Rationale and aims

Applying Rigney’s Indigenist Research approach to implementation [29] and guided by the Lowitja Institute Evaluation Framework [30], this study aims to increase cervical screening participation among under- and never-screened Aboriginal and Torres Strait Islander women and people with a cervix in partnership with ACCHOs by implementing HPV self-collection into practice.

The objectives of Screen Your Way are to:

1. 1.Co-design, implement and evaluate models to support HPV self-collection and other strategies that increase cervical screening within ACCHOs
2. 2.Assess the impact of HPV self-collection implementation models on cervical screening participation
3. 3.Explore providers’ and clients’ views and experiences of the project to provide context for the cervical screening participation data and inform the evaluation of the implementation strategies
4. 4.Disseminate findings to assist with the evidence based national scale up of HPV self-collection.

Positionality

The authors are a team of Indigenous researchers (LJW, TB, SE, KF, GG, BL, CT, MW) and non-Indigenous researchers (LM, DW, KW, JC, RG, HM, CN, MAS, MS, CZ, KC, NT, JB) whose perspectives are shaped by their diverse cultural backgrounds and knowledge systems. Together, the team acknowledges that these positionalities influence the design and implementation of the research.

Ethics

This project respects and acts in accordance with the ethical guidelines set out by the Australian Institute of Aboriginal and Torres Strait Islander Studies (AIATSIS) to ensure respect, integrity, and collaboration in all our work [32]. Screen Your Way is Aboriginal and Torres Strait Islander designed, led and governed. Approval has been obtained from the AIATSIS Research Ethics Committee (REC-0092), the Aboriginal Health and Medical Research Council of New South Wales Ethics Committee (2078/23), the Australian National University Human Research Ethics Committee (H/2023/1103), the HREC of the Northern Territory Department of Health and Menzies School of Health Research (HREC 2023–4557), and the Metro South Human Research Ethics Committee (HREC/2025/QMS/115155). Additional site-specific governance will be obtained to meet local ACCHO requirements (e.g., board or community jury).

Approach and guiding principles

Screen Your Way is designed to deliver equitable, sustainable and scalable reductions in cervical cancer incidence through cervical screening by fostering strong relationships between communities and organisations; their combined local expertise and priorities will shape the research design and implementation. This project takes a systems approach, recognising that Aboriginal and Torres Strait Islander women and people with a cervix have various needs, within and outside of the health system. The theory of change is illustrated in Fig 2.

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Fig 2. Screen Your Way: Theory of Change Model.

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Indigenist Implementation Methodological Framework

This study is underpinned by an Indigenist implementation methodology, introduced here to provide conceptual clarity in contexts where conventional implementation science has typically failed Indigenous sovereignty and authority. We position Rigney’s Indigenist Research Approach [29] as the theoretical foundation through which implementation science is re‑oriented toward Indigenous rights, relational accountability, and community‑led governance.

Guided by the United Nations Declaration on the Rights of Indigenous Peoples [33], implementation centres Aboriginal and Torres Strait Islander peoples’ sovereignty, self‑determination, and definitions of health across all stages of the work. The approach to implementation supports the identification and dismantling of systemic structures that contribute to disparities in cervical cancer outcomes while building the foundations of an Indigenist system capable of care.

Rather than assuming that better implementation can repair entrenched racism or that poor outcomes stem simply from access issues, this approach explicitly acknowledges the limitations of applying implementation science within a colonial health system. It is therefore oriented toward system‑level transformation and (re)building. That is, identifying and dismantling harmful structures and practices, and strengthening Indigenist approaches that support wellbeing. This research program is deliberately oriented toward driving systems transformation to ensure that research findings yield meaningful and enduring benefit and resists colonial research frameworks.

Operationally, the implementation approach draws on the care, governance, and innovation demonstrated within the ACCHO sector, as well as insights generated across cancer‑system touchpoints and the leadership of Aboriginal and Torres Strait Islander communities. Implementation is treated as a cyclical, iterative process – learning, adapting, and intentionally de‑implementing harmful colonial practices while embedding practices aligned with Indigenous sovereignty and community priorities. Through this approach, research implementation is positioned not only as a mechanism for translating evidence into practice, but as a driver of (re)building a health system grounded in Indigenous sovereignty and governance, and capable of caring for Aboriginal and Torres Strait Islander peoples.

A multidisciplinary mixed-methods research approach will be used that incorporates Indigenous research methodologies, foregrounds Indigenous intellectual sovereignty and is implementation focused. This Indigenist implementation methodology informs the study design and will be evaluated in accordance with the principles outlined within the Lowitja Evaluation Framework [30], with a key focus on identifying elements important to implementation success in Indigenous communities (e.g., the criticality of Indigenous self-determination, concept of culture centredness, community control and, in primary care, quality improvement processes) [34].

Governance

The Governance Framework illustrated in Fig 3 will ensure cultural and clinical oversight of the research and maximise real-time knowledge sharing. Cultural governance will be monitored by Aboriginal and Torres Strait Islander Reference Group, Thiitu Tharrmay, at the Australian National University. Thiitu Tharrmay in Ngiyampaa language translates as ‘to share/exchange knowledge’. An Aboriginal and Torres Strait Islander Project Caucus comprised of Aboriginal and Torres Strait Islander Chief and Associate Investigators will provide over-arching project governance and ensure that the project is culturally safe and meets the needs and priorities of Aboriginal and Torres Strait Islander people and communities. An Investigator team has been established in line with the Medical Journal of Australia guidelines [35] and the principles of the Indigenist research approach [29,36].

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Fig 3. Screen your way governance framework.

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Setting

Screen Your Way will take place in ACCHOs and/or primary care organisations whose context is similar to that of an ACCHO in the Australian States and Territories of Queensland (Qld), New South Wales (NSW) and the Northern Territory (NT). At the last Census date more than 164,000, or over 70%, of Aboriginal and Torres Strait Islander women of screening age were recorded to live across these three jurisdictions [37]. Sampling in this setting will provide geographical and service diversity in the study to inform national scale up plans. Service recruitment commenced on the 1st October 2023, when ACCHOs were invited to submit an expression of interest to participate in the study. Services were recruited between 5th February 2024 and 8th August 2025. Following recruitment, each site undertook a co-design phase tailored to local needs. The 12-month implementation period began at sites in between the 1st September 2024 and is expected to continue until 8th September 2026, depending on each site’s start date. Cervical screening participant recruitment and data collection is anticipated to be completed by 30th September 2026, with study results expected in 2027.

Study design

After recruitment of services to the study, strategies will be co-designed with each service to meet local needs and then implemented for 12 months to allow for a maximum number of screening events. An overview of the study design can be found in Fig 4.

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Fig 4. Steps for working with Aboriginal Community Controlled Health Organisations.

https://doi.org/10.1371/journal.pone.0336004.g004

Step 1: Recruitment of services to participate in Screen Your Way

A minimum of six services (two per jurisdiction) will be recruited, using a process similar to that used successfully with ACCHOs in the literature [38,39]. Support to approach services about participation in the research has been obtained from relevant community-controlled National and State-based governing bodies, including National Aboriginal Community Controlled Health Organisation (NACCHO), Queensland Aboriginal and Islander Health Council (QAIHC), Aboriginal Health and Medical Research Council (AHMRC) of NSW and Aboriginal Medical Services Alliance Northern Territory (AMSANT). Services will be invited to submit an expression of interest. The communication avenue(s) used will through existing networks and guided by QAIHC, AMSANT and AHMRC but will likely include contact through their member email lists and newsletters (usually sent to service Chief Executive Officers, Medical Directors and/or Boards).

Services will be purposefully sampled in line with the following eligibility criteria:

1. 1.Are an ACCHO, or a primary healthcare organisation with a majority of clients being Aboriginal and Torres Strait Islander people whose context is similar to that of an ACCHO (referred to as ACCHOs hereinafter)
2. 2.Are located in Qld, NSW or the NT
3. 3.Have 120 or more Aboriginal and Torres Strait Islander women or people with a cervix aged 25–74 years who are active clients (defined as three or more clinic visits in past two years)
4. 4.Have at least one cervical screening certified health professional
5. 5.Consent to provide screening data related to cervical screening.

Services will be excluded if they are unable to meet the inclusion criteria or if they are involved in other trials relating to cervical screening given the potential to contaminate results.

Written informed consent will be obtained from the ACCHO Chief Executive Officer, Medical Director, and/or Board. Consent may be withdrawn from the study at any time before dissemination of the findings. Individual patient consent for this study will not be sought from clients attending the health service for the provision of deidentified cervical screening data or for the implementation of strategies as these activities would be part of routine cervical screening occurring at the service. Where assistance is requested to support data cleaning or audit, additional ethics approval will be sought for research personnel to access client level data for this purpose. Individual informed consent will be obtained for Yarns at the time of participation.

Step 2: Co-design of strategies for implementing self-collection at each site

We will work with nominated staff at participating services to facilitate co-design workshops, set priorities collaboratively, and design locally tailored strategies, engaging community members as determined by each service. This process will follow key principles of co-design with Aboriginal and Torres Strait Islander peoples, including leadership, cultural grounding, respect, benefit to community, inclusive partnerships, transparency, evaluation, and reciprocity [40,41].

Co-design will occur through a structured yet flexible and iterative process facilitated by the research team and tailored to each site. We will begin by meeting with nominated service staff, often those involved in cervical screening or research, to agree on the preferred approach and identify who should participate, such as other clinical staff, non-clinical staff, and local community members or groups. Each site will be offered up to two in-person visits; however, workforce availability and geographic challenges may mean many engagements occur online, supplemented by virtual planning meetings and collaborative workshops.

While co-design will be guided by each service, it will broadly address local priorities and goals for cervical screening, explore context, identify barriers and facilitators, and develop strategies to enhance access. These ideas will be refined into implementation strategies through multiple interactions between the research team and service staff. This iterative approach allows strategies to evolve in response to feedback and context, ensuring each solution is tailored to the unique needs of the service. In practice, this means strategies may iteratively develop over the course of the implementation period as new priorities are identified. There will be no predetermined list of strategies; all ideas will emerge through co-design to support local needs. However, a common focus across sites will be improving data support and access. Strategies to achieve this will vary depending on local systems and capacity. All strategies will aim to increase participation of under- and never-screened women and people with a cervix in cervical screening using HPV self-collection. Strategies may include community engagement, participant-level interventions, workforce development, and system or service-level changes.

By co-designing strategies within an Indigenist Research Approach, we ensure Aboriginal and Torres Strait Islander people are the “architects of health advancement rather than accessories to failed health policy frameworks” (p.198) [42]. The research team’s role is to support and enable this process by providing facilitation, evidence synthesis, and implementation support. Participating services will work closely with the research team to create personalised, evidence-based implementation models suited to their service and communities. This step is anticipated to take approximately six months.

Step 3: Implementation of cervical screening strategies

Participating services will be provided a customised report with findings from co-design workshops. This will be used to clearly define the strategies chosen and outline the roles and responsibilities of the research team and the service in implementing the strategies. Support will be provided to update cervical screening data (as requested) along with direct research costs to further promote availability of self-collection and cervical screening during the pilot period, using the most appropriate methods for their community. The research team will undertake resource development, facilitate training of the workforce and other means of strengthening existing capabilities in cervical screening as determined during co-design. Services will implement the co-designed strategies for 12 months to improve delivery of cervical screening in their communities and increase service level participation. Strategies will be implemented with support from research staff tailored to local service requests.

Each participating site will co-design and implement locally tailored strategies to improve cervical screening participation among Aboriginal and Torres Strait Islander women and people with a cervix. These strategies reflect community priorities and service capacities, and were developed collaboratively between health services, community members, and the research team. Rather than being prescriptive, the strategies are designed to enhance usual clinical care and allow each service to select and adapt approaches that best suit their local context. This includes choosing from a suite of options based on identified needs, existing resources, and community preferences. The flexible design ensures that HPV self-collection is embedded into routine care sustainably. Research staff meet regularly with each participating service according to their individual needs and provide tailored support and adaptation. Examples of strategies include:

1. 1.Community engagement strategies:
   1. a. Community awareness campaigns: Co-designed posters, brochures, and social media content developed jointly by service staff and the research team. These materials promote the choice of HPV self-collection directly to ACCHO clients.
   2. b. Health promotion: Community events and campaigns hosted by ACCHO to raise awareness of HPV self-collection, provide education, and encourage clients to participate in cervical screening.
2. 2.Participant level strategies:
   1. a. Follow-up reminders: Modification of SMS or phone call reminders for clients who are due for cervical screening with the offer of self-collection.
   2. b. Incentives: Participants who complete cervical screening (i.e., either clinician collected or self-collected sample) are offered a small incentive, such as a gift card or wellbeing pack, to acknowledge their participation and encourage uptake. Incentives are provided immediately after screening by service staff, either during consultations or at community events.
3. 3.Workforce level strategies
   1. a. Staff education and training: Delivered by the research team, these sessions cover cervical screening guidelines, self-collection procedures, and communication strategies for ACCHO clients. Training is provided in-person or online depending on site needs.
   2. b. Clinical champions: Identified within each service to support implementation, mentor staff, and liaise with the research team.
4. 4.Health service level strategies:
   1. a. Data Audit and Cleaning: Practice staff and/or research support teams conduct detailed audits of cervical screening data within practice management software to identify eligible participants and ensure data accuracy. This process involves checking individual client records against the NCSR and manually updating local records where discrepancies are found. The aim is to create a reliable and up-to-date screening register within each service, which supports targeted outreach and follow-up, and ensures that screening invitations are based on accurate information.
   2. b. Workflow Integration: Services have integrated cervical screening checks into routine clinical workflows to promote opportunistic screening. This includes embedding prompts into appointment systems and clinical templates to ensure that cervical screening status is reviewed and self-collection is offered during regular visits, such as 715 health checks or chronic disease reviews. Staff are encouraged to offer screening as part of everyday care, supported by incentives for participants who complete cervical screening and streamlined documentation processes to reduce administrative burden and improve uptake.

Step 4: Evaluation

Evaluation Framework.

The evaluation of this research will be conducted within an overarching conceptual framework that combines key constructs from the RE-AIM Framework [43] with the Health Equity Implementation Framework [44]. The evaluation variables are outlined in Table 1. During the co-design process services may identify additional variables or research questions of interest to their unique context and these will be added to the evaluation framework. Quantitative data will be used to assess intervention impact, interpreted alongside an understanding of how colonial health structures shape outcomes. Indigenist qualitative methods will provide context, centring participants’ experiences, voices, and definitions of meaningful change. Evidence of “success” will be judged equally by increases in the primary outcome toward cervical screening elimination targets (i.e., 70% participation) and by the extent to which participants define the co-design and implementation phases as “successful”, including the degree to which these practices embody sovereignty and support health system (re)build.

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Table 1. Evaluation variables.

https://doi.org/10.1371/journal.pone.0336004.t001

Data collection and analysis

Analysis

Primary and secondary outcomes will be calculated comparing data from the before (T0) and after (T1) period. Retention of effects will be measured for services who provide data at 3- and 6-month intervals in the post-implementation period. For the primary outcome, the number and proportion of all screen eligible clients at the services who are under-screened or never-screened at T1 compared to T0 (number of under- and never-screened screen eligible clients/number of screen eligible women). Secondary outcomes are cervical screening participation rate (number with a recorded cervical screen in the previous 5-years/number of screen eligible clients), and the number and rate of cervical screens conducted using self-collection (number of tests conducted using self-collection/number of screening tests), and the HPV positivity (number of HPV positive tests/number of screening tests). Descriptive analysis will be used to analyse cervical screening data, with regular interim reports made available to participating services. Primary and secondary outcomes will be calculated comparing data from the before (T0, > 24 months) and after (T1, 12 months) period. The before and after intervention periods will be compared descriptively, and using multi-level logistic regression models clustered on site and allowing for participants who are active in both periods. Due to the small number of participating services, modelled findings and secondary subgroup analyses will be interpreted cautiously, with emphasis on direction and magnitude. A subgroup analysis will also be conducted of the primary outcome among women who have never screened or screened >10 years ago. These will be considered exploratory with no adjustment for multiplicity planned given the implementation focus. Data will be analysed using Microsoft Excel (Microsoft Corporation) and STATA software (StataCorp, version 18).

Sample size

As per clinical guidelines, any women and people with a cervix who have not screened under the new HPV screening program will be considered under screened (at least four years overdue); this equates to about 50% or more of eligible screen eligible clients at the services. The baseline screening rate assumption is that 5–10% of screen eligible women and people with a cervix currently move from under screened to screened per 12 months; assuming an increase with policy change to open access to self-collection in 2022 (prior to study intervention) to 20% per 12-month period. To detect a doubling in participation among under screened women and people with a cervix, from 20% in 12 months at baseline to 40%, with 80% power (2-alpha = 5%) and a conventional non-clustered design, would require 91 women and people with a cervix per arm. Allowing up to 12 clusters before and after, and assuming a conservative Intraclass correlation coefficient (ICC) of 0.1, then an average of 50 women and people with a cervix per cluster per period would give a design effect of 5.9, so a total of 1074 women and people with a cervix are required, rounding up to 1200 women and people with a cervix (600 before period, 600 after period). This is feasible given the typical service populations of ACCHOs and the chosen jurisdictions.

Limitations

The study uses cervical screening data from available sources, including practice management software. This presents several limitations as screening records within these platforms can contain inconsistencies and incomplete fields. To mitigate this, strategies focusing on data audits and cleaning will be prioritised (where feasible). Where this is not possible, we will explicitly acknowledge the resulting uncertainty. Missingness will be assessed descriptively to characterise data quality, but no formal imputation will be undertaken consistent with the study’s implementation focus.

Yarns

Semi-structured Yarns and Yarning circles will be used to explore providers’ and clients’ views and experiences of the project, evaluate implementation strategies and to provide contextual information to support cervical screening participation data. Data collection will include individual and group Yarns with approximately 20–30 service staff involved in cervical screening strategies (including doctors, nurses, and Aboriginal Health Practitioners) and separately with 20–40 women and people with a cervix who are clients of the service and who were offered cervical screening. All participants (both screening participants and providers) will provide individual informed consent prior to the Yarns or Yarning circles. Yarns may take place any time during the implementation (after) period of the study but will be concentrated towards the end of, or after, the 12 months allocated to the implementation of strategies. Yarns may take place in-person, online via virtual meeting software or over the phone and will be audio-recorded and transcribed verbatim.

Yarning is a culturally appropriate Indigenous research methodology grounded in Aboriginal and Torres Strait Islander peoples’ traditional ways of communicating, building relationships and sharing knowledge [45,46]. It involves distinct but interconnected types of Yarning including social Yarning to establish relationality and trust, research Yarning to explore the research topic, and therapeutic Yarning to create space for healing conversations if needed [45]. Where possible, trained female Aboriginal and/or Torres Strait Islander researchers will Yarn with participants. Non-Indigenous researchers may also conduct Yarns with appropriate training and mentoring from Aboriginal and Torres Strait Islander people to ensure a culturally safe approach.

Data (transcripts and field notes) will be managed with NVivo software (QSR International, V.12). Framework analysis (also known as “codebook thematic analysis” [47]) will be used to systematically identify themes in the data, using both inductive and deductive coding [48]. An initial coding framework will be developed by Aboriginal and Torres Strait Islander researchers, drawing on the Indigenist research approach, the Lowitja Evaluation Framework, and early inductive coding of a subset of transcripts. This framework will be refined throughout the study to recognise and respect the sovereignty, knowledge systems, and diverse contexts of each participating service and the community they serve. In line with the Indigenist research approach, Aboriginal and Torres Strait Islander people will lead analysis, with support from non-Indigenous researchers. This approach centres Aboriginal and Torres Strait Islander people’s worldviews and lived experiences in the interpretation and analysis of the data. The Lowitja Evaluation Framework will guide analysis, ensuring social, structural and environmental factors influencing the uptake of self-collection are considered alongside individual level factors and grounded within an Indigenist research approach.

Process data

Process data will be used to examine the fidelity of strategy implementation and explore factors that may have influenced their effectiveness in increasing cervical screening participation. Process data will include service level information including the service size, number of eligible clients, the number of cervical screening providers and provider type, remoteness; as well as information on the range of activities implemented in the models (e.g., resources/materials used, provider training activities, community events undertaken, location of self-collect, recalls set, reports provided). Any unrelated activities that may have influenced health care attendance (e.g., major cultural or other health promotion activities) will be captured. A worksheet based on the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS) [49] will be used to collect process data. This tool will allow the research team and the ACCHOs to track when, why and how strategies have been implemented and any associated costs or time.

Dissemination plan

Our co-design process will develop materials, procedures and processes which can be used broadly, beyond the research. Our partnership and governance structure will ensure efficient knowledge transfer mechanisms, facilitated through respectful collaboration, including leaders in the Aboriginal community-controlled sector, cervical screening and academia. Findings will be disseminated to support the evidence-informed national scale up of self-collection. This will include publication in peer review journals and presentations at conferences. Publications will adhere to CONSolIDated critERtia for strengthening the reporting of health research involving Indigenous Peoples (CONSIDER) statement [50]. Findings will also be shared in a variety of other formats previously shown to be successful in translating implementation research findings into policy and practice including translational workshops, evidence briefs and presentations, reports and the creation of resources.

Implications

This research directly aligns to recommendations in Australia’s National Strategy for the Elimination of Cervical Cancer [51] and the World Health Organization’s Global Strategy to Accelerate the Elimination of Cervical Cancer [2] where the immediate priority is: to save women’s lives in the short term by scaling up screening participation and receipt of treatment globally by 2030. Overcoming universal self-collection implementation issues will be necessary to increase participation and achieve equity in cervical cancer elimination for Aboriginal and Torres Strait Islander people.

Co-designed strategies have the potential to transform practice and outcomes, and study findings will be readily transferrable to ACCHOs across Australia. With change, they are also likely to be adaptable to Indigenous women and people with a cervix in other countries. By encouraging community-driven innovations relating to self-collection, we aim to embed these practices in ACCHO service delivery long after the study is completed and provide a way to take the findings and implement nationally. This will both honour community voices and maximize cervical screening participation through a mechanism that we know works. This is critical to ensure that Aboriginal and Torres Strait Islander women and people with a cervix are not left behind as Australia approaches elimination of cervical cancer.