Clinical trial NCT06647173: Blued Pilot App in China
Official title: Integrating a Combination HIV Prevention Intervention Into a Widely-Used Geosocial App for Chinese MSM: Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pre-Exposure Prophylaxis
Keywords: HIV Prevention
HIV Testing
Condom use
MSM
Dating Mobile Application
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: BlueD China
First posted: 2024-10-17
Enrollment: 423
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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
* 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

Primary outcomes:
measure: Feasibility of Blued+ in China
timeFrame: 12 months after intervention
measure: Acceptability of Blued+ in China
timeFrame: 12 months after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: BlueD
Study officials:
affiliation: Emory University
name: Aaron Siegler, PhD
role: PRINCIPAL_INVESTIGATOR
References: