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

Hiv Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05781165
• Other study ID #: MSS346R
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2023
• Est. completion date: August 2023

Study information

• Verified date: March 2023
• Source: Chinese University of Hong Kong
• Contact: Secretariat
• Phone: +85222528812
• Email: ceid[@]med.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: August 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hiv

Intervention

Other:
• Augmented reality
Step-by-step 3D models displayed with augmented reality guiding the self-test procedures

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Usability of the augmented reality web app	Score measured by single ease question ranged from 1 to 7 (higher scores mean easier)	Month 3
Secondary	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
Secondary	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