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

Sponsor

Aminu Kano Teaching Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05540171

Collaborator

NIH Office of AIDS Research (OAR) (NIH), Fogarty International Center of the National Institute of Health (NIH)

170

Enrollment

Arms

6.1

Anticipated Duration (Months)

Study Details

Study Description

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=170) 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.

Condition or Disease	Intervention/Treatment	Phase
HIV Dental Caries Quality of Life Oral Disease Oral Infection Oral Manifestations	Other: Oral health education and instructions/training for self-oral care	N/A

Detailed Description

Eligible children will be randomized to intervention (oral health education and demonstration of how to perform oral self-care) arm and control (no intervention) arms.

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 170 (85 participants/arm).

Ethical Approval: Has been obtained from Aminu Kano Teaching Hospital (AKTH) and Kano State research ethics committees.

Study instrument/measures:

Socio-demographic/clinical information: Age, gender, family size, household income, caregiver occupation/education, birth history, caregiver self-reported HIV-status (if known), child's antiretroviral treatment (ART) regimen, comorbidities, recent viral load, helper T cells (CD4+) count.
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.
Oral health status:

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

International Caries Detection and Assessment System, (ICDAS) (caries severity) (0=sound tooth- 6=distinctly cavitated tooth).
Pulp (visible), Ulceration (oral mucosa), Fistula and Abscess due to caries (PUFA/pufa) index scored: P/p, U/u, F/f, A/a.
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).
Gingival index (GI): 0=normal gingiva, 3=severely inflamed gingiva/spontaneous bleeding.
HIV-associated oral lesions.

Study Procedures/Data collection:

One trained research assistant (RA) per site will be hired (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.

Participants will be randomly assigned 1:1 to intervention and control arms by a computerized algorithm.

Intervention: Trained instructor will give 45-minute oral health education and instructions/training for self-oral care to each child and primary caregiver.

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 flyers reinforcing the oral health education will be provided.

Control arm: will not receive oral health intervention.

Participants with findings that require treatment will be linked to appropriate services; they will be financially responsible for such care. All participants will receive toothbrushes and toothpastes as incentive.

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 Design

Study Type:

Interventional

Anticipated Enrollment :

170 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A 2-arm randomized control study which involves two groups of participants who will be randomly assigned into the intervention arm and the control arm. The randomization process will be through a computerized algorithm which will generate the sequence that will be implemented.A 2-arm randomized control study which involves two groups of participants who will be randomly assigned into the intervention arm and the control arm. The randomization process will be through a computerized algorithm which will generate the sequence that will be implemented.

Masking:

Single (Outcomes Assessor)

Masking Description:

The participants will not be aware of the sequence and so also, the main members of the research team.

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Sep 26, 2022

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Education intervention (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.	Other: Oral health education and instructions/training for self-oral care Education intervention
No Intervention: No intervention (Control) The control arm/group will receive no intervention.

Arm

Intervention/Treatment

Experimental: Education intervention (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.

Other: Oral health education and instructions/training for self-oral care

Education intervention

No Intervention: No intervention (Control)

The control arm/group will receive no intervention.

Outcome Measures

Primary Outcome Measures

Oral Health Status [6 months]
Oral Hygiene Index-Simplified (OHI-S) score
Gingival Health Status [6 months]
Modified Gingival Index (MGI) 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

Dental Caries Status [One month]
Decayed, Missing, and Filled (DMFT/dmft) index
Dental Caries Sequelae [6 months]
Pulp which is visible, Ulcerated oral mucosa, Fistula due to caries, Abscess due to caries (PUFA/pufa) index
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
Other dental problems [One month]
Malocclusion, Molar-Incisor Hypomineralization (MIH), Trauma

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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