Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001255572
Ethics application status
Approved
Date submitted
17/06/2024
Date registered
14/10/2024
Date last updated
14/10/2024
Date data sharing statement initially provided
14/10/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of Senior High School Nurse-led Educational (SHiNE) Project in improving knowledge and attitudes towards primary and secondary prevention of cervical cancer among Students in Ghana: A pilot Cluster Non-randomised Controlled Trial
Scientific title
The effect of Senior High School Nurse-led Educational (SHiNE) Project in improving knowledge and attitudes towards primary and secondary prevention of cervical cancer among Students in Ghana: A pilot Cluster Non-randomised Controlled Trial
Secondary ID [1] 312210 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical cancer 333890 0
HIV/AIDS 333891 0
Condition category
Condition code
Public Health 330565 330565 0 0
Health promotion/education
Cancer 330566 330566 0 0
Cervical (cervix)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The current study is a pilot and feasibility test aiming to refine the intervention with students from n = 4 schools.

A nurse-led health education session or Senior High School Nurse-led Educational (SHiNE) project. A one-day multimodal (verbal, printed and multimedia) school-based intervention will include a set of evidence-based strategies. This strategy of the session were selected based on a) critical review of models for school-based sex education, health education towards HIV/AIDs and use of contraception, b) improving health knowledge among high school students based on literature reviews and judgement by the health behaviour researchers, local educationist and health professional including oncology nurses and doctors,

The proposed intervention consists of four components:
Face-2-face session
Printed leaflets
Web-education
Game APP

Face-2-face session: Sessions will be delivered by a nurse, the investigator given her experience in conducting health education among adolescents over one hour. The nurse will use PowerPoint presentations with relevant learning aids such as videos (downloaded from YouTube) and pictures to enhance learning. Existing resources from evidence-based literature of cervical cancer including WHO information on cervical cancer and HPV vaccination program in low-income countries and Uganda HPV vaccination project leaflet were included in the presentation materials. These resources and leaflets were adopted because of their ability to provide comprehensive cervical cancer and HPV vaccine information incorporating medical and psychosocial content, simple, plain words and transferability to the Ghanaian setting. Additionally, these messages can reduce various myths and beliefs about cervical cancer in Ghana. Also, information sources and the list of locations in Ghana where HPV vaccinations are included. A research assistant will be provided with an observer sheet to record attendance and participant. delivery of modules.

Printed leaflets will be available at the session to be distributed to the attendees for reference after the face-2-face session.

Web-based education: The web education will be provided to students after the face-2-face session. The website contains very similar information in the slides for the face-to-face presentation. The platform is anonymous, and no names and contact details will be collected. Minor designs changes of the website may be required following findings from the pilot study. Minor revision of the content of the website may also be updated including adding a frequently asked questions (FAQs) section, contact details of clinics and any guideline update from the World Health Organization about cervical cancer. The FAQs section will be populated from questions, concerns and issues emerging from the feasibility study. Short videos and images about cervical cancer incidence in Ghana; risk factors, signs and symptoms, primary and secondary prevention will be embedded in the website. The videos will be provided in English and two most spoken local languages. Adherence will be assessed using website analytics and self-administered evaluation surveys.

Gaming APP: A gaming APP will be developed as part of the intervention. The content of the gaming APP will contain questions pooled from comments and questions provided by students in the comment section of a descriptive survey conducted prior to this project. It will also contain evidence and non-evidence based statements about cervical cancer and HPV infection from the WHO website and other evidence from the literature. The gaming APP will be compatible with android devices only as android devices are mostly used in Ghana. Adherence will be assessed using analytics and self-administered evaluation surveys.
Intervention code [1] 328656 0
Prevention
Intervention code [2] 328657 0
Behaviour
Comparator / control treatment
Schools will be allocated to the control group and will receive usual care. Usual care will include information on sexually transmitted diseases and other reproductive health topics as part of the mandatory core subjects (social studies and integrated science) in the SHS curriculum in Ghana.
Control group
Active

Outcomes
Primary outcome [1] 338322 0
Knowledge about cervical cancer and HPV
Timepoint [1] 338322 0
Baseline and 4 weeks post education
Primary outcome [2] 338323 0
Cervical cancer risk behaviours
Timepoint [2] 338323 0
Baseline and 4 weeks post education
Primary outcome [3] 338324 0
Attitudes toward cervical cancer
Timepoint [3] 338324 0
Baseline and 4 weeks post education
Secondary outcome [1] 435429 0
Perceptions about cervical cancer
Timepoint [1] 435429 0
Baseline and 4 weeks post education
Secondary outcome [2] 435430 0
Uptake of cervical cancer screening using study-specific survey.
Timepoint [2] 435430 0
Baseline and 4 weeks post education
Secondary outcome [3] 435431 0
Uptake of HPV vaccination
Timepoint [3] 435431 0
Baseline and 4 weeks post education
Secondary outcome [4] 435432 0
Feasibility of SHINE intervention
Timepoint [4] 435432 0
4 weeks post education
Secondary outcome [5] 435433 0
Acceptability of SHINE intervention
Timepoint [5] 435433 0
4 weeks post education
Secondary outcome [6] 436445 0
Attitudes towards HPV
Timepoint [6] 436445 0
Baseline and 4 weeks post education
Secondary outcome [7] 436446 0
Perceptions about HPV
Timepoint [7] 436446 0
Baseline and 4 weeks post education

Eligibility
Key inclusion criteria
i) female
ii) aged 16 years or older
iii) enrolled in senior high school level two (i.e. second year of senior high school, which is approximately equivalent to students in high school grade 11 in Australia) at one of the selected schools
iv) able to read and understand English adequately to provide informed consent and complete a questionnaire.
Minimum age
16 Years
Maximum age
24 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
27/09/2023
Date of last participant enrolment
Anticipated
Actual
29/09/2023
Date of last data collection
Anticipated
Actual
29/11/2023
Sample size
Target
300
Accrual to date
Final
293
Recruitment outside Australia
Country [1] 26334 0
Ghana
State/province [1] 26334 0

Funding & Sponsors
Funding source category [1] 316587 0
University
Name [1] 316587 0
University of Newcastle
Country [1] 316587 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Hunter Medical Research Institute
Address
Country
Australia
Secondary sponsor category [1] 318768 0
None
Name [1] 318768 0
Address [1] 318768 0
Country [1] 318768 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315374 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 315374 0
Ethics committee country [1] 315374 0
Australia
Date submitted for ethics approval [1] 315374 0
26/06/2020
Approval date [1] 315374 0
27/07/2020
Ethics approval number [1] 315374 0

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

Contacts
Principal investigator
Name 134502 0
Dr Lisa Mackenzie
Address 134502 0
The University of Newcastle, Newcastle, Callaghan, NSW, University Dr 2304
Country 134502 0
Australia
Phone 134502 0
+61 2 4042 0710
Fax 134502 0
Email 134502 0
lisa.mackenzie@newcastle.edu.au
Contact person for public queries
Name 134503 0
Dr Ama Gyamfua Ampofo
Address 134503 0
The University of Newcastle, Newcastle, Callaghan, NSW, University Dr 2304
Country 134503 0
Australia
Phone 134503 0
+61 246491989
Fax 134503 0
Email 134503 0
ama.ampofo@newcastle.edu.au
Contact person for scientific queries
Name 134504 0
Dr Ama Gyamfua Ampofo
Address 134504 0
The University of Newcastle, Newcastle, Callaghan, NSW, University Dr 2304
Country 134504 0
Australia
Phone 134504 0
+61 246491989
Fax 134504 0
Email 134504 0
ama.ampofo@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.