Abstract
BackgroundHIV infection in a family may affect optimum child development. Our hypothesis is that child development outcomes among HIV-exposed infants will be improved through a complex early childhood stimulation (ECS) programme, and income and loans saving programme for HIV positive parents.MethodsThe study was a cluster-randomized controlled trial in 30 clinic sites in two districts in Zimbabwe. Clinics were randomised in a 1:1 allocation ratio to the Child Health Intervention for Development Outcomes (CHIDO) intervention or Ministry of Health standard care. The CHIDO intervention comprises three elements: a group ECS parenting programme, an internal savings and lending scheme (ISALS) and case-management home visits by village health workers. The intervention was aimed at caregiver-child dyads (child aged 0–24 months) where the infant was HIV exposed or infected. The primary outcomes were cognitive development (assessed by the Mullen Scales of Early Learning) and retention of the child in HIV care, at 12 months after enrolment. A comprehensive process evaluation was conducted.DiscussionThe results of this cluster-randomised trial will provide important information regarding the effects of multi-component interventions in mitigating developmental delays in HIV-exposed infants living in resource-limited environments.Trial registrationThis trial is registered with the Pan African Clinical Trials Registry (www.pactr.org), registration number PACTR201701001387209; the trial was registered on 16th January 2017 (retrospectively registered).
Highlights
HIV infection in a family may affect optimum child development
Intervention components and data collection preparation Usual care arm Clinics in the usual care arm received the recommended standard of care provided by Zimbabwean Ministry of Health and Child Care (MOHCC) for HIV exposed and/ or infected children aged 0–24 month delivered according to 2013 National ART guidelines
Several studies have highlighted the effectiveness of implementing comprehensive programmes to improve early childhood development (ECD) and nutrition outcomes [16, 35]
Summary
Aims and objectives The overall aim of this trial was to determine the impact of a comprehensive community-based intervention set up to simultaneously enhance child stimulation, reduce economic insecurity and improve retention in care among HIV exposed and infected children aged 0–24 month. Intervention components and data collection preparation Usual care arm Clinics in the usual care arm received the recommended standard of care provided by Zimbabwean Ministry of Health and Child Care (MOHCC) for HIV exposed and/ or infected children aged 0–24 month delivered according to 2013 National ART guidelines. The same sample size provides 80% power to detect a risk difference of 20% in retention in care, assuming retention is 65% in the control arm and k = 0.2 Based on these calculations our recruitment target was 528 caregiver-child dyads in total from 30 clinics. Routine programme data were used to track participation in the intervention, complemented by qualitative research, using semi-structured in-depth interviews (IDIs) with ECS staff, case managers, clinic staff and participating caregivers conducted at 3, 6 and 12 months after the start of the programme. Changes to the current protocol at the Pan-African Clinical Trials Registry will be updated online
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