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Trial registered on ANZCTR
Registration number
ACTRN12624000788572
Ethics application status
Approved
Date submitted
5/01/2024
Date registered
26/06/2024
Date last updated
26/06/2024
Date data sharing statement initially provided
26/06/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
Comparing a New Flipchart Approach to Traditional Methods of Human Immunodeficiency Virus (HIV) Counselling in Premarital adult couples.
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Scientific title
Effect of the Pause Flipchart method of premarital HIV counselling on knowledge of AIDS in adult couples: A randomised control study
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Secondary ID [1]
311223
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Nil known
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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:
human immunodeficiency virus
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acquired immunodeficiency syndrome.
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Condition category
Condition code
Infection
329119
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0
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Acquired immune deficiency syndrome (AIDS / HIV)
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Public Health
329183
329183
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0
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Health promotion/education
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
For participants in the interventional arm, counseling is provided using a structured approach with the PAUSE© flipchart, which is designed to standardize the delivery of HIV knowledge. The counseling sessions for this group are conducted by the primary researcher, ensuring consistency in the presentation of information. These sessions are documented in terms of their duration, which typically lasts about 30 minutes. Clients in the interventional arm participate in one counseling session only. Following the session, clients complete the HIV knowledge questionnaire (post-test) to assess the impact of the counseling. Additionally, these clients complete the Patient Education Materials Assessment Tool for Printable Materials (PEMAT-P) to evaluate the understandability of the PAUSE© flipchart.
The content of the PAUSE© flipchart includes comprehensive information on HIV transmission, prevention, and treatment, adhering to current guidelines and best practices. This approach aims to enhance clients' understanding of HIV, equipping them with the knowledge necessary to prevent its spread effectively.
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Intervention code [1]
327684
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Prevention
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Comparator / control treatment
In this study, participants in the control arm undergo a pre-test using the HIV knowledge questionnaire to assess their baseline understanding of HIV/AIDS. Following this initial assessment, these clients receive premarital counseling delivered by healthcare professionals at the clinic. This conventional method of counseling is characterized by its non-structured approach, where the content is spontaneously tailored based on the attending doctor's knowledge and experience. Information during these sessions is conveyed ad hoc, which is reflective of current clinical practice.
The duration of each counseling session ranges from 10 to 20 minutes per couple. To ensure adherence to the study protocol, attendance is meticulously recorded for each session. After receiving the counseling, clients complete the HIV knowledge questionnaire once again as a post-test to evaluate changes in their HIV knowledge. This method allows for the analysis of the counseling's effectiveness based on pre and post-session knowledge scores.
During conventional counseling, participants receive a broad overview of HIV/AIDS, focusing on key aspects such as the mechanisms through which HIV is transmitted, including unprotected sexual contact and blood transfusions. Counselors also discuss preventive strategies like the use of condoms and safe sexual practices to prevent the transmission of HIV. Additionally, the sessions cover the symptoms and progression of HIV/AIDS, emphasizing the importance of early detection and consistent treatment. Treatment options, particularly antiretroviral therapy (ART), are explained, highlighting the necessity of adhering to prescribed medication regimens to manage the condition effectively. This approach ensures that all participants are informed about essential aspects of HIV prevention, management, and the potential impacts of the disease.
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Control group
Active
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Outcomes
Primary outcome [1]
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composite primary outcome :Total Cognitive AIDS Knowledge and AIDS Transmission Knowledge
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Assessment method [1]
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For assessing HIV knowledge among participants, we utilize the "HIV Knowledge and Transmission Questionnaire," an adaptation of the original version developed by Nyamathi et al. in 2008. This version has been translated into Malay and validated in the Malaysian context by Nurin et al., as detailed in their study published in the Malaysian Journal of Public Health Medicine. The adapted questionnaire includes two subscales: Cognitive HIV Knowledge and HIV Transmission Knowledge, consisting of 21 items with responses categorized as 'yes', 'no', and 'unsure'. Correct responses are awarded 1 point, while incorrect and 'unsure' responses receive 0 points, making the total achievable score 21/21. This scoring method helps in accurately measuring the participants' understanding of HIV knowledge before and after the intervention.
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Timepoint [1]
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pre-HIV counselling and immediately post-HIV counselling
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Secondary outcome [1]
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composite secondary outcome :understandability and actionability of a patient education material using Patient Education Materials Assessment Tool for Printable Materials (PEMAT-P)
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Assessment method [1]
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Patient Education Materials Assessment Tool for Printable Materials (PEMAT-P)
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Timepoint [1]
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immediately post counselling session using PAUSE© flipchart
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Eligibility
Key inclusion criteria
• Premarital clients registered for HIV testing
• Age greater than or equal to 18 years
• Able to understand and read Malay
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Minimum age
18
Years
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Maximum age
60
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
• Already received premarital HIV counselling before
•Already tested for HIV infection before
• Health care personnel
• Clients with hearing or vision impairment
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
There are 16 Primary Health Care Clinics (PHCC) in Johor Bahru. Based on previous data, the average attendance of premarital clients in each clinic is about around 600 per year. Eight out of the 16 PHCC will be randomly selected using the fish bowl method. The list of premarital clients scheduled for each day at the selected clinic will be obtained from the EPRS system and clients will be randomly assigned for premarital counselling using the PAUSE© flipchart (Intervention group) and the conventional method (Control group).
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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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
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
15/04/2024
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Date of last participant enrolment
Anticipated
30/06/2024
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Actual
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Date of last data collection
Anticipated
30/06/2024
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Actual
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Sample size
Target
180
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Accrual to date
170
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Final
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Recruitment outside Australia
Country [1]
26057
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Malaysia
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State/province [1]
26057
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JOHOR
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Funding & Sponsors
Funding source category [1]
315482
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University
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Name [1]
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National University of Malaysia (UKM)
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Address [1]
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Sekretariat Etika Penyelidikan Universiti Kebangsaan Malaysia, Tingkat 1, Blok Klinikal, Hospital Canselor Tuanku Muhriz, Pusat Perubatan UKM, Jalan Yaacob Latif, Bandar Tun Razak, 56000 Cheras Kuala Lumpur.
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Country [1]
315482
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Malaysia
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Primary sponsor type
Individual
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Name
Magaletchumi a/p Chelladorai
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Address
Family Medicine Department , Chancellor Tuanku Muhriz Hospital, UKM Medical Center, Yaacob Latif Road, Bandar Tun Razak, 56000 Cheras, Kuala Lumpur, Malaysia
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Country
Malaysia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
317584
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
314391
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MALAYSIA MEDICAL RESEARCH & ETHICS COMMITTEE
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Ethics committee address [1]
314391
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Kompleks Institut Kesihatan Negara (NIH) No.1, Persiaran Setia Murni U13/52, Seksyen U13 Setia Alam, 40170 Shah Alam, Selangor.
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Ethics committee country [1]
314391
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Malaysia
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Date submitted for ethics approval [1]
314391
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11/07/2023
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Approval date [1]
314391
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25/09/2023
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Ethics approval number [1]
314391
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23-02155-HJV
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Ethics committee name [2]
314407
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ETHICAL COMITTEE OF NATIONAL UNIVERSITY OF MALAYSIA
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Ethics committee address [2]
314407
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Hospital Canselor Tuanku Muhriz UKM, Jalan Yaacob Latif, Bandar Tun Razak, 56000 Cheras, Wilayah Persekutuan Kuala Lumpur
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Ethics committee country [2]
314407
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Malaysia
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Date submitted for ethics approval [2]
314407
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03/04/2023
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Approval date [2]
314407
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19/04/2023
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Ethics approval number [2]
314407
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FF-2023-117
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Summary
Brief summary
This is a randomised control study to compare the efficacy of the PAUSE© flip chart tool (PAUSE©) against the conventional method of premarital HIV counselling among clients attending public primary health care centres in rural regions in Johor. The authors also undertake to evaluate the understandability of this tool among the participants. Better efficacy and understandability of this tool would help extend its use nationwide as a more structured and standardised method of delivering pre-marital HIV counselling.This study(data collection) will be conducted from 15/4/2024 till 30/6/2024.The list of premarital clients scheduled for each day at the selected clinic will be obtained from the EPRS system and clients will be randomly assigned for premarital counselling using the PAUSE© flipchart (Intervention group) and the conventional method (Control group). Participants will not be aware of the grouping assigned to them (single blind).
Clients from both arms interventional and control arms will first fill the HIV knowledge questionnaire (pre-test). Then the control arm clients will receive counselling by the doctors who service the premarital clinic using the conventional method of counselling which is the current practice. This is usually done by using a non-structured approach where information is delivered adhoc based on the knowledge and experience of the doctor. The clients in the intervention arm will be counselled using a structured approach based on the PAUSE© flipchart and will be carried out by the primary researcher. Next, clients from both arms will fill the HIV knowledge question again (post-test) and their scores will be analysed. Clients who are in the interventional arm will also fill the Patient Education Materials Assessment Tool for Printable Materials (PEMAT-P) which assesses understandability of the PAUSE© flipchart tool. The researcher will also record the duration of counselling using the PAUSE© flipchart.
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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
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Prof Professor Madya Dr Leelavathi a/p Muthupalaniappen
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Address
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Hospital Canselor Tuanku Muhriz UKM, Family medicine department ,National university,Jalan Yaacob Latif, Bandar Tun Razak, 56000 Cheras, Wilayah Persekutuan Kuala Lumpur
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Country
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Malaysia
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Phone
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+60039145 9475
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Fax
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603 91459479
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Magaletchumi a/p Chelladorai
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Address
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Hospital Canselor Tuanku Muhriz UKM, Family medicine department ,National university,Jalan Yaacob Latif, Bandar Tun Razak, 56000 Cheras, Wilayah Persekutuan Kuala Lumpur
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Country
131415
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Malaysia
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Phone
131415
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+60039171001
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Fax
131415
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+603 91459479
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Magaletchumi a/p Chelladorai
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Address
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Hospital Canselor Tuanku Muhriz UKM, Family medicine department ,National university,Jalan Yaacob Latif, Bandar Tun Razak, 56000 Cheras, Wilayah Persekutuan Kuala Lumpur
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Country
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Malaysia
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Phone
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+60039171001
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Fax
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+603 91459479
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Email
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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)?
Yes
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What data in particular will be shared?
age, gender, ethnicity and education background,the marks obtained
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When will data be available (start and end dates)?
30/9/2024-30/11/2028
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Available to whom?
researchers with a sound proposal only
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Available for what types of analyses?
no specific type of analysis
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How or where can data be obtained?
data can obtained by requesting via email .
[email protected]
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
21293
Study protocol
387089-(Uploaded-31-05-2024-19-48-59)-protocol latest.pdf
21296
Informed consent form
387089-(Uploaded-05-01-2024-13-45-06)-Study-related document.docx
21297
Ethical approval
387089-(Uploaded-25-12-2023-20-10-08)-Study-related document.pdf
23840
Other
patient education material assessment tool
387089-(Uploaded-31-05-2024-19-51-40)-Patient Education Materials Assessment Tool for Printable Materials.docx
23841
Other
flipchart(PAUSE©
387089-(Uploaded-31-05-2024-19-56-21)-PAUSE FINAL (1).pdf
23842
Other
Zainal, N., Abdul Aziz, A. F., Tan, C. E., Kamaludin, R., Periyasamy, P., & Binti Sulaiman, N. A. (2023). PAUSE©: THE CASE FOR DEVELOPING A PREMARITAL HIV TESTING AID FOR PRIMARY CARE SETTINGS IN MALAYSIA. Malaysian Journal of Public Health Medicine, 23(3), 190–200. Retrieved from https://mjphm.org/index.php/mjphm/article/view/2085
knowledge questions
387089-(Uploaded-25-06-2024-16-14-29)-magaletchumi borang soal selidik 1 (5).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.
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