Condition category
Oral Health
Date applied
15/12/2017
Date assigned
17/01/2018
Last edited
18/01/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Worldwide, antiretroviral therapy (ART) has dramatically improved the mortality (death rate) of perinatally HIV-infected children. The perinatally HIV-infected children treated with ART have now reached adolescence. However, promoting high ART adherence in children is difficult due to various factors. Among HIV-uninfected children, serious dental caries (cavities) may cause eating disorders or infectious diseases. This may increase the risk of malnutrition, developmental delay or lower quality of life. If the same relationship exists among children living with HIV, oral care might help to maintain their health. However, it is unclear whether oral health status is related to the overall health including infectious diseases, or the development of children living with HIV. Cambodia has achieved success in reducing new HIV infections. However, the prevalence is rather high among South-Asian countries. Additionally, oral health is a critical issue to be tackled among children in Cambodia. The aim of this study is to assess the effectiveness of an oral health intervention at improving overall health status among children living with HIV in Cambodia.

Who can participate?
Children 3-15 years old living with HIV and treated with antiretroviral therapy for at least three months, HIV-negative children, and their caregivers

What does the study involve?
Participants are allocated into three groups: the intervention group (group A) and two control groups (group B and C). Group A and B include children living with HIV and their caregivers. Group C includes HIV-negative children and their caregivers. The intervention group receives an intervention for two years from May 2018 to April 2020. The interventions include oral health education sessions and daily oral care. Children and caregivers in the intervention group see research monitoring assistants at the hospital every three months following the education sessions. There are no interventions for the control groups. The impact of the intervention is assessed by comparing children in the intervention and the control groups, and by assessing the changes in the intervention groups at the start, middle and end of the study.

What are the possible benefits and risks of participating?
Participants benefit from improved oral health knowledge and behaviours. The intervention will be introduced to the control group participants immediately if it is found to have a positive impact. Hospitals are encouraged to refer if they identify minor, acute, or chronic illness in children in either the intervention or control groups. The intervention is not invasive, so the participants are not exposed to marked risks.

Where is the study run from?
National Pediatric Hospital (Cambodia)

When is the study starting and how long is it expected to run for?
January 2018 to March 2021

Who is funding the study?
Japan Society for the Promotion of Science (Japan)

Who is the main contact?
1. Dr Kimiyo Kikuchi (public)
2. Dr Yi Siyan (scientific)

Trial website

Contact information

Type

Public

Primary contact

Dr Kimiyo Kikuchi

ORCID ID

Contact details

3-1-1
Maidashi
Higashi-ku
Fukuoka
812-8582
Japan

Type

Scientific

Additional contact

Dr Yi Siyan

ORCID ID

Contact details

#33
Street 71
Tonle Bassac
Chamkar Mon
Phnom Penh
3
Cambodia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1.0

Study information

Scientific title

Oral health intervention for improving overall health status of children living with HIV in Cambodia: a randomized controlled trial

Acronym

Study hypothesis

How will the oral health intervention influence the overall health status of children living with HIV?

Ethics approval

National Ethics Committee for Health Research, Cambodia - approval pending

Study design

Multicentre randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

HIV, AIDS, oral health

Intervention

The intervention group and two control groups will be allocated in a 1:1:1 ratio. By the nature of the study, participants and care providers will not be masked. Randomization scheme generated via a computerized algorithm will be used to assign participants to study arms. Although randomization is not blinded, recruiters will not be aware of group allocation until after participants have completed the baseline assessment. Information on group assignments will be provided to the recruiters in sealed envelopes.

An intervention study will be conducted in Phnom Penh, Cambodia. The intervention effectiveness will be evaluated by comparing data collected at baseline, mid-term (a year after implementing the intervention) and endline. The study participants will be included in three arms: the intervention arm (group A) and two control arms (group B and C). Targets of group A and B will include children living with HIV and their caregivers. Targets of group C will be HIV-negative children and their caregivers. For groups A and B, children will be included in the study if they are in the age group of 3 to 15 years and under ART for at least three months. For group C, children will be included in the study if they are aged 3 to 15 years old and HIV-negative. Sample size of each arm has been set in a total of 260 dyads of a child and a caregiver. The minimum required number of dyads in the three arms would be 780.

Target children and caregivers will receive an intervention for two years from May 2018 to April 2020. The main components of the intervention will include oral health education sessions and being recommended to practice daily oral care. Children and caregivers in the intervention arm will see research monitoring assistants at the hospital every three months following the education sessions. There will be no intervention for the control groups.

The impact of the intervention will be assessed by comparing key outcome indicators among children in the intervention and the control arms, as well as by metachronic changes of the intervention arms. The comparison between arms will be performed by measuring outcome indicators at baseline, mid-term and endline.

Baseline: January 2018
Mid-term: April 2019
Endline: April 2020
Follow-up tests: every three months.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Oral health status (decayed, missing, filled permanent teeth), assessed by dental check by dentist at baseline, mid-term, and endline survey
2. CD4 count, measured by blood examination in the routine care of people living with HIV every 3 months

Secondary outcome measures

1. Saliva buffer capacity, measured by examining collected saliva by rapid test kit (CAT21buf) at baseline, mid-term, and endline survey
2. Number of cariogenic bacteria, measured by examining collected saliva by rapid test kit (Cariscreen) every 3 months
3. Debris index score, measured by staining plaque with staining liquid for teeth every 3 months
4. Saliva secretion capacity: measured by examining collected saliva by rapid test kit (CAT21buf) at baseline, mid-term, and endline survey
5. Nutrition status, measured by measuring height and weight at baseline, mid-term, and endline survey
6. Quality of life, measured using Pediatric Quality of Life Inventory (version 4.0) every 3 months

Overall trial start date

04/01/2018

Overall trial end date

31/03/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Children living with HIV: 3-15 years old, under antiretroviral therapy for at least three months
2. HIV-negative children: 3-15 years old, HIV negative
3. Caregiver: 18 or above, child's primary caregiver

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

a) Intervention group: HIV positive children and caregivers: 260 dyads, b) Control group: HIV positive children and caregivers: 260 dyads, c) Control group: HIV negative children and caregivers: 260 dyads

Participant exclusion criteria

Mentally or physically too sick to participate in the study

Recruitment start date

01/02/2018

Recruitment end date

31/03/2020

Locations

Countries of recruitment

Cambodia

Trial participating centre

National Pediatric Hospital
100 Russian Federation Boulevard
Phnom Penh
N/A
Cambodia

Sponsor information

Organisation

Institute of Decision Science for a Sustainable Society, Kyushu University

Sponsor details

744 Motooka
Nishi-ku
Fukuoka
819-0395
Japan

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

Japan Society for the Promotion of Science

Alternative name(s)

JSPS

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

Japan

Results and Publications

Publication and dissemination plan

Protocol will be submitted to the journal before the intervention study. Other study findings will be published in a high-impact peer reviewed journal at one year after the overall trial end date.

IPD sharing statement
The participant level data will not be expected to be made available because the data contains personal information of people living with HIV including sero-status of participants and their family.

Intention to publish date

31/03/2022

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

18/01/2018: Internal review.