Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:03 PM
Study NCT ID:
NCT07213258
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-08
First Post:
2025-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CHAMPION: Combining HIV And Meth Prevention and Treatment Interventions Optimized for HIV-Negative MSM
Sponsor:
University of California, San Diego
Organization:
Study Overview
Official Title:
CHAMPION: Combining HIV And Meth Prevention and Treatment Interventions Optimized for HIV-Negative MSM
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-10
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:
CHAMPION
Brief Summary:
The goal of this randomized controlled trial is to pilot test new mobile health (mHealth) interventions to improve PrEP adherence among HIV-negative men who have sex with men (MSM) with mild to moderate methamphetamine use disorder (MUD). The CHAMPION intervention combines two mHealth tools-PrEPAPP and CBT4CBT-to address both HIV prevention and MUD treatment needs in this population. The study's specific aims are:
* To evaluate the feasibility and acceptability of the CHAMPION intervention based on treatment retention and engagement rates.
* To examine the preliminary efficacy the CHAMPION intervention to improve PrEP adherence, as measured by dried blood spot (DBS) tests compared to the waitlist control group.
* To evaluate the feasibility and acceptability of the CHAMPION intervention based on treatment retention and engagement rates.
* To examine the preliminary efficacy the CHAMPION intervention to improve PrEP adherence, as measured by dried blood spot (DBS) tests compared to the waitlist control group.
Detailed Description:
The CHAMPION (Combining HIV And Meth Prevention and Treatment Interventions Optimized for HIV-Negative MSM) study, a randomized controlled trial that aims to pilot test state-of-the-art multi-modal pharmaco-behavioral interventions to increase PrEP adherence among HIV-negative MSM who use meth, versus a waitlist control. The study will enroll 100 HIV-negative MSM with mild or moderate meth use disorder (MUD) and sub-optimal PrEP adherence. The study will follow participants for 6 months. The intervention arm will receive the 6-month mHealth intervention package, CHAMPION, at baseline, while the waitlist control will receive it at month-3 follow-up. Results of this pilot study will determine the viability of combining interventions that reduce meth use and enhance PrEP adherence, informing the direction of future interventions for MSM who use meth.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R21DA060856 | NIH | None | https://reporter.nih.gov/quic… | View |