Otitis MediaHfLINCT03916029
Hearing for Learning Initiative - a Health Facilitator Model for Otitis Media
A study testing facilitator in people with Otitis Media and Conductive Hearing Loss, run by Menzies School of Health Research at 20 sites in Australia.
Trial summary
The Hearing for Learning Initiative is a stepped-wedge cluster randomised controlled trial. The HfLI will implement and rigorously evaluate an innovative community-based service-enhancement model of ear and hearing health, in partnership with participating communities and health and education services. Read more about this study
- Who is it for?
- Ages 1 week to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Otitis Media, Conductive Hearing Loss
- What is being tested?
- facilitator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 20 sitesAustralia
- Study dates
- 3 Feb 2019to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 week to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Inclusion Criteria: Aboriginal or Torres Strait Islander, resident in participating community (cluster)
Exclusion Criteria: none
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Australia20 sites
Ali Curung
Ali Curung, Northern Territory
Ampilatwatja
Ampilatwatja, Northern Territory
Darwin
Darwin, Northern Territory, 0800
Galiwin'ku
Galiwin'ku, Northern Territory
Gunbalanya
Gunbalanya, Northern Territory
Kalkarindji Primary Health Centre
Kalkarindji, Northern Territory, 0852
Wurli Wurlinjang Health Service
Katherine, Northern Territory, 0850
Lajamanu Primary Health Centre
Lajamanu, Northern Territory
Mala'la Health Service
Maningrida, Northern Territory, 0820
Milikapiti Community Health Centre
Milikapiti, Northern Territory
Milingimbi Health Clinic
Milingimbi, Northern Territory, 0822
Minjilang Community Health Centre
Minjilang, Northern Territory
Nauiyu
Nauiyu, Northern Territory
Palumpa Community Health Centre
Palumpa, Northern Territory, 0822
Pirlangimpi Health Clinic
Pirlangimpi, Northern Territory, 0822
Ti Tree Community Health Centre
Ti Tree, Northern Territory, 0872
Wadeye Community Health Centre
Wadeye, Northern Territory, 0822
Warruwi Community Health Centre
Warruwi, Northern Territory, 0822
Julanimawu (Nguiu) Community Health centre
Wurrumiyanga, Northern Territory, 0822
Yirrkala Clinic
Yirrkala, Northern Territory, 0880
About this study
Official title: The Hearing for Learning Initiative - a Service-enhancement Model of Ear Health Facilitators to Address the Crisis in Ear and Hearing Health of Aboriginal Children in the Northern Territory: a Stepped-wedge Cluster Randomised Trial
The Hearing for Learning Initiative is a stepped-wedge cluster randomised controlled trial. The HfLI will implement and rigorously evaluate an innovative community-based service-enhancement model of ear and hearing health, in partnership with participating communities and health and education services.
This initiative will address the following research question: In urban, rural and remote Aboriginal communities in the Northern Territory, does employment, training and integration of local Ear and Hearing Clinical and Education Support Officers into health and education services (the Hearing for Learning initiative), compared to current practice, increase the proportion of children who receive an ear assessment, reduce the prevalence of ear and hearing problems and improve education outcomes of Aboriginal and Torres Strait Islander children, during a four year trial period?
Read the detailed description
Background: Australian Indigenous children achieve lower scores in school readiness and education outcomes than their non-Indigenous peers. Chronic otitis media and hearing loss during early childhood are associated with lower scores for these outcomes. Local problem: Failure to meet child health program schedules and evidence based practice in ear and hearing health is linked to high turnover of the health workforce, inadequate clinical skills and poor knowledge of ear and hearing health needs of children.
This Hearing for Learning Initiative aims to improve health care and education services.
Interventions: The intervention involves training and employing non-professional community members to facilitate busy primary health care services to deliver evidence-based ear and hearing health assessments in children 0 to 16 years of age, and to facilitate the teaching and home learning of hearing impaired children (the intervention).
Trial design: A stepped-wedge community (n=18) cluster-randomised trial will compare the proportion of children receiving an ear assessment (primary outcomes) in the HfLI (intervention) periods with no HfLI (control) periods. Participating communities will be randomly assigned in 6-monthly steps to shift from control to intervention on pre-specified start dates.
Outcomes: the primary outcome is the change in the proportion of Aboriginal and Torres Strait Islander children who receive an ear assessment, between intervention and control periods.
- Conditions
- Otitis Media, Conductive Hearing Loss
- Being tested
- facilitator
- Keywords
- primary health care, workforce, Aboriginal or Torres Strait Islander, facilitator, education
- Medical subject headings
- Otitis Media, Hearing Loss, Conductive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
facilitatorBehavioural
Training and employment of community members to assist the diagnosis and management of otitis media
| Study group | Role | What they receive |
|---|---|---|
| Facilitator | Active comparator | 120 hours training for local community members delivered on-country face-to-face during 6 4-day weeks and over a 3-6 month period. Certificate II modules in Aboriginal Primary Health Care, ear and hearing health skills development (otoscopy, tympanometry, and hearScreen) and employment as Ear Health Facilitators to the end of the trial. Receives: Behavioral: facilitator |
| Control | No intervention | No Facilitator. Brief 6-monthly 2 to 3 hour in-service training via zoom for health professionals. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ear assessment
Proportion of children who have had a documented ear assessment
Measured: 3-monthly
Secondary outcomes (4)
Prevalence of otitis media
Proportion of children with any otitis media
Measured: 3-monthly
Management plan
Proportion of otitis media cases with a management plan
Measured: 6-monthly
Appropriate management plan
Proportion of management plans that are appropriate
Measured: 6-monthly
Follow-up
Proportion of cases with follow-up within 10 days
Measured: 6-monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start3 Feb 2019
- Primary completion30 Jun 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Otitis MediaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Stepped-wedge cluster randomised controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menzies School of Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- Australian Government Department of Health and Ageing, Northern Territory Government of Australia
- Responsible party
- Sponsor
- Investigators
- Amanda Leach, PhD, Principal investigator, Menzies School of Health ResearchKelvin Kong, MBBS, Study director, Newcastle UniversityPeter S Morris, MBBS, PhD, Study director, Menzies School of Health ResearchAlan Cass, MBBS, PhD, Study director, Menzies School of Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03916029
- Sponsor's protocol ID
- R813
- Other IDs
- TEHREC -18-3264, CAHREC - 19-330
- Acronym
- HfLI
- Status last verified
- Aug 2026
- First submitted
- 12 Apr 2019
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leach AJ, McCullough A, Websdale E, Su JY, Oguoma VM, Morris PS, Taylor S, Nelson S, Kong K, Paterson J, Dixon J, Cass A. A workforce enhancement model for Australian remote community Primary Health Care services: implementation of a stepped-wedge cluster randomised trial (SW-CRT). BMC Health Serv Res. 2026 Jan 29;26(1):289. doi: 10.1186/s12913-025-13743-0.
PubMed 41612286Kong K, Cass A, Leach AJ, Morris PS, Kimber A, Su JY, Oguoma VM. A community-based service enhancement model of training and employing Ear Health Facilitators to address the crisis in ear and hearing health of Aboriginal children in the Northern Territory, the Hearing for Learning Initiative (the HfLI): study protocol for a stepped-wedge cluster randomised trial. Trials. 2021 Jun 16;22(1):403. doi: 10.1186/s13063-021-05215-7.
PubMed 34134736
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hearing for Learning Initiative - a Service-enhancement Model of Ear Health Facilitators to Address the Crisis in Ear and Hearing Health of Aboriginal Children in the Northern Territory: a Stepped-wedge Cluster Randomised Trial
- ClinicalTrials.gov ID
- NCT03916029
- Acronym / sponsor ID
- HfLI / R813
- Conditions
- Otitis Media, Conductive Hearing Loss
- Keywords
- primary health care, workforce, Aboriginal or Torres Strait Islander, facilitator, education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Menzies School of Health ResearchUniversity, hospital or other
- Collaborators
- Australian Government Department of Health and Ageing, Northern Territory Government of Australia
- Study start
- 3 Feb 2019 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Hearing for Learning Initiative is a stepped-wedge cluster randomised controlled trial. The HfLI will implement and rigorously evaluate an innovative community-based service-enhancement model of ear and hearing health, in partnership with participating communities and health and education services.
This initiative will address the following research question: In urban, rural and remote Aboriginal communities in the Northern Territory, does employment, training and integration of local Ear and Hearing Clinical and Education Support Officers into health and education services (the Hearing for Learning initiative), compared to current practice, increase the proportion of children who receive an ear assessment, reduce the prevalence of ear and hearing problems and improve education outcomes of Aboriginal and Torres Strait Islander children, during a four year trial period?
Detailed description
Background: Australian Indigenous children achieve lower scores in school readiness and education outcomes than their non-Indigenous peers. Chronic otitis media and hearing loss during early childhood are associated with lower scores for these outcomes. Local problem: Failure to meet child health program schedules and evidence based practice in ear and hearing health is linked to high turnover of the health workforce, inadequate clinical skills and poor knowledge of ear and hearing health needs of children.
This Hearing for Learning Initiative aims to improve health care and education services.
Interventions: The intervention involves training and employing non-professional community members to facilitate busy primary health care services to deliver evidence-based ear and hearing health assessments in children 0 to 16 years of age, and to facilitate the teaching and home learning of hearing impaired children (the intervention).
Trial design: A stepped-wedge community (n=18) cluster-randomised trial will compare the proportion of children receiving an ear assessment (primary outcomes) in the HfLI (intervention) periods with no HfLI (control) periods. Participating communities will be randomly assigned in 6-monthly steps to shift from control to intervention on pre-specified start dates.
Outcomes: the primary outcome is the change in the proportion of Aboriginal and Torres Strait Islander children who receive an ear assessment, between intervention and control periods.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Stepped-wedge cluster randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Facilitator | Active comparator | Behavioral: facilitator120 hours training for local community members delivered on-country face-to-face during 6 4-day weeks and over a 3-6 month period. Certificate II modules in Aboriginal Primary Health Care, ear and hearing health skills development (otoscopy, tympanometry, and hearScreen) and employment as Ear Health Facilitators to the end of the trial. |
| Control | No intervention | –No Facilitator. Brief 6-monthly 2 to 3 hour in-service training via zoom for health professionals. |
Who may qualify
- Ages
- 1 week to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| facilitatorTraining and employment of community members to assist the diagnosis and management of otitis media | Behavioural | Facilitator |
Primary outcome
Ear assessment
Time frame: 3-monthly
Proportion of children who have had a documented ear assessment
4 secondary outcomes
Prevalence of otitis media
Time frame: 3-monthly
Management plan
Time frame: 6-monthly
Appropriate management plan
Time frame: 6-monthly
Follow-up
Time frame: 6-monthly
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Derived from this study: PubMed 41612286Leach AJ, McCullough A, Websdale E, Su JY, Oguoma VM, Morris PS, Taylor S, Nelson S, Kong K, Paterson J, Dixon J, Cass A. A workforce enhancement model for Australian remote community Primary Health Care services: implementation of a stepped-wedge cluster randomised trial (SW-CRT). BMC Health Serv Res. 2026 Jan 29;26(1):289. doi: 10.1186/s12913-025-13743-0.
- Derived from this study: PubMed 34134736Kong K, Cass A, Leach AJ, Morris PS, Kimber A, Su JY, Oguoma VM. A community-based service enhancement model of training and employing Ear Health Facilitators to address the crisis in ear and hearing health of Aboriginal children in the Northern Territory, the Hearing for Learning Initiative (the HfLI): study protocol for a stepped-wedge cluster randomised trial. Trials. 2021 Jun 16;22(1):403. doi: 10.1186/s13063-021-05215-7.
- Individual participant dataSharing planned: No
Related trials for Otitis Media
Active, not recruiting
In-Office Clinical Study of the Solo+ TTD
Ear Infection, Otitis Media
Recruiting
CLIKX® Tympanostomy Tube Delivery System for the Placement of Tympanostomy Tubes
Otitis Media, Otitis Media Chronic
Not yet recruiting
Short-term Application of Lactoferrin Ventilation Tubes
Otitis Media With Effusion (OME)
Recruiting
Nasopharyngeal Carriage of S. Pneumoniae
Nasopharyngeal Carriage, Children, Only
Recruiting
Platelet-Rich Fibrin in Revision Cartilage Tympanoplasty
Tympanic Membrane Perforation, Chronic Otitis Media
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda Leach, PhD principal investigator
Menzies School of Health Research
Kelvin Kong, MBBS study director
Newcastle University
Peter S Morris, MBBS, PhD study director
Menzies School of Health Research
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing facilitator in people with Otitis Media and Conductive Hearing Loss, run by Menzies School of Health Research at 20 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ear assessment (time frame: 3-monthly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03916029, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.