Innovation for an HIV-free generation: Mother-Baby Pack 6 month report: Implementation Phase 1 - January 2011

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1 Innovation for an HIV-free generation: Mother-Baby Pack 6 month report: Implementation Phase 1 - January 2011 Background Everyday around 1,000 babies are newly infected with HIV during pregnancy, birth or breastfeeding. These infections can be averted by implementing a programmatic intervention called Prevention of Mother to Child Transmission (PMTCT). PMTCT provides medicines that reduce the risk of HIV transmission from the HIV positive mother to her child. When implemented effectively PMTCT can result in a less than 5 per cent chance of HIV infection the child without this programme there is a per cent rate of infection in in babies. However, weak health systems, logistical challenges, drug stock-outs, distances to health facilities, availability and cost of transportation and their own health often make it difficult for mothers to access the PMTCT medicines for their own health and the well-being of their child. In 2007, health workers in Lesotho overcame some of these challenges by packing all medicines needed for PMTCT in one convenient take-home bag - with impressive results. Based on the lessons learnt from this innovation, in 2009, UNICEF and partners took the idea to scale and developed the Mother-Baby Pack. This pack contains all antiretroviral drugs and prophylactic antibiotic cotrimoxazole - from 14 weeks of pregnancy until 6 weeks after delivery - needed to reduce HIV transmission from the mother to the child during pregnancy, delivery and breastfeeding. The first phase - implementation with validation - of the Mother-Baby Pack, is currently underway in Cameroon, Kenya, Lesotho and Zambia, delivering approximately 27,000 Mother-Baby-Packs and related commodities to mothers in need. Funding Support The initial cost of phase I of implementation with validation was estimated at $3,414,063 in June 2010 (see proposal). This proposal was supported through National Committee contributions from Austria, Germany, Japan, Netherlands, the United Kingdom and the United States of America. Further contributions and increased demand for the packs has resulted in an overall budget of $5.61 million with additional contributions from UNITAID, OPEC and the US Centers for Disease Control (CDC). *UNICEF, UNAIDS & WHO Towards Universal Access: Scaling up priority services for women and children in the health sector Progress Report, 2008, pg. 80 UNICEF Mother-Baby Pack Report January

2 MBP Implementation with validation: Progress at a Glance Kenya National and district level MBP planning meetings held in October ,000 MBP received in October 2010 Developed district and national level plan and budget Staff trained in December 2010, all staff trained by March 2011 MBP will be implemented in 281 health facilities in 2 provinces Global launched by UNICEF Executive Director on October 29 th 2010 Lesotho Piloted a take-home pack of PMTCT drugs in 2008 which inspired the development of the Mother-Baby Pack Developed a modified MBP in 2010, using existing supplies which were co-packaged into MBP boxes (53,000 boxes prepared) Country updated the PMTCT guidelines in September 2010 PMTCT and MBP trainings conducted in December 2010 Country-wide roll out of the MBP to all pregnant women living with HIV is ongoing MBP launch on 28th January 2011 in Mukhunoane health center, Botha Bothe district Zambia National and district level MBP planning meetings held in September ,500 MBPs received in November 2010 Developed district and national level plan and budget Training Tools developed for PMTCT including MBP Trainings take place in early January 2011 MBP will be implemented in 200 health facilities in 8 districts MBP launch in January 2011 Cameroon National and district level MBP planning meetings held in November Developed district and national level plan and budget 1,200 MBPs ordered in December 2010 PMTCT guidelines and training tools to be developed in January 2011 Trainings to be conducted by February 2011 MBP will be implemented in 65 health facilities in 3 districts MBP launch in March 2011 Progress: Partnership to develop the MBP In February 2009, UNICEF established a Mother-Baby Pack Technical working group (TWG) made up of WHO and other key implementation partners to guide and inform on the progress and challenges of the Mother-Baby Pack development process. The TWG provided advice on the content and packaging of the Mother-Baby Pack and guidance in the selection of the countries for the phased implementation with validation of the packs. The members also support the implementation at country level through their various representatives. Getting Mother-Baby Packs to the countries In June, 2010, the first order of 10,000 English version Mother-Baby Packs was placed with CIPLA in India. The production of packs was completed in October 2010 and 4,500 packs were shipped to the implementing countries. UNICEF worked with partners and the governments to ensure that the clearance and approval for the import of the MBP from the National Drug Authorities / Pharmacy and Poisons Boards was obtained. UNICEF Mother-Baby Pack Report January

3 CIPLA submitted all documentation required by the local regulatory authorities in the four implementing countries to register the Mother-Baby Pack including each individual component. The quantification of the Mother-Baby Packs need was based on estimates that governments reviewed with support from UNICEF and partners in the context of their current PMTCT coverage and HIV prevalence. The final quantification also included important commodities required to ensure an efficient PMTCT program such as diagnostics for testing for HIV, Nevirapine solution for the exposed infant for 12 months, and cotrimoxazole for the mother and the baby beyond the pack s period (6 weeks after birth) to support safe and exclusive breastfeeding. In order to simplify the Mother-Baby Pack ordering process and to expand the pack to Francophone countries, UNICEF has developed a French version of the pack. This version will be available for the coming Mother-Baby Pack orders to CIPLA in Currently, during the phased Implementation with validation, the procurement of the packs is done by governments through UNICEF s Supply Division. Planning to ensure effective delivery of Mother-Baby Packs To ensure the effective delivery of Mother-Baby Packs to mothers in need, extensive orientation, planning and training was undertaken at national and local levels in the implementing countries. Orientation meetings were held in each country between the government, UNICEF, implementing partners and stakeholders to inform partners on the Mother-Baby packs and to discuss the possibility of MBP implementation. National and district level planning meetings were held in Zambia (September 2010), Kenya (October 2010) and Cameroon (November 2010). These meetings included participation from The Ministry of Health Province, district managers Department of AIDS Control Health workers Central Medical Stores Community support groups Drugs Regulatory Authority Women living with HIV Government agencies involved in laboratory and diagnostic services Implementing partner organizations at national and district levels Government agencies involved in Bilateral Organizations monitoring and evaluation and research Multilateral Agencies Planning meetings included a review of technical background information on the PMTCT programme, the Mother-Baby Packs, the Procurement and Supply Management (PSM) system, laboratory and diagnostic system, monitoring, evaluation and operations research and discussed key operational questions. These included: 1. What should the minimum requirements for facilities be to provide the Mother-Baby Pack? 2. How should capacities for CD4 cell count testing for the mother be addressed, to assess her eligibility for anti-retroviral therapy for her own health (ART)? 3. How can individuals, families and communities be involved in a meaningful and useful way? UNICEF Mother-Baby Pack Report January

4 4. How to address issues of possible stigma and discrimination? 5. How should extra or left-over drugs be managed? 6. Should the Mother-Baby Pack be provided in ante-natal care clinics, delivery settings or at the community level? 7. Should nurses, midwives, community health workers, lay counsellors or peers provide the Mother-Baby Pack to the pregnant women? 8. Should the Mother-Baby Pack be provided on the day of the pregnant women s HIV positive test result or when her CD4 test result is known? 9. Should the Mother-Baby Pack be provided to women all at one time or in parts during the period of care for Maternal and Newborn Child Health (MNCH)? 10. If am HIV positive pregnant woman receives the Mother- Baby Pack, should a different pack be provided to all other women to reduce stigma? 11. What elements of systems strengthening / capacity development are required to support infant feeding and maternal / paediatric nutrition? 12. How to address capacity for EID testing Meeting participants in technical groups discussed programmatic and coordination questions related to the Mother-Baby Pack implementation within the existing PMTCT programme in the respective country and developed recommendations for: 1. Mother-Baby Packs and maternal and neonatal health services 2. Mother-Baby Packs and the supply of commodities and laboratory needs 3. Community involvement for utilization of ANC and delivery services and uptake of PMTCT and Mother-Baby Packs 4. Monitoring and evaluation of PMTCT and Mother-Baby Packs 5. Coordination and follow up for the Mother-Baby Pack implementation District specific working groups discussed the Mother-Baby Pack implementation including capacity building, community involvement and quantification of packs at district level. The groups developed district specific action plans including activities and budgets taking into consideration the technical recommendations. Lessons learnt from the country level planning process 1. The national planning meetings reinforced the importance of the involvement and participation of communities in the Mother-Baby Pack implementation process. Community support and participation are a crucial element in support of the mothers and their families and for the successful and sustainable implementation of the Mother-Baby Pack. 2. The national planning meetings and implementation plans highlighted the importance of strengthening overall health systems including the maternal and child health platform (ANC, delivery, postnatal care) from which the PMTCT programme including the MBP implementation are operating. Ensuring the continuum of care for mothers and their babies is vital and includes access to MCH services and to important commodities such as HIV tests, CD4 tests, and nevirapine suspension for children beyond the pack. 3. The planning meetings also reinforced the importance of partnerships at all levels, global, national, district and facility to ensure effective implementation of the MBP. UNICEF Mother-Baby Pack Report January

5 Launching the Mother-Baby Packs in the implementing countries Following the National and District level planning workshops, countries developed costed district and national action plans and budgets. The countries prepared for the Mother-Baby Pack launch in the following way: 1. Activities to strengthen programme management, coordination and monitoring at central, district and health facility level Strengthening maternal and child health services to ensure the availability of comprehensive services for the mother and her baby including access to CD4 testing, early infant diagnosis, infant and young child nutrition services, Nevirapine for the baby and care and support for mothers and children infected with HIV. Updating the recording and reporting tools to be able to monitor the packs implementation 2. PSM activities Detailed quantification of MBP needs and post-natal PMTCT commodities based on revised district goals and targets Ordering of commodities with support from UNICEF supply division Ensuring the distribution and storage of the Mother-Baby Packs 3. Capacity building including development of training tools and actual trainings Development of training tools for the 2010 PMTCT guidelines and the MBP implementation Training of health workers in the implementing districts 4. Community engagement to support participation and implementation Sensitization meetings Global launch of the Mother-Baby Pack: Maisha Initiative in Kenya The Maisha Initiative is a Kenyan government-led programme that aims to ensure the elimination or reduction to no more than five per cent of HIV transmission from mothers to babies in 2 provinces by 2013, and the country-wide elimination of mother-to-child transmission of HIV by In order to achieve this goal, strategies were developed to address five gaps areas in the current programme: 1. Lack of skilled birth attendants, male involvement and infant feeding support: Implement a Community Health Worker Strategy and a Performance Based Incentive for Health Facilities (HSSF) 2. Address loss to follow up and infant feeding support: Implement Mentor Mothers (M2M) and rapid SMS for community health workers to promote mothers returning to clinics for follow up care and support 3. Inefficacious regimens and drug shortages in clinics: Promote more efficacious regimens of medicines provided through PMTCT by implementing the 2010 WHO guidelines and the MBP 4. Low testing of infants: Scaled implementation of Clinton HIV/AIDS Initiative (CHAI) and Government of Kenya early infant diagnosis (EID) strategy 5. Discrimination and lack of family support: Involve men to support their pregnant spouses and develop effective messages for infant and young children feeding (Kata Shauri Strategy) The Maisha initiative was launched in October 2010 by the Government of Kenya in the presence of the UNICEF Executive Director, Mr. Anthony Lake and other dignitaries with the Mother-Baby Pack highlighted as a key component to this comprehensive approach. UNICEF Mother-Baby Pack Report January

6 Staying on track and learning as we deliver Continuously learning from the Mother-Baby Pack implementation at country level is of highest importance for UNICEF and partners and is part of the validation process. UNICEF in partnership with the Elizabeth Glazer Pediatric AIDS Foundation (EGPAF) developed a monitoring and evaluation (M&E), and operations research (OR) framework to monitor the implementation of the packs. The M&E and OR activities as part of the framework will generate evidence to strengthen overall PMTCT programme performance and assess the performance of Mother-Baby Pack implementation. The key operational questions are: 1. How is the PMTCT programme performing? 2. What is impact of Mother-Baby Pack implementation on the health system and on PMTCT performance? 3. What is the impact of the Mother-Baby Pack implementation on pregnant women, their families and on health workers and what are facilitators and barriers to implementation Answers to these questions will guide the future Mother-Baby Pack implementation and scale up to additional sites in the four countries and to additional countries. A programme review will be conducted in mid 2011 and will include an analysis of programme data (collected during the implementation) to assess progress, identify gaps, inform policy makers on programmatic corrections required and identify sites for more detailed operations research. The evidence generated will guide detailed recommendations for scale up of the MBP by the end of Mother-Baby Pack Monitoring, Evaluation and Operations Research Framework The Monitoring & Evaluation (M&E) component objectives: 1. Strengthen the countries PMTCT M&E systems in light of the 2010 WHO guidelines and updated indicators 2. Implement a Mother-Baby Pack monitoring system to generate evidence on the performance and impact of the implementation The Operations Research component objectives: 1. Determine the acceptability and feasibility of the Mother-Baby Pack implementation at country level 2. Describe the effect of receiving the Mother-Baby Pack on: Disclosure of HIV status, perceived stigma, social harm experienced, pregnancy/postnatal care-seeking behavior by women after delivery 3. Assess among women who receive the Mother-Baby Pack and health care workers who dispense it their knowledge of PMTCT the use of the Mother-Baby Pack appropriate drug dosing 4. Determine whether the use of the pack increases the proportion of pregnant women living with HIV who receive and adhere to the recommended medicines for PMTCT prophylaxis compared with the standard PMTCT practice 5. Identify and document barriers to and facilitators of successful Mother-Baby Pack implementation Partnerships for success UNICEF continues to engage with a number of partners to support the development and implementation of the MBP. Some key partnerships include: Chaired by UNICEF and WHO, the Inter-agency Task Team (IATT) on the prevention of infection in pregnant women, mothers and their children and care and treatment of HIV-infected children comprises of 23 members. The purpose of the IATT is to help scale-up programmes that prevent HIV infection in women, mothers and their children, in line with UNGASS resolutions, as well as expand UNICEF Mother-Baby Pack Report January

7 the UN comprehensive approach to PMTCT and setting the global agenda. The IATT accomplishes this by assisting in the development of policy and operational guidance and providing technical assistance to national governments Recent discussions with Johnson & Johnson have taken place regarding the strengthening of the Mother-Baby Pack packaging and presentation based on detailed feedback from mothers, health workers and the community during the initial implementation. UNITAID continues to support the broader PMTCT services delivery and has embraced the Mother- Baby Pack as a key innovation to increase access to women in need. Other key partners include: WHO, Elizabeth Glaser Pediatric AIDS Foundation, The Clinton Foundation, Office of the US Global AIDS Coordinator including CDC and USAID, Columbia University s Mailman School of Public Health and PATH

8 Print : 1. Le Berry Républicain, Dec Un «pack maman-bébé 2. L'Indépendant, Dec Sida : lancement d'un «pack» thérapeutique maman-bébé 3. La Charente Libre, Dec Sida: des raisons d'espérer 4. Shinano Mainichi Shimbun, Japan (local newspaper) - Aug Article's title: "Sekai no Kodomotachi" (Children of the World) (attached) Online: 1. Capital News, Kenya- Mothers targeted to stop HIV spread BY SARAH WAMBUI Capital news 2. Daily Nation, Kenya New plan to prevent HIV spread to babies By DANIEL OTIENO Daily Nation /1070/ /-/view/printVersion/-/6utronz/-/index.html 3. Vietnam news National English Language Daily, Vietnam Innovation for HIV-free generation 4. Xinhua, China UNICEF rolls out innovative way to prevent mother-to-child HIV transmission in Kenya 5. Top News New Zealand Mother-Baby Packs Introduced in Kenya to Reduce HIV Transmission 6. VOA News, USA Kenya, UN Take New Approach to AIDS Babies 7. Plus News, Global KENYA: Mother-baby packs to reduce HIV transmission 8. Business Daily Africa : By IRIN and IPS, Regional Mother-baby packs to reduce HIV transmission in Kenya Kenya%20/-/539444/ /-/item/2/-/dxb1qfz/-/index.html 9. Daily News Pulse, 14 Dec UNICEF Releases Report Declaring Achievable Goal of Eliminating Pediatric HIV/AIDS Enfant, Dec Le pack Maman-Bébé : l'espoir d'une génération sans sida Maman-Bebe-l-espoir-d-une-generation-sans-sida.html 11. Voxy, New Zealand, Dec Hiv Positive Babies Born Daily Unnecessarily BBC, Dec Journée mondiale contre le sida The Standard, Hong Kong, Nov Runners make numbers count in AIDS race &fc=10 Timeline October 2010 November 2010 December 2010 January 2011 March 2011 June 2011 Mother-Baby Packs arrive in Kenya and Zambia Official Mother-Baby Pack launch by Anthony Lake in Kenya Lesotho receives MBP boxes to co package their own Mother-Baby Packs Start of trainings of health workers in the 2010 PMTCT guidelines and in the Mother-Baby Pack Official Mother-Baby Pack launch in Zambia and Lesotho Mother-Baby Packs arrive in Cameroon Official Mother-Baby Pack launch in Cameroon Review of Mother-Baby Pack programme performance Planning for phase 2 August 2011 Final Report Mother-Baby Pack Phase 1 November 2011 One year reflection of the Mother Baby Pack UNICEF Mother-Baby Pack Report January

9 Anthony Lake: Executive Director, UNICEF To achieve an AIDS-free generation we need to do more to reach the hardest hit communities. Every day, nearly 1000 babies in sub-sarahan Africa are infected with HIV through mother to child transmission our Fifth Stocktaking Report on Children and AIDS highlights innovations like the Mother-Baby Pack that can bring life-saving ARV treatment to more mothers and their babies than ever before We know how to reach those hit hardest by the AIDS crisis and the time has come that for us to recongise that because we can we must (respond) Jimmy Kolker: Chief, HIV Section Prevention of mother-to-child HIV transmission is a highly effective way to safeguard babies from the virus, so it s crucial in eastern and southern Africa the region hit hardest by the global epidemic. What s more, AIDS is the leading cause of mortality among women in this part of the world, and the drugs used to block transmission protect the health of both mother and child. Everyone has to do more, national governments need to increase responsibility to for both prevention and treatment, care and support and donor money needs to used effective and we are working clearly in 190 countries around the world as UNICEF to help build that government capacity to use the resources as effectively as possible Dr. Chewe Luo: Senior Advisor, HIV Section We know what is required to prevent mother to child HIV transmission. These medicines already exist. The real challenge is how to ensure availability and to encourage women to follow the complicated regimen that changes over the course of pregnancy, labor, and after the baby is born. One of the main thrusts of this work is to simplify how these drugs can be delivered to mother, simplify the messaging with the provider and also to simplify the planning for these drugs for the program managers. Flora: Mentor Mother from Kenya In 2006, when she was pregnant with her last-born child, she was tested and found to be HIV positive. At that time, there was no Mentor Mothers programme. Flora went home with her ARVs. No one told her about disclosure -- how she was supposed to inform her husband. So, when she did tell him, she was met with constant torrents of abuse. Consequently, it was difficult for her to keep on taking the ARVs. Flora was so stressed that she wasn t even eating properly. When it was time for her to have the baby, she did not adhere to the instructions for taking the ARVs that would have protected her child from being infected. The labour was prolonged and her baby was born HIV positive. Her child is on HAART. As a Mentor Mother, Flora has been able to help so many women by providing information and psycho-social support. I am happy about the Mother-Baby Pack as some mothers only come once for ANC. Now after they get the information from the Mentor Mothers they will understand how important it is to use the Mother-Baby Pack in the right way. UNICEF Mother-Baby Pack Report January

10 UNICEF Mother-Baby Pack Report January th