Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000443493
Ethics application status
Approved
Date submitted
29/10/2024
Date registered
12/05/2025
Date last updated
12/05/2025
Date data sharing statement initially provided
12/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
ScreenEQUAL: Informed Cervical Screening Participation for People with Intellectual Disability
Scientific title
Overcoming inequity: Informed cervical screening participation for people with intellectual disability (ScreenEQUAL)
Secondary ID [1] 310500 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ScreenEQUAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cervical screening (cervical cancer prevention) 331292 0
Condition category
Condition code
Public Health 332235 332235 0 0
Health promotion/education
Cancer 328063 328063 0 0
Cervical (cervix)
Public Health 332234 332234 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The resource for people with intellectual disability is multimodal, incorporating Easy Read written information, social stories and videos to support accessibility for people with high support needs (hereon referred to as the ‘intervention’). The intervention builds on the Family Planning Australia ‘Just Checking’ resource series which supports cancer screening for people with intellectual disability, their families and support people. The intervention has been reviewed and approved by the University of Sydney for the purpose of assessing cervical screening informed decision-making for people with intellectual disability, which is the primary outcome of this clinical research trial.

During the initial consent process, people with intellectual disability will be invited to meet with the expert disability researchers, with support from the research team, either in-person at a location of their choice (disability service, UNSW Sydney, the University of Sydney, disability service or grassroots organisations known to people with intellectual disability) or online using Zoom or Teams, depending on the participants preference. During initial consent, the research team will explain the project to potentially eligible participants using a range of tailored approaches (e.g. website, online newsletters, hard copies of participant information sheet and consent form (PISCF)) and answer any questions. Participants who are interested in taking part will then be invited to provide their consent either in writing or via audio-recording. This approach aims to make the trial aims are easily understood and to facilitate voluntary informed consent, including participants’ choice for written and/or verbal consent. At the end of the initial consent process, the research team will invite participants (verbally) to join one of 5 or 6 accessible workshops of approximately 10 people with intellectual disability and 2 to 3 trained support people, facilitated by members of the research team. The verbal invitation will be accompanied with Easy Read information to support participants understanding about the time and location of the intervention workshop and to provide the contact details (telephone number and email address) of the disability researchers and workshop facilitators.

The research team will invite consenting participants to answer a brief set of accessible questions delivered using an interview-style-format, eliminating the need for written text. Accessible questions will include general demographic questions (e.g. their year of birth, residential postcode, gender and cultural background, including whether they identify as Aboriginal and/or Torres-Strait Islander, living status and educational history) and closed and open-ended accessible questions to assess informed decision-making about cervical screening (primary outcome) across the domains of knowledge, attitudes and intention to screen. The accessible questions will include participant’s understanding about the role of screening in preventing cervical cancer, screening options, including the choice of a self-collected test, and the likely consequences of screening including recommended follow-up after an abnormal test result. Response options include 'Yes', 'No' and 'I don't know', which are accompanied by images of a thumbs up (indicating a 'yes' response), thumbs down (indicating a 'no response') and a neutral thumb ('indicating 'I don't know'). The same response scale and visual cues will be used to assess participants’ attitudes towards screening. For example, "For me, having a cervical screening test is a good thing" ('Yes', 'No', 'I don't know'). The accessible informed decision-making tool for people with intellectual disability has been reviewed and approved by the University of Sydney HREC.

It is important to note that written surveys are not accessible for many people with intellectual disability. To address this challenge and given the lack of an existing validated tool to measure informed decision-making by people with intellectual disability about cervical screening, the research team, led by the chief investigator with intellectual disability and health literacy experts at the Health Literacy Lab at the University of Sydney, modified an existing tool.

The accessible intervention workshops will be delivered at disability services and grassroots organisations known to people with intellectual disability in the community and take up to 4-hours. At the start of the intervention workshop, the expert disability researchers will introduce the research team, including the trained facilitators, describe what will happen during the workshop, answer any questions and invite participant’s continuous consent, including consent to audio-record the intervention workshop (for data collection and analysis purposes only). The trained support people will then use the intervention with participants in a way that simulates what would happen in a community setting. At the end of the workshop, participants with intellectual disability will be supported to repeat the primary outcome questions to assess changes in informed decision-making.

At the end of the workshop, a sub-set of participants with intellectual disability (n ˜ 20 or until saturation is reached) will be invited to participate in post-intervention qualitative interviews, with the option of additional body-mapping, to provide further insights into perceptions of the resources and to support the interpretation of the study outcomes. Body-mapping involves the participant (or, if preferred, an expert disability researcher) tracing around their body to create a life-sized outline and being invited to fill their body outline by drawing or attaching pictures, writing words, or using colours, associated with their own experiences with cervical screening.
Intervention code [1] 326898 0
Early detection / Screening
Intervention code [2] 326897 0
Prevention
Comparator / control treatment
No control group - this study employs a pragmatic single-arm trial design for people with intellectual disability.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335932 0
Change in informed decision-making about cervical screening, assessed using a brief set of pre-and post intervention closed-and-open-ended accessible questions across three domains: knowledge, attitudes to screening and intention to screen. This outcome will be assessed as a composite outcome.
Timepoint [1] 335932 0
Participants with intellectual disability will be invited to complete the primary outcome (accessible informed decision-making tool) during initial consent, before intervention exposure, and repeated again at the end of the intervention workshop, after intervention exposure (pre-and-post study design).
Secondary outcome [1] 441462 0
Intervention feasibility will be measured through a semi-structured qualitative interview and optional additional body-mapping for people with intellectual disability.
Timepoint [1] 441462 0
Up to 4-months post-intervention.
Secondary outcome [2] 441459 0
HPV Test Collection Method by people with intellectual disability (practitioner or self-collected) using linked data with the National Cervical Screening Registry. Participants' HPV test collection method will be accessed in the subsequent 9-months after the trial, using screening data in the National Cervical Screening Registry records, held by the Cancer Institute NSW.
Timepoint [2] 441459 0
Participants' screening histories (HPV Test Collection Method) will be accessed in the subsequent 9-months after the trial, using screening data in the National Cervical Screening Registry records, held by the Cancer Institute NSW. These records include the NSW Pap Test Register (NSW PTR), which collected data on women who has a Pap test including information on Pap tests, cervical histology, and HPV DNA tests prior to January 2018 and (ii) the current National Cervical Screening Program (NCSP) (which collected screening data from 2018 onwards).
Secondary outcome [3] 426174 0
Participation in the National Cervical Screening Program by people with intellectual disability (yes or no) using linked data with the National Cervical Screening Registry.
Timepoint [3] 426174 0
Participants' screening histories (participation in the NCSP) will be accessed in the subsequent 9-months after the trial, using screening data in the National Cervical Screening Registry records, held by the Cancer Institute NSW.
Secondary outcome [4] 441461 0
Intervention acceptability will be measured through a semi-structured qualitative interview and optional additional body-mapping for people with intellectual disability.
Timepoint [4] 441461 0
Up to 4-months post-intervention.
Secondary outcome [5] 441460 0
Reason For HPV Test/Cytology will be collected using linked data with the National Cervical Screening Registry records, held by the Cancer Institute NSW.
Timepoint [5] 441460 0
Participants' screening histories (Reason for HPV Test) will be accessed in the subsequent 9-months after the trial, using screening data in the National Cervical Screening Registry records, held by the Cancer Institute NSW. These records include the NSW Pap Test Register (NSW PTR), which collected data on women who has a Pap test including information on Pap tests, cervical histology, and HPV DNA tests prior to January 2018 and (ii) the current National Cervical Screening Program (NCSP) (which collected screening data from 2018 onwards).
Secondary outcome [6] 441463 0
Intervention usability will be measured through a semi-structured qualitative interview and optional additional body-mapping for people with intellectual disability.
Timepoint [6] 441463 0
Up to 4-months post-intervention.

Eligibility
Key inclusion criteria
- People with intellectual disability due or overdue for cervical screening in the NCSP (age 25 to 74 years with a cervix)
- live in New South Wales
- can communicate verbally or non-verbally (including through augmentative and alternative communication)
- has not participated in Stage 1 of the study
Minimum age
25 Years
Maximum age
74 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any participant who is unable to give informed consent directly, including people requiring third-party consent (consent from a support person or family member) will be excluded. In line with the Mental Capacity Act, where the research team take all practical steps to support capacity without success, the person will be excluded from participating in the clinical trial,

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
Efficacy
Statistical methods / analysis
Sample size calculations:
The sample size calculation is based on a difference in the proportion of people with intellectual disability making an informed decision about cervical screening pre-and-post the intervention. Noting that making an informed decision may not necessarily lead to a person having a screening test due to barriers such as a history of sexual assault, a baseline proportion of 20% was selected based on the last published national Australian figure of 10% screening uptake for this group. It was estimated that 44 participants would be needed to detect a change in the proportion (%) of those assessed as being able to make an informed decision (across the domains of knowledge, attitudes, and intention to screen) from 20% pre-intervention to 50% post-intervention, with power and alpha set at 80 and 5%, respectively. Due to the novelty of our study in terms of participants and intervention, no known estimates were available for pre-post correlation between the items in the modified informed decision-making tool or outcome variability at both time points. Consequently, a conservative approach was adopted by assuming there was zero correlation between pre-post observations measured by the modified tool and that these observations displayed maximum variability, i.e., standard deviation=0.5. Assuming a dropout rate of 10% the adjusted sample was increased to 48.

Planned quantitative analyses:
Descriptive statistics will summarise participants’ baseline characteristics in the main trial. The impact of the intervention (i.e., effects) on the primary and secondary outcomes will be assessed using multivariable logistic regression modelling. This approach adjusts for the data being correlated because of the pre-and-post study design. Effects will be reported as adjusted odds ratios (ORs) with 95% Confidence Intervals (CIs). Univariable logistic analyses will be used to identify potentially confounding variables such as age and place of residence. Two-sided p-values less than 0.05 will be considered as significant. Stata Version 18 (StataCorp LLC, College Station, TX) will be used to analyse data.

The normality of continuous data will be checked analytically by the Kolmogorov-Smirnov test and graphically by the Q-Q plot (Yap & Sim, 2011). If there is no evidence of non-normality, this data will be described by means and standard deviations, otherwise, they will be described by medians and interquartile ranges. For the secondary outcome of change in the screening rate before and after the intervention, univariable logistic regression will be performed to identify significant variables for inclusion in a multivariable logistic regression model. To test for temporal change, this model will incorporate time as a binary variable (pre-intervention, post-intervention). As each participant will potentially provide two correlated observations, we will use the variance covariance cluster method with each participant identified as an individual cluster. Effect sizes will be reported as unadjusted and adjusted odds ratios with accompanying 95% confidence intervals. The McFadden pseudo-R-squared statistic (Smith & McKenna, 2013) will be used as an indicator of the proportion of the variance. In addition, model diagnostics will also be performed to assess the presence and effect of potential outliers or influential observations (Dhakal, 2017). These will be identified using measures such as deviance residuals and leverage statistics (Sheather & Sheather, 2009). The Hosmer and Lemeshow goodness-of-fit test (Hosmer et al., 1988) will also provide evidence of the goodness of fit. Statistical significance will be set at the alpha level of 5% and all tests will be two-sided. All statistical analyses will be conducted with Stata Version 18.0 (StataCorp, College Station, Texas, USA).

Following post-intervention data collection, secondary outcome data will be checked for outliers and missing values. If the proportion of missing values is less than 10% on all relevant variables and there is evidence that the pattern of missing data is missing completely at random, on all relevant variables, then a complete-case approach will be used for the data analysis. If, however, this is not the case, then we will follow the missing-at-random assumption, which allows valid analysis independently of the missing value mechanism by imputing missing data using multiple imputations. A sensitivity analysis will then be used to compare estimates from this approach to those calculated using a complete-case analysis. Both sets of results will be reported.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/05/2025
Actual
Date of last participant enrolment
Anticipated
31/07/2025
Actual
Date of last data collection
Anticipated
31/03/2026
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 314700 0
Government body
Name [1] 314700 0
National Health and Medical Research Council (NHMRC)
Country [1] 314700 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 316672 0
None
Name [1] 316672 0
Address [1] 316672 0
Country [1] 316672 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313715 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 313715 0
Ethics committee country [1] 313715 0
Australia
Date submitted for ethics approval [1] 313715 0
25/02/2025
Approval date [1] 313715 0
06/03/2025
Ethics approval number [1] 313715 0
2024/HE001371

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129114 0
Prof Deborah Bateson
Address 129114 0
The University of Sydney Level 5, 1 King Street, Newtown, NSW 2006
Country 129114 0
Australia
Phone 129114 0
+61 0432222026
Fax 129114 0
Email 129114 0
[email protected]
Contact person for public queries
Name 129115 0
Dr Lauren Winkler
Address 129115 0
The University of Sydney Level 5, 1 King Street, Newtown, NSW 2006
Country 129115 0
Australia
Phone 129115 0
+61412331225
Fax 129115 0
Email 129115 0
[email protected]
Contact person for scientific queries
Name 129116 0
Deborah Bateson
Address 129116 0
The University of Sydney Level 5, 1 King Street, Newtown, NSW 2006
Country 129116 0
Australia
Phone 129116 0
+61 0432222026
Fax 129116 0
Email 129116 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Participant data will be de-identified and aggregated for the purpose of scientific publications and conferences and will not include individual participant data. This decision was made to protect the confidentiality and anonymity of clinical trial participants. The primary outcome does not require identification of individual participant data with regards to the statistical analyses processes being undertaken, and the methods for the reporting the trial results.



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.