Evaluating the effectiveness of a multicomponent intervention on early childhood development in paediatric HIV care and treatment programmes: a randomised controlled trial

Background: HIV 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.

Methods: The 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.

Discussion: The 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 registration: This 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).

Keywords: Early childhood stimulation, Internal savings and lending scheme, Case management, HIV exposed infants,

Zimbabwe