1. OVC Special Initiative Zimbabwe

2. Country Background: HIV & ECD Context Economic meltdown from 2001 to 2009 Children in Zimbabwe still face nutritional and developmental challenges (ZIMSTAT 2012, 2014) There are an estimated 1 million orphans Approximately 170,000 children (0-14 years) are living with HIV HIV prevalence is 13% for ages 15-49 years PMTCT services are provided in 95% of health facilities ECD services focus on 3-5 year olds, activities prepare children for school Few ECD programs provide interventions for children 0-2

3. The project is designed to support the GoZ in accelerating access to care and treatment to children living with HIV. Co-funding from PEPFAR/USAID Special Initiative (demand-side) and ELMA Philanthropies (supply- side) Based on the realization that less than 50% of ART- eligible children are actually on care and treatment (38%-46%) Expected reach: 23,000 children linked to care and treatment in 17 underserved districts over 3 years EIP Project Components

5. 1) Strengthen capacity of community-level cadres to identify children for enrollment in the ART program and to support adherence, nutrition, and psychosocial needs of families of HIV positive children (demand side- PEPFAR/USAID) 2) Increase uptake of and retention in PMTCT services for mother-baby pairs and increasing treatment access for HIV-exposed infants, children, and adolescents (demand side-PEPFAR/USAID) EIP Project Objectives

6. 3) Support the MOHCC to decentralize paediatric ART services from district hospitals to primary health care facilities (supply side-ELMA) 4) Strengthen the capacity of the primary health care delivery system to initiate early infant diagnosis and early infant HIV care and treatment (supply side-ELMA) EIP Project Objectives cont.

7. Research Component A Trial to Determine the Effects of a Comprehensive Community-based Multi- component Intervention on Early Childhood Development in Paediatric HIV Care and Treatment Programs

8. Partnership Framework

9. Intervention Description Intervention group will receive: 1.Parental Early Childhood Stimulation Training delivered monthly/fortnightly 2.Economic Strengthening through internal savings and lendings (ISALS) 3.Case Management for household follow-up on adherence & retention 4.MoHCC Standard of Care (adherence & retention counselling by facility staff) The control group will receive the Ministry of Health and Child Care standard of care (adherence & retention counselling by facility staff)

10. Early Childhood Stimulation Parenting Topics 1.Social support and how to access services 2.Responsive parenting practices 3.A well-nourished baby and young child (pregnancy and infancy) 4.A healthy infant and young child 5.Overview of child development 6.Physical/motor development 7.Social and emotional development 8.PMTCT and treatment adherence 9.Complementary feeding, hygiene 10.Communication and language development 11.Cognitive development - thinking and understanding the world 12.Positive discipline

11. ECS PILOT INTERVENTION PMTCT clients with children aged 0-2 years who obtain service at Makumbe Hospital constitute the target population. HIV infected and exposed children aged 0 to 2 years will be selected for the study. 50 mother-baby pairs will be selected from the health registers at the clinic. Five groups of ten (5x10) will be formed for the ECS program. ISALS groups will meet soon after the ECS education sessions Quality Assurance will be done by World Education and MoHCC THE SAME WILL BE DONE IN MAIN STUDY WITH ADAPTATIONS FROM LESSONS LEARNED IN THE PILOT

12. Pilot Implementation Strategy Duration of pilot study is three months: August to October 2015 Pilot study seeks to find if the curriculum is practical, usable, if the training duration and meetings are realistic, as well as determine cultural acceptability Mavambo ECD Officer will train community facilitators, and supervise the ECD programme Community ECD Facilitators will conduct fortnightly sessions with mothers and conduct home visits Case Care Workers will do referrals, follow-ups and home visits Community Based Trainers will provide ISALS training MoHCC Health Staff at hospitals and clinics will collect routine data World Education will offer technical support Research Consultant will collect research data, and conduct data analysis and reporting

13. Site Description The pilot site, Makumbe District Hospital, was chosen because of its high volumes of PMTCT clients (size of catchment area) The site provides accessibility for the training groups and ISALS, so as to enable supervision and quality assurance Study sites with similar research implemented by other programs were excluded Pilot site will be at least 20km from the main study sites to avoid contamination Sites with similar geographical, social and economic characteristics were selected for comparison IN THE MAIN STUDY, CLINICS FROM SAME DISTRICT WILL BE SELECTED, AS WELL AS THOSE FROM ADJOINING HIGH DENSITY URBAN AREA

14. Proposed Theory of Change

15. Study Design Randomised clustering of mother-baby pairs will be done based on catchment clinics Randomisation procedure will be undertaken, and will involve stakeholders like MoHCC, research consultant firm, World Education, NGO implementing partners and the community Sample size still to be determined to ensure adequate power for the various outcomes to be determined PRIMARY OUTCOMES compared between trial arms will include: Child development outcomes using the Mullen Scales for Early Learning I.Mean childhood development global score Child HIV outcomes I.% of HIV exposed or infected children with full retention in care (>80%) at 12 months II.% of HIV infected children with HIV viral load > 1000 copies per ml at 12 months

16. Study Design (continued) SECONDARY outcomes will be compared between trial arms: Child development outcomes using the Mullen scales for Early Learning –visual reception –expressive language –receptive language –fine motor skills Nutritional Outcomes –weight-for-age –height-for-age –weight-for-height –(BMI) z-scores Parenting outcomes –Parenting Stress Index

17. Study Design (continued) Adherence –% retention in care among HIV infected mothers at 12 months, categorized as (i) full retention (>80%), (ii) partial retention (30- 80%) or (iii) non retention (<30%). –% of HIV infected mothers with full retention in care (>80%) at 12 months –% of HIV infected mothers with a suppressed HIV viral load at 12 months –% retention in care among HIV exposed or infected children children at 12 months, categorized as (i) full retention (>80%), (ii) partial retention (30-80%) or (iii) non retention (<30%). – % of HIV exposed or infected children reporting > 95% adherence to cotrimoxazole +/- ART as appropriate in the previous 24 hours and previous 7 days

18. Key Timelines: Immediate milestones for piloting and initial study phases Training of Trainers conducted, 8 - 14 June 2015 Review of the ECD curriculum underway, final draft by 3 July 2015 Recruitment of 50 mother-baby pairs for pilot study by 28 July 2015 Cascading of training for ECD Community Facilitators, scheduled for 27 - 31July 2015 Main study to run November 2015 - October 2016

19. Learning Agenda & Information Dissemination The findings of the research will be disseminated to stakeholders and to ministries who influence policy and national program designs. Specific target ministries include: –Ministry of Health & Child Care: Responsible for PMTCT programs, antenatal and postnatal education of mothers –Ministry of Primary & Secondary Education: Responsible for ECD programming –Department of Child Welfare and Probation Services: Target the most vulnerable households and equip them with skills to cope with infants –Other donor & NGO programs that enable scale up of early childhood interventions

20. Thank You This presentation is made possible by the generous support of the American people through the United States Agency for International Development (USAID), AID 613-A-13-00002, and does not necessarily reflect the views of USAID or the US government. health@worlded.co.zw

21. A TRIAL TO DETERMINE THE EFFECTS OF A COMPREHENSIVE COMMUNITY BASED MULTI-COMPONENT INTERVENTION ON EARLY CHILDHOOD DEVELOPMENT, HOUSEHOLD ECONOMIC RESILIENCE, AND ADHERENCE AND RETENTION IN PAEDIATRIC HIV CARE AND TREATMENT PROGRAMS

22. Collaborative Study World Education Zimbabwe University College London CeSHHAR Zimbabwe London School of Hygiene and Tropical Medicine Stellenbosch University Oxford University

23. Setting Zimbabwe 14 million people 890,000 orphans 2012 Census estimated that 72% living below ‘poverty line’ 27.8% under 5’s moderate and severe stunting 11.2% under 5’s moderate or sever underweight Estimated that 1.4 million people living with HIV including 170,000 children (0-14 years) Uptake of ART among children suboptimal Option B+ rollout from Nov 2013

24. Goal To improve ECD, parenting, economic resilience and HIV retention and care outcomes among HIV exposed and infected infants aged 0-2 years as well as retention in care among their mothers using a comprehensive, community- based intervention

26. Outcomes after 12 months Primary Mean childhood development global score % of HIV exposed or infected children with full retention in care (>80%) at 12 months % of HIV infected children with HIV viral load > 1000 copies per ml at 12 months Secondary Childhood development scores –Visual, fine motor, receptive and expressive language Nutritional –Weight for age, height for age, Weight for height Parental stress index Adherence and retention in care– maternal and child Maternal mental health Food security

27. Formative work Pilot ECD intervention (around 50 participants in four groups) –Once weekly –Once every 2 weeks –Once every four weeks Pilot recruitment to ISALS group - Feasibility of allocating women to ISALS Pilot research procedures –Enrolment procedures –Questionnaire – before and after –Feasibility of using Mullen ECD score in this setting –Assess any changes in Child development scores as a result of ECD intervention Training, session content,, delivery, interval between sessions, acceptability, feasibility

28. Refine trial design How many clusters? How many dyads per cluster? Finalise intervention –Content of ECD sessions –Training and supervision required –Timing of session delivery –ISALS or not Enrolment procedures Follow up procedures Outcomes measurement

30. Timetable Formative work April to September –IRB approval, formative work, finalise trial design –MRCZ approval, RCZ submission under review, training for ECD intervention complete –Hope to start mid July Recruitment for trial over 12months (one pair of communities per month) – start date October 1 Follow up for 12 months