Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-25 @ 9:15 PM
Study NCT ID:
NCT04426656
Status:
COMPLETED
Last Update Posted:
2022-03-02
First Post:
2020-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Development of a Mobile-based App to Increase Uptake of Pre-Exposure Prophylaxis (PrEP) by Men Who Have Sex With Men in China
Sponsor:
University of North Carolina, Chapel Hill
Organization:
Study Overview
Official Title:
IGHID 12001 - The Development of a Mobile-based App to Increase Uptake of Pre-Exposure Prophylaxis (PrEP) by Men Who Have Sex With Men in China
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to use a mini-application on the popular Chinese social media mobile platform, WeChat, to improve HIV pre-exposure prophylaxis (PrEP) uptake among at-risk men who have sex with men (MSM). UNC investigators will work in close partnership with a well-established HIV special hospital and the local MSM community to understand key barriers to PrEP use, and develop a mobile-based intervention to increase PrEP uptake among young MSM in Guangzhou, China.
Detailed Description:
This study includes two parts. Before the start of Part 1, a mini-app prototype for promoting HIV pre-exposure prophylaxis (PrEP) uptake will have been developed from a prior MSM community-driven hackathon contest. PrEP is an antiretroviral medicines-based prevention strategy against HIV infection, which has been proved save and effective.
Part 1 includes in-depth interviews with 40 HIV-negative young MSM (18 and above) with a brief survey to collect demographic data. The interview topics include PrEP-related perceptions and feedback on the design of a mini-app prototype. Findings from Part 1 will inform refining the mini-app before the start of Part 2.
In Part 2, a small two-arm randomized control trial with 70 young MSM (18 and above) will be conducted to evaluate the preliminary efficacy of the mini-app in improving PrEP-related perceptions and actual PrEP uptake, compared to a control group of standard of care.
Participants in Part 2 will be followed up for 12 weeks (8 week intervention and after-intervention follow-up at 12th week). A subgroup of participants (n=15) from both the intervention arm and the control arm will receive two rounds of in-depth interviews, separately at the 4th and 8th week, to share their experience of using the app and changed perceptions and/or behaviors related to PrEP.
Part 1 includes in-depth interviews with 40 HIV-negative young MSM (18 and above) with a brief survey to collect demographic data. The interview topics include PrEP-related perceptions and feedback on the design of a mini-app prototype. Findings from Part 1 will inform refining the mini-app before the start of Part 2.
In Part 2, a small two-arm randomized control trial with 70 young MSM (18 and above) will be conducted to evaluate the preliminary efficacy of the mini-app in improving PrEP-related perceptions and actual PrEP uptake, compared to a control group of standard of care.
Participants in Part 2 will be followed up for 12 weeks (8 week intervention and after-intervention follow-up at 12th week). A subgroup of participants (n=15) from both the intervention arm and the control arm will receive two rounds of in-depth interviews, separately at the 4th and 8th week, to share their experience of using the app and changed perceptions and/or behaviors related to PrEP.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01AI114310 | NIH | None | https://reporter.nih.gov/quic… | View |