The Blued+ Combination HIV Prevention Pilot Study in China

NCT ID: NCT06647173

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 423 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-15
• Study Completion Date: 2024-02-28

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

BlueD China

UNKNOWN

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Aaron Siegler

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aaron Siegler, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

BlueD

Beijing, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 41021915 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

R01AI143875

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00116983

Identifier Type: -

Identifier Source: org_study_id