Clinical trial NCT05540171: An Educational Intervention Program to Improve the Oral Health of HIV-Positive Children in Kano, Nigeria.
Official title: An Educational Intervention Program to Improve the Oral Health of HIV-Positive Children in Kano, Nigeria.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Dental Caries
Quality of Life
Oral Disease
Oral Infection
Oral Manifestations
Keywords: HIV
Children
Oral Health Status
Oral Health Related Quality of Life
Kano
Self oral care
Oral health education
Randomized controlled study
Lead sponsor: Aminu Kano Teaching Hospital
Sponsor class: OTHER
Collaborators: name: NIH Office of AIDS Research (OAR)
name: Fogarty International Center of the National Institute of Health
First posted: 2022-09-14
Enrollment: 172
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A 2-arm randomized control study which involves two groups of participants who will be recruited into the study at the sites. The sites would have been randomized into control and intervention arms using a simple lottery technique.

Four (4) identical slips of paper with 'control' printed on 2 on them and 'intervention' on the other 2 slips will be provided. Each paper will be sealed in envelopes which will all be identical, and they will be placed in a box. An individual unconnected to the study will be asked to select two (2) envelopes from the box and these will be assigned the control group while the two (2) envelopes left in the box will be the assigned the intervention group.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Oral Health Status
timeFrame: 6 months
measure: Gingival Health Status
timeFrame: 6 months
measure: Oral Health Related Quality of Life (OHRQoL)
timeFrame: 6 months
Secondary outcomes:
measure: Dental Caries Status
timeFrame: One month
measure: Dental Caries Sequelae
timeFrame: 6 months
measure: Dental Caries Status
timeFrame: 6 months
measure: HIV-associated oral lesions
timeFrame: One month
measure: Other dental problems
timeFrame: One month
Other outcomes:
Locations:
city: Kano
country: Nigeria
facility: Aminu Kano Teaching Hospital
Study officials:
affiliation: Bayero University, Kano/ Aminu Kano Teaching Hospital
name: Yewande I ADEYEMO, BDS
role: PRINCIPAL_INVESTIGATOR
References: