HIV Education Kit for Adolescents (Pencegahan HIV di Kalangan Remaja), PREM-Kit (PREM-Kit)
Primary Purpose
Human Immunodeficiency Virus
Status
Recruiting
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
PREM-Kit
Sponsored by
About this trial
This is an interventional other trial for Human Immunodeficiency Virus focused on measuring Human Immunodeficiency Virus, Adolescents, Information-Motivation-Behavioral Skills Model
Eligibility Criteria
Inclusion Criteria: late adolescents aged 18 - 19 years student who attends Health Science Diploma course in the year 2023 Malaysian citizen Exclusion Criteria: student who refused to participate in the study student who is absent on the first session of the intervention student who does not understand the Malay language
Sites / Locations
- Universiti Teknologi MARA (UiTM Campus Tapah)Recruiting
- Universiti Teknologi MARA (Bertam Campus)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
PREM-Kit group
Control group
Arm Description
Outcomes
Primary Outcome Measures
Change in knowledge score related to HIV prevention
Knowledge score will be determined by using 15 questions related to HIV/AIDS transmission and prevention. The participants will be asked to respond on the individual statement using "Yes" or "No" or "I do not know" response. Each correct answer will be credited with 1 point, whereas wrong answers and ''I don't know'' answers will be assigned 0 points. The sum calculated to determine a total score for this scale. The possible range of total score is 0 to 15, where higher score indicates higher level of knowledge.
Change in attitude score related to HIV prevention
To assess the attitude score, eight items are used to assess the participants' attitude toward HIV/AIDS prevention. It consists of 5-point Likert scale (strongly agree, agree, undecided, disagree and strongly disagree). The scale given to the answers which is positive or agreeable is in the order of 5, 4, 3, 2, and 1. The scale given to the negative answers is in the reverse order. The possible range of the total score is 8 to 40, where higher score indicates higher positive attitude related to HIV prevention.
Change in practice score related to HIV prevention
Practice score will be assessed by six questions. All practice items are measured by "Yes", "No" and "I do not know" response. For questions such as (i) Do you watch any form of pornography?, (ii) Do you smoke?, (iii) Have you ever drink alcohol?, (iv) Have you ever tried any narcotic drugs?, and (v) Have you ever had sexual intercourse?, the "Yes" and "I do not know" responses will be scored as 0 point and "No" response will be scored as 1. On the other hand, the question of (vi) Have you ever talked about AIDS or HIV infection with your parents or other adults in your family?, "Yes" response will score 1 point, whereas, "No" and "I do not know" response will score 0. The possible range of total score of this practice measure is between 0 to 6, where higher score is indicative for more good practices related to HIV prevention.
Secondary Outcome Measures
Full Information
NCT ID
NCT05623800
First Posted
November 3, 2022
Last Updated
May 9, 2023
Sponsor
Universiti Teknologi Mara
1. Study Identification
Unique Protocol Identification Number
NCT05623800
Brief Title
HIV Education Kit for Adolescents (Pencegahan HIV di Kalangan Remaja), PREM-Kit
Acronym
PREM-Kit
Official Title
HIV Education Kit for Adolescents (Pencegahan HIV di Kalangan Remaja), PREM-Kit
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 31, 2023 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Teknologi Mara
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this community trial is to provide HIV education based on the newly developed HIV education kit (PREM-Kit) and evaluate the knowledge, attitude and practices related to HIV prevention among the late adolescents (aged 18 to 19 years old) in Malaysia. The main question it aims to answer is does the PREM-Kit improve the knowledge, attitude and practices related to HIV prevention among the adolescent?
Participants will be asked to:
answer a questionnaire as a baseline screening to determine their knowledge, attitude and practices related to HIV prevention.
Using PREM-Kit, they will participate in a series of health education sessions. There will be three sessions in total which will be delivered two weekly apart. Each of the sessions will take approximately 20 minutes duration.
Following the last session (third session), participants will have to complete the same questionnaire twice; once immediately after the last session and once 12 weeks later.
Researchers will compare participants who received the existing Basic Science and Biology module to see if there is any improvement in the knowledge, attitude and practices related to HIV prevention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus
Keywords
Human Immunodeficiency Virus, Adolescents, Information-Motivation-Behavioral Skills Model
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
184 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PREM-Kit group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
PREM-Kit
Intervention Description
The PREM-Kit, which was created based on the Information-Motivation-Behavioral Skills model, is used in a series of HIV education sessions as part of the intervention. Over the course of three sessions, there will be a total of six weeks (one session for every two weeks). Three sub-modules, namely HIV facts and information, motivation for HIV preventive behavior, and behavioral skills for HIV prevention, will be emphasized in each session to the participants via flip chart and health educational videos. Additionally, participants will receive a QR code that gives them access to the PREM-Kit's e-flip chart, which they can see at a later time.
Primary Outcome Measure Information:
Title
Change in knowledge score related to HIV prevention
Description
Knowledge score will be determined by using 15 questions related to HIV/AIDS transmission and prevention. The participants will be asked to respond on the individual statement using "Yes" or "No" or "I do not know" response. Each correct answer will be credited with 1 point, whereas wrong answers and ''I don't know'' answers will be assigned 0 points. The sum calculated to determine a total score for this scale. The possible range of total score is 0 to 15, where higher score indicates higher level of knowledge.
Time Frame
Time point 1: Measurement of knowledge score at baseline (before intervention). Time point 2: Measurement of knowledge score at week 6 (immediately post-intervention). Time point 3: Measurement of knowledge score at week 18 (12 weeks post-intervention).
Title
Change in attitude score related to HIV prevention
Description
To assess the attitude score, eight items are used to assess the participants' attitude toward HIV/AIDS prevention. It consists of 5-point Likert scale (strongly agree, agree, undecided, disagree and strongly disagree). The scale given to the answers which is positive or agreeable is in the order of 5, 4, 3, 2, and 1. The scale given to the negative answers is in the reverse order. The possible range of the total score is 8 to 40, where higher score indicates higher positive attitude related to HIV prevention.
Time Frame
Time point 1: Measurement of attitude score at baseline (before intervention). Time point 2: Measurement of attitude score at week 6 (immediately post-intervention). Time point 3: Measurement of attitude score at week 18 (12 weeks post-intervention).
Title
Change in practice score related to HIV prevention
Description
Practice score will be assessed by six questions. All practice items are measured by "Yes", "No" and "I do not know" response. For questions such as (i) Do you watch any form of pornography?, (ii) Do you smoke?, (iii) Have you ever drink alcohol?, (iv) Have you ever tried any narcotic drugs?, and (v) Have you ever had sexual intercourse?, the "Yes" and "I do not know" responses will be scored as 0 point and "No" response will be scored as 1. On the other hand, the question of (vi) Have you ever talked about AIDS or HIV infection with your parents or other adults in your family?, "Yes" response will score 1 point, whereas, "No" and "I do not know" response will score 0. The possible range of total score of this practice measure is between 0 to 6, where higher score is indicative for more good practices related to HIV prevention.
Time Frame
Time point 1: Measurement of practice score at baseline (before intervention). Time point 2: Measurement of practice score at week 6 (immediately post-intervention). Time point 3: Measurement of practice score at week 18 (12 weeks post-intervention).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
late adolescents aged 18 - 19 years
student who attends Health Science Diploma course in the year 2023
Malaysian citizen
Exclusion Criteria:
student who refused to participate in the study
student who is absent on the first session of the intervention
student who does not understand the Malay language
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wan Nur Syamimi N Wan Mohamad Darani
Phone
+60126370747
Email
wnsyamimi3007@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wan Nur Syamimi N Wan Mohamad Darani
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universiti Teknologi MARA (UiTM Campus Tapah)
City
Tapah
State/Province
Perak
ZIP/Postal Code
35400
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wan Nur Syamimi N Wan Mohamad Darani
Phone
+60126370747
Email
wnsyamimi3007@gmail.com
First Name & Middle Initial & Last Name & Degree
Wan Nur Syamimi N Wan Mohamad Darani
Facility Name
Universiti Teknologi MARA (Bertam Campus)
City
Kepala Batas
State/Province
Pulau Pinang
ZIP/Postal Code
13200
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wan Nur Syamimi N Wan Mohamad Darani
Phone
+60126370747
Email
wnsyamimi3007@gmail.com
First Name & Middle Initial & Last Name & Degree
Wan Nur Syamimi N Wan Mohamad Darani
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
HIV Education Kit for Adolescents (Pencegahan HIV di Kalangan Remaja), PREM-Kit
We'll reach out to this number within 24 hrs