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

NCT ID: NCT05781165

Last Updated: 2023-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-31

Study Completion Date

2023-08-31

Brief Summary

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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

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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.

Conditions

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Hiv

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Augmented reality

Intervention Type OTHER

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

Control

Participants in the control arm will be asked to follow the instruction sheet to perform the HIV self-test

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Augmented reality

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Tsz Ho Kwan

Research Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tsz Ho Kwan, PhD

Role: PRINCIPAL_INVESTIGATOR

Jockey Club School of Public Health and Primary Care

Central Contacts

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Secretariat

Role: CONTACT

+85222528812

Other Identifiers

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MSS346R

Identifier Type: -

Identifier Source: org_study_id

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