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

Sponsor

Chinese University of Hong Kong (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05781165

Collaborator

(none)

200

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hiv	Other: Augmented reality	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Usability of the augmented reality web app [Month 3]
Score measured by system usability scale ranged from 0 to 100 (higher scores mean more usable)
Usability of the augmented reality web app [Month 3]
Score measured by single ease question ranged from 1 to 7 (higher scores mean easier)
Usability of the augmented reality web app [Month 3]
Score measured by after scenario questionnaire (average score of the 3-item questionnaire ranged from 1 to 7, higher scores mean more usable)
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Chinese University of Hong Kong

Investigators

Principal Investigator: Tsz Ho Kwan, PhD, Jockey Club School of Public Health and Primary Care

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tsz Ho Kwan, Research Assistant Professor, Chinese University of Hong Kong

ClinicalTrials.gov Identifier:

NCT05781165

Other Study ID Numbers:

MSS346R

First Posted:

Mar 23, 2023

Last Update Posted:

Mar 30, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 30, 2023