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Trial registered on ANZCTR

Registration number

ACTRN12625000471482

Ethics application status

Approved

Date submitted

13/05/2025

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 Healthcare Providers

Scientific title

Overcoming inequity: Informed cervical screening participation for people with intellectual disability - Substudy for Healthcare Providers

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 healthcare providers

Health condition

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

cervical screening (cervical cancer prevention)

Condition category

Condition code

Public Health

Health service research

Cancer

Cervical (cervix)

Public Health

Health promotion/education

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This project aims to evaluate the effectiveness of a trauma-informed online training module for healthcare providers (GPs and nurses) to support their cervical screening practice for people with intellectual disability.

Health professionals (N=433) will be invited into a single-arm pre-post study. Immediately after completing their pre-intervention online survey (via Redcap), they will receive access to the online training via the intervention website. Specifically, health professionals will receive an email generated through Redcap with a link to the intervention website together with lay information about how to navigate the intervention website,

Participants will have access to a single online training module hosted on the intervention website, which participants can work through at their own pace and in their own time over a four-month exposure period. The module will take up to 60-minutes to complete. The online training module has been accredited with the Australian College of Rural and Remote Medicine and healthcare providers can self-record their 1 hour of Continuing Professional Development.

The single online training module was 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 includes information about:
- the importance of cervical screening for people with intellectual disability,
- practice tips for optimising care,
- the role of support people, rapid rapport building,
- strategies to enhance communication and '
- person centred-care
- managing consent
- background information about HPV infection and cervical disease,
- eligibility,
- comparing clinician collection and self-collection of a cervical screening test,
- a cervical screening checklist,
- preparing for a colposcopy referral and additional resources.
In addition to the online training module, participants will also have access to an 'All About Me' resource to support rapid rapport building with patients with intellectual disability and videos demonstrating optimal cervical screening practice with a patient with intellectual disability.
A detailed outline of the healthcare provider training content was reviewed and approved by the University of Sydney HREC.

During the 4-month intervention period, healthcare providers will also receive up to 4 automated text-message reminders, delivered once a month, for 4-months, using a professional and encrypted paid text-messaging software approved by the University of Sydney HREC and the Clinical Trials Risk and Governance Team at the University of Sydney (e.g https://www.clicksend.com/au/. These text-messages were included in the intervention to maintain participant's engagement with the online training module and clinician resources, over the study 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 brief summary of key highlights of the online training materials (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).

Fidelity will be assessed in the post-intervention survey, through participants' self-report about whether they completed (all or some) of the online training module. If the participant endorses completing only 'some' of the module, Redcap will automatically trigger a follow-up question inviting participants to self-report which of the topics they completed. All participants will also be invited to self-report which (if any) of the additional healthcare provider resources they engaged with including the cervical screening checklist (part of the training module), All About Me resource and practitioner videos.

Intervention code [1]

Early detection / Screening

Intervention code [2]

Prevention

Comparator / control treatment

No control group - this study employs a single-arm pre-post-trial for healthcare providers (GPs and Nurses).

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Changes in healthcare providers' knowledge about cervical screening for eligible 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 [1]

Changes in healthcare providers' self-efficacy/preparedness regarding cervical screening for people with intellectual disability

Assessment method [1]

Pre-post differences in healthcare providers’ self-efficacy/preparedness regarding cervical screening for people with intellectual disability will be collected using pre-and-post study-specific surveys, delivered online using Redcap. Healthcare providers' self-efficacy (confidence) will be measured using Likert scale items purposely co-designed by the research time, with four response options (Not at all confident, not very confident, Confident enough, very confident). For example, "We are interested in how confident/prepared you feel about offering cervical screening with eligible people with intellectual disability. How confident do you feel about your ability to": 1) Offer cervical screening testing to an eligible person with intellectual disability 2) Offer cervical screening testing to an eligible person with intellectual disability who is reluctant to have cervical screening 3) Explain the association between HPV and cervical screening to a person with an eligible intellectual disability, and why it is important.? 4) Explain what having a clinician-collected cervical screening test involves to an eligible person with intellectual disability.? 5) Explain what having a self-collected cervical screening test involves for an eligible person with intellectual disability. 6) Obtain informed consent from a person with intellectual disability to have a cervical screening test using strategies to optimise capacity 7)Communicate with family members or support people of a person with intellectual disability about having a cervical screening test.? 8) Recommend and/or discuss self-collection with an eligible person with intellectual disability.? 9) Ask a family member or support person to leave the clinic room if that is the person with intellectual disabilities preference 10) Explain people’s rights and choices for having a cervical screening test. 11)Talk about sex and sexual activity including sexual abuse with an eligible person with intellectual disability during a cervical screening consultation 12 Explain an HPV 16/18 test result to an eligible person with intellectual disability 13) Explain an HPV (not16/18) test result to an eligible person with intellectual disability 14) Explain an HPV not detected test result to an eligible person with intellectual disability who will be asked to return in 5 years 15) Discuss the need to return for an LBC test following a self-collected HPV (not 16/18) detected test result? 16) Discuss with and refer an eligible person with intellectual disability for colposcopy for a screen-detected abnormality Pre-and-post study-specific surveys for healthcare providers (GPs and Nurses) have been reviewed and approved by the University of Sydney HREC and the Risk and Governance Office at the University of Sydney.

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 healthcare providers' attitudes about 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 healthcare providers

Timepoint [3]

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

Secondary outcome [4]

Feasibility of the intervention for healthcare providers

Timepoint [4]

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

Eligibility

Key inclusion criteria

- Registered GP or Nurse
- practice in Australia
- speak English

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

None, Note that GPs and nurses do NOT need to have to have a current patient with intellectual disability who is eligible for screening in the NCSP in order to participate in this study

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

Sample size calculations
For healthcare providers, it was estimated that a sample size of 393 would be needed to detect a change in preparedness to provide cervical screening from 65% pre-intervention to 75% post-intervention based on a recent Australian cervical screening survey (Sultana et al.., 2020). As per the other sample size calculations, a conservative approach was undertaken. Assuming a dropout rate of 10%, recruitment of 433 healthcare providers would be required.

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

433

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 online training for healthcare providers to support their cervical screening practice for people with intellectual disability. 

Who is it for?
You may be eligible for this study if you are a GP or nurse working in Australia. 

Study details:
Participants will have access an online training module designed to help them provide better cervical screening for people with intellectual disabilities. The training covers topics such as the importance of cervical screening, communication strategies, and managing consent. They will have access to this training for four months. Participants will be asked to complete a short survey before and after accessing the training.

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