Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001146381
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
27/08/2026
Date registered
Help: Date registered
15/09/2026
Date last updated
Help: Date last updated
15/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
15/09/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness and implementation of Men in Mind (MiM) Primary Care: a study of training for general practitioners (GPs), nurses and pharmacists to help them feel more confident in treating and engaging men in their care.
Scientific title
Men in Mind (MiM) Primary Care: Training primary care practitioners to better engage men in care, a pre-post effectiveness and implementation study.
Additional trial identifiers [1] 317981 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Men's health 342957 0
Condition category
Condition code
Public Health 339074 339074 0 0
Health service research
Mental Health 339625 339625 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Men in Mind (MiM) Primary Care is a self-paced online training programme for primary care practitioners (GPs, pharmacists, nurses, and rural generalists). The programme comprises three parts, totalling approximately 2.5 hours:

Part 1, Reframing Masculinity: builds foundational knowledge of gender socialisation and how it shapes men's health behaviours and healthcare engagement.
Part 2, Meet Him Where He's At: introduces practical consultation skills through the MALE framework for engaging male patients.
Part 3, Hiding in Plain Sight: focuses on recognising and responding to male presentations of mental health difficulties, using case-based learning.

The training is delivered through the Skilljar learning management system and combines short instructional videos, filmed consultation demonstrations, written content, case-based vignettes, interactive reflective activities, and knowledge-check questions within each part.

Practitioners complete the training individually at their own pace over approximately 2.5 hours in total. Adherence is assessed objectively through the learning management system, which records module-level progress, completion of each of the three parts, and time on task for each participant. Completion of the final module triggers the post-training (T2) outcome survey automatically. Participants who do not complete all three parts are identified from platform records and handled as specified in the Statistical Analysis Plan.
Intervention code [1] 334852 0
Behaviour
Description of the comparator or control
No control group. This is a single-arm pre-post study, all enrolled practitioners receive the MiM Primary Care training; there is no separate comparator condition. Outcomes are compared within the same participants before (T1) and after (T2, immediately post-training; T3, 12 weeks post-training) completion of the training, using a two-way fixed effects statistical design.

What is the comparator: none, each participant serves as their own control (within-person comparison over time)
Control group
Uncontrolled

Outcomes
Primary outcome [1] 346310 0
Practitioner knowledge of, and confidence in, engaging male patients. This will be assessed as a composite outcome, using the total score of the Engaging Men in Primary Care Scale (EMPCS).
Timepoint [1] 346310 0
Baseline (T1, pre-training), immediately post-training (T2, primary timepoint), and 12 weeks post-training (T3)
Secondary outcome [1] 467030 0
Appropriateness of MiM Primary Care
Timepoint [1] 467030 0
Immediately post-training (T2) and 12 weeks post-training (T3)
Secondary outcome [2] 467031 0
Acceptability of MiM Primary Care
Timepoint [2] 467031 0
Immediately post-training (T2) and 12 weeks post-training (T3)
Secondary outcome [3] 467032 0
Feasibility of MiM Primary Care
Timepoint [3] 467032 0
Immediately post-training (T2) and 12 weeks post-training (T3)
Secondary outcome [4] 467033 0
Adoption of core MiM Primary Care training components
Timepoint [4] 467033 0
Immediately post-training (T2) and 12 weeks post-training (T3)
Secondary outcome [5] 467583 0
Practitioner knowledge and confidence across the five domains of the Engaging Men in Primary Care Scale (EMPCS)
Timepoint [5] 467583 0
Timepoint: T1, T2 and T3.

Eligibility
Key inclusion criteria
Qualified and registered GPs, practice nurses, pharmacists, or rural generalists currently practising in Australia at the time of registration, who provide informed consent. Practitioners who participated in prototype testing of an earlier version of MiM Primary Care are excluded.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Practitioners who participated in prototype testing of an earlier version of MiM Primary Care. These individuals are identified via a screening question at registration, by name, or by Skilljar student ID where records from prototype testing can be linked to current registration, and are removed from both the effectiveness analysis and the validation dataset.

Any student practitioners who are under 18 years of age will be excluded via a screening question at registration.

Study design
Purpose of the study
Educational / counselling / training
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A repeated measures ANOVA power analysis in G*Power was used as a planning approximation, as no established power procedure exists for the two-way fixed effects (TWFE) model used in the primary analysis. Parameters: alpha = 0.05, power = 0.80, three measurement timepoints, conservative effect size f = 0.42 (equivalent to dz = 0.6), correlation among repeated measures = 0.50. This indicated a minimum total sample of 11 practitioners (actual power = 0.81), applied as a floor within each of the three professional groups, giving a minimum of 33 overall.

This is a statistical floor rather than a recruitment target. All practitioners completing MiM Primary Care during the evaluation period will be invited to participate, and anticipated enrolment substantially exceeds the floor. The binding sample size consideration is the confirmatory factor analysis of the EMPCS, which requires 80 to 160 participants for a 15-item scale. The larger sample also absorbs attrition across timepoints, supports subgroup analysis by practice setting, and provides a buffer against PHN-level clustering.

Full analysis detail is provided in the Statistical Analysis Plan.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/09/2026
Actual
Date of last participant enrolment
Anticipated
24/02/2028
Actual
Date of last data collection
Anticipated
18/05/2028
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 322530 0
Government body
Name [1] 322530 0
Australian Government Department of Health, Disability and Ageing
Country [1] 322530 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Movember Foundation
Address
Country
Australia
Secondary sponsor category [1] 325452 0
None
Name [1] 325452 0
Address [1] 325452 0
Country [1] 325452 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321013 0
Bellberry Human Research Ethics Committee A
Ethics committee address [1] 321013 0
Ethics committee country [1] 321013 0
Australia
Date submitted for ethics approval [1] 321013 0
16/07/2026
Approval date [1] 321013 0
27/08/2026
Ethics approval number [1] 321013 0
2026-07-1235

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

Contacts
Principal investigator
Name 152366 0
A/Prof Zac Seidler
Address 152366 0
Movember Foundation, Level 4, 21-31 Goodwood Street, Richmond VIC 3121, Australia
Country 152366 0
Australia
Phone 152366 0
+61 432 438 254
Fax 152366 0
Email 152366 0
[email protected]
Contact person for public queries
Name 152367 0
Dr Bethany Croak
Address 152367 0
Movember Europe, 52-54 Rosebery Avenue, London EC1R 4RP, United Kingdom
Country 152367 0
United Kingdom
Phone 152367 0
+4420 7952 2060
Fax 152367 0
Email 152367 0
[email protected]
Contact person for scientific queries
Name 152368 0
Dr Bethany Croak
Address 152368 0
Movember Europe, 52-54 Rosebery Avenue, London EC1R 4RP, United Kingdom
Country 152368 0
United Kingdom
Phone 152368 0
+4420 7952 2060
Fax 152368 0
Email 152368 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Ethical approval for this study does not extend to sharing individual participant data. The Human Research Ethics Committee approval specifies that data collected for this project cannot be used for any other purpose without separate HREC approval, and participants did not consent to their individual data being shared beyond the research team. Aggregated and de-identified findings will be published. Requests for further information can be directed to the Principal Investigator.



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Statistical analysis plan    MiM_Pro_Statistical_Analysis_Plan_v1.1.docx


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.