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NCT Number: NCT06647173

The Blued+ Combination HIV Prevention Pilot Study in China

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.

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Key information

Conditions

Pre-exposure Prophylaxis

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

BlueD

Beijing, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • Additional Inclusion criteria apply for PrEP

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.
  • Additional Inclusion criteria apply for PrEP

Treatment and study plan

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.

Primary outcomes

  1. 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+

  2. 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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • BlueD China
  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

Integrating a Combination HIV Prevention Intervention Into a Widely-Used Geosocial App for Chinese MSM: Pilot Study

Acronym: Blued+

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Oct 17, 2024
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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