Trials (Dec 2018)
Improving overall health of children living with HIV through an oral health intervention in Cambodia: study protocol for a randomized controlled trial
Abstract
Abstract Background Currently, the number of children living with HIV is the highest ever. This has led to an increased focus on a healthy life expectancy in this population. Improving oral health status may contribute to improved immunity, which could in turn lead to greater overall health in this population. This study aims to evaluate the effectiveness of an oral health intervention in improving oral health and immune status among children living with HIV in Cambodia. Methods A randomized controlled trial will be conducted in Phnom Penh from May 2018 to April 2020. Among 520 dyads of children living with their respective caregivers, half will be randomly allocated to the intervention group and the other half to the control group. Children aged 3–15 years who are currently receiving antiretroviral therapy at the National Pediatric Hospital will be recruited. In addition, 260 HIV-uninfected children (age-matched to the intervention group) will be recruited from the communities. They, together with their caregivers, will comprise the second control group. The main components of the intervention will include oral health education sessions for the children, as well as daily oral self-care under the supervision of their caregivers. The primary study outcome will be the change in oral health status including the number of decayed, missing, or filled permanent teeth, and the secondary outcome will be CD4 count. The effects of the intervention will be assessed by comparing outcome indicators between the children in the intervention and those in the control groups. Discussion This trial will investigate the effects of an oral health intervention on the improvement of oral health and immune status among children living with HIV and determine the differences compared with the control groups. This intervention would encourage the promotion of oral health interventions among children living with HIV and thus contribute to delaying the onset of AIDS. Trial registration Current Controlled Trials, International Standard Randomized Controlled Trial Number Register, ISRCTN15177479. Registered on 17 January 2018.
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