The Ministry of Health (MOH) plays the primary implementing role in the national HIV response. They complement the National AIDS Commission (NAC) and the Office of the President and Cabinet (OPC) policy development role through collaborative development of guidelines and scale-up plans to implement programs in the health sector, and to guide the private sector in their activities. MOH was a new Implementing Mechanism in FY09, and several departments are supported in under-funded areas which are critical to ensure effective and complete implementation of national programs supported by the Global Fund.

Within MOH, this implementing mechanism supports several departments: The HIV and AIDS Department, the Central Monitoring and Evaluation Department (CMED), the Community Health Sciences Unit (CHSU), the National TB Program (NTP), the Nursing Department, the Department of Finance and the Department of Diagnostics. The role of this implementing mechanism is to have national level impact on increasing access, quality, and sustainability in the following areas: Comprehensive HIV services including HIV Counseling and Testing (HTC), pre-ART care for those not yet eligible for ART, Prevention with Positives (PwP) interventions in pre-ART and ART settings, adult and pediatric antiretroviral therapy (ART), prevention of mother-to-child transmission of HIV (PMTCT); referrals between all HIV services; coordination, implementation and monitoring of TB/HIV activities; scale-up of HIV-related lab services; health management and information systems (HMIS) and monitoring and evaluation (M&E) systems.

In the second year of the program the Malawi Ministry of Health will continue implementing activities started in FY09. USG funding will be used to support the implementation of the National Action Framework (NAF) through expanding both the scope and quality of HIV and AIDS prevention, treatment, and care and support services, and to address cross-cutting issues such as training, capacity building, policy development and staffing and management.

The MOH implementing mechanism has several specific objectives: 1) To strengthen comprehensive HIV services across the continuum of care from prevention to treatment, with an emphasis on improved referrals and linkages 2) To increase access to adult and pediatric HIV care and treatment 3) To expand the range and quality of PMTCT services, including the strengthening of infant follow-up, care and treatment 4) To strengthen coordination, implementation and monitoring of integrated TB and HIV services 5) To scale-up the provision of HIV-related laboratory services 6) To support critical surveillance activities around HIV incidence, and emerging adult and pediatric drug resistance 7) To strengthen health management and information systems (HMIS) and monitoring and evaluation (M&E) systems 8) To increase the capacity of policy makers and program managers in the Malawi MOH to design, implement and evaluate HIV and TB services.

MOH will coordinate the use of the funds, which will be in a discrete account, separate from other donor and Ministry funds. The monitoring of activities in each department will be done through quarterly meetings a steering committee comprised of the Directors of those departments implementing the Cooperative Agreement. Reporting on activities conducted will be through existing reporting mechanisms in MOH, from health centers to district level, and district level directly to zonal health offices (ZHO) and

the relevant Department in MOH. Progress and financial reports will be provided as needed to CDC.

Budget Summary PFIP Year 1 Funding - $1,720,000 (includes 50,000 CHSU; 200,000 NTP) PFIP Year 2 Funding - $4,200,000

HBHC - $430,000 (Department for HIV and AIDS & Nursing Dept) (Department for HIV and AIDS $250,000, activities 1-3; Nursing Dept $180,000, activities 4-6)

Malawi is making progress towards achieving its target of enrolling 250,000 individuals on antiretroviral therapy (ART) by 2010. By March 2009 there were 223 public and private health facilities delivering ART in all districts, with 158,137 patients alive on ART. The National ART program is working to decentralize ART to lower level health facilities as well as to develop a pre-ART program as part of its scale up plan (2010-2013), and will need extensive support to succeed. The Nursing Department will work to ensure

linkages between facility and community are strengthened, and care and prevention activities are implemented at community level.

A formalized pre-ART program is being planned which will improve the management of PLWA from diagnosis until the initiation of ART through: • Minimizing patients 'lost-to-follow-up' between HTC and ART clinics • Following HIV-positive individuals closely enough to ensure timely initiation of ART and minimize early mortality • Reaching the population most at risk of transmitting HIV to those who are negative with effective HIV prevention messages

The Department for HIV and AIDS will start program development and implementation activities in Year 1 and continued in Year 2, including: 1. Conceptualization and development of pre-ART program a. Conduct 2 one-day meetings with stakeholders and implementers to determine the minimum pre-ART package, which will include facility based Pre-ART (Adult & pediatric) and community based Pre-ART which will include issues to do with community support, counseling, prevention issues including BCC and prevention with Positives activities (Year 1) b. Conduct 2 two-day workshops to develop and produce guidelines and training manuals for Pre-ART to be incorporated into existing guidelines and manuals (Year 1) 2. Implementation of pre-ART program a. Conduct 5 (in each zone) TOT training on the guidelines and modules for Pre-ART b. Conduct training and in-service training for new and current providers on Pre-ART c. Roll out Pre-ART to all sites which can implement the minimum package according to guidelines d. Conduct onsite mentoring for sites implementating pre-ART to ensure smooth programme implementation and improve scale-up through an iterative learning process 3. The development and roll-out of M&E tools for monitoring Pre-ART programme and client outcomes (outcomes will be divided into died, defaulted, transferred out, started on ART or discharged for exposed infants found HIV negative at 18 months /after weaning) a. Conduct a 2 day workshop for stake holders & implementors to develop M & E tools for Pre-ART (Year 1) b. Produce and distribute Pre-ART registers, Master cards and patient ID's for Adult/PMTCT Pre-ART, Infant & pediatric Pre-ART c. Conduct 5 (in each zone) TOT trainings on M & E tools for Pre-ART d. Conduct training & in-service training for new and current providers on the M & E Tools e. Conduct quarterly supervision of the Pre-ART package implementation by integrating with the quarterly TB/ART supervision

The Nursing Department will emphasize the complementary community activities through: 1. Review and update the National Community Home based Care Policy and Guidelines (NAF Objective 2.3.1) to incorporate community-based pre-ART a. Conduct one 5 day meeting to revise CHBC policy and guidelines b. Print revised CHBC policy and guidelines c. Conduct 3 regional 2 day meetings to disseminate revised policy and guidelines at zonal level 2. Build capacity of community health nurses, medical assistants and HSAs to provide community-based pre-ART services. a. Incorporate pre-ART into existing CHBC training manuals b. Develop job aids for providers on community based pre-ART package c. Print and distribute community-based pre-ART job aid and training manuals d. Train community health nurses, HSAs and community volunteers in community based pre-ART in districts 3. Strengthen capacity of PLHIV support groups on pre-ART a. Map out existing PLHIV support groups in collaboration with PLHIV support groups e.g. NAPHAM, MANET, etc b. Support community health nurses and HSAs, in collabortion with NAPHAM, MANET, to establish community-based PLHIV support groups c. Develop handbook on formation and managing PLHIV support groups and strengthening capacity of PLHIV support groups to provide pre-ART services (counselling on need for CD4 testing/staging and OI management, and referral for such services; status disclosure, stigma reduction, treatment literacy, adherence, positive prevention, defaulter tracing, psychosocial and spiritual support, nutrition counselling, and referral of pre-ART and ART patients to other social support services (nutrition, income generating activities, legal services, etc)), 4. Strengthen supervision and oversight of implementation of community-based pre-ART in districts a. Provide transport support to community health nurses and HSAs to monitor and supervise implementation of community-based pre-ART services b. Conduct quarterly mentoring visits to districts

HVCT - $350,000 (Department for HIV and AIDS) HIV Testing and Counseling (HTC) has scaled up rapidly in the last few years, and Malawi is now preparing to roll out Provider-Initiated Testing and Counseling (PITC) in mid-2009 while continuing to

strengthen other areas such as couples and pediatric testing. Support is needed to strengthen provision of comprehensive HTC services including PITC, increase the quality of HTC services nationally, print and disseminate HTC tools and materials, and conduct basic program evaluation.

Activity 1: Strengthen provision of comprehensive HIV Testing and Counseling (HTC) services 1. Institutionalize and roll out Provider-Initiated Testing and Counseling The focus will be on rolling out provider initiated HIV testing and counseling services to government health care institutions, especially the district hospitals and CHAM facilities. PITC will continue being introduced throughout the health care system, and especially in paediatric wards, female and male medical wards, OPDs, ANC, STI clinics, Under 5 clinics and family planning clinics. Training and orientation of health care workers including TOT will continue to ensure that health care worker comply with guides and protocols for PITC.

While institutiionalizing PITC; • the linkages between linkages between HTC, PMTCT, ART, TB, and other related service will further be strengthened, and, • the supply chain management systems for HIV test kits and other HIV commodities will be consolidated.

2. Intensify Couple HIV and Child HIV Counseling Training and orientation of HTC trainers in Couple and Child Counselling will continue to ensure that all HTC trainers are proficient in training counsellors in couple and child HIV Counselling. This will cascade to refreshing and strenthening skills for all HTC counsellors in health care facilities and NGOs/CBOs in counselling couples and discordant couples.

3. Improve the quality of post test counseling Revising the post-test counseling curriculum will strengthen prevention messages, and improve completion of referrals, enrollment and retention in care.

Activity 2: Strengthen Quality of HTC services Intensified supervision through training in HTC supervision Strengthen quality of HTC services through: • intensified training in HTC supervision, • intensified monitoring of HTC supervisors at district level • support to national supervision of HTC week campaign events • improvement of transport capacity for HTC supervision; and • review and update all HTC superivision tools.

• Quality Assurance for Whole Blood Rapid Testing: • Quality of HTC will further be improved through the sustained provision of Quality Asssurance for Whole Blood Rapid Testing (WBRT) and profiency testing.

Activity 3: Procurement, printing and production of HTC resource Materials This will include additional procurement of stop watches, additional printing of Couple HIV Counselling Training Guide and Participant Manual, Child Counselling Training Guide and Participant Manual, additional printing of the generic HTC Training Participant Manual; additional procument of HTC training aids, e.g. DVDs.

Activity 4: Basic Program Evaluation Develop and review innovative models aiming to strengthen referrals between HTC, PMTCT, TB, Pediatric and adult ART, and community-based programs with the aim of ensuring continuum of care and minimizing loss to follow up. A specific focus will be to evaluate effectiveness of referrals of HIV positives from HTC into the new pre-ART clinics 'Family HIV Care Clinics'.

Development and implementation of models and guidelines/recommendations based on the above evaluations and current international best practices.

HVSI - $400,000 (CHSU Epi $300,000; CMED $100,000)

Community Health Sciences Unit The Epidemiology section at Community Health Sciences Unit (CHSU) of the Ministry of Health is mandated to coordinate disease surveillance activities including HIV surveillance. For HIV surveillance: the activities have included conducting surveys for HIV prevalence, HIV drug resistance and sexually transmitted infections (STI).

In the financial year 2009-2010, the Epidemiology Unit will implement with USG support, HIV Incidence surveillance among high risk populations and general population, providing training in basic epidemiology, and prospective monitoring of HIV drug resistance strains among adult patients taking ART. In the financial year 2010 we shall continue with the prospective monitoring of drug resistance in adult patients, incidence surveillance, and training in basic epidemiology. In addition there will be

monitoring of HIV drug resistance among pediatric patients.

Activity 1: Prospective monitoring of HIV Drug Resistance Strains Prospective monitoring of drug resistance started in February 2008 and will continue until 2010. Samples are collected every 12 months and next sample collection is due February 2009 and thereafter February 2010. Sample collection will be in March 2010, activities will include supervision, data abstraction, procurement of reagents and supplies.

Activity 2: Monitoring of pediatric of HIV Drug resistance in pediatric patients Transmitted drug resistance from mother to child will be assessed using residual samples from the early infant diagnosis program. This program keeps samples collected from six weeks after delivery. Activities shall include protocol development, and data abstraction from medical records.

Activity 3: Incidence surveillance Incidence surveillance using laboratory Assays in Malawi starts in 2009 in Malawi and is using samples collected as part of Demographic and Health Surveys in 2004, and in Behavioral and biological surveys conducted in 2006 among high risk populations. DHS will be repeated in 2009 and next BSS is scheduled for 2010. These samples will be tested for incidence monitoring in 2010.

Activity 4: Internet and network connections Epidemiology unit collects surveillance data from health facilities on selected priority diseases including HIV/AIDS. For the unit to provide timely information and response there is need to have up to date communication facilities and equipments. Currently the unit is not connected to internet or any network that facilitates transfer of data between offices. In this proposal we plan to connect internet and network facilities within Epidemiology unit.

Activity 5: Basic Epidemiology Training In the 2009 financial year we are introducing basic training in Epidemiology in order to strengthen surveillance skills. This program will continue in the year 2010 to send MOH staff members for short courses.

Central Monitoring and Evaluation Division ($100,000) The Central Monitoring and Evaluation Division which falls under Department of Planning and Policy Development is responsible for coordinating the overall Health Management Information System (HMIS) in MOH. This HMIS is guided by the principles of integration of all routine information systems, decentralization in information generation and use, and provision of information for action which is simple to establish and maintain.

The integrated HMIS is designed to provide program managers and staff with reports on how well each program is functioning and to alert the service providers and program managers to take timely necessary corrective actions. In the FY10, CMED will collect and analyze GIS data, support the roll out of electronic data systems for ART clinics, engage with stakeholders on security, data exchange and interoperability of health information and install the data repository server.

Activity 1: Capacity Building in GIS data analysis In Year 1 CMED will collect GIS data for health facilities including ART clinics in order to update the existing information that was last collected in 2003. The GIS Training workshop for district HMIS officers will serve as a capacity building platform for local use and information gathering for the zone and national level. Subsequent GIS data analyses will use GOM ORT funding.

Activity 2: Support Electronic Data System of the HMIS CMED will continue to provide policy leadership on data collection including the functioning of EDS operated by Baobab Health, Luke International Norway, and MSF among others so that they are in line with the HIS Policy and Strategy. This will be achieved through: • Supervision of installation and functioning of the EDS • Supervision of on job training for Health Care Workers in implementation of the EDS at facility level

Activity 3: Implementation of National Data Standards • Support to CMED for the implementation of National Data Standards involves: • Consensus building on issues of National Data Standards Technical Working Group; • Disseminate knowledge and experience sharing at International Data Standards forums; • Annual review meeting to review changing technical knowledge.

Activity 4: Establishment and maintenance of the Central Data Repository Server The support for EDS and roll out of the web-based DHIS will require the procurement of data warehousing facility at the national level. This will benefit from the continuous process of instituting a platform for the national data standards and will in FY0 involve: • Reviewing technical specifications for the DRS • On-the-job training (OJT) in Central Data Repository Server for CMED staff and zone M&E officers

With Year 2 PEPFAR funds the previous activities will be continued, and the following activities will be implemented:

Activity 5: Update tools for forecasting and quantification of commodities and other supplies

Activity 6: Train health workers, statistical clerks and M&E officers on the newly developed/updated data collection tools

HVOP - $70,000 (Department for HIV and AIDS)

With the renewed emphasis on increasing sustainability of national ART programs, it is imperative that all HIV services have integrated HIV prevention activities which are practical and feasible for the country context, and which more completely address the issue of reducing multiple concurrent partnerships among other risky behaviors. Prevention is also important for those on ART, to minimize the likelihood of contracting or transmitting potentially resistant strains of HIV to partners.

A reduction in incidence of new HIV infections will be achieved through combination prevention encompassing prevention counseling, ART as prevention, PMTCT, BCC, condom promotion, distribution and use, male circumcision and prevention with positives. This will be done through developing a Prevention-with-Positives (PwP) strategy applicable to both clinical and community settings, and identifying health facilities and communities for implementation in a phased-in approach.

Activities will include: • Identify feasible and practical Prevention-with-Positives (PwP) activities to be integrated with clinical HIV services including the new pre-ART program • Produce IEC materials for all prevention strategies • Conduct zonal awareness raising workshops with stakeholders including NGO's and PLWHA support groups • Develop and implement guidelines for prevention activities in collaboration with the National AIDS Commission and the Office of the President and Cabinet

1. PMTCT Budget Code ($1,100,000.00)

PMTCT services have scaled-up very rapidly since 2007, from less than 25% of Maternal and Child

Health (MCH) sites offering PMTCT services at the start of 2007, to 77% of MCH sites offering PMTCT by September 2008. The scale-up will continue with an increasing focus on improving the quality of PMTCT services, improving coverage and the choice of prophylaxis regimens used nationally, strengthening systems for the identification and follow-up of HIV-exposed infants and their mothers, and increasing access to infant diagnosis and referral for ART.

Activities for FY09 which will be continued in FY2010 include:

Activity 1: Strengthen district capacity to provide PMTCT services, and to sensitize communites on PMTCT • Organize national co-ordination meetings • Support districts to develop male friendly services in order to increase couple counseling, disclosure of HIV positive results and support for these women when they receive results together with their spouses • Develop and implement a community PMTCT strategy to increase access to HIV prevention, care and treatment by HIV positive women, men and children through developing community support structures such as support groups

Activity 2: Increase the capacity of health workers to provide PMTCT services • Finalize, print and implement ANC, Labour and Delivery and Postnatal Care Pre- and Post Counseling and Testing Tools and improve the skills of health workers in providing this service • Conduct PMTCT training to increase the number of health facilities offering PMTCT services • Orient Health Surveillance Assistants (HSAs) who provide HTC for pregnant women and who work in under-five clinics on PMTCT to improve the quality or pre-test group education, individual pre and post- test testing and counseling and identification of HIV exposed infants respectively • Train health care workers in early infant diagnosis to increase access for universal ART for HIV infected infants

Activity 3: Improve the access to and quality of PMTCT services provided • Provide job aids to help health care workers to improve the quality PMTCT service provision inclusive of giving appointments to pregnant women for return visits to health facilities • Consolidate and sustain quality of PMTCT services in public, CHAM and private health facilities providing at least one MCH services through building the capacity of zones and PMTCT Coordinators to manage and provide regular supportive supervision of staff providing PMTCT services • Develop, print and disseminate Psychosocial Support Guidelines to encourage women to appreciate the importance of the knowing their HIV status for early access to CPT and ART as needed • Increase the number of pregnant women receiving a complete course of ARV prophylaxis • Train PMTCT service providers to roll out combination regimen

• Revise and print the PMTCT Training Package to make it up-to-date • Orient health care workers on the use of newly developed ANC and Maternity Registers to improve the quality of data recording and reporting

Activity 4: Improve the linkages, referrals and follow-up for all HIV-positive pregnant women • Develop sustainable referral system for HIV positive pregnant women between PMTCT, HCT, ART, STI and TB services, including linking the mother's status to baby • Support development of Postnatal Care and Follow Up to improve management of HIV positive mothers and their infants/children

Activity 5: Strengthen infant follow-up and care • Roll out 'Family HIV Care Clinics': Integrate follow-up clinics for HIV exposed infants with the new national pre-ART program • Increase the proportion of HIV-exposed infants starting on CPT from six weeks of age • Increase the proportion of HIV-exposed infants accessing PCR testing from 6 weeks of age • Support the diagnostic department to increase laboratory capacity in DBS processing • Develop the a sustainable CD4 and DBS sample transportation • Procure hemacule machines and cuvettes • Support the central medical stores to to develop a sustainable storage mechanism for early infant diagnosis supplies • Support development and printing of Under-five and Follow Up registers, patient cards and revision of the child health passport to include HIV information • Conduct basic program evaluation to inform best practices and decision-making in mother-baby follow- up

Activity 6: Supporting rapid dissemination of new guidelines to PMTCT Providers ($50,000) • Finalize on the new PMTCT guidelines • Print the guidelines • Disseminate the guidelines through successive trainings of PMTCT ToT's at zonal level

Activity 7: Training of nurses and other providers at ANC sites in provision of ART ($400,000) • Train nurses in ANC to provide ART in a continued effort to decentralize ART and to minimize loss-to- follow up of pregnant women eligible for ART

Activity 8: Decentralization of pediatric treatment and scale-up of pediatric Cotrimoxazole ($100,000) • Train PMTCT and under-5 clinic providers in early infant follow up for exposed infants, including DNA- PCR testing, provision of CPT from six weeks of age, and strengthened referrals for children presumed

positive in sites where DNA-PCR diagnosis is not available

Activity 9: Monitoring national Indicators ($150,000) • Printing of revised PMTCT registers • Finalization of the under-5 register to include a component on screening for HIV-exposed infants • Printing of the under-5 register • Development of a register to follow HIV-exposed infants if not adequately included in the pre-ART tools • Printing of HIV-exposed infant register • Training of providers in revised registers

HLAB - $150,000 (CHSU lab $50,000; Diagnostics $100,000)

In 2010 the National Reference Laboratory and the Diagnostics Unit will continue the activities initiated with FY09 funding. The emphasis in on improving the quality of services provided by the labs nationally, increasing the lab capacity at sites, including the equipment available and the technicians trained to utilize the lab.

1. Provide national quality assurance for all surveillance and laboratory-based activities in support of the diagnosis, treatment, and care of HIV/AIDS

2. Conduct training for Central Reference Lab Technologist on EQA management

3. Procure essential supplies and equipments

4. Enhance program for quality assurance of CD4, viral load, biochemical and hematological tests for monitoring HIV and AIDS patients on treatment

5. Undertake orientation of supervisors on EQA activities

6. Provide corrective actions to underperforming sites

7. Support regular maintenance of equipment at CHSU

HVTB - $400,000 (Department for HIV and AIDS & NTP) (Department for HIV and AIDS $200,000; NTP $200,000)

As in other Sub-Saharan African countries, Malawi faces the challenge of dual epidemic of HIV and TB. The high HIV prevalence in Malawi (12% among adults) has also fueled the TB epidemic and has lead to a five-fold increase in the reported TB cases from around 5,000 cases in 1885 to 27,000 cases in 2007. HIV prevalence among TB patients is 70%. Because of the high TB/HIV co-morbidity, it is crucial that the integration of TB/HIV activities be strengthened at all levels and across all services in the health care system.

Malawi has been in the forefront in the global TB/HIV response. Several models of integrated TB/HIV activities have been piloted by lighthouse, MSF, and TBCAP, however these activities have not been rolled out nationally. NTP in collaboration with the Department for HIV and AIDS will address these critical gaps in the implementation of integrated TB/HIV activities, with the goal of reducing the dual burden of TB and HIV through provision of universal access to integrated TB/HIV prevention, treatment care and support services.

With the support of previous PEPFAR funding, NTP and department of HIV/AIDS had planned to nationally roll out the integrated package of TB/HIV services. This roll out would be coordinated with other partners like TBCAP, Dignitas, MSF or Lighthouse supporting TB/HIV activities and other funding sources like the Global Fund. Routine provider initiated HIV testing and counseling and referral to ART services will be a standard package of care for all TB patients. Within the same comprehensive care approach, patients on ART are screened for TB using a standard checklist at every visit and referred to TB clinic if TB is evident or suspected. Similarly all HIV positive clients identified at a co-located HTC center are screened for TB using a standard checklist and referred for TB services if responses meet a set of predetermined criteria. These interventions are expected to reduce the burden of TB in HIV patients and the burden of HIV in patients. USG funding would also support monitor the implementation of TB/HIV activities through quarterly supervision and regular review meetings.

The PFIP Year 2 funds would continue to support to expand the geographic coverage of TB/HIV activities with a focus on the following activities. The activities would be coordinated with activities supported by the other funding resources to avoid duplication and to ensure that it compliments the existing resources and support. 1. Support national roll out of TB/HIV activities

National TB/HIV sub-group would continue to be supported to coordinate TB/HIV activities at the national level. Zonal and district health management teams would be sensitized on TB/HIV integration to ensure that these activities are incorporated into the district implementation plans. The FY10 funds would also be used to train of all ART and HTC staff in TB screening, diagnostic evaluation and TB infection control.

2. Integrate provision of ART in TB registration sites

Though there has been a great progress made with HIV testing among TB patients, uptake of ART among HIV-infected TB patients is very low. Improving uptake of ART among HIV-infected TB patients would be one of the priority areas. In addition to improving referral and linkages between TB registration sites and ART clinics, provision of ART at selected TB registration sites will be piloted at selected sites and rolled out to additional clinics.

3. TB infection control

Zonal and district level quality improvements teams would be trained in TB infection control. These quality improvement teams are expected to assist the facilities to implement TB infection practices through resources available under Global Fund round 7. TB infection control job aids like cough posters and triage poster would also be developed and made available at all the TB and HIV clinics.

4. Strengthen monitoring and supervision of TB/HIV activities:

Quarterly joint supervision by the national and zonal TB and HIV staff as well quarterly review meetings to monitor implementation of TB/HIV activities would be supported. An evaluation of the revised TB recording and reporting system would also be supported to assess quality of data.

5. Build capacity in pediatric TB/HIV integrated activities:

NTP would partner with Baylor Pediatric Center to build capacity to address TB/HIV issues in the pediatric population.