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

Not Applicable

Not yet recruiting

• Conditions: Hiv
• Interventions: Other: Augmented reality

• Registration Number: NCT05781165
• Lead Sponsor: Chinese University of Hong Kong

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.

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 Timeline

• Status Verified: 2023-03
• Study Start: 2023-03
• Study First Submitted: 2023-03-01
• Study First Submitted QC: 2023-03-11
• Study First Posted: 2023-03-23
• Last Update Submitted: 2023-03-24
• Last Update Posted: 2023-03-30
• Primary Completion: 2023-05
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 200

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Confidence in performing the self-test	Month 3	Confidence in performing the self-test in a Likert scale of 1 (least confident) to 10 (most confident)

Secondary Outcome Measures

Name	Time	Method
Usability of the augmented reality web app	Month 3	Score measured by subjective mental effort questionnaire ranged from 0 to 150 (higher scores mean more difficult)