NCT07039682

Brief 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. 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:

  • 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

June 18, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 26, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

July 31, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

June 26, 2025

Status Verified

June 1, 2025

Enrollment Period

5 months

First QC Date

June 18, 2025

Last Update Submit

June 18, 2025

Conditions

Keywords

hiv preventionadolescent healthhealth educationdigital intervention

Outcome Measures

Primary Outcomes (1)

  • 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.

    Within 3 months after initial platform engagement

Secondary Outcomes (1)

  • Change in HIV Knowledge and Self Awareness Among Adolescents

    From baseline to 4 weeks after initial platform use.

Study Arms (2)

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.

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.

Interventions

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.

Digital HIV Education and Self-Screening (EKSTRIM Model)

Eligibility Criteria

Age15 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitas Sebelas Maret

Surakarta, Central Java, 57126, Indonesia

Location

Related Publications (10)

  • 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.

    PMID: 37593515BACKGROUND
  • Felsen 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.

    PMID: 33673778BACKGROUND
  • Xiong 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.

    PMID: 36725977BACKGROUND
  • Jenkins 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.

    PMID: 35302946BACKGROUND
  • Cheng 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.

    PMID: 37208668BACKGROUND
  • Ibrahim 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.

    PMID: 35340904BACKGROUND
  • Ninsiima 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.

    PMID: 37013535BACKGROUND
  • Putri 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.

    PMID: 38254186BACKGROUND
  • Johnston 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.

    PMID: 34143341BACKGROUND
  • Yoon 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.

    PMID: 35072816BACKGROUND

Related Links

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeHealth Education

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 DiseasesAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Rizka Ayu Setyani, Doctoral/PhD

    Universitas Sebelas Maret

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rizka Ayu Setyani, Doctoral/PhD

CONTACT

Fika Lilik Indrawati, Master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
This study uses a double-blind design in which both participants and investigators are unaware of group allocation (intervention or control). The outcomes assessor is also blinded to minimize assessment bias. Only the data analyst, independent from the implementation team, will have access to the allocation code after data collection is complete.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Universitas Sebelas Maret

Study Record Dates

First Submitted

June 18, 2025

First Posted

June 26, 2025

Study Start

July 31, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

June 26, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

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.

Available IPD Datasets

Study Protocol (EKSTRIM study protocol)Access
Informed Consent Form (EKSTRIM_ICF)Access

Locations