- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04379206
Social Network Approach for Increasing Testing Coverage Among Men Who Have Sex With Men
December 19, 2021 updated by: Tsz Ho Kwan, Chinese University of Hong Kong
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
463
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Sha Tin, Hong Kong
- Stanley Ho Centre for Emerging Infectious Diseases
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Adult men who have sex with men in Hong Kong
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Men who have sex with men
MSM receiving a self-test kit with optional assistance
|
fingerprick and oral fluid HIV self-tests with optional on-site or hotline staff assistance
Gamification or neumorphism user interface
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
effectiveness of the approach in reaching MSM who have never or not recently tested for HIV
Time Frame: Through study completion, at year 2
|
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
Time Frame: Through study completion, at year 2
|
System Usability Scores (SUS) and proportion of testers giving a score of at least 71
|
Through study completion, at year 2
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determinants of key actors in the social network
Time Frame: Through study completion, at year 2
|
Network metrics predicting important actors in the referral network
|
Through study completion, at year 2
|
Preference of two forms of HIV self-testing
Time Frame: Through study completion, at year 2
|
Proportion of testers favouring each form of self-testing
|
Through study completion, at year 2
|
Effect of network-based HIV self-test promotion in controlling transmission among MSM
Time Frame: Through study completion, at year 2
|
Number of infections identified from the agent-based model
|
Through study completion, at year 2
|
Proportion and characteristics of promoters
Time Frame: Through study completion, at year 2
|
Promoters are testers giving an SUS score of at least 80
|
Through study completion, at year 2
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Valente TW. Network interventions. Science. 2012 Jul 6;337(6090):49-53. doi: 10.1126/science.1217330.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2021
Primary Completion (Actual)
May 12, 2021
Study Completion (Actual)
May 12, 2021
Study Registration Dates
First Submitted
May 2, 2020
First Submitted That Met QC Criteria
May 6, 2020
First Posted (Actual)
May 7, 2020
Study Record Updates
Last Update Posted (Actual)
January 11, 2022
Last Update Submitted That Met QC Criteria
December 19, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MSS324R (Other Grant/Funding Number: AIDS Trust Fund)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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