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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04379206
Other study ID # MSS324R
Secondary ID MSS324R
Status Completed
Phase
First received
Last updated
Start date March 1, 2021
Est. completion date May 12, 2021

Study information

Verified date December 2021
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 463
Est. completion date May 12, 2021
Est. primary completion date May 12, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - male - had sex with another male in the preceding year - able to communicate in written Chinese or English - normally resided in Hong Kong Exclusion Criteria: - prisoners - having mental illnesses that informed consent cannot be obtained

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
HIV self-test kit
fingerprick and oral fluid HIV self-tests with optional on-site or hotline staff assistance
Other:
Graphical User Interface
Gamification or neumorphism user interface

Locations

Country Name City State
Hong Kong Stanley Ho Centre for Emerging Infectious Diseases Sha Tin

Sponsors (1)

Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Determinants of key actors in the social network Network metrics predicting important actors in the referral network Through study completion, at year 2
Secondary Preference of two forms of HIV self-testing Proportion of testers favouring each form of self-testing Through study completion, at year 2
Secondary Effect of network-based HIV self-test promotion in controlling transmission among MSM Number of infections identified from the agent-based model Through study completion, at year 2
Secondary Proportion and characteristics of promoters Promoters are testers giving an SUS score of at least 80 Through study completion, at year 2
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