Effect of the Newhints home-visits intervention on neonatal mortality rate and care practices in Ghana: a cluster randomised controlled trial.

BACKGROUND: In 2009, on the basis of promising evidence from trials in south Asia, WHO and UNICEF issued a joint statement about home visits as a strategy to improve newborn survival. In the Newhints trial, we aimed to test this home-visits strategy in sub-Saharan Africa by assessing the effect on all-cause neonatal mortality rate (NMR) and essential newborn-care practices. METHODS: The Newhints cluster randomised trial was undertaken in 98 zones in seven districts in the Brong Ahafo Region, Ghana. 49 zones were randomly assigned to the Newhints intervention and 49 to the control intervention by use of restricted randomisation with stratification to ensure comparability between interventions. Community-based surveillance volunteers (CBSVs) in Newhints zones were trained to identify pregnant women in their community and to make two home visits during pregnancy and three in the first week of life to promote essential newborn-care practices, weigh and assess babies for danger signs, and refer as necessary. Primary outcomes were NMR and coverage of key essential newborn-care practices. Analyses were by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00623337. FINDINGS: 16,168 (99%) of 16,329 deliveries between November, 2008, and December, 2009, were livebirths; the status at 1 month was known for 15,619 (97%) livebirths. 482 neonatal deaths were recorded. Coverage data were available from 6029 women in Newhints zones; of these 4358 (72%) reported having CBSV visits during pregnancy and 3815 (63%) reported having postnatal visits. This coverage increased substantially from June, 2009, after the introduction of new implementation strategies and reached almost 90% for pregnancy visits by the end of the trial and 75% for postnatal visits. The Newhints intervention significantly increased coverage of key essential newborn-care behaviours, except for four or more antenatal-care visits (5975 [76%] of 7859 vs 5988 [74%] of 8121, respectively; relative risk 1·02, 95% CI 0·96-1·09; p=0·52) and baby delivered in a facility (5373 [68%] vs 5539 [68%], respectively; 0·97, 0·81-1·14; p=0·69). The largest increase was for care-seeking, with 102 (77%) of 132 sick babies in Newhints zones taken to a hospital or clinic compared with 77 (55%) of 139 in control zones (1·43, 1·17-1·76; p=0·001). Increases were also noted in bednet use during pregnancy (5398 [69%] of 7859 vs 5135 [63%] of 8121, respectively; 1·12, 1·03-1·21; p=0·005), money saved for delivery or emergency (5730 [86%] of 6681 vs 5525 [80%] of 6941, respectively; 1·09, 1·05-1·12; p<0·0001), transport arranged in advance for facility (2496 [37%] vs 2061 [30%], respectively; 1·30, 1·12-1·49; p=0·0004), birth assistant for home delivery washed hands with soap (1853 [93%] of 1992 vs 1817 [87%] of 2091, respectively; 1·05, 1·02-1·09; p=0·001), initiation of breastfeeding in less than 1 h of birth (3743 [49%] of 7673 vs 3280 [41%] of 7921, respectively; 1·22, 1·07-1·40; p=0·004), skin to skin contact (3355 [44%] vs 1931 [24%], respectively; 2·30, 1·85-2·87; p=0·0002), first bath delayed for longer than 6 h (3131 [41%] vs 2269 [29%], respectively; 1·65, 1·27-2·13; p<0·0001), exclusive breastfeeding for 26-32 days (1217 [86%] of 1414 vs 1091 [80%] of 1371; 1·10, 1·04-1·16; p=0·001), and baby sleeping under bednet for 8-56 days (4548 [79%] of 5756 vs 4291 [73%] of 5846; 1·09, 1·03-1·15; p=0·002). There were 230 neonatal deaths in the Newhints zones compared with 252 in the control zones. The overall NMRs per 1000 livebirths were 29·8 and 31·9, respectively (0·92, 0·75-1·12; p=0·405). INTERPRETATION: The reduction in NMR with Newhints is consistent with the reductions achieved in three trials undertaken in programme settings in south Asia. Because there is no suggestion of any heterogeneity (p=0·850) between these trials and Newhints, the meta-analysis summary estimate of a reduction of 12% (95% CI 5-18) provides the best evidence for the likely effect of the home-visits strategy delivered within programmes in sub-Saharan Africa and in south Asia. Improvements in the quality of delivery and neonatal care in health facilities and development of innovative, effective strategies to increase coverage of home visits on the day of birth could lead to the achievement of more substantial reductions. FUNDING: WHO, Bill & Melinda Gates Foundation, and UK Department for International Development

Cost and cost-eff ectiveness of newborn home visits: fi ndings from the Newhints cluster-randomised controlled trial in rural Ghana

Background Every year, 2·9 million newborn babies die worldwide. A meta-analysis of four cluster-randomised controlled trials estimated that home visits by trained community members in programme settings in Ghana and south Asia reduced neonatal mortality by 12% (95% CI 5–18). We aimed to estimate the costs and cost-eff ectiveness of newborn home visits in a programme setting. Methods We prospectively collected detailed cost data alongside the Newhints trial, which tested the eff ect of a homevisits intervention in seven districts in rural Ghana and showed a reduction of 8% (95% CI –12 to 25%) in neonatal mortality. The intervention consisted of a package of home visits to pregnant women and their babies in the fi rst week of life by community-based surveillance volunteers. We calculated incremental cost-eff ectiveness ratios (ICERs) with Monte Carlo simulation and one-way sensitivity analyses and characterised uncertainty with cost-eff ectiveness planes and cost-eff ectiveness acceptability curves. We then modelled the potential cost-eff ectiveness for baseline neonatal mortality rates of 20–60 deaths per 1000 livebirths with use of a meta-analysis of eff ectiveness estimates. Findings In the 49 zones randomly allocated to receive the Newhints intervention, a mean of 407 (SD 18) communitybased surveillance volunteers undertook home visits for 7848 pregnant women who gave birth to 7786 live babies in 2009. Annual economic cost of implementation was US$203 998, or$0·53 per person. In the base-case analysis, the Newhints intervention cost a mean of $10 343 (95$352 (95% CI 104 to –268) per discounted life-year saved, and had a 72% chance of being highly cost eff ective with respect to Ghana’s 2009 gross domestic product per person. Key determinants of cost-eff ectiveness were the discount rate, protective eff ectiveness, baseline neonatal mortality rate, and implementation costs. In the scenarios modelled with the meta-analysis results, the ICER increased from $127 per life-year saved at a neonatal mortality rate of 60 deaths per 1000 livebirths, to$379 per life-year saved at a rate of 20 deaths per 1000 livebirths. The strategy had at least a 99% probability of being highly cost eff ective for lower-middle-income countries in all neonatal mortality rate scenarios modelled, and at least a 95% probability of being highly cost eff ective for low-income countries at neonatal mortality rates of 30 or more deaths per 1000 livebirths. Interpretation Our fi ndings show that the seemingly modest mortality reductions achieved by a newborn home-visit strategy might in fact be cost eff ective. In Ghana, such strategies are also likely to be aff ordable. Our fi ndings support recommendations from WHO and UNICEF that low-income and middle-income countries implement newborn home visits

Maximizing community participation and engagement: lessons learned over 2 decades of field trials in rural Ghana

BACKGROUND: Successful implementation of community-based research is dominantly influenced by participation and engagement from the local community without which community members will not want to participate in research and important knowledge and potential health benefits will be missed. Therefore, maximising community participation and engagement is key for the effective conduct of community-based research. In this paper, we present lessons learnt over two decades of conducting research in 7 rural districts in the Brong Ahafo region of Ghana with an estimated population of around 600,000. The trials which were mainly in the area of Maternal, Neonatal and Child Health were conducted by the Kintampo Health Research Centre (KHRC) in collaboration with the London School of Hygiene and Tropical Medicine (LSHTM). METHODS: The four core strategies which were used were formative research methods, the formation of the Information, Education and Communication (IEC) team to serve as the main link between the research team and the community, recruitment of field workers from the communities within which they lived, and close collaboration with national and regional stakeholders. RESULTS: These measures allowed trust to be built between the community members and the research team and ensured that potential misconceptions which came up in the communities were promptly dealt with through the IEC team. The decision to place field workers in the communities from which they came and their knowledge of the local language created trust between the research team and the community. The close working relationship between the District health authorities and the Kintampo Health Research Centre supported the acceptance of the research in the communities as the District Health Authorities were respected and trusted. CONCLUSION: The successes achieved during the past 2 decades of collaboration between LSHTM and KHRC in conducting community-based field trials were based on involving the community in research projects. Community participation and engagement helped not only to identify the pertinent issues, but also enabled the communities and research team to contribute towards efforts to address challenges

NEWHINTS cluster randomised trial to evaluate the impact on neonatal mortality in rural Ghana of routine home visits to provide a package of essential newborn care interventions in the third trimester of pregnancy and the first week of life: trial protocol

BACKGROUND: Tackling neonatal mortality is essential for the achievement of the child survival millennium development goal. There are just under 4 million neonatal deaths, accounting for 38% of the 10.8 million deaths among children younger than 5 years of age taking place each year; 99% of these occur in low- and middle-income countries where a large proportion of births take place at home, and where postnatal care for mothers and neonates is either not available or is of poor quality. WHO and UNICEF have issued a joint statement calling for governments to implement "Home visits for the newborn child: a strategy to improve survival", following several studies in South Asia which achieved substantial reductions in neonatal mortality through community-based approaches. However, their feasibility and effectiveness have not yet been evaluated in Africa. The Newhints study aims to do this in Ghana and to develop a feasible and sustainable community-based approach to improve newborn care practices, and by so doing improve neonatal survival. METHODS: Newhints is an integrated intervention package based on extensive formative research, and developed in close collaboration with seven District Health Management Teams (DHMTs) in Brong Ahafo Region. The core component is training the existing community based surveillance volunteers (CBSVs) to identify pregnant women and to conduct two home visits during pregnancy and three in the first week of life to address essential care practices, and to assess and refer very low birth weight and sick babies. CBSVs are supported by a set of materials, regular supervisory visits, incentives, sensitisation activities with TBAs, health facility staff and communities, and providing training for essential newborn care in health facilities.Newhints is being evaluated through a cluster randomised controlled trial, and intention to treat analyses. The clusters are 98 supervisory zones; 49 have been randomised for implementation of the Newhints intervention, with the other 49 acting as controls. Data on neonatal mortality and care practices will be collected from approximately 15,000 babies through surveillance of women of child-bearing age in the 7 districts. Detailed process, cost and cost-effectiveness evaluations are also being carried out. TRIAL REGISTRATION: http://www.clinicaltrials.gov (identifier NCT00623337)

Health providers' perceptions of clinical trials: lessons from Ghana, Kenya and Burkina Faso.

BACKGROUND: Clinical trials conducted in Africa often require substantial investments to support trial centres and public health facilities. Trial resources could potentially generate benefits for routine health service delivery but may have unintended consequences. Strengthening ethical practice requires understanding the potential effects of trial inputs on the perceptions and practices of routine health care providers. This study explores the influence of malaria vaccine trials on health service delivery in Ghana, Kenya and Burkina Faso. METHODS: We conducted: audits of trial inputs in 10 trial facilities and among 144 health workers; individual interviews with frontline providers (n=99) and health managers (n=14); and group discussions with fieldworkers (n=9 discussions). Descriptive summaries were generated from audit data. Qualitative data were analysed using a framework approach. RESULTS: Facilities involved in trials benefited from infrastructure and equipment upgrades, support with essential drugs, access to trial vehicles, and placement of additional qualified trial staff. Qualified trial staff in facilities were often seen as role models by their colleagues; assisting with supportive supervision and reducing facility workload. Some facility staff in place before the trial also received formal training and salary top-ups from the trials. However, differential access to support caused dissatisfaction, and some interviewees expressed concerns about what would happen at the end of the trial once financial and supervisory support was removed. CONCLUSION: Clinical trials function as short-term complex health service delivery interventions in the facilities in which they are based. They have the potential to both benefit facilities, staff and communities through providing the supportive environment required for improvements in routine care, but they can also generate dissatisfaction, relationship challenges and demoralisation among staff. Minimising trial related harm and maximising benefits requires careful planning and engagement of key actors at the outset of trials, throughout the trial and on its' completion

Effect of vitamin A supplementation in women of reproductive age on cause-specific early and late infant mortality in rural Ghana: ObaapaVitA double-blind, cluster-randomised, placebo-controlled trial

Objectives To assess the effect of vitamin A supplementation in women of reproductive age in Ghana on cause- and age-specific infant mortality. In addition, because of recently published studies from Guinea Bissau, effects on infant mortality by sex and season were assessed. Design Double-blind, cluster-randomised, placebo-controlled trial. Setting 7 contiguous districts in the Brong Ahafo region of Ghana. Participants All women of reproductive age (15-45 years) resident in the study area randomised by cluster of residence. All live born infants from 1 June 2003 to 30 September 2008 followed up through 4-weekly home visits. Intervention Weekly low-dose (25 000 IU) vitamin A. Main outcome measures Early infant mortality (1-5 months); late infant mortality (6-11 months); infection-specific infant mortality (0-11 months). Results 1086 clusters, 62 662 live births, 52 574 infant-years and 3268 deaths yielded HRs (95% CIs) comparing weekly vitamin A with placebo: 1.04 (0.88 to 1.05) early infant mortality; 0.99 (0.84 to 1.18) late infant mortality; 1.03 (0.92 to 1.16) infection-specific infant mortality. There was no evidence of modification of the effect of vitamin A supplementation on infant mortality by sex (Wald statistic =0.07, p=0.80) or season (Wald statistic =0.03, p=0.86). Conclusions This is the largest analysis of cause of infant deaths from Africa to date. Weekly vitamin A supplementation in women of reproductive age has no beneficial or deleterious effect on the causes of infant death to age 6 or 12 months in rural Ghana. Trial registration number http://ClinicalTrials.gov: NCT00211341

Health service provider education and/or training in infant male circumcision to improve short- and long-term morbidity outcomes: protocol for systematic review.

BACKGROUND: There has been an expansion of circumcision services in Africa as part of a long-term HIV prevention strategy. However, the effect of infant male circumcision on morbidity and mortality still remains unclear. Acute morbidities associated with circumcision include pain, bleeding, swelling, infection, tetanus or inadequate skin removal. Scale-up of circumcision services could lead to a rise in these associated morbidities that could have significant impact on health service delivery and the safety of infants. Multidisciplinary training programmes have been developed to improve skills of health service providers, but very little is known about the effectiveness of health service provider education and/or training for infant male circumcision on short- and long-term morbidity outcomes. This review aims to evaluate the effectiveness of health service provider education and/or training for infant male circumcision on short- and long-term morbidity outcomes. METHODS/DESIGN: The review will include studies comparing health service providers who have received education and/or training to improve their skills for infant male circumcision with those who have not received education and/or training. Randomised controlled trials (RCTs) and cluster RCTs will be included. The outcomes of interest are short-term morbidities of the male infant including pain, infection, tetanus, bleeding, excess skin removal, glans amputation and fistula. Long-term morbidities include urinary tract infection (UTI), HIV infection and abnormalities of urination. Databases such as MEDLINE (OVID), PsycINFO (OVID), EMBASE (OVID), CINAHL, Cochrane Library (including CENTRAL and DARE), WHO databases and reference list of papers will be searched for relevant articles. Study selection, data extraction and synthesis and risk of bias assessment using the Cochrane risk of bias assessment tool will be conducted. We will calculate the pooled estimates of the difference in means and risk ratios using random effects models. If insufficient data are available, we will present results descriptively. DISCUSSION: This review appears to be the first to be conducted in this area. The findings will have important implications for infant male circumcision programmes and policy. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42015029345

Implementing effective community-based surveillance in research studies of maternal, newborn and infant outcomes in low resource settings

Background Globally adopted health and development milestones have not only encouraged improvements in the health and wellbeing of women and infants worldwide, but also a better understanding of the epidemiology of key outcomes and the development of effective interventions in these vulnerable groups. Monitoring of maternal and child health outcomes for milestone tracking requires the collection of good quality data over the long term, which can be particularly challenging in poorly-resourced settings. Despite the wealth of general advice on conducting field trials, there is a lack of specific guidance on designing and implementing studies on mothers and infants. Additional considerations are required when establishing surveillance systems to capture real-time information at scale on pregnancies, pregnancy outcomes, and maternal and infant health outcomes. Main body Based on two decades of collaborative research experience between the Kintampo Health Research Centre in Ghana and the London School of Hygiene and Tropical Medicine, we propose a checklist of key items to consider when designing and implementing systems for pregnancy surveillance and the identification and classification of maternal and infant outcomes in research studies. These are summarised under four key headings: understanding your population; planning data collection cycles; enhancing routine surveillance with additional data collection methods; and designing data collection and management systems that are adaptable in real-time. Conclusion High-quality population-based research studies in low resource communities are essential to ensure continued improvement in health metrics and a reduction in inequalities in maternal and infant outcomes. We hope that the lessons learnt described in this paper will help researchers when planning and implementing their studies

Quality of newborn care: a health facility assessment in rural Ghana using survey, vignette and surveillance data

Peer reviewe