NCT05781165

Brief Summary

Objective: To apply augmented reality (AR) technology in HIV self-test and to assess its impacts in enhancing testing performance among men who have sex with men (MSM). Design: Parallel randomised controlled, open label, trial. Block randomisation with a block size of 4 would be used to allocate the study arms. Participants: men who have sex with men in Hong Kong Intervention: Self-test assisted by AR vs self-test with instruction sheets Main outcome measures: Effectiveness, usability, learnability, efficiency and satisfaction scores; rate of completion and result upload; acceptability of AR approach in assisting self-test Anticipated results: 200 MSM would be recruited with 50 and 150 in control and intervention group, respectively. The scores in the intervention group are 10% higher than the control group. Proportion of satisfied participants in the intervention group is 10% more than the control group. AR approach is feasible and acceptable to MSM for assisting in HIV self-test.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
349

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 23, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2023

Completed
Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

March 1, 2023

Last Update Submit

March 17, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Confidence in performing the self-test

    Confidence in performing the self-test in a Likert scale of 1 (least confident) to 10 (most confident)

    Month 3

Secondary Outcomes (4)

  • Usability of the augmented reality web app

    Month 3

  • Usability of the augmented reality web app

    Month 3

  • Usability of the augmented reality web app

    Month 3

  • Usability of the augmented reality web app

    Month 3

Study Arms (2)

Intervention

EXPERIMENTAL

Participants in the intervention arm will be able to access the augmented reality page in the web app to perform the HIV self-test

Other: Augmented reality

Control

NO INTERVENTION

Participants in the control arm will be asked to follow the instruction sheet to perform the HIV self-test

Interventions

Step-by-step 3D models displayed with augmented reality guiding the self-test procedures

Intervention

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult men who have sex with men
  • Has access to a smartphone with internet access

You may not qualify if:

  • Unable to communicate in written Chinese or English
  • Unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanley Ho Centre for Emerging Infectious Diseases

Shatin, Hong Kong

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

  • Tsz Ho Kwan, PhD

    Jockey Club School of Public Health and Primary Care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

March 1, 2023

First Posted

March 23, 2023

Study Start

April 1, 2023

Primary Completion

August 29, 2023

Study Completion

August 29, 2023

Last Updated

March 19, 2026

Record last verified: 2026-03

Locations