Integrated Intervention Package Research Articles

Impact of an integrated health, nutrition, and early child stimulation and responsive care intervention package delivered to preterm or term small for gestational age babies during infancy on growth and neurodevelopment: study protocol of an individually randomized controlled trial in India (Small Babies Trial)

BackgroundPreterm and term small for gestational age (SGA) babies are at high risk of experiencing malnutrition and impaired neurodevelopment. Standalone interventions have modest and sometimes inconsistent effects on growth and neurodevelopment in these babies. For greater impact, intervention may be needed in multiple domains—health, nutrition, and psychosocial care and support. Therefore, the combined effects of an integrated intervention package for preterm and term SGA on growth and neurodevelopment are worth investigating.MethodsAn individually randomized controlled trial is being conducted in urban and peri-urban low to middle-socioeconomic neighborhoods in South Delhi, India. Infants are randomized (1:1) into two strata of 1300 preterm and 1300 term SGA infants each to receive the intervention package or routine care. Infants will be followed until 12 months of age. Outcome data will be collected by an independent outcome ascertainment team at infant ages 1, 3, 6, 9, and 12 months and at 2, 6, and 12 months after delivery for mothers.DiscussionThe findings of this study will indicate whether providing an intervention that addresses factors known to limit growth and neurodevelopment can offer substantial benefits to preterm or term SGA infants. The results from this study will increase our understanding of growth and development and guide the design of public health programs in low- and middle-income settings for vulnerable infants.Trial registrationThe trial has been registered prospectively in Clinical Trial Registry – India # CTRI/2021/11/037881, Registered on 08 November 2021.

Can an integrated intervention package including peer support increase the proportion of health facility births? A cluster randomised controlled trial in Northern Uganda

ObjectiveTo assess the effect of an integrated intervention package compared with routine government health services on the frequency of health facility births.SettingThree subcounties of Lira district in Northern Uganda.DesignA cluster...

Measuring the effectiveness of an integrated intervention package to improve the level of infection prevention and control: a multi-centre study in Bangladesh

Infection prevention and control (IPC) is a critical component of delivering safe, effective and high-quality healthcare services, and eliminating avoidable healthcare-associated infections (HAIs) in health facilities, predominantly in population-dense settings such as Bangladesh. Our study aimed to assess the effect of an integrated intervention package in improving the IPC level of the health facilities in Bangladesh. We conducted a pre-post intervention study in six district hospitals (DHs) and 13 Upazila Health Complexes (UHCs) in the six districts of Bangladesh. Baseline and endline assessments were conducted between March and December 2021 using the adapted World Health Organization Infection Prevention and Control Assessment Framework (WHO-IPCAF) tool. The IPCAF score, ranging from 0-800, was calculated by adding the scores of eight components, and the IPC promotion and practice level was categorized as Inadequate (0-200), Basic (201-400), Intermediate (401-600) and Advanced (601-800). The integrated intervention package including IPC committee formation, healthcare provider training, logistics provision, necessary guidelines distribution, triage/flu corners establishment, and infrastructure development was implemented in all facilities. The average IPCAF score across all the facilities showed a significant increase from 16% (95% CI: 11.5-20.65%) to 54% (95% CI: 51.4-57.1%). Overall, the IPCAF score increased by 34 percentage points (P<0.001) in DHs and 40 percentage points (P<0.001) in UHCs. Following the intervention, 12 (three DHs, nine UHCs) of 19 facilities progressed from inadequate to intermediate, and another three DHs upgraded from basic to intermediate in terms of IPC level. The integrated intervention package improved IPCAF score in all facilities.

Comparative Study on Integrated Psychosocial Stimulation, Nutritional Support, Water Sanitation Hygiene Interventions among Malnourished Children in Kanam, North Central Nigeria

This study is determined to compare the effect of integrated psychosocial stimulation, nutritional support, and water sanitation hygiene interventions on malnourished children. An individual randomized trial design comprising weekly home visits for 3 months in four locations of Kanam Local Government Area, Plateau state, was adopted. The eligible malnourished children were identified through a door–to–door survey using standard procedures of anthropometric measurements (weight, height, mid-upper arm circumference) and children with body mass index (BMI) &lt; 16Kg/m2 were selected. A focus group discussion session, follow-up home visitation on weekly and monthly facilitation/support of mother-to-mother, weekly distribution of food supplements, home stimulation environment through the provision of WASH material and age-specific psychosocial stimulation activities were part of intervention strategies adopted for the study. The result shows a significant difference between base-line and end-line data, impacted by integrated package delivery which enhanced and improved nutritional and developmental outcomes of malnourished children over the period of intervention. Furthermore, the findings reveal that there is a non-significant difference among the study groups. However, the observed effect on outcomes based on average BMI indicators is at causal pathways to improve child nutritional status outcomes. The study concludes that the integrated intervention package improved the developmental and nutritional outcomes in malnourished children. Implementation of these integration packages over a longer duration is needed to witness a significant improvement.

Residual Effect of Texting to Promote Medication Adherence for Villagers with Schizophrenia in China: 18-Month Follow-up Survey After the Randomized Controlled Trial Discontinuation.

BackgroundReducing the treatment gap for mental health in low- and middle-income countries is a high priority. Even with treatment, adherence to antipsychotics is rather low. Our integrated intervention package significantly improved medication adherence within 6 months for villagers with schizophrenia in resource-poor communities in rural China. However, considering the resource constraint, we need to test whether the effect of those behavior-shaping interventions may be maintained even after the suspension of the intervention.ObjectiveThe aim of this study is to explore the primary outcome of adherence and other outcomes at an 18-month follow-up after the intervention had been suspended.MethodsIn a 6-month randomized trial, 277 villagers with schizophrenia were randomized to receive either a government community mental health program (686 Program) or the 686 Program plus Lay health supporters, e-platform, award, and integration (LEAN), which included health supporters for medication or care supervision, e-platform access for sending mobile SMS text messaging reminders and education message, a token gift for positive behavior changes (eg, continuing taking medicine), and integrating the e-platform with the existing 686 Program. After the 6-month intervention, both groups received only the 686 Program for 18 months (phase 2). Outcomes at both phases included antipsychotic medication adherence, functioning, symptoms, number of rehospitalization, suicide, and violent behaviors. The adherence and functioning were assessed at the home visit by trained assessors. We calculated the adherence in the past 30 days by counting the percentage of dosages taken from November to December 2018 by unannounced home-based pill counts. The functioning was assessed using the World Health Organization Disability Assessment Schedule 2.0. The symptoms were evaluated using the Clinical Global Impression–Schizophrenia during their visits to the 686 Program psychiatrists. Other outcomes were routinely collected in the 686 Program system. We used intention-to-treat analysis, and missing data were dealt with using multiple imputation. The generalized estimating equation model was used to assess program effects on adherence, functioning, and symptoms.ResultsIn phase 1, antipsychotic adherence and rehospitalization incidence improved significantly. However, in phase 2, the difference of the mean of antipsychotic adherence (adjusted mean difference 0.05, 95% CI −0.06 to 0.16; P=.41; Cohen d effect size=0.11) and rehospitalization incidence (relative risk 0.65, 95% CI 0.32-1.33; P=.24; number needed to treat 21.83, 95% CI 8.30-34.69) was no longer statistically significant, and there was no improvement in other outcomes in either phase (P≥.05).ConclusionsThe simple community-based LEAN intervention could not continually improve adherence and reduce the rehospitalization of people with schizophrenia. Our study inclined to suggest that prompts for medication may be necessary to maintain medication adherence for people with schizophrenia, although we cannot definitively exclude other alternative interpretations.

Conceptualizing a Low Resource-Low Intensity Psychosocial-SRH Integrated Intervention to Improve Sexual and Reproductive Health Care Seeking among Young Women in Humanitarian Settings

Despite the availability of sexual and reproductive health (SRH) services in some humanitarian contexts, most young women have limited access to these services. Furthermore, many young women in humanitarian settings suffer from distress and cannot access care. In response to this double burden, WHO is conceptualizing a potentially scalable psychosocial (PSS) and SRH integrated intervention package to improve the use of selected SRH services and wellbeing among young women (aged 15-24 years) in humanitarian settings. Informed by two systematic reviews exploring the efficacy of PSS and SRH educational interventions on selected SRH outcomes (coupled with expert consultations, reviewing existing WHO PSS interventions for common mental disorders, and active community engagement), a three-tiered PSS and SRH integrated intervention package is being designed to, 1) engage young women and their social circles through community education and advocacy activities, and 2) enhance women’s socio-emotional capabilities and SRH-related knowledge and behaviours. This intervention will consist of a women groups ‘component (a package of eight-modules), a community component, and up to three sessions of focused support through home visits for vulnerable young women. This article describes the process of conceptualising the intervention package and provides an overview of the content of this PSS-SRH integrated intervention.

Impact of an integrated nutrition, health, water sanitation and hygiene, psychosocial care and support intervention package delivered during the pre- and peri-conception period and/or during pregnancy and early childhood on linear growth of infants in the first two years of life, birth outcomes and nutritional status of mothers: study protocol of a factorial, individually randomized controlled trial in India

BackgroundThe period from conception to two years of life denotes a critical window of opportunity for promoting optimal growth and development of children. Poor nutrition and health in women of reproductive age and during pregnancy can negatively impact birth outcomes and subsequent infant survival, health and growth. Studies to improve birth outcomes and to achieve optimal growth and development in young children have usually tested the effect of standalone interventions in pregnancy and/or the postnatal period. It is not clearly known whether evidence-based interventions in the different domains such as health, nutrition, water sanitation and hygiene (WASH) and psychosocial care, when delivered together have a synergistic effect. Further, the effect of delivery of an intervention package in the pre and peri-conception period is not fully understood. This study was conceived with an aim to understand the impact of an integrated intervention package, delivered across the pre and peri-conception period, through pregnancy and till 24 months of child age on birth outcomes, growth and development in children.MethodsAn individually randomized controlled trial with factorial design is being conducted in urban and peri-urban low- to mid-socioeconomic neighbourhoods in South Delhi, India. 13,500 married women aged 18 to 30 years will be enrolled and randomized to receive either the pre and peri-conception intervention package or routine care (first randomization). Interventions will be delivered until women are confirmed to be pregnant or complete 18 months of follow up. Once pregnancy is confirmed, women are randomized again (second randomization) to receive either the intervention package for pregnancy and postnatal period or to routine care. Newborns will be followed up till 24 months of age. The interventions are delivered through different study teams. Outcome data are collected by an independent outcome ascertainment team.DiscussionThis study will demonstrate the improvement that can be achieved when key factors known to limit child growth and development are addressed together, throughout the continuum from pre and peri-conception until early childhood. The findings will increase our scientific understanding and provide guidance to nutrition programs in low- and middle-income settings.Trial registrationClinical Trial Registry – India #CTRI/2017/06/008908; Registered 23 June 2017, http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=19339&EncHid=&userName=society%20for%20applied%20studies

Effect of a community-based integrated nurturing care interventions on early childhood development in rural China: a quasi-experimental study

Background17 million children under the age of 5 years are at elevated risk of poor development outcomes in China. We aimed to assess whether an integrated package of community-based nurturing care intervention led to a reduction in the prevalence of suspected neurodevelopmental delay to promote early development in rural China's poorest children under the age of 3 years. MethodsFrom July 1, 2014, the Integrated Early Childhood Development (IECD) programme composing comprehensive early development services was implemented in four poverty-stricken areas in China (Liping county, Songtao county, Fenxi county, and Lin county). Five nurturing care intervention components (nutrition, responsive care, child safety and social assistance, early learning support, healthy growth, and development assessment) were delivered via home visits, group sessions, ECD centres, village clinics, and mobile resource units. We evaluated the effectiveness of the intervention using a quasi-experimental design, with baseline data collection in 2013 and endline data collection in 2016, in four interventions and two control counties in which no intervention was applied (Pan county and Fangshan county). Risk factors and outcomes were assessed by use of UNICEF's Multiple Indicator Cluster Survey, Zung Self-Rating Depression Scale, and Ages & Stages Questionnaire-Chinese Edition. We applied a difference-in-differences regression approach adjusting confounding factors to estimate the effect of the intervention on the children's neurodevelopmental outcomes. We used a path analysis to examine underlying mechanisms through which the IECD intervention package could predict children's developmental health. Ethical clearance for all aspects of the study was obtained from the Ethics Review Board in Peking University. An informed consent was obtained in writing before data collection. FindingsBetween July and September, 2013, 2953 children younger than 3 years and their caregivers were interviewed at baseline. Between July and September, 2016, 2745 children younger than 3 years and their caregivers were interviewed after intervention. Prevalence of overall suspected developmental delay was reduced by 18% (from 37% at baseline to 19% after intervention) in intervention villages. This reduction significantly differed from the reduction in control villages (from 30% to 20%; adjusted odds ratio 0·69 (95% CI 0·54–0·89). Consistent findings were found across the communication, gross motor, fine motor, problem solving, and personal-social domains. Path analysis indicated that higher developmental health was partly mediated by multiple family nurturing care factors, including cognitive stimulation, positive discipline, length for age, and haemoglobin. InterpretationThe community-based integrated intervention package significantly reduced the prevalence of suspected developmental delay in children under age three in rural China. This nurturing care intervention could maybe to help improve human capital in China's poorest areas. FundingThis work was supported by Porsche (China) Motors Ltd.

Effect of an integrated intervention package of preventive chemotherapy, community-led total sanitation and health education on the prevalence of helminth and intestinal protozoa infections in C\xf4te d\u2019Ivoire

BackgroundPreventive chemotherapy with donated anthelminthic drugs is the cornerstone for the control of helminthiases. However, reinfection can occur rapidly in the absence of clean water and sanitation coupled with unhygienic behaviour. The purpose of this study was to assess the effect of an integrated package of interventions, consisting of preventive chemotherapy, community-led total sanitation (CLTS) and health education, on the prevalence of helminth and intestinal protozoa infections and on participants’ knowledge, attitude, practice and beliefs (KAPB) towards these diseases including water, sanitation and hygiene (WASH).MethodsA cross-sectional survey was carried out in nine communities of south-central Côte d’Ivoire to assess people’s infection with helminths and intestinal protozoa and KAPB. Subsequently, interventions were targeted to five communities, while the remaining communities served as control. The intervention encouraged latrine construction and an evaluation was done 6–7 months later to determine open defecation status of the respective communities. Anthelminthic treatment was provided to all community members. A follow-up cross-sectional survey was conducted approximately one year later, using the same procedures.ResultsOverall, 810 people had complete baseline and follow-up data and were given anthelminthic treatment. The baseline prevalence of hookworm, Schistosoma haematobium, Trichuris trichiura, Schistosoma mansoni and Ascaris lumbricoides was 31.1%, 7.0%, 2.0%, 1.0% and 0.3%, respectively. Four of the five intervention communities were classified open-defecation free. For hookworm infection, we observed higher negative changes in terms of proportion of decrease (-0.10; 95% confidence interval (CI): - 0.16, -0.04) and higher egg reduction rate (64.9 vs 15.2%) when comparing intervention with control communities. For intestinal protozoa, prevalence reduction was higher in intervention compared to control communities (8.2 vs 2.6%) and WASH indicators and intervention outcomes associated with lower odds for infection at follow-up. The intervention significantly impacted on reported latrine use (before: 15.5%, after: 94.6%), open defecation in the community surroundings (before: 75.0%, after: 16.7%) and awareness for environmental contamination through open defecation (before: 20.4%, after: 52.2%).ConclusionsAn integrated package of interventions consisting of preventive chemotherapy, health education and CLTS reduces the prevalence of helminth and intestinal protozoa infection. Additional studies in other social-ecological settings are warranted to confirm our findings.

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

BackgroundTackling 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.MethodsNewhints 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 registrationhttp://www.clinicaltrials.gov (identifier NCT00623337)

Improving control of hypertension by an integrated approach ??? results of the ???Manage it well!??? programme

Patient non-compliance is a significant contributor to poor blood pressure control. Although measures to improve compliance are known, they are not in routine use. To apply measures based on current recommendations in an integrated approach in the 'Manage it well!' (MIW) programme, and to determine the improvement in blood pressure control. During the prospective open cohort study, 348 primary and 156 secondary care centres enrolled 6941 hypertensive patients and followed them for 6 months. An integrated intervention package also applicable to everyday practice was introduced to improve treatment adherence, including education programmes for patients and physicians, tight follow-up with frequent office visits and regular home blood pressure measurements. Treatment was based on either trandolapril or verapamil SR with dose titration, with added-on therapy if necessary. Rates of control of blood pressure to < 140/90 mmHg. Data were evaluated from 5468 patients, 72% known to have hypertension and 26% newly diagnosed [2% not available (n.a.)]. At baseline only 2.9% of treated patients had their hypertension well controlled (< 140/90 mmHg), but during the programme this increased to 40.9% (P < 0.001). The absolute reduction in office blood pressure was also significant (from 168 +/- 19/97 +/- 11 mmHg to 139 +/- 13/83 +/- 7 mmHg; P < 0.001). No differences in blood pressure control were found between trandolapril and verapamil SR regimens. Office blood pressure was greater than home blood pressure at baseline (168 +/- 19/97 +/- 11 mmHg compared with 151 +/- 17/89 +/- 10 mmHg; P < 0.001), but this difference disappeared at 6 months (139 +/- 13/83 +/- 7 mmHg compared with 140 +/- 13/84 +/- 7 mmHg, respectively). The integrated, patient-focused approach used in the MIW programme significantly increases the success of treatment in a 'real-world' setting.