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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.
Scientific title
Effect of the Pause Flipchart method of premarital HIV counselling on knowledge of AIDS in adult couples: A randomised control study
Secondary ID [1] 311223 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
human immunodeficiency virus 332430 0
acquired immunodeficiency syndrome. 332431 0
Condition category
Condition code
Infection 329119 329119 0 0
Acquired immune deficiency syndrome (AIDS / HIV)
Public Health 329183 329183 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 327684 0
Prevention
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.
Control group
Active

Outcomes
Primary outcome [1] 336952 0
composite primary outcome :Total Cognitive AIDS Knowledge and AIDS Transmission Knowledge
Timepoint [1] 336952 0
pre-HIV counselling and immediately post-HIV counselling
Secondary outcome [1] 430245 0
composite secondary outcome :understandability and actionability of a patient education material using Patient Education Materials Assessment Tool for Printable Materials (PEMAT-P)
Timepoint [1] 430245 0
immediately post counselling session using PAUSE© flipchart

Eligibility
Key inclusion criteria
• Premarital clients registered for HIV testing
• Age greater than or equal to 18 years
• Able to understand and read Malay
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Already received premarital HIV counselling before
•Already tested for HIV infection before
• Health care personnel
• Clients with hearing or vision impairment

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)
central randomisation by computer
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).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
15/04/2024
Date of last participant enrolment
Anticipated
30/06/2024
Actual
Date of last data collection
Anticipated
30/06/2024
Actual
Sample size
Target
180
Accrual to date
170
Final
Recruitment outside Australia
Country [1] 26057 0
Malaysia
State/province [1] 26057 0
JOHOR

Funding & Sponsors
Funding source category [1] 315482 0
University
Name [1] 315482 0
National University of Malaysia (UKM)
Country [1] 315482 0
Malaysia
Primary sponsor type
Individual
Name
Magaletchumi a/p Chelladorai
Address
Family Medicine Department , Chancellor Tuanku Muhriz Hospital, UKM Medical Center, Yaacob Latif Road, Bandar Tun Razak, 56000 Cheras, Kuala Lumpur, Malaysia
Country
Malaysia
Secondary sponsor category [1] 317584 0
None
Name [1] 317584 0
Address [1] 317584 0
Country [1] 317584 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314391 0
MALAYSIA MEDICAL RESEARCH & ETHICS COMMITTEE
Ethics committee address [1] 314391 0
Kompleks Institut Kesihatan Negara (NIH) No.1, Persiaran Setia Murni U13/52, Seksyen U13 Setia Alam, 40170 Shah Alam, Selangor.
Ethics committee country [1] 314391 0
Malaysia
Date submitted for ethics approval [1] 314391 0
11/07/2023
Approval date [1] 314391 0
25/09/2023
Ethics approval number [1] 314391 0
23-02155-HJV
Ethics committee name [2] 314407 0
ETHICAL COMITTEE OF NATIONAL UNIVERSITY OF MALAYSIA
Ethics committee address [2] 314407 0
Hospital Canselor Tuanku Muhriz UKM, Jalan Yaacob Latif, Bandar Tun Razak, 56000 Cheras, Wilayah Persekutuan Kuala Lumpur
Ethics committee country [2] 314407 0
Malaysia
Date submitted for ethics approval [2] 314407 0
03/04/2023
Approval date [2] 314407 0
19/04/2023
Ethics approval number [2] 314407 0
FF-2023-117

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131414 0
Prof Professor Madya Dr Leelavathi a/p Muthupalaniappen
Address 131414 0
Hospital Canselor Tuanku Muhriz UKM, Family medicine department ,National university,Jalan Yaacob Latif, Bandar Tun Razak, 56000 Cheras, Wilayah Persekutuan Kuala Lumpur
Country 131414 0
Malaysia
Phone 131414 0
+60039145 9475
Fax 131414 0
603 91459479
Email 131414 0
drleelaraj@yahoo.com
Contact person for public queries
Name 131415 0
Dr Magaletchumi a/p Chelladorai
Address 131415 0
Hospital Canselor Tuanku Muhriz UKM, Family medicine department ,National university,Jalan Yaacob Latif, Bandar Tun Razak, 56000 Cheras, Wilayah Persekutuan Kuala Lumpur
Country 131415 0
Malaysia
Phone 131415 0
+60039171001
Fax 131415 0
+603 91459479
Email 131415 0
magaletchumi89@gmail.com
Contact person for scientific queries
Name 131416 0
Dr Magaletchumi a/p Chelladorai
Address 131416 0
Hospital Canselor Tuanku Muhriz UKM, Family medicine department ,National university,Jalan Yaacob Latif, Bandar Tun Razak, 56000 Cheras, Wilayah Persekutuan Kuala Lumpur
Country 131416 0
Malaysia
Phone 131416 0
+60039171001
Fax 131416 0
+603 91459479
Email 131416 0
magaletchumi89@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
age, gender, ethnicity and education background,the marks obtained
When will data be available (start and end dates)?
30/9/2024-30/11/2028
Available to whom?
researchers with a sound proposal only
Available for what types of analyses?
no specific type of analysis
How or where can data be obtained?
data can obtained by requesting via email .
magaletchumi89@gmail.com


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21293Study protocol    387089-(Uploaded-31-05-2024-19-48-59)-protocol latest.pdf
21296Informed consent form    387089-(Uploaded-05-01-2024-13-45-06)-Study-related document.docx
21297Ethical approval    387089-(Uploaded-25-12-2023-20-10-08)-Study-related document.pdf
23840Other    patient education material assessment tool 387089-(Uploaded-31-05-2024-19-51-40)-Patient Education Materials Assessment Tool for Printable Materials.docx
23841Other    flipchart(PAUSE© 387089-(Uploaded-31-05-2024-19-56-21)-PAUSE FINAL (1).pdf
23842OtherZainal, 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.