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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hiv
• Intervention / Treatment: Other: Augmented reality

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Secretariat; Phone Number: +85222528812; Email: ceid@med.cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Tsz Ho Kwan, PhD, Jockey Club School of Public Health and Primary Care

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: March 1, 2023
• First Submitted That Met QC Criteria: March 11, 2023
• First Posted (Actual): March 23, 2023

Study Record Updates

• Last Update Posted (Actual): March 30, 2023
• Last Update Submitted That Met QC Criteria: March 24, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: MSS346R

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No