The Blued+ Combination HIV Prevention Pilot Study in China

NCT06647173 | Completed Results

• 2 other identifiers: IRB00116983R01AI143875
• Study Type: observational
• Target: 423
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pre-Exposure Prophylaxis

Keywords

HIV Prevention; HIV Testing; Condom use; MSM; Dating Mobile Application

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Blued App

A three-month run-in period with the standard of care followed by the Blued+ intervention with participants for 12 months.

Behavioral: Blued+ Service Platform

Interventions

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.

Blued App

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Emory University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• BlueD China: collaborator

Study Sites (1)

BlueD

Beijing, China

Location

Related Publications (1)

• 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.

  PMID: 41021915 DERIVED

Limitations and Caveats

This was a pilot study with a single arm.

Results Point of Contact

• Title: Dr. Aaron Siegler
• Organization: Emory University

asiegle@emory.edu

404-712-9733

Study Officials

• Aaron Siegler, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 17, 2024
• Study Start: July 15, 2022
• Primary Completion: December 12, 2023
• Study Completion: February 28, 2024
• Last Updated: July 16, 2025
• Results First Posted: July 16, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)