MedPath

Blued Pilot App in China

Completed
Conditions
Pre-Exposure Prophylaxis
Registration Number
NCT06647173
Lead Sponsor
Emory University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
423
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Feasibility of Blued+ in China12 months after intervention

The intervention will be determined to be feasible if a minimum proportion of participants receive services for home HIV testing (benchmark ≥30%), and PrEP prescription (benchmark ≥20%)

Acceptability of Blued+ in China12 months after intervention

The intervention will be considered acceptable if it reaches a systems usability scale rating benchmark score of 'good' (≥71 out of 100) and Likert component mean rating benchmark of 'acceptable' (≥3 out of 5).

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

BlueD

🇨🇳

Beijing, China

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