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| ID | Type | Description | Link |
|---|---|---|---|
| R01AI143875 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| BlueD China | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blued App | A three-month run-in period with the standard of care followed by the Blued+ intervention with participants for 12 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blued+ Service Platform | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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+ | 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. | 12 months after intervention initiation, 15 months after first study interaction |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Aaron Siegler, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BlueD | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41021915 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Blued App | A three-month run-in period with the standard of care followed by the Blued+ intervention with participants for 12 months. Blued+ Service Platform: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Blued App | A three-month run-in period with the standard of care followed by the Blued+ intervention with participants for 12 months. Blued+ Service Platform: 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. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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+ | Participants retained at endline | Posted | Count of Participants | Participants | 12 months after intervention initiation, 15 months after first study interaction |
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Data were collected throughout the 12-month pilot study period.
Definitions do not differ from clinical trials.gov definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Blued App | A three-month run-in period with the standard of care followed by the Blued+ intervention with participants for 12 months. Blued+ Service Platform: 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. |
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This was a pilot study with a single arm.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Aaron Siegler | Emory University | 404-712-9733 | asiegle@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jul 17, 2023 | Jun 6, 2025 | Prot_SAP_ICF_000.pdf |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | 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. | Participants completing all items in the SUS scale | Posted | Mean | Standard Deviation | score on a scale | 12 months after intervention initiation, 15 months after first study interaction |
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| 423 |
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| 423 |
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| 423 |
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