Human Immunodeficiency VirusPREM-KitNCT05623800
HIV Education Kit for Adolescents (Pencegahan HIV di Kalangan Remaja), PREM-Kit
A study testing PREM-Kit in people with Human Immunodeficiency Virus, run by Universiti Teknologi Mara at 2 sites in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- PREM-Kit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 2 sitesMalaysia
- Study dates
- 31 Mar 2023to 3 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 19 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- late adolescents aged 18 - 19 years
- student who attends Health Science Diploma course in the year 2023
- Malaysian citizen
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Malaysia2 sites
Universiti Teknologi MARA (Bertam Campus)
Kepala Batas, Pulau Pinang, 13200
Universiti Teknologi MARA (UiTM Campus Tapah)
Tapah, Perak, 35400
About this study
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:
Read more
- 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.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- PREM-Kit
- Keywords
- Human Immunodeficiency Virus, Adolescents, Information-Motivation-Behavioral Skills Model
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PREM-KitOther
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.
| Study group | Role | What they receive |
|---|---|---|
| PREM-Kit group | Experimental | Not described Receives: Other: PREM-Kit |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start31 Mar 2023
- Primary completion3 Aug 2023
- Study completion3 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Teknologi Mara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wan Nur Syamimi Binti Wan Mohamad Darani, Universiti Teknologi Mara
- Investigators
- Wan Nur Syamimi N Wan Mohamad Darani, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05623800
- Sponsor's protocol ID
- REC/05/2022 (ST/MR/85)
- Acronym
- PREM-Kit
- Status last verified
- Feb 2024
- First submitted
- 3 Nov 2022
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV Education Kit for Adolescents (Pencegahan HIV di Kalangan Remaja), PREM-Kit
- ClinicalTrials.gov ID
- NCT05623800
- Acronym / sponsor ID
- PREM-Kit / REC/05/2022 (ST/MR/85)
- Conditions
- Human Immunodeficiency Virus
- Keywords
- Human Immunodeficiency Virus, Adolescents, Information-Motivation-Behavioral Skills Model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Universiti Teknologi MaraUniversity, hospital or other
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 3 Aug 2023 (actual)
- Study completion
- 3 Aug 2023 (actual)
- First posted
- 21 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PREM-Kit group | Experimental | Other: PREM-Kit |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- late adolescents aged 18 - 19 years
- student who attends Health Science Diploma course in the year 2023
- Malaysian citizen
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PREM-KitThe 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. | Other | PREM-Kit group |
Primary outcome
Change in knowledge score related to HIV prevention
Time frame: 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.
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
Time frame: 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.
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
Time frame: 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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wan Nur Syamimi N Wan Mohamad Darani principal investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PREM-Kit in people with Human Immunodeficiency Virus, run by Universiti Teknologi Mara at 2 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in knowledge score related to HIV prevention (time frame: 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.