Clinical trial NCT05781165: Application of Augmented Reality (AR) in HIV Self-test in Men Who Have Sex With Men Community
Official title: Application of Augmented Reality (AR) in HIV Self-test in Men Who Have Sex With Men Community
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hiv
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-03-23
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Confidence in performing the self-test
timeFrame: Month 3
Secondary outcomes:
measure: Usability of the augmented reality web app
timeFrame: Month 3
measure: Usability of the augmented reality web app
timeFrame: Month 3
measure: Usability of the augmented reality web app
timeFrame: Month 3
measure: Usability of the augmented reality web app
timeFrame: Month 3
Other outcomes:
Locations:
Study officials:
affiliation: Jockey Club School of Public Health and Primary Care
name: Tsz Ho Kwan, PhD
role: PRINCIPAL_INVESTIGATOR
References: