The Blued+ Combination HIV Prevention Pilot Study in China

Completed

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

Inclusion Criteria

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 Outcome Measures

Name	Time	Method
Feasibility of Blued+ in China	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+
System Usability Scale (SUS)	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.

Secondary Outcome Measures