1. Comprehensive Goals and Objectives

Despite an extensive literature on improved PMTCT regimens, post-exposure prophylaxis, and rapid clinical progression in HIV-infected infants, there has been scant progress made on how best to coordinate and ensure delivery of the multiple services that HIV-positive mothers and their infants require in the real-world setting. In the Lilongwe area, the BCM-CFM Tingathe outreach program has made

strides in developing systems to improve the quality and utilization of PMTCT, EID, and pediatric HIV care services. The main goal of this project is to expand the scope and reach of the Tingathe program resulting in a majority of mothers and infants at participating facilities receiving the full complement of PMTCT and EID services and prompt entry of infected infants and mothers into care for optimal treatment outcomes. This goal will be achieved through the following objectives:

a. Conduct operations research to identify barriers to mothers and infants accessing of services and strategies to overcome these barriers and improve service delivery. b. Sensitize the community to reduce stigma and increase utilization of services. c. Strengthen coordination and linkages between services to help ensure provision of comprehensive medical care. d. Improve the quality of existing services and their capacity to absorb increased patient load via training, mentorship, and supervision of MOH staff, with a focus on the Northern Zone and Blantyre District for clinical HIV services more broadly, as well as capacitating other partners to provide enhanced support to improve pediatric HIV on a national level. e. Provide a continuum of care for infected women and their infants starting at ANC and continuing until a definitive positive or negative diagnosis of exposed infant. f. Improve identification of HIV-infected women and children and early referral to care through both health facility based and community home based testing and active case finding. g. Improve adherence supervision and defaulter tracking activities. h. Engage and coordinate services provided by local NGOs, CBOs, FBOs and other stakeholders to HIV- infected mothers and their infants.

2. Linkage to Partnership Framework (PF) between PEPFAR and the Government of Malawi (GOM) The Tingathe program addresses all four goals of the Partnership Framework as follows:

a. To reduce new HIV Infections in Malawi. Through improved utilization of PMTCT and EID services there will be a dramatic decrease in the number of children infected through MTCT, which currently accounts for up to one quarter of all new infections.

b. To improve the quality of treatment and care for Malawians impacted by HIV. The main goal of this project is to use Community Healthcare workers (CHWs) to improve quality and linkages between PMTCT, EID, and pediatric HIV Care and Treatment services.

c. To mitigate the economic and psychosocial effects of HIV and AIDS and improve the quality of life for PLHIV. Through this program, patients and their families will be followed by CHWs who will advocate for them and ensure that they are receiving all available services.

d. To support the above listed goals in Prevention, Treatment and Care by providing discrete systems strengthening support in human resources. Our CHWs will serve to improve quality of services and the continuum of care at participating health care facilities and will serve as an example of how task-shifting can result in overall strengthening of the care system.

3. Geographic Coverage Service delivery will be focused on ten high burden sites in the Central Region. Based on successful implementation at these sites, we have plans to expand coverage to high burden sites in both the North and South. Site assessments in the North and South will begin during year one of the program, with initial implementation activities starting during the second year.

4. Health System Strengthening Through demonstration of improved service delivery, this project aims to inform policy on optimal and efficient use of task shifting and community health workers to improve PMTCT, EID and Pediatric HIV Care and Treatment Services.

5. Cross-Cutting Attributions a. Human Resources for Health (HRH) b. Food and Nutrition- Policy, Tools, and Service Delivery c. Food and Nutrition - Commodities

6. Key Issues a. Health-Related Wraparounds: Child Survival Activities; Safe Motherhood b. Gender: Increasing Gender Equity in HIV AIDS Activities and Services; Addressing Male Norms and Behaviors

7. Cost Efficiency We expect that cost efficiency of the programs will improve as we develop best practices and refine our training, mentorship, and supervision tools. We anticipate long-term cost savings for the health care system as successful PMTCT should reduce the number of patients needing chronic HIV care.

8. Linkage with GOM Activities Our letters of support from MOH affirm that this program is fully in line with the MOH emphasis being placed on PMTCT. Our program addresses many of the activities outlined under Strategic Objectives 1 and 2 from the Malawi National HIV Prevention Strategy (2009-2013), specifically: 5.1.1 Reduce multiple and concurrent sexual among adults; 5.1.5 Reduce HIV transmission among HIV-discordant partners.

5.2.1 To provide universal HIV testing and counseling for women and their partners, adolescents in child- bearing age. 5.2.3 Strengthen linkages between PMTCT, ART, prevention, reproductive health, maternal and child health, and primary health care services. 5.2.5 Provide comprehensive PMTCT, care, treatment and support to HIV positive pregnant and lactating women and their families. 5.2.6 Provide care and support to all HIV exposed infants at facility and community levels.

9. Summary of Monitoring and Evaluation We have developed standardized registers and patient mastercards to track identified pregnant women, exposed infants, and infected children. Site coordinators will collect and input data into a Microsoft Access database. They will also be required to randomly supervise at least 15% of visits for quality assurance purposes. Clinicians will also conduct site visits and review data regularly. Data will be crosschecked with national registers.

4. BUDGET CODE: HVCT ($53,375 for Year 1; $99,688 for Year 2)

One of the primary goals of Tingathe is to increase the capacity to identify and provide services to patients with HIV. A significant limitation to identifying patients has been that VCT is facility-based and conducted passively at health centers with a limited number of trained VCT counselors. To overcome this obstacle, all members of the outreach team will be trained in HTC. CHWs will be involved in both facility based and door-to-door home-based testing. They will also be used to ensure that all family members of known infected patients are offered testing. When infected patients are identified, the CHW continues to follow them to ensure that they enter clinical care and are receiving all required, available services. In addition, CHWs are trained to do active case ?nding in the community and health centers to aid early identi?cation.

Activity 1: Training of CHWs in HIV Counseling and Testing All CHWs will be trained in HTC and EID. CHWs will get extended supervision by more senior counselors and CHWs. Once this training is complete they will start to conduct testing at the health center and within the community.

This activity includes the Cross-Cutting Attribution: Human Resources for Health (HRH) as our CHWs will greatly augment the capacity to conduct counselling and testing.

Products/Deliverables: • 75 CHWs trained in HTC and EID

Activity 2: Health Facility Based HCT and Active Case Finding Our CHWs will augment the human resource capacity at the health center to conduct HIV Counseling and Testing. CHWs will be involved not only with passive testing, but will also engage patients at other key access points include ANC, TB clinic, adult ART clinic, STI, OTP and supplemental feeding nutrition clinics. The goal will be to make sure patients and their families at these high burden sites have been offered and counseled on the importance of HIV testing. Often patients are unable to bring their whole families to the health center for testing. Home-based testing will be offered for those clients who have family members at home who require testing. This is described further in activity three below. CHWs will also attempt to link patients who already know their status into care and treatment.

Products/Deliverables: • 3,500 adults and children receiving HTC within the health facility

• >95% of exposed infants receiving PCR test at <18months • 400 new or known but not in care HIV infected adults and children identified and enrolled into care • 250 new exposed infants identified

Activity 3: Community Based HCT and Active Case Finding During the first year of the Tingathe program, CHWs conducted over 7500 HIV tests in the community in a door-to-door fashion. This activity was a great success and well received by the community. A number of patients who otherwise might not have accessed counseling and testing were able to receive the service. We plan to expand the reach and scope of this activity with the proposed expansion of the program. CHWs will also attempt to link patients who already know their status into care and treatment.

Products/Deliverables: • 8,500 adults and children receiving HTC • 600 new or known but not in care HIV infected adults and children identified and enrolled into care • 100 number of new exposed infants identified

3. BUDGET CODE: PDCS (Cost: $68,750 for Year 1; $171,875 for Year 2)

BCM-CFM has a strong history of developing innovative pediatric HIV care and treatment programs. With our proposed program we aim to apply these lessons to improve important aspects of pediatric care including adherence supervision, nutritional support, defaulter tracking, and routine childhood health maintenance activities. CHWs will follow all newly identified and treatment non-adherent patients monthly and provide adherence counseling, as well as, infant feeding counseling, nutritional screening, and prompt referral for support. In addition, they will make sure that their patients receive all available health related services. As part of this effort, they will engage local partners and stakeholders on an ongoing basis to help coordinate more comprehensive care for their patients.

Activity 1: Improved coordination between pre-HAART, ART, and Under-5 clinics As described under MTCT Activity 5, our CHWs will be working to improved coordination between PMTCT, EID, and Pediatric HIV Care And Treatment programs. To date, programs have especially struggled with linking exposed and infected infants into care. With this program, our CHWs will provide the necessary link to ensure these infants enter care. CHWs will ensure that exposed infants will receive

the correct ARV prophylaxis, PCR testing, cotrimaxazole prophylaxis, that mothers are appropriately counseled on safe breastfeeding, and that newly positive infants are enrolled into care.

This activity is related to the Key Issue: Health Related Wrap Around: Child Survival.

Products/Deliverables: • 1500 infants enrolled into Tingathe program • 1500 infants having PCR test • 1450 infants receiving ARV prophylaxis • 1500 infants receiving cotrimaxazole prophylaxis • 125 infants started on HAART

Activity 2: Nutritional Support This activity relates to Cross-Cutting Attribution: Food and Nutrition: Policy, Tools, and Service Delivery. BCM-CFM is developing a training package on nutrition and infant feeding in the context of HIV. All CHWs and selected MOH staff working at target health centers will be trained in the curriculum. Topics such as breastfeeding, replacement feeding, complementary feeding, safe infant and young child feeding, nutritional assessment, and nutritional support (OTP, supplementary feeding) will be covered.

The Cross-Cutting Attribution Food and Nutrition: Commodities is also covered within this activity. As part of their regular monthly patient visits, CHWs will counsel patients on infant and young child feeding antenatally, perinatally and postnatally. They will support HIV-positive mothers concerning infant feeding options, as well as provide ongoing complete nutritional assessment using weight, length, MUAC, and assessment for edema. They will make referrals and ensure that their clients are receiving appropriate services. In addition, currently in partnership with Feed the Children, HIV-infected pregnant women and exposed infants followed in the Tingathe program, are given nutritional supplementation with Vitameal.

Products/Deliverables: • Nutrition and Infant feeding in the context of HIV training curriculum • 50 MOH staff trained in infant feeding in the context of HIV • 3500 HIV infected children and adults screened for malnutrition using MUAC • 50 HIV infected children and adults referred for treatment for malnutrition (OTP) • 1500 pregnant/lactating women and exposed infants supported with supplementary feeding. • 1500 number of pregnant/lactating women receiving on-going nutritional assessment • 1000 number of exposed infants receiving on-going nutritional assessment • >95% infants exclusively breast feeding

• 1500 number of HIV infected women receiving antenatal, peri- and postpartum counseling on infant and young child feeding

Activity 3: Adherence Supervision Adherence is critical to the success of ARV treatment. Good adherence prevents the development of resistant forms of HIV virus, and resulting treatment failure. Studies on adherence show that adherence rates must be 95% or higher for long-term treatment success. Patients judged to be at risk for poor adherence and all newly diagnosed patients will be assigned a CHW. CHWs will follow these patients at least monthly to monitor adherence to treatment.

Products/Deliverables: • 1000 infected adults and children started on Cotrimoxazole prophylaxis • 1000 patients followed monthly for adherence supervision • 250 number of infected children started on HAART

Activity 4: Defaulter Tracing As mentioned above, adherence is critical to the success of ARV treatment. Hence, bringing defaulters back into care and conducting home visits to address the issues that place patients at high risk for poor adherence is essential to preventing treatment failure once patients are in care. We have developed a mapping and locator protocol to facilitate tracking of defaulters. Defaulters will be actively traced by CHWs. As with new patients and patients with documented poor adherence, defaulters will be followed at least monthly to monitor adherence to treatment.

Products/Deliverables: • 100 defaulters tracked • Percent defaulter rate for patients on HAART <5 percent

Activity 5: Engage and coordinate services provided by local NGOs, CBOs, FBOs and other stakeholders Prior to Tingathe, there had been minimal coordination between our clinical care providers and the grass- roots groups and organizations providing services within communities. Several community-based organization (CBO) leaders voiced desires to improve contacts between groups providing services. Tingathe hosted a number of meetings for local community leaders, religious leaders and staff from NGO/CBO/FBOs. CHWs also conducted basic assessments of many of the NGO/CBO/FBOs in our catchment areas. These summaries were used to develop a NGO/CBO/FBO directory. This referral directory is meant to improve coordination among organizations and more comprehensive patient care. We plan to improve and expand these activities as we engage new facilities and catchment areas.

Products/Deliverables: • Regular meetings of organization providing services to women and children • Compilation of list of organizations providing services to women and children • Detailed assessments of organizations providing services to women and children • Compilation of Community Resource Directory • Regular Updating of Community Resource Directory

BUDGET CODE #2: PDTX In partnership with MoH, BCM-CFM has endeavored to scale up provision of comprehensive pediatric HIV care at ART clinics nationally through our Pediatric HIV Outreach and Training program. BCM-CFM has developed a systematic approach, called Mphatso, to on-site training and clinical mentorship in pediatric HIV care and has contributed to the improved capacity of ART clinics and providers to provide quality care and increase the enrollment of HIV infected and exposed children into care. This program proposes to use lessons learnt from the Mphatso experience to develop a comprehensive package of training in PMTCT, EID, and Pediatric HIV Care and Treatment. MOH providers will be trained and supervised so all sites participating in the program will be able to offer this minimum package of services.

Activity 1: Site Assessments Thorough site assessments will be carried out before the roll out of interventions. Information to be gathered will assess PMTCT, EID, and ART service delivery. BCM-CFM will develop a minimum package for excellence in service delivery of PMTCT, EID, HIV care and treatment. The information gathered through site assessments will be used to create detailed and specific plans for each center to achieve the minimum package for excellence. This activity includes the Cross-Cutting Attribution Human Resources for Health (HRH) as it involves planning for the necessary workforce to accomplish the proposed improvements to PMTCT, EID, and Pediatric HIV Care and Treatment Services. Site assessments for the North and South will also begin in the first year of the program. All site assessments and action plans will be done in collaboration with the district and zonal health offices.

Activity 2: Training, Mentorship, and Supervision of MOH Providers Our proposed program will result in an increase in the number of HIV-positive pregnant women, exposed infants and infected children accessing services at participating sites. MOH staff will need to be well

prepared and trained for this increase in demand. BCM-CFM has a developed systematic program, called MPHATSO (Malawi Pediatric HIV/AIDS Treatment Support Outreach), to conduct on-site training and clinical mentorship in pediatric HIV care and has contributed to the improved capacity of ART clinics and providers to provide quality care for HIV exposed and infected infants and children. The MPHATSO approach relies on mentorship teams consisting of doctors, nurses, clinical officers, data clerks, and CHWs to mentor MOH staff and improve services. This program proposes to use lessons learnt from the MPHATSO experience to develop a comprehensive package of training in PMTCT, EID, and Pediatric HIV Care and Treatment. Clinical officer and nurse mentors will be recruited to work with Baylor Pediatricians to instruct and supervise MOH staff in this comprehensive package. Support will be provided by the UNC project and the KCH/Bwaila Department of Obstetrics and Gynecology for mentorship on PMTCT and antenatal care. This activity includes the Cross-Cutting Attribution Human Resources for Health (HRH) as it involves pre-service and in-service training of health care providers.

Activity 3: Support for decentralization of pediatric treatment on a national level

With the support of the MOH, Baylor College of Medicine has played an important national leadership role in developing high quality service delivery models for pediatric care and treatment including approaches to expand PITC in high-volume facilities, linking children and families into longitudinal care, strengthening community-based systems to improve retention of children in clinical care, and providing on-site mentoring and training to build staff skills in pediatric treatment. Given their expertise in pediatric care and treatment as well as in training and mentoring of MOH ART clinics, Baylor is well-positioned to complement the technical assistance other partners are providing to facilities, and to develop service outreach models which would allow pediatric ART to be decentralized to lower-level health centers, so that all ART providers throughout the country are equipped to also treat children through a family- centered approach. A small proportion of FY10 PMTCT additional funds will be utilized to further expand these efforts to decentralize pediatric ART to high-burden districts which are not currently benefitting from the program. Baylor physicians, nurses, and clinical officers will accompany the other 4 zonal mentoring partners is some instances to provide district level technical assistance to help capacitate more lower- level ART sites to initiate a large number of children on treatment, especially children <18 months, using both DNA-PCR testing as well as presumptive therapy

Activity 4: Maternal and neonatal health: Piloting rapid EID turnaround and immediate treatment initiation in the peripartum period

Given that extended postnatal NVP is now being recommended for PMTCT, it will be even more

important to attempt to rule-out infection of neonates with EID before starting this. It also may be strategic to link EID to the time surrounding delivery rather than waiting to perform the test at 4-6 weeks as is currently practiced, so that infants in need of ART can be initiated on treatment as soon as possible. Therefore, at a small number of high volume urban sites with capacity support, Baylor will pilot and evaluate an approach in which HIV-positive postpartum women and their infants remain at the hospital or maternal waiting facilities until they receive EID and CD4 results with a rapid turn around. This could enable HIV-infected children to start ART immediately and non-infected to children to start postnatal NVP prophylaxis, while at the same time ensuring HIV-positive pregnant women receive quality postpartum care and ART initiation if eligible. A brief report documenting implementation experience of piloting and evaluating immediate postnatal EID and ART initiation for eligible children will be produced.

1. BUDGET CODE #1: MTCT ($802,523.00)

Activity 1. Supportive mentorship and quality improvement in the Northern Zone and Blantyre District: Baylor mentorship activities will focus on supporting the Northern Zonal Health Office and the Blantyre district. Team of Baylor physicians, clinical officers, and nurses will mentor and support ZHOs and DHOs to build their capacity to supervise, plan, and to help PMTCT sites develop and implement systems for better managing patient care and data flow. Sites will be supported to provide a comprehensive package of PMTCT services for mothers and children, with an emphasis strengthening linkages and referrals between HIV care and treatment services and PMTCT. These efforts are part of a broader zonal quality improvement initiative, in which, under MOH leadership, Baylor will collaborate with 4 other USG partners who are supporting the other 4 zones and share best practices to improve the quality of PMTCT services with one another. Baylor will especially focus its mentorship activities on the Karonga district and high volume sites within the Mzimba district, as these have much higher prevalence than the other districts in the North, as well as at high volume and high prevalence sites in Blantyre district where Baylor will also be providing support for service delivery through its Tingathe community health worker program.

Activity 2. Scaling up Tingathe program to additional high-volume sites The move to start pregnant women on ART at an earlier CD4 count will necessitate more intensive psychosocial support, as data from several settings seem to indicate that such clinically well patients are at a higher risk for default than other patients starting ART. The Tingathe program, which is implemented

in Malawi by Baylor College of Medicine, is an example of a successful intervention with lay cadres that has shown dramatic results in the improvement in the PMTCT cascade. Using additional PMTCT funding, Baylor will scale-up the Tingathe program to at least double the number, focusing on high prevalence sites in Lilongwe's central region, Blantyre, and Karonga. Complementary support will be provided through the USG for similar approaches implemented through a network of community-based platforms that are already on the ground to expand these lay workers in a way that is sustainable and can be taken to national scale. Please see PACT, CHAM, and MSH entries for more details.

Activity 3. Support for decentralization of pediatric treatment on a national level

With the support of the MOH, Baylor College of Medicine has played an important national leadership role in developing high quality service delivery models for pediatric care and treatment including approaches to expand PITC in high-volume facilities, linking children and families into longitudinal care, strengthening community-based systems to improve retention of children in clinical care, and providing on-site mentoring and training to build staff skills in pediatric treatment. Given their expertise in pediatric care and treatment as well as in training and mentoring of MOH ART clinics, Baylor is well-positioned to complement the technical assistance other partners are providing to facilities, and to develop service outreach models which would allow pediatric ART to be decentralized to lower-level health centers, so that all ART providers throughout the country are equipped to also treat children through a family- centered approach. A small proportion of FY10 PMTCT additional funds will be utilized to further expand these efforts to decentralize pediatric ART to high-burden districts which are not currently benefitting from the program. Baylor physicians, nurses, and clinical officers will accompany the other 4 zonal mentoring partners is some instances to provide district level technical assistance to help capacitate more lower- level ART sites to initiate a large number of children on treatment, especially children <18 months, using both DNA-PCR testing as well as presumptive therapy.

Activity 4. Maternal and neonatal health: Piloting rapid EID turnaround and immediate treatment initiation in the peripartum period

Given that extended postnatal NVP is now being recommended for PMTCT, it will be even more important to attempt to rule-out infection of neonates with EID before starting this. It also may be strategic to link EID to the time surrounding delivery rather than waiting to perform the test at 4-6 weeks as is currently practiced, so that infants in need of ART can be initiated on treatment as soon as possible. Therefore, at a small number of high volume urban sites with capacity support, Baylor will pilot and evaluate an approach in which HIV-positive postpartum women and their infants remain at the hospital or maternal waiting facilities until they receive EID and CD4 results with a rapid turn around. This could enable HIV-infected children to start ART immediately and non-infected to children to start postnatal NVP

prophylaxis, while at the same time ensuring HIV-positive pregnant women receive quality postpartum care and ART initiation if eligible. A brief report documenting implementation experience of piloting and evaluating immediate postnatal EID and ART initiation for eligible children will be produced.

Activity 5. Renovations of high volume MCH sites in the Central East and Northern Zone and Blantyre district

Renovations will mainly focus on upgrading antenatal sites to meet the MOH criteria for qualification as ART sites, and also will improve the condition of labor and deliver wards at high-volume sites, provide additional space for storage of commodities, and enhance patient flow between services. The process to select sites for renovations will be done in close consultation with the MOH and other stakeholders and utilize evidence-based criteria, for example prioritizing those sites that could enroll many more women on ART if they had the proper physical infrastructure. Efforts will also be made to leverage already approved Global Fund resources for renovations at MCH sites that would enable the renovations to achieve more national coverage of MCH sites, and also to utilize USG non-HIV health funding to increase the scale of effort further. Renovations will be coordinated with those to be funded under other sources (i.e. Global Fund, SWAp) to ensure that there is no duplication. Activity 6. Capacity building to improve data utilization and reporting in the Northern Zone and Blantyre Baylor staff will work side by side with Northern Zonal staff and district health staff of Chitipa, Mzimba, Karonga, and Blantyre to build their capacity to use data to improve programs and to better report to the MOH on the national level what they have accomplished. Baylor will then report to PEPFAR how they its efforts have helped the Northern zone and districts receiving support. PMTCT Data will be reviewed on at least a quarterly basis with health officers; action plans will be developed and implemented to address data quality issues identified; and feedback will be provided to PMTCT sites to enable them to improve their program in specific ways and monitor such improvements.

Activity 7. Operations Research Programs supported by UNC Project in Lilongwe have found that provision of free clean water materials is associated with increased antenatal attendance and postnatal follow-up and also that sites which provide targeted food supplementation to HIV-positive lactating women in the postnatal period have much higher rates of follow-up. Support is also to be provided through other partners in Malawi through the Baylor Tingathe program and other platforms to use lay cadres to reduce loss-to-follow-up. The UNC Project will therefore collaborate with Baylor and other partners to conduct operational research around this important area to help inform national policy on how these various approaches should be used appropriately. The research will attempt to evaluate the cost-effectiveness and sustainability of different approaches. This will broadly address the PEPFAR priority PMTCT/peds OR question: "What are the interventions at the program, facility, community, and household level that have the greatest impact on

retention in care, especially in the first 12 months of life?" The program design for the Tingathe Program is fairly simple. Pregnant women who are diagnosed with HIV in community health centers are assigned a CHW and enrolled into the program via opening of a patient mastercard. Detailed location information is gathered at this point to allow proper follow-up. CHWs are responsible for ensuring that mother-baby pairs receive all appropriate services including obtaining CD4 counts, following up CD4 results, enrollment into ARV clinic if appropriate, provision of ARV prophylaxis for mother and child, testing/diagnosis of exposed infants, provision of CPT to exposed infants, counseling on infant feeding, and enrollment of newly positive infants into care. They follow their clients at their homes and at the health centers, from initial diagnosis up until cessation of breastfeeding and negative diagnosis or successful enrollment of positive infants into care (activities and services provided to infants to be described in PDCS and PDTX budget codes). Mothers of infants who test negative will be enrolled in the new adult pre-HAART clinics as they are formed. Listed below are the main activities involved under budget code MTCT. Many of these activities have considerable overlap with activities under budget codes PDTX, PDCS, and HVCT and this is noted in the description.