Behavior, HealthNCT04434950
Promoting Repeated HIV Self-testing Among MSM in Hong Kong
A study testing Promoting and implementing repeated HIV self-testing and online real-time counseling in people with Behavior, Health, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
In this longitudinal study, we will firstly construct a cohort of HIV negative MSM, who will be exposed to an online video-based intervention promoting HIV testing in general and real-time HIV self-testing with online counselling service (HIVST-online) in particular. 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
- Behavior, Health
- What is being tested?
- Promoting and implementing repeated HIV self-testing and online real-time counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jul 2020to 31 Jul 2021
- Phase
- Interventional
- 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
Who may be able to join
- Hong Kong Chinese speaking men
- ≥18 years old
- Anal intercourse with at least one man in the last six months
- Access to online face-to-face communication tools (e.g., Line, Skype, WhatsApp)
Who cannot join
- Self-reported to be HIV positive
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Centre for Health Behaviours Research, the Chinese University of Hong Kong
Hong Kong, 666888
Zixin Wang, PhD, +852 22528740, wangzx@cuhk.edu.hk
Mary Ip, BSc, +852 22528724, mitk@cuhk.edu.hk
About this study
Official title: A Longitudinal Study for Promotion and Implementation of Repeated HIV Self-testing With Online Real-time Counseling
In this longitudinal study, we will firstly construct a cohort of HIV negative MSM, who will be exposed to an online video-based intervention promoting HIV testing in general and real-time HIV self-testing with online counselling service (HIVST-online) in particular. Participants will receive intervention at baseline, Month 6 and Month 12.
Read the detailed description
500 MSM will be recruited via venue-based, online outreach, and NGO referrals. At baseline, Month 6 and Month 12, participants received online intervention promoting HIV testing in general and HIV testing with online real-time counseling service. Free HIV self-testing kits will be mailed to participants at baseline, Month 6 and Month 12. Upon appointment, a testing administrator will provide online real-time pre-test and post-test counseling service for HIV self-testing users.
- Conditions
- Behavior, Health
- Being tested
- Promoting and implementing repeated HIV self-testing and online real-time counseling
- Keywords
- HIV testing, HIV self-testing
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promoting and implementing repeated HIV self-testing and online real-time counselingBehavioural
At baseline, Month 6 and Month 12, participants will view an online video clip promoting the needs for HIV testing in general and HIV self-testing with online real-time counseling. A free HIV self-testing kit will be sent to participants. An HIVST administrator will provide online real-time pre-test and post-test counseling.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention group Receives: Behavioral: Promoting and implementing repeated HIV self-testing and online real-time counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV testing of any type
Taking up any type of HIV testing during the follow-up period
Measured: 14 months
Secondary outcomes (1)
HIV self-testing
Taking up HIV self-testing during the follow-up period
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start1 Jul 2020
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior, HealthStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zixin Wang, Chinese University of Hong Kong
- Investigators
- Zixin Wang, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04434950
- Sponsor's protocol ID
- MSS269R
- Status last verified
- Aug 2020
- First submitted
- 15 Jun 2020
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Study for Promotion and Implementation of Repeated HIV Self-testing With Online Real-time Counseling
- ClinicalTrials.gov ID
- NCT04434950
- Acronym / sponsor ID
- MSS269R
- Conditions
- Behavior, Health
- Keywords
- HIV testing, HIV self-testing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 17 Jun 2020 (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.
In this longitudinal study, we will firstly construct a cohort of HIV negative MSM, who will be exposed to an online video-based intervention promoting HIV testing in general and real-time HIV self-testing with online counselling service (HIVST-online) in particular. Participants will receive intervention at baseline, Month 6 and Month 12.
Detailed description
500 MSM will be recruited via venue-based, online outreach, and NGO referrals. At baseline, Month 6 and Month 12, participants received online intervention promoting HIV testing in general and HIV testing with online real-time counseling service. Free HIV self-testing kits will be mailed to participants at baseline, Month 6 and Month 12. Upon appointment, a testing administrator will provide online real-time pre-test and post-test counseling service for HIV self-testing users.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Promoting and implementing repeated HIV self-testing and online real-time counselingIntervention group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hong Kong Chinese speaking men
- ≥18 years old
- Anal intercourse with at least one man in the last six months
- Access to online face-to-face communication tools (e.g., Line, Skype, WhatsApp)
Key exclusion criteria (1 listed)
- Self-reported to be HIV positive
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 |
|---|---|---|
| Promoting and implementing repeated HIV self-testing and online real-time counselingAt baseline, Month 6 and Month 12, participants will view an online video clip promoting the needs for HIV testing in general and HIV self-testing with online real-time counseling. A free HIV self-testing kit will be sent to participants. An HIVST administrator will provide online real-time pre-test and post-test counseling. | Behavioural | Intervention |
Primary outcome
HIV testing of any type
Time frame: 14 months
Taking up any type of HIV testing during the follow-up period
1 secondary outcome
HIV self-testing
Time frame: 14 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Individual participant dataSharing planned: No
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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.
Zixin Wang principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Promoting and implementing repeated HIV self-testing and online real-time counseling in people with Behavior, Health, 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 1 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: status not confirmed, as of the sponsor's last update on 13 Aug 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zixin Wang (51669414, wangzx@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV testing of any type (time frame: 14 months). 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 13 Aug 2020.