NCT05623800

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
189

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 21, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

March 31, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2023

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

4 months

First QC Date

November 3, 2022

Last Update Submit

February 2, 2024

Conditions

Keywords

Human Immunodeficiency VirusAdolescentsInformation-Motivation-Behavioral Skills Model

Outcome Measures

Primary Outcomes (3)

  • 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.

Study Arms (2)

PREM-Kit group

EXPERIMENTAL
Other: PREM-Kit

Control group

NO INTERVENTION

Interventions

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.

PREM-Kit group

Eligibility Criteria

Age18 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • late adolescents aged 18 - 19 years
  • student who attends Health Science Diploma course in the year 2023
  • Malaysian citizen

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universiti Teknologi MARA (UiTM Campus Tapah)

Tapah, Perak, 35400, Malaysia

Location

Universiti Teknologi MARA (Bertam Campus)

Kepala Batas, Pulau Pinang, 13200, Malaysia

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Wan Nur Syamimi N Wan Mohamad Darani

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 3, 2022

First Posted

November 21, 2022

Study Start

March 31, 2023

Primary Completion

August 3, 2023

Study Completion

August 3, 2023

Last Updated

February 6, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations