Background: Nigeria is the second biggest contributor to global child mortality. Infectious diseases continue to be major killers. In Bauchi State, Nigeria, a stepped wedge cluster randomised controlled trial tested the health impacts of universal home visits to pregnant women and their spouses. We present here the findings related to early child health. Methods: The home visits took place in eight wards in Toro Local Government Authority, randomly allocated into four waves with a delay of 1 year between waves. Female and male home visitors visited all pregnant women and their spouses every 2 months during pregnancy, with a follow up visit 12–18 months after the birth. They presented and discussed evidence about household prevention and management of diarrhoea and immunisation. We compared outcomes among children 12–18 months old born to mothers visited during the first year of intervention in each wave (intervention group) with those among children 12–18 months old pre-intervention in subsequent waves (control group). Primary outcomes included prevalence and management of childhood diarrhoea and immunisation status, with intermediate outcomes of household knowledge and actions. Generalised Estimating Equations (GEE), with an exchangeable correlation matrix and ward as cluster, tested the significance of differences in outcomes. Results: The analysis included 1796 intervention and 5109 control children. In GEE models including other characteristics of the children, intervention children were less likely to have suffered diarrhoea in the last 15 days (Odds Ratio (OR) 0.40, 95% confidence interval (CI) 0.30–0.53) and more likely to have received increased fluids and continued feeding in their last episode of diarrhoea (OR 6.06, 95% CI 2.58–14.20). Mothers of intervention children were more likely to identify lack of hygiene as a cause of diarrhoea (OR 2.24, 95% CI 1.27–3.95) and their households had better observed hygiene (OR 3.29, 95% CI 1.45–7.45). Intervention children were only slightly more likely to be fully immunised (OR 1.67, 95% CI 0.78–3.57). Conclusions: Evidence-based home visits to both parents stimulated household actions that improved prevention and management of childhood diarrhoea. Such visits could help to improve child health even in settings with poor access to quality health services. Trial registration: ISRCTN82954580. Date: 11/08/2017. Retrospectively registered.
A stepped-wedge cluster randomised controlled trial (RCT) tested the impact on maternal and child health outcomes of universal home visits that engaged pregnant women and their spouses [21]. The trial covered eight wards (administrative units) of Toro local government area (LGA) of Bauchi state, Nigeria. An epidemiologist not involved in the fieldwork randomly allocated wards into annual waves of intervention. An analysis after the first year of implementation of the intervention in wave 1 wards documented a significant positive impact on maternal health outcomes [22] and further analysis found a significant impact on male knowledge and attitudes (Anne Cockcroft, personal communication, 10 December 2020). This article focuses on the impact of the universal home visits on prevention and management of childhood diarrhoea and child immunisation, and on intermediate outcomes of parental knowledge and home care practices. Bauchi State in north-eastern Nigeria has a population of around 5 million, based on projections from the 2006 national census. The main religion is Islam, family sizes are large, and polygamy is common. Some 63% of women and 44% of men in Bauchi have no education, compared with 35 and 22% nationally [4]. Toro is the largest LGA in Bauchi, with a projected population of 487,100 living in 18 wards. More than 95% of the population is Muslim and predominantly Hausa (80%) or Fulani (12%) ethnicity. The 2018 Demographic and Health Survey [4] reported only 20% of children aged 12–23 months had received all basic vaccinations in Bauchi State, and the two-week prevalence of diarrhoea among children under 5 years was 34%. A 2013 survey found 14% of children aged 12–23 months in Toro LGA had received all basic vaccinations and 31% of children less than 5 years of age had diarrhoea during 2 weeks prior to the survey [23]. The overall trial methods appear in detail in the published protocol [21]. The stepped wedge cluster randomised design involved a sequential crossover of pairs of clusters (wards) from control to intervention, so that that each pair of wards after the initial one began in as a control and later received the intervention, with the order of inclusion randomly determined. Fig. 1 shows the trial design. Each sequential wave receiving the intervention comprised two wards. We selected the eight wards included in the trial from the pool of 18 wards in Toro LGA, excluding wards where the security situation was precarious. Each ward included urban, rural and rural remote communities. The home visits intervention began immediately upon allocation in the initial two wards (wave 1) and began in subsequent waves of two wards after 1 year of implementation in the previous wave. Stepped wedge design of the trial. Each ward is represented by a square box with two wards in each wave. The intervention measurement was made on children aged 12-18 months born to pregnant women visited during the first one year of home visits implementation in waves 1, 2 and 3, in a follow up visit 12-18 months after the birth. The pre-intervention (control) measurement was made on children aged 12-18 months identified in a pre-intervention visit to all households in waves 2, 3 and 4 We measured child health outcomes among children born to pregnant women who were visited in households during the first year of intervention in each wave, in a follow up visit when these children had reached 12–18 months of age. We compared them with child health outcomes among children aged 12–18 months old identified in pre-intervention visits to households in the subsequent waves (serving as controls). The last two wards (wave 4) did not go on to receive the intervention. We did not collect data about child health outcomes for children aged 12–18 months old in wave 1 wards before the home visits began in these wards. Thus, wave 1 wards only contributed information on child health outcomes to the intervention group and wave 4 wards only contributed information on child health outcomes to the control group. Wave 2 and wave 3 wards contributed child outcome information to both the intervention and the control group. Because the two visits for data collection were at least a year apart, the children included in the control and intervention groups in wave 2 and wave 3 wards were different. Fieldworkers administered a questionnaire to collect socio-demographic characteristics of the mother and other household members at the pre-intervention visits in wards in waves 2, 3 and 4 and in the first intervention visit in wave 1 wards. The trial protocol includes a detailed description of the home visits intervention [21]. The research team recruited most of the home visitors to work within their own home communities, guided by community, ward and LGA leaders. The table in Additional file 1 shows characteristics of the female and male home visitors in the different waves. Most of the home visitors were married and aged 25 years or above. More male than female home visitors had post-secondary education. Characteristics of the home visitors were similar across waves, except that those in wave2 tended to be older and fewer of them had post-secondary education. We conducted a separate training for home visitors for each wave, just before the start of the intervention in that wave. To ensure the consistency and quality of the training across all waves, the same team of trainers conducted all the trainings using a standardised curriculum. Each training over 11 days included classroom sessions and field practice. The training stressed the importance of conducting all visits and interactions with privacy and covered practical ways of ensuring privacy in the household setting in Bauchi. We trained more potential home visitors than we needed and evaluated them to select only those who had attained the required understanding and level of skills. Each team of one female and one male home visitor had a catchment area of about 300 households. This was sometimes a whole community in rural areas, or part of a bigger urban site. The wards had between 8 and 27 catchment areas, covering all households in the ward. There were 51 catchment areas in total across all the wards. The female home visitors visited every household in their catchment areas every 2 months during daylight hours. During the first visit they registered the household and collected information about the demographic and socio-economic status of the household and listed all women of childbearing age (14–49 years). During subsequent two-monthly visits the female home visitors checked for any new pregnancies and registered and followed all pregnant women during the pregnancy. The male home visitors visited the spouses of the pregnant women, also two-monthly, at a convenient time, usually in the evening or on weekends. On each visit the home visitors interacted with the registered pregnant women and their spouses using a surveillance questionnaire and a structured discussion guide. The discussion guide for both women and men included information about early childhood health and care, specifically covering prevention and management of diarrhoea and routine immunisation. Using the guide, the home visitors gave the pregnant women and their spouses’ information about prevention of diarrhoea, including improving household hygiene and management of drinking water containers, and about home management of childhood diarrhoea, including giving extra fluids, continuing feeding, and avoiding medicines to stop the diarrhoea. They also gave information about the benefits of childhood immunisation. They asked what actions women, their spouses and other family members could take to prevent childhood diarrhoea, to manage diarrhoea when it happened, and to ensure immunisation of children. They concluded by asking about progress with actions planned by the women and their spouses during the previous visit. In one of the two wards in each wave, the home visitors supported their discussions in the household with short video-docudramas. We will examine the potential added value of these videos in a separate analysis among the intervention group only. The repeated evidence-based interactions with women and their spouses aimed to support them to make informed decisions and take actions which would lead to improved outcomes for the child. For example, they would gain knowledge about the connection between hygiene and the risk of childhood diarrhoea, discuss within the household how to improve hygiene, and then take actions to improve hygiene, leading to a reduction in childhood diarrhoea. The conceptual framework for the home visits intervention was based on the CASCADA results chain [24], a version of the theory of planned behaviour [25]. It proposes increasing Conscious knowledge, changing Attitudes, deviating from unhelpful Subjective norms, intention to Change, perceived Agency to change, Discussion about change, and finally Acting to implement change. The home visitors collected information from mothers (or other main carers) of children aged 12–18 months old. For children in the intervention group (born during the first 1 year of the home visits in each wave), they collected the information in a follow up visit when the child was 12–18 months old. For children in the control group, they collected this information about children aged 12–18 months old identified in the pre-intervention visits. They collected information on child health status and caring practices during the child’s first year of life as well as knowledge, attitudes and practices of the woman and her spouse about child health and care. They administered an electronic questionnaire, recording responses on GPS-enabled android handsets, and uploading records to a central server using a cellular connection. We used open-source Open Data Kit (ODK) software for this electronic data collection [26]. The background meta-data automatically stamped each record with the GPS location, the visit date, and the duration of the interaction. This enabled quality control, to check if the home visitors conducted interviews appropriately in the intended households. The fieldworkers collected information about education of the father, education of the mother and food security of the mother on the first home visit to households in wards in wave 1 and in the pre-intervention visit to households in wards in waves 2, 3, and 4. The primary outcomes were prevalence of diarrhoea in the last 15 days and prevalence of severe diarrhoea (with blood in the stool) within the last 15 days. Intermediate outcomes included the mother’s knowledge about poor hygiene as a cause of diarrhoea, reported treatment of drinking water, and the state of household hygiene and the water container, as observed by the home visitors. Mothers reported on their management of the child’s last episode of diarrhoea, including whether the child received increased fluids and continued feeding during the episode and whether the child was given any anti-diarrhoeal medicine. Intermediate outcomes included the mother’s knowledge about management of diarrhoea: increased fluids and continued feeding and avoidance of anti-diarrhoeal medicine. The home visitors asked if each child had received routine vaccinations, including the number of doses for multi-dose vaccinations. They did not request to see the child’s vaccination card. The indicator of immunisation status was whether the child was fully immunised: a fully immunised child had received the full course of BCG, Pentavalent DTP-hepB-Hib (Diphtheria, Tetanus, Pertussis, Hepatitis-B, Haemophilus Influenza), Polio, Yellow fever and Measles vaccines. Intermediate outcomes were the mother’s perception about the value of immunisation, discussions about immunisations in the family, and the mother’s involvement in the decision about immunisation of the child. We calculated the trial sample size using the clinical trials simulator of Taylor and Bosch [27] and based on maternal health outcomes [22]. For child health outcomes, there were 1796 children in the intervention group and 5109 in the pre-intervention (control) group (see Table 2). Analysis of the stepped wedge trial used six clusters in the intervention arm and six in the control arm. With a prevalence of diarrhoea in the last 2 weeks of 34% in control clusters, the trial could detect a reduction of 12% with 80% power at the 5% significance level. Trial flow of participants a The number of children born during the first year of the intervention in each wave. As expected from the larger number of households in wave 3, there were more live births during the first year of intervention in wave 3 than in the equivalent period in wave 1 and wave 2 b The number of children that died soon after birth or before they reached 12 months old cThe number of children born during the first one year of intervention in the wave who had not reached 12 months old by the time of the end of the overall project fieldwork, so did not have outcomes measured. This only occurred for children born during the intervention period in wave 3 dThe number of children eligible for measurements who did not have the follow up visit to make the measurements. The reasons included: some households moved away from the ward; in some areas there was a high turnover of female visitors and by the time new workers could complete the follow-up the children were over 18 months old; and in some areas security concerns limited the ability to make the follow-up visits e The net number of children included in the intervention group for the analysis is the number of live births minus the deaths, minus the < 12 months, and minus the lost to follow up We divided the eight participating wards into two geographically separated sets of four wards each. An epidemiologist not involved in the field implementation of the trial (NA) created four waves of two wards, with one ward from each of the two sets of wards in each wave. He randomly assigned the four waves to the sequence for implementation of the home visits, using a computer-generated random sequence. It was not possible to blind home visitors or pregnant women and their spouses to the intervention status once the implementation began. We standardised the procedures of administering the questionnaire about child health outcomes and the questionnaire used in both the intervention and pre-intervention (control) visits was the same. Fieldworkers had no reason to conduct the process differently in intervention and pre-intervention visits. Each householder gave informed consent to receive visits and to respond to questionnaires, without being aware if they were allocated to a treatment or control group. We followed the principles embodied in the Declaration of Helsinki to conduct the trial. We shared the study protocol and design in non-technical terms with each participating community, ward and LGA leadership and sought their approval before starting the trial. The home visitors sought and recorded oral informed consent from each household, woman and spouse to be visited and to respond to questionnaires. Statistical analysis used CIETmap open-source software, [28] which interfaces with the R programming language. Ward was the unit of randomisation, of intervention and analysis. We used the Mantel-Haenszel procedure [29] to examine differences in characteristics between the intervention and control groups potentially related to the outcomes. To assess the impact of home visits on pre-defined primary and intermediate child health outcomes we undertook logistic regression using Generalised Estimating Equations (GEE) [30], using an exchangeable correlation matrix and ward as cluster. For each outcome, we first ran the model including only the intervention and cluster. We then repeated the analysis, beginning with a saturated model including the six variables potentially related to the outcome and measured in intervention and control groups: urban/rural location, sex of the child, education of the mother, age of the mother, education of the father, food security of the mother. We used the same set of six variables in saturated models for all outcomes. The analysis stepped down variable by variable to a model where all variables were significantly associated with the outcome. We report the robust odds ratios (OR) and 95% confidence intervals (CIs) from the final GEE models. The intervention measurement included only children born within the first 1 year of intervention in all waves, so exposure time was equal for all the waves in the analysis. To examine the effect of not having pre-intervention outcomes data for wave 1 wards, and not having post-intervention outcomes data for wave 4 wards, a sensitivity analysis included only wards in wave 2 and wave 3. As for the main analysis, the initial GEE model for each outcome included ward as cluster and other characteristics of the children potentially related to the outcomes.
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