Pre-Exposure ProphylaxisBlued+NCT06647173
The Blued+ Combination HIV Prevention Pilot Study in China
An observational study of Pre-Exposure Prophylaxis, run by Emory University at 1 site in China.
Trial summary
The proposed research includes a longitudinal pilot study to assess the feasibility and acceptability of Blued+. This combination HIV prevention intervention will integrate a combination package of HIV prevention services into Blued, a gay dating App, for men who have sex with men (MSM) in China. 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
- Pre-Exposure Prophylaxis
- What is being tested?
- Blued+ Service Platform
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 423 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2022to 28 Feb 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: The study population includes registered Blued users who self-report male sex at birth, are age 18 years or older, who report anal sex with a man in the past 6 months, behaviorally eligible for PrEP, and who do not report an HIV diagnosis. Eligible men will be residents of metropolitan areas of Beijing or Chengdu, China.
Who may be able to join
- Registered Blued app user
- ≥18 years of age
- Male sex at birth
- Self-report anal sex with a man in the last 6 months
- HIV-negative or unknown HIV status
- Behaviorally eligible for PrEP per published China guidance
Show all 10Show fewer
- Able to complete study instruments in Mandarin Chinese
- Resident of the metropolitan area of Beijing or Chengdu, China
- Eligible for PrEP based on China's consensus statement
- Additional Inclusion criteria apply for PrEP
Who cannot join
- Not a registered Blued app user
- <18 years of age
- Not male sex at birth
- Does not report anal sex with a man in the last 6 months
- Has previously tested positive for HIV
- Not eligible for PrEP per published China guidance
Show all 11Show fewer
- Unable to complete study instruments in Mandarin Chinese
- Not a resident of the metropolitan area of Beijing or Chengdu, China
- Currently enrolled in another HIV prevention study
- Evidence of fraudulent participation, such as a duplicate IP address, multiple screening attempts, duplicate emails, etc.
- Additional Inclusion criteria apply for PrEP
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrating a Combination HIV Prevention Intervention Into a Widely-Used Geosocial App for Chinese MSM: Pilot Study
The proposed research includes a longitudinal pilot study to assess the feasibility and acceptability of Blued+. This combination HIV prevention intervention will integrate a combination package of HIV prevention services into Blued, a gay dating App, for men who have sex with men (MSM) in China.
Despite high HIV incidence among MSM, HIV prevention interventions such as pre-exposure prophylaxis (PrEP) use remains low in China. If the HIV prevention intervention services provided through the Blued+ App prove feasible and acceptable, the pilot test will facilitate the design of a larger study of intervention efficacy.
The study population will be self-reported HIV-negative Blued users who are 18 years of age or greater, were assigned a male sex at birth, report having anal sex with a man in the last 6 months, eligible for PrEP according to China's consensus statement, and reside in metropolitan Beijing or Chengdu, China.
Read the detailed description
The pilot study will be an interrupted time series cohort of 400 MSM. In two cities, a three-month baseline standard of care (SOC) period with measurement at 0 and 3 months will be followed by a 12-month intervention period with the measurement at 6, 9, 12, and 15 months.
During the intervention, enrolled study participants will take surveys every 3 months, as well as have free access to the enhanced version of the Blued App, Blued+, which additionally provides HIV prevention intervention services such as HIV health messages, PrEP drugs, at-home HIV self-testing kits, condoms, and lubricants for no costs. Participants interested in PrEP will be required to have additional PrEP initiation physical exam clinical visits, follow-up clinical visits, and dry blood spot collection lab visits for blood PrEP level measurements.
The total study period is 15 months (3 months control run-in period and 12 months intervention). Online surveys are provided over the study period, 2 for the enrollment and basement, and 4 follow-ups for every 3 months of the intervention; physical exam visits are required for participants who chose to initiate and refill PrEP; 1 dry blood spot collection visit is provided for participants who chose to measure blood PrEP level.
The participants will be recruited online through the Blued App.
- Conditions
- Pre-Exposure Prophylaxis
- Being tested
- Blued+ Service Platform
- Keywords
- HIV Prevention, HIV Testing, Condom use, MSM, Dating Mobile Application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blued+ Service PlatformBehavioural
During the intervention period, participants received the enhanced version of the Blued app. The free HIV prevention services were integrated into the Blued app: health messaging, in-home HIV testing, linkage to care for those testing HIV positive, condoms, lubricants, in-app screening, and provision to PrEP.
| Study group | Role | What they receive |
|---|---|---|
| Blued App | A three-month run-in period with the standard of care followed by the Blued+ intervention with participants for 12 months. Receives: Behavioral: Blued+ Service Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Blued+ in China
The intervention will be determined to be feasible if a minimum proportion of participants receive services for home HIV testing (benchmark ≥30%) and PrEP initiation (benchmark ≥20%) through Blued+
Measured: 12 months after intervention initiation, 15 months after first study interaction
System Usability Scale (SUS)
Acceptability of Blued+ in China will be measured using the System Usability Scale (SUS). The SUS is a widely used scale that evaluates the usability of products and systems through a 10-item question set. The total range of a score on this scale is 0 to 100. This scale does not have any sub-scales. Higher scores on this scale represent higher levels of intervention usability, with 100 being the highest usability and 0 being the lowest usability. Information on this scale and how to calculate values is found in: Bangor, Aaron, Philip T. Kortum, and James T. Miller. "An empirical evaluation of the system usability scale." Intl. Journal of Human-Computer Interaction 24.6 (2008): 574-594.
The intervention will be considered acceptable if it reaches a total SUS rating score of ≥ 71/100, which has been interpreted as being 'good' usability.
Measured: 12 months after intervention initiation, 15 months after first study interaction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start15 Jul 2022
- Primary completion12 Dec 2023
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pre-Exposure ProphylaxisStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 423 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), BlueD China
- Responsible party
- Principal investigator, Aaron Siegler, Emory University
- Investigators
- Aaron Siegler, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06647173
- Sponsor's protocol ID
- IRB00116983
- Other IDs
- R01AI143875
- Acronym
- Blued+
- Status last verified
- Jun 2025
- First submitted
- 16 Oct 2024
- Last updated
- 16 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang W, Ning K, Koh SHE, Mi G, Yu F, Liu Y, Stegmueller D, Powers KA, Baral S, Sullivan PS, Siegler AJ. Integrating a Combination HIV Prevention Intervention Into a Widely Used Geosocial App for Chinese Men Who Have Sex With Men: Protocol for a Single-Arm Pilot and Repeated Cross-Sectional Study. JMIR Res Protoc. 2025 Sep 29;14:e69536. doi: 10.2196/69536.
PubMed 41021915
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating a Combination HIV Prevention Intervention Into a Widely-Used Geosocial App for Chinese MSM: Pilot Study
- ClinicalTrials.gov ID
- NCT06647173
- Acronym / sponsor ID
- Blued+ / IRB00116983
- Conditions
- Pre-Exposure Prophylaxis
- Keywords
- HIV Prevention, HIV Testing, Condom use, MSM, Dating Mobile Application
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 423 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), BlueD China
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 17 Oct 2024 (actual)
- Results
- Posted 16 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed research includes a longitudinal pilot study to assess the feasibility and acceptability of Blued+. This combination HIV prevention intervention will integrate a combination package of HIV prevention services into Blued, a gay dating App, for men who have sex with men (MSM) in China.
Despite high HIV incidence among MSM, HIV prevention interventions such as pre-exposure prophylaxis (PrEP) use remains low in China. If the HIV prevention intervention services provided through the Blued+ App prove feasible and acceptable, the pilot test will facilitate the design of a larger study of intervention efficacy.
The study population will be self-reported HIV-negative Blued users who are 18 years of age or greater, were assigned a male sex at birth, report having anal sex with a man in the last 6 months, eligible for PrEP according to China's consensus statement, and reside in metropolitan Beijing or Chengdu, China.
Detailed description
The pilot study will be an interrupted time series cohort of 400 MSM. In two cities, a three-month baseline standard of care (SOC) period with measurement at 0 and 3 months will be followed by a 12-month intervention period with the measurement at 6, 9, 12, and 15 months.
During the intervention, enrolled study participants will take surveys every 3 months, as well as have free access to the enhanced version of the Blued App, Blued+, which additionally provides HIV prevention intervention services such as HIV health messages, PrEP drugs, at-home HIV self-testing kits, condoms, and lubricants for no costs. Participants interested in PrEP will be required to have additional PrEP initiation physical exam clinical visits, follow-up clinical visits, and dry blood spot collection lab visits for blood PrEP level measurements.
The total study period is 15 months (3 months control run-in period and 12 months intervention). Online surveys are provided over the study period, 2 for the enrollment and basement, and 4 follow-ups for every 3 months of the intervention; physical exam visits are required for participants who chose to initiate and refill PrEP; 1 dry blood spot collection visit is provided for participants who chose to measure blood PrEP level.
The participants will be recruited online through the Blued App.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blued App | – | Behavioral: Blued+ Service PlatformA three-month run-in period with the standard of care followed by the Blued+ intervention with participants for 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes registered Blued users who self-report male sex at birth, are age 18 years or older, who report anal sex with a man in the past 6 months, behaviorally eligible for PrEP, and who do not report an HIV diagnosis. Eligible men will be residents of metropolitan areas of Beijing or Chengdu, China.
Key inclusion criteria (10 listed)
- Registered Blued app user
- ≥18 years of age
- Male sex at birth
- Self-report anal sex with a man in the last 6 months
- HIV-negative or unknown HIV status
Key exclusion criteria (11 listed)
- Not a registered Blued app user
- <18 years of age
- Not male sex at birth
- Does not report anal sex with a man in the last 6 months
- Has previously tested positive for HIV
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 |
|---|---|---|
| Blued+ Service PlatformDuring the intervention period, participants received the enhanced version of the Blued app. The free HIV prevention services were integrated into the Blued app: health messaging, in-home HIV testing, linkage to care for those testing HIV positive, condoms, lubricants, in-app screening, and provision to PrEP. | Behavioural | Blued App |
Primary outcome
Feasibility of Blued+ in China
Time frame: 12 months after intervention initiation, 15 months after first study interaction
The intervention will be determined to be feasible if a minimum proportion of participants receive services for home HIV testing (benchmark ≥30%) and PrEP initiation (benchmark ≥20%) through Blued+
System Usability Scale (SUS)
Time frame: 12 months after intervention initiation, 15 months after first study interaction
Acceptability of Blued+ in China will be measured using the System Usability Scale (SUS). The SUS is a widely used scale that evaluates the usability of products and systems through a 10-item question set. The total range of a score on this scale is 0 to 100. This scale does not have any sub-scales. Higher scores on this scale represent higher levels of intervention usability, with 100 being the highest usability and 0 being the lowest usability. Information on this scale and how to calculate values is found in: Bangor, Aaron, Philip T. Kortum, and James T. Miller. "An empirical evaluation of the system usability scale." Intl. Journal of Human-Computer Interaction 24.6 (2008): 574-594. The intervention will be considered acceptable if it reaches a total SUS rating score of ≥ 71/100, which has been interpreted as being 'good' usability.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41021915Huang W, Ning K, Koh SHE, Mi G, Yu F, Liu Y, Stegmueller D, Powers KA, Baral S, Sullivan PS, Siegler AJ. Integrating a Combination HIV Prevention Intervention Into a Widely Used Geosocial App for Chinese Men Who Have Sex With Men: Protocol for a Single-Arm Pilot and Repeated Cross-Sectional Study. JMIR Res Protoc. 2025 Sep 29;14:e69536. doi: 10.2196/69536.
- 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.
Aaron Siegler, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-Exposure Prophylaxis, run by Emory University 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 10 inclusion and 11 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: finished, as of the sponsor's last update on 16 Jul 2025. 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. 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?
Yes. Results are posted in the registry (first posted 16 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Feasibility of Blued+ in China (time frame: 12 months after intervention initiation, 15 months after first study interaction). 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?
On the ClinicalTrials.gov record for NCT06647173, 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 16 Jul 2025.