Human Immunodeficiency Virus (HIV) InfectionEKSTRIMNCT07039682
Empowering Knowledge, Self-Testing & Resilience Through Innovative Methods for HIV
A study testing Digital HIV Education and Self-Screening (EKSTRIM Model) in people with Human Immunodeficiency Virus (HIV) Infection and HIV Prevention, run by Universitas Sebelas Maret at 1 site in Indonesia.
Trial summary
The goal of this study is to learn whether a digital tool can help improve HIV knowledge, self-awareness, and testing among adolescents in Yogyakarta, Indonesia. The tool includes online HIV education, a self-assessment for HIV risk, and access to trained peer educators for support. Read more about this study
- Who is it for?
- Ages 15 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus (HIV) Infection, HIV Prevention, Adolescent Health
- What is being tested?
- Digital HIV Education and Self-Screening (EKSTRIM Model)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteIndonesia
- Study dates
- 31 Jul 2025to 31 Dec 2025
- Phase
- Interventional
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 15 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Adolescents aged 15-17 years
- Reside or attend school in the Yogyakarta area
- Currently enrolled in one of the participating high schools
- Able to read and understand Bahasa Indonesia
- Own or have regular access to a smartphone or digital device with internet connectivity
- Provide informed assent to participate in the study
- Have obtained written parental or guardian consent
Who cannot join
- Adolescents outside the 15-17 age range
- Unable to access digital devices or internet independently
- Previously diagnosed with HIV (as this study targets prevention and self-screening among untested adolescents)
- Unwilling or unable to provide informed assent or whose parents/guardians do not provide consent
- Currently participating in another HIV-related intervention study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site
Universitas Sebelas Maret
Surakarta, Central Java, 57126
Rizka Ayu Setyani, Doctoral/PhD, +6285647026667, setyanirizkaayu@gmail.com
Rizka Ayu Setyani, Doctoral/PhD
About this study
Official title: Developing a Digital-Based Education and Self-Screening Model to Improve Knowledge, Self-Awareness, and HIV Testing Coverage Among Adolescents
The goal of this study is to learn whether a digital tool can help improve HIV knowledge, self-awareness, and testing among adolescents in Yogyakarta, Indonesia. The tool includes online HIV education, a self-assessment for HIV risk, and access to trained peer educators for support. The study will also explore how comfortable and willing adolescents are to use this kind of digital health service.
The main questions the study aims to answer are:
Read more
- Can this digital tool help adolescents better understand HIV and their personal risk?
- Will more adolescents be willing to get tested for HIV after using the tool?
- What factors affect whether adolescents accept and use digital HIV services?
Researchers will compare two groups of high school students:
- One group will use the digital tool for 6 weeks
- The other group will receive standard HIV education (not through the tool)
Participants will:
- Answer surveys before and after the 6-week period
- Learn about HIV through videos and interactive content
- Use the tool to assess their personal HIV risk
- Receive support from trained peer educators (online)
The researchers hope this study will lead to new ways of using technology to improve HIV prevention and testing for young people.
Read the detailed description
This study is designed to develop and evaluate a digital-based model for HIV education and self-screening aimed at increasing HIV-related knowledge, self-awareness of risk, and testing uptake among adolescents in Yogyakarta, Indonesia. Despite widespread access to digital technology, adolescent HIV testing coverage remains low due to stigma, limited knowledge, privacy concerns, and lack of youth-friendly services. The intervention model, named EKSTRIM (Edukasi dan Skrining HIV Mandiri), will be developed using a research and development framework based on the ADDIE model, which includes the stages of Analysis, Design, Development, Implementation, and Evaluation.
The study will proceed in three phases. In Phase I, an explanatory sequential mixed-methods design will be employed to assess the readiness, needs, and perceptions of adolescents and HIV program implementers regarding the use of digital platforms for HIV education and self-screening. Quantitative data will be collected through structured questionnaires, followed by qualitative data from focus group discussions and in-depth interviews. This phase will inform the technical and content requirements for the intervention.
Phase II will involve the design and development of the digital intervention model. The EKSTRIM platform will include interactive web-based modules on HIV prevention, a self-risk screening tool, peer educator support features, and links to adolescent-friendly HIV services. The platform will be evaluated using McCall's Quality Model to ensure functionality, reliability, and user-friendliness.
Phase III will test the effectiveness of the model using a double-blind, parallel-group randomized controlled trial with a pretest-posttest design. A total of 400 adolescents will be recruited using cluster random sampling from high schools in Yogyakarta. Participants will be randomly allocated to either the intervention group, which will access the EKSTRIM platform, or the control group, which will receive standard HIV educational materials. The intervention period will last six weeks.
Primary outcomes will include changes in HIV-related knowledge, self-awareness of HIV risk, and HIV testing uptake. Data analysis will involve general linear models, non-parametric tests (Wilcoxon and Mann-Whitney), difference-in-difference analysis, and multilevel linear modeling to assess the intervention's impact and identify contributing factors. It is anticipated that the digital intervention will lead to significant improvements in the targeted outcomes and that factors such as stigma, digital acceptance, and initial understanding of HIV will influence results.
This study aims to provide scientific evidence on the effectiveness of a digital, adolescent-centered HIV intervention that emphasizes privacy, peer support, and accessibility. The model is expected to be a scalable and sustainable solution for HIV prevention among youth and may inform broader policy and programmatic strategies at the local and national levels. Ethical approval will be obtained prior to study initiation, and all participants will provide informed consent or assent, with parental or guardian consent obtained as required under national regulations.
- Conditions
- Human Immunodeficiency Virus (HIV) Infection, HIV Prevention, Adolescent Health, Digital Education Interventions, Digital Health Intervention, Health Education
- Being tested
- Digital HIV Education and Self-Screening (EKSTRIM Model)
- Keywords
- hiv prevention, adolescent health, health education, digital intervention
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital HIV Education and Self-Screening (EKSTRIM Model)Device
Participants in this arm will receive access to the EKSTRIM platform, a web-based digital tool designed for adolescents. The platform includes interactive educational content on HIV prevention, a self-assessment screening tool to evaluate individual HIV risk, and online peer educator support. The intervention will be implemented over a 6-week period. Participants will be encouraged to use the platform independently, with monitoring of access logs and engagement levels.
| Study group | Role | What they receive |
|---|---|---|
| Digital HIV Education and Self-Screening (EKSTRIM Model) | Experimental | Participants in this arm will receive access to the EKSTRIM platform, a web-based digital tool designed for adolescents. The platform includes interactive educational content on HIV prevention, a self-assessment screening tool to evaluate individual HIV risk, and online peer educator support. The intervention will be implemented over a 6-week period. Participants will be encouraged to use the platform independently, with monitoring of access logs and engagement levels. Receives: Device: Digital HIV Education and Self-Screening (EKSTRIM Model) |
| Standard/Usual HIV Education Program | No intervention | Participants in this arm will receive standard HIV-related education as provided through the school health program. This includes printed materials and classroom-based health education without access to digital tools or peer educator interaction. This group will serve as the comparison to evaluate the added impact of the digital EKSTRIM intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV Testing Uptake Among Adolescents Using a Digital Self-Screening and Education Platform
Proportion of adolescents aged 15-17 who undergo voluntary HIV testing following engagement with the EKSTRIM digital platform, which includes audiovisual education, risk self-assessment, and online counseling. This outcome measures the effectiveness of the intervention in increasing HIV testing behavior compared to baseline where no participants had ever been tested, despite prior exposure to HIV-related information. Data will be collected through platform records and follow-up surveys to confirm testing uptake and linkage to services.
Measured: Within 3 months after initial platform engagement
Secondary outcomes (1)
Change in HIV Knowledge and Self Awareness Among Adolescents
Measured change in HIV-related knowledge and self-perceived risk awareness before and after using the EKSTRIM digital platform. Participants complete standardized pre- and post-intervention questionnaires assessing HIV transmission, prevention, testing, and risk awareness. The outcome evaluates the educational impact of audiovisual content and interactive modules. Scores will be compared using paired statistical analysis to determine knowledge gains and shifts in perceived vulnerability.
Measured: From baseline to 4 weeks after initial platform use.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start31 Jul 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency Virus (HIV) InfectionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Sebelas Maret
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rizka Ayu Setyani, Universitas Sebelas Maret
- Investigators
- Rizka Ayu Setyani, Doctoral/PhD, Principal investigator, Universitas Sebelas Maret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07039682
- Sponsor's protocol ID
- 63/UN27.06.11/KEP/EC/2025
- Other IDs
- 400422-409
- Acronym
- EKSTRIM
- Status last verified
- Jun 2025
- First submitted
- 18 Jun 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to ethical and legal considerations related to adolescent privacy and consent. The study involves minors, and sharing of their sensitive health-related data, even in de-identified form, poses potential confidentiality risks. Data use is restricted by local institutional review board (IRB) protocols and national data protection regulations in Indonesia.
Publications
Tang L, Wang J. Exploring the Relationship between Health Information Literacy and Health Behaviors of the Elderly. Iran J Public Health. 2023 Jul;52(7):1439-1446. doi: 10.18502/ijph.v52i7.13245.
PubMed 37593515Felsen UR, Tlamsa A, Moir L, Shukla S, Thompson D, Weiss JM, Heo M, Litwin AH. Comparing Routine HIV and Hepatitis C Virus Screening to Estimate the Effect of Required Consent on HIV Screening Rates Among Hospitalized Patients. Public Health Rep. 2022 Jan-Feb;137(1):102-109. doi: 10.1177/0033354921999170. Epub 2021 Mar 5.
PubMed 33673778Xiong S, Lu H, Peoples N, Duman EK, Najarro A, Ni Z, Gong E, Yin R, Ostbye T, Palileo-Villanueva LM, Doma R, Kafle S, Tian M, Yan LL. Digital health interventions for non-communicable disease management in primary health care in low-and middle-income countries. NPJ Digit Med. 2023 Feb 1;6(1):12. doi: 10.1038/s41746-023-00764-4.
PubMed 36725977Jenkins CL, Imran S, Mahmood A, Bradbury K, Murray E, Stevenson F, Hamilton FL. Digital Health Intervention Design and Deployment for Engaging Demographic Groups Likely to Be Affected by the Digital Divide: Protocol for a Systematic Scoping Review. JMIR Res Protoc. 2022 Mar 18;11(3):e32538. doi: 10.2196/32538.
PubMed 35302946Cheng AL, Leo AJ, Calfee RP, Dy CJ, Armbrecht MA, Abraham J. Multi-stakeholder perspectives regarding preferred modalities for mental health intervention delivered in the orthopedic clinic: a qualitative analysis. BMC Psychiatry. 2023 May 19;23(1):347. doi: 10.1186/s12888-023-04868-9.
PubMed 37208668Ibrahim MS, Mohamed Yusoff H, Abu Bakar YI, Thwe Aung MM, Abas MI, Ramli RA. Digital health for quality healthcare: A systematic mapping of review studies. Digit Health. 2022 Mar 18;8:20552076221085810. doi: 10.1177/20552076221085810. eCollection 2022 Jan-Dec.
PubMed 35340904Ninsiima M, Nyabigambo A, Kagaayi J. Acceptability of integration of cervical cancer screening into routine HIV care, associated factors and perceptions among HIV-infected women: a mixed methods study at Mbarara Regional Referral Hospital, Uganda. BMC Health Serv Res. 2023 Apr 3;23(1):333. doi: 10.1186/s12913-023-09326-6.
PubMed 37013535Putri WCWS, Ulandari LPS, Valerie IC, Prabowo BR, Hardiawan D, Sihaloho ED, Relaksana R, Wardhani BDK, Harjana NPA, Nugrahani NW, Siregar AYM, Januraga PP. Costs and scale-up costs of community-based Oral HIV Self-Testing for female sex workers and men who have sex with men in Jakarta and Bali, Indonesia. BMC Health Serv Res. 2024 Jan 22;24(1):114. doi: 10.1186/s12913-024-10577-0.
PubMed 38254186Johnston LG, Soe P, Widihastuti AS, Camellia A, Putri TA, Rakhmat FF, Nurwandani RA, Prabhu SM, Sulaiman N, Pronyk PM. Alarmingly High HIV Prevalence Among Adolescent and Young Men Who have Sex with Men (MSM) in Urban Indonesia. AIDS Behav. 2021 Nov;25(11):3687-3694. doi: 10.1007/s10461-021-03347-0. Epub 2021 Jun 18.
PubMed 34143341Yoon J, Lee M, Ahn JS, Oh D, Shin SY, Chang YJ, Cho J. Development and Validation of Digital Health Technology Literacy Assessment Questionnaire. J Med Syst. 2022 Jan 24;46(2):13. doi: 10.1007/s10916-022-01800-8.
PubMed 35072816