and stand-alone) in the district offering VCT with data on clients/patients and blood donors tested and found to be HIV-positive in 2003

This situational assessment will add to the one carried out by MOHP and NAC for 2002. It will provide country-wide base-line data for the scale up which will occur in 2004, and it will provide MOHP with preliminary information about hospital preparedness for starting ARV therapy. The HIV-TB team will carry out the assessment, and a report will be ready by end March. At the same time as the visit takes place, the opportunity will be taken to motivate the district health team to actively participate in the scaling up of ARV drug delivery.

Private Sector: An assessment in the private sector will be carried out looking at VCT and ARV delivery in private hospitals, private clinics and by private companies. This will be organised by the HIV/AIDS co-ordinator and the HIV care and support staff of NAC. The assessment will be completed as a report by end March.

2.1.1.2. Assessment of the number of patients who will be treated with HAART over the first year of ARV implementation (July 2004 to June 2005)

The hospitals to deliver HAART have been categorised into Low Burden, Medium Burden and High Burden ARV Units. Low Burden units will provide HAART cumulatively to 25 patients per month. Medium Burden units will provide HAART cumulatively to 50 patients per month. High Burden Units will provide HAART cumulatively to 150 patients per month. The categorisation of the 50 public health hospitals and the other 28 public hospitals / private hospitals are shown respectively in Appendix 3 and Appendix 4.

Based on this categorisation, the number of patients coming onto HAART during the first year (July 2004 to June 2005) has been calculated and is shown in Appendix 5. In brief:

• If the scale up plan just involves the 50 primary ARV delivery sites, then by the end of June 2005 there will be an estimated 34,500 patients on HAART.

• If the scale up plan involves all of the other 28 ARV delivery sites then by the end of June 2005, there will be an estimated 44,100 patients on HAART.

These calculations are based on the following assumptions:- a) all ARV delivery sites to be ready to provide HAART by July 2004 b) 100% follow-up rate c) 100% success rate with no deaths and no stoppages on treatment

These assumptions are unlikely to be met., and therefore the scenarios are probably an overestimate of the number of patients coming on to HAART.

2.1.1.3. Assessment of ARV drug quantification, costs and specification

2.1.1.3.1. Quantification of ARV drugs:

Phase 1 scale up will involve the use of 2 drugs, each sub-divided into a d4T-30 and d4T-40 preparation.

D4T30mg + 3TC150mg + NVP 200mg D4T40mg + 3TC150mg + NVP 200mg D4T30mg + 3TC150mg D4T40mg + 3TC150mg

If all 78 sites start to deliver ARV therapy in July 2004, then the cumulative number of patient months of HAART between July 2004 and June 2005 is 319,650 (see Appendix 6).

2.1.1.3.2. Costs of ARV drugs:

Detailed work is needed on drug costs, and decisions need to be made about calculating the costs according to patient months on treatment or purchasing of drugs according to Starter packs and Continuation packs.

Some preliminary calculations based on patient months of treatment are as follows. The cost of the main triple drug for one month is approximately USD$18.5. Added to this are costs of procurement (UNICEF charges 5%), insurance, freight, transport, storage and distribution (an extra 15%). With 20% extra, the costs are USD21.3 per patient per month. Thus, based on 319,650 patient months of treatment, the total costs for the first year are estimated at USD$7,096,230 (see Appendix 6). This calculation does not include a buffer stock: A buffer stock of 3 months drug consumption (based on 44,000 patients on HAART) would cost USD$936,100, making the total cost of drugs to be USD$8,032,330.

In the Global Fund Budget, for the purchase of ARV drugs there is USD$2,205,000 for the Financial year (2003/2004, ending May 2004), and USD$7,350,000 for the Financial year (2004/2005, ending May 2005). There is therefore a total of USD$9,555,000, in the GFATM budget for drug costs.

2.1.1.3.3. ARV drug specifications

HIV/AIDS Unit and UNICEF is currently working on ARV drug specifications, and the exercise has yet to be completed. A few general points have been agreed:

• ARV drugs will be scored • ARV drugs will be embossed with a symbol of Malawi Government to try and prevent theft • ARV drugs should have a shelf-life of 3 years, if possible • ARV drugs should be fixed dose combinations

ARV drugs to be provided are for First Line Regimen only. There are two types of d4T/3TC/ NVP as outlined above: the d4T-30 and d4T-40 tablets combinations, given respectively to patients under 60Kg and over 60Kg. There is also a run in period, during which these drugs are started at half dose for two weeks and thus d4T/3TC-30 and d4T.3TC-40 strength tablets have to be provided for a two-week period.

Experience suggests that 80% of the drug order should be for the d4T/3TC/NVP – 30 and d4T/3TC-30 and 20% for the d4T/3TC/NVP – 40 and d4T/3TC-40.

2.1.1.4. ARV Monitoring Tools in place and being used

ARV Registers will be printed and placed in units already providing ARV therapy. Where possible these registers will be back-dated to when ARV therapy was introduced. Clerks will need to be trained in how to use ARV registers and keep good files of the individual treatment master cards. In addition the ARV treatment cards, identity cards, and cohort analysis forms (shown in the ARV Treatment Guidelines) will be printed and distributed. Unique codes need to be developed for each ARV treatment site, and these will be based on the codes issued by HMIS (see Appendix 1).

Monitoring and reporting systems from provider unit back to central level will need to be worked out.

The HIV/AIDS Unit will be responsible for initially getting the necessary stationary printed and distributed to all ARV clinic sites in the country. The replenishment of registers, treatment master cards and patient identity cards will then be the responsibility of the HIV/AIDS team in each hospital. Details of how this is done will be worked out.

2.1.1.5. Development of Training modules and Preparedness criteria for delivery of ARV therapy

The ARV Training and Preparedness Development Committee will take on this task, and will develop the training module and the preparedness criteria. The dates for the first meeting of the ARV Training and Preparedness Development Committee, comprising representatives from HIV/AIDS Unit, the Main Training Institutions in Malawi and staff working in ARV delivery sites, will be February 16-21.

2.1.1.5.1. Training:

The issues to be worked out include:- • Development of the training curriculum for rapid scale up (content, length, resource needs, assessments, certification) • Logistics (venue for trainings, number of trainees at a time, dates, funding mechanisms) • Who will actually do the training • On going site supervision and mentor-ship (teams, composition of teams, catchment areas , frequency of supervision, content of supervision, funding)

The HIV/AIDS Unit and the ARV Training Committee will work with the Colleges of Medicine, Nursing and Health Sciences to ensure that the teaching on ARV delivery is incorporated into pre-service curricula training. There needs to be consideration given to a system of accrediting newly qualified graduates as competent in delivering ARV therapy.

The HIV/AIDS Unit will liaise with the College of Nursing about developing a short separate training course for ARV clerks. 20

2.1.1.5.2. Preparedness criteria:

It will be necessary to develop the tools and mechanisms by which all hospitals listed in Appendix 1 and 2 can be assessed in terms of preparedness for starting ART. This will then be shared with hospitals when they attend for briefings and discussions about preparedness for scaling up ARV therapy.

2.1.1.6. Strengthened HIV/AIDS Unit

As described above, the HIV/AIDS Unit is small and under-resourced in terms of staff, office space and material resources. There is a need for suitable office space, preferably in MOHP Head-quarters, for the current and (possible) expanded staff. One suggestion to strengthen the HIV/AIDS Unit is for the HIV-TB team, currently under the umbrella of the NTP, to be seconded across to the HIV/AIDS Unit for one year in the first instance. This team have HIV-related TB tasks to undertake, but these are complimentary to the goals and objectives of the HIV-AIDS unit. The staff members consisting of a clinical officer, two counsellors, a data entry clerk and an administrator/secretary could rapidly ensure that the HIV/AIDS unit staff are brought up to adequate numbers. In addition, it could be suggested that NAC second one member involved in HIV care and support to the HIV/AIDS unit.

2.1.1.7. Improved HIV/AIDS care management and coordination

The Ministry of Health has approved the Document on “Institutional arrangements within MOHP for the HIV/AIDS response.

The HIV/AIDS Unit, which has responsibility for ARV, opportunistic infections (OI) and VCT, will start having regular 2-weekly management meetings to keep track on the ARV scale up plan. Minutes will be taken and circulated. TORs will be developed and the composition of membership at these meetings will be determined.

The HIV/AIDS Implementation group will be formed and start having monthly meetings, chaired by the head of the HIV/AIDS Unit. This group consists of representatives from the concerned directorates in MOH (PMTCT, blood safety, injection safety, Central Medical Stores, HMIS) and also includes CHAM and BLM.

Other strategies designed to improve management and coordination will be discussed and worked out as necessary.

2.1.1.8. Meetings of Preparedness for ARV delivery

2.1.1.8.1. Health Care Providers:

A series of regional two day meetings will be held with the medical officer in charge, the matron and key partners and district organizations to discuss and prepare for ARV delivery. Specifically, at these meetings there will be presentations and discussions on a) ARV Treatment Guidelines, b) ARV Scale Up Plan, c) ARV preparedness criteria by which hospitals will be assessed in terms of readiness to deliver ARV therapy.

2.1.1.8.2. Development Agencies:

There will be meetings with bilateral and multilateral development agencies to keep them briefed about the ARV scale up plan and progress being made. These meetings can also serve as a forum for MOH to present requests for support and assistance.

2.1.1.9. Campaign to inform the general public

A campaign to inform the general public about the rapid scale up of ARV therapy will need to be prepared. The campaign will involve schools, churches, and civil society. The National AIDS Commission needs to provide leadership in this regard. It will be important to be transparent in the briefing to the general public that initially there will be a ceiling on the number of patients accessing and starting ARV therapy in order to allow the systems time to work within the system.

2.1.1.10. Patient Education

This is an integral part of the ARV treatment Guidelines. A focus needs to be made on developing information materials for patients and their guardians about adherence to ARV therapy. Health Education Unit will be mandated to take a lead in this activity.

2.1.1.11. Procurement, distribution and security of ARV drugs

Preliminary suggestions are that procurement will be in 3-month packs, using the lowest denominator: ie the Low Burden Unit. For one Low Burden Unit, a package of drugs with the correct specifications and drug sub-types will be calculated to meet the estimated needs for 3 months. There will be two types of package: the Starter Pack and Continuation Pack. Medium Burden Units will need 2 packs and High Burden Units 6 packs for a three-month period. Calculations are shown in Appendix 7.

The systems to distribute these drugs need to be worked out.

The issues around drug security need to be worked out. There are issues of security from the level of procurement to end provider, and from end provider to patients. The Malawi ARV Treatment Guidelines provide a section on security of drugs at end user level.

2.1.1.12. Budget development and Financing Mechanisms

A budget to fund the activities in the Scale-up Plan needs to be developed and presented to the National AIDS Commission for funding. Activities in broad terms to be funded are shown in Appendix 8. Ways of ensuring swift transfer of funds from NAC to the MOH in order to move rapidly on implementing activities need to be agreed upon and then implemented.

2.1.1.13. Summary: Activities to be completed by end of March:

• A country-wide situational assessment of VCT and ARV in the public and private sector

• An estimate of the number of patients who will access HAART in the first year

• An assessment of the number of ARV drugs required, costs, and specification

• ARV monitoring tools in use in hospitals providing ARV therapy

• An ARV training module and preparedness criteria for delivery of ARV therapy ready to be used for training staff and hospitals

• A strengthened HIV/AIDS Unit in MOHP

• HIV/AIDS care management and coordination groups formed and functioning

• Meetings with health care providers and development agencies on ARV Scale Up

• A strategy to inform the general public about ARV scale up being developed

• The start of development and production of materials on “patient education about ARV adherence”

• A procurement, distribution and security plan for units to deliver ARV drugs

• Budget developed and funding mechanisms for transfer of funds between NAC and MOH worked out

2.1.2. Next three months (April to June 2004)

During this 3 months all central, district and mission hospitals in the country will start to get ready to deliver ARV therapy for the period July – December 2004. Private hospitals and private company clinics, that are providing HAART or getting ready to deliver HAART, will also be included.

2.1.2.1. Training

During these 3 months a minimum number of core staff from each hospital need to be trained in ARV delivery. There are public health 50 hospitals included in Appendix 1. Each hospital will be encouraged to ensure that at least one clinician (preferably two), one nurse, one counsellor and one clerk (preferably two) undergo the training in ART. If possible, other health facilities and private sector hospital staff may be included.

The intensive training of staff needs to start in the second quarter and continue on a regular basis up to the end of the year. The Malawi Medical Council also needs to be involved to provide the necessary accreditation when training and passing of exams are complete.

2.1.2.2. VCT site and ARV Clinic Preparedness

During these 3 months all central, district and mission hospitals, with their partners, will develop a simple district ARV Implementation Plan, and will continue preparations for VCT and ARV delivery. Each hospital will have a VCT room, suitably prepared and equipped (condoms, demonstration penis, VCT Guidelines, VCT registers). Each hospital will also have identified a room to be used as the ARV clinic, suitably prepared with an ARV register/ ARV treatment cards, filing systems/ one lockable steel cabinet and weighing scales. The possibility for nurse led-review clinics could be considered in these plans. In June, the DHMT will ensure that the pharmacy has adequate stocks of HIV test kits.

Similarly, the private sector needs to work on site preparedness, using the same principles as have been developed for the public sector.

The HIV/AIDS Unit will need to ensure that enough ARV monitoring tools (ARV registers, ARV Treatment cards, ARV identity cards) are produced and distributed to all hospitals in the country.

The Health Education Unit (HEU) will need to ensure that patient education messages and measures have been developed and are distributed to hospitals.

2.1.2.3. Supervision and Mentorship

As this is a new form of treatment, with which most hospital staff will have little experience, hospitals will need on-site supervision from the supervisory teams. These teams will visit all the hospitals to ensure that site preparedness is progressing satisfactorily. Members of the teams might consider holding ARV therapy meetings once a month; certain specialists can make themselves available by phone or email to deal with difficult patient problems.

2.1.2.4. Monitoring and Evaluation

As sites become prepared for ARV delivery for July – December, a mechanism to report, monitor and evaluate the ARV delivery needs to be set up. At the ARV clinic level, reporting will be from the ARV clinic to the officer in charge of the hospital. Data then has to regularly feed from hospital to HIV/AIDS unit and HMIS. The National TB Control Programme, through its regional TB officers, will provide in the first instance the human resources and infrastructure for quarterly monitoring and evaluation and collection of data for the central unit. Regional TB officers visit every major health facility in Malawi every three months to supervise and collect data related to TB control. On to the structured supervisory check-list can be added a concise and structured check list for VCT and ARV delivery and security (see ARV Treatment Guidelines). This check-list needs to be prepared (responsibility falls with the HIV/AIDS Unit) and the Regional TB officers need to be trained. Discussions must be held with NTP about the extra resources needed for NTP regional staff to take on this extra burden of work.

HMIS must be involved, so that there are appropriate indicators with respect to ARV delivery.

The HIV/AIDS Unit also needs to work out what it will do with the data coming in from around the country every three months. The data officer seconded from the TB- HIV team can be set up with a computer and data entry system to regularly enter and collate data on VCT and ARV delivery. The data collected by the HIV/AIDS Unit needs to be disseminated to all relevant stakeholders in and outside of the country. Who and how this should be done need to be worked out.

If hospitals are failing in their delivery systems, it is proposed that they will continue to see patients already recruited to the system but will not recruit any new patients.

2.1.2.5. Operational Research

During this phase of preparation, operational research questions may be developed. They should be written up into full proposals and submitted for evaluation. The mechanisms for doing this, assessing proposals and granting support need to be worked out.

2.1.2.6. Summary: Activities to be completed by the end of June:-

• The 50 hospitals in the country which are included in Appendix 1 will have ensured that their staff to deliver ARV therapy has been trained. Other hospitals including the private sector may also have had their staff trained.

• The 50 hospitals in the country will have prepared VCT sites and ARV clinics, and will have been assisted in this by the supervisory teams

• The TB programme, supported by additional staff from the HIV/AIDS Unit, will have made preparations for monitoring and evaluating ARV delivery. In addition, HMIS will have additional ARV indicators and the HIV/AIDS unit will have worked out how to collate, analyse and disseminate the country- wide data

• The system of how to manage operational research will have been developed

2.1.3. Next three months (July to September 2004)

2.1.3.1. Hospitals assessed as being ready for delivering ARV therapy

All hospitals will be visited by a team(s) coordinated by the HIV/AIDS Unit. At these visits, using a structured proforma, the hospitals will be assessed as being ready or not to deliver HAART. Visits will be organised at a regional level, ie all hospitals which have prepared for ARV delivery in the Northern Region will be visited during a Northern Region tour.

Hospitals, which have been given the go-ahead, will be provided with ARV drugs. UNICEF will be informed and will arrange delivery, region by region.

Hospitals, which are not ready, will be encouraged to further develop their sites and will be visited in the next quarter (October to December).

2.1.3.2. Hospital implementation of ARV therapy

Hospitals provided with ARV drugs will start implementation of ARV therapy.

2.1.3.3. Hospital site visitation

During this 3-month period there will be no data to collect. However, it is important that all sites delivering ARV therapy are visited by TB Programme staff , staff from HIV-AIDS Unit, and the training teams, to check that:- a) individual patient recruitment systems are running well, b) ARV registers are being properly maintained, c) there are sufficient stocks of HIV test kits and ARV drugs, d) problems are identified and sorted out. Systems for supervision and consultation (phone, email) can be tested out during this time. 26

2.1.4. Next three months (October to December 2004)

2.1.4.1. Implementation of ARV delivery.

ARV delivery sites that started in July or that start in October need to continue to deliver ARV therapy

2.1.4.2. Monitoring and evaluation.

The first proper monitoring and evaluation will be carried out in this quarter, bringing back data collected in the third quarter of 2004. This exercise will be carried out in October and November 2004, with data collated and analysed in December. By the end of December a report on country-wide ARV delivery for the third quarter of 2004 should be ready and disseminated to all stakeholders.

2.1.4.3. Supervision.

The supervisory systems worked out will be implemented.

2.1.5. The first year 2004 (summary)

The activities of scale up in the first year of 2004 are shown in tabular form in Appendix 9. 27

2.2. CENTRAL, DISTRICT AND MISSION HOSPITAL LEVEL

2.2.1. First three months (January to March 2004):

Each hospital will start working on site preparedness so that VCT and ARV delivery systems are in place and ready to start between July and December 2004. Many hospitals already have VCT services underway in one form or another, and some have already started to implement ARV delivery. The following are suggested.

2.2.1.1. Hospital HIV/AIDS Care team. The ARV clinical officer, with the support of the District Health Management Team, should form an HIV/AIDS care team to assist with rapidly moving forward on hospital preparedness. Other hospital staff (ie TB officers, staff from PMTCT teams), partners and interested NGOs working in the district should be incorporated into these teams. Teams should be formed during the first three months, develop TORs and meet initially monthly at least. One of the key activities is for the team to develop a district plan for comprehensive AIDS care, which includes the scale up of ARV therapy.

2.2.1.2. VCT systems in place. A check-list has already been developed and been discussed and taken back for use by district hospitals to develop their VCT services.

2.2.1.3. Systems in place for Providing ARV treatment. A check-list needs to be developed for ARV preparedness, and taken back to hospitals to be used. An example of the activities which might be included in this check list are shown in the Table.

A room dedicated for ARV delivery on at least two days per week Dedicated ARV room suitably equipped (table, cabinets, chairs, weighing scales) ARV monitoring tools in place (ARV Registers, Treatment cards, Identity cards) Development of the patient circuits (in-patient/ out-patient) System worked out of clinic days and how to see new patients and follow-ups ARV drugs (first line only in the pharmacy)

2.2.1.4. Staff identified who will provide the ARV service. Clinical officers, nurses, counsellors and clerks who will provide the ARV service and who need to be trained should be identified

2.2.2. Next three months (April to June 2004)

During this three month period, hospitals will ensure final preparations for site preparedness and will have sent their staff for training of ARV delivery. Hospitals must communicate with the HIV/AIDS Unit about preparedness for starting ARV therapy in July.

2.2.3. Next six months (July to December 2004)

During the six month period, hospitals will deliver ARV therapy (first line regimen only to eligible patients). All patients will be properly documented in the ARV register and using ARV treatment cards. ARV Clinics will prepare in October quarterly reports on patients starting ARV therapy between July – September, and report at the start of October how many patients are alive, dead, stopped therapy or transferred to another unit. It is suggested that an ARV Clinic runs on at least two days a week and that at the beginning of each month the ARV clinic dedicates the first 2- 3 days to seeing follow-up patients. In this way follow-ups are seen at a regular time and new patients are seen during the clinic days in the rest of the month. The activities during each three-month period are shown in the Table.

ARV Clinic operates 2 or more days a week and sees new patients ARV Clinic sees follow-up patients on days best suited to the site All patients have ARV identity card and unique ARV treatment cards kept in Files ARV clerk ensures ARV Register maintained and up to date each day In first week of each quarter ARV team prepare quarterly analysis of ARV usage HIV/AIDS Team every quarter prepare procurement order of stationary, HIV test kits, and ARV drugs

All hospitals will see adult patients eligible for ARV therapy. Because of the complexity around ARV therapy for children, only the sites currently seeing children will manage HAART in the paediatric population. However, every effort will be undertaken to develop a feasible and safe model to scale up access to ARV therapy for this age group.

SECTION 3: OPERATIONAL PLAN: THE SECOND YEAR 2005

3.1. NATIONAL LEVEL

The framework only for the second year is shown below:

HIV/AIDS Unit coordinates the roll-out and implementation of HAART country wide and ensures continuation of activities started in 2004. These include:

• Health promotion and advocacy • Procurement and distribution of stationary, HIV test kits and ARV drugs • Recruiting more ARV units to providing HAART in public and private sectors • Co-ordination planning meetings • Co-ordinating quarterly supervision of ARV implementation • Co-ordinating quarterly monitoring and evaluation of ARV implementation • Updating Treatment Guidelines and Training Manuals • Co-ordinating training of staff from new ARV units as well as co-ordinating the training of sites ready to move up to use full ARV Treatment Guidelines • Scaling up training for all clinical staff in the country • Operational research • Annual surveillance for viral drug resistance (see ARV Treatment Guidelines) • Issuing 6-monthly reports to all stakeholders • Annual review meetings, particularly a national meeting on lessons learned during the first 6 months of implementation

3.2. CENTRAL, DISTRICT AND MISSION HOSPITAL LEVEL

The framework only for the second year is shown below:

Each hospital will ensure the following:-

• Implementation of ARV therapy from the hospital ARV clinic • Regular systems of ordering supplies and drugs • Providing quarterly reports to supervising teams • Identification of other sites and personnel to provide ARV therapy in addition to the hospital ARV clinic (this includes sending personnel for training) • Considering scaling up from a simplified approach to providing ART in accordance with ART Guidelines.

APPENDIX 1: PUBLIC SECTOR HOSPITALS TO START HAART IN JULY 2004

North Region Codes (to link with HMIS) Chitipa District Hospital CTA Karonga District Hospital KRA Likoma District Mission Hospital LKO Nkhata Bay District Hospital NBY Rumphi District Hospital RHU Livingstonia Mission Hospital in Rhumpi LVG Mzuzu Central Hospital MZU Mzuzu Moyale Barracks Hospital (Malawi Defence Force) MOY Mzimba District Hospital MZB St Johns Mission Hospital in Mzimba/ Mzuzu STJ Ekwendeni Mission Hospital in Mzimba (already implementing) EKW Embangweni Mission Hospital in Mzimba EMB Central region Mchinji District Hospital MCH Ntcheu District Hospital NCH Dedza District Hospital DZA Mua Mission Hospital in Dedza MUA Kasungu District Hospital KSU Dowa District Hospital DWA Madisi Mission Hospital in Dowa MDI Mtengawatenga Mission Hospital in Dowa (already implementing) MWA Ntchisi District Hospital NCH Salima District Hospital SAL Nkhotakhota District Hospital NKK St Anne's Mission Hospital in Nkotakota SAN Lilongwe Central Hospital –Lighthouse (already implementing) LHL Nkhoma Mission Hospital in Lilongwe NKM Likuni Mission Hospital in Lilongwe LIK St Gabriels Mission Hospital in Namitete, Lilongwe NMT Lilongwe Kamuzu Barracks Hospital (Malawi Defence Forces) LKB South Region Nsanje District Hospital NSJ Trinity Mission Hospital in Nsanje TRN Chikwawa District Hospital CKW Montfort Mission Hospital in Chikwawa MNT Mangochi District Hospital MAN Machinga District Hospital MAC Balaka District Hospital BLK Thyolo District Hospital (already implementing) THY Malamulo Mission Hospital in Thyolo MAL Mulanje District Hospital MJD Mulanje Mission Hospital in Mulanje MJM Phalombe Mission Hospital PHL Mwanza District Hospital MWA Chiradzulu District Hospital (already implementing) CZU St Joseph's Mission Hospital, Nguludi, Chiradzulu NGU Zomba Central Hospital ZCH Zomba Cobbe Barracks Hospital (Malawi Defence Forces) ZCB Zomba Police Hospital ZPH St Lukes Mission Hospital SLK Queen Elizabeth Central Hospital in Blantyre (already implementing) QEC Mlambe Mission Hospital in Blantyre MLB

APPENDIX 2: OTHER HEATH FACILITIES WHICH MAY BE CONSIDERED FOR HAART IN PUBLIC AND PRIVATE SECTOR ACCORDING TO REGION AND DISTRICT

Region and Public Sector Facilities Private Sector Facilities District

North Region

Chitipa Kaseye Mission Hospital Karonga Nkhata Bay Chinteche Rural Hospital Rumphi Mzimba Katete Rural Mission Hospital

Central region

Mchinji Kapiri Rural Mission Hospital Ntcheu Dedza Kasungu Nkhamenya Mission Hospital Dowa Mponela Mission Hospital Ntchisi Salima Nkhotakhota Dwangwa Sugar Plantation Clinic Lilongwe Mlale Mission Hospital Lingadzi Private Clinic Lilongwe Bottom Hospital African Bible College Mitundu Rural Hospital MARS Hospital Kabadula Rural Hospital Lilongwe SOS site City Centre Clinic Adventist Clinic

South Region

Nsanje No Chikwawa Sucoma Estate Clinic Ngabu Rural Hospital Mangochi St Martins Mission Hospital Machinga Balaka Thyolo Mulanje Phalombe Mwanza Chiradzulu Zomba Zomba Central Prison Blantyre Ndirande Health Centre Mwaiwathu Private Hospital Chilomoni Health Centre Chitawira Private Hospital Limbe Health Centre Seven Day Adventist Mission Hospital Bangwe Health Centre

APPENDIX 3: ASSESSMENT OF NUMBER OF NEW PATIENTS CUMULATIVELY ACCESSING HAART IN THE FIRST YEAR: JULY 2004 TO JUNE 2005 (* already implementing ARV therapy): THE 50 PRIMARY SITES

Category Q3 2004 Q4 2004 Q1 2005 Q2 2005 Chitipa District Hospital Low 75 150 225 300 Karonga District Hospital Medium 150 300 450 600 Likoma District Mission Hospital Low 75 150 225 300 Nkhata Bay District Hospital Medium 150 300 450 600 Rumphi District Hospital Medium 150 300 450 600 Livingstonia Mission Hospital Low 75 150 225 300 Mzuzu Central Hospital Medium 150 300 450 600 Mzuzu Moyale Barracks Hospital Low 75 150 225 300 Mzimba District Hospital Medium 150 300 450 600 St Johns Mission Hospital Low 75 150 225 300 Ekwendeni Mission Hospital * Low 75 150 225 300 Embangweni Mission Hospital Low 75 150 225 300 Mchinji District Hospital Medium 150 300 450 600 Ntcheu District Hospital Medium 150 300 450 600 Dedza District Hospital Low 75 150 225 300 Mua Mission Hospital Low 75 150 225 300 Kasungu District Hospital Medium 150 300 450 600 Dowa District Hospital Medium 150 300 450 600 Madisi Mission Hospital Low 75 150 225 300 Mtengawatenga Mission Hospital * Medium 150 300 450 600 Ntchisi District Hospital Low 75 150 225 300 Salima District Hospital Medium 150 300 450 600 Nkhotakhota District Hospital Medium 150 300 450 600 St Anne's Mission Hospital Low 75 150 225 300 Lilongwe CH –Lighthouse * High 450 900 1350 1800 Nkhoma Mission Hospital Low 75 150 225 300 Likuni Mission Hospital Medium 150 300 450 600 St Gabriels Mission Hospital Low 75 150 225 300 Lilongwe Kamuzu Barracks Hospital Medium 150 300 450 600 Nsanje District Hospital Medium 150 300 450 600 Trinity Mission Hospital Low 75 150 225 300 Chikwawa District Hospital Medium 150 300 450 600 Montfort Mission Hospital Low 75 150 225 300 Mangochi District Hospital Medium 150 300 450 600 Machinga District Hospital Medium 150 300 450 600 Balaka District Hospital Low 75 150 225 300 Thyolo District Hospital * High 450 900 1350 1800 Malamulo Mission Hospital Medium 150 300 450 600 Mulanje District Hospital Medium 150 300 450 600 Mulanje Mission Hospital Medium 150 300 450 600 Phalombe Mission Hospital Low 75 150 225 300 Mwanza District Hospital Medium 150 300 450 600 Chiradzulu District Hospital * High 450 900 1350 1800 St Joseph's Mission Hospital Low 75 150 225 300 Zomba Central Hospital Medium 150 300 450 600 Zomba Cobbe Barracks Hospital Medium 150 300 450 600 Zomba Police Hospital Low 75 150 225 300 St Lukes Mission Hospital Low 75 150 225 300 QECH in Blantyre * High 450 900 1350 1800 Mlambe Mission Hospital Medium 150 300 450 600

APPENDIX 4: ASSESSMENT OF NUMBER OF NEW PATIENTS CUMULATIVELY ACCESSING HAART IN THE FIRST YEAR: JULY 2004 TO JUNE 2005: THE OTHER HEALTH FACILITIES AND PRIVATE SECTOR

Category Q3 2004 Q4 2004 Q1 2005 Q2 2005 Kaseye Mission Hospital Low 75 150 225 300 Chinteche Rural Hospital Low 75 150 225 300 Katete Mission Hospital Low 75 150 225 300 Kapiri Mission Hospital Low 75 150 225 300 Nkhamenya Mission Hospital Low 75 150 225 300 Mponela Mission Hospital Low 75 150 225 300 Dwangwa Clinic Low 75 150 225 300 Mlale Mission Hospital Low 75 150 225 300 Lilongwe Bottom Hospital Medium 150 300 450 600 Mitundu Rural Hospital Low 75 150 225 300 Kabadula Rural Hospital Low 75 150 225 300 Lingadzi Private Clinic Low 75 150 225 300 African Bible College Clinic Low 75 150 225 300 MARS Hospital Low 75 150 225 300 Lilongwe SOS Clinic Low 75 150 225 300 City Centre Clinic Low 75 150 225 300 Adventist Clinic Low 75 150 225 300 Sucoma Estate Clinic Low 75 150 225 300 Ngabu Rural Hospital Low 75 150 225 300 St Martins Mission Hospital Low 75 150 225 300 Zomba Central Prison Low 75 150 225 300 Ndirande Health Centre Medium 150 300 450 600 Chilomoni Health Centre Low 75 150 225 300 Limbe Health Centre Low 75 150 225 300 Bangwe Health Centre Low 75 150 225 300 MwaiWathu Private Hospital Medium 150 300 450 600 Chitawira Private Hospital Low 75 150 225 300 Seven Day Adventist Hospital Medium 150 300 450 600

APPENDIX 5: CALCULATIONS OF THE NUMBER OF PATIENTS ACCESSING HAART

This assessment of the number of patients is calculated as follows:-

a) Patients in the public health sector on HAART by July 1st 2004.

It is known from the hospitals already implementing HAART (QECH, Lighthouse, Thyolo, Chiradzulu and Ekwendeni) that just under 4,000 patients were on HAART by Janaury 1st 2004. It is predicted that another 2,000 patients will start on HAART in these institutions between January 1st and June 30th 2004.

Thus, by July 1st 2004 6,000 patients will be on HAART.

b) Patients in the private sector on HAART by July 1st 2004.

This figure is unknown at the present time.

c) Patients in the public health sector in the 50 primary ARV delivery hospitals who start on HAART between July 2004 and June 2005

Hospitals in these groups are divided into 3 categories: Low burden – recruiting 25 new patients per month; Medium categories – recruiting 50 new patients per month; and High categories – recruiting 150 new patients per month. Of the 50 hospitals, 21 are low burden, 25 medium burden and 4 are high burden. For each hospital the cumulative number of patients recruited to HAART by end June 2005 is shown in Appendix 3.

After a 12 month period, it is calculated that 28,500 new patients will have started on HAART by end of June 2005.

d) Patients in the other28 public and private ARV delivery hospitals who may start on HAART between July 2004 and June 2005

Hospitals in these groups are divided into 2 categories: Low burden – recruiting 25 new patients per month; Medium categories – recruiting 50 new patients per month. Of the 28 hospitals, 24 are low burden and 4 are medium burden. For each hospital the cumulative number of patients recruited to HAART by end June 2005 is shown in Appendix 4.

After a 12 month period, it is calculated that 9,600 new patients will have started on HAART by end of June 2005. 35

APPENDIX 6: PATIENT MONTHS ON HAART (WRITTEN IN EXCEL)

(See separate document)

APPENDIX 7: ARV PROCUREMENT: STARTER PACKS AND CONTINUATION PACKS

7.1. Composition of each Starter pack and Continuation pack

The calculations are based on:- a) Low Burden Units, seeing 25 patients per month. 3-month periods (ie 75 patients per month) An estimate that 80% of patients will be 60Kg or less (ie needing d4T-30mg) and 20% will be 61Kg or more (ie needing d4T-40mg) b) For each patient, a 15 day induction phase with d4T/3TC plus d4T/3TC/NVP followed by 30 days therapy with d4T/3TC/NVP twice a day

Basic 3-month Starter Pack for a Low-Burden Unit

60 tins [containing 15 tablets] of d4T/3TC – (d4T-30mg strength)

15 tins [containing 15 tablets] of d4T/3TC – (d4T-40mg strength)

60 tins [containing 15 tablets] of d4T/3TC/NVP – (d4T-30mg strength)

15 tins [containing 15 tablets] of d4T/3TC/NVP – (d4T-40mg strength)

120 tins [containing 60 tablets] of d4T/3TC/NVP – (d4T-30mg strength)

30 tins [containing 60 tablets] of d4T/3TC/NVP – (d4T-40mg strength)

Basic 3-month Continuation Pack for a Low-Burden Unit

180 tins [containing 60 tablets] of d4T/3TC/NVP – (d4T-30mg strength)

45 tins [containing 60 tablets] of d4T/3TC/NVP – (d4T-40mg strength)

7.2. Estimates of the number of Starter packs and Continuation Packs for the 12 month period (July 2004 to June 2005)

If all 78 sites started in July 2004, there will be 45 Low Burden sites (needing one basic pack), 29 Medium Burden sites (needing two basic packs) and 4 High Burden sites (needing 6 basic packs).

The number of starter packs in each 3 month period stays the same at 127.

The number of continuation packs increases as the year progresses: In Q3 2004 there is no continuation pack needed In Q4 2004, there is need for every unit to have 127 continuation packs In Q1 2005, there is need for every unit to have 127 x 2 (254) continuation packs In Q2 2005, there is need for every unit to have 127 x 3 (381) continuation packs

Packs: Q3 2004 Q4 2004 Q1 2005 Q2 2005

Number of Starter packs 127 127 127 127

Number of Continuation packs Nil 127 254 381

APPENDIX 8: BUDGET FOR THE YWO-YEAR PLAN

Issues to consider for programme costs include:-

• Training – development of training module and implementation of training courses

• Site preparedness – refurbishing of rooms, cabinets, tables, chairs, weighing scales, phones and telephone lines

• Stationary – ARV registers, treatment cards, identity cards

• Patient education materials

• HIV test kits

• ARV drugs

• Quarterly supervisions

• Planning and coordination meetings

• Operational research

• Annual review meetings

38 APPENDIX 9: TIME FRAME FOR SCALING UP ANTIRETROVIRAL (ARV) THERAPY IN 2004

Scale Up Activities Months of 2004 with January = month 1 and December = month 12 1 2 3 4 5 6 7 8 9 10 11 12 Country-wide situational assessment (public and private sectors) X X X Assessment of number of patients treated with HAART X X X ARV drug quantification, costs and specification X X X ARV Monitoring Tools printed and in place in sites giving ART X X X Training modules and preparedness criteria produced X X X HIV/AIDS Unit strengthened X X X Improved HIV/AIDS care management and coordination X X X X X X X X X X X X Meetings for preparedness (health sector / development agencies) X X X Campaign to inform the general public X X X X X X X X X X X X Patient Education materials developed and produced X X X X X X X X X X X X Procurement, distribution and security of ARV drugs X X X X X X Budget development and financing mechanisms X X X Training of staff to deliver ARV therapy in hospitals X X X VCT and ARV Clinic preparedness X X X X X X Development of Monitoring and Evaluation mechanism X X X Development of Supervisory systems X X X X X Coordination and support of operational research X X X X X X X X X Hospitals assessed as being ready to implement ARV therapy X X X X X X Hospital implementation of ARV therapy X X X X X X Hospital site visits by Supervisory teams X X X X X X Monitoring/ evaluation/ recording and reporting of Q3 X X X

40 Appendix 6: Calculation of ARV drug needs (patient-months) and costs for '2 YEAR PLAN TO SCALE UP ART IN MALAWI'

Public sector hospitals to start HAART in July 2004 (see appendix 1)

Burden of # new patients health facility # of facilities per month July August September October Novembe

r December January February March April May June small 21 25 525 13,650 26,775 39,900 53,025 66,150 79,275 92,400 105,525 118,650 131,775 144,900 medium 25 50 1,250 63,750 2004 126,250 188,750 251,250 313,750 376,250 438,750 2005 501,250 563,750 626,250 688,750 large 4 150 600 90,600 180,600 270,600 360,600 450,600 540,600 630,600 720,600 810,600 900,600 990,600

2,375 168,000 333,625 499,250 664,875 830,500 996,125 1,161,750 1,327,375 1,493,000 1,658,625 1,824,250

Current number of people on HAAR total public sector hospitals T

6,000 6,000 6,000 6,000 6,000 6,000 6,000 6,000 6,000 6,000 6,000 6,000

Other health facilities (including some private facilities) (see appendix 2)

Burden of # new patients health facility # of facilities per month July August2004 Septembe 2005

r October November December Januaryy March Februar April May June small 24 25 600 15,600 30,600 45,600 60,600 75,600 90,600 105,600 120,600 135,600 150,600 165,600 medium 4 50 200 10,200 20,200 30,200 40,200 50,200 60,200 70,200 80,200 90,200 100,200 110,200 large nil total other facilities 800 25,800 50,800 75,800 100,800 125,800 150,800 175,800 200,800 225,800 250,800 275,800

GRAND TOTAL (# people on ART, 9,175 199,800 390,425 581,050 771,675 962,300 1,152,925 1,343,550 1,534,175 1,724,800 1,915,425 2,106,050

# patient-months on ART (cumulative) 9,175 208,975 599,400 1,180,450 1,952,125 2,914,425 4,067,350 5,410,900 6,945,075 8,669,875 10,585,300 12,691,350

costs of drugs by end of month (cumulative), 203,685 4,639,245 13,306,680 26,205,990 43,337,175 64,700,235 90,295,170 120,121,980 154,180,665 192,471,225 234,993,660 281,747,970