An Educational Intervention Program to Improve the Oral Health of HIV-Positive Children in Kano, Nigeria.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 2
- 主要终点
- Gingival Health Status
研究概览
简要总结
The aim of this 2- arm randomized-control study is to determine the effect of an oral hygiene self care intervention on the oral health status and oral health-related quality of life (OHRQoL) of HIV-positive children (age: 8-16 years, n=172) presenting to five pediatric HIV clinics in Kano, Nigeria.
The intervention will comprise oral health education and instructions on oral self-care.
Data on oral health status and OHRQoL will be obtained at baseline and at 1, 3 and 6 months.
Study findings will help inform policies to improve the oral health and OHRQoL of HIV-positive Nigerian children and guide the integration of oral health care services into HIV programs.
详细描述
The paediatric HIV clinic sites will be randomized into intervention and control groups and all consecutive consenting eligible participants will be recruited and enrolled into the study at the sites until the estimated sample size for each study arm (86 participants per arm) is reached. The number of participants per arm will be allocated in proportions observed from each site's population. Baseline data collection will commence after all participants have been screened, recruited, and enrolled. The intervention arm will consist of oral health education and demonstration of how to perform oral self-care.
Hypothesis: There will be a mean difference of 0.5 in children's oral hygiene scores between intervention and control arms at 6 months post-intervention.
Based on reported oral hygiene score standard deviation=0.96, desired power=0.90, Type I error rate=0.05, we need 77 participants/arm to detect a clinically meaningful mean difference of 0.5 in oral hygiene score between intervention and control arms at 6 months post-intervention.
To account for possible loss to follow-up over 6 months, the participants' total sample size was increased to 172 (86 participants/arm).
Ethical Approval: Has been obtained from Aminu Kano Teaching Hospital (AKTH) and Kano State research ethics committees.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The research assistants (dentists) collecting data and the study statistician will be blinded as to which sites are the intervention and control arms.
The primary investigator and instructor will not be blinded as knowledge of the intervention will be necessary to ensure proper implementation of the intervention protocol.
入排标准
- 年龄范围
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •HIV-infected children aged 8-16 years (who can self-implement the oral health intervention with minimal caregiver supervision) attending selected clinics. HIV status will be based on clinic records.
- •Primary caregiver consent; assent from child.
- •On ART for ≥3 months.
排除标准
- •Children who
- •Have co-morbid conditions that increase their risk for oral diseases.
- •Have good oral hygiene.
- •Do not meet inclusion criteria.
- •Decline assent or lack caregiver consent.
结局指标
主要结局
Gingival Health Status
时间窗: 6 months
Modified Gingival Index (MGI) score
Oral Health Status
时间窗: 6 months
Oral Hygiene Index-Simplified (OHI-S) score
Oral Health Related Quality of Life (OHRQoL)
时间窗: 6 months
Child Perception Questionnaire for varying ages 8 to 10 and 11 to 14 and upward (CPQ8-10, CPQ11-14)
次要结局
- Dental Caries Sequelae(6 months)
- Other dental problems(One month)
- Dental Caries Status(6 months)
- HIV-associated oral lesions(One month)
研究者
Yewande Isabella Adeyemo
Dr.
Aminu Kano Teaching Hospital