HIV/AIDSonline-RASSLNCT03320239
Using HIV Risk Assessment Tool to Promote HIV Testing Among Men Who Have Sex With Men
A study testing HIV risk assessment and tailored suggestions and HIV risk behavior assessment in people with HIV/AIDS and HIV Infections, run by National Center for AIDS/STD Control and Prevention, China CDC at 1 site in China.
Trial summary
The objective of the study is to evaluate the effectiveness of a HIV risk assessment tool to promote HIV testing and to reduce high risk sexual behaviors among men who have sex with men (MSM). Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS, HIV Infections, Social Media
- What is being tested?
- HIV risk assessment and tailored suggestions and HIV risk behavior assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4,500 participants
- Where
- 1 siteChina
- Study dates
- 12 Oct 2017to May 2018
- 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 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male at birth.
- Having had homo-sexual behaviors (anal/oral) in the past 6 months before enrollment.
- An age of 18 years or older.
- Living in Beijing, China.
- Self-reporting HIV negative or unknown.
- Willingly participating into the baseline survey and the six months follow ups.
- Agreeing not to share the research link to others.
- Owning a mobile phone and having had downloaded the social networking Application Blued before enrollment.
Who cannot join
- Not accepting blood sampling within the study period.
- Reporting injecting drugs use in the past six months before enrollment.
- Being currently involved in other HIV behavioral interventions for MSM.
- Having a specific plan to leave from Beijing in the next 6 months.
- Self-reporting female.
- Other reasons the investigators deem make participation either detrimental to the participants or the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
national center for AIDS control and prevention
Beijing, Beijing Municipality, 10026
Zunyou Wu, PHD, 010-58900946, wuzy@263.net
About this study
Official title: Using HIV Risk Assessment Tool to Promote HIV Testing Among Men Who Have Sex With Men in Beijing: a Social Media-based Randomized Trial
The objective of the study is to evaluate the effectiveness of a HIV risk assessment tool to promote HIV testing and to reduce high risk sexual behaviors among men who have sex with men (MSM). It hypothesizes that the social media-based HIV risk assessment tool can increase 20% HIV testing proportion during the six months follow-up period.
- Conditions
- HIV/AIDS, HIV Infections, Social Media
- Being tested
- HIV risk assessment and tailored suggestions, HIV risk behavior assessment, placebo control
- Keywords
- HIV, risk assessment, HIV testing, unprotected anal intercourse, Social medica
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV risk assessment and tailored suggestionsBehavioural
The intervention contains: HIV risk investigation, tailored suggestions and free HIV testing link
HIV risk behavior assessmentBehavioural
It only contains HIV risk behavior assessment and routine education
placebo controlBehavioural
It only contains HIV/AIDS knowledge assessment and routine education
| Study group | Role | What they receive |
|---|---|---|
| the online-RASSL intervention group | Experimental | HIV risk assessment and tailored suggestions, free HIV testing link Receives: Behavioral: HIV risk assessment and tailored suggestions |
| intervention group 2 | Experimental | HIV risk behavior investigation and routine education Receives: Behavioral: HIV risk behavior assessment |
| the control group | Placebo comparator | The placebo control: HIV/AIDS knowledge assessment, routine education Receives: Behavioral: placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of HIV testing during the study period
The numerator is the number of participants who come to the specific HIV testing clinics for HIV test during the study period, the denominator is the number of participants randomized per group.
Measured: 1 month
Secondary outcomes (2)
unprotected anal intercourse
Questionaire will be used to collect the frequency of unprotected anal intercourse at month 1, month 3 and month 6 after the study starts.
Measured: 6 months
Post exposure prophylaxis (PEP)
Questionaire will be used to collect data on whether participants use PEP at month 1, month 3 and month 6.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start12 Oct 2017
- Primary completionMay 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 4,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Center for AIDS/STD Control and Prevention, China CDC
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Wu Z You, PhD, Study director, NATIONAL CENTER FOR HIV/STD CONTROL AND PREVENTION
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03320239
- Sponsor's protocol ID
- risk assessment
- Acronym
- online-RASSL
- Status last verified
- Oct 2017
- First submitted
- 17 Oct 2017
- Last updated
- 25 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Luo Q, Wu Z, Mi G, Xu J, Scott SR. Using HIV Risk Self-Assessment Tools to Increase HIV Testing in Men Who Have Sex With Men in Beijing, China: App-Based Randomized Controlled Trial. J Med Internet Res. 2023 Sep 1;25:e45262. doi: 10.2196/45262.
PubMed 37656500
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using HIV Risk Assessment Tool to Promote HIV Testing Among Men Who Have Sex With Men in Beijing: a Social Media-based Randomized Trial
- ClinicalTrials.gov ID
- NCT03320239
- Acronym / sponsor ID
- online-RASSL / risk assessment
- Conditions
- HIV/AIDS, HIV Infections, Social Media
- Keywords
- HIV, risk assessment, HIV testing, unprotected anal intercourse, Social medica
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,500 participants (estimated)
- Lead sponsor
- National Center for AIDS/STD Control and Prevention, China CDCOther government
- Study start
- 12 Oct 2017 (actual)
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 25 Oct 2017 (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 objective of the study is to evaluate the effectiveness of a HIV risk assessment tool to promote HIV testing and to reduce high risk sexual behaviors among men who have sex with men (MSM). It hypothesizes that the social media-based HIV risk assessment tool can increase 20% HIV testing proportion during the six months follow-up period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| the online-RASSL intervention group | Experimental | Behavioral: HIV risk assessment and tailored suggestionsHIV risk assessment and tailored suggestions, free HIV testing link |
| intervention group 2 | Experimental | Behavioral: HIV risk behavior assessmentHIV risk behavior investigation and routine education |
| the control group | Placebo comparator | Behavioral: placebo controlThe placebo control: HIV/AIDS knowledge assessment, routine education |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male at birth.
- Having had homo-sexual behaviors (anal/oral) in the past 6 months before enrollment.
- An age of 18 years or older.
- Living in Beijing, China.
- Self-reporting HIV negative or unknown.
Key exclusion criteria (6 listed)
- Not accepting blood sampling within the study period.
- Reporting injecting drugs use in the past six months before enrollment.
- Being currently involved in other HIV behavioral interventions for MSM.
- Having a specific plan to leave from Beijing in the next 6 months.
- Self-reporting female.
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 |
|---|---|---|
| HIV risk assessment and tailored suggestionsThe intervention contains: HIV risk investigation, tailored suggestions and free HIV testing link | Behavioural | the online-RASSL intervention group |
| HIV risk behavior assessmentIt only contains HIV risk behavior assessment and routine education | Behavioural | intervention group 2 |
| placebo controlIt only contains HIV/AIDS knowledge assessment and routine education | Behavioural | the control group |
Primary outcome
The proportion of HIV testing during the study period
Time frame: 1 month
The numerator is the number of participants who come to the specific HIV testing clinics for HIV test during the study period, the denominator is the number of participants randomized per group.
2 secondary outcomes
unprotected anal intercourse
Time frame: 6 months
Post exposure prophylaxis (PEP)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2017.
- Derived from this study: PubMed 37656500Luo Q, Wu Z, Mi G, Xu J, Scott SR. Using HIV Risk Self-Assessment Tools to Increase HIV Testing in Men Who Have Sex With Men in Beijing, China: App-Based Randomized Controlled Trial. J Med Internet Res. 2023 Sep 1;25:e45262. doi: 10.2196/45262.
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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.
Wu Z You, PhD study director
NATIONAL CENTER FOR HIV/STD CONTROL AND PREVENTION
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIV risk assessment and tailored suggestions and HIV risk behavior assessment in people with HIV/AIDS and HIV Infections, run by National Center for AIDS/STD Control and Prevention, China CDC at 1 site in China.
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 8 inclusion and 6 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 25 Oct 2017. 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 China. 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. Some participants in this study may receive a placebo. 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 Wu Z You, PhD (010-58900946, wuzy@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of HIV testing during the study period (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03320239, which also lists 1 linked publication.
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 25 Oct 2017.