Effect of the Uganda Newborn Study on care-seeking and care practices: A cluster-randomised controlled trial

Background: Care for women and babies before, during, and after the time of birth is a sensitive measure of the functionality of any health system. Engaging communities in preventing newborn deaths is a promising strategy to achieve further progress in child survival in sub-Saharan Africa. Objective: To assess the effect of a home visit strategy combined with health facility strengthening on uptake of newborn care-seeking, practices and services, and to link the results to national policy and scale-up in Uganda. Design: The Uganda Newborn Study (UNEST) was a two-arm cluster-randomised controlled trial in rural eastern Uganda. In intervention villages volunteer community health workers (CHWs) were trained to identify pregnant women and make five home visits (two during pregnancy and three in the first week after birth) to offer preventive and promotive care and counselling, with extra visits for sick and small newborns to assess and refer. Health facility strengthening was done in all facilities to improve quality of care. Primary outcomes were coverage of key essential newborn care behaviours (breastfeeding, thermal care, and cord care). Analyses were by intention to treat. This study is registered as a clinical trial, number ISRCTN50321130. Results: The intervention significantly improved essential newborn care practices, although many interventions saw major increases in both arms over the study period. Immediate breastfeeding after birth and exclusive breastfeeding were significantly higher in the intervention arm compared to the control arm (72.6% vs. 66.0%; p = 0.016 and 81.8% vs. 75.9%, p = 0.042, respectively). Skin-to-skin care immediately after birth and cord cutting with a clean instrument were marginally higher in the intervention arm versus the control arm (80.7% vs. 72.2%; p = 0.071 and 88.1% vs. 84.4%; p = 0.023, respectively). Half (49.6%) of the mothers in the intervention arm waited more than 24 hours to bathe the baby, compared to 35.5% in the control arm (p < 0.001). Dry umbilical cord care was also significantly higher in intervention areas (63.9% vs. 53.1%, p < 0.001). There was no difference in care-seeking for newborn illness, which was high (around 95%) in both arms. Skilled attendance at delivery increased in both the intervention (by 21%) and control arms (by 19%) between baseline and endline, but there was no significant difference in coverage across arms at endline (79.6% vs. 78.9%; p = 0.717). Home visits were pro-poor, with more women in the poorest quintile visited by a CHW compared to families in the least poor quintile, and more women who delivered at home visited by a CHWafter birth (73.6%) compared to those who delivered in a hospital or health facility (59.7%) (p < 0.001). CHWs visited 62.8% of women and newborns in the first week after birth, with 40.2% receiving a visit on the critical first day of life. Conclusions: Consistent with results from other community newborn care studies, volunteer CHWs can be effective in changing long-standing practices around newborn care. The home visit strategy may provide greater benefit to poorer families. However, CHW strategies require strong linkages with and concurrent improvement of quality through health system strengthening, especially in settings with high and increasing demand for facility-based services.

UNEST was implemented in Iganga and Mayuge districts in eastern Uganda, within the Iganga-Mayuge Health and Demographic Surveillance Site (HDSS). The HDSS was established in 2004 in collaboration between the two districts, Makerere University, Uganda, and Karolinska Institutet, Sweden. The HDSS is predominately rural, comprising 65 villages and a total population of approximately 70,000 at the time of the study. Thirteen peri-urban villages form the Iganga Town Council. The main economic activity is subsistence farming. Other occupations include small-scale businesses, such as grain milling, market vending and motorcycle transport, and civil service employment. The predominant ethnic group in the HDSS is the Basoga, a Bantu-speaking group, which makes up 10% of Uganda's population. The HDSS is served by one 100-bed hospital and at least 19 government-run and private-sector health centres that offer delivery services (13). A rising proportion of women in the Central East region – over two-thirds of them – deliver at health facilities (14). The cluster unit for the study was the village. Each of the 63 villages in the HDSS was randomly allocated to the intervention or control arm, without any stratification or matching due to the relatively large number of study units. Computer-generated restricted randomisation was done in a one-to-one ratio by an independent epidemiologist from the London School of Hygiene and Tropical Medicine. A total of 31 villages were allocated to the intervention arm and 32 to the control arm. More information on the study setting and design are available elsewhere (15). The trial included all consenting pregnant women and their newborns residing in the HDSS between September 2009 and August 2011. A team of data collectors linked to the HDSS conducted a baseline household survey to establish coverage of maternal and newborn care behaviours and practices. The baseline survey was conducted between March and August 2008 and included women with a live birth within 4 months of the survey. Information on household asset ownership, care received during pregnancy, childbirth and the postnatal period, and nutritional indicators were collected. Data for the endline survey were collected between September and November 2011 amongst women who had a live birth within 12 months of the survey (Fig. 1). The primary outcomes of the study were improved coverage of services for antenatal care (ANC), birth preparedness, skilled attendance at delivery, and postnatal care, as well as increases in healthy practices including breastfeeding, thermal care, and hygiene. The study was not powered to detect mortality differences; however, routine birth and death reports were collected as part of household surveillance in the HDSS, but are not reported on here. Prospective data on pregnancies and their outcomes were collected between 2006 and 2010 through routine surveillance in the HDSS. In 2011, a cross-sectional pregnancy history study was conducted amongst 10,540 women aged 15–49, and details are reported elsewhere (16). Village-based scouts notified verbal autopsy interviewers of deaths, including maternal deaths, stillbirths, and neonatal deaths, as they occurred. UNEST trial profile. Meetings were held in each district in August 2008 to introduce UNEST and explain the proposed randomisation process to village members and prospective CHWs. The UNEST package was intended to be an integrated intervention package (Fig. 2), based on extensive formative research (17–22), and developed and implemented in close collaboration with national policy makers and experts and the district health management teams of the trial districts. Following a design workshop, the intervention was piloted between November 2008 and February 2009. Building on the pilot, 61 CHWs from the intervention clusters were recruited by the community with the aim of identifying individuals with the following attributes: empathy; experience of similar problems and situations; respected in the local community; and considered to be a natural helper or someone that community members would naturally go to in the event of a problem. Women were preferred, although males were also accepted (women and men can serve as VHT members according to the national strategy). UNEST conceptual framework. Source: Adapted from Kerber et al. (22). The CHWs were then trained for 5 days on the intervention package, which included identification of pregnant women in their community and undertaking two home visits during pregnancy and three visits after birth at or as close to days 1, 3, and 7 as possible. Each cluster had at least one CHW, with most villages having two, in line with the national VHT strategy (23), amounting to one CHW per 100–150 households on average. More details, including the selection, training, and supervision of CHWs as well as the content of each visit can be found in the trial protocol (15). After the initial training no additional off-site trainings were conducted, but knowledge and skills were reinforced during quarterly supervisory meetings and through directly observed supervision. We found this strategy to be effective in imparting and retaining skills (24, 25). CHWs’ incentives were simple, and included a t-shirt, briefcase, certificate, and official commission following their training. The CHWs were not paid a salary by the study, but received a travel refund after supervision meetings. While UNEST was initially envisioned to be a community-based intervention, the formative research identified relatively high rates of care-seeking at health facilities with low quality care (18). In response, efforts were made to design the intervention to ensure that all 20 public and private health facilities in and around the study area were strengthened through a 6-day in-service training, provision of a once-off catalytic supply of equipment and medicines, as well as collaboration with the district health team to continuously improve the quality of care provided to mothers and newborns (13, 15). Training modules included goal-oriented ANC, managing maternal complications, infection prevention, managing normal labour and partograph use, neonatal resuscitation, care of the sick newborn, and extra care for the small baby using kangaroo mother care. Space for newborn care, including designated kangaroo mother care beds, was set up in the referral sites. Further details of the health system strengthening are provided elsewhere (13). In the comparison villages, women and their newborns had access to the standard health services, overseen by the district health team, in addition to the improved health facilities. The trial protocol was approved by Makerere University School of Public Health and the Uganda National Council of Science and Technology. In addition, approval was sought from the district authorities and local leaders in the communities where the study was conducted. The study had a data safety monitoring board comprising local and international maternal and newborn experts which met annually. The trial also had a local advisory board which consisted of academics, national policy and programme managers, and development partners. These met quarterly under the auspices of the Uganda National Newborn Steering Committee. The study was registered as randomised controlled trial ISRCTN50321130. The number of clusters was fixed a priori as the existing villages within the HDSS. Study investigators reviewed data collection tools for accuracy and completeness. Data were double entered in databases with consistency and quality checked. We used an intention to treat approach, where we compared summary variables in the intervention and control arms with adjustment for clustering. Statistical analyses were conducted with Stata version 12. We calculated means and proportions of the background characteristics and compared them with t tests or χ 2 tests as appropriate to assess differences at baseline. Using the svy command in Stata (version 12), primary sampling units and strata for the data set were defined to account for the cluster-randomised design. At baseline and endline an asset index score was constructed using principal component analysis to rank households according to asset ownership and then divided into quintiles. Details of how the index was built are described elsewhere (19). The effect of the health system strengthening was assessed using a ‘before–after’ comparison.

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