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

NCT05540171 | Completed

• 2 other identifiers: NHREC/17/03/20182D43TW010543-06
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• Oral Health Status

  Oral Hygiene Index-Simplified (OHI-S) score

  6 months

• Gingival Health Status

  Modified Gingival Index (MGI) score

  6 months

• Oral Health Related Quality of Life (OHRQoL)

  Child Perception Questionnaire for varying ages 8 to 10 and 11 to 14 and upward (CPQ8-10, CPQ11-14)

  6 months

Secondary Outcomes (5)

• Dental Caries Status

  One month

• Dental Caries Sequelae

  6 months

• Dental Caries Status

  6 months

• HIV-associated oral lesions

  One month

• Other dental problems

  One month

Study Arms (2)

Education intervention (Oral health education and instructions/training for self-oral care)

EXPERIMENTAL

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

No intervention (Control)

NO INTERVENTION

The control arm/group will receive no intervention (Oral health education) until right after the study is over.

Interventions

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

Education intervention

Education intervention (Oral health education and instructions/training for self-oral care)

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Have co-morbid conditions that increase their risk for oral diseases.
• Have good oral hygiene.
• Decline assent or lack caregiver consent.

Sponsors & Collaborators

• Aminu Kano Teaching Hospital: lead
• NIH Office of AIDS Research (OAR): collaborator
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

Aminu Kano Teaching Hospital

Kano, 770225, Nigeria

Location

Related Publications (1)

• Adeyemo YI, Aliyu MH, Folayan MO, Coker MO, Riedy CA, Maiyaki BM, Denloye OO. A 2-arm randomized controlled study to improve the oral health of children living with HIV in Nigeria: Protocol and study design. Contemp Clin Trials. 2024 Jan;136:107375. doi: 10.1016/j.cct.2023.107375. Epub 2023 Oct 30.

  PMID: 38404532 DERIVED

MeSH Terms

Conditions

Dental Caries; Mouth Diseases; Oral Manifestations

Interventions

Health Education, Dental

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Public Health Dentistry; Environment and Public Health

Study Officials

• Yewande I ADEYEMO, BDS

  Bayero University, Kano/ Aminu Kano Teaching Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: 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.

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: September 14, 2022
• Study Start: December 22, 2022
• Primary Completion: September 15, 2023
• Study Completion: September 15, 2023
• Last Updated: March 7, 2024

Record last verified: 2024-03

Locations

NG (1)