Type of Review: Annual Review Project Title: Impact of improved Sanitation/ Hygiene and Infant Nutrition on environmental enteropathy, growth, and anaemia among young children in Zimbabwe. (SHINE) Date started: June 2010 Date review undertaken: 9-13 June 2014 Introduction and Context What support is the UK providing? SHINE (Sanitation, Hygiene, Infant Nutrition Efficacy project) is a community-based, clusterrandomized trial being conducted in two rural districts of Zimbabwe (Chirumanzu and Shurugwi). SHINE will determine the independent and combined effects of two interventions (improved Water, Sanitation and Hygiene (WASH) and improved infant feeding) on stunting and anaemia of 4,800 children followed from under 14 weeks gestation to 18 months of life. The project is being implemented by Zvitambo, a locally based non-profit organisation in close collaboration with the Ministry of Health and Child Care (MoHCC) in Zimbabwe (and decentralised authorities) and in partnership with Johns Hopkins Bloomberg School of Public Health, Cornell University, and the University of London. Behaviour change interventions are delivered by Village Health Workers (VHWs), latrine construction was managed through a subcontract to Oxfam/UK but Zvitambo and the MoHCC environmental health department have now assumed full responsibility for implementing this part of SHINE, while research staff measure intermediary and ultimate outcomes. Stunting and anaemia affect 33% and up to 75% of young children respectively growing up in low income countries (including Zimbabwe). Often referred to as “invisible malnutrition,” these two problems together cause 20% of under 5-year mortality, and lead to long-term cognitive deficits, fewer years of completed schooling, and poorer performance while in school, and lower adult economic productivity. SHINE takes an innovative approach to the hypothesis that Environmental Enteropathy (EE) is a major underlying cause of both stunting and anaemia. EE is a subclinical injury of the small bowel which leads to reduced nutrient absorption and increased systemic immune activation (IA). IA, in turn, suppresses linear growth and red blood cell production. The researchers hypothesize that EE is caused by exposure to faecal-contaminated living environments and can be prevented or reduced by household water, sanitation, and hygiene (WASH) interventions that target faecal-oral pathways in infants. They also hypothesize that the effects on stunting of improved WASH will be additive to those of improved infant feeding practices. No randomized trial of sanitation has ever looked at child health outcomes. No trial has combined sanitation and hygiene with an infant feeding intervention, and no study of any design has documented the pathways from household sanitation and hygiene behaviours to the enteric health and nutritional status of infants. The study is also uncovering evidence about maternal capacities to support pregnancy and will be able to draw associations between maternal exposure to EE and adverse pregnancy outcomes (miscarriage, premature birth, low birth weight and stunting at birth). There are three other trials globally, that we know of, that are looking at the impact of sanitation on stunting. The “WASH Benefits” programmes in Bangladesh and Kenya will randomise WASH, infant nutrition and both together1. “SHARE” in Odisha in India will randomise latrine provision and water to test proportional impact on stunting. 1 Arnold et al, Wash Benefits Study rationale, BMJ Open 2013;3:e003476 1 Following the publication of the original hypothesis in the Lancet, DFID-Zimbabwe approved a £3 million pound contribution (over five years) to support the Zvitambo Tropical Enteropathy study in June 2010 (later called Environmental Enteropathy and now called Environmental Enteric Dysfunction, or EED). £3m represented about 30% of the initial funding requirement over 5 years. EED results when high concentrations of faecal bacteria are ingested, overwhelm the gastric barrier, and colonize the small bowel. The study will test the hypothesis that the primary pathway from poor sanitation/hygiene to under-nutrition is EED, and not, in fact, diarrhoea and that EED can be prevented or reduced in young children by cleaning up the home environment, removing faeces (human, chicken, animal), providing household toilets and promoting hand washing after faecal contact. Since June 2010, the study has developed substantially. The study timeframe has extended to end of 2017. Costs have increased with the extended timeframe and complexity of the study but knowledge and outcomes are already expected to be greater than previously anticipated. DFID Zimbabwe therefore invested a further £1m in financial year 2012-13 towards the Zimbabwe-based costs of the programme bringing its total contribution to £4m over 5 years. After the last Annual Review in 2013 in recognition that there was still a significant funding gap DFID’s Policy and Research and Evidence Divisions agreed to contribute a further £3.2m from April 2014 to December 2017 to ensure that this trial remains on track. This brings the total investment by DFID to £7.2m around 33% of the total contribution of around US35m by other donors including the Bill and Melinda Gates Foundation, CIDA, Welcome Trust, NIH, UNICEF and Swiss Development Cooperation. The accountable grant was signed at the time of this review. There are high costs of running an RCT of this nature in Zimbabwe due to factors such as low population density, high infrastructure costs, salary costs and inflation. However Zvitambo has an established history in Zimbabwe, good relationships, and Zimbabwe has high levels of stunting and yet low underweight making the study topic amenable to the population. What are the expected results? There are four kinds of results expected from this trial and its associated programmes: 1. Capacity building and infrastructure in Zimbabwe: a. Laboratory capacity and infrastructure developed across four hubs in the two study districts along with central capacity in Harare; b. Research knowledge and skills (social science, medical, metabolic); c. Nurses trained in using information systems, computer based research tools, motorcycle driving, management of others (village health workers); d. Village Health Workers (VHWs) trained and deployed, supervised and managed. e. Improvements to tippy tap construction; f. Development of an infant play mat to support the sustained management of infants in a faeces-free environment. 2. Zimbabwe focused policy inputs and tools and public goods: a. SHINE staff participate in the National Taskforce for the development of the National Strategy for Food Security and Nutrition Policy Guidelines; b. SHINE staff have contributed to the re-writing of the national VHW handbook; c. SHINE staff work on Prevention of Mother To Child HIV Transmission (PMTCT) policy guidelines and have advised MOHCC about Exclusive Breast Feeding (EBF); d. Developing VHW teaching and training modules to facilitate nutrition and WASH education to mothers/ households in the study districts; e. Improved understanding of breast-feeding culture and interventions designed to address community concerns and Shona cultural beliefs about breastfeeding, the management of 2 f. the fontanelle and colic in very young babies; and Mapping relevant infrastructure and sharing the databases and information systems so far compiled, so enabling others to make use of these resources saving time, improving outcomes and strengthening value for money across a range of programmes. 3. Contribution to science and knowledge applicable globally by: a. Increasing knowledge about what causes infant stunting and thus support to better health outcomes in children; b. Improving understanding about the associations between maternal exposure to EED and adverse maternal outcomes (miscarriages, still births, premature births); c. An understanding about faecal-oral transmission pathways for infants (as opposed to older members of household) and poor health outcomes in children resulting from subclinical gut disease (as distinct from diarrhoea clinical disease); d. Better knowledge about how to implement programmes at community level on a large scale; and e. Practical lesson learning about multi-sectorial programming, working across disciplines, measuring impact, engaging communities at scale and integration into community, district and provincial structures. 4. Immediate and direct benefits to households in two poor districts of Zimbabwe over the study period: a. 4800 more households with functional, high quality latrines; b. 4800 households with tippy taps that facilitate hand-washing; c. Knowledge about handwashing, faeces, sanitation, healthy eating, improved health; d. Access to early pregnancy identification; e. Immediate/ early referral for PMTCT and the prevention of HIV transmission to babies; f. Community knowledge about exclusive breast feeding and nutrition in young babies and children. NB: The logframe was updated in time for this review and more stretching indicators added for the already achieved outputs. What is the context in which UK support is provided? The UK supported Zvitambo (the implementing partner leading the SHINE trial) through DFID Zimbabwe’s Mothers and Babies programme (2007-2010) to build knowledge and implementation capacity around exclusive breastfeeding and other interventions to support Infant and Young Child feeding (IYCF) especially in HIV exposed but negative babies. This support also allowed Zvitambo Director, Professor Jean Humphrey (Johns Hopkins University) to develop and publish the enteropathy hypothesis. Since its publication, this hypothesis has transformed research on the role of WASH as a cause of stunting. Major trials funded by the Bill and Melinda Gates Foundation have been adapted to take account of this hypothesis and the growing evidence pointing to faecal-oral pathways as an important contributor to child stunting. DFID Support (Subject of this Review) This review looks at the last year of DFID Zimbabwe’s £4m contribution to the SHINE trial up to May 2014. Zvitambo continued early pregnancy identification by Village Health Workers and introduced measures to accelerate the rate of recruitment into the trial; finalized behaviour change interventions for exclusive breastfeeding, WASH, and infant feeding and prepared related manuscripts; strengthened the process of latrine building (set up brick moulding sites in the study area, modified the latrine model to one that uses half the quantities of cement and bricks), published formative biomedical findings pertaining to 3 child health and nutrition, and started antenatal data collection visits on enrolled women. At the time of this review the trial was well under way and data on behaviour change was starting to be analysed. In July 2013 Zvitambo identified a serious problem with latrine and ‘Tippy Tap’ implementation by the subcontractor, Oxfam GB: in that month, 646 women had been enrolled into the WASH arms of the study, 467 were past due for receiving WASH hardware, yet only 45 latrines had been constructed. Following a series of meetings, the Oxfam subcontract was discontinued and Zvitambo and the MoHCC environmental health department assumed full responsibility for implementing this part of SHINE. They managed to ensure ‘catch up’ and all enrolled pregnant women were receiving a household toilet by the time of this review. In December of 2013, the community of scientists investigating EE (Environmental Enteropathy) changed its name to Environmental Enteric Dysfunction (EED), which we have now adopted in this report. Section A: Detailed Output Scoring Output 1: Capacity of Zimbabwe Ministry of Health and Child Care strengthened in primary health care, environmental health and Prevention of Mother to Child Transmission of HIV (PMTCT). Output 1 score and performance description: A+ Outputs moderately exceeded expectation Progress against expected results: Output Indicator 1.1 “Number of male and female Village Health Workers trained and mentored in Ministry of Health and Child Care curriculum and new interventions designed for this project (target 320) MoHCC Curriculum VHW training: In Chirumanzu and Shurugwi, 181 and 173 (total 354) VHWs respectively, have been fully trained and are regularly submitting reports to their respective health centres. As new health related information that needs to be disseminated into communities is released (e.g. changes to the Expanded Programme on Immunization schedule, guidance on PMTCT), VHWs have received the necessary refresher training. An additional 20 and 41 VHWs were recruited and received training during 2013 and 2014 respectively, to (1) replace VHWs who have died or permanently moved out of the area, (2) strengthen areas that are too large – either in geography or number of households – and cannot be adequately covered by a single VHW, (3) serve areas that have recently been populated as a result of resettlement, and (4) provide back up support to VHWs who are otherwise unable to effectively deliver intervention messages due to chronic illness, visual impairment or old age. SHINE-specific VHW training: VHW training on SHINE-specific tasks conducted during the reporting period are presented in the table below: Dates Content of training Which VHWs trained Number of VHWs trained June 2013 July 2013 July 2013 February 2014 WASH modules 4,5 WASH and WASH+Nutrition 180 IYCF modules 1,2,3,5 Nutrition and WASH+Nutrition 180 SOC messages All 360 MoHCC Curriculum; Early Newly Recruited VHWs in all 41 Pregnancy Identification; SOC intervention arms 4 messages Output Indicator 1.1 Milestone for 2014: Replacement programme for VHWs lost to attrition in place. 1. In order to ensure consistent coverage, Zvitambo has worked with the Provincial and District Health Teams to formulate a replacement strategy for VHW positions arising due to natural wastage (attrition). During this period 27 VHWs have been replaced and the programme is in place. The strategy, which is outlined below, is currently under implementation and ongoing discussion with the MoHCC: a. Recruited 27 new VHWs through the stipulated processes of (1) community sensitization with communication of eligibility criteria, (2) nomination of ~2 candidates by the community, (3) screening and interview by health center staff, (4) orientation by district level MoHCC. b. Conducted a brief (~2-3 wk) basic training to provide the 27 new VHWs with requisite knowledge and skills. c. In the process of ensuring on-the-job-training and support by (SHINE and MoHCC) for the 27 new VHWs; VHW supervisors to both augment this training and introduce SHINE-specific information. Provide additional instruction and remedial support to the 27 recently recruited VHWs during annual refresher training sessions. Output Indicator 1.2: Number of health centres in which Health Workers have been trained and mentored in WHO 2010 PMTCT Guidance (target of 42 achieved in 2012) Health workers in all health centres have been trained and mentored in delivering the WHO 2010 PMTCT Guidance. In addition, progress has been made toward accrediting all sites to initiate and follow up ART patients. This process is slow because it is done centrally by a team from the MoHCC head office. First, at least one person must be trained in Opportunistic Infections/Antiretroviral therapy (OI/ART); this has now been completed in all health centres in the two districts. Next, certain physical infrastructure must be in place (e.g., secure drug store rooms); this has been done for health centres in both districts. To date, 8 health centres centres in Chirumanzu and 4 in Shurugwi have been assessed and are awaiting approval. All remaining centres are ready (training and infrastructure improvements have been completed) and are awaiting assessment visits. Following Canadian International Development Agency (CIDA) scaling down of support to Zimbabwe in March 2013 and given shortage of funds, Zvitambo elected to turn over PMTCT support to EGPAF who hired and deployed a District Focal Person to Chirumanzu and Shurugwi in April 2013. Zvitambo works closely with EGPAF to ensure a high level of PMTCT care is delivered throughout the SHINE study area. Output Indicator 1.3: Amount and quality of district-level WASH information (target of WASH database dissemination achieved in 2012). The Sanitation Survey tool and data were shared with the districts and with the National Coordinating Unit (NCU). The Water point survey data were shared with the districts. In Shurugwi, the district acquired a water drilling rig and received funds for drilling boreholes in the district from the Community Share Ownership Trust. The CEO, who is also the trust administrator, asked for assistance in siting the boreholes while maintaining the Shine study integrity. The Zvitambo Associate Director of Statistics/Data Management and IT Services is working with the committee tasked with deciding where the boreholes will be dug to advise them on the places where a new borehole will result in the greatest increase of the population with access to water. Through this process Zvitambo ensured that the randomized arms of the study remain balanced in access to water. Progress towards 2013 Annual Review Recommendations 1. In order to ensure consistent coverage, Zvitambo has worked with the Provincial and District Health Teams to formulate a replacement strategy for VHW positions arising due to natural wastage (attrition). The strategy, which is outlined 1-c above, is currently under implementation 5 and ongoing discussion with the MoHCC. 2. In December 2013 Zvitambo instituted an incentive package for VHWs; this includes an incentive for referral of eligible women to SHINE. In addition, in January 2014 Zvitambo initiated recruitment of eligible women from antenatal clinics in addition to the VHW communitybased referral system. 3. Plans are being made to publish the behavior change modules as web-based supplements to the publications reporting their development. Thus, the WASH modules will be published with paper #15, the IYCF modules will be published with paper #22, and the EBF modules with paper #23 (see section B 1.6 below for the full list of papers). Recommendations: Zvitambo and the wider SHINE team need to develop an exit strategy to best prepare all stakeholders, those reliant on SHINE for income and the district health systems for 2017 when the significant support and infrastructure may cease, or be temporarily suspended. This strategy should highlight the optimal use of existing research ‘know how’, infrastructure and Government staff who have been ensuring the trial is implemented. (June 2015) SHINE needs to prepare a contingency plan for any ‘salary shocks’ that might arise due to Government of Zimbabwe being unable to pay staff salaries through any period to the end of the trial; this is especially pertinent for the Environmental Health Officers who at present do not receive any ‘top up’ from the multi-donor Health Transition Fund and would therefore become entirely reliant on incentives. Impact Weighting : 10 % Revised since last Annual Review? Y Risk: Medium Revised since last Annual Review? NO Output 2: Interventions to improve household WASH and infant nutrition practices are developed, piloted, implemented by male and female Village Health Workers and assessed for uptake and effectiveness (Target Achieved in 2013) Output 2 score and performance description: A++ Outputs substantially exceeded expectation Progress against expected results: Output Indicator 2.1: Progress in developing an effective intervention for improving WASH behaviours Output Indicator 2.2: Progress in developing an effective intervention for improving infant nutrition practices Both fully achieved. Progress toward implementing 2013 Annual Review Recommendations Zvitambo proposes the addition of a set of stretch outputs pertaining to the measurement and reporting of fidelity of implementation of the WASH and infant nutrition interventions by VHWs and increasing uptake by a certain margin from baseline, information that we could extract from our outcome measurement. New Indicators for Output Indicators 2: 6 Output Indicator 2.1: Proportion of WASH behaviour change modules delivered by VHWs within the recommended timeframe [2014 milestone – 60%] Output Indicator 2.2: Proportion of infant nutrition behaviour change modules delivered by VHWs within the recommended timeframe [2014 milestone – 60%] Output Indicator 2.3: Uptake and effectiveness of WASH interventions defined and reported for WASH households [2014 Milestone - WASH intervention uptake and impact is being documented from ongoing data collection] Output Indicator 2.4: Uptake and effectiveness of IYCF interventions defined and reported for IYCF households [2014 Milestone - IYCF intervention uptake and impact is being documented from on-going data collection] All behaviour change modules (EBF, WASH, and IYCF) have been completed, piloted, and finalized. Intervention modules have been printed and distributed to VHWs. Production of interactive tools for participating households is ongoing, based on maturation of the cohort. This graph shows module timing and intervention delivery. The SHINE protocol allows a one-month window for delivery of each module. Within the month: Week 1 = ideal; Week 2 = acceptable; Weeks 3 and 4 = allowable. As of early March 2014, 91% of the WASH modules delivered so far had been delivered within the recommended timeframe, against a 2014 milestone of 60% (Output Indicator target 2.1). Modules are continuously delivered until all women in the trial have received all of them. Thus, Zvitambo is on track to exceed this target if it keeps up its module delivery performance within the window required. A breakdown of WASH modules delivered by week is presented below. 7 500 450 400 350 300 250 200 150 100 50 0 Before Window Mod-W1 54 Ideal Accepta Allowabl Beyond Defaults ble e Window 68 48 20 36 Mod-W2 22 397 55 42 27 34 Mod-W3 4 159 39 30 13 13 Mod-W4 2 109 11 15 6 3 Mod-W5 2 81 10 7 3 2 456 For IYCF modules, 98% of them have been delivered within the recommended timeframe for far up to early March 2014, against a milestone of 60% (Output Indicator target 2.2). Similarly, Zvitambo will exceed its 2014 target if it continues this performance by the end of the year. The specific messages delivered for IYCF are presented below. 70 60 50 40 30 20 10 0 BeforeW indow Mod-N1 2 Ideal 65 Accepta Allowabl Beyond Defaults ble e Window 9 3 1 0 Mod-N2 0 36 6 7 0 0 Mod-N3 0 6 2 1 0 0 Mod-N4 0 4 0 0 0 0 SHINE project staff trained to support WASH and Infant and Young Child Feeding programme uptake All 32 SHINE Intervention Nurses have been trained to support and supervise Village Health Workers. The supportive supervisory system for SHINE has been designed to continually and proactively monitor and strengthen the delivery and implementation of SHINE interventions and assess uptake. 1) Intervention Nurses directly supervise Village Health Workers (VHWs) through individual contacts on-site and (monthly) group cluster meetings. 2) Nurse Intervention Managers frequently (weekly) meet with the Intervention Nurses they supervise and attend some cluster meetings. 3) Lastly, the Interventions department holds quarterly meetings wherein fidelity of implementation (FOI) is discussed and flags indicating sub-optimal delivery or uptake of interventions are discussed. 8 Problems pertaining to VHW capacity and performance are corrected through individual and cluster meetings, or through annual refresher training. External reasons for problems in delivery (e.g. cultural or religious beliefs or local misperceptions about SHINE) are addressed through community engagement mechanisms; such as local meetings with health workers or traditional leaders and targeted awareness-raising sessions. Serious problems (such as collapse of a poorly built latrine – this happened to a few of the Oxfam latrines) in intervention delivery or uptake are reported to study investigators and upon confirmation of the veracity and distribution of the problem, corrective action is made in line with the principles outlined below: Fundamental changes to the interventions are made (1) across all clusters assigned to the treatment/intervention arm and (2) in as short a period of time as possible to avoid differential modification of study interventions. Detailed records of the scope and timing of changes to the interventions and intervention delivery system are maintained centrally. When changes are made at the household/participant level or to study inputs, this information is documented in the participant’s data record. Potential problems due to attrition or natural wastage (resignation, relocation, or death of VHWs) are addressed through proactive replacement of VHWs (recruitment, training and deployment) that minimises the time during which a cluster is not serviced by a VHW. Data on the uptake of WASH and IYCF interventions are being collected on an ongoing basis as part of SHINE data collection, meeting 2014 Milestones 2.3 and 2.4, Indicators of WASH and IYCF programme uptake are summarised below. Indicator of WASH behaviours WASH Module Observed Reported Proper disposal of Presence of latrine at household Youngest/index child’s most faeces Presence of faeces in the latrine recent defecation disposed of Presence of faeces in yard into the latrine (reported) Entrance to the latrine is not obstructed Path to the latrine is well-trodden Latrine not being used as storage facility Hand washing with Presence of Tippy Tap/HW station Youngest/index child’s or soap Presence of soap near HW station or mother’s most recent HW with liquid soap in Tippy Tap soap Youngest/index child’s or mother’s hands are visibly clean Evidence of recent Tippy Tap use (i.e. ground is wet beneath it) Respondent mother demonstrates handwashing using all recommended practices Household is storing chlorinated drinking Water treatment water (residual chlorine test) Play space Cleanliness (visible) of the flooring Index child placed on play material/play space space in past (1) 24 hr (2) 1-3 d Hygienic handling of Containers with index child’s food are complementary food covered Food utensils are clean Indicators of IYCF behaviours IYCF Modules Observed Reported Continue EBF to 6 Using EBF tool developed by months Zvitambo Nutributter Number of remaining packets is Diet history includes Nutributter consistent with days since Nutributter feeding distribution by VHW Preparing family foods Diet history for infants 9 Feeding during illness IYCF knowledge and practices during illness questionnaire Diet history Diet Diversity Recommendations: 1. SHINE should maximize the opportunities that arise from their extensive data and experience of implementing WASH, IYCF interventions and behavior change to: a. Provide cost effectiveness/benefit evidence for those interventions that prove to be successful in reducing stunting and/or changing key behaviours b. Provide implementation research findings that demonstrates ‘how’ SHINE has provided interventions at high quality and achieved impact, such as the delivery of the behaviour change modules and the delivery of a combination of interventions. Impact Weighting (%): 40% Revised since last Annual Review? Y Risk: Low Revised since last Annual Review? N Output 3: Coverage of new/improved sanitation is increased in two districts Output 3 score and performance description: B Outputs moderately did not meet expectation Progress against expected results: Output Indicator 3.1: Number of households with new/improved sanitation facilities. Milestone 2014: All women enrolled into WASH receive a toilet within 6 weeks of recruitment or by 28 months gestation. Progress in numbers: As of March 31, 2014 Number of women consented into WASH arm of trial Number of latrines for which construction has been initiated Number of completed latrines 10 1590 46 998 A backlog in delivering the WASH hardware developed within the first 3 months of the trial and then steadily grew. In the progress report on 25 March 2013, two latrines had been constructed against a target of 240 leaving a backlog of 238. The rate of latrine construction has been too slow all year and reached critical levels of delay in June regardless of the fact that Oxfam had assured Zvitambo that they hired and trained a sufficient number of staff to clear the backlog by the end of June and then to keep up with the anticipated increases in recruitment. To monitor this more closely, Zvitambo designed a tool to present numbers of women recruited into the WASH arm of the trial each week, and progress in latrine construction, colour-coding latrines that were overdue (ie, not completed within 8 weeks of the woman’s entry into the project). This report was generated weekly and shared with all levels of Oxfam personnel. The results were disappointing. Oxfam failed to timeously deliver the two outcomes specified in their proposal: latrines and Tippy Taps were not constructed within 6 weeks of mothers’ enrolment By July 9, 2013, 534 women had been enrolled into the WASH arm while only 42 latrines had been constructed leaving a backlog of 492; moreover of these, 8 were not built to standard and required rebuilding. In July, Oxfam submitted a proposal describing a plan to clear the backlog in both districts by September 15. Oxfam proposed to contract external latrine builders instead of employing local builders who they claimed were not adequately skilled for the work. Zvitambo accepted this proposal. However, by August 15, three weeks into the emergency backlog clearing period, Oxfam had built only 22 additional latrines and installed no Tippy Taps while enrolment into the WASH arm had grown to 712, such that the backlog grew to 646. The only substantial progress that had been made was in siting – and this was done by the MoHCC Environmental Health Technicians working alone on motorbikes. The growing backlog became a crisis for the trial in August because it was then 9 months after recruitment had started and the cohort of pregnant women began reaching parturition. By end August, 118 women in the WASH arm had either delivered or were due to deliver their babies. From that time going forward, the cohort was expected to deliver about 100 babies each subsequent month. While the protocol specified that latrine and Tippy Taps be constructed within 6 weeks of enrolment (~20 weeks gestation) the trial senior statistician decided that mother-infant pairs could still be included in the trial if all hardware was delivered at least by birth, but that mother-infant pairs who did not receive the latrine and Tippy Taps by the time the infant was born would need to be excluded from the primary analysis and replaced through additional recruitment. On September 3, as part of a new emergency strategy, Zvitambo took over latrine construction in Shurugwi district working directly with the MoHCC environmental health team and locally engaged builders, while Oxfam was tasked to focus all their personnel (including the subcontracted external builders) on overcoming the backlog in Chirumanzu district. Though the July Oxfam backlog proposal had committed to clearing the backlog in both districts by September 15, this new plan required Oxfam to complete the backlog in one district by 31 October. In the end, Oxfam required a 2-week extension to complete the target 307 households by November 15, an additional vehicle and driver for a week, and assistance with procurement and delivery of bricks for 23 households. Over the same period, the MoHCC team with locally engaged builders and Zvitambo logistical support completed 377 households in Shurugwi district. 11 By September 25, 2013, Zvitambo was satisfied that the MoHCC environmental health teams would better achieve the WASH outcomes of the trial than Oxfam. Zvitambo notified Oxfam that the subcontract would be terminated October 31 after Oxfam cleared the backlog in Chirumanzu. Zvitambo hired 4 Wash Officers and one WASH Coordinator, purchased 2 lorries and 2 single cabs, hired 8 drivers and provided EHTs with protective clothing, builders with bikes and set up an Ecocash payment system to pay casual labourers in the field helping build latrines in the communities. As of December 1, 2013, construction of 819 latrines had started and a total of 676 latrines were completed. Zvitambo/MoHCC is also in ongoing consultation with Dr. Peter Morgan about latrine models that use less bricks and cement to reduce the cost per latrine and reduce building time. Towards this end, a revised model that requires half the number of bricks and cement has been developed and was rolled out in March 2014. This revision will both reduce unit cost of latrines and enable faster delivery. Zvitambo has also initiated sand-cement brick molding within the two districts to further reduce cost. The process of catch-up was impeded by the rainy season, which began in December and was particularly heavy during the period January through March 2014. In the study area, some bridges were washed away or un-crossable and houses completely inaccessible. With rains slowing down, Zvitambo and the MoHCC implemented another “blitz” in April/May 2014 to completely catch up; ensuring that all households enrolled in WASH to March 31 received a latrine by the end of May. This entailed building about 400 during the month of April alone. 12 Monthly and cumulative latrine completion - Nov 2012-May 2014 1800 1600 1400 1200 1000 800 600 400 200 0 Nov-12 Jan-13 Mar-13 May-13 Jul-13 Nov-12 Dec-12 Jan-13 Feb-13 Mar-13 Apr-13 May-13 Jun-13 Sep-13 Nov-13 Jan-14 Mar-14 May-14 Jul-13 Aug-13 Sep-13 Oct-13 Nov-13 Dec-13 Jan-14 Feb-14 Mar-14 Apr-14 May-14 Completed latrines 2 4 10 0 2 12 15 18 150 185 260 148 49 72 129 111 329 Latrines built 2 6 16 16 18 30 45 63 213 398 658 806 855 927 1056 1167 1496 Households Enrolled 51 127 208 296 388 467 537 646 746 853 968 1064 1172 1325 1460 1584 1703 1790 Latrines due 0 0 51 127 208 296 388 467 537 646 746 853 968 1064 1172 1325 1460 1584 Completed latrines Latrines built Households Enrolled Latrines due Thus, from March 2014 going forward, Zvitambo met the 2014 Milestone of all WASH mothers receiving a latrine within 6 weeks of recruitment. Furthermore, Zvitambo are now molding bricks and slabs at several sites within the districts and will stockpile these before the next rainy season to ensure they will not run behind again. During the annual review the team saw that a number of households already had a latrine, however a new Blair toilet had been built alongside these latrines. The environmental health teams explained that the existing latrines did not match the standard required by the trial. Upon further investigation, of the 1,496 latrines built to date, only 52 (3.5%) have been built next to an existing (substandard) latrine. The cost to build a new one is usually significantly more than to rehabilitate. So far, new latrines have always been built (the need for uniformity and high standards), but during the field trip the specific inadequacies of existing toilets was not always clear. Given the small additional cost implications (due to the low number of existing latrines), the high standards expected by local authorities, and the importance of efficacy for the trial, erring on the side of caution is acceptable, and building new latrines is likely to continue in many cases. However, this should be monitored, see recommendation below. SHINE is facing differential recruitment in the WASH arm, with a potential 4 month lag for the other arms, (faster enrollment for the WASH arm compared to other arms of the trial), which could affect the research quality. During the field visits we heard that this could be due to increased pregnancies to ensure families get a quality latrine. 13 Progress toward 2013 Annual Review recommendations: With latrine construction now under Zvitambo and MoHCC control, there should not be any further delays in constructing latrines for women enrolled into the WASH arm within 2 months enrolment. The current log frame goal is to complete 2400 latrines in 2014; given the slower than predicted recruitment, we anticipate this goal will now be achieved by mid-2015. Recommendations: 1. The SHINE team needs to ensure EHTs have clear guidance on whether or not existing latrines are acceptable and the adaptations that can be made to those toilets to maintain quality. They can consult Dr Morgan on the quality adaptations, if needed. The number of households with existing latrines should be continually monitored in case this proportion increases significantly and becomes a value for money consideration. 2. The SHINE team have modified the initial design (under the guidance of Dr Morgan) and achieved substantial cost reductions per latrine. Zvitambo may want to explore any further cost reduction potential, whilst maintaining standards, before building the bulk of toilets at the end of the trial for all families enrolled. Beneficiary families, however, should not be left with the impression that their promised toilets are sub-standard. 3. SHINE should further investigate the reasons for differential recruitment and whether there are incentives for pregnancy increase. See Section B. Impact Weighting (%): 40% Revised since last Annual Review? Y Risk: High Revised since last Annual Review? N 14 Output 4: Increased uptake of improved nutrition and health interventions in two districts Output 4 score and performance description: A+ Outputs moderately exceeded expectation Progress against expected results: Output Indicator 4.1: Proportion of children being Exclusively Breast Fed (EBF) from birth to 6 months 2014 Milestone: EBF to 6 months rate is 30% based on the observed rate among participating infants As of June 1, 2014, only 112 women had reached the 6 month visit. Of these, 71 provided complete data, responding to whether or not they had ever fed each of 44 different foods; for the remaining 41 mothers, their response regarding at least one of these foods was missing. A problem with these early 6 month data is that it was collected just after 6 months when the mother had already correctly begun introduction of other foods. These two problems will be addressed through modifying the questionnaire or additional training of the data collectors. Following are the best estimates of the proportion of women practicing EBF at 1, 3, and 6 months of age, based on those who provided complete data to this series of questions, and assuming that a food left unanswered was not fed to the infant: Assumption 1 month Complete data only 92.8% Skipped food not fed to 88.9% infants 3 months 88.1% 89.0% 6 months 23.9% 34.8% Despite this being based on small initial numbers, the data shows an impressive increase in EBF for the first month, the key time for maximum benefits, from 4% to 93%, the rate remains high at the 3 month mark but significantly drops at 6 months. Based on that work, the EBF promotion now particularly targets the poor practices of feeding nonbreast milk foods to very young infants to prevent actual or perceived fontanelle and colic problems. The much higher rates at 1 and 3 months among SHINE mothers indicates these messages are effective. The Logframe indicator can be adjusted to illustrate the improvements at these different stages. Output Indicator 4.2. Proportion of HIV+ pregnant women receiving WHO-recommended interventions in the project area districts 2014 Milestone: INTERVENTION TAKEN OVER BY OTHER ORGANIZATIONS At the beginning of this DFID grant, virtually no women were receiving the WHO 2010 PMTCT Guidance in the whole of Zimbabwe including the two SHINE districts. By December 2012, 80% of HIV-positive women delivering in Chirumanzu, and 86% of HIV-positive women delivering in Shurugwi received either the More Efficacious Regimen (MER) or were started on HAART for life, based on their CD4 cell counts, in accordance with the WHO 2010 guidance. This is attributed to several PMTCT trainings held in the district and strengthened VHW follow up – both under Zvitambo support. VHWs also play a pivotal role in encouraging early booking and promoting the benefits of PMTCT interventions in the community. ARVs for PMTCT were continuously in stock during the period under review. In addition, in Chirumanzu and Shurugwi, respectively, 1772/1928 (92%) and1836/1928 (95.2%), respectively, of ANC-registered women knew their HIV status at the time of delivery, and 2288/2569 (89%) and 1928/2220 (87%), respectively, of all deliveries in the two districts were conducted in health institutions. This is well above the national average of 70%. This high institutional delivery rate can be attributed to efforts made by the VHWs (trained in partnership with Zvitambo) and discouragement of non-trained midwives to conduct deliveries. Primary Care Nurses (PCNs) are 15 currently undergoing training in midwifery to improve their skills in handling deliveries. This has boosted the nurses’ confidence in handling pregnant women right through to delivery and post-delivery care. That this institutional delivery rate has increased is notable despite an overall drop in deliveries. Progress toward implementing 2013 Annual Review recommendations Because this element of the programme has been handed to Elizabeth Glazer Pediatric AIDS Foundation (EGPAF), Zvitambo have proposed rewriting the logframe to refer only to VHW role in PMTCT uptake; the only part of PMTCT they are now responsible for. The indicators agreed with DFID prior to this AR are below: New Output 4 Indicators: Output Indicator 4.2: Proportion of women enrolled into SHINE < 14 weeks gestation disaggregated by HIV status [2014 target: at least 67% of both positive and negative women.] A total of 248 of 336 (74%) HIV- positive women consented into SHINE at < 14 weeks gestation. A total of 1,238 of 1,612 (77%) HIV-negative women consented into SHINE at <14 weeks gestation. Output Indicator 4.3: Proportion of women enrolled in SHINE who have booked for ANC at the time of the study 32 week visit, disaggregated by HIV status [2014 target: at least 67% of both positive and negative women.] A total of 141 of 148 (95%) HIV-positive women who had a 32 week visit had already booked for ANC. A total of 728 of 761 (96%) HIV-negative women who had a 32 week visit had already booked for ANC. Recommendations: 1. SHINE needs to create a research uptake strategy that details how they envision having the maximum policy uptake of their research products as defined by new programmes tackling child stunting using these interventions or the evidence they create. This includes the important work the review team heard about that is creating evidence on: maternal capacities, vaccine efficacy, fidelity of interventions, design of interventions and intervention science. The update strategy should be comprehensive based on a stakeholder analysis, routes of influence, and the modalities of collaboration with researchers of other related trials for maximizing impact. 2. As previously highlighted SHINE should maximise the opportunities for evidence and lesson learning from delivery of their behaviour change modules, especially showing these significant improvements in early breastfeeding and the high rates of ANC attendance. This will be important if and when the trial shows a significant result and is extremely valuable for nutrition programmes worldwide. 3. The logframe should be updated to reflect data on EBF at 1, 3, and 6 months. Impact Weighting (%): 10% Revised since last Annual Review? Y Risk: Medium Revised since last Annual Review? N Section B: Results and Value for Money. 16 1. Progress and results 1.1 Has the logframe been updated since last review? YES 1.2 Overall Output Score and Description: A+ - outputs moderately exceeded 1.3 Direct feedback from beneficiaries During the review the team visited seven beneficiary households and spoke with women enrolled in the trial, sometimes independently. We observed taking of baseline data, WASH behaviour change module delivery, new childcare practises (use of the play pen). We got beneficiary views on acceptability of interventions, PMTCT provision, understanding of being a participant in an RCT, taking biological samples (such as blood - a taboo in Zimbabwe), ethics and life changes since enrolling. Beneficiaries were on the whole happy, appreciative and understood their role in the SHINE trial. We also discussed with VHWs, EHTs, nurse supervisors and data collectors the experience of participants. 1.4 Summary of overall progress Progress in numbers: As of March 31, 2014 Pregnant women referred by Village Health Workers 3555 Women consenting to join SHINE 2814 Women completing baseline surveys 2431 SHINE Intervention modules delivered by VHWs 9359 Withdrawals 51 Average SHINE maternal age 26.2 As of March 31, 2014, 3555 women have been referred by village health workers to SHINE, 2814 of those women have consented to participate in the trial, and 2431 baseline visits have been conducted. Referrals have been systematically higher in the WASH (n=949) and WASH/IYCF (n=994) arms of the trial compared with the SOC (n=799) and IYCF (n=807) arms. Although consent rates are consistent across arms, the uneven referrals have created unbalanced enrolment. 1.5 Key challenges - Research Slow Recruitment. In designing the trial Zvitambo estimated that there were nearly 5000 live births per year in the study area, and planned that recruitment could therefore be completed in 15 months (at ~330/month). However, recruitment ranged from 150 through 200 participants per month over the period November 2012 – December 2013. This was slower than expected and has been ascribed to low referral rates of newly identified pregnant women by Village Health Workers. Once identified, the consent rate of eligible women is very high. Thus, causes of the slow recruitment may be: overestimation in Zvitambo’s original estimates of live births in the study area, declines in fertility since those estimates, or inability of Village Health Workers 17 to identify all the newly pregnant women. Zvitambo have implemented the following strategies to increase recruitment: o Relaxed inclusion criteria in September 2013 to allow women up to 18 weeks gestation. o Stationed a research nurse at Antenatal Clinics to talk with all women booking their pregnancy to estimate how many newly pregnant women have been missed in the community and their gestational age at booking; based on findings Zvitambo will use antenatal clinics as another entry for recruitment and/or reinforce areas where the Village Health Worker is weak. o In November 2013 Zvitambo received approval from the MoHCC to roll out a VHW incentive programme to reward VHWs for referral of mothers. o Zvitambo are investigating a partnership with a local cell phone carrier to provide cell phones and airtime to women as an incentive for trial participation and to facilitate field operations. o Based on the plausible assumption that the poor performance by Oxfam in constructing latrines and Tippy Taps (see discussion on page 14) contributed to slow recruitment (due to diminished trust of the project by the communities consequent to the failure to provide the inputs as promised), Zvitambo caught up on the latrine backlog. The combination of mitigating strategies appears to be working since recruitment has surpassed and remained at 200+ per month since January 2014. Considering the timing of their implementation against a backdrop of negative impact of the rainy season on programme performance and community agriculture/livelihood commitments, the improvement in recruitment trajectory is likely attributable to the set of interventions above. Differential Recruitment. Referrals have been systematically higher in the WASH arms of the trial thereby creating unbalanced enrolment. In terms of the validity of the trial, it is important to understand the causes of this differential recruitment. Recruitment data suggest that the differential is at the level of VHW referrals to SHINE – once SHINE receives a referral, acceptance is similarly high across arms at about 95% (5% refusals during consent visits). Village Health Workers in SOC arms believe that fertility rates are higher in the WASH arms: that women are choosing to become pregnant to receive the latrine. Zvitambo are working to address this issue by providing additional incentives (cell phones) for recruited women, undertaking more community engagement events and maximizing VHW coverage of women of child bearing age (WCBA). Furthermore, Zvitambo have identified the following potential reasons for this problem, and will conduct a review of VHW registers to ascertain the predominant cause: o Greater number of WCBA in WASH arms; o Same number of WCBA across intervention arms, but those in WASH arms are younger and at higher risk of pregnancy; o Same number of WCBA and similar age distribution but higher fertility; o Acceptance rate for pregnancy testing is higher in WASH arms; o Among pregnant women identified, acceptance rate for referral to SHINE is higher in WASH arms; and o VHW performance (in pregnancy identification and sensitization about SHINE) and/or Intervention Nurses (VHW supervisor) supervisory performance is higher in WASH arms. Protocol deviations due to delays in latrine construction and Tippy Tap installation. Further to the discussion above, there are 130 WASH arm women who received latrine and/or Tippy Taps at ~0-3 months postpartum instead of receiving them ideally within 6 weeks of recruitment (24 weeks gestation) and before the index child’s birth at the latest, as stated in the protocol. The team of investigators who provide technical scientific guidance on the design, implementation and integrity of the study met in March 2014, and decided that the best response to this challenge is to include all pairs in an intention-to-treat analysis, but to conduct an a priori per protocol analysis that excludes the 538 pairs recruited before April 1, 2014 which would include the WASH women who did not receive hardware until after delivery and those in other arms recruited during same period. The team advised recruiting an additional 538 to ensure sufficient statistical power in this per protocol analysis. Oxfam have agreed to pay the costs of recruiting these additional women. 18 Key challenges – Policy & intervention Delayed latrine construction and Tippy Tap installation. The challenges with Oxfam delivery are well described in detail above and payment of damages will cover the enrollment of additional women needed to maintain the integrity and power of the trial. This shows impressive perseverance by Zvitambo, but it would be useful to consider lessons learnt for future management of contracts. Research Uptake Although at this stage there is not an expectation of the evidence created during this trial impacting on global funding for WASH and IYCF, this is the hope post 2017 if there is a positive result. This means that SHINE needs to prepare the ground and be strategic about facilitating research uptake as early as possible. See output 4 recommendations. Motorbike Accidents. A total of 63 Data Collector and Intervention Nurses ride motorbikes. When SHINE was first launched these staff experienced a high rate of accidents. SHINE provided professional motorbike riding training (during which some applicants were deemed unable to ride and were excluded from employment), continued training by on-site mechanics, a full set of protective clothing, imported top-grade helmets, and frequent warnings not to speed. Zvitambo consulted with an expert in motorbike injury prevention who confirmed they are doing more than most projects and that the main way to reduce injury is to reduce exposure. Zvitambo procured additional vehicles with drivers to reduce Km driven and increased safety training and began careful monitoring of the accident rate: the accidents/1000 Km driven declined from a peak of 0.38 per 1000 Km ridden in January to ~0.06 per 1000 Km ridden during June – November 2013. However, in December 2013 – February 2014 the rate increased again due to the poor road conditions during the rainy season, though it was not as high as it had been the previous rainy season, reflecting the greater experience of the nurses. During the review visit the team witnessed a motorbike accident involving a nurse supervisor losing control of the motorbike. 1.6 Annual Outcome Assessment Outcome Goal: New knowledge in Water/Sanitation/Hygiene, Infant Nutrition, and Health systems is generated and disseminated and informs child health programmes in Zimbabwe and globally. Outcome Indicator 1: Number of articles published in peer reviewed literature. Indicator 2014: 2 papers Manuscripts prepared under DFID support that are published, in press, submitted for publication, submitted for presentation, and in preparation are listed below with description of contribution to child health programmes. Highlighted below are papers published since the last annual review resulting from research supported by DFID.. Manuscript Contribution to child health programming Published 1. Humphrey JH: Child undernutrition, tropical enteropathy, toilets, and handwashing. Lancet 2009; 374:1032-35. 2. Paul KH, Muti M, Chasekwa B, Mbuya MNN, Madzima RC, Humphrey JH, Stoltzfus RJ. Complementary feeding Articulated the hypothesis that environmental enteric dysfunction (EED) is a primary cause of under-nutrition and that the child growth effects of improved WASH are primarily mediated through EED rather than diarrhea. Identified the key misconceptions regarding infant feeding in rural Zimbabwe (children cannot eat fruits, vegetables, meat because they cannot chew and swallow these foods) 19 messages that target cultural barriers enhance both the use of lipid-based nutrient supplements and underlying feeding practices to improve infant diets in rural Zimbabwe :Maternal and Child Nutrition: DOI: 10.1111/j.17408709.2010.00265.x 3. Mbuya MNN, Humphrey JH, Majo F, Chasekwa B, Jenkins A, Israel-Ballard K, Muti M, Paul KH, Madzima R, Moulton LH, Stoltzfus RJ. Heat treatment of expressed breast is a feasible option for feeding HIVexposed uninfected children after 6 months of age in rural Zimbabwe. J Nutr 2010 Aug;140(8):1481-8. 4. Paul KH, Muti M, Khalfan SS, Humphrey JH, Caffarella R, and Stoltzfus RJ. Beyond food insecurity: Comparing two sites in Sub-Saharan Africa to determine how context can help improve complementary feeding interventions. Food Nutr Bull 2011; 32(3):244-53. 5. Mutasa K., Ntozini, R., Prendergast, A., Iliff P., Rukobo S., Moulton LH., Ward B. Impact of six-week viral load on mortality in HIV-infected Zimbabwean infants PIDJ (2013):31:9:948-950. 6. Ngure FM, Humphrey JH, Mbuya MNN, Majo F, Mutasa K, Govha M, Mazarura E, Chasekwa B, Prendergast PJ, Curtis V, Boor KJ, Stoltzfus RJ. Formative Research on Hygiene Behaviors and Geophagy as Part of Interventions to Improve Infants’ Growth in Zimbabwe. Am J Trop Med Hyg (2013),89:4:709-716 7. Ngure FM, Reid BM, Humphrey JH, Mbuya MN, Pelto G, Stoltzfus RJ. Water, sanitation, and hygiene (WASH), environmental enteropathy, nutrition, and early child development: making the links. Annals of the New York Academy of Sciences. 2014;1308:118-28. and created messages (a child can eat anything an adult eats if it is processed) that resulted in mothers providing nutritionally adequate infant diets with locally available foods alone (except for iron and zinc which were filled by Nutributter). Demonstrated that HIV-positive mothers could safely stop direct breastfeeding and provide adequate volumes of expressed and heat-treated (EHT) breast milk to their infants for up to 4 months. With the WHO 2010 PMTCT Guidance recommending ART therapy during breastfeeding, EHT is still a useful feeding method for HIVpositive mothers for use temporarily when they are delayed in refilling ART supply. This was the first formative infant feeding research conducted to design the IYCF intervention for the SHINE trial. The paper describes the process to inform other countries on how to collect and use context-specific knowledge and practices to improve the efficacy of their complementary feeding interventions. This study used archived blood samples from HIV+ infants participating in the ZVITAMBO vitamin A trial. It showed that a single viral load measurement at 6 weeks of age strongly predicts mortality throughout infancy. This paper demonstrates the importance of early infant diagnosis followed by immediate treatment. This was formative research to inform the SHINE WASH intervention. 23 infants were observed for a total of 130 hours to identify pathways for fecal-oral transmission in <18 month children. Demonstrated that ingestion of heavily contaminated soil (geophagia) and chicken faeces in addition to frequently mouthing their own unwashed hands are major pathways for fecal-oral transmission in infants and young children that may not be interrupted by conventional WASH interventions designed for older members of the household. In this paper, we reviewed evidence linking WASH, anemia, and child growth, and highlight pathways through which WASH may affect early child development, primarily through inflammation, stunting, and anemia. Based on this review and formative work in Zimbabwe (#6), we concluded that current early child development research and programs lack evidence-based interventions to provide a clean play and infant feeding environment in addition to established priorities of nutrition, stimulation, and child protection. Consequently, we propose the concept of baby WASH as an additional component of early childhood development programs. 20 8. Prendergast AJ, Rukobo S, Chasekwa B, Mutasa K, Ntozini R, Mbuya MNN, Jones A, Stoltzfus RJ, Humphrey JH. (2014) Stunting Is Characterized by Chronic Inflammation in Zimbabwean Infants. PLoS ONE 9(2): e86928. doi:10.1371/journal.pone.0086928 infants This study used archived blood samples from infants participating in the ZVITAMBO vitamin A trial: we identified 100 who were stunted (cases) and 100 who were not stunted at 18 months (controls) and then used data and specimens collected during the antecedal period from birth to 18 months. We found that children who were stunted at 18 months were already shorter at birth and both they and their mothers had lower IGF-1 (a hormone governing linear growth). Throughout infancy, children who were stunted at 18 months, had high inflammatory markers, lower IFG-1, and higher I-FABP (an indicator of gut damage) levels. There were no associations between stunting and diarrhea. These findings support the SHINE hypothesis that EED and chronic inflammation impair infant growth, and also highlights that maternal factors (possibly maternal EED and inflammation) are also critical pathways that must be targeted to reduce stunting. 9. Palha De Sousa C, Brigham T, Chasekwa B, Mbuya MMN, Tielsch J, Humphrey JH, Prendergast AJ. Dosing of praziquantel by height in sub-Saharan African women. Am J Trop Med Hyg (2014) 90:4: 634-7 This study was conducted following the release of a MoHCC National Survey which demonstrated a very high prevalence of schistosomiasis in the study area. As part of preparing to treat women enrolled in SHINE, in accordance with WHO recommendations, we developed a simple way to quantify praziquantel doses for women based on height (as is done for children). Subsequently, the MoHCC informed us, contrary to WHO recommendations, Zimbabwe has elected to delay dosing of pregnant women until after delivery, so this plan was removed from the protocol. This study sought to determine, using DHS data (including Zimbabwe 2010-1), the cross-country patterns of associations of each of WHO IYCF indicators with child stunting, wasting, height-for-age z-score (HAZ) and weightfor-height z-score (WHZ). The WHO indicators showed mixed associations with child anthropometric indicators across countries. This is likely due to a lack of sensitivity and specificity of many of the IYCF indicators. The WHO indicators are clearly valuable tools for broadly assessing the quality of child diets and for monitoring population trends in IYCF practices over time. However, additional measures of dietary quality and quantity (such as intensive 24hr diet recalls) may be necessary to understand how specific IYCF behaviours relate to child growth faltering. These analyses are informative for our evaluation of the effects of the IYCF interventions on practices and growth outcomes. This study used archived blood samples from infants participating in the ZVITAMBO vitamin A trial: it provides the first values for serum hepcidin in normal healthy infants. Hepcidin is a recently discovered hormone that is the “master regulator” of iron metabolism, but there are currently no reference values for infancy – anan age group at very high risk of anemia. Hepcidin values help distinguish anemia due to iron deficiency from anemia of immune activation. Hepcidin will be an important marker in SHINE to understand how much infant anemia could be prevented by improving WASH verses improving infant intake of dietary iron. 10. Jones AD, Ickes SB, Smith LE, Mbuya MN, Chasekwa B, Heidkamp RA, Menon P, Zongrone AA, Stoltzfus RJ. World Health Organization infant and young child feeding indicators and their associations with child anthropometry: a synthesis of recent findings. Maternal & Child Nutrition. 2014 Jan;10:1-17. 11. Jones AD, Mbuya MN, Ickes SB, Heidkamp RA, Smith LE, Chasekwa B, Menon P, Zongrone AA, Stoltzfus RJ. Reply to Correspondence: is the strength of association between indicators of dietary quality and the nutritional status of children being underestimated? Maternal & Child Nutrition. 2014 Jan;10:161-2. 12. Mupfudze TG, Stoltzfus RJ, Rukobo S, Moulton LH, Humphrey JH, Prendergast AJ, the SHINE Project Team. Hepcidin decreases over the first year of life in healthy African infants. British Journal of Haematology. 2013 doi:10.1111/bjh.12567. Accepted for Publication 13. Desai A, Mbuya MNN, Chigumira A, Chasekwa B, Humphrey JH, Moulton LH, This study provided initial evidence that ~40% of women interrupt EBF during the first month of life by feeding 21 Pelto G, Gerema G, Stoltzfus RJ Traditional oral remedies and perceived breastmilk insufficiency are major barriers to exclusive breastfeeding in rural Zimbabwe. Journal of Nutrition (in press) Submitted for publication 14. Ngure FM, Humphrey JH, Mbuya MNN, Mutasa K, Rukobo S, Ntozini R, Mangwiro I, Prendergast PJ, Chigumire A, Stoltzfus RJ. Aflatoxin Exposure among Mothers is Associated with Severe Stunting in 6-59 Month Old Children in Zimbabwe. 15. Mbuya MNN, Stoltzfus RJ, Curtis V, Pelto GH, Kambarami R, Fundira D, Malaba TR, Mangwadu G, Humphrey JH. Iterative Intervention Design Research to minimize ingestion of environmental microbes by young children in rural Zimbabwe. Submitted for presentation 16. Ntozini R, Marks S, Heylar W, Mbuya MNN, Gerema G, Humphrey JH, Garikai, Moulton LH, and Zungu LI Assessing rural water and sanitation coverage using Google Earth and rapid community assessments: A case study from two districts in Zimbabwe. For Presentation at the UNC Water and Health Conference, October 2013, Chapel Hill, North Carolina, USA. In preparation for submission for publication in 2014: (anticipated month of submission) 17. Desai A, Mbuya MNN, Pelto G, Humphrey JH, Stoltzfus RJ Emic perspectives on traditional oral remedies (such as cooking oil and water) to treat or prevent perceived illnesses of the fontanel or digestive system. From ~ 2 months of age, the main reason for feeding non-breast milk foods is that mothers believe their breast milk is not enough or insufficient to support the infant’s needs. These findings suggest that both misconceptions need to be specifically addressed in programs promoting EBF. This study analysed archived urine samples collected by MoHCC in a previous nationally representative survey and demonstrated very high aflatoxin exposure is prevalent among Zimbabwean mothers (15%) and strongly associated with stunting in their children. Based on this study, measurement of aflatoxin exposure was added to SHINE protocol. Will enable us to adjust for it in determining the effects of the randomized interventions on stunting and estimate the fraction of stunting attributable to aflatoxin. This paper reports the preliminary and formative research and pilot studies undertaken by SHINE to develop the WASH intervention. The paper will guide others in Zimbabwe and elsewhere in designing effective interventions to improve household WASH. Furthermore the methodology presented demonstrates the utility of an iterative intervention design process wherein interventionists or programme planners continually reflect on new information, and undergo a series of conceptual shifts, each leading to further modification towards an optimal intervention package. This paper describes the novel method SHINE took to assess water coverage in the study areas. Water point surveys were carried out by MoHCC Environmental Health Technicians using handheld electronic data collection devices programmed with GPS capacity and custom software. The resulting data base includes information on all water points (6000) in the two districts including: functionality, seasonality, degree of protection, and GPS coordinates. All households were identified by Google Earth and mapped together with the water points allowing us to calculate the average distance from households to nearest water point for communities, wards, and districts. These distances can be compared across communities to identify those in greatest need; the data can also be modeled to determine which boreholes should be rehabilitated or at which sites boreholes should be drilled to yield the optimal cost--benefit ratio in terms of percent of households served per dollar spent. This study of in-depth interviews with 30 mothers of young infants was conducted to learn more about early EBF 22 infant care are not consistent with “optimal” feeding of rural Zimbabwean infants less than six months old: implications for exclusive breastfeeding intervention development (June) 18. Desai A, Mbuya MNN, Pelto G, Stoltzfus RJ, Humphrey JH Impact of a complementary feeding intervention implemented by Village Health Workers in a pilot study on assimilative and transformational learning of rural Zimbabwean mothers (August) 19. Mupfudze T, Mbuya MNN, Stoltzfus RJ, Tielsch J, Prendergast PJ Humphrey JH Infant and young child feeding and water, sanitation and hygiene practices that are predictive of anemia during infancy: an analysis of the Zimbabwe 2011 DHS Data (August) 20. Mupfudze T, Stoltzfus RJ, Humphrey JH, Mutasa K, Prendergast PJ. Changes in plasma hepcidin associated with HIV exposure, HIV infection, and anemia in Zimbabwean infants at 3, 6, and 12 months of age (September) 21. Mduduzi N.N. Mbuya; Lawrence H. Moulton Goldberg Mangwadu Rebecca J. Stoltzfus; James M. Tielsch; Andy Prendergast;, Jean H. Humphrey; A cluster randomized 2x2 factorial study of the effects of sanitation/hygiene and infant nutrition interventions on infant growth in rural Zimbabwe: Design and methods (October). 22. Desai A, Mbuya MNN, Pelto G, Stoltzfus RJ, Humphrey JH. Impact of a complementary feeding intervention implemented by Village Health Workers in a pilot study on nutritional adequacy of diets fed to young children in rural Zimbabwean mothers (November). 23. Cynthia R. Matare, Mduduzi N. Mbuya, Katherine L. Dickin, Mark A. Constas, Naume V. Tavengwa, Dadirai Fundira, Thokozile R. Malaba, Jean H. Humphrey, Rebecca J. Stoltzfus. A Village Health Worker-led intervention to promote and support exclusive breastfeeding in rural Zimbabwe is feasible, acceptable and effective interruption. Two themes emerged. Soon after birth, mothers are concerned with guarding their infants against nhova (non-pulsating/sunken fontanel), a condition in Shona culture considered to have metaphysical causes. Beginning in the first month of life, mothers were concerned with treating ruzoka (colic/stomach problems). Both conditions are treated with home remedies and traditional medicines that can expose infants to pathogens. After the first month of life, mothers were concerned their milk was not sufficient to meet the infant’s needs. The study guided development of the SHINE EBF modules. This paper presents the findings from the piloting of the SHINE IYCF intervention in Gweru district which demonstrated that Village Health Workers were able to deliver the intervention and that it succeeded in increasing the depth and breadth of maternal knowledge regarding infant feeding. In addition, substantial evidence of transformational learning demonstrated that mothers engaged in a process of learning that is necessary for behavior change. This secondary data analysis of Zimbabwe 2010 DHS data demonstrated that the only factors collected in the DHS that independently predicted anemia in children (in addition to child’s sex and maternal haemoglobin) were whether the household had a handwashing station with soap and whether the household disposed properly of the youngest child’s stool. No indicators of infant diet were predictive of anemia. The analysis is consistent with the SHINE hypothesis that improving WASH will reduce infant anemia. This paper will describe hepcidin values measured in archived blood samples from children who participated in ZVITAMBO vitamin A trial who were HIV infected or whose mothers are HIV infected. These data will aide in interpreting hepcidin values and the causes and solutions to anemia among in HIV-exposed children enrolled in SHINE. This paper will be a detailed presentation of the background, design, and methods of the SHINE project. It will be submitted to a journal which allows ample word count for all the details to be recorded in one place and therefore be easily accessible to the public health community. This paper will present follow on data to paper #10 by presenting the pilot data on the impact of the IYCF intervention on improving the nutritional adequacy of infant diets. This paper will report the pilot study of the EBF intervention designed by SHINE to address identified barriers to exclusive breastfeeding and also impart knowledge and skills at the critical timepoints that they are needed. The paper will guide others in Zimbabwe and elsewhere in designing effective interventions to (1) improve EBF practices, (2) leverage community based health workers towards the production of health outcomes, and (3) facilitate EBF behaviour change using adult learning techniques. 23 Outcome Indicator 2: Number of programmes or policies changed as a result of project activities and research findings in Zimbabwe and globally. Logframe indicator for 2014: Ministry of Health and Child Care representatives at national, provincial and district levels confirm continuing strong partnership with Zvitambo It was apparent during the field visit and with Government partners in Harare (MoHCC) that Zvitambo is well regarded and there are very strong trusted relationships at various levels of Government of Zimbabwe, national and local. There is a strong understanding from Govt. of the political challenges of implementing a RCT but an understanding of the powerful evidence that will be generated. The District Administrator in Shurugwi articulated well the importance of randomisation for evidence creation and we heard this again and again. A Village Counsellor told us ‘we will be with Zvitambo till the Hallelujah’. Zvitambo was obviously well respected and trusted as a long standing organisation in Zimbabwe and Govt of Zimbabwe lend them vehicles and helpf facilitate progress. In terms of the longer term outcome of clear policy and programme uptake from the SHINE experience here are a few examples. Members of Zvitambo were asked to update the PMTCT Section of the MoHCC Manual for Village Health Workers. This section included early identification and referral of pregnant women and infant feeding in the context of HIV. The methodology for conducting a survey of water infrastructure through physical inspection, documentation of geological coordinates and assessment of state of functionality was summarized and shared with district and national level policy makers (the National Coordination Unit, NCU) for possible adoption for use in building and updating water facility inventories. This methodology has potential applications in (1) assessing baseline status (of availability and coverage), (2) prioritization of water points for new infrastructure installation or repairs based on better estimation of need, or (3) evaluation of impact of water access programmes with better estimation of value for money. Members of Zvitambo were asked to share their experience of home HIV testing and counselling (which is part of the SHINE protocol) with the MoHCC who is in the process of rolling out home T&C. In addition Zvitambom staff are now in positions of influence with Government of Zimbabwe, and using their experience of research to support policy design. On the basis of technical assistance to the Ministry of Health and Child Care towards stunting reduction efforts, Dr Mbuya of Zvitambo, is a member of the government convened National Food and Nutrition Security Advisory Group. The Advisory Group was convened in January 2011 to oversee the development of the recently launched (May 2013) Food and Nutrition Security Policy for Zimbabwe. The role of the Advisory Group has been to advise the Food and Nutrition Council in (1) defining the scope, content and breadth of the Policy, (2) implementing strategies for ensuring ownership and relevance of the Policy within the relevant national Ministries and institutions, (3) contributing to the policy development process through designing national consultative meetings, and (4) ensuring mechanisms for the Policy’s implementation. This is a pivotal policy role and Zvitambo had not expected to be invited to sit on this advisory group. The Govt will now be creating a new nutrition strategy and are keen to work with SHINE to understand how to implement across sectors. Government officials talked about the usefulness of ‘compelling evidence’ and the importance of SHINE in its generation (Nutrition Lead in MoHCC). They said that the Permanent Secretary and Minister of Health both were supported of SHINE, but that there needed to be good information to help understand which elements of the interventions could be replicated at lower cost. Government of Zimbabwe and other stakeholders urged that this RCT would not ‘pack and go’ but leave behind good replication and approaches that other NGOs can implement, and ensure that the two districts remained an example for other areas of Zimbabwe. Examples given were the potential 24 need to reduce the costs of play pens – currently imported - and toilets. Members of the study team have held dissemination meetings with district and provincial stakeholders and presented preliminary findings emanating from the design, planning and implementation of the trial at national and international fora. The dissemination fora have included: National technical groups: the Nutrition Cluster, Unicef Collaborating Centre for Operational Research and Evaluation (CCORE) Brown Bag; Universities seminars and teaching: University of Zimbabwe, Johns Hopkins Bloomberg School of Public Health, Cornell University, University of London; Technical meetings and invited seminars: Stunting Reduction Forum (2013), Experimental Biology Meeting of the American Society for Nutrition (FASEB 2013, 2014), USAID/Washington DC brown bag and Webinar (2013) In addition the ‘toilet crisis’ has ensured that a cheaper Blair VIP toilet is now being used in SHINE and a design for toilet base is being created centrally which should influence future toilet production in Zimbabwe for rural WASH projects. 2. Costs and timescale 2.1 Is the project on-track against financial forecasts: Yes, now that the funding gap has been filled by existing donors for the study to be completed. DFID Zimbabwe’s contribution of £4 million up to 31 March 2014 has been fully disbursed according to accurate forecasts submitted quarterly as per the Accountable Grant with Zvitambo. Policy and Research and Evidence Divisions have recently signed the amended Accountable Grant Arrangement with Zvitambo for £3.2M from1 April 2014 to 31 December 2017 for the remaining study trial period and quarterly disbursements will commence shortly. Zvitambo mentioned during the review that they are approaching other donors to fund elements of their work, including communications and other areas of research. 2.2 Key cost drivers The primary cost drivers during this fiscal year were personnel costs which makes up 55% of the total global budget over the lifetime of SHINE) and latrine construction. This includes incentives paid to Village Health Workers and Environmental Health Technicians. It should be acknowledged that SHINE leans towards ‘efficacy’ with high standards, high quality interventions involving intense behavior change, including the building of toilets and the provision of play pens, along with the taking of samples from clients. For example the toilets being built cost $788 as opposed to much cheaper ‘bush’ toilets without surrounding high quality infrastructure. This complex large size trial takes place in the context of low population density and resulting long distances causing high transport costs. 2.3 Is the project on-track against original timescale: No The trial was delayed by the length it took for Chiramanzu District to sign the MoU, delays in enrolment of pregnant women to the study and this year by the delays caused by latrine construction and tippy tap installation under the Oxfam contract the trial. However the trial should now be on track to complete 25 by end of 2017 as proposed during the 2013 Annual Review. 3. Evidence and Evaluation 3.1 Assess any changes in evidence and implications for the project A great deal of evidence has already been generated from SHINE. Formal research that’s has been instigated during this review period includes: Efficacy of rotavirus vaccine in the study participants, hypothesizing that EED is a major cause of vaccine ineffectiveness Village Health Worker performance and analysis of uptake of behavior change as it relates to performance Maternal capacities and differential uptake of good nutritional and sanitation practices Myotoxin and the impact on stunting These nested studies will all use the existing extensive research to provide evidence useful for global advances in nutrition science, and are valuable additions to understanding implementation science. Links through to details. Zvitambo has begun the process of ensuring research uptake by policy and programme authorities through our linkages with UNICEF, FNC, Govt of Zimbabwe, international research community, and WHO. Zvitambo also share learning with other relevant trials and with the EED research community globally. Zvitambo have widely articulated the SHINE hypothesis and its implications through invited talks at UNICEF/SE Asia and New York, the Micronutrient Forum; the European tropical medicine congress. Zvitambo have fund-raised (so far not successfully) to enable a production of a film on SHINE that would engage the public (especially the UK tax-payer) and policy makers; Zvitambo have produced manuscripts reporting the development of behavior change modules which will be freely available through journals’ open access. SHINE is in close communication with the WASH Benefits trial in Kenya and Bangladesh that is testing the same hypothesis, with two cluster randomised control trials in rural areas and intervention arms of water, sanitation, hand washing and nutrition. Outcomes being measured are stunting and diarrhoea. The SHARE trial (DFID funded) in India similarly measures the impact of latrines on stunting, diarrhoea and intestinal nematodes infection and started in 2010. SHINE were not aware of this trial and should ensure that lessons learnt and research uptake strategies are aligned. The MRC and members of the Data safety Board were met as part of the review and both were positive about the ethics and implementation of the RCT, amongst the 12 currently underway in Zimbabwe. The MRC head said that SHINE ‘set a good example’ . 3.2 Where an evaluation is planned what progress has been made? Not applicable 26 4. Risk 4.1 Output Risk Rating: Medium There are still 11 Risks at the time of this review 2014 – 7 low, 2 medium, 2 high. One low risk identified from start of project happened in 2013 (slow Latrines building and cancelling of Oxfam contract) but is now overcome. One medium risk delayed the project significantly (MoU signing) • • • High Risks include lower recruitment rate of pregnant women than needed and differential recruitment into WASH arm and availability of drugs in Zimbabwe through 2014. Medium risks include breastfeeding rates don’t rise as high as needed, and focus on research obscures development impact. Low risks include data insecurity, a lack of understanding of research in communities and lowering motivation of VHWs Risks identified last year that are now not relevant include the funding shortfall, (unless costs increase beyond expectations) and the risk of losing support in the district because of implementation of the UNICEF WASH project in the neighboring districts. This does not seem to be the case currently although SHINE are hopeful that UNICEF will continue with their rural WASH programme in the research districts post trial. The Parliamentary elections did not disrupt the research. Perceived Risk Original Risk 1. Administration of Chirumanzu Rural District Medium Council does not cooperate allowing the trial to continue (previous administration had blocked signing of MoU; new administration much more co-operative and has signed MoU, but evolution of the relationship with Zvitambo will need to be monitored carefully) 2. Pregnant women recruitment rate will be lower Low than the estimated average of 335 newly pregnant women per month 3. Focus on research outcomes obscures Medium development impact of the project (development impact is high for the study area). 4. Economic hardships continue and salaries paid by Ministry of Health and Child Care not adequate to minimise health worker attrition and costs continue to rise. 27 Medium Revised Risk 2014 Probability Low: MoU eventually signed and now District is enthusiastic. Impact Medium Probability High: Risk remains high as recruitment is still slower than hoped and now differential in the WASH arms. Impact Medium: there are cost implications is the trial takes longer than planned Probability Medium as benefits are felt by households but SHINE needs a broader research uptake strategy. Impact Low: development impact is clearly being felt and monitored closely Probability Low : inflation is very low. The Health Transition Fund (HTF) is paying allowances to clinic staff and health managers and Zvitambo pays incentives. However this risk is higher for EHTs who do not receive HTF allowances. Impact Medium: Whilst attrition may happen, Zvitambo would likely become the main source of income for EHTs. 5. Ministry of Health and Child Welfare does not Low prioritise revitalisation of Village Health Worker system and the implementation of the 2010 PMTCT Guidance 6. Political instability disrupts implementation in project areas project Medium 7. Oxfam discontinues sanitation construction Low subcontract arrangement with Zvitambo. Can be removed for next AR. 8. VHWs are demotivated. Low 9. Communities do not fully understand the Medium randomized nature of the trial and tension is created when not all households receive their latrines at the same time. 10. Exclusive Breast Feeding is not amenable to Low change in response to interventions 11. Ministry of Health and Child Care and donors are High not successful in mobilising sufficient funding for drugs and reagents to enable full implementation of 2010 Guidance (for the PMTCT interventions on which EGPAF leads – failure to provide PMTCT could confound the results) 12. NEW risk: Data saved and backed up in Low Zimbabwe by Zvitambo, or samples stored in freezers maybe lost. 13. NEW risk: GOZ is unable to pay salaries regularly and in full, leading to outmigration of health workers and/or absenteeism 28 Medium Probability and Impact both Low so no change: MOHCC is still giving this sufficient priority and PMTCT well established in routine services. Probability Low: elections did not disrupt research. Impact Low: previous mitigation measures have been very effective. Zvitambo discontinued contract with Oxfam, as per output 3 and is no longer relevant. Probability Low: SHINE is providing intensive support and incentives and VHWs are motivated. Impact Medium Probability Low: community sensitisation has been successful. Impact Medium Probability Low: EBFF has risen significantly in the first month as new data showed during this review, but needs to continue to 6 months. Impact: Medium Probability High – the Adult regimen has changed and there is a funding gap next year. DFID is likely to stop funding paediatric ARVS post 2015. EGPAF, GF, USG and others are actively working to fill the funding gap. Impact Medium: whilst important for optimal results, PMTCT is not a trial arm Probability Low – Zvitambo have moved to a permanent base with generators and will explore international back up options. Impact High Probability Medium – The economy generally, and GOZ’s capacity to accommodate the recent civil service pay rise are both fragile. In addition to allowances, HTF is rolling out results based financing, which includes additional reward payments to HWs. It is important for Zvitambo to monitor the situation and develop a contingency plan, particularly for those the trial depends on who are not HTF recipients. Impact Medium: see risk 4 above Probability Medium - Zvitambo is implementing more accidentavoidance activities than most projects involving the frequent use of motorbikes. Average accidents have reduced but the monthly rates are still erratic. These are being closely monitored and further measures may need to be considered if the rate starts to rise. Impact Low NOTE: Zvitambo are avoiding using local banks affected by the banking liquidity crisis, and much of their funds are held outside of the country, to be drawn down when needed. 14. NEW risk: motorbike accidents increase, leading to interruptions supervision on data collection Medium and 4.2 Assessment of the risk level The project is low to medium risk. A low risk actually happened last year with the Oxfam contract, however SHINE have resolved this well and reduced many other risks such as stakeholders understanding of the need for a randomised approach. However Zimbabwe is a fragile environment with low population density which creates a range of additional challenges for research of this nature. Risks to the research remain differential recruitment and incentives for the WASH arm. Main risks to the programme are the precarious salary situation of government staff. 4.3 Risk of funds not being used as intended Low as the contribution is to the general support of the project and not earmarked for a particular component of the project. Quarterly statements are all in order and Annual Audited Statements by Deloitte and Touche are received annually for the DFID accountable grant. Zvitambo has an Employee Policy Manual in place which stipulates policy on financial or other conflicts of interests, fraud zero tolerance and Whistle Blower procedures. A micro-assessment of Zvitambo was carried out by Moore Stephens Ltd in July 2013. The assessment scored the implementing partner as Low risk, commenting that they were ‘A well-established entity…with an independent board of directors in place’. They also highlighted that ‘the corporate structure of the Implementing Partner is appropriate as it has the requisite skill and experience staff both on the financial and programme side.’ 4.4 Climate and Environment Risk Low. Considered to have a marginal negative impact resulting from the construction of latrines from building materials that require some energy to create and significant use of transport for a RCT in a low population density area. Impact of latrine construction has been off-set this year as now bricks and slabs are locally moulded and sun dried. This is generally considered to have a positive impact resulting from the improved living conditions associated with the project and environmental cleanliness. Better nourished and healthier children will learn better and consume fewer health care resources over their childhoods. The major environmental impact is the high volume of road transport need to visit sparsely populated areas of Zimbabwe to carry out the research, which due to the randomised nature of the trial is necessarily not efficiently planned. 29 5. Value for Money 5.1 Performance on VfM measures Effectiveness As explained in Section 2 clinical trials are expensive, especially a rural, cluster-randomized trial, so SHINE cannot be evaluated for VFM in the same way as a programme in which activities would be planned very differently. However the RCT should be marked alongside similar trials and on that basis it is expensive. For example the SHARE trial in India, within 2500 households enrolled has a total budget of $3.5M, versus $25m for SHINE. However, direct comparison cannot be made as there are many reasons for this cost difference, including: a) Unit costs in Zimbabwe are generally much higher b) The Zimbabwe health system was still recovering from the financial crisis and additional costs were incurred (such as for the VHW programme) to establish functional systems c) Multiple sources of funds required high managerial costs d) Zvitambo incurred significant expenses to conduct the formative research that has had a great impact on the potential benefit of the trial including VHW behavior change, cultural barriers to exclusive breastfeeding, and infant injestion practices e) The SHINE trial has a much greater laboratory component to establish biomedical causal pathways f) More than twice the number of households are included (4,800 vs 1,992) If the study demonstrates a clear causal pathway (or clearly demonstrates no causal pathway), this will contribute to clarifying which interventions (and how much of them) are necessary for children across Africa and Asia to grow well. The policy uptake of the findings and impact on child stunting globally improves the VFM considerably but depends on a positive result and uptake. World Bank estimates 23% of GDP in developing countries is lost due to undernutrition. If the results do, indeed, lead to a transformational change in nutrition interventions across many countries it could be one of the most cost effective of DFID funded programmes. Therefore the trial needs to balance intervention standards (to ensure proof of concept is demonstrated) with value for money; despite an ‘efficacy’ trial it still uses local infrastructure to deliver interventions 5.2 Commercial Improvement and Value for Money Economy and Efficiency Examples of cost-saving measures Zvitambo have taken in the past year to increase efficiency: 1. Purchased property for its office, laboratory, and data centers. This prevents the risks of eviction and very high rental increases they had when renting. 2. Innovative provision of mobile phones to mothers enrolled in SHINE to reduce the costs and risks of wasted home visits in terms of transport and time when mothers are not available and to recover missing data. 3. Obtained best prices for mobile phones used by SHINE staff and SHINE mothers from Econet. They have given the project free handsets and have committed to putting up additional towers to ensure complete coverage in the two districts, in exchange for Zvitambo purchasing solar chargers and $3 per mother phone. . 4. Provision of small gifts (<$1) when mothers are available for their scheduled visits to motivated them to keep these appointments and prevent wasted time and petrol costs and wear and tear on motorbikes. (Costs $55 for VHW to visit client.) 5. Commissioned Peter Morgan to design a new Blair VIP latrine model that is both more 30 stable in sandy wet soils and less costly to build using less bricks at less cost. 6. Insisted that casual laborers (pit excavators, latrine builders, brick molders) have an Econet telephone to enable Zvitambo to pay them via ecocash to reduce risks of traveling with large amounts of cash. 7. Centralised moulding of latrine slabs and bricks. Location selected at optimum site close to river for sand and water for moulding bricks at the local clinic for security. More efficient use of time and transport costs. The cost of bricks when procured from a commercial vendor is about $0.28 compared to the cost when made in the district which is $0.13. Internal Cost Management: The annual budget is Zvitambo’s primary cost control tool; variances from the budget are analyzed on a monthly basis. Each department head is responsible for controlling expenditure within budgetary limits. Requests to spend money on items not in the budget require compelling justification before approval is given. Monthly stock count of inventory kept at each hub (building materials and other consumables) to contain loss. Daily stock counts of petrol and diesel coupons to contain loss. Scrutinize requests for paying vendors for accuracy and completeness. Improving procurement capacity and capability: Zvitambo has a procurement policy which covers the procurement of goods and services. The policy also establishes the use of competitive bidding as a priority practice. Their procurement systems are robust, highly competitive and transparent, thus resulting in contracting of the best possible suppliers on the market. They have documented procurement policies and procedures in place including: Highly trained staff who are certified procurement practitioners through the Chartered Institute of Purchasing and Supply (CIPS) Clear communication of the procurement strategy across all departments through sharing of the procurement policy and guidelines. This has helped to ensure that everyone is pulling in the same direction. Clearly documenting processes across the whole procurement cycle so that Zvitambo are able to identify areas where activities can be streamlined and average cycle times reduced; ensuring lean processes are followed throughout all activity. The outcome results of this so far are that Zvitambo are able to manage more with the same resources. Consolidating purchasing requests and intervals hence cutting down on delivery costs and purchasing documentation especially for most of the items that are imported internationally and regionally. Training staff on cost effective purchasing and encourage them to save money whenever possible. Centralising disparate purchasing functionality, which allows for savings in staff, processes and technology. Registration of suppliers. Creating a database of competent suppliers with the aim of eliminating the middle man. 5.3 Role of project partners The relationship between the Ministry of Health and Zvitambo appears to be very positive both in Harare and in the two districts of Shirugwi and Chiramanzu and it is to Zvitambo’s credit that the understanding of complex research methods is apparent from the District Administrators’ office down to the individual households. To some extent the wide range of financial incentives may play some part in ensuring these relationships are solid, but it does seem that the long history and careful management of relationships and investment by Zvitmabo are ensuring trust has been built. 31 Close collaboration with the MoHCC means that Zvitambo is able to hold the brick moulding at their clinics without paying rent, store cement and other commodities securely without extra warehousing payments, and they also share office space within MoHCC buildings in the district hospitals. 5.4 Does the project still represent Value for Money : Yes Despite the expense, the trial still does represent value for money because the value of the findings has scope to be transformational in the arena of tackling undernutrition. Additionally, Zvitambo has constantly tried to trim costs and has made substantial savings across the range of its interventions, whilst maintaining its commitment to ensuring its interventions are of the highest quality to maintain its efficacy imperative. If the results are as expected, the value for money will need to be demonstrated through policy uptake. We have also recommended that the research team undertakes cost benefit analysis in order to provide recommendations on the set of interventions that will be appealing to policy makers and accompanied by costings. Many of the cost drivers are based on conducting the research in Zimbabwe, inflation, high staff costs, population density requiring transport costs and it would be useful to understand the costs of implantation in different contexts. In order to ensure policy uptake once a result in known this data should be collected. 5.5 If not, what action will you take? 6. Conditionality 6.1 Update on Partnership Principles (for all programmes) and specific conditions Only condition was that the initial DFID funding would attract a similar or greater contribution from other partners and this has been achieved. No other conditions are in place. No funds directly through GoZ financial systems and procedures. This means no UK aid is managed by or is under the direct control of the Government of Zimbabwe using its own financial systems and procedures. 7. Conclusions and actions Zvitambo has established strong relationships at all levels of Government and local communities; this was especially striking in discussions about complex research methodologies where understanding is good. The management of and passion for the research is obvious and paramount and translates into good beneficiary understanding and ethical practises. SHINE is maximising their research to create ‘nested’ studies that should provide good global knowledge but also ensure better update of what are essentially long standing public health and sanitation interventions. SHINE will not point towards a new simple solution or magic bullet for development but an intensive community based overlaying of interventions, if the result is positive. This, with the other 3 trials we are aware of globally studying this hypothesis, now needs to have more of a priority in their work. Recommendations 1. Zvitambo and the wider SHINE team need to develop an exit strategy to best prepare all stakeholders, those reliant on SHINE for income and the district health systems, for 2017 when the significant support and infrastructure may cease. This strategy should highlight the optimal 32 use of existing research ‘know how’, infrastructure and Government staff who have been ensuring the trial is implemented. The strategy should also highlight how Zvitambo will maintain organizational sustainability, possibly through diversifying its activities/services offered. (June 2015) 2. SHINE needs to prepare for any ‘salary shocks’ that might arise due to Govt of Zimbabwe being unable to pay staff salaries through any period to the end of the trial; this is especially pertinent for the Environmental Health Officers who at present do not receive any ‘top up’ from the multi–donor Health Transition Fund and would therefore become entirely reliant on incentives. 3. SHINE should maximize the opportunities that arise from their extensive data and experience of implementing WASH, IYCF interventions and behavior change to: a. Provide cost effectiveness/benefit evidence for those interventions that prove to be successful in reducing stunting b. Provide implementation research that demonstrates ‘how’ SHINE has provided interventions at high quality for impact, such as the delivery of the behavior change modules and the delivery of a combination of interventions. c. Promote lesson learning from the effective delivery of SHINE interventions through public services in rural areas. 4. The SHINE team needs to monitor the proportion of Blair VIP toilets built where there are existing toilets and ensure EHTs have clear guidance on the adaptations that can be made to those toilets to maintain quality. This is to avoid costs being incurred in building new toilets with acceptable toilets exist. Dr Morgan can be consulted on the quality adaptations. (October 2014) 5. The SHINE team may want to also further explore any further cost-saving modifications in toilet design (without compromising standards) before building the bulk of toilets at the end of the trial for the remaining families enrolled. 6. SHINE should further investigate the reasons for differential recruitment and whether there are incentives for pregnancy increase. 7. SHINE needs to create a research uptake strategy that details how they envision having the maximum policy uptake of their research products as defined by new programmes tackling child stunting using these interventions or the evidence they create. The uptake strategy should be comprehensive and based on a stakeholder analysis. This includes the important work the review team heard about that is creating evidence on: maternal capacities, vaccine efficacy, fidelity of interventions, design of interventions and intervention science. DFID will support this work with examples of other research update strategies and contact with the DFID/academic best practice on this. (June 2015) 8. Zvitambo needs to expand their discussions on WASH Benefits to reach out to the SHARE consortium in India (as well as other Gates funded similar trials), to ensure that their similar research is learning lessons from each other and ultimately will be ready to communicate together a ‘policy friendly’ message for maximum uptake. 9. Zvitambo should ensure their data is also stored internationally for security, in case the two backups are lost within Zimbabwe. 10. DFID should ensure that the accountable grant is accompanied by an agreement with Zvitambo on our standard data policy that also covers future specimen use. Action: DFID Zimbabwe to follow up with RED on our standard policies. 11. DFID HQ (HDD and RED) should be clear on own level of technical inputs to DFID Zimbabwe. Action: DFID Zimbabwe to provide roles and responsibilities for management of programme with Human Development Department in Policy Division and Climate and Environment Team in Policy Division to confirm commitment to participate advisory time to future ARs. 33 8. Review Process This review was conducted by Anne Philpott (Senior Evaluation Advisor, Africa Directorate) and Sally Chakawhata (Policy Officer, AIDS and Reproductive Health Team, Human Development Department) working with the DFID Zimbabwe team, Zvitambo and the trial team, and the local district authorities in the two study districts. The review incorporates available documentation, interviews with stakeholders including travel to the field to observe; VHW and EHT conduct training and interviews with household beneficiaries as well as brick moulding and latrine slab construction. Interviews were held with other donors, Ministry officials, Dr Peter Morgan (designer of the Blair VIP latrine) local authorities, nurses, VHWs and latrine builders as well as stakeholders and household beneficiaries. A ‘live scoring’ exercise was conducted by Anne Philpott, the DFID Zimbabwe programme management team and the Zvitambo team on 13th June. Final editing and quality control of this report was done by DFID Zimbabwe’s Health Adviser, based on comments from the Basic Services Team Leader/a/g Deputy Head and Results Adviser before final sign-off by the Head of Office. Meetings included: SHINE team presentations on research, IT, Data, laboratory, behaviour change modules. Mvuma Hub members in Chirumanzu, MOHCC Districts nurse officers, Shirugwi Hub leadership, District Administrators, enrolled households, EHT teams, Village Counsellors, VHWs and supervisors, Nurse Supervisors, Data Collectors. 34