Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06647173
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-16
Brief Title:
Blued Pilot App in China
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Integrating a Combination HIV Prevention Intervention Into a Widely-Used Geosocial App for Chinese MSM Pilot Study
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Blued
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 Chinas consensus statement and reside in metropolitan Beijing or Chengdu 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 Chinas 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None