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OpenTrials
Completed

NCT Number: NCT05781165

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.

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Stanley Ho Centre for Emerging Infectious Diseases

Shatin, Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Augmented Reality

Other

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

Primary outcomes

  1. Confidence in performing the self-test

    Time frame: Month 3

    Confidence in performing the self-test in a Likert scale of 1 (least confident) to 10 (most confident)

Secondary outcomes

  1. Usability of the augmented reality web app

    Time frame: Month 3

    Score measured by system usability scale ranged from 0 to 100 (higher scores mean more usable)

  2. Usability of the augmented reality web app

    Time frame: Month 3

    Score measured by single ease question ranged from 1 to 7 (higher scores mean easier)

  3. Usability of the augmented reality web app

    Time frame: 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)

  4. Usability of the augmented reality web app

    Time frame: Month 3

    Score measured by subjective mental effort questionnaire ranged from 0 to 150 (higher scores mean more difficult)

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 23, 2023
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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