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The coverage of community-based maternal, neonatal, and child health (MNCH) services remains low, especially in hard-to-reach areas. We evaluated the effectiveness of a mobile-phone-and web-based application, Innovative Mobile-phone Technology for Community Health Operations (ImTeCHO), as a job aid to the government's Accredited Social Health Activists (ASHAs) and Primary Health Center (PHC) staff to improve coverage of MNCH services in rural tribal communities of Gujarat, India. This open cluster-randomized trial was conducted in 22 PHCs in six tribal blocks of Bharuch and Narmada districts in India. The ImTeCHO mobile-phone-and web-based application included various technology-based job aids to facilitate scheduling of home visits, screening for complications, counseling during home visits, and supportive supervision by PHC staff. Primary outcome indicators were a composite index calculated based on coverage of important MNCH services and coverage of at least two home visitations by ASHA within the first week of birth. Primary analysis was intention to treat (ITT). Generalized Estimating Equation (GEE) was used to account for clustering. Eleven PHCs each were randomly allocated to the intervention (280 ASHAs, population: 234,134) and control (281 ASHAs, population: 242,809) arms. The intervention was implemented from February, 2016 to January, 2017. At the end of the implementation, 6,493 mothers were surveyed. Most of the surveyed women were tribal (5,571, 85.8%), and reported having a government-issued certificate for living below poverty line (4,916, 75.7%). The coverage of at least two home visits within first week of birth was 32.4% in the intervention clusters compared to 22.9% in the control clusters (adjusted effect size 10.2 [95% CI: 6.4, 14.0], p < 0.001). Mean number of home visits within first week of birth was 1.11 and 0.80 for intervention and control clusters, respectively (adjusted effect size 0.34 [95% CI: 0.23, 0.45], p < 0.001). The composite coverage index was 43.0% in the intervention clusters compared to 38.5% (adjusted effect size 4.9 [95% CI: 0.2, 9.5], p = 0.03) in the control clusters. There were substantial improvements in coverage home visits by ASHAs during antenatal period (adjusted effect size 15.7 [95% CI: 11.0, 20.4], p < 0.001), postnatal period (adjusted effect size 6.4, [95% CI: 3.2, 9.6], p <0.001), early initiation of breastfeeding (adjusted effect size 7.8 [95% CI: 4.2, 11.4], p < 0.001), and exclusive breastfeeding (adjusted effect size 13.4 [95% CI: 8.9, 17.9], p < 0.001). Number of infant and neonatal deaths was similar in the two arms in the ITT analysis. The limitations of the study include potential risk of inaccuracies in reporting events that occurred during pregnancy by the mothers and the duration of intervention being 12 months, which might be considered short. In this study, we found that use of ImTeCHO mobile- and web-based application as a job aid by government ASHAs and PHC staff improved coverage and quality of MNCH services in hard-to-reach areas. Supportive supervision, change management, and timely resolution of technology-related issues were critical implementation considerations to ensure adherence to the intervention. Study was registered at the Clinical Trial Registry of India (www.ctri.nic.in). Trial number: CTRI/2015/06/005847. The trial was registered (prospective) on 3 June, 2015. First enrollment was done on 26 August, 2015.

Objective To assess the effectiveness of an integrated early child development intervention, combining stimulation and micronutrient supplementation and delivered on a large scale in Colombia, for children’s development, growth, and hemoglobin levels.Design Cluster randomized controlled trial, using a 2×2 factorial design, with municipalities assigned to one of four groups: psychosocial stimulation, micronutrient supplementation, combined intervention, or control.Setting 96 municipalities in Colombia, located across eight of its 32 departments.Participants 1420 children aged 12-24 months and their primary carers.Intervention Psychosocial stimulation (weekly home visits with play demonstrations), micronutrient sprinkles given daily, and both combined. All delivered by female community leaders for 18 months.Main outcome measures Cognitive, receptive and expressive language, and fine and gross motor scores on the Bayley scales of infant development-III; height, weight, and hemoglobin levels measured at the baseline and end of intervention.Results Stimulation improved cognitive scores (adjusted for age, sex, testers, and baseline levels of outcomes) by 0.26 of a standard deviation (P=0.002). Stimulation also increased receptive language by 0.22 of a standard deviation (P=0.032). Micronutrient supplementation had no significant effect on any outcome and there was no interaction between the interventions. No intervention affected height, weight, or hemoglobin levels.Conclusions Using the infrastructure of a national welfare program we implemented the integrated early child development intervention on a large scale and showed its potential for improving children’s cognitive development. We found no effect of supplementation on developmental or health outcomes. Moreover, supplementation did not interact with stimulation. The implementation model for delivering stimulation suggests that it may serve as a promising blueprint for future policy on early childhood development.Trial registration Current Controlled trials ISRCTN18991160.

ObjectiveA process evaluation of the Children and Young People’s Health Partnership (CYPHP) model of integrated care for the interpretation of trial findings and building evidence on the implementation of integrated care for children.DesignA mixed-methods process evaluation.SettingCYPHP was implemented at scale across two inner-city London boroughs in South London, England, as a pragmatic cluster-randomised controlled trial involving nearly 98 000 children, with a nested process evaluation.ParticipantsLinked data were available from 73 000 participants. Qualitative data collection was through 102 interviews (group and 1:1) and observations.InterventionsLocal child health clinics delivered by paediatricians and general practitioners and a nurse-led early intervention service for children with tracer conditions (asthma, eczema and constipation), decision support, a primary care hotline, self-management support and health promotion.Main outcome measuresFive domains of the RE-AIM implementation framework: Reach, Effectiveness, Adoption, Implementation and Maintenance.ResultsImplementation varied depending on resource availability, competing priorities and natural changes over time. Successful implementation drivers included cohesive interprofessional and partnership collaboration.ConclusionsIntegrated care for children can be implemented at scale, but variability, particularly low reach, may limit measurable impact at the population level. Significant health system strengthening, implementation plasticity and contextual tailoring are crucial for ensuring the efficacy and sustainability of impactful integrated care for children.Trial registration number NCT03461848.

To evaluate the cost-effectiveness of results-based financing and input-based financing to increase use and quality of maternal and child health services in rural areas of Zambia. In a cluster-randomized trial from April 2012 to June 2014, 30 districts were allocated to three groups: results-based financing (increased funding tied to performance on pre-agreed indicators), input-based financing (increased funding not tied to performance) or control (no additional funding), serving populations of 1.33, 1.26 and 1.40 million people, respectively. We assessed incremental financial costs for programme implementation and verification, consumables and supervision. We evaluated coverage and quality effectiveness of maternal and child health services before and after the trial, using data from household and facility surveys, and converted these to quality-adjusted life years (QALYs) gained. Coverage and quality of care increased significantly more in results-based financing than control districts: difference in differences for coverage were 12.8% for institutional deliveries, 8.2% postnatal care, 19.5% injectable contraceptives, 3.0% intermittent preventive treatment in pregnancy and 6.1% to 29.4% vaccinations. In input-based financing districts, coverage increased significantly more versus the control for institutional deliveries (17.5%) and postnatal care (13.2%). Compared with control districts, 641 more lives were saved (lower-upper bounds: 580-700) in results-based financing districts and 362 lives (lower-upper bounds: 293-430) in input-based financing districts. The corresponding incremental cost-effectiveness ratios were 809 United States dollars (US$) and US$ 413 per QALY gained, respectively. Compared with the control, both results-based financing and input-based financing were cost-effective in Zambia.

As the number of HIV-infected women initiating lifelong antiretroviral therapy (ART) during pregnancy increases globally, concerns have emerged regarding low levels of retention in HIV services and suboptimal adherence to ART during the postpartum period. We examined the impact of integrating postpartum ART for HIV+ mothers alongside infant follow-up within maternal and child health (MCH) services in Cape Town, South Africa. We conducted a randomised trial among HIV+ postpartum women aged ≥18 years who initiated ART during pregnancy in the local antenatal care clinic and were breastfeeding when screened before 6 weeks postpartum. We compared an integrated postnatal service among mothers and their infants (the MCH-ART intervention) to the local standard of care (control)-immediate postnatal referral of HIV+ women on ART to general adult ART services and their infants to separate routine infant follow-up. Evaluation data were collected through medical records and trial measurement visits scheduled and located separately from healthcare services involved in either arm. The primary trial outcome was a composite endpoint of women's retention in ART care and viral suppression (VS) (viral load < 50 copies/ml) at 12 months postpartum; secondary outcomes included duration of any and exclusive breastfeeding, mother-to-child HIV transmission, and infant mortality. Between 5 June 2013 and 10 December 2014, a total of 471 mother-infant pairs were enrolled and randomised (mean age, 28.6 years; 18% nulliparous; 57% newly diagnosed with HIV in pregnancy; median duration of ART use at randomisation, 18 weeks). Among 411 women (87%) with primary endpoint data available, 77% of women (n = 155) randomised to the MCH-ART intervention achieved the primary composite outcome of retention in ART services with VS at 12 months postpartum, compared to 56% of women (n = 117) randomised to the control arm (absolute risk difference, 0.21; 95% CI: 0.12-0.30; p < 0.001). The findings for improved retention in care and VS among women in the MCH-ART intervention arm were consistent across subgroups of participants according to demographic and clinical characteristics. The median durations of any breastfeeding and exclusive breastfeeding were longer in women randomised to the intervention versus control arm (6.9 versus 3.0 months, p = 0.006, and 3.0 versus 1.4 months, p < 0.001, respectively). For the infants, overall HIV-free survival through 12 months of age was 97%: mother-to-child HIV transmission was 1.2% overall (n = 4 and n = 1 transmissions in the intervention and control arms, respectively), and infant mortality was 1.9% (n = 6 and n = 3 deaths in the intervention and control arms, respectively), and these outcomes were similar by trial arm. Interpretation of these findings should be qualified by the location of this study in a single urban area as well as the self-reported nature of breastfeeding outcomes. In this study, we found that integrating ART services into the MCH platform during the postnatal period was a simple and effective intervention, and this should be considered for improving maternal and child outcomes in the context of HIV. ClinicalTrials.gov NCT01933477.

Objective To investigate the impact of a long-term nurse home visiting programme, embedded within a universal child health system, on the health, development and well-being of the child, mother and family. Design Randomised controlled trial. Setting/participants 208 (111 intervention, 97 comparison) eligible at-risk mothers living in a socioeconomically disadvantaged area in Sydney, booking into the local public hospital for confinement. Intervention A sustained and structured nurse home visiting antenatal and postnatal parenting education and support programme. Control Usual universal care. Main outcome measures The quality of the home environment for child development (12–24 months), parent–child interaction and child mental, psychomotor and behavioural development at 18 months. Results Mothers receiving the intervention were more emotionally and verbally responsive (HOME observation) during the first 2 years of their child's life than comparison group mothers (mean difference 0.5; 95% CI 0.1 to 0.9). Duration of breastfeeding was longer for intervention mothers than comparison mothers (mean difference 7.9 weeks; 95% CI 2.9 to 12.9). There was no significant difference in parent–child interaction between the intervention and comparison groups. There were no significant overall group differences in child mental, psychomotor or behavioural development. Mothers assessed antenatally as having psychosocial distress benefitted from the intervention across a number of areas. Conclusion This sustained nurse home visiting programme showed trends to enhanced outcomes in many, but not all, areas. Specifically, it resulted in clinically enhanced outcomes in breastfeeding duration and, for some subgroups of mothers, women's experience of motherhood and children's mental development. Trial registration number ACTRN12608000473369.

Background Reducing perinatal HIV transmission and optimizing maternal and child health (MCH) outcomes in high HIV prevalence settings is an urgent, but complex, priority. Extant interventions over-emphasize individual-level provider and patient behaviors, and neglect critical health systems-level changes. The ‘Integrated Management Team to Improve Maternal-Child Outcomes (IMPROVE)’ study implemented a three-part, patient-centered, health-systems-level intervention to improve MCH and HIV outcomes in Lesotho. Ensuring intervention fit within the health systems context is important, but often overlooked. This manuscript describes implementation research conducted to tailor and adapt intervention implementation to optimize appropriateness, acceptability, and feasibility. It identifies resulting implementation variation across study sites and lessons learned. Methods The research team reviewed intervention implementation documentation and conducted structured reflections to: 1) assess implementation strategy adaptations, 2) identify facility-specific strategies employed to improve the MCH patient experience, and 3) synthesize lessons. Results Facility-based, integrated, multi-disciplinary management teams (MDT) were feasible and acceptable to establish through engagement with facility leadership and facilitation of a participatory training curriculum that established shared values between cadres supporting MCH, and identified facility-specific service delivery gaps and potential solutions. Ongoing MDT meetings provided coordination between facility and community-based MCH service providers to implement early ANC follow-up. Facility-specific improvement strategies included fee, staffing, and patient documentation-based changes. Piloting Positive Health, Dignity, and Prevention-focused counseling approaches resulted in tailored job aids pre-implementation. Leadership involvement was critical for improved coordination while staff turnover and competing donor priorities challenged MDT efforts. Conclusions IMPROVE created facility-specific adaptation opportunities through participatory intervention implementation practices. The MDTs, benefitting from leadership support, built relationships between HCW cadres, led facility-specific quality improvements, and, importantly, offered HCWs sought-after positive feedback by recognizing HCW efforts. The coordination, monitoring and cross-cadre communication functions of the MDTs supported implementation of other interventions, and may serve as a valuable platform for improving patient-centered care practices in similar settings and for other health services. Trial registration number: NCT04598958, 05 October 2020, retrospectively registered. Trial registration ClinicalTrials.gov, NCT04598958. Registered 05 October 2020—Retrospectively registered, https://clinicaltrials.gov/ct2/show/record/NCT04598958

Background Over the past decade, prevalence of maternal and child morbidity and mortality in Togo, particularly in the northern regions, has remained high despite global progress. The causes of under-five child mortality in Togo are diseases with effective and low-cost prevention and/or treatment strategies, including malaria, acute lower respiratory infections, and diarrheal diseases. While Togo has a national strategy for implementing the integrated management of childhood illness (IMCI) guidelines, including a policy on integrated community case management (iCCM), challenges in implementation and low public sector health service utilization persist. There are critical gaps to access and quality of community health systems throughout the country. An integrated facility- and community-based initiative, the Integrated Community-Based Health Systems Strengthening (ICBHSS) initiative, seeks to address these gaps while strengthening the public sector health system in northern Togo. This study aims to evaluate the effect and implementation strategy of the ICBHSS initiative over 48 months in the catchment areas of 21 public sector health facilities. Methods The ICBHSS model comprises a bundle of evidence-based interventions targeting children under five, women of reproductive age, and people living with HIV through (1) community engagement and feedback; (2) elimination of point-of-care costs; (3) proactive community-based IMCI using community health workers (CHWs) with additional services including family planning, HIV testing, and referrals; (4) clinical mentoring and enhanced supervision; and (5) improved supply chain management and facility structures. Using a pragmatic type II hybrid effectiveness-implementation study, we will evaluate the ICBHSS initiative with two primary aims: (1) determine effectiveness through changes in under-five mortality rates and (2) assess the implementation strategy through measures of reach, adoption, implementation, and maintenance. We will conduct a mixed-methods assessment using the RE-AIM (reach, effectiveness, adoption, implementation, maintenance) framework. This assessment consists of four components: (1) a stepped-wedge cluster randomized control trial using a community-based household survey, (2) annual health facility assessments, (3) key informant interviews, and (4) costing and return-on-investment assessments for each randomized cluster. Discussion Our research is expected to contribute to continuous quality improvement initiatives, optimize implementation factors, provide knowledge regarding health service delivery, and accelerate health systems improvements in Togo and more broadly. Trial registration ClinicalTrials.gov , NCT03694366 , registered 3 October 2018

Background Community health workers (CHWs) play key roles in delivering health programmes in many countries worldwide. CHW programmes can improve coverage of maternal and child health services for the most disadvantaged and remote communities, leading to substantial benefits for mothers and children. However, there is limited evidence of effective mentoring and supervision approaches for CHWs. Methods This is a cluster randomised controlled trial to investigate the effectiveness of a continuous quality improvement (CQI) intervention amongst CHWs providing home-based education and support to pregnant women and mothers. Thirty CHW supervisors were randomly allocated to intervention ( n  = 15) and control ( n  = 15) arms. Four CHWs were randomly selected from those routinely supported by each supervisor ( n  = 60 per arm). In the intervention arm, these four CHWs and their supervisor formed a quality improvement team. Intervention CHWs received a 2-week training in WHO Community Case Management followed by CQI mentoring for 12 months (preceded by 3 months lead-in to establish QI processes). Baseline and follow-up surveys were conducted with mothers of infants <12 months old living in households served by participating CHWs. Results Interviews were conducted with 736 and 606 mothers at baseline and follow-up respectively; socio-demographic characteristics were similar in both study arms and at each time point. At follow-up, compared to mothers served by control CHWs, mothers served by intervention CHWs were more likely to have received a CHW visit during pregnancy (75.7 vs 29.0%, p  < 0.0001) and the postnatal period (72.6 vs 30.3%, p  < 0.0001). Intervention mothers had higher maternal and child health knowledge scores (49 vs 43%, p  = 0.02) and reported higher exclusive breastfeeding rates to 6 weeks (76.7 vs 65.1%, p  = 0.02). HIV-positive mothers served by intervention CHWs were more likely to have disclosed their HIV status to the CHW (78.7 vs 50.0%, p  = 0.007). Uptake of facility-based interventions were not significantly different. Conclusions Improved training and CQI-based mentoring of CHWs can improve quantity and quality of CHW-mother interactions at household level, leading to improvements in mothers’ knowledge and infant feeding practices. Trial registration ClinicalTrials.Gov NCT01774136