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

ABSTRACT

Background: Good oral health is an integral part of overall child health. However, immune-deficient states like the presence of Human Immunodeficiency Virus (HIV) will compromise oral health and salivary bacterial composition, leading to adverse oral conditions. Nigeria has 1.9 million HIV-positive residents, and 0.2% of incident HIV infections occur among children below 15 years. Aim: This study aims to determine through a randomized control study, the effect of an educational intervention on the oral health status and oral health-related quality of life (OHRQoL) of HIV-positive children presenting to five pediatric HIV clinics in Kano, Nigeria. Methods/Design: This 2-arm randomized control 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-infected frequency matched children aged 8-16 years (they can self-implement the oral health intervention with minimal supervision from the caregivers) who will be randomized and allocated into control and intervention groups. The evaluation and oral health assessment will be carried out by five examiners who will be trained and calibrated. Discussion: Our 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 registration ClinicalTrails.gov ID National Clinical Trial (NCT) NCT05540171. Registered on 12th September 2022.