Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001254583
Ethics application status
Approved
Date submitted
18/04/2024
Date registered
14/10/2024
Date last updated
14/10/2024
Date data sharing statement initially provided
14/10/2024
Type of registration
Prospectively 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 Cluster 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 Cluster Randomised Controlled Trial
Secondary ID [1] 310533 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical cancer
 331421 0
HIV/AIDS 333669 0
Condition category
Condition code
Public Health 328166 328166 0 0
Health promotion/education
Cancer 330357 330357 0 0
Cervical (cervix)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 was 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 obstetricians, c) probability of being scaled up and sustained across senior high schools in Ghana. d) a pilot and feasibility test to refine the intervention with n = 293 students from n = 4 schools (This pilot trial was completed in 2023). The pilot intervention was well received and there will be no planned refinements to the intervention delivered as part of this RCT.

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 (prepared as part of the pilot intervention) with relevant learning aids such as videos and pictures to enhance learning. These materials have been reviewed and no refinements needed after the pilot study.

Leaflets: Printed leaflets was developed as part of the pilot intervention (no refinements needed after pilot study) and will be available at the session to be distributed to the attendees for reference after the face-2-face session. 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. The 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. A research assistant will be provided with an observer sheet to record attendance and participant. delivery of modules.


Web-based education: Web-based education will be provided to students after the face-2-face session. The website was developed as part of the pilot study and 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. 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 as well as information sources and the list of locations in Ghana where HPV vaccinations and cervical screening can be accessed. The videos are presented 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 was be developed as part of the pilot intervention study. The content of the gaming APP contain questions pooled from comments and questions provided by students in the comment section of a descriptive survey conducted prior to this project. It 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 is 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] 326973 0
Prevention
Intervention code [2] 326974 0
Behaviour
Comparator / control treatment
Schools randomly allocated to this group will receive the usual care. This is 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] 336044 0
Knowledge about cervical cancer and HPV assessed using study-specific survey.
Timepoint [1] 336044 0
Baseline and 8 weeks post education
Primary outcome [2] 338019 0
Cervical cancer risk behaviours assessed using standardized items from the Youth Risk Behavior Surveillance System (YRBSS) survey and study-specific items.
Timepoint [2] 338019 0
Baseline and 8 weeks post education
Primary outcome [3] 338126 0
Attitudes about cervical cancer assessed using study-specific survey.
Timepoint [3] 338126 0
Baseline and 8 weeks post education
Secondary outcome [1] 434605 0
Attitudes about HPV assessed using study-specific survey.
Timepoint [1] 434605 0
Baseline and 8 weeks post education
Secondary outcome [2] 434606 0
Perceptions about cervical cancer assessed using study-specific survey.
Timepoint [2] 434606 0
Baseline and 8 weeks post education
Secondary outcome [3] 434607 0
Uptake of cervical cancer screening assessed using study-specific survey.
Timepoint [3] 434607 0
Baseline and 8 weeks post education
Secondary outcome [4] 434608 0
Uptake of HPV vaccination assessed using using study-specific survey.
Timepoint [4] 434608 0
Baseline and 8 weeks post education
Secondary outcome [5] 435427 0
Feasibility of SHINE intervention assessed using study-specific survey and interviews.
Four to five focused group discussions will be conducted using a semi-structured interview guide lasting between 30-60 minutes.
Timepoint [5] 435427 0
8 weeks post education
Secondary outcome [6] 435428 0
Acceptability of SHINE intervention assessed using study-specific survey and interviews.
Four to five focused group discussions will be conducted using a semi-structured interview guide lasting for about 30 - 60 minutes.
Timepoint [6] 435428 0
4 weeks post education
Secondary outcome [7] 436447 0
Perceptions about HPV assessed using study-specific survey.
Timepoint [7] 436447 0
Baseline and 8 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
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation: An independent statistician at the clinical research design, IT and statistical support (CReDITSS) unit at the Hunter Medical Research Institute (HMRI) will assist with the randomization. A computer based randomization will be used for group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Schools will be randomly allocated to either an experimental group (n=5) or control group (n = 5) using a computer generated random sequence.
Baseline characteristics of schools will be tabulated and assessed for possibilities of matching schools with similar characteristics. Matched pairs of schools will be randomized to receive either the intervention or the control using permuted block randomization.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment outside Australia
Country [1] 25765 0
Ghana
State/province [1] 25765 0

Funding & Sponsors
Funding source category [1] 314734 0
University
Name [1] 314734 0
University of Newcastle
Country [1] 314734 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Hunter Medical Research Institute
Address
Lot 1 Kookaburra Cct, New Lambton Heights NSW 2305
Country
Australia
Secondary sponsor category [1] 316711 0
None
Name [1] 316711 0
Address [1] 316711 0
Country [1] 316711 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313744 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 313744 0
Ethics committee country [1] 313744 0
Australia
Date submitted for ethics approval [1] 313744 0
23/06/2020
Approval date [1] 313744 0
27/07/2020
Ethics approval number [1] 313744 0
H-2020-0184

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

Contacts
Principal investigator
Name 129214 0
Dr Lisa Mackenzie
Address 129214 0
The University of Newcastle, Newcastle, Callaghan, NSW, University Dr 2304
Country 129214 0
Australia
Phone 129214 0
+61 2 4042 0710
Fax 129214 0
Email 129214 0
lisa.mackenzie@newcastle.edu.au
Contact person for public queries
Name 129215 0
Ama Gyamfua Ampofo
Address 129215 0
The University of Newcastle, Newcastle, Callaghan, NSW, University Dr 2304
Country 129215 0
Australia
Phone 129215 0
+61 246491989
Fax 129215 0
Email 129215 0
ama.ampofo@newcastle.edu.au
Contact person for scientific queries
Name 129216 0
Ama Gyamfua Ampofo
Address 129216 0
The University of Newcastle, Newcastle, Callaghan, NSW, University Dr 2304
Country 129216 0
Australia
Phone 129216 0
+61 246491989
Fax 129216 0
Email 129216 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.