NCT04379206

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
463

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 7, 2020

Completed
10 months until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2021

Completed
Last Updated

January 11, 2022

Status Verified

December 1, 2021

Enrollment Period

2 months

First QC Date

May 2, 2020

Last Update Submit

December 19, 2021

Conditions

Keywords

men who have sex with menself-testingsocial networkagent-based modelHIVGamificationNeumorphism

Outcome Measures

Primary Outcomes (2)

  • 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

    Through study completion, at year 2

  • Usability and acceptability of two user interfaces

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

    Through study completion, at year 2

Secondary Outcomes (4)

  • Determinants of key actors in the social network

    Through study completion, at year 2

  • Preference of two forms of HIV self-testing

    Through study completion, at year 2

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

    Through study completion, at year 2

  • Proportion and characteristics of promoters

    Through study completion, at year 2

Study Arms (1)

Men who have sex with men

MSM receiving a self-test kit with optional assistance

Diagnostic Test: HIV self-test kitOther: Graphical User Interface

Interventions

HIV self-test kitDIAGNOSTIC_TEST

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

Men who have sex with men

Gamification or neumorphism user interface

Men who have sex with men

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult men who have sex with men in Hong Kong

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanley Ho Centre for Emerging Infectious Diseases

Shatin, Hong Kong

Location

Related Publications (8)

  • 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.

    PMID: 29127535BACKGROUND
  • Valente TW. Network interventions. Science. 2012 Jul 6;337(6090):49-53. doi: 10.1126/science.1217330.

    PMID: 22767921BACKGROUND
  • 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.

    PMID: 31271148BACKGROUND
  • 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.

    PMID: 30680538BACKGROUND
  • 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.

    PMID: 21259130BACKGROUND
  • 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.

    PMID: 29614104BACKGROUND
  • 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.

  • 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.

MeSH Terms

Conditions

HIV InfectionsHomosexuality

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSexualitySexual BehaviorBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral Fellow

Study Record Dates

First Submitted

May 2, 2020

First Posted

May 7, 2020

Study Start

March 1, 2021

Primary Completion

May 12, 2021

Study Completion

May 12, 2021

Last Updated

January 11, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations