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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]

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)

Condition category

Condition code

Cancer

Cervical (cervix)

Public Health

Health service research

Public Health

Health promotion/education

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]

Prevention

Intervention code [2]

Early detection / Screening

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]

Changes in family members' and support people's health literacy to support cervical screening for people with intellectual disability

Assessment method [1]

Pre-post differences in family members’ and support peoples’ health literacy in supporting cervical screening for people with intellectual disability will be collected using pre-and-post surveys, delivered online using Redcap. Pre-and-post study-specific surveys for families and support people have been reviewed and approved by the University of Sydney HREC and the Risk and Governance Office at the University of Sydney, Health literacy for families and support people will be evaluated using 12 Likert scales, purposely co-designed by the research time, with three response options (True, Fale or Unsure). A summary of the scale items is included below. This is not a test. Your responses will help us to improve our resources for other families and support people and to make sure we have just enough information, but not too much. 1) The cervical screening test checks for the Human Papillomavirus, HPV for short. False/Unsure/True 2) HPV can cause changes in the cervix that could lead to cancer. 3) Cervical screening can protect a person from having cervical cancer. 4) A person with intellectual disability only needs cervical screening if they have pain or irregular bleeding. 5) A person with intellectual disability doesn't need cervical screening if they have had the HPV vaccination. 6) A person with intellectual disability doesn't need cervical screening if they have been through menopause. 7) A person with intellectual disability can take the test themselves with a self-swab. 8) A person with intellectual disability can ask the doctor or nurse to take the test from their cervix using a tool called a speculum. 9) A person with intellectual disability can tell the doctor or nurse to stop the test at any time. 10) I know where people with intellectual disability can go to have cervical screening. 11) If the test shows HPV, a person with intellectual disability might be asked to come back for more testing. 12) If the test does not show HPV, it usually means further testing is needed for 5 years.

Timepoint [1]

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]

Changes in family members' and support people's attitudes towards supporting cervical screening for people with intellectual disability

Timepoint [1]

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]

Changes in family members' and support people's self-efficacy (confidence) in supporting cervical screening for people with intellectual disability

Timepoint [2]

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]

Acceptability of the intervention for family members and support people

Timepoint [3]

The post-intervention survey will be completed up to 4-months post-intervention.

Secondary outcome [4]

Feasibility of the intervention for family members and support people

Timepoint [4]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council (NHMRC)

Address [1]

Country [1]

Australia

Primary sponsor type

University

Name

The University of Sydney

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Sydney Human Research Ethics Committee

Ethics committee address [1]

https://www.sydney.edu.au/research/research-integrity-and-ethics.html

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

25/02/2025

Approval date [1]

06/03/2025

Ethics approval number [1]

2024/HE001371

Summary

Brief summary

The primary aim of this project is to evaluate the effectiveness of accessible cervical screening information for people supporting people with intellectual disability to make an informed decision about whether to have a cervical screening test. 

Who is it for?
You may be eligible for this study if you area 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 National Cervical Screening Program.

Study details:
Participants will receive a link to a website with accessible cervical screening information, including Easy Read information and videos about the Cervical Screening Test, and resources to support communication about the test with people with intellectual disability and healthcare providers. They will have access to these resources for four months. Participants will be asked to complete a short survey before and after accessing these resources.

It is hoped that the findings of this study will help us to improve access to and experiences of cervical screening amongst people with intellectual disability.

Trial website

Not yet finalised

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Deborah Bateson

Address

The University of Sydney Level 5, 1 King Street, Newtown, NSW 2006

Country

Australia

Phone

+61 0432222026

Fax

[email protected]

Contact person for public queries

Name

Dr Lauren Winkler

Address

The University of Sydney Level 5, 1 King Street, Newtown, NSW 2006

Country

Australia

Phone

+61412331225

Fax

[email protected]

Contact person for scientific queries

Name

Deborah Bateson

Address

The University of Sydney Level 5, 1 King Street, Newtown, NSW 2006

Country

Australia

Phone

+61 432222026

Fax

[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?

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.

Trial Review

Documents added manually

Documents added automatically