HIV Education Kit for Adolescents (Pencegahan HIV di Kalangan Remaja), PREM-Kit (PREM-Kit)

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 answer the same questionnaire ; once immediately after the last session, once at 3-months post-intervention, and lastly, at 4-months post-intervention.

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.

Study Overview

• Status: Completed
• Conditions: Human Immunodeficiency Virus
• Intervention / Treatment: Other: PREM-Kit

• Study Type: Interventional
• Enrollment (Actual): 189
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wan Nur Syamimi N Wan Mohamad Darani; Phone Number: +60126370747; Email: wnsyamimi3007@gmail.com

Study Locations

• Malaysia
  • Perak
    • Tapah, Perak, Malaysia, 35400
      • Universiti Teknologi MARA (UiTM Campus Tapah)
  • Pulau Pinang
    • Kepala Batas, Pulau Pinang, Malaysia, 13200
      • Universiti Teknologi MARA (Bertam Campus)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 19 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: PREM-Kit group	Other: PREM-Kit; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	t1:Measurement of knowledge score before intervention. t2:Measurement of knowledge score immediately post-intervention. t3:Measurement of knowledge score at 3-months post-intervention. t4:Measurement of knowledge score at 4-months post-intervention.
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.	t1:Measurement of attitude score before intervention. t2:Measurement of attitude score immediately post-intervention. t3:Measurement of attitude score at 3-months post-intervention. t4:Measurement of attitude score at 4-months post-intervention.
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.	t1:Measurement of practice score before intervention. t2:Measurement of practice score immediately post-intervention. t3:Measurement of practice score at 3-months post-intervention. t4:Measurement of practice score at 4-months post-intervention.

Collaborators and Investigators

• Sponsor: Universiti Teknologi Mara
• Investigators: Principal Investigator: Wan Nur Syamimi N Wan Mohamad Darani

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2023
• Primary Completion (Actual): August 3, 2023
• Study Completion (Actual): August 3, 2023

Study Registration Dates

• First Submitted: November 3, 2022
• First Submitted That Met QC Criteria: November 13, 2022
• First Posted (Actual): November 21, 2022

Study Record Updates

• Last Update Posted (Actual): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Adolescents; Human Immunodeficiency Virus; Information-Motivation-Behavioral Skills Model
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immune System Diseases; Slow Virus Diseases; Urogenital Diseases; Genital Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes
• Other Study ID Numbers: REC/05/2022 (ST/MR/85)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No