Effectiveness of a Home-Based Counselling Strategy on Neonatal Care and Survival: A Cluster-Randomised Trial in Six Districts of Rural Southern Tanzania.

BACKGROUND: We report a cluster-randomised trial of a home-based counselling strategy, designed for large-scale implementation, in a population of 1.2 million people in rural southern Tanzania. We hypothesised that the strategy would improve neonatal survival by around 15%. METHODS AND FINDINGS: In 2010 we trained 824 female volunteers to make three home visits to women and their families during pregnancy and two visits to them in the first few days of the infant's life in 65 wards, selected randomly from all 132 wards in six districts in Mtwara and Lindi regions, constituting typical rural areas in Southern Tanzania. The remaining wards were comparison areas. Participants were not blinded to the intervention. The primary analysis was an intention-to-treat analysis comparing the neonatal mortality (day 0-27) per 1,000 live births in intervention and comparison wards based on a representative survey in 185,000 households in 2013 with a response rate of 90%. We included 24,381 and 23,307 live births between July 2010 and June 2013 and 7,823 and 7,555 live births in the last year in intervention and comparison wards, respectively. We also compared changes in neonatal mortality and newborn care practices in intervention and comparison wards using baseline census data from 2007 including 225,000 households and 22,243 births in five of the six intervention districts. Amongst the 7,823 women with a live birth in the year prior to survey in intervention wards, 59% and 41% received at least one volunteer visit during pregnancy and postpartum, respectively. Neonatal mortality reduced from 35.0 to 30.5 deaths per 1,000 live births between 2007 and 2013 in the five districts, respectively. There was no evidence of an impact of the intervention on neonatal survival (odds ratio [OR] 1.1, 95% confidence interval [CI] 0.9-1.2, p = 0.339). Newborn care practices reported by mothers were better in intervention than in comparison wards, including immediate breastfeeding (42% of 7,287 versus 35% of 7,008, OR 1.4, CI 1.3-1.6, p < 0.001), feeding only breast milk for the first 3 d (90% of 7,557 versus 79% of 7,307, OR 2.2, 95% CI 1.8-2.7, p < 0.001), and clean hands for home delivery (92% of 1,351 versus 88% of 1,799, OR 1.5, 95% CI 1.0-2.3, p = 0.033). Facility delivery improved dramatically in both groups from 41% of 22,243 in 2007 and was 82% of 7,820 versus 75% of 7,553 (OR 1.5, 95% CI 1.2-2.0, p = 0.002) in intervention and comparison wards in 2013. Methodological limitations include our inability to rule out some degree of leakage of the intervention into the comparison areas and response bias for newborn care behaviours. CONCLUSION: Neonatal mortality remained high despite better care practices and childbirth in facilities becoming common. Public health action to improve neonatal survival in this setting should include a focus on improving the quality of facility-based childbirth care. TRIAL REGISTRATION: ClinicalTrials.gov NCT01022788

Meta-analysis of the effect of home visits on NMR.

<p>Data are the number of deaths (newborn mortality rate per 1,000 live births). Proof-of-principle studies: Gadchiroli, India, 2005 [<a href="http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1001881#pmed.1001881.ref004" target="_blank">4</a>]; Hala, Pakistan [<a href="http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1001881#pmed.1001881.ref007" target="_blank">7</a>]; Projahnmo, Bangladesh, 2008 [<a href="http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1001881#pmed.1001881.ref006" target="_blank">6</a>]; Shivgarh, India, 2008 [<a href="http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1001881#pmed.1001881.ref005" target="_blank">5</a>]; Projahnmo-2, Bangladesh [<a href="http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1001881#pmed.1001881.ref033" target="_blank">33</a>]; Hala, Pakistan [<a href="http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1001881#pmed.1001881.ref031" target="_blank">31</a>], Integrated Management of Neonatal and Childhood Illnesses, India [<a href="http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1001881#pmed.1001881.ref032" target="_blank">32</a>]; Newhints, Ghana [<a href="http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1001881#pmed.1001881.ref009" target="_blank">9</a>]; and Improving Newborn Survival in Southern Tanzania (INSIST). Shivgarh-1 = home visits only. Shivgarh-2 = home visits plus thermospot.</p

Home counselling visit coverage reported by women with a live birth in the year prior to the 2013 survey.

<p>* Volunteer who used the Mtunze counselling card or doll during the visit and where a card was left with the family</p><p>Home counselling visit coverage reported by women with a live birth in the year prior to the 2013 survey.</p

Trial profile.

<p>Trial profile.</p

Primary analysis: Newborn mortality in intervention areas compared to comparison areas in 2007 and 2013 and adjusted for baseline.

<p>^~We used multilevel logistic regression to compute ORs specifying the ward and subvillage level. The intracluster correlation coefficients were 5.6% (95% CI 3.5%–8.8%) for the subvillage nested within the ward. The respective value for the ward level was 0.5% (95% CI 0.1%–2.7%).</p><p>Primary analysis: Newborn mortality in intervention areas compared to comparison areas in 2007 and 2013 and adjusted for baseline.</p

Characteristics of respondents of intervention and comparison wards in the 2007 and 2013 surveys.

<p>The 2007 survey included the five districts of Lindi Rural, Ruangwa, Nachingwea, Newala, and Tandahimba. The 2013 survey additionally included the Mtwara Rural district.</p

Secondary analysis, neonatal mortality in subgroups by intervention status, 2013 survey.

<p>* Volunteer who used the Mtunze counselling card or doll during the visit</p><p>^# Volunteer visit in pregnancy and postpartum in which a Mtunze counselling card or doll was used during the visit</p><p>Secondary analysis, neonatal mortality in subgroups by intervention status, 2013 survey.</p

Coverage of newborn care behaviours in the years prior to the 2007 and 2013 survey and changes between 2007 and 2013 restricted to the five districts with baseline data.

<p>Key behaviours marked in bold</p><p>* all women who reported a live birth</p><p>^~ women who reported a live birth delivered at home</p><p>^# women who reported a live birth with the baby surviving at least 3 d</p><p>^{^} live-born baby who the mother reported was born prematurely</p><p>^¤ mother reported any sickness of her live-birth baby in the first month of life. N/A, not available</p><p>Coverage of newborn care behaviours in the years prior to the 2007 and 2013 survey and changes between 2007 and 2013 restricted to the five districts with baseline data.</p

Behaviours promoted in home-based counselling, adapted from [26].

<p>Behaviours promoted in home-based counselling, adapted from [<a href="http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1001881#pmed.1001881.ref026" target="_blank">26</a>].</p