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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
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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
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Secondary ID [1]
312210
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cervical cancer
333890
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HIV/AIDS
333891
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Condition category
Condition code
Public Health
330565
330565
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0
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Health promotion/education
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Cancer
330566
330566
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0
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Cervical (cervix)
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
328656
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Prevention
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Intervention code [2]
328657
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Behaviour
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Knowledge about cervical cancer and HPV
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Assessment method [1]
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Knowledge about cervical cancer and HPV assessed using study-specific survey.
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Timepoint [1]
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Baseline and 4 weeks post education
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Primary outcome [2]
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Cervical cancer risk behaviours
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Assessment method [2]
338323
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Cervical cancer risk behaviours assessed using standardized items from the Youth Risk Behavior Surveillance System (YRBSS) and study specific items.
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Timepoint [2]
338323
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Baseline and 4 weeks post education
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Primary outcome [3]
338324
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Attitudes toward cervical cancer
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Assessment method [3]
338324
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Attitudes toward cervical cancer using study-specific survey.
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Timepoint [3]
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Baseline and 4 weeks post education
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Secondary outcome [1]
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Perceptions about cervical cancer
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Assessment method [1]
435429
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Perceptions about cervical cancer using study-specific survey.
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Timepoint [1]
435429
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Baseline and 4 weeks post education
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Secondary outcome [2]
435430
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Uptake of cervical cancer screening using study-specific survey.
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Assessment method [2]
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Uptake of cervical cancer screening
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Timepoint [2]
435430
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Baseline and 4 weeks post education
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Secondary outcome [3]
435431
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Uptake of HPV vaccination
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Assessment method [3]
435431
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Uptake of HPV vaccination using study-specific survey.
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Timepoint [3]
435431
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Baseline and 4 weeks post education
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Secondary outcome [4]
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Feasibility of SHINE intervention
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Assessment method [4]
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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 for about 30 -60 minutes.
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Timepoint [4]
435432
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4 weeks post education
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Secondary outcome [5]
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Acceptability of SHINE intervention
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Assessment method [5]
435433
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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.
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Timepoint [5]
435433
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4 weeks post education
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Secondary outcome [6]
436445
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Attitudes towards HPV
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Assessment method [6]
436445
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Attitudes about HPV assessed using study-specific survey.
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Timepoint [6]
436445
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Baseline and 4 weeks post education
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Secondary outcome [7]
436446
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Perceptions about HPV
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Assessment method [7]
436446
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Perceptions about HPV assessed using study-specific survey.
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Timepoint [7]
436446
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Baseline and 4 weeks post education
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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.
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Minimum age
16
Years
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Maximum age
24
Years
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
None
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
27/09/2023
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Date of last participant enrolment
Anticipated
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Actual
29/09/2023
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Date of last data collection
Anticipated
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Actual
29/11/2023
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Sample size
Target
300
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Accrual to date
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Final
293
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Recruitment outside Australia
Country [1]
26334
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Ghana
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State/province [1]
26334
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of Newcastle
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Address [1]
316587
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Country [1]
316587
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Australia
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Primary sponsor type
Other Collaborative groups
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Name
Hunter Medical Research Institute
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Address
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Country
Australia
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Secondary sponsor category [1]
318768
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None
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Name [1]
318768
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Address [1]
318768
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Country [1]
318768
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315374
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The University of Newcastle Human Research Ethics Committee
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Ethics committee address [1]
315374
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http://www.newcastle.edu.au/research/research-services/human-ethics/
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Ethics committee country [1]
315374
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Australia
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Date submitted for ethics approval [1]
315374
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26/06/2020
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Approval date [1]
315374
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27/07/2020
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Ethics approval number [1]
315374
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Summary
Brief summary
This cluster non-randomised controlled trial aims to test whether the SHiNE Project improves knowledge of cervical cancer risk and protective factors among female students attending senior high school in the Ashanti region of Ghana. Eligible students from selected classes from each participating school will be invited to participate in survey at baseline and at four weeks follow-up. Participants from the control the schools will receive usual care (information on reproductive health taught as part of mandatory subjects in the school curriculum in Ghana). Participants from the intervention school will receive usual care plus access to nurse-led education about cervical cancer after completion of baseline survey. The education is a multicomponent intervention including oral, printed and online education about cervical cancer. Following implementation of the intervention, participants will be invited to complete an evaluation survey. Follow-up interviews will be conducted among participants for in-depth understanding participants views about education intervention
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
134502
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Dr Lisa Mackenzie
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Address
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The University of Newcastle, Newcastle, Callaghan, NSW, University Dr 2304
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Country
134502
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Australia
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Phone
134502
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+61 2 4042 0710
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Fax
134502
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Email
134502
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[email protected]
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Contact person for public queries
Name
134503
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Dr Ama Gyamfua Ampofo
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Address
134503
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The University of Newcastle, Newcastle, Callaghan, NSW, University Dr 2304
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Country
134503
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Australia
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Phone
134503
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+61 246491989
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Fax
134503
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Email
134503
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[email protected]
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Contact person for scientific queries
Name
134504
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Dr Ama Gyamfua Ampofo
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Address
134504
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The University of Newcastle, Newcastle, Callaghan, NSW, University Dr 2304
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Country
134504
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Australia
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Phone
134504
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+61 246491989
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Fax
134504
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Email
134504
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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