A 2-arm randomized controlled study to improve the oral health of children living with HIV in Nigeria: Protocol and study design

Abstract

BackgroundGood oral health is an integral part of overall child health. However, immunodeficiency states like those associated with the presence of Human Immunodeficiency Virus (HIV) compromise oral health and salivary bacterial composition, leading to adverse oral conditions. Nigeria has 1.9 million people living with HIV, and 0.2% of incident HIV infections occur among children below 15 years. AimThis study aims to determine through a randomized controlled study, the effect of an educational intervention on the oral health status and oral health-related quality of life (OHRQoL) of children living with HIV presenting to five pediatric HIV clinics in Kano, Nigeria. Methods/designThis 2-arm randomized controlled study will be conducted in five pediatric HIV outpatient clinics in Kano State, Nigeria over a period of 6 months. Eligible participants will include 172 HIV-positive children aged 8–16 years (able to self-implement the oral health intervention with minimal supervision from the caregivers). The evaluation and oral health assessment will be carried out by five examiners who will be trained and calibrated. DiscussionOur findings will help inform policies to improve the oral health and OHRQoL of HIV-positive Nigerian children and inform the need to integrate oral health care services into HIV programs in similar settings. Trial registrationClinicalTrails.gov ID: National Clinical Trial (NCT) NCT05540171. Registered on 12th September 2022.