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HIV InfectionsNCT04379206

Social Network Approach for Increasing Testing Coverage Among Men Who Have Sex With Men

An observational study of HIV Infections, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

HIV testing is essential in shortening the time to identify a new infection, the first 90 of the UNAIDS 90-90-90 targets. However, over one-third of the men who have sex with men (MSM) had never been tested for HIV; even if they did, one-fifth had their tests done more than a year ago. Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
HIV self-test kit and Graphical User Interface
Type of treatment
Pill or oral medicine
How many people
463 participants
Where
1 siteHong Kong
Study dates
1 Mar 2021to 12 May 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Adult men who have sex with men in Hong Kong

Who may be able to join

  • male
  • had sex with another male in the preceding year
  • able to communicate in written Chinese or English
  • normally resided in Hong Kong

Who cannot join

  • prisoners
  • having mental illnesses that informed consent cannot be obtained

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • Stanley Ho Centre for Emerging Infectious Diseases

    Shatin

Other trials in Hong Kong

About this study

HIV testing is essential in shortening the time to identify a new infection, the first 90 of the UNAIDS 90-90-90 targets. However, over one-third of the men who have sex with men (MSM) had never been tested for HIV; even if they did, one-fifth had their tests done more than a year ago. Assortative mixing pattern observed in the HIV-positive MSM group shaped the transmission dynamics and could be leveraged for intervention. Barriers to access HIV testing services could, on the other hand, be hurdled by self-tests. A network approach for intervention could therefore be promising in delivering effective HIV self-tests. To experiment with such an approach, a 2-phase study was conceptualised incorporating actual network-based referred HIV self-tests and an agent-based simulation evaluating its impact. Sixty-four MSM would be recruited as seeds for promoting HIV self-tests within their network and those being referred could refer their friends for the same after passing online training. To facilitate the process, an online platform would be developed offering information, collecting informed consent, requesting HIV self-test kits, returning results, performing online training, and referring peers. Participants could opt to receive self-tests by delivery or to conduct it on-site with staff assistance. A hotline with video conferencing support would be maintained to assist those who self-test at home. They could also choose between blood and oral fluid tests. Two user interfaces, namely gamification and neumorphism, would be randomly assigned. Primary outcomes to measure are number and proportion of MSM who had never or not tested within 12 months and the associating factors, and usability of the two user interfaces. Data collected in the empirical study would be used for parameterising the agent-based simulation to evaluate the impact of the approach in increasing testing coverage and shortening time to diagnosis. Its economic assessment would also be performed to cost each new infection to be identified. The approach could be feasible and effective to be adopted for future broader implementation for peer-led HIV self-test kit or HIV prevention message distribution.

Conditions
HIV Infections
Being tested
HIV self-test kit, Graphical User Interface
Keywords
men who have sex with men, self-testing, social network, agent-based model, HIV, Gamification, Neumorphism
Medical subject headings
HIV Infections, Homosexuality

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HIV self-test kitDiagnostic test

    fingerprick and oral fluid HIV self-tests with optional on-site or hotline staff assistance

  • Graphical User InterfaceOther

    Gamification or neumorphism user interface

Study groups in NCT04379206
Study groupRoleWhat they receive
Men who have sex with menMSM receiving a self-test kit with optional assistance
Receives: Diagnostic Test: HIV self-test kit; Other: Graphical User Interface

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. effectiveness of the approach in reaching MSM who have never or not recently tested for HIV

    proportion of testers who have never or not recently tested for HIV

    Measured: Through study completion, at year 2

  2. Usability and acceptability of two user interfaces

    System Usability Scores (SUS) and proportion of testers giving a score of at least 71

    Measured: Through study completion, at year 2

Secondary outcomes (4)

  1. Determinants of key actors in the social network

    Network metrics predicting important actors in the referral network

    Measured: Through study completion, at year 2

  2. Preference of two forms of HIV self-testing

    Proportion of testers favouring each form of self-testing

    Measured: Through study completion, at year 2

  3. Effect of network-based HIV self-test promotion in controlling transmission among MSM

    Number of infections identified from the agent-based model

    Measured: Through study completion, at year 2

  4. Proportion and characteristics of promoters

    Promoters are testers giving an SUS score of at least 80

    Measured: Through study completion, at year 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2020
  2. Study start1 Mar 2021
  3. Primary completion12 May 2021
  4. Study completion12 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
463 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04379206
Sponsor's protocol ID
MSS324R
Other IDs
MSS324R
Status last verified
Dec 2021
First submitted
2 May 2020
Last updated
11 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kwan TH, Lee SS. Predictors of HIV Testing and Their Influence on PrEP Acceptance in Men Who Have Sex with Men: A Cross-Sectional Study. AIDS Behav. 2018 Apr;22(4):1150-1157. doi: 10.1007/s10461-017-1978-0.

    PubMed 29127535

  • Valente TW. Network interventions. Science. 2012 Jul 6;337(6090):49-53. doi: 10.1126/science.1217330.

    PubMed 22767921

  • Kwan TH, Lee SS. Bridging Awareness and Acceptance of Pre-Exposure Prophylaxis Among Men Who Have Sex With Men and the Need for Targeting Chemsex and HIV Testing: Cross-Sectional Survey. JMIR Public Health Surveill. 2019 Jul 3;5(3):e13083. doi: 10.2196/13083.

    PubMed 31271148

  • Cao B, Saffer AJ, Yang C, Chen H, Peng K, Pan SW, Durvasula M, Liu C, Fu H, Ong JJ, Tang W, Tucker JD. MSM Behavior Disclosure Networks and HIV Testing: An Egocentric Network Analysis Among MSM in China. AIDS Behav. 2019 May;23(5):1368-1374. doi: 10.1007/s10461-019-02404-z.

    PubMed 30680538

  • Song Y, Li X, Zhang L, Fang X, Lin X, Liu Y, Stanton B. HIV-testing behavior among young migrant men who have sex with men (MSM) in Beijing, China. AIDS Care. 2011 Feb;23(2):179-86. doi: 10.1080/09540121.2010.487088.

    PubMed 21259130

  • Philbin MM, Hirsch JS, Wilson PA, Ly AT, Giang LM, Parker RG. Structural barriers to HIV prevention among men who have sex with men (MSM) in Vietnam: Diversity, stigma, and healthcare access. PLoS One. 2018 Apr 3;13(4):e0195000. doi: 10.1371/journal.pone.0195000. eCollection 2018.

    PubMed 29614104

  • Kwan TH, Chan DPC, Wong SY, Lee SS. Implementation Cascade of a Social Network-Based HIV Self-testing Approach for Men Who Have Sex With Men: Cross-sectional Study. J Med Internet Res. 2023 Apr 26;25:e46514. doi: 10.2196/46514.

    PubMed 37099364

  • Kwan TH, Chan DPC, Lee SS. User Experience and Usability of Neumorphism and Gamification User Interface Designs in an HIV Self-Test Referral Program for Men Who Have Sex With Men: Prospective Open-Label Parallel-Group Randomized Controlled Trial. JMIR Serious Games. 2022 Jun 22;10(2):e35869. doi: 10.2196/35869.

    PubMed 35731564

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infections, run by Chinese University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

effectiveness of the approach in reaching MSM who have never or not recently tested for HIV (time frame: Through study completion, at year 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04379206, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.

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