Application of Augmented Reality (AR) in HIV Self-test in Men Who Have Sex With Men Community

Study Overview
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Brief Summary
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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
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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.

Official Title
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Application of Augmented Reality (AR) in HIV Self-test in Men Who Have Sex With Men Community

Conditions
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Hiv

Intervention / Treatment
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* Other: Augmented reality


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult men who have sex with men Has access to a smartphone with internet access Exclusion Criteria: Unable to communicate in written Chinese or English Unable to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* Step-by-step 3D models displayed with augmented reality guiding the self-test procedures<br>|
| No Intervention: Control<br>Participants in the control arm will be asked to follow the instruction sheet to perform the HIV self-test | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability of the augmented reality web app | Score measured by system usability scale ranged from 0 to 100 (higher scores mean more usable) | Month 3 | 
| Usability of the augmented reality web app | Score measured by single ease question ranged from 1 to 7 (higher scores mean easier) | 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) | 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) | Month 3 |