ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12622000572763

Ethics application status

Approved

Date submitted

30/03/2022

Date registered

14/04/2022

Date last updated

16/03/2023

Date data sharing statement initially provided

14/04/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

The effect of a Pasifika intervention on rates of rheumatic fever in South Auckland Pacific communities

Scientific title

The effect of a Pasifika intervention on rates of rheumatic fever in South Auckland Pacific communities

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Rheumatic fever

Condition category

Condition code

Inflammatory and Immune System

Autoimmune diseases

Infection

Other infectious diseases

Inflammatory and Immune System

Other inflammatory or immune system disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The aim of this study is to develop, design, implement and evaluate a new innovative intervention to reduce rheumatic fever for Pasifika communities in South Auckland.

This mixed-methods study utilises the Fa’afaletui paradigm. This is a Pacific centred methodology that enables discussion with a range of different and sometimes conflicting perspectives. A co-design approach will be utilised where the community participants and clinicians work together alongside researchers to develop a novel and innovative intervention to reduce the rheumatic fever burden impacting Pasifika communities. Phase two and three of the overall project outline the co-design, development, implementation, and evaluation of the intervention.

Phase 2: Designing the intervention and developing the implementation plan.
This will include a stocktake of programmes and interventions aimed at reducing rheumatic fever in NZ. This will occur as part of a scoping review to broadly identify the range of approaches used currently and in the past, where they have been implemented and whether they have been successful. Concise summaries of the scoping review results will be produced using a variety of techniques such as PowerPoint presentations, brochures, posters and storyboards. This will aid in informing workshop participants of what has been tried before, what has been successful and what might be useful for their co-designed intervention.

Approximately four day-long workshops will be conducted over a period of six months with PPHAG, PPBRN and other relevant Pasifika community members and stakeholders to explore their views of current and past rheumatic fever interventions and to co-design alternatives.

• The Pacific People’s Health Advisory Group (PPHAG): This group comprises male and female community members aged in their 20s to their 70s, of mixed Pasifika ethnicities (Samoan, Tongan, Niuean, Cook Islands) with a range of occupations, for example, nursing students, teachers, social workers, broadcasters and retirees.
• Pacific Practice-Based Research Network (PPBRN): All PBRN research officers (which include general practitioners, nurses, and receptionists depending on the practice) from South Auckland practices in the Network will be invited to participate in the workshops. Other practice staff members identified by PBRN research officers may also participate, should they wish to do so.
• Patients with rheumatic fever and their families: PPBRN practices will recruit Pacific patients diagnosed with rheumatic fever to test and evaluate the intervention. The invitation will also be extended to their extended family members who would like to participate. We will use purposive sampling aiming for a diversity of Pacific ethnicities, ages and other key characteristics of these participants.
• Other relevant stakeholders: Other stakeholders including community pharmacists, Primary Health Organisation (PHO) personnel, community members and/or others identified during the study may be invited to participate.

The workshops will be facilitated by six members from the Pacific Rheumatic Fever Project research team:
• 1 x Senior Lecturer with experience in Pacific community health, health promotion and community engagement.
• 2x General Practitioners with vast experience in teaching, general practice, and Pacific health research.
• 2x Research Fellows

Where possible, workshops will take place in-person (or virtually depending on pandemic restrictions) using cultural protocols and approaches. Dialogue within the workshops will follow Talanga, a Tongan participant-centred approach that means “interactive talking with a purpose” and enables empowering and interactive dialogue towards action.

Workshops will begin with short presentations of the current data trends and previous rheumatic fever interventions, such as the Ministry of Health's Rheumatic Fever Prevention Programme, community awareness strategies such as "Take it to Heart" run by Alliance Health Plus and school throat swabbing initiatives such as Mana Kidz. Participants will then collaboratively workshop innovative solutions using their expertise as members of the Pasifika community in South Auckland. Groups may be provided with large sheets of paper and whiteboards to brainstorm, and these data will be collected at the end of the workshop.

Once an intervention has been drafted, PPHAG, PPBRN and researchers will collectively refine it via further workshops. Expert reviewers will also contribute to this process to ensure that strategy is feasible and can be implemented in South Auckland. Factors to be addressed in the intervention include what components it entails (e.g. health promotion, education, prescribing, dispensing, patient reminders, family/whanau involvement), who leads it (eg doctor, nurse, pharmacist, team, community-led), and where it takes place (eg health premises, community location).

Implementation plan
To map the implementation of the final intervention, a framework will be developed using a logic model of change. This will outline the inputs (such as resources, personnel and funding required), activities (encompassing the tasks necessary for implementation), outputs (measures demonstrating implementation has occurred) and short-term outcomes (the expected changes).

Phase 3: Intervention implementation and Evaluation
The intervention will then be trialled in South Auckland and tested to see how well it works. It is anticipated that Phase 3 will start approximately six months after the conclusion of Phase 2 and implemented and evaluated over a 12 month period. Precise details of the evaluation will depend on the nature of the novel intervention and its characteristics.

Study approach
This phase will use an implementation science approach, which is a systematic study of the activities that facilitate the successful uptake of an evidence-based health intervention, in this case a strategy and programme to reduce rheumatic fever rates amongst Pasifika in South Auckland. The design of the evaluation of the intervention implementation will be underpinned by a theoretical framework and informed by behavioural change theory, whereby a person’s attitudes, personal or subjective norms and their perceived behaviour controls (not doing what they think is wrong) shape an individual’s behavioural intentions and hence their actual behaviours.

Intervention code [1]

Prevention

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

The incidence of Pacific Island acute rheumatic fever cases within the Counties Manukau District Health Board, by accessing District Health Board-collected incidence data.

Timepoint [1]

3 months, 6 months and 12 months (primary endpoint) post-intervention commencement

Primary outcome [2]

Hospitalisations in Auckland for first-episode acute rheumatic fever in Pacific people, accessed via hospitalisation data from the National Minimum Dataset.

Timepoint [2]

6 months and 12 months (primary endpoint) post-intervention commencement

Secondary outcome [1]

The acceptability of intervention delivery obtained via 5-point Likert scale surveys and semi-structured interviews with end-users.

Timepoint [1]

6 months post-intervention commencement

Secondary outcome [2]

Barriers and enablers of intervention delivery assessed using a semi-structured interviews with end-users.

Timepoint [2]

6 months post-intervention commencement

Secondary outcome [3]

The feasibility of the intervention as assessed via an audit of study enrolment logs to investigate recruitment and retention rates, the time required to recruit, adherence and rate of completion.

Timepoint [3]

6 months post-intervention commencement

Eligibility

Key inclusion criteria

Pasifika patients, families and communities affected by rheumatic fever

Minimum age

11 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Participants aged <11 years
Participants who are not able to give to give consent or assent (where applicable).
Participants with a terminal or severe illness.

Study design

Purpose of the study

Prevention

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/04/2024

Actual

Date of last participant enrolment

Anticipated

30/06/2024

Actual

Date of last data collection

Anticipated

30/06/2025

Actual

Sample size

Target

100

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

South Auckland

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Royal Society Te Aparangi

Address [1]

11 Turnbull Street, Thorndon, Wellington 6011

Country [1]

New Zealand

Primary sponsor type

Individual

Name

Dr Siobhan Tu'akoi

Address

Pacific Health section, School of Population Health
Faculty of Medical and Health Sciences
The University of Auckland
Bldg 507, Level 1, Room 1001
28 Park Avenue, Grafton
Auckland 1023
New Zealand

Country

New Zealand

Secondary sponsor category [1]

Individual

Name [1]

Dr Malakai 'Ofanoa

Address [1]

Pacific Health section, School of Population Health
Faculty of Medical and Health Sciences
The University of Auckland
Bldg 507, Level B, Room B005
28 Park Avenue, Grafton
Auckland 1023
New Zealand

Country [1]

New Zealand

Secondary sponsor category [2]

Individual

Name [2]

Professor Felicity Goodyear-Smith

Address [2]

Department of General Practice and Primary Healthcare, School of Population Health
Faculty of Medical and Health Sciences
The University of Auckland
Bldg 507, Level 3, Room 3018
28 Park Avenue, Grafton
Auckland 1023
New Zealand

Country [2]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Auckland Health Research Ethics Committee

Ethics committee address [1]

The Auckland Health Research Ethics Committee
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

10/02/2022

Approval date [1]

21/03/2022

Ethics approval number [1]

AH23838

Summary

Brief summary

Building on previous knowledge about rheumatic fever prevention, a new innovative intervention will be designed, implemented and evaluated to reduce incidence rates in Pasifika in South Auckland. 

The study will employ mixed methodology (quantitative and qualitative) based on the Samoan Fa'afaletui framework. This approach focuses on the importance of considering different perspectives in research, including ‘people at the top of the mountain’ (for example, a national overview) ‘at the top of the tree’ (regional perspective), who bring long- and middle-distance lenses to the issue, and the ‘man in a canoe fishing’, who is closest to the ‘school of fish’, and most affected by the problem (community members, patients, primary care clinicians). 

Phase 1 explores the trends of rheumatic fever across New Zealand and within Auckland, and has been described in a separate observational study registration form. 

Phase 2: To develop the intervention, a series of workshops (anticipated to be 2 or 3) will be conducted with members of the Pacific Peoples Health Advisory Group (PPHAG), the Pacific Practice-Based Research Network PPBRN), Alliance Health Plus (AH+) and other key stakeholders. A concise, user-friendly summary of the types of complex interventions which have already been tried, and what has been shown to be effective in different contexts, will help inform the development. The new intervention will be designed through qualitative enquiry using nominal group technique where possible to ensure all voices are heard. 

Phase 3: The intervention will then be trialled in South Auckland, and tested to see how well it works.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Siobhan Tu'akoi

Address

Pacific Health section, School of Population Health
Faculty of Medical and Health Sciences
The University of Auckland
Bldg 507, Level 1, Room 1001
28 Park Avenue, Grafton
Auckland 1023
New Zealand

Country

New Zealand

Phone

+64 9 923 2368

Fax

s.tuakoi@auckland.ac.nz

Contact person for public queries

Name

Siobhan Tu'akoi

Address

Pacific Health section, School of Population Health
Faculty of Medical and Health Sciences
The University of Auckland
Bldg 507, Level 1, Room 1001
28 Park Avenue, Grafton
Auckland 1023
New Zealand

Country

New Zealand

Phone

+64 9 923 2368

Fax

s.tuakoi@auckland.ac.nz

Contact person for scientific queries

Name

Felicity Goodyear-Smith

Address

Country

New Zealand

Phone

+64 9 923 2357

Fax

f.goodyear-smith@auckland.ac.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Attachment
15619	Study protocol	383628-(Uploaded-30-03-2022-07-49-29)-Study-related document.pdf
15620	Informed consent form	383628-(Uploaded-30-03-2022-07-49-41)-Study-related document.pdf
15621	Ethical approval	383628-(Uploaded-30-03-2022-07-49-48)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Co-designing an intervention to prevent rheumatic fever in Pacific People in South Auckland: a study protocol	2022	https://doi.org/10.1186/s12939-022-01701-9

N.B. These documents automatically identified may not have been verified by the study sponsor.

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