Mixed-method study to assess the feasibility, acceptability and early effectiveness of the Hospital to Home programme for follow-up of high-risk newborns in a rural district of Central Uganda: a study protocol.

INTRODUCTION: A follow-up programme designed for high-risk newborns discharged from inpatient newborn units in low-resource settings is imperative to ensure these newborns receive the healthiest possible start to life. We aim to assess the feasibility, acceptability and early outcomes of a discharge and follow-up programme, called Hospital to Home (H2H), in a neonatal unit in central Uganda. METHODS AND ANALYSIS: We will use a mixed-methods study design comparing a historical cohort and an intervention cohort of newborns and their caregivers admitted to a neonatal unit in Uganda. The study design includes two main components. The first component includes qualitative interviews (n=60 or until reaching saturation) with caregivers, community health workers called Village Health Team (VHT) members and neonatal unit staff. The second component assesses and compares outcomes between a prospective intervention cohort (n=100, born between July 2019 and September 2019) and a historical cohort (n=100, born between July 2018 and September 2018) of infants. The historical cohort will receive standard care while the intervention cohort will receive standard care plus the H2H intervention. The H2H intervention comprises training for healthcare workers on lactation, breast feeding and neurodevelopmentally supportive care, including cue-based feeding, and training to caregivers on recognition of danger signs and care of their high-risk infants. Infants and their families receive home visits until 6 months of age, or longer if necessary, by specially trained VHTs. Quantitative data will be analysed using descriptive statistics and regression analysis. All results will be stratified by cohort group. Qualitative data will be analysed guided by Braun and Clarke's thematic analysis technique. ETHICS AND DISSEMINATION: This study protocol was approved by the relevant Ugandan ethics committees. All participants will provide written informed consent. We will disseminate through peer-reviewed publications and key stakeholders and public engagement. TRIAL REGISTRATION NUMBER: ISRCTN51636372; Pre-result

Early care and support for young children with developmental disabilities and their caregivers in Uganda: The Baby Ubuntu feasibility trial.

Background: Early care and support provision for young children with developmental disabilities is frequently lacking, yet has potential to improve child and family outcomes, and is crucial for promoting access to healthcare and early education. We evaluated the feasibility, acceptability, early evidence of impact and provider costs of the Baby Ubuntu participatory, peer-facilitated, group program for young children with developmental disabilities and their caregivers in Uganda. Materials and methods: A feasibility trial, with two parallel groups, compared Baby Ubuntu with standard care. Caregivers and children, aged 6-11 months with moderate-severe neurodevelopmental impairment, were recruited and followed for 12 months. Quantitative and qualitative methods captured information on feasibility (ability to recruit), acceptability (satisfactory attendance), preliminary evidence of impact (family quality of life) and provider costs. Results: One hundred twenty-six infants (median developmental quotient, 28.7) were recruited and randomized (63 per arm) over 9 months, demonstrating feasibility; 101 (80%) completed the 12-month follow-up assessment (9 died, 12 were lost to follow up, 4 withdrew). Of 63 randomized to the intervention, 59 survived (93%); of these, 51 (86%) attended ≥6 modules meeting acceptability criteria, and 49 (83%) completed the 12 month follow-up assessment. Qualitatively, Baby Ubuntu was feasible and acceptable to caregivers and facilitators. Enabling factors included community sensitization by local champions, positive and caring attitudes of facilitators toward children with disability, peer support, and the participatory approach to learning. Among 101 (86%) surviving children seen at 12 months, mixed methods evaluation provided qualitative evidence of impact on family knowledge, skills, and attitudes, however impact on a scored family quality of life tool was inconclusive. Barriers included stigma and exclusion, poverty, and the need to manage expectations around the child's progress. Total provider cost for delivering the program per participant was USD 232. Conclusion: A pilot feasibility trial of the Baby Ubuntu program found it to be feasible and acceptable to children, caregivers and healthcare workers in Uganda. A mixed methods evaluation provided rich programmatic learning including qualitative, but not quantitative, evidence of impact. The cost estimate represents a feasible intervention for this vulnerable group, encouraging financial sustainability at scale. Clinical trial registration: [https://doi.org/10.1186/ISRCTN44380971], identifier [ISRCTN44380971]