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Trial registered on ANZCTR


Registration number
ACTRN12625000472471
Ethics application status
Approved
Date submitted
7/05/2025
Date registered
16/05/2025
Date last updated
16/05/2025
Date data sharing statement initially provided
16/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
ScreenEQUAL: Informed Cervical Screening Participation for People with Intellectual Disability - Substudy for Family Members and Support People
Scientific title
Overcoming inequity: Informed cervical screening participation for people with intellectual disability - Substudy for Family Members and Support People
Secondary ID [1] 314379 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ScreenEQUAL
Linked study record
This project is a sub-study to the main ScreenEQUAL trial (ACTRN12625000443493), but focuses on the experiences of family members and support people.

Health condition
Health condition(s) or problem(s) studied:
cervical screening (cervical cancer prevention) 337379 0
Condition category
Condition code
Public Health 333759 333759 0 0
Health service research
Public Health 333760 333760 0 0
Health promotion/education
Cancer 333758 333758 0 0
Cervical (cervix)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project aims to evaluate the effectiveness of materials for families and support people to support people with intellectual disability to undertake cervical screening, over a 4-month timeframe.

Family members and supporters (paid and unpaid, n=48) will be invited into a single-arm pre-post study. After completing the pre-intervention online survey (via Redcap), they will be directed to the intervention materials on the ScreenEQUAL website. Specifically, families and support people will receive an email generated through Redcap with a link to the intervention website together with lay information about how to use and navigate the intervention website. The intervention materials comprise:
(1) The Cervical Screening Test - Easy Read Booklet (explaining what the test is, how it can be done, and what happens during the test);
(2) three social stories about people with intellectual disabilities' experiences of the Cervical Screening Test (Before My Cervical Screening Test, During My Cervical Screening Test, After My Cervical Screening Test);
(3) a resource toolkit for support people: an "All About Me" introducing the person with intellectual disability to their healthcare providers, a conversation planning template, and a tool for family members and support people to support people with intellectual disability about the Cervical Screening Test; and
(4) three videos depicting a person with intellectual disability getting a letter about the Cervical Screening Test (2min), talking to a doctor about her options (6min), and talking to a doctor about what happens after the test (4min).
There is no formal training/modules or fixed frequency/schedule; participants are able to go through the resources at their own pace during the four month exposure period (intervention duration).

These intervention materials were co-designed specifically for this study by the project team, partner organisations and people with intellectual disability in an earlier stage of the ScreenEQUAL project, and they can be accessed on the project website: https://screenequal.org.au/information-library/. All interventions materials for families and support people have been reviewed and approved by the University of Sydney HREC and will be housed and delivered using an intervention website, purpose built and hosted by the University of Sydney. To optimise families and support people's familiarization with intervention materials and to help navigate through the intervention website, the website will include brief informational videos, co-produced by Family Planning Australia.

Families and support people will also receive up to 4 automated text-messages, delivered once a month, for 4-months, using professional and encrypted paid text-messaging software (e.g. ClickSend: https://www.clicksend.com/au/) to maintain their engagement over the 4-month intervention period. Intervention text-messages will include an initial welcome message to participants within 1-week of receiving access to the intervention website (message 1), a summary of key highlights of the intervention materials including the informational videos (message 2), a reminder about their upcoming post-intervention survey invitation (message 3) and an end of intervention thank you message at the end of the intervention (4-months after receiving access to the intervention website). Fidelity will be assessed in the post-intervention survey, through participants' self-report of the videos/resources they watched/read, supplemented by website analytics (page views, time spent on website, resource downloads, etc).
Intervention code [1] 330992 0
Early detection / Screening
Intervention code [2] 330991 0
Prevention
Comparator / control treatment
This is a single-arm pre-post-trial for families and supporters of cervical screening eligible people with intellectual disability. There is no control or comparator group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341341 0
Changes in family members' and support people's health literacy to support cervical screening for people with intellectual disability
Timepoint [1] 341341 0
The pre-intervention survey will be completed within 4-6 weeks of consenting into the study. The post-intervention survey will be completed up to 4-months post-intervention.
Secondary outcome [1] 447185 0
Changes in family members' and support people's self-efficacy (confidence) in supporting cervical screening for people with intellectual disability
Timepoint [1] 447185 0
The pre-intervention survey will be completed within 4-6 weeks of consenting into the study. The post-intervention survey will be completed up to 4-months post-intervention.
Secondary outcome [2] 447181 0
Changes in family members' and support people's attitudes towards supporting cervical screening for people with intellectual disability
Timepoint [2] 447181 0
The pre-intervention survey will be completed within 4-6 weeks of consenting into the study. The post-intervention survey will be completed up to 4-months post-intervention.
Secondary outcome [3] 447189 0
Acceptability of the intervention for family members and support people
Timepoint [3] 447189 0
The post-intervention survey will be completed up to 4-months post-intervention.
Secondary outcome [4] 447190 0
Feasibility of the intervention for family members and support people
Timepoint [4] 447190 0
The post-intervention survey will be completed up to 4-months post-intervention.

Eligibility
Key inclusion criteria
- Family member or support person (unpaid or paid, for example, disability support worker or family carer) of a person/people with intellectual disability who are eligible for screening in the NCSP
- live or work in Australia (any State or Territory)
- speak English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Family members and support people who participated in an earlier stage of the ScreenEQUAL project (co-designing the materials currently being evaluated) will not be eligible for this stage of the project.

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
Study sample size calculations are based on a difference in the pre-post intervention survey outcomes. Given the lack of baseline data related to sub-study outcomes related to health literacy, attitudes and self-efficacy for families and support people, the sample size (n = 48) derived for the main trial was also considered to be adequate to detect a change of 30% in pre and post measures for this group.

Planned quantitative analyses:
Descriptive statistics will summarise participants’ baseline characteristics in the substudies. 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
19/05/2025
Actual
Date of last participant enrolment
Anticipated
31/07/2025
Actual
Date of last data collection
Anticipated
30/11/2025
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] 318898 0
Government body
Name [1] 318898 0
National Health and Medical Research Council (NHMRC)
Country [1] 318898 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 321361 0
None
Name [1] 321361 0
Address [1] 321361 0
Country [1] 321361 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317513 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 317513 0
Ethics committee country [1] 317513 0
Australia
Date submitted for ethics approval [1] 317513 0
25/02/2025
Approval date [1] 317513 0
06/03/2025
Ethics approval number [1] 317513 0
2024/HE001371

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

Contacts
Principal investigator
Name 141286 0
Prof Deborah Bateson
Address 141286 0
The University of Sydney Level 5, 1 King Street, Newtown, NSW 2006
Country 141286 0
Australia
Phone 141286 0
+61 0432222026
Fax 141286 0
Email 141286 0
[email protected]
Contact person for public queries
Name 141287 0
Dr Lauren Winkler
Address 141287 0
The University of Sydney Level 5, 1 King Street, Newtown, NSW 2006
Country 141287 0
Australia
Phone 141287 0
+61412331225
Fax 141287 0
Email 141287 0
[email protected]
Contact person for scientific queries
Name 141288 0
Deborah Bateson
Address 141288 0
The University of Sydney Level 5, 1 King Street, Newtown, NSW 2006
Country 141288 0
Australia
Phone 141288 0
+61 432222026
Fax 141288 0
Email 141288 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires approval by an ethics committee
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Data repository: A final electronic de-identified qualitative and quantitative data set produced by this research will be stored in a searchable repository, available on request, following approval from the University of Sydney Research Ethics Office, for retrieval and analysis. The specific repository has not yet been decided on.

Are there extra considerations when requesting access to individual participant data?
No


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.