An Educational Intervention Program to Improve the Oral Health of HIV-Positive Children in Kano, Nigeria.

Not Applicable

Completed

• Conditions: Oral Manifestations; Quality of Life; Oral Infection; HIV; Oral Disease; Dental Caries
• Interventions: Other: Oral health education and instructions/training for self-oral care

• Registration Number: NCT05540171
• Lead Sponsor: Aminu Kano Teaching Hospital

Brief Summary

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.

Detailed Description

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.

Study instrument/measures:

1. Socio-demographic/clinical information: Age, gender, family size, household income, caregiver occupation/education, birth order/rank, HIV status of caregiver (self-reported/extracted from records), child's antiretroviral treatment (ART) regimen, comorbidities, most recent viral load, helper T cells (CD4+) count.

2. OHRQoL: The child perception questionnaire (CPQ) captures global ratings of child's oral health; four domains: oral symptoms, functional limitations, emotional and social well-being; Likert scale ('never'=0 to everyday/ almost every day'=4). The questionnaire will be translated into Hausa.

3. Oral health status:

i. Decayed, Missing, and Filled Teeth (DMFT/dmft) index, scored: D/d, M/m, F/f.

ii. International Caries Detection and Assessment System, (ICDAS) (caries severity) (0=sound tooth- 6=distinctly cavitated tooth).

iii. Pulp (visible), Ulceration (oral mucosa), Fistula and Abscess due to caries (PUFA/pufa) index scored: P/p, U/u, F/f, A/a.

iv. Oral Hygiene Index-Simplified (OHI-S): comprising Debris index (DI) and Calculus index (CI), each scored 0-3. OHI-S scored: good (0.0-1.2) to poor oral hygiene (3.1-6.0).

v. Gingival index (GI): 0=normal gingiva, 3=severely inflamed gingiva/spontaneous bleeding.

vi. Other lesions present (including HIV-associated oral lesions).

Study Procedures/Data collection:

One trained research assistant (RA) per site will be hired, trained, and calibrated (minimum kappa score: 0.8). Consented primary caregivers of eligible children will be contacted by RAs.

Baseline data will be extracted from participants' clinic charts. OHRQoL will be assessed for each participant. Baseline oral health status will be assessed and scored per established guidelines following intra-oral clinical examination.

All participants will be frequency matched.

Intervention: Trained instructor will give 45-minute oral health education and instructions/training for self-oral care to groups of 4 or 5 children and primary caregivers along with cards for oral self care record purposes.

The intervention will include oral hygiene instructions and motivation for oral self-care (dietary counseling; post-meal rinsing; flossing; brushing frequency, time, and method; tongue cleaning; toothbrush type/care; toothpaste quantity/type; dental visits). Audiovisual aids and leaflets reinforcing the oral health education will be provided. Reminders will be sent out monthly via text messages.

Control arm: will not receive oral health intervention at the time of the study, but as soon as the period of the study is over, the intervention will be given.

Participants with findings that require treatment will be linked to appropriate services and they will be financially responsible for such care. All participants will receive toothbrushes and toothpastes as incentive and funds for transportation cost during study visits.

After baseline measurement and intervention to the intervention group, data collection for both groups will be done at 1 month, 3 months and 6, months.

Study Timeline

• Study First Submitted: 2022-09-09
• Study First Submitted QC: 2022-09-12
• Study First Posted: 2022-09-14
• Study Start: 2022-12-22
• Primary Completion: 2023-09-15
• Study Completion: 2023-09-15
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

• 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.

Exclusion Criteria

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Education intervention (Oral health education and instructions/training for self-oral care)	Oral health education and instructions/training for self-oral care	The intervention arm will be given a 45 minute oral health education which will include oral hygiene instructions and motivation/training for oral self-care (dietary counselling; snacking during and not mealtimes; post-meal rinsing; flossing; brushing frequency, time, and method; tongue cleaning; toothbrush type/care; toothpaste quantity/type; dental visits). Audio-visual aids and leaflets reinforcing the oral health education will also be provided.

Primary Outcome Measures

Name	Time	Method
Gingival Health Status	6 months	Modified Gingival Index (MGI) score
Oral Health Status	6 months	Oral Hygiene Index-Simplified (OHI-S) score
Oral Health Related Quality of Life (OHRQoL)	6 months	Child Perception Questionnaire for varying ages 8 to 10 and 11 to 14 and upward (CPQ8-10, CPQ11-14)

Secondary Outcome Measures

Name	Time	Method
Dental Caries Sequelae	6 months	Pulp which is visible, Ulcerated oral mucosa, Fistula due to caries, Abscess due to caries (PUFA/pufa) index
Other dental problems	One month	Malocclusion, Molar-Incisor Hypomineralization (MIH), Trauma etc.
Dental Caries Status	6 months	International Caries Detection and Assessment System (ICDAS)
HIV-associated oral lesions	One month	Oral lesions that are associated with HIV

Trial Locations

Locations (1)

Aminu Kano Teaching Hospital; 🇳🇬 Kano, Nigeria