Home » Trials » SLCTR/2024/039
Effectiveness of an Mhealth KaPi programe to increase physical and psychological capability of HIV voluntary counseling and testing among deaf community; Study protocol for quasi experimental study
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SLCTR Registration Number
SLCTR/2024/039
Date of Registration
The date of last modification
Nov 27, 2024
Scientific Title of Trial
Effectiveness of an Mhealth KaPi programe to increase physical and psychological capability of HIV voluntary counseling and testing among deaf community; Study protocol for quasi experimental study
Public Title of Trial
Effectiveness of an Mhealth KaPi programe to increase physical and psychological capability of HIV voluntary counseling and testing among deaf community: A quasi experimental study
Disease or Health Condition(s) Studied
HIV
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1309-2657
Any other number(s) assigned to the trial and issuing authority
No.036/KEPK.02.01/V/2023
What is the research question being addressed?
Is the Mhealth KaPi programe (an android mobile application) effective in increasing physical and psychological capability of HIV voluntary counseling and testing among deaf community compared to the standard e-book?
Type of study
Interventional
Study design
Allocation
Non-randomized controlled trial
Masking
Single blinded : Participants
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Health services research
Study Phase
Phase 2-3
Intervention(s) planned
Study setting This research will be carried out in GERKAKIN, Yogyakarta Special Region, Indonesia,
Randomization Participants will be divided into two groups: the control group and the intervention group. Each group will be assigned participant with a ratio of 1:1 with block randomization. The interventions that will be provided are in the form of education related to knowledge, attitude, and practice of voluntary HIV and counseling testing, coping self-efficacy, and psychological distress through mobile applications.
The intervention group will be administered an android mobile app with education videos on mental health information, HIV information upto the conseling process. The app will be administered once a week for one month.
The control group will receive the standard e book/leaflet once a week for one month.
Inclusion criteria
The study consisted of deaf Indonesian nationals 1. Age 18 to 65 years. 2. All gender (Male,Female, and other) 3. Sexually active 4. Has access to a smart phone.
Exclusion criteria
This study will exclude those who are deaf and 1. pregnant, 2. already diagnosed with HIV/AIDS, 3. illiterate 4. can’t speak Indonesian sign language.
Primary outcome(s)
|
1.
Increase in physical and psychological capability of HIV voluntary counseling and testing using the following tools Use questionarie : 1. Kessler Psychological Distress Scale (K10) 2. Coping self-efficacy questionnaire 3. Knowledge, attitude, and practice HIV voluntary and counselling testing questionnaire (K-A-PVCT) |
[ 4 weeks post intervention and 12 weeks post intervention ] |
Secondary outcome(s)
Target number/sample size
80 (40 in a group)
Countries of recruitment
Indonesia
Anticipated start date
2024-11-25
Anticipated end date
2024-09-15
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
none
Regulatory approvals
Status
Approved
Date of Approval
2023-05-11
Approval number
No.036/KEPK.02.01/V/2023
Details of Ethics Review Committee
| Name: | Dwi Nugroho Heri Saputro, S.Kep., Ns., M.Kep., Sp.Kep.MB., P.hD.NS |
| Institutional Address: | HEALTH RESEARCH ETHICS COMMITTEE STIKES BETHESDA YAKKUM |
| Telephone: | (0274) 517065 |
| Email: | kepk@stikesbethesda.ac.id |
Contact person for Scientific Queries/Principal Investigator
Yafi Sabila Rosyad
Assistant Professor
Jln Nitikan no 69 Yogyakarta Indonesia
082388417765
rosyad2yafi@gmail.com
Contact Person for Public Queries
Musher Aljabari
Associate Professor
Lincoln University Collage Malaysia
+60111551656
Musheer.jaberi@lincoln.edu.my
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
Yes
IPD sharing plan description
All individual participant data collected during the trial will be shared. after de-identification. Study protocol and results of study at open acces journal will also be available. Data will be available immediately following publication, no end date. Data will be shared with anyone who wishes to access the data, for any purpose. Data will be available indefinitely at journal article and google drive link at https://drive.google.com/drive/folders/16Wb93lsqeNrIPvaVCbt fW9yT83DXpj5R?usp=sharing
Study protocol available
Yes
Protocol version and date
Publication in January 2025
Protocol URL
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
