HivNCT06189729
Facilitating Routine HIV Testing Among MSM by a Subscription-based Self-test Distribution Model
A study testing Text reminder and HIV self-test in people with Hiv, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The goal of this stepped wedge trial is to assess if a subscription-based HIV self-test distribution model could facilitate routine HIV testing in the men who have sex with men community. 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
- What is being tested?
- Text reminder and HIV self-test
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Jan 2024to 29 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- be aged 18 years or above
- be biologically male
- have ever had sex with another men
- have more than 1 male sex partners in the past 6 months
- normally reside in Hong Kong
- be able to communicate in written and spoken Chinese or English
Who cannot join
- previously HIV diagnosis
- unable or unwilling to give informed consent, to complete the questionnaires, to receive text messages as scheduled and when necessary, and to provide the mobile phone number to receive text messages for reminders and delivery notices
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Facilitating Routine HIV Testing Among MSM by a Subscription-based HIV Self-test Distribution Model: a Stepped Wedge Randomised Controlled Trial
The goal of this stepped wedge trial is to assess if a subscription-based HIV self-test distribution model could facilitate routine HIV testing in the men who have sex with men community. The main questions it aims to answer are the effectiveness of the model in enhancing routine HIV testing and its acceptability in the community. The 1-year observation period would be divided into control and intervention period. Participants will be reminded to get HIV tested via instant messaging apps or short message service during the control period. During the intervention period, the researchers will deliver an HIV self-test to the participants. Researchers will compare the testing rate between the two periods to see if the intervention can facilitate HIV testing.
Read the detailed description
Participants would be assigned randomly to a sequence group and crossed over from the control to intervention. In this study, the 1-year observation period is divided into four three-month intervals. All sequences would start with a control period. The three sequences would cross over to the intervention at Month 3, 6, and 9, respectively. All participants would therefore eventually receive intervention. The investigators adopt an mHealth approach for both control and intervention. Based on the results of a previous study that text messages through short message service (SMS) and instant messing (IM) apps are acceptable and feasible in promoting HIV self-management, participants during the control period would receive trimonthly text reminders through their designated IM app or SMS. The message would invite them to get HIV tested with free VCT service provider information. After 14 days, a follow-up message with the link to an online survey would be sent to enquire whether the participants had been tested or not. Participants during the intervention period would receive a trimonthly text messages asking them to choose a pickup point run by the delivery company to collect the free HIVST. Upon receiving the delivery instruction, the HIVST with bilingual (Chinese and English) instructions would be delivered to the designated location. Participants would be asked to perform the self-test and return the photographed result within 14 days. Similarly, after 14 days, a follow-up message with the link to an online survey would be sent to ask them to upload the photo of the test result. The uploaded images would be verified by the research team who are experienced in reading HIVST results both online and offline. Follow-up confirmation testing and medical service referral would be offered if the result was indeterminate or suspected to be positive. If the results were not returned after 14 days, an exit survey would be sent to the participants through IM apps or SMS.
- Conditions
- Hiv
- Being tested
- Text reminder, HIV self-test
- Keywords
- men who have sex with men, hiv self-test
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text reminderBehavioural
Participants will receive trimonthly text reminders through instant messaging mobile applications or short message service.
HIV self-testBehavioural
Participants will receive trimonthly text messages asking them to choose a pickup point run by the delivery company to collect the free HIV self-test. Upon receiving the delivery instruction, the self-test kit with bilingual (Chinese and English) instructions would be delivered to the designated location.
| Study group | Role | What they receive |
|---|---|---|
| Cluster 1 | Other | Participants will receive text reminders at Month 0 only. They will receive an HIV self-test at Months 3, 6, 9 and 12, upon submission of the self-test result. Receives: Behavioral: Text reminder; Behavioral: HIV self-test |
| Cluster 2 | Other | Participants will receive text reminders at Months 0 and 3. They will receive an HIV self-test at Months 6, 9 and 12, upon submission of the self-test result. Receives: Behavioral: Text reminder; Behavioral: HIV self-test |
| Cluster 3 | Other | Participants will receive text reminders at Months 0, 3 and 6. They will receive an HIV self-test at Months 9 and 12, upon submission of the self-test result. Receives: Behavioral: Text reminder; Behavioral: HIV self-test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of HIV tests performed with result returned
Number of HIV self-test results returned divided by the total number of HIV self-tests delivered
Measured: Month 3 to Month 12
Retention rate
Proportion of participants completed the questionnaire at Month 12
Measured: Month 12
Secondary outcomes (5)
HIV incidence
Dividing the number of laboratory confirmed HIV-positive results by the total number of person-years
Measured: Month 3 to Month 12
Linkage to care rate
The proportion of tests requiring further confirmation and medical service referral.
Measured: Month 3 to Month 12
Single ease question
In a scale of 1-7, how easy or difficult was the task was?
Measured: Month 3 to Month 12
Net promoter score
In a scale of 0-10, how likely would the participant recommend this model to their peers?
Measured: Month 3 to Month 12
System usability scale
There are ten 5-point Likert scale questions. The scores would be summed and multiply by a factor of 2.5 according to the formula to come up with the score between 0 to 100.
Measured: Month 3 to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start15 Jan 2024
- Primary completion18 Dec 2025
- Study completion29 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a stepped wedge trial. In this study, the 1-year observation period is divided into four three-month intervals. All sequences would start with a control period. The three sequences would cross over to the intervention at Month 3, 6, and 9, respectively. All participants would therefore eventually receive intervention.
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tsz Ho Kwan, Chinese University of Hong Kong
- Investigators
- Tsz Ho Kwan, PhD, Principal investigator, Jockey Club School of Public Health and Primary Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189729
- Sponsor's protocol ID
- 22-0406
- Status last verified
- Mar 2026
- First submitted
- 21 Nov 2023
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating Routine HIV Testing Among MSM by a Subscription-based HIV Self-test Distribution Model: a Stepped Wedge Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06189729
- Acronym / sponsor ID
- 22-0406
- Conditions
- Hiv
- Keywords
- men who have sex with men, hiv self-test
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 18 Dec 2025 (actual)
- Study completion
- 29 Nov 2026 (estimated)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this stepped wedge trial is to assess if a subscription-based HIV self-test distribution model could facilitate routine HIV testing in the men who have sex with men community. The main questions it aims to answer are the effectiveness of the model in enhancing routine HIV testing and its acceptability in the community. The 1-year observation period would be divided into control and intervention period. Participants will be reminded to get HIV tested via instant messaging apps or short message service during the control period. During the intervention period, the researchers will deliver an HIV self-test to the participants. Researchers will compare the testing rate between the two periods to see if the intervention can facilitate HIV testing.
Detailed description
Participants would be assigned randomly to a sequence group and crossed over from the control to intervention. In this study, the 1-year observation period is divided into four three-month intervals. All sequences would start with a control period. The three sequences would cross over to the intervention at Month 3, 6, and 9, respectively. All participants would therefore eventually receive intervention. The investigators adopt an mHealth approach for both control and intervention. Based on the results of a previous study that text messages through short message service (SMS) and instant messing (IM) apps are acceptable and feasible in promoting HIV self-management, participants during the control period would receive trimonthly text reminders through their designated IM app or SMS. The message would invite them to get HIV tested with free VCT service provider information. After 14 days, a follow-up message with the link to an online survey would be sent to enquire whether the participants had been tested or not. Participants during the intervention period would receive a trimonthly text messages asking them to choose a pickup point run by the delivery company to collect the free HIVST. Upon receiving the delivery instruction, the HIVST with bilingual (Chinese and English) instructions would be delivered to the designated location. Participants would be asked to perform the self-test and return the photographed result within 14 days. Similarly, after 14 days, a follow-up message with the link to an online survey would be sent to ask them to upload the photo of the test result. The uploaded images would be verified by the research team who are experienced in reading HIVST results both online and offline. Follow-up confirmation testing and medical service referral would be offered if the result was indeterminate or suspected to be positive. If the results were not returned after 14 days, an exit survey would be sent to the participants through IM apps or SMS.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a stepped wedge trial. In this study, the 1-year observation period is divided into four three-month intervals. All sequences would start with a control period. The three sequences would cross over to the intervention at Month 3, 6, and 9, respectively. All participants would therefore eventually receive intervention.
| Arm | Type | Receives |
|---|---|---|
| Cluster 1 | Other | Behavioral: Text reminder, Behavioral: HIV self-testParticipants will receive text reminders at Month 0 only. They will receive an HIV self-test at Months 3, 6, 9 and 12, upon submission of the self-test result. |
| Cluster 2 | Other | Behavioral: Text reminder, Behavioral: HIV self-testParticipants will receive text reminders at Months 0 and 3. They will receive an HIV self-test at Months 6, 9 and 12, upon submission of the self-test result. |
| Cluster 3 | Other | Behavioral: Text reminder, Behavioral: HIV self-testParticipants will receive text reminders at Months 0, 3 and 6. They will receive an HIV self-test at Months 9 and 12, upon submission of the self-test result. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- be aged 18 years or above
- be biologically male
- have ever had sex with another men
- have more than 1 male sex partners in the past 6 months
- normally reside in Hong Kong
Key exclusion criteria (2 listed)
- previously HIV diagnosis
- unable or unwilling to give informed consent, to complete the questionnaires, to receive text messages as scheduled and when necessary, and to provide the mobile phone number to receive text messages for reminders and delivery notices
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text reminderParticipants will receive trimonthly text reminders through instant messaging mobile applications or short message service. | Behavioural | Cluster 1, Cluster 2, Cluster 3 |
| HIV self-testParticipants will receive trimonthly text messages asking them to choose a pickup point run by the delivery company to collect the free HIV self-test. Upon receiving the delivery instruction, the self-test kit with bilingual (Chinese and English) instructions would be delivered to the designated location. | Behavioural | Cluster 1, Cluster 2, Cluster 3 |
Primary outcome
Proportion of HIV tests performed with result returned
Time frame: Month 3 to Month 12
Number of HIV self-test results returned divided by the total number of HIV self-tests delivered
Retention rate
Time frame: Month 12
Proportion of participants completed the questionnaire at Month 12
5 secondary outcomes
HIV incidence
Time frame: Month 3 to Month 12
Linkage to care rate
Time frame: Month 3 to Month 12
Single ease question
Time frame: Month 3 to Month 12
Net promoter score
Time frame: Month 3 to Month 12
System usability scale
Time frame: Month 3 to Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tsz Ho Kwan, PhD principal investigator
Jockey Club School of Public Health and Primary Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text reminder and HIV self-test in people with Hiv, 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 6 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: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Proportion of HIV tests performed with result returned (time frame: Month 3 to Month 12). 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?
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 19 Mar 2026.