HivNCT05781165
Application of Augmented Reality (AR) in HIV Self-test in Men Who Have Sex With Men Community
A study testing Augmented reality in people with Hiv, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hiv
- What is being tested?
- Augmented reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 349 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Apr 2023to 29 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult men who have sex with men
- Has access to a smartphone with internet access
Who cannot join
- Unable to communicate in written Chinese or English
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
About 200 MSM would be recruited through community-based organisations and Internet channels where MSM socialise and seek partners. Fifty and 150 participants would be randomly assigned into the control and intervention group by block randomisation with a block size of 4, respectively. After giving informed consent, subjects would be invited to complete an online questionnaire and request for an HIV self-test kit in the online portal before randomisation. Participants in the control group would be given a standard commercially available self-test kit which included bilingual instruction sheets. Subjects in the intervention arm would be asked to use the AR element to assist the same standard commercially available self-test kit. All participants would be asked to upload the test result and complete a post-test questionnaire on the usability of the test and the AR approach. The result would be validated by an experienced research staff. Subjects with a positive result would be contacted for follow up. Main outcome measures in this study would include the confidence in performing the self-test and the usability of HIV self-testing between the two arms.
- Conditions
- Hiv
- Being tested
- Augmented reality
- 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.
Augmented realityOther
Step-by-step 3D models displayed with augmented reality guiding the self-test procedures
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confidence in performing the self-test
Confidence in performing the self-test in a Likert scale of 1 (least confident) to 10 (most confident)
Measured: Month 3
Secondary outcomes (4)
Usability of the augmented reality web app
Score measured by system usability scale ranged from 0 to 100 (higher scores mean more usable)
Measured: Month 3
Usability of the augmented reality web app
Score measured by single ease question ranged from 1 to 7 (higher scores mean easier)
Measured: Month 3
Usability of the augmented reality web app
Score measured by after scenario questionnaire (average score of the 3-item questionnaire ranged from 1 to 7, higher scores mean more usable)
Measured: Month 3
Usability of the augmented reality web app
Score measured by subjective mental effort questionnaire ranged from 0 to 150 (higher scores mean more difficult)
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start1 Apr 2023
- Primary completion29 Aug 2023
- Study completion29 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 349 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tsz Ho Kwan, Chinese University of Hong Kong
- Investigators
- Tsz Ho Kwan, PhD, Principal investigator, Jockey Club School of Public Health and Primary Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781165
- Sponsor's protocol ID
- MSS346R
- Status last verified
- Mar 2026
- First submitted
- 1 Mar 2023
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Augmented Reality (AR) in HIV Self-test in Men Who Have Sex With Men Community
- ClinicalTrials.gov ID
- NCT05781165
- Acronym / sponsor ID
- MSS346R
- Conditions
- Hiv
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 349 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 29 Aug 2023 (actual)
- Study completion
- 29 Aug 2023 (actual)
- First posted
- 23 Mar 2023 (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.
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.
Detailed description
About 200 MSM would be recruited through community-based organisations and Internet channels where MSM socialise and seek partners. Fifty and 150 participants would be randomly assigned into the control and intervention group by block randomisation with a block size of 4, respectively. After giving informed consent, subjects would be invited to complete an online questionnaire and request for an HIV self-test kit in the online portal before randomisation. Participants in the control group would be given a standard commercially available self-test kit which included bilingual instruction sheets. Subjects in the intervention arm would be asked to use the AR element to assist the same standard commercially available self-test kit. All participants would be asked to upload the test result and complete a post-test questionnaire on the usability of the test and the AR approach. The result would be validated by an experienced research staff. Subjects with a positive result would be contacted for follow up. Main outcome measures in this study would include the confidence in performing the self-test and the usability of HIV self-testing between the two arms.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Augmented realityParticipants in the intervention arm will be able to access the augmented reality page in the web app to perform the HIV self-test |
| Control | No intervention | –Participants in the control arm will be asked to follow the instruction sheet to perform the HIV self-test |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult men who have sex with men
- Has access to a smartphone with internet access
Key exclusion criteria (2 listed)
- Unable to communicate in written Chinese or English
- Unable to give informed consent
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 |
|---|---|---|
| Augmented realityStep-by-step 3D models displayed with augmented reality guiding the self-test procedures | Other | Intervention |
Primary outcome
Confidence in performing the self-test
Time frame: Month 3
Confidence in performing the self-test in a Likert scale of 1 (least confident) to 10 (most confident)
4 secondary outcomes
Usability of the augmented reality web app
Time frame: Month 3
Usability of the augmented reality web app
Time frame: Month 3
Usability of the augmented reality web app
Time frame: Month 3
Usability of the augmented reality web app
Time frame: Month 3
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 19 Mar 2026.
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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.
Tsz Ho Kwan, PhD principal investigator
Jockey Club School of Public Health and Primary Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented reality in people with Hiv, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 2 inclusion and 2 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 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. 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?
Confidence in performing the self-test (time frame: Month 3). 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 19 Mar 2026.